An IR emitter for treating a patient with inflammatory bowel disease, methods, systems, devices and modules thereof
The IR emitter device addresses the ineffectiveness of current Crohn's disease therapies by using photobiomodulation with an IR emitter that applies infrared radiation and pressure to the abdomen, achieving significant reductions in inflammation and improvements in clinical symptoms.
Patent Information
- Application Number
- PCT/IL2024/050920
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-09-12
- Filing Date
- 2024-09-12
- Publication Date
- 2025-03-20
AI Technical Summary
Current therapies for Crohn's disease are associated with adverse events and are ineffective in up to 35% of patients, prompting the need for complementary therapies such as photobiomodulation using infrared (IR) wavelength treatments.
An IR emitter device is developed to administer a therapeutically effective amount of photobiomodulating infrared emission to the patient's abdomen, emitting electromagnetic radiation ranging from 0.8 to 50 microns and providing room temperature to about 70 degrees Celsius, while applying pressure to the abdomen to facilitate deeper tissue penetration.
The IR emitter device effectively reduces inflammation and promotes tissue regeneration in patients with inflammatory bowel disease, as evidenced by improved clinical symptoms and reduced fecal calprotectin levels in clinical trials.
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Figure IL2024050920_20032025_PF_FP_ABST
Abstract
Description
[0001] AN IR EMITTER FOR TREATING A PATIENT WITH INFLAMMATORY BOWEL
[0002] DISEASE, METHODS, SYSTEMS, DEVICES AND MODULES THEREOF
[0003] FIELD OF THE INVENTION
[0004] The present invention pertains to an infrared (IR) emitter for treating a patient with inflammatory bowel disease, to methods, systems, devices and modules thereof.
[0005] BACKGROUND OF THE INVENTION
[0006] Current therapies of Crohn's disease are associated with adverse events and are ineffective in up to 35% of patients. Thus, many patients turn to complementary therapies. One possible modality is photobiomodulation (PBM) by using infrared (IR) wavelength treatments of the intestines.
[0007] IR has been shown in laboratory and experimental animal model studies to possess antiinflammatory and tissue regeneration properties and to be effective in inflammatory diseases including faster healing of wounds, improvement in Achilles' tendonitis, reduction of endothelial inflammation in arteriovenous fistulas in hemodialysis patients, reduction of post-surgery inflammation in patients receiving total hip arthroplasty, short-term alleviation of pain and stiffness in patients with rheumatoid arthritis or ankylosing spondylitis and more.
[0008] The anti-inflammatory effects of IR can be attributed to a least two general modes of action. One is simply by heating (hyperthermia), and the other is usually referred to as photobiomodulation (PBM) and involves a more focused activation of various proteins. As a hyperthermia treatment, IR radiation is readily absorbed as heat by water and by other biological molecules. The positive effect of heat for alleviating chronic inflammation has been long known. One recent study assessed heat as a treatment for granulomatous lobular mastitis, a chronic inflammatory breast condition that is characterized by granulomatous inflammation, showing that patients receiving local heat therapy achieved remission significantly faster compared with those receiving corticosteroids (5.30 months vs. 11.27 months).
[0009] As a PBM modality, current research indicates that IR stimulates cytochrome C oxidase in the mitochondria and leads to increase in ATP production and to modulation of reactive oxygen species and nitric oxide, both involved in the inflammatory process. IR also helps to downregulate the expression level of pro-inflammatory transcription factors and cytokines and promotes an
[0010] 1
[0011] SUBSTITUTE SHEET (RULE 26) analgesic effect during inflammation by activating peripheral inhibitory neuro-receptors. Other mechanisms that might also be at play in reducing inflammation by IR include reduction of oxidative stress and protection from inflammation-induced cell damage in cell cultures, improvement of blood circulation and stimulation of fibroblast proliferation, thereby aiding in tissue rehabilitation.
[0012] Within the IR range, far-infrared (IR) radiation, usually referring to wavelengths of 3-1000 um, penetrates deeper into the body than near IR, and is able to heat water molecules much more efficiently than near IR. The ability of IR to affect tissues and processes deep in the body is exemplified in several studies all using IR within the range of 2-50 um: IR reduced knee pain and joint effusion in patients; led to reduction in lymphedema; improved dysmenorrhea symptoms; and improved peritoneal function in end-stage renal disease patients with peritoneal dialysis. These studies are also important with regard to the safety of this modality.
[0013] SUMMARY OF THE INVENTION
[0014] It is one object of the invention to disclose an IR emitting device for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, comprising an emitter for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing room temperature to about 70 degrees Celsius; when emitting, the emitter is pushed towards the patient, so that the outermost abdomen surface is pressed inwards the intestines about 50 mm, at least 4 mm; or otherwise at least 20 mm, at least 40 mm, no more than about 95 mm, no more than about 85 mm.
[0015] It is another object of the invention to disclose the device as defined above, wherein the device further comprises a belly massager whilst emitting IR for treating a patient with inflammatory bowel disease by administering it to the patient's outermost abdomen surface; characterized by that it further comprises a massaging module provided with means for applying the emitter towards patient body with a force selected from high forces (about 1.5 to about 3 kg cm'2) and / or low forces (about 0.1 to aboutl.5 kg cm'2).
[0016] It is another object of the invention to disclose the device as defined in any of the above, wherein the device is provided in a wearable garment.
[0017] 2
[0018] SUBSTITUTE SHEET (RULE 26) It is another object of the invention to disclose a wearable garment comprising the device as defined in any above.
[0019] It is another object of the invention to disclose the device as defined in any of the above, wherein the device further comprises a robot-arm for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission.
[0020] It is another object of the invention to disclose the device as defined in any of the above, wherein the device comprises robotic assistance which is controlled by a controller or an operator or both, for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission.
[0021] It is another object of the invention to disclose the device as defined in any of the above, wherein the device further comprises user- or artificial intelligence (Al) programming for determining the treatment protocol, for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission.
[0022] It is another object of the invention to disclose a static system comprising the device as defined in any of the above.
[0023] It is another object of the invention to disclose a method for treating a patient with inflammatory bowel disease, comprising administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, comprising an emitter for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing room temperature to about 70 degrees Celsius, e.g., 37 to 45 degrees Celsius; when emitting, the emitter is pushed towards the patient, and pressing the outermost abdomen surface inwardly towards the intestines at least 4 mm, or otherwise about 50 mm, at least 4 mm; or otherwise at least 20 mm, at least 40 mm , no more than about 95 mm, no more than about 85 mm.
[0024] ; the pressure is provided continuously or in an intermittent manner for a period of time of about 10 to about 60 min.
[0025] It is another object of the invention to disclose a method of treating a patient with inflammatory bowel disease, comprising wearing a garment comprising the device as defined in any of the above, and then administering patient's outermost abdomen surface with a therapeutically effective
[0026] 3
[0027] SUBSTITUTE SHEET (RULE 26) amount of photobiomodulating infrared emission, comprising an emitter for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius; when emitting, the emitter is pushed towards the patient, for applying the emitter towards the patient body with a force selected from high forces (about 1.5 to about 3 kg cm'2) and low force (about 0.1 to about 1.5 kg cm'2) for a period of time of about 10 to about 60 min.
[0028] It is another object of the invention to disclose a method of treating a patient with inflammatory bowel disease, comprising wearing a garment comprising the device as defined in any of the above, administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, comprising an emitter for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing room temperature to about 70 degrees Celsius, e.g., 37 to 45 degrees Celsius; when emitting, the emitter is pushed towards the patient, and presses the outermost abdomen surface inwardly towards the intestines for at least 4 mm or otherwise about 50 mm, at least 4 mm; or otherwise at least 20 mm, at least 40 mm , no more than about 95 mm, no more than about 85 mm; the pressing is provided continuously or in an intermittent manner for a period of time of about 10 to about 60 min.
[0029] It is another object of the invention to disclose a method of treating a patient with inflammatory bowel disease, comprising wearing a garment comprising the device as defined in any of the above, and then administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, comprising an emitter for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius; when emitting, the emitter is pushed towards the patient, for applying the emitter towards patient body forces, selected from high forces (about 1.5 to about 3 kg cm'2) and low force (about 0.1 to about 1.5 kg cm'2) for a period of time of about 10 to about 60 min.
[0030] It is yet another object of the invention to disclose an IR emitter for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, characterized by that the IR emitter is provided with means for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing room temperature to about 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0031] 4
[0032] SUBSTITUTE SHEET (RULE 26) It is another object of the invention to disclose an IR emitter and a belly massager for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating IR emission; characterized by that it comprises both a massaging module and an IR emitter provided with means for emitting electromagnetic radiation ranging from 0.8 to 50 microns, providing room temperature to about 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0033] It is another object of the invention to disclose an IR emitter for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating IR emission; characterized by that it applies pressure on the abdomen and the IR emitter is provided with means for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing room temperature to about 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0034] It is another object of the invention to disclose an IR emitter and belly massager for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating IR emission ; characterized by that it comprises both a massaging module and / or a pressure module and an IR emitter provided with means for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing 45 to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0035] It is another object of the invention to disclose a wearable garment for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, characterized by that it comprises an IR emitter, provided with means for emitting electromagnetic radiation ranging from about 0.8 to 50 microns, providing 45 to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0036] It is another object of the invention to disclose a wearable garment for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, characterized by that it comprises both a massaging module for belly massaging and an IR emitter, provided with means for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0037] It is another object of the invention to disclose a robot-arm or an assisting robotic arm for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface
[0038] 5
[0039] SUBSTITUTE SHEET (RULE 26) with a therapeutically effective amount of photobiomodulating infrared emission, characterized by that it comprises a robotic arm with or in connection with an IR emitter, provided with means for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0040] It is another object of the invention to disclose a robot-arm or an assisting robotic arm for treating a patient with inflammatory bowel disease by administering the patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, characterized by that it comprises a robotic arm with or in connection with both a massaging module for belly massaging and an IR emitter, provided with means for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing 45 to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0041] It is another object of the invention to disclose a static system for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, characterized by that it comprises a bed-like or mattress-like member, comprising or in connection with an IR emitter, provided with means for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0042] It is another object of the invention to disclose a static system for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, characterized by that it comprises a bed-like or mattress-like member, comprising or in connection with both a massaging module for belly massaging and an IR emitter, provided with means for emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0043] It is another object of the invention to disclose a medical device useful for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, characterized by that it comprises an article of manufacture selected from a wearable, including a jacket-like garment, robotic arm, static system and any combination thereof, comprising or in connection with an IR emitter, provided with means for emitting electromagnetic radiation ranging from about 0.8 to
[0044] 6
[0045] SUBSTITUTE SHEET (RULE 26) about 50 microns, providing room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0046] It is another object of the invention to disclose a medical device useful for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, characterized by that it comprises article of manufacture selected from a wearable, including a jacket-like garment, robotic arm, static system and any combination thereof, comprising or in connection with both a massaging module for belly massaging and an IR emitter, provided with means for emitting electromagnetic radiation ranging from 0.8 to 50 microns, providing room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius.
[0047] It is another object of the invention to disclose a medical device chosen from any of the options and combinations described above for treating a patient with an inflammatory bowel disease by by administering the patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, and further comprising a module for cooling the IR emitter or the skin of the patient or both.
[0048] It is another object of the invention to disclose a method of treating a patient with inflammatory bowel disease, comprising administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, ranging from about 0.8 to about 50 microns, providing room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius, at least one a week.
[0049] It is still another object of the invention to disclose a method of treating a patient with inflammatory bowel disease, comprising providing patient with an article of manufacture selected from a wearable, including a jacket-like garment, robotic arm, static system and any combination thereof, comprising an IR emitter, and administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, ranging from about 0.8 to about 50 microns, providing room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius, at least one a week.
[0050] It is another object of the invention to disclose a method of treating a patient with inflammatory bowel disease, comprising providing patient with an article of manufacture selected from a wearable, including a jacket-like garment, robotic arm, static system and any combination thereof, comprising both an IR emitter and a massaging module, and administering, namely heating and
[0051] 7
[0052] SUBSTITUTE SHEET (RULE 26) massaging patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, ranging from about 0.8 to about 50 microns, room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius, at least one a week.
[0053] Lastly, it is another object of the invention to disclose a method of treating a patient with inflammatory bowel disease with a medical device chosen from any of the options and combinations described above for treating a patient with an inflammatory bowel disease by administering the patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, and further comprising a module for cooling the IR emitter or the skin of the patient or both.
[0054] The device as defined in any of the above is intended for the treatment of inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, but also irritable bowel syndrome, diverticulitis, gastritis, pancreatitis, other abdominal inflammatory conditions, and also endometriosis, polycystic ovary syndrome and other gynecological conditions; cystitis and kidney diseases, and symptoms thereof.
[0055] BRIEF DESCRIPTION OF THE FIGURES
[0056] The accompanying figures where like reference numerals refer to identical or functionally similar elements throughout the separate views, and which together with the detailed description below are incorporated in and form part of the specification, serve to further illustrate various embodiments and to explain various principles and advantages all in accordance with the present invention. Figures 1 to 3 hence are a schematic representation of a few embodiments of devices and methods of the invention.
[0057] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0058] It should be noted that the term “about” is used herein to mean within the typical ranges of tolerances in the art. For example, the term can be understood as about 2 standard deviations from the mean. In certain embodiments, about means ±20%.
[0059] The term "abdomen" refers hereinafter in a non-limiting manner to the belly and adjunct area, back or a side portion of the abdomen.
[0060] A “patient” or “subject” includes an animal, such as a human, dog, cat, monkey, ape, cow, horse, sheep, lamb, pig, chicken, turkey, quail, mouse, rat, rabbit or guinea pig. The animal can be a
[0061] 8
[0062] SUBSTITUTE SHEET (RULE 26) mammal, such as a non-primate or a primate (e.g., monkey, ape, and human). In some embodiments, a patient is a human, such as a human infant, child, adolescent, or adult, as being e.g., pregnant, sportsmen or one who suffers from acute or chronic symptoms or diseases.
[0063] The term “inflammatory bowel disease” or “IBD,” as used herein, defines a group of chronic relapsing and remitting inflammatory diseases of the gastrointestinal tract, of which the two primary subgroups are Crohn's disease and ulcerative colitis, but also irritable bowel syndrome and related or associated diseases, see e.g., US20230201135A1 incorporated herein as a reference. Patients with IBD are also much more likely to have other chronic inflammatory diseases, including primary sclerosing cholangitis, ankylosing spondylitis, psoriasis and multiple sclerosis, amongst others (Urlep et al, Minerva Gastroenterol. Dietol. 51: 147-63 (2005)). In some embodiments, IBD symptoms may include, without limitation, inflammation of the intestine resulting in abdominal cramping and persistent diarrhea. Inflammatory bowel diseases include, but are not limited to, ulcerative colitis (UC), Crohn's disease (CD), indeterminate colitis (IC), chronic colitis, discontinuous or patchy disease, ileal inflammation, extracolonic inflammation, granulomatous inflammation in response to ruptured crypts, aphthous ulcers, transmural inflammation, microscopic colitis, diverticulitis and diversion colitis. The term “ulcerative colitis” or “UC”, as used herein, refers to a condition involving inflammation of the large intestine and rectum. The term “Crohn's disease” or “CD”, as used herein, to refers to a condition involving chronic inflammation of the gastrointestinal tract. Crohn's-related inflammation usually affects the intestines, but may occur anywhere from the mouth to the anus, as well as the skin, eyes, joints and more. CD differs from UC in that the inflammation extends through all layers of the intestinal wall and involves mesentery as well as lymph nodes. As used herein, CD may be one or more of several types of CD, including without limitation, ileocolitis (affects the ileum and the large intestine); ileitis (affects the ileum); gastroduodenal CD (inflammation in the stomach and the duodenum); jejunoileitis (spotty patches of inflammation in the jejunum); and Crohn's (granulomatous) colitis (only affects the large intestine). The term “irritable bowel syndrome” or “IBS”, as used herein, includes a group of functional bowel diseases or conditions characterized by one or more symptoms including, but not limited to, abdominal pain, abdominal discomfort, change in bowel pattern, loose or more frequent bowel movements, diarrhea, and constipation, typically in the absence of any apparent structural abnormality. There are at least three forms of IBS, depending on which symptom predominates: (1) diarrhea-predominant (IBS-D); (2)
[0064] 9
[0065] SUBSTITUTE SHEET (RULE 26) constipation-predominant (IBS-C); and (3) IBS with alternating stool pattern (IBS-A). IBS can also occur in the form of a mixture of symptoms (IBS-M). There are also various clinical subtypes of IBS, such as post-infectious IBS (IBS-PI) and a post-diverticulitis IBS. In some embodiments, IBS can be associated with inflammation. In certain embodiments, IBS is associated with inflammation in subjects with diarrhea-predominant (IBS-D) or with presumed post-infectious IBS (IBS-PI). When IBS is associated with inflammation, mucosal immune system activation may be characterized by alterations in particular immune cells and markers.
[0066] As used herein, “administration” of a composition or therapy refers to delivering the same to a subject, regardless of the route or mode of delivery. Administration may pertain to a single administration, a continuous one (i.e., without stopping, or at regular intervals without a predetermined end), or intermittently. Administration may be for treating a subject already confirmed as having a recognized condition, disease or disease state, or for treating a subject susceptible to or at risk of developing such a condition, disease or disease state.
[0067] "Effective amount” or “therapeutically effective amount” refers to that amount of a PBM therapy described herein which, when administered to a mammal (e.g., human), is sufficient to aid in treating a disease, alone or in combination with other treatments, such as, but not limited to, steroids, immune-modulating drugs, surgery or diet. The amount of PBM therapy that constitutes an effective amount will vary depending on the condition to be treated and its severity, the manner of administration, the age, weight and size of the mammal to be treated, but can be determined routinely by one of ordinary skill in the art having regard to her own knowledge and to this disclosure. When referring to an individual active component (e.g., light of a PBM wavelength or wavelengths), administered alone, an effective dose refers to that component alone. When referring to a combination, an effective dose refers to combined amounts of the active components (e.g., light of different wavelengths) that result in the therapeutic effect, whether administered serially, concurrently or simultaneously.
[0068] "Photobiomodulation,” also referred to as “PBM” herein, refers to the effect of light energy, typically of a wavelength from about 500 nm to 50,000 nm, to stimulate, suppress, or otherwise modulate a biological activity. PBM is distinguishable from other forms of light-based intervention, such as photoablating or photocoagulating lasers, in that it does not cause significant damage (e.g., cauterize, ablate, coagulate, kill, or scar) to target cells or tissue. Without being bound by theory, PBM may act at the cellular level by activating mitochondrial respiratory chain
[0069] 10
[0070] SUBSTITUTE SHEET (RULE 26) components, resulting in stabilization of metabolic function. For example, it has been suggested that cytochrome C oxidase (CCO) is a key photoacceptor of light in the far red to near infrared spectral range. Grossman et al., Lasers. Surg. Med. 22:212-218 (1998); Kara et al., J. Photochem. Photobiol. B. 27:219-223 (1995); Kara and Kolyakov, Photomed. Laser Surg. 23:355-361 (2005); Kara et al., Lasers Surg. Med. 36:307-314 (2005); and Wong-Riley et al., J. Biol. Chem. 280:4761- 4771 (2005) and US20210178178, all are incorporated herein as a reference.
[0071] It is according to one aspect of the invention wherein the electromagentic radiation is mixture of Near Infrared, Short Wave Infrared, Medium Wave Infrared, Long Wave Infrared and / or Far Infrared, namely NIR, SWIR, MWIR, LWIR and FIR (respectively) for Wavelength (pm) ranges of (0.78 ... 1.4), (1.4 ... 3.0), (3.0 ... 10.0), (10.0 ... 50.0) and (50.0 ... 1,000.0), respectively.
[0072] It is according to another aspect of the invention wherein the electromagnetic radiation is mixture of Midrange Infrared and Long Wave Infrared, namely MWIR and LWIR (respectively) for Wavelength (pm) ranges of (3.0 ... 10.0) and (100 ... 50.0), respectively.
[0073] It is according to yet another aspect of the invention wherein the electromagnetic radiation is mixture of MWIR and LWIR in a ratio of 1: 1 to 1:20, or otherwise 1:20 to 1:200, or otherwise 1:200 to 1:2000.
[0074] It is according to still another aspect of the invention wherein the electromagnetic radiation is mixture of (NIR + SWIR), LWIR and MWIR in ration of 1 : 1 : 1 to 1 :20:200, or otherwise 1 :20:200 to 1:200:8000.
[0075] Reference is now made to figure 1, schematically illustrating in an out-of-scale manner a wearable garment 100 for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission. The garment comprises, within its inner portion, facing the belly, at least one area 1. Either within or in connection with area 1, there are provided both a massaging module 20 for belly massaging and at least one, or otherwise a plurality or an array of IR emitters 11 and 12, configured for emitting electromagnetic radiation ranging from 0.8 to 50 microns, providing room temperature to 70 degrees Celsius. A power source is not shown here.
[0076] The term "massage" refers in a non-limiting manner to a combination of moving and pressing.
[0077] In one embodiment of the invention, at least one portion of the IR emitters is static. In another embodiment of the invention, at least one portion of the IR emitters is movable, e.g., in a
[0078] 11
[0079] SUBSTITUTE SHEET (RULE 26) mechanical sliding mechanism, a "printer head" mechanism, a pan-tilt-zoom (PTZ) mechanism, electric or magnetic facilitated mechanism, pneumatic or hydraulic mechanism, etc.
[0080] In one embodiment of the invention, at least one portion of area 1 comprises or is otherwise connected to a belly massaging module 20. In one embodiment of the invention, the module 20 comprises an endless flexible tube, e.g., rubber pipe, elastomeric sleeve or silicone conduit, filled with thermoregulated fluid, adapted to either or both to heat or cool the body by a pump / thermoregulator module 21. The fluid, e.g., water, salt, air, is periodically compressed, so that a peristaltic motion 24 (see inflation 23 deflation 22) is provided, gently and controllably massaging the belly portion.
[0081] Additionally, or alternatively, an array of vertically-reciprocating massaging members for pressing belly portions in a timely manner (module 29) is provided. Hence as an example, a plurality of fluid-filled inflatable structures (protrusions, bubbles or fingers-like members), configured to exert a net force upon a body or a body portion in a defined manner along a time period. The module is operable in a manual, hydraulic, pneumatic, mechanic, electric or a combination of the same, in a manner utilizable for reversibly and temporarily increase (inflate 26) or decrease (deflate 25) a pressure (different tensions along time, see dashed line depicting a sinus-curve 26a) in the inflatable structures, as previously disclosed e.g., in US11071678.
[0082] Additionally, or alternatively, the inflatable structures are transparent to an IR beam, concurrently emitted to the body (e.g., belly portion). The emission is applicable in various manners: perpendicular to the body portion, in a tilted manner, towards a belly portion, towards body side portion, towards body rear portion, and any combination thereof. Box 29 schematically illustrates hydraulic / pneumatic massager, where fluid inflows 27a to inlet 27, compresses finger-like inflatable sleeve 26 located in a specific location in an array of inflatable structures, then outflows 28a via fluid outlet 28. Emitter 12 and / or sensor 13 are provided under, above or in connection with the inflatable structures.
[0083] Reference is still made to figure 1. It is well in the scope of the invention wherein the electromagnetic radiating device integrates, stores and / or is feedbacked by time -resolved and offline anatomical data from intestinal imaging, such as, CT, MRI, US, or from colonoscopy reports, in order to direct the treatment more efficiently to inflamed areas. Hence, either or both the massaging and the electromagnetic radiating modules are interconnectable with at least one sensor 13, e.g., imaging sensor, thermal sensor, conductivity sensor, acoustical sensor, EKG, heart
[0084] 12
[0085] SUBSTITUTE SHEET (RULE 26) rate monitors; minimally invasive temperature probes; force sensors; pressure sensors; oximeter; glucometer; magnetometer; electrocardiogram sensor; heart rate sensor; electroencephalogram sensor; electromyogram sensor; respiration rate sensor; skin impedance detectors etc.
[0086] In an embodiment of the invention, the IOT-IR emitter 10 is wirelessly intercommunicated with a remote computer 14, for effectively and timely regulating the therapy by regulating an IR controller 15.
[0087] Reference is further made to figure 1. Another embodiment of the invention is a non-wearable, non- or semi-portable systems (200, 300), used for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission. The system is characterized by an IR emitter configured for emitting electromagnetic radiation ranging from 0.8 to 50 microns, providing room temperature to 70 degrees Celsius, e.g., 37 to 45 degrees Celsius, 22 to 37 degrees Celsius, or 37 to 57 degrees Celsius.
[0088] Hence, system 200 comprises e.g., a mattress 29 on bed 202, with the hydraulic / pneumatic massager (29) on which a patient 201 lays face down.
[0089] Alternatively, or additionally, as shown in box 300, patient 201 is laying on top of a mattress 29, face up, and both (a) an IR robotic emitter 302, and (b) massaging robotic arm 301 are concurrently treating him / her.
[0090] Reference is now made to figure 2, schematically illustrating in an out-of-scale manner a method of treating a patient with inflammatory bowel disease, comprising providing patient, directly or indirectly, e.g., by using the jacket 100 defined above, with an IR emitter and a massaging module, and administering, namely heating and massaging patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, ranging from 0.8 to 50 microns, room temperature to 70 degrees Celsius at least one a week. A set of six schemes 40-45 is shown, where the X axis is time (e.g., minutes), the left Y axis is heating intensity, and the right Y axis (dashes lines) is pressure provided on a certain area of the belly outmost surface. In Scheme 40, heating 34 is emitted on the certain belly area portion continuously and periodically, and pressure maxima are either at heat maxima 35 or at heat minima 36. In Scheme 41, heating and massaging are provided in an intermittent manner so that massaging in that area is provided only or especially when heating stops. In Scheme 42, heating at a certain area is provided continuously and periodically, at a somewhat constant intensity whilst pressure applied along the massaging is
[0091] 13
[0092] SUBSTITUTE SHEET (RULE 26) not steady, namely increases, or decreases, or both. In Scheme 43, both heating intensity and pressure applied by the massaging is not at a constant level, and both may increase, or decrease, or both. In Scheme 44, heating at a certain area decreases, or vice versa, increases, whilst massaging intensity (amplitude, frequency or both) increase, or vice versa, decreases. In Scheme 44, heating by IR electromagnetic radiation is provided either as a continuous wave, or pulsed. The electromagnetic radiation may be characterized as rectangular profile, sinusoidal profile, sawteeth profile or any combination thereof.
[0093] It is well in the scope of the invention wherein the electromagnetic radiating device can easily cause burns if it is held on a given skin area for longer than a few seconds, but the heat might be necessary in order to produce a strong enough infrared radiation. Cooling the skin during the treatment is hence an important part of the invention.
[0094] It is also in the scope of the invention wherein the electromagnetic radiating module(s) is / are configured for automatically moving along the abdomen and / or lower back while applying pressure, and will be guided by a proprietary algorithm, which may or may not include artificial intelligence tools, that will record hot-spots (both by integrating data reported from the patient, and by measuring skin temperature), will cool the skin, and potentially also contain an additional heating mode, and additional wavelengths. Movement of the device is an important part of the invention.
[0095] The cooling surface may be a thermally conductive electrode providing power to the source. Alternatively, the cooling surface may be a surface of a thermally conductive heat sink that is thermally coupled to the source as defined in US8182473B2. Additionally, or alternatively, contact surface may be cooled through the use of a coolant evaporator house within a blind bore formed in aluminum block. The coolant, which may be of various commercially available types, commonly Freon® or other fluorinated hydrocarbons, is directed to evaporator through a coolant liquid line and is recycled back to a refrigerant compressor through a coolant vapor return line as defined in US8474463B2. Cooling may also be administered by cool air or an electrically refrigerated surface. Cooling may be administered concomitantly with the IR emission, or immediately following it. The cooling module may be part of the IR emmiter, detached from it, or surrounding it.
[0096] 14
[0097] SUBSTITUTE SHEET (RULE 26) It is also in the scope of the invention wherein this medical device is controlled manually in addition to the automatic mode, in order to avoid skin burns and in order to customize the treatment per patient. The parameters entered by the patient will be integrated into a personalized database.
[0098] EXAMPLE 1
[0099] Treatment consists of about 30 to about 60 minutes of administering, namely irradiating and massaging the abdomen with a therapeutically effective amount of photobiomodulating energy by using the Onnetsu™ device commercially available by MITSUI ONNETSU Co (JP), a midinfrared emitting device, utilizing about 8 to about 10 microns wavelength, once or twice a week. The device's temperature ranges from about 45 to about 70 degrees Celsius. After achieving remission, treatment intervals can be longer (once every 2-3 weeks). We also apply pressure on the abdomen while working with the device. We find that this pressure appliance is critical, and it is part of the novel invention (current devices do not apply pressure). As part of the treatment, we locate regions that feel subjectively or objectively warmer. These "hot-spots" might correspond to inflamed regions in the intestines, and locating such hot-spots automatically is also part of the invention.
[0100] EXAMPLE 2
[0101] The anti-inflammatory effects of IR therapy led us to hypothesize that IR therapy will be a safe and efficient treatment for CD patients.
[0102] Preliminary data demonstrate that weekly sessions of IR administration to the abdomen of clinically and biomarker-active CD patients (n=7), significantly improved clinical symptoms (specifically abdominal pain and number of bowel movements) and decreased fecal calprotectin (Fcal) level. In fact, all patients demonstrated clinical response to the therapy and 4 of the 7 patients (57%) achieved complete clinical remission after 10 sessions of such treatment. Fcal of 6 patients, for whom data was available before and after the intervention, dropped from an average of 471 ug / g [116-889] to 153 ug / g [31-478].
[0103] EXAMPLE 3
[0104] Treatment is provided useful by using an IR emitting jacket, configured for administering PBM in a protocol which comprises one step or a train of steps of, e.g., about 5 to about 60 minutes of
[0105] 15
[0106] SUBSTITUTE SHEET (RULE 26) irradiating and / or irradiating-massaging and / or massaging the abdomen by an infrared device (about 0.8 to about 50 microns wavelength), once or twice a week. The jacket inner temperature ranges from about 24 to about 37, from about 40 to about 50, or about 60, or about 70 degrees Celsius. The jacket inner humidity ranges from about 50% to about 60%, from about 40% to about 60%, or about 70%, or about 80% or more.
[0107] The term jacket refers here to a wearable item, garment, coat, waistcoat, clothing or the like, at least partially provided on top the upper body. It may envelop a body portion below and above the hip, around the abdomen or belly.
[0108] EXAMPLE 4
[0109] IR emitting jacket, configured for administering PBM in a protocol as defined in any of the above. The term "jacket" refers here to a wearable item, garment, coat, waistcoat, clothing or the like, at least partially provided on top the upper body. It may envelop a body portion below and above the hip, around the abdomen or belly.
[0110] EXAMPLE 5
[0111] IR emitting and massaging fixed construction(s), such as a bed, mattress, futon, pillow, support, or the like. Similarly, a wearable (e.g., a jacket-like configuration), a movable or a portable IR emitter, utilized in conjunction with a massaging fixed construction.
[0112] EXAMPLE 6
[0113] IR emitting and massaging robotic arm(s). Similarly, a wearable (e.g., a jacket-like configuration), a movable or portable IR emitter, utilized in conjunction with a robotic massaging module, provided e.g., in connection with a portable or fixed constructions.
[0114] EXAMPLE 7
[0115] Reference is now made to figure 3, defining a flowchart for the operation of one or an array of IR emitters configured for treating a patient with inflammatory bowel disease by administering patient's outermost upper, lower or side-surface with a therapeutically effective amount of photobiomodulating infrared emission, characterized by that the IR emitter is provided with means for emitting electromagnetic radiation ranging from 0.8 to 50 microns, providing room temperature
[0116] 16
[0117] SUBSTITUTE SHEET (RULE 26) to 70 degrees Celsius, according to an embodiment of the invention. The IR emitter applies a controlled pressure on a tissue; e.g., between 0 to about 15 kg / cm2. The pressure is applied normal to a body tissue, or in angles up to 45 degrees.
[0118] Additionally, or alternatively, and according to an embodiment of the invention, IR is emitted in a wavelength of between about 0.8 to about 50 microns. Temperature created by the emitter ranges between room temperature to 70 degrees Celsius, e.g., about 22 to about 57 degrees Celsius. A cooling system is applicable and utilizable. The emission may target abdominal tissues.
[0119] Additionally, or alternatively, and according to an embodiment of the invention, emitter(s) (or a collimator thereof) is / are placed on at least one carrier configurable to move along XYZ axes, and potentially rotatable or tiltable around, or in respect to the XYZ axes.
[0120] Additionally, or alternatively, and according to an embodiment of the invention, emitter moves in a velocity of 0 to about 30 cm / sec, using e.g., at least one actuator, and having e.g., at least one accelerator, accelerating sensor or locator thereof. Optionally, the carrier is located in or in connection with a robotic arm.
[0121] Additionally, or alternatively, and according to an embodiment of the invention, the emitter(s) or carrier thereof are connected to a frame that is position proximate to the tissue to be treated. The actuator may be, or may comprise, or may be provided in connection with a member of a group consisting of electric motor, hydraulic piston, pneumatic actuator.
[0122] Additionally, or alternatively, and according to an embodiment of the invention, the emitter contains or otherwise in communicable with a pressure sensor; temperature sensor; a tissue cooling module, and any combination thereof.
[0123] Additionally, or alternatively, and according to an embodiment of the invention, a control system is utilizable to regulate both massaging module and emitter, and other optional modules, such as sensors, cooling system etc. The controller may be operatable in connection with a pre-determined scanning and pressure program, databases, such as patient-related predefined characteristics etc. The control system optionally enables recording of a manual scanning and pressure path. Optionally, it includes an external user interface, GUI or communicable device (smartphone, smart watch, computer interface located in a remote location etc.) that enables to stop the treatment, to change at least one of the treatment parameters, to alarm operator located either near the patient in a remote location, or any combination thereof.
[0124] 17
[0125] SUBSTITUTE SHEET (RULE 26) EXAMPLE 8
[0126] IR emitting jacket as defined in any of the above, configured for administering both PBM and a massage in a protocol as defined in any of the above. PBM is administrated by IR emitter, LED, laser etc. It is well in the scope of the invention wherein infrared emitters comprise a usable peak emission wavelength ranging from 0.8 to 50 pm. Within this range, there are three subdivisions. Those subdivisions are long, medium and short wavelengths. Long wave emitters, fIR, have a peak emission range in the 3-50 pm range. This range generally refers to ceramic elements which consist of a FeCrAl resistance coil embedded into either a solid or hollow constructed, highly emissive ceramic body. Ceramic emitters are manufactured by Ceramicx™ in a number of industry standard sizes with either flat or curved (trough style) emitting surfaces. Hotter peak emission wavelengths are achieved by higher-using emission sources with higher surface temperatures. Quartz cassette style emitters are available in similar industry standard sizes to that of ceramic, and they consist of a series of translucent quartz tubes built into a polished aluminized steel housing. These emitters can operate with higher front surface temperatures and emit in the long to medium wave range. At the shorter end of the medium wave range is the quartz tungsten infrared emitter. This consists of a sealed linear clear quartz tube containing a star design tungsten coil. The tungsten coil provides a fast response time with low thermal inertia. At the shorter end of the spectrum lies the shortwave halogen range. The basic construction is similar to that of the fast medium wave tungsten emitter with the exception that a round tungsten coil is used instead. The higher coil temperature results in the generation of white light and a peak emission wavelength in the short-wave range. As an example, Ceramic Elements are used for emitting 2 to 10 pm. Quartz Elements are used for emitting 1.5 to 8 pm. Quartz Tungsten Tubes are used for emitting 1.6 to 2 pm. Quartz Halogen Tubes are used for emitting 1.0 to 1.4 pm.
[0127] Another example is using IR-LEDs, as those presented by Elhamdi, I., et al. "A far -red-emitting ZnAl 1.95 Cr 0.05 O 4 phosphor for plant growth LED applications. " Dalton Transactions (2023). Another example is using far-infrared-emitting fabric, as presented by Silva, et al. "A pilot study on the effects of far-infrared-emitting fabric on neuromuscular performance of knee extensor and male fertility." Lasers in Medical Science 37.9 (2022): 3713-3722. The IR is composed of a fabric with EMANA® technology (Rhodia Poliamida Especialidades LTDA) and emissive properties within the far-IR (> 3 pm), see also in Silva, et al. "Far-infrared-emitting fabric improves
[0128] 18
[0129] SUBSTITUTE SHEET (RULE 26) neuromuscular performance of knee extensor." Lasers in Medical Science 37.5 (2022): 2527- 2536; and WO2013175289A2 , all of the above are incorporated herein as a reference.
[0130] Another example is using garments made with a commercially available THERMOLITE® INFRARED by The LYCRA Company (UK) technology increase their temperature when exposed to solar or artificial light. This fiber uses near infrared yarns with proprietary additives to transform the energy of near infrared rays into heat the wearer can feel. In addition, the system’s integrated high-quality insulation traps air and minimizes heat loss for enhanced comfort in cold temperatures, this garment is useable, e.g., alone or in a combination with a commercially available IR-SKIN® by Yooneek®, namely a textile fabric infused with Titanium fibers that enhance the body’s own IR emissions, unlike many other thermal insulations. IR-SKIN® reflects IR back into the derma layer of your body ensuring that energy radiated by the body is recovered to positively affect performance capacity and wellbeing.
[0131] EXAMPLE 9
[0132] The present invention provides a method of treating a patient with inflammatory bowel disease. The method comprises steps of administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, ranging from about 0.8 to about 50 microns, providing up to about about 70 degrees Celsius, optionally with a continuous or pulsed cooling. When emitting, the emitter is pushed towards the patient, and presses the outermost abdominal surface inwardly towards the intestines for at least about 4 mm or otherwise about 50 mm, at least 4 mm; or otherwise at least 20 mm, at least 40 mm , no more than about 95 mm, no more than about 85 mm. The pressure is provided continuously or in an intermittent manner for a period of time of about 10 to about 60 min. In some cases, this method is effective when the electromagnetic radiation is a mixture of (NIR + SWIR), LWIR and MWIR in ratio of 1:2:2 to 1:20:200. In other cases, this method is also effective when the electromagnetic radiation is a mixture of (NIR + SWIR), LWIR and MWIR in ratio of, or otherwise about 1 :20:200 to about 1:200:8000.
[0133] The present invention also provides a method of treating a patient with inflammatory bowel disease, comprising a step of wearing a garment. The garment, in at least one of its portions, comprises or otherwise is provided in connection with a device as defined in any of the above. The method further comprising steps of administering patient's outermost abdomen surface with a
[0134] 19
[0135] SUBSTITUTE SHEET (RULE 26) therapeutically effective amount of photo-biomodulating infrared emission; emitting electromagnetic radiation ranging from about 0.8 to about 50 microns, providing about room temperature to about 70 degrees Celsius, optionally by a continues or pulse-wise cooling; when emitting, the emitter is pushed towards the patient, for applying the emitter towards patient body forces, selected from high forces (about 3 to about 1.5 kg cm'2) and low force (about 1.5 to about 0.5 kg cm'2) for a period of time of about 10 to about 60 min. In some cases, this method is effective when THE electromagnetic radiation is a mixture of (NIR + SWIR), LWIR and IR in ratio of about 1:2:2 to 1:20:200. In other cases, this method is also effective when the electromagnetic radiation is a mixture of (NIR + SWIR), LWIR and IR in ratio of, or otherwise about 1 :20:200 to 1 :200: 8000.
[0136] EXAMPLE 10
[0137] In accordance with an embodiment of the invention, the operator's manual, GUI, and operating system are configured to control movement, force, and the delivery of electromagnetic radiation. As illustrated in Fig. 3, various methods and means for operation are provided as non-limiting examples.
[0138] A transducer is applied vertically to the tissue and is capable of movement along the X, Y, and Z axes and rotations thereof. The emitter is designed to tilt along at least one axis, with its movement adjustable to varying speeds, ranging from 0 to about 10 cm / sec. The emitter's mobility is particularly beneficial when it applies variable force, within a range of 0 to about 6 kg / cm2.
[0139] According to another embodiment of the invention, the scanning process is facilitated by the movement of the emitting head during operation. This movement divides the treatment area, such as the abdomen, into a series of sections, typically between 3 and 24 segments. Mapping is tailored to accommodate diverse shapes, sizes, and heights of treatment areas. Additionally, movement and pressure can be configured differently in each section, incorporating parameters such as pressure, duration, and thermal output.
[0140] In a further embodiment of the invention, sensing capabilities are included for various parameters including force, temperature, proximity, and angle. Mapping functionalities are also available for manual scanning of surfaces, visualization through cameras, and real-time mapping during operation.
[0141] 20
[0142] SUBSTITUTE SHEET (RULE 26) This invention recognizes the importance of patient feedback, allowing for adjustments in treatment parameters based on pain scale reports, emergency stop requests, and modifications to heat and force levels for each treatment section.
[0143] Moreover, the operation of the device and its modules is enabled in several ways: through manual scanning; adjusting heat and force levels in each section while treatment mapping is performed by the operator; and utilizing a control panel specifically designed for the operator to manage parameters for each section.
[0144] In addition, system fixation options are presented in a non-limiting manner that includes fixation to a bed, fixation to the body, and / or fixation to a stand with or without wheels.
[0145] Heating is accomplished through far -infrared emission, with wavelengths ranging from about 2.8 to 50 microns, optionally combined with further temperature control to achieve temperatures between about 37 and 70 degrees Celsius.
[0146] Furthermore, the invention provides a cooling system for the emitter, allowing for control over the surface temperature. Operators also have the flexibility to select the types, values, measures, and operational profiles of the emitters and / or LEDs.
[0147] The embodiments described above are illustrative examples and it should not be construed that the present invention is limited to these particular embodiments. Thus, various changes and modifications may be affected by one skilled in the art without departing from the spirit or scope of the invention as defined in the appended claims.
[0148] 21
[0149] SUBSTITUTE SHEET (RULE 26)
Claims
CLAIMS1. An IR emitting device for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, comprising an emitter for emitting electromagnetic radiation ranging from 0.8 to 50 microns, providing room temperature to 70 degrees Celsius; when emitting, said emitter is pushed towards the patient, so that said outermost abdomen surface is pressed inwards towards the intestines for one the following: at least 4 mm or about 50 mm, at least 4 mm; or otherwise at least 20 mm, at least 40 mm , no more than about 95 mm, no more than about 85 mm.
2. The device of claim 1 , further comprising a belly massager whilst emitting IR for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface; characterized by that it further comprises a massaging module provided with means for applying said emitter towards patient body with forces selected from high forces (1.5 to 10 kg cm'2) and low forces (0.1-1.5 kg cm'2).
3. The device of claim 1, wherein the electromagnetic radiation is mixture of (NIR + SWIR), LWIR and MWIR in ratio of 1: 1:1 to 1:20:200;4. The device of claim 1, wherein the electro radiation is mixture of (NIR + SWIR), LWIR and MWIR in ratio of 1:20:200 to 1:200:8000.
5. The device of claim 1, provided in a wearable garment.
6. A wearable garment comprising the device of claim 1.
7. The device of claim 2, provided in a wearable garment.
8. A wearable garment comprising device of claim 2.
9. The device of claim 1 , comprising a robot-arm for treating a patient with inflammatory bowel disease by administering the patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission.
10. The device of claim 2, comprising a robot-arm for treating a patient with inflammatory bowel disease by administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission.
11. A static system comprising the device of claim 1.
12. A static system comprising the device of claim 2.22SUBSTITUTE SHEET (RULE 26)13. A method of treating a patient with inflammatory bowel disease, comprising administering the patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, ranging from 0.8 to 50 microns, emitted by an emitter, and providing room temperature to 70 degrees Celsius, optionally with a continuous or pulsed cooling; when emitting, said emitter is pushed towards the patient, and presses said outermost abdomen surface inwardly towards the intestines for at least 4 mm for one the following: at least 4 mm or about 50 mm, at least 4 mm; or otherwise at least 20 mm, at least 40 mm , no more than about 95 mm, no more than about 85 mm.
14. ; said pressure is provided continuously or in an intermittent manner for a period of time of 10 to 60 min.
15. A method of treating a patient with inflammatory bowel disease, comprising wearing a garment comprising the device of claim 2, and then administering the patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, comprising emitting by an emitter electromagnetic radiation ranging from 0.8 to 50 microns, providing room temperature to 70 degrees Celsius, optionally with a continuous or pulsed cooling; when emitting, said emitter is pushed towards the patient, with forces selected from high forces (1.5 to 10 kg cm'2) and low forces (0.1 -1.5 kg cm'2) for a period of time of 10 to 60 min.
16. A method of treating a patient with inflammatory bowel disease, comprising wearing a garment comprising the device of claim 1, administering patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, comprising emitting by an emitter electromagnetic radiation ranging from 0.8 to 50 microns, providing room temperature to 70 degrees Celsius, optionally with a continuous or pulsed cooling; when emitting, said emitter is pushed towards the patient, and presses said outermost abdomen surface inwardly towards the intestines for at least 4 mm; said pressure is provided continuously or in an intermittent manner for a period of time of 10 to 60 min.
17. A method of treating a patient with inflammatory bowel disease, comprising wearing a garment comprising the device of claim 2, and then administering the patient's outermost abdomen surface with a therapeutically effective amount of photobiomodulating infrared emission, comprising emitting by an emitter electromagnetic radiation ranging from 0.8 to 50 microns, providing room temperature to 70 degrees Celsius, optionally with a continuous23SUBSTITUTE SHEET (RULE 26)or pulsed cooling; when emitting, said emitter is pushed towards the patient with forces selected from high forces (3 to 10 kg cm'2) and low force (0.1 to 1.5 kg cm-2).
18. The method of claim 14, wherein the electromagnetic radiation is mixture of (NIR + SWIR), LWIR and MWIR in ratio of 1: 1:1 to 1:20:200.
19. The device of claim 14, wherein the electromagnetic radiation is mixture of (NIR + SWIR), LWIR and MWIR in ratio of 1:20:200 to 1:200:8000 , or otherwise.
20. The method of claim 15, wherein the electromagnetic radiation is mixture of (NIR + SWIR), LWIR and MWIR in ratio of 1: 1:1 to 1:20:200.
21. The device of claim 15, wherein the electromagnetic radiation is mixture of (NIR + SWIR), LWIR and IR in ratio of, or otherwise 1:20:200 to 1:200:8000.
22. The method of claim 16, wherein the electromagnetic radiation is mixture of (NIR + SWIR), LWIR and MWIR in ratio of 1:2:2 to 1:20:200.
23. The device of claim 16, wherein the electromagnetic radiation is mixture of (NIR + SWIR), LWIR and MWIR in ratio of, 1:20:200 to 1:200:8000.24SUBSTITUTE SHEET (RULE 26)
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