Patent Grant
10004661
The present invention pertains generally to systems and methods which are used for conducting radiation therapy. More particularly, the present invention pertains to epidermal and/or implantable patches that generate and radiate energy toward target tissue inside the body of a person for therapeutic purposes. The present invention is particularly, but not exclusively, useful for incorporation into systems and methods that are used for electromagnetic or sonic radiation therapy and that include a titration capability for monitoring in vivo cellular and gene expression responses to the sonic radiation.
The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
It is well known that human beings will physically react to sonic energy. Hearing is but one example of this phenomenon. It often happens, however, that the human reaction to sonic energy is not immediately perceptible. Instead, the perception is the result of a longer term evolutionary process. In this last category, in vivo cellular reactions and gene expressions have been attributed to the influence of sonic radiation. Of particular interest here are cellular reactions that result in a phenotypic differentiation of the target tissue.
Apart from the phenotypic cell differentiation that can result from exposure to sonic radiation, it is also known that meditative states and/or alpha brain wave/relaxation states are greatly influenced by sonic radiation. On this point, consider the effect music can have on an individual. Also, consider the effect an exposure to loud, abrasive and/or startling noises can have on an individual, regardless whether the sound is instantaneous, repetitive or continuous.
Although a wide variety of protocols for sonic radiation therapy have 5 been, and can be, proposed, it is axiomatic that for beneficial therapy, sonic radiation must be effectively directed onto the proper target tissue. With this objective in mind, an effective delivery of sonic radiation necessarily requires a controlled exposure to the radiation. This control, in turn, requires the employment of preplanned operational parameters for the radiation (i.e. frequency, intensity, and duration), at predetermined exposure intervals. Preferably, all this is done with minimal requirements for patient supervision.
With the above in mind, it is an object of the present invention to provide a system and method for directing vibrational oscillating sonic waves toward a target tissue in the body of a person to influence a phenotypic differentiation of the target tissue at a cellular level. Another object of the present invention is to provide a system and method for using sonic radiation to induce meditative states and/or to establish alpha brain wave/relaxation states for the user. Yet another object of the present invention is to provide a system and method for monitoring the efficacy of sonic radiation therapy by employing a titration capability in the operational protocol. Still another object of the present invention is to provide a system and method for providing sonic radiation therapy that is easy to use, is simple to implement, and is relatively cost effective.
The present invention pertains generally to the transformational or morphological change of cellular tissue under the influence of waveform energy radiation. From an engineering perspective, it is well known that waveform energy radiation creates forces (i.e. exerts pressure) on an object when the radiation is incident on the object. Further, it is also well known that these external forces can cause changes to tissue structure. The present invention is based on this interactive phenomenon.
For purposes of the present invention, the target tissue of interest may be any in vivo or in vitro cellular structure of the human body. It may be an individual cell, or it may be a group of cells together within the intercellular tissue (matrix) that supports the cells. As envisioned for the present invention, target tissue may also be an identifiable structure inside a cell, such as a chromosome. In each case, it is important to appreciate that as a mechanical structure, the cellular structure of a target tissue will have a unique natural frequency.
An initial consideration for implementation of the present invention is the task of defining a desired phenotype for the outcome. For example, the objective of a protocol for the present invention may be the creation of a particular type of stem cell (e.g. liver cell) from an otherwise undefined or undifferentiated cell. In this case, the desired phenotype (outcome) will be defined to have the requisite characteristics of the particular type stem cell that is desired (e.g. liver cell). As another example, the objective of a protocol may be to terminate the viability of a cellular structure, such as by killing 3 cancer cells. Other examples can be cited. In each instance, however, and regardless of the specific outcome that is desired, the present invention employs waveform energy radiation for the purpose of epigenetically influencing a target tissue for its transformation or morphological change into a structure that corresponds to the desired phenotype.
As envisioned for the present invention, the radiation to be employed for influencing target tissue may be of any waveform energy known in the art It may be electromagnetic radiation in the spectrum between wavelengths of 10−25 m to 103 m. It may also be periodic mechanical vibrations. In this latter case, the radiation may be acoustic sound waves in the range between 20 Hz and 20 kHz, and may also include infrasound waves (<20 Hz) and ultrasound waves (>20 kHz). Further, the radiation may be either continuous or pulsed, and the tone of the radiation may be either pure (single frequency) or complex (multi-frequency).
Structurally, a system for using a radiation of waveform energy to influence cellular structures within a target tissue will include a combination of various components. These include: components for generating and directing the radiation onto the target tissue; components for monitoring the target tissue; and a computer for controlling the generator and the radiation unit in accordance with a predetermined protocol.
In detail, the generator is used for generating the particular waveform energy radiation that is necessary to influence the target tissue. For this purpose it is important that the radiation be characterized by operational parameters having respective values which are established relative to the natural frequency of the target tissue. At a minimum, these operational parameters will include a frequency f and a volume intensity level v for the radiation, as well as a time duration td during which the target tissue is to be radiated. A radiation unit, which is incorporated with the generator, may include optics that are used for directing the radiation electromagnetic radiation (e.g. lasers) onto the target tissue and the cellular structure. Specifically, all of this is done in accordance with a predetermined protocol that is designed to epigenetically influence the target tissue and the cellular 4 structure that may be within the target tissue. In a preferred embodiment of the present invention the radiation unit will be positioned at a distance d from the target tissue. Typically, the distance d will be greater than 10 millimeters (d>10 mm).
As indicated above, control over the system during the conduct of a protocol is managed by a computer. To do this, a device is provided for monitoring a phenotypic response of the target tissue and the cellular structure during the protocol. As envisioned for the present invention, this monitoring function can be performed by an appropriate sensor, or by the periodic performance of a biopsy. In the event, management and control of the protocol by the computer is terminated when the phenotypic response corresponds with the desired phenotype.
A method in accordance with the present invention begins by identifying the target tissue to be influenced (including the cellular structure), and by defining a desired phenotype for the target tissue. A natural frequency for the phenotype can then be determined by reference to the literature. It is then necessary to establish values for the operational parameters (e.g. p, v and td) that will properly characterize the radiation that is to be used. In particular, it is desirable to establish operational values that are operationally relative to the natural frequency of the target tissue (cellular structure). In detail, with knowledge of this natural frequency, the radiation frequency f can be set to resonate, or partially resonate, with the cellular structure that is to be influenced during conduct of the protocol.
Operationally, once parameters have been established for the radiation, the radiation can be directed onto the target tissue in accordance with a predetermined protocol. As noted above, the purpose here is to epigenetically influence the target tissue and the cellular structure. During the protocol, the target tissue is then monitored in a titration-like process to detect a phenotypic response from the target tissue and the cellular structure. The protocol is terminated when the phenotypic response corresponds with the desired phenotype.
In an embodiment of the present invention the radiation can be pulsed. For this embodiment, each radiation pulse will have a predetermined time duration td within a predetermined time interval ti. Specifically, ti will extend between the successive beginnings of respective radiation pulses (i.e. ti>td).
In some embodiments of the inventive concept a system is provided for directing sonic waves toward preselected target tissue within the body of a person. This can be done for any of several reasons. For one, the sonic waves can be directed toward tissue to improve the overall health and wellness of the person. For another, they can be used to induce meditative states and/or to establish alpha brain wave/relaxation states for the person.
As envisioned, the system will include a patch that is attached to the human body. Thus, it may be either an epidermal patch or an implantable patch. In either case, and regardless where it is positioned on the user, the overall functionality of the patch is to direct sonic waves toward target tissue of the user in a manner that will entrain cellular functions locally in the target tissue, for an intended purpose.
Structurally, for a monopolar version of a system for the present invention, the patch will include a base member and a sonic generator which is mounted on the base member. In the case of an epidermal patch, a connecter is also included which may be either a fastener or an adhesive. For its use, the connector is affixed to the base member to hold the patch at a preselected location (position) on the body of the person (user).
A sounding board (speaker cone) can be employed with a sonic generator on the base member of the patch. If used, the sounding board speaker cone) will concentrate and more accurately direct operationally effective sonic frequencies toward the target tissue. Further, a transceiver can be mounted on the base member of the patch to establish a communication link between the sonic generator and a remote central control unit. In particular, the information to be transmitted by the transceiver from the patch to the central control unit will typically pertain to information that is pertinent to the operation of the sonic generator.
An extracorporeal titration unit is incorporated into the present invention to provide for communication between the patch and the central control unit. Specifically, the titration unit is employed to monitor the influence that the sonic waves have on the target tissue. In detail, the titration unit monitors changes of an expression level of the target tissue that result due to phenotypic differentiation of the tissue's cellular structure. This monitoring by the titration unit can be accomplished in either of several ways. For example, it can be accomplished using any of various imaging technologies, such as Optical Coherence Tomography (OCT) and ultrasound. The monitoring can also be accomplished by periodically conducting biopsies of the target tissue, or by taking periodic bio-impedance measurements.
For a bipolar version of the present invention, a second patch can also be employed in combination with the monopolar patch disclosed above. Like the patch for the monopolar embodiment disclosed above, this second patch may be either an epidermal or an implantable patch. Similarly, it can also be used anywhere on the body of the user. When used, the second patch will typically be complementary to the operation of the other patch. For instance, the second patch can be positioned on the opposite side of the body from the first patch to enhance bio-impedance measurements. It can also be used to radiate sonic energy simultaneously with the first patch to achieve different radiation perspectives on the target tissue.
Operationally, the system of the present invention can be employed to generate sonic waves in accordance with a scheduled program. As envisioned for the present invention, this program can provide for variations in the intensity and/or magnitude of oscillating frequencies of the sonic wave. Preferably, each frequency that is to be used will be selected from a sonic spectrum that includes ultrasonic, audible sonic, and infrasonic frequencies.
As implied above, the functionality of the present invention is established to achieve an intended outcome for the target tissue. In particular, this outcome will most likely be a phenotypic response for the target tissue. To achieve this, the titration unit monitors the target tissue during employment of the patch (system). Signals that are pertinent to the expression level (phenotypic differentiation) of the target tissue are then sent from the monitor to the central control unit. At the central control unit they are methodically compared with a desired phenotype (i.e. a base reference). Based on this comparison, employment of the system may be either continued or terminated. In particular, a use of the system for the present invention is to be terminated whenever the desired phenotype response has been achieved.
Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.
The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which:
Referring initially to
Still referring to
As also shown in
For example, sensor 22 may be employed to perform titration-like methodologies with processes such as bioelectrical impedance analysis and quantitative Polymerase Chain Reaction (PCR) techniques. The results of the monitoring performed by sensor 22 are then provided as input to the comparator 24. In the system 10, the comparator 24 is connected with the computer 20.
For an alternative to the use of a sensor 22 as disclosed above, it will be understood and appreciated by the skilled artisan that an epigenetic change (transformation/morphology) in the target tissue 16 can also be monitored by performing periodic biopsies 26 of the target tissue 16. Again, a titration methodology can be employed. In the event, the particular protocol which is used, its periodicity, and the extent to which the biopsy(ies) 26 is/are employed will be established on a case-by-case basis by the user of the system 10.
In addition to the hardware components for the system 10 mentioned above, various inputs for these components are required for an operation of the system 10. Importantly, the parameters 28 that are required for establishing the waveform energy of radiation 14 are a primary consideration. In particular the parameters 28 will necessarily include a selected frequency f for the vibration of the sound wave in the radiation 14. Also included will be the intensity level v for the max peak amplitudes of the sound wave, and a predetermined time duration td for the radiation 14. Depending on the particular application, the time duration td for the radiation 14 may be either continuous or pulsed.
Referring to
Insofar as the frequency f of the radiation 14 is concerned, several considerations are possible. For one, as noted above, the frequency f may be pure or complex. For another, during a radiation 14, the predetermined frequency f may be alternated between a first frequency f1 and a different second frequency f2 (i.e. f1≠f2). Further, alternation of the frequencies may be set to occur at a predetermined repetition rate.
In an operation of the present invention, it is necessary for there to first 30 be a determination and an identification of a desired phenotype 30. By definition, as used for the present invention, a phenotype 30 is set of observable characteristics of an individual resulting from its interaction with 8 the environment. Here, reference to the word “individual” in the definition is taken to mean a cellular structure, a contiguous group of cellular structures, or a portion of a cellular structure, such as a chromosome. For the present invention, the cellular structure is alive and can be either in vivo or in vitro. With this in mind, consider the exemplary cellular structures 32 and 34 shown in
For the examples presented here with reference to
In detail, during the conduct of a protocol 36, the sensor 22 (biopsy 26) is used to observe the cellular structure 32, and the comparator 24 is used to compare the cellular structure 32 with the desired phenotype 30′. Thus, the comparator 24 effectively monitors the transformation/morphology of the 25 cellular structure 32 as it is being influenced by the radiation 14. When the comparator 24 determines a cellular structure 30′/32 has been created which corresponds with the desired phenotype 30′ (i.e. a cancer-free cell), the protocol 36 can be terminated.
For another example, consider the transformation/morphology of a cellular structure such as an undifferentiated cell 34. In this case, the desired phenotype 30″ may be selected from any of various particular type cells (e.g. a liver cell). As with the earlier example, definitional parameters 28 for a 9 desired phenotype 30″ are input into the comparator 24. Also, the required parameters 28 for radiation 14 are established, and an appropriate protocol 36 is followed. As before, when the comparator 24 determines a cellular structure 30″/34 has been created which corresponds with the desired phenotype 30″ (i.e. a liver cell), the protocol 36 can be terminated.
For the conduct of a typical protocol 36, refer to
Once system 10 has been set for operation as described above, block 40 indicates that the protocol 36 can be performed. The actual conduct of the protocol 36, however, is very event-dependent and may vary considerably depending on the transformation/morphology desired for a particular target tissue 16. Moreover, due to the titration-like methodology that is envisioned 20 by the present invention for a protocol 36, and the many variables that are involved, the actual conduct of a protocol 36 must necessarily be essentially under the purview of the user of the system 10. Accordingly, any time requirements for the protocol 36 that are to be maintained (see inquiry block 42), and a determination of phenotypic correspondence that is indicative of 25 operational completion (see inquiry block 44), are effectively dependent on operational judgments of the user.
Referring initially to
Still referring to
In
For an operation of the present invention, a protocol is selected for the particular purpose of the intended operation of system 510. Essentially, this requires establishing operational parameters for the electromagnetic or sonic radiation 520. In detail, the selection of a frequency or frequencies, the intensity of each frequency to be used, the establishment of timed radiation intervals, the type of radiation to be employed (i.e. pulsed or continuous), and time requirements for the protocol are all to be considered as operational parameters. Furthermore, possible variations in any of these parameters during the course 520 of a protocol are also to be considered. As envisioned for the present invention, a selected protocol can be entered or pre-programmed in the central control unit 16. The protocol is then transmitted to the transceiver 26 of the patch 512/524, and the generator 28 is activated to operate the sounding board (speaker cone) 32 for directing radiation 520 (for example, sonic radiation) onto the target tissue 522.
It is also envisioned by the present invention that during the conduct of a protocol, the titrating unit 518 will be employed to monitor a phenotypic differentiation of the target tissue 522 at the cellular level. As disclosed above, this monitoring can be accomplished using OCT and/or ultrasound techniques. Additionally, it may be desirable to evaluate the target tissue 522 by periodically taking a biopsy of the target tissue 522.
An alternative protocol that may either complement phenotypic cell differentiation, or be conducted separately, is also envisioned for the present invention. In this case, the operational parameters set forth above can be selected to induce meditative states and/or to establish alpha brain wave/relaxation states for the patient/user 514. In all instances, regardless whether system 510 is used with a mono polar configuration (i.e. patch 512 only) or a bipolar configuration (i.e. both patch 512 and patch 24) the particular protocol to be followed is dependent on the needs of the patient/user 514.
While the particular System and Method for Titrating In Vivo Cellular Reaction and Gene Expression Using Varying Oscillation Frequencies as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design 15 herein shown other than as described in the appended claims.
This application is a continuation of U.S. patent application Ser. No. 14/738,518, filed Jun. 12, 2015, which is a continuation-in-part of U.S. patent application Ser. No. 14/488,101 filed Sep. 16, 2014, which is currently pending. These and all other referenced extrinsic materials are incorporated herein by reference in their entirety. Where a definition or use of a term in a reference that is incorporated by reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein is deemed to be controlling.
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| Number | Date | Country | |
|---|---|---|---|
| 20180125747 A1 | May 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14738518 | Jun 2015 | US |
| Child | 15862110 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14488101 | Sep 2014 | US |
| Child | 14738518 | US |
