REGENERATIVE CO2 TREATMENT SYSTEM AND METHOD
20220125831 · 2022-04-28
Inventors
Cpc classification
A61K45/06
HUMAN NECESSITIES
A61N1/40
HUMAN NECESSITIES
A61K9/0019
HUMAN NECESSITIES
A61K33/00
HUMAN NECESSITIES
A61K2800/82
HUMAN NECESSITIES
A61K33/00
HUMAN NECESSITIES
A61K2300/00
HUMAN NECESSITIES
A61K2300/00
HUMAN NECESSITIES
A61K9/0014
HUMAN NECESSITIES
A61K9/7023
HUMAN NECESSITIES
International classification
A61K33/00
HUMAN NECESSITIES
A61K45/06
HUMAN NECESSITIES
A61K9/00
HUMAN NECESSITIES
A61K9/70
HUMAN NECESSITIES
A61N1/40
HUMAN NECESSITIES
Abstract
The present technology provides regenerative treatment methods and apparatus to stimulate hair growth. Regenerative treatments to stimulate hair growth include the subcutaneous application of carbon dioxide, and may also include suction, energy input, and topical application of nutrients to a patient's scalp. Regenerative treatment methods include an initial treatment phase and a maintenance treatment phase.
Claims
1. A regenerative treatment method for stimulating hair growth, the method comprising: conducting an initial treatment phase comprising at least one initial phase therapy session and at least one initial phase personal administration, wherein each initial phase therapy session includes at least subcutaneously applying carbon dioxide in at least one location on a scalp of a patient and each initial phase personal administration includes at least applying a high frequency device to the scalp; and conducting a maintenance treatment phase after the initial treatment phase, the maintenance phase comprising at least one maintenance phase therapy session and at least one maintenance phase personal administration, wherein each maintenance phase therapy session includes at least subcutaneously applying carbon dioxide in at least one location on the scalp of the patient and each maintenance phase personal administration includes at least at least applying a high frequency device to the scalp.
2. The regenerative treatment method of claim 1, wherein each initial phase therapy session further comprises a step of: administering a nitric oxide test to the patient.
3. The regenerative treatment method of claim 1, wherein each therapy session further comprises: applying suction to the scalp after the subcutaneously applying carbon dioxide.
4. The regenerative treatment method of claim 1, wherein each therapy session further includes: conducting a secondary treatment of the scalp that includes at least one of: applying nutrients topically onto the scalp; and applying energy input to the scalp.
5. The regenerative treatment method of claim 4, wherein the secondary treatment comprises the applying energy input to the scalp, and the applying energy input includes providing electrical current to the scalp using a high frequency device that operates at 50 Hertz.
6. The regenerative treatment method of claim 4, wherein the secondary treatment comprises the applying energy input to the scalp, and the applying energy input includes providing near infrared light to the scalp.
7. The regenerative treatment method of claim 4, wherein the secondary treatment comprises the applying energy input to the scalp, and the applying energy input includes providing electromagnetic pulses using electromagnetic fields of from about 25 MHz to about 27 Mhz.
8. The regenerative treatment method of claim 7, wherein the secondary treatment comprises the applying nutrients topically onto the scalp.
9. The regenerative treatment method of claim 4, wherein the secondary treatment comprises the applying nutrients topically onto the scalp; and the applying a high frequency device to the scalp.
10. The regenerative treatment method of claim 1, wherein each initial phase personal administration comprises: applying a high frequency device to the scalp.
11. The regenerative treatment method of claim 10, wherein the high frequency device operates at 50 Hertz.
12. The regenerative treatment method of claim 10, wherein the high frequency device applied for a period of time that is at least about 5 minutes.
13. The regenerative treatment method of claim 1, wherein each initial phase personal administration comprises: administering a first patch to skin of a patient, the first patch including glutathione; administering a second patch to the skin of the patient, the second patch comprising a plurality of vitamins; and applying a high frequency device to the scalp.
14. A regenerative treatment kit for use during personal administration sessions of a regenerative treatment therapy to stimulate of hair growth, the regenerative treatment kit comprising: a high frequency device; a first patch configured to be applied to a patient's skin, the first patch including glutathione; and nitric oxide.
15. The regenerative treatment kit of claim 14, further comprising a second patch configured to be applied to a patient's skin, the second patch including a plurality of vitamins.
16. The regenerative treatment kit of claim 14, wherein the regenerative treatment kit comprises a plurality of first patches, each first patch including glutathione, and a plurality of second patches, each second patch including a plurality of vitamins.
17. The regenerative treatment kit of claim 14, wherein the high frequency device is configured to operate at 50 hertz.
18. The regenerative treatment kit of claim 14, further comprising a posture shoulder strap.
19. The regenerative treatment kit of claim 14, further comprising a posture wedge pillow.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Specific examples have been chosen for purposes of illustration and description, and are shown in the accompanying drawings, forming a part of the specification. Like components within the drawings are given the same reference numbers.
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
DETAILED DESCRIPTION
[0024] Regenerative systems and treatment methods of the present technology may be used to treat biological tissue damage and/or deterioration in a patient's scalp and stimulate hair growth. Generally, poor circulation of blood tends to result in a poor supply of oxygen to bodily tissues, which leads to deterioration of bodily tissues, since such tissues rely upon oxygen to remain intact and healthy. When body tissues are stressed or damaged, they often experience inflammation. Repeated inflammation over time can cause a buildup of scar tissue and adhesion, which is poorly vascularized. Lack of blood flow to poorly vascularized areas can cause deterioration of and further damage to the biological tissue. When such damage occurs in the human scalp, hair follicles no longer produce hair and baldness can result.
[0025] Regenerative treatments methods of the present technology may be used to treat damage to the fascia of the scalp, including the hair follicles.
[0026] Regenerative treatment methods of the present technology include subcutaneous applications of carbon dioxide. The subcutaneous application of carbon dioxide is administered during therapy sessions, in a clinical setting. Regenerative treatment methods of the present technology also include inducement of ionic flux, such as by using a high frequency ozone producing device, and may include topical application of nutrients to a patient's scalp. Various steps of the regenerative treatment methods of the present technology may be administered in a clinical setting during therapy sessions, or may be self-administered by the patient or a caregiver during a personal administration session.
[0027] As shown in
[0028] The maintenance phase at step 104 includes at least one maintenance phase therapy session at step 110, and may also include at least one maintenance phase personal administration 112, as well as repetitions of each step as desired or recommended. The repetitions of step 110 maintenance phase therapy session may be spaced father apart in time than the initial phase therapy sessions at step 106, and are intended to at least maintain the level of regeneration achieved during the initial treatment phase at step 102. The number of maintenance phase therapy sessions 110 may be indefinite, and may be periodic continuously for any suitable period of time, up to and including the lifetime of the patient. Steps 110 and 112 may be carried out in succession and that succession may be repeated a set number of times. Alternatively, during the maintenance phase 104, either of maintenance phase therapy session at step 110 or the maintenance phase personal administrations at step 112 may be repeated prior to any further occurrence of the other step. Preferably, the maintenance phase 104 includes at least one maintenance phase therapy session at step 110, and also includes at least one maintenance phase personal administration session at step 112 that occurs after the at least one maintenance phase therapy session at step 112. In at least some examples, the maintenance phase personal administration sessions at step 112 may be repeated multiple times between each maintenance phase therapy session at step 110.
[0029] The number of initial phase therapy sessions 106 may vary from patient to patient, or based upon the type regenerative treatment. For regenerative treatment of the scalp to stimulate hair growth, the number of initial phase therapy sessions 106 may be any suitable number of therapy sessions, such as from ten to twenty initial therapy sessions. The number of initial phase therapy sessions may vary depending upon the severity and duration of the patient's balding. In some instances, the number of initial phase therapy sessions 106 may be less than ten, or greater than twenty. In other instances, the number of initial phase therapy sessions 106 may be about twenty, or between about ten and about twenty, such as from about twelve to about fifteen, from about fifteen to about twenty, or from about twenty to about twenty five. In some examples, the number of initial phase therapy sessions 106 may be ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, twenty, twenty-one, twenty-two, or twenty five.
[0030] The frequency of initial phase therapy sessions 106 may also vary from patient to patient, or based upon the type regenerative treatment. For regenerative treatment of the scalp to stimulate hair growth, during the initial treatment phase 102, initial phase therapy sessions 106 are preferably scheduled to occur about once per week, or about once every seven to ten days. For example, in some cases, initial phase therapy sessions 106 may occur once every seven to ten days for twenty visits.
[0031] The maintenance phase 104 of regenerative treatment method 100 is intended to occur after the initial phase 102. The maintenance phase 104 may include maintenance phase therapy sessions at step 110, which may be spaced apart over a greater periods of time than the initial phase therapy sessions at step 106. For example, for hair regrowth regenerative treatments during the maintenance phase 104, the step of a maintenance phase therapy session 110 may be performed once per month, once every two months, or once every three months. In addition, or alternatively, to therapy sessions, the maintenance phase 104 may include maintenance phase personal administration sessions at step 112. Maintenance phase personal administration at step 112 may occur more frequently than therapy sessions 110 during the maintenance phase 104, such as once per week, or even as needed.
[0032]
[0033] Each therapy session 200 of the present technology includes subcutaneously applying carbon dioxide in at least one location on the scalp of the patient at step 206. Subcutaneous application of carbon dioxide is administered by a clinician, and the carbon dioxide is injected in at least one location within the target area. In regenerative treatments to stimulate hair growth, subcutaneously applying carbon dioxide includes injecting carbon dioxide into the patient's scalp, into the subcutaneous tissue underneath the epidermis and dermis. The carbon dioxide may be injected in at least one location, or at multiple locations on the patient's scalp. In examples where subcutaneously applying carbon dioxide includes injecting carbon dioxide at multiple locations on the patient's scalp, the injections may be placed in a spaced pattern. One example of a spaced pattern that may be used is a grid. The configuration of the spaced pattern may vary as the regenerative treatment progresses. In some examples, such as during the first few initial phase therapy sessions, a closer spaced pattern, such as a grid with injection points being about one inch apart, may be used. Over time, fewer injections may be needed, and the spaced pattern may include wider spacing, such as two injections per quadrant of a patient's scalp.
[0034] Without being bound by any particular theory, injection of carbon dioxide is believed to provide many benefits, including potentially ripping scar tissue, stimulating blood flow, and promoting collagen formation. Injection of carbon dioxide may create a positive electrical event, and the carbon dioxide may disrupt all cells in the whole plane into which it is injected, causing an ionic gradient from resting to positive. With reference to phase 1 of the regenerative processes discussed above, injection of carbon dioxide may cause injury of cells so that the target biological tissue can regenerate new cells. Injection of carbon dioxide may initiate a downstream cascade of events via HIF (hypoxia induced factor) via the mTOR pathway as well as other pathways. With reference to phase 2 of the regenerative processes discussed above, injection of carbon dioxide may cause changes in the gap junction, which may initiate electrical field and membrane potential changes.
[0035] Injection of carbon dioxide may also induce ionic flux and PH gradient changes due to the H+ characteristic of the CO.sub.2 molecules in the carbon dioxide gas.
[0036] As an optional step, therapy session 200 may include administering a nitric oxide test at step 202, to assess the patient's nitric oxide level. Administration of the nitric oxide test may occur as one of the first procedures during a therapy session, such as prior to subcutaneously applying carbon dioxide at step 206. A nitric oxide test may include measurement of a patient's salivary nitrite, such as by applying the patient's saliva onto a nitric oxide test strip. Several types of nitric oxide test strips are commercially available for general use, and are designed to measure the amount of nitric oxide that is recirculated through the patient's saliva. While not being bound by any particular theory, the measurement is believed to be representative of the bioavailability of nitric oxide in the patient's body, and that having sufficient levels of nitric oxide within a patient's body promotes healing in the skin and other tissues. With at least some known nitric oxide test strips, when saliva is applied to the correct area on the test strip, color coded results appear that indicate whether a patient has sufficient levels of nitric oxide. If a patient is determined to have low levels of nitric oxide, based on the results indicated by the nitric oxide test strip, therapy session 200 may include administration of nitric oxide at step 204. Nitric oxide can be administered orally, and may be in the form of a tablet or capsule.
[0037] Each therapy session 200 may also include steps that are intended to cause or promote the third, fourth, and fifth phases of the regenerative process described above. Without being bound by any particular theory, it is believed that the subcutaneous application of carbon dioxide causes a wound, and initiates the first and second phases of the regenerative process. The carbon dioxide also serves as an anti-inflammatory, which may reduce the likelihood that the body will produce scar tissue, and thus facilitate the promotion of tissue regeneration. Regenerative treatments of the present technology take advantage of the presence of the subcutaneous carbon dioxide, and use the additional therapy steps described below to promote tissue regeneration.
[0038] For example, regenerative treatments to stimulate hair growth may include applying suction to the scalp at step 208. Suction may be performed using a suction device. Suction devices for applying suction to a patient's skin for various purposes are commercially available. Use of a suction device in regenerative treatments of the present technology, by applying suction to the scalp at step 208, after subcutaneously applying carbon dioxide at step 206, may pull the subcutaneously injected carbon dioxide up through the skin layers of the scalp up to the epidermis, and may break up adhesion.
[0039] Additionally, each therapy session 200 of the present technology may include applying at least one secondary treatment to the target area at step 210. Examples of secondary treatments for use in regenerative treatments to stimulate hair growth include, for example, applying energy input and/or applying nutrients topically to the scalp. Secondary treatment performed at step 210 can be performed during a therapy session after applying subcutaneous carbon dioxide at step 206, and can also be performed after applying suction to the scalp at step 208.
[0040] Without being bound by any particular theory, secondary treatments of the present technology may cause or promote ionic flux, and flipping positive and negative polarities within the target biological tissue. Either alone, or in combination with application of carbon dioxide to the target area at step 206, secondary treatment at step 210 may trigger a regenerative cascade within the target biological tissue.
[0041]
[0042] Secondary treatment 300 may include at least applying nutrients topically onto the scalp at step 302. The nutrients may include a combination of nutrients. The nutrients may be in a in the form of a nutrient mixture, and may be contained within a carrier fluid such as a liquid or gel. Applying nutrients topically onto the scalp at step 302 may include applying the nutrient mixture to the scalp and rubbing the nutrient mixture into the scalp.
[0043] Secondary treatment 300 may further include applying energy input at step 304. In some examples, energy input may be applied after applying subcutaneous carbon dioxide at step 206. In other examples, energy input may be applied after applying suction at step 208. Further, energy input may be applied after applying nutrients topically onto the scalp at step 302.
[0044] Energy input may be applied in various ways, depending upon the desired clinical outcome and status of the tissues in a patient's scalp, such as the severity of the baldness. For example, energy input may be applied in the form of an electrical current or electromagnetic pulse, or near infrared (NIR) light therapy. Various devices for applying electrical current and electromagnetic pulses, and for conducting NIR light therapy are known. Without being bound by any particular theory, it is believed that applying energy input induces ionic flux and promotes electroporation. Electroporation is a technique in which an electrical field is applied to increase the permeability of cells within the target tissue.
[0045] In examples where the a patient's baldness is not severely advanced, energy input may be applied during a therapy session 200 by using a high frequency device. High frequency devices are known for use in facial treatment, such as to reduce acne or wrinkles.
[0046] In examples where a patient's baldness is moderately advanced, energy input may be applied during a therapy session 200 by using NIR light therapy. Light is a form electromagnetic radiation characterized by particle- and wave-like properties. NIR light therapy uses directional low-power but high-fluency light, monochromatic or quasimonochromatic, from lasers or light-emitting diodes (LEDs) usually in the wavelengths from about 600 nm to about 1000 nm). NIR light therapy devices of various types are known, and often includes a panel or grid of LEDs that emit light in the near infrared spectrum. NIR light therapy includes using an NIR light therapy device to apply near infrared light to the target tissue, such as the patient's scalp.
[0047] In examples where a patient's baldness is severely advanced, energy input may be applied during a therapy session 200 by applying electrical current, such as by generating electromagnetic pulses directed to penetrate the target tissue, such as the patient's scalp. Examples of treatments using electromagnetic pulses are pulsed shortwave (PSWT) therapy and pulsed electromagnetic diathermy. Various devices suitable for generating electromagnetic pulses directed to penetrate the target tissue are known. One example is the ActiPtach® device, available from BioElectronics Corporation. The device has an antenna and functions to produce a 27 MHz electromagnetic field 1000 times per second. When the antenna is placed over the target tissue, energy from the antenna is transferred into the target tissue as a localized therapy within the area covered by the antenna. Electromagnetic fields of from about 25 MHz to about 27 Mhz can be used to applying electrical current during energy input at step 304 in secondary treatments of the present technology for severely advanced baldness.
[0048] Referring back to
[0049]
[0050] Referring to
[0051] The regenerative treatment kit 500 includes a high frequency device 502, at least one a first patch 504, at least one second patch 506, and nitric oxide 508. The high frequency device 502 may be configured to operate at 50 Hertz. The first patch 504 may be configured to be applied to a patient's skin, and may include glutathione. The regenerative treatment kit 500 kit may include a plurality of first patches. The second patch 506 may be configured to be applied to a patient's skin, and may include a plurality of vitamins. The regenerative treatment kit 500 kit may include a plurality of second patches. The nitric oxide 508 may be in a form to be taken orally. The regenerative treatment kit 500 may also include one or more posture improvement devices, such as a posture shoulder strap 510 and a posture wedge pillow 512. Posture shoulder strap 510 has two straps, each of which is configured as a loop through which a patient's arm can be inserted. The posture shoulder strap 510 also includes a connector, configured to connect the two straps and rest on the patient's back. The posture wedge pillow 512 has a wedge shaped profile, and a cut-out or dip in the center of the top edge. The posture wedge pillow 512 is configured to be used with a patient laying down with the high edge towards the patient and the patient's neck resting in the cut-out or dip.
[0052] One example of a method 600 of conducting a personal administration session is shown in
[0053] The method 600 of conducting a personal administration session may also include one or more posture improvement steps. As shown in
EXAMPLES
[0054] The treatment method described herein is exemplary and it should be understood that the present technology encompasses, but is not limited to, the specific examples provided.
A. Hair Growth Stimulation
[0055] One example of a treatment method of the present technology is directed to the treatment of the scalp of a patient to stimulate hair growth. The initial treatment phase includes multiple initial phase therapy sessions, for example a total of twenty therapy sessions, where the therapy sessions are scheduled once or twice per week over a period of ten weeks.
[0056] Each initial phase therapy session includes subcutaneous application of carbon dioxide to the scalp of the patient. Prior to the subcutaneous application of carbon dioxide, the patient's nitric oxide level may be tested, and nitric oxide may be administered.
[0057] Subcutaneous application of carbon dioxide includes a plurality of injections of carbon dioxide in a grid pattern on the patient's scalp.
[0058] After the subcutaneous application of carbon dioxide, the clinician or a clinician's assistant applies suction to the patient's scalp using a suction device.
[0059] After the suction, nutrients are topically applied to the scalp and are physically rubbed into the scalp.
[0060] As a final step during the initial phase therapy session, an energy input step is performed. In one example, a high frequency device is used to apply electrical current to the scalp at 50 Hertz for a period of time from about 5 minutes to about 10 minutes. In an alternative example, an NIR therapy device is used to apply near infrared light to the patient's scalp for a period of time from about 5 minutes to about 10 minutes. In another alternative example, a device that generates electromagnetic pulses is used to direct electromagnetic pulses to penetrate the patient's scalp for a period of time from about 5 minutes to about 10 minutes.
[0061] During the time period between scheduled initial phase therapy sessions, the clinician may instruct the patient to self-administer one or more high frequency device applications. For example, the patient may self-administer the high frequency device once daily on days when a therapy session is not scheduled. The patient may also self-administer a first patch containing glutathione and a second patch containing a plurality of vitamins daily. In some instances, the patient may self-administer nitric oxide. The patient may also self-administer one or more posture improvement devices, such as a posture pillow wedge and/or a posture shoulder strap.
[0062] Once the initial treatment phase is complete, the maintenance phase may include a plurality of maintenance phase therapy sessions, which may be administered once every three months for a period of nine months. Each maintenance phase therapy session may include the same steps as an initial phase therapy session, but maintenance phase therapy sessions are administered farther apart in time than initial phase therapy sessions. During the maintenance phase, the patient may conduct maintenance phase personal administration, which may include an or all of the same stapes as an initial phase personal administration. For example, during a maintenance phase personal administration, the patient may at least self-administer the high frequency device. In some examples, the patient may conduct aa maintenance phase personal administration by applying the high frequency device to the scalp about once per week for a period of about five minutes at each occurrence. The patient may also periodically self-administer a first patch containing glutathione and a second patch containing a plurality of vitamins. In some instances, the patient may periodically self-administer nitric oxide. The patient may also periodically self-administer one or more posture improvement devices, such as a posture pillow wedge and/or a posture shoulder strap.
[0063] From the foregoing, it will be appreciated that although specific examples have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit or scope of this disclosure. It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to particularly point out and distinctly claim the claimed subject matter.