Patent Application
20250073503
The present disclosure relates generally to wearable harnesses, and, more specifically, wearable harnesses for securing and positioning an ultrasound device on a subject.
The nervous system is the major system that controls, regulates, and communicates between the body and the brain. Bioelectronic medicine is based on the idea that stimulating a nerve can affect biological functions. More and more medical devices applied to nerves are emerging as treatment for diseases, from regulating blood glucose levels to curbing pain, and even treating inflammatory disease such as rheumatoid arthritis, etc. Bioelectronic biomedicine technologies include anything from electrical signal to electro-magnetic fields to even ultrasound, and there has been development of both invasive implantable devices that are wrapped around a nerve or non-invasive stimulation such as cochlear and nerve stimulation at the surface of the skin. More recently, Cotero et al. showed that suborgan non-invasive low-intensity ultrasound can alleviate cytokine production and even hyperglycemia in a model of endotoxin-induced hyperglycemia and cytokine production. Furthermore, Huerta et al. showed that focused ultrasound can alleviate liver inflammation and reduce fat accumulation in an obese pre-clinical model. The results were comparable with traditionally invasive vagus nerve stimulation (VNS) devices that have been shown to induce a similar response, suggesting the possibility that a non-invasive approach via ultrasound can have a similar clinical effect as the more invasive approaching of directly stimulating the relevant nerve via implantable electrodes or cuffs.
Development of invasive electrical stimulation devices to treat chronic diseases is ongoing.
With respect to inflammatory diseases, the cholinergic anti-inflammatory pathway is known to modulate the mammalian immune response. The parasympathetic vagus nerve can transmit signals from the brain to the adrenergic splenic nerve, which interacts with splenic immune cells to modulate the immune system. The splanchnic sympathetic nerves synapse at the celiac-superior mesenteric plexus ganglion with the splenic nerve. Specifically, stimulation of the splenic nerve releases norepinephrine which stimulates splenic T cells that can then subsequently signal to the cytokine producing macrophages to reduce pro-inflammatory cytokine production. VNS has been shown to reduce production of cytokines like TNF-α and other interleukines associated with inflammatory diseases like rheumatoid arthritis, Crohn's disease, chronic kidney disease, and psoriasis. Furthermore, ultrasound stimulation has shown to be able to induce similar electrical activity for treatment of peripheral neuropathic disease in the clinic.
With respect to kidney/organ rejection/organ transplant, every 10 minutes, a patient (e.g., human or subject) is added to the national kidney transplant waiting list. In 2019, 91,834 kidneys were transplanted worldwide, costing $40.6B. In 2018, 20,000 kidneys were transplanted in the USA, meeting 20% of the US demand alone. Kidney transplantation is the only curative treatment for patients with end-stage renal disease who have a 70% 5-year mortality on dialysis. End-stage renal disease patients often require dialysis three times a week at a medical center, considerably reducing their quality of life. Global Burden of Disease study attributes 2.17% of deaths every year and 1.47% of disability-adjusted life years (DALYs) to chronic kidney disease. Unfortunately, up to 30% of people who receive a kidney transplant experience some degree of rejection, and this number has not been significantly changed in the past 40 years. Most rejections occur within six months after transplantation but can occur at any time, even years later. Prompt treatment can reverse the rejection in most cases and prevent further organ damage, but current treatments are mostly anti-inflammatory drugs and immunosuppressant drugs that have undesirable side effects, are hard to personalize, and are not ideal for long-term use.
In addition, there are studies showing that kidney transplant patients have elevated cytokine levels related to a systemic inflammatory response to the foreign organ, and that this is an underlying cause of kidney rejection.
Noninvasive ultrasound (US) stimulation targeting the spleen has been explored as a safe and effective alternative to invasive or systemic anti-inflammatory treatment. US stimulation targets the cholinergic anti-inflammatory pathway consisting of the vagus nerve to spleen circuit. This treatment was shown to have protective and therapeutic effects a K/BxN serum-transferred model of inflammatory arthritis, a rheumatoid arthritis (RA) mouse model, both when it was applied before or at the beginning of the disease. Single-cell RNA sequencing revealed that in T and B-cells, certain genes are upregulated in arthritis mice after receiving US treatment. Those genes included transcription factors c-Jun and JunB. C-Jun and JunB can form dimers, thus forming the transcription factor AP-1, which induces the transcription of pro-inflammatory genes. Further, both B and T-cells increased the transcription of genes involved in microtubule formation (like Ssh2) and crosslinking upon US treatment. This suggests that alterations in the cytoskeleton could alter the polarization or migration of lymphocytes, so that immune cell infiltration and inflammation are reduced. This is supported by the finding that upon vagus nerve stimulation, B cells showed reduced antibody production migration, which led them to aggregate in the marginal zone of the spleen. This demonstrates that the anti-inflammatory pathway regulates immune cell migration. Further, splenic US treatment of rats with intra-abdominal sepsis decreased TNF-α and MCP-1 levels.
In mice exposed to US before renal ischemia, the treatment protected kidney function and morphology, mediated by CD4+ T-cells. T-cell dependency of this effect was confirmed by using both an α7nAChR agonist and antagonist as well as α7nAChR deficient mice, which did not show the protective effect. This study identified the cholinergic anti-inflammatory pathway as an essential mediator of the anti-inflammatory effect of ultrasound, possibly by interacting with the splenic nerve, as it was previously shown to be the case in sepsis. The isolation and transfer of splenocytes from ultrasound treated mice into naïve mice alone had a protective effect on the kidney during IRI and CLP-induced sepsis, suggesting that ultrasound treatment may have changed the phenotype of these cells. Further, it has been demonstrated that this effect depends on the splenic nerve, as the deleterious effect of a splenectomy was also achieved by splenic denervation alone. This supports the findings that suggest that the spleen is involved in modulating inflammation during kidney injury mediated by the splenic nerve.
The α7 nicotinic acetylcholine receptor belongs to a family of ion channel receptors. Various types of immune cells, like B-cells, T-cells, microglia, monocytes and macrophages or dendritic cells, express the α7 nicotinic acetylcholine receptor and therefore respond to nicotine. Acetylcholine binding to α7nAChR triggers Ca2+ and sodium influx, which leads to neurotransmitter release in neuronal cells. In non-neuronal cells, Ca2+ influx causes calcium to be released from stores. In addition, kinases and phosphatases are activated, which results in signaling cascades that are independent from ion flux. For example, α7nAChR activation can inhibit TLR3/4/9 signaling, which promote the secretion of pro-inflammatory cytokines. In macrophages, the receptor can recruit Jak2, which induces the phosphorylation and activation of STAT3. This pathway is associated with the production of anti-inflammatory mediators. Downstream, it prevents the activation of the pro-inflammatory NF-kB pathway, which triggers pro-inflammatory cytokine production. Further, p38 MAP-kinase activation is inhibited, which prevents the release of pro-inflammatory cytokines like TNFa. In T-cells, it was suggested that the expression of α7nAChR is up-regulated during immune activation. Treatment with nicotine was shown to reduce T cell proliferation and the release of pro-inflammatory Th1 (TNF, IFN-y) and Th17 (IL-17, IL-17FIL-21, IL-22) cytokines, while anti-inflammatory IL-4 levels were increased. The activation of the receptor promoted a shift from Th1 to Th2 cells. NF-kB activation and IL-2 production were reduced after treatment. These effects were sufficient to reduce experimental autoimmune encephalomyelitis severity as well as immune cell infiltration and demyelination.
Further, US treatment inhibited the recruitment of neutrophils and myeloid cells into the kidney during renal ischemia. Macrophages play a key role in inflammation by producing cytokines. Therefore, modulating their activity may be a promising approach to treat or prevent inflammation in acute kidney rejection (AKI). Adrenergic stimulation was shown to inhibit the secretion of pro-inflammatory cytokines like TNF-a or IL-6 by splenic macrophages in a sepsis mouse model through an up-regulation of IL-10. This process is thought to be mediated by protein kinase A. The same effect was observed in an endotoxemia model, where vagus nerve stimulation reduced TNF production by macrophages in the spleen, while α7 KO abolished this effect. Modulation of splenic macrophage behavior in inflammation depends on the cholinergic anti-inflammatory pathway specifically through a preganglionic, which originates in the dorsal motor nucleus of the vagus nerve, and a second postganglionic, originating in the celiac-superior mesenteric plexus, and projecting in the splenic nerve. Interestingly, the immunomodulary properties of splenic nerve stimulation seem to be translatable to other animal models and even humans. A study using pigs as a model for human splenic innervation demonstrated that splenic nerve stimulation protects the animals from cardiovascular damage and reduces cytokine production upon LPS exposure. In a rodent endotoxemia model, pro-inflammatory cytokines TNF, IL-6, IFN-y, IL-1β, IL-1a and IL-12 were reduced in splenic lysates after splenic ultrasound. A first study compared the effects of US treatment on healthy individuals and five RA patients. US treatment of the spleen of healthy individuals for only three minutes was sufficient to reduce TNF production in the blood when it was exposed to LPS ex vivo. Daily splenic US treatment of RA patients resulted in the reduction of mRNA levels of pro-inflammatory cytokines such as IL-1β and IL-8 by monocytes. In CD8+ T-cells, IFN-y transcription was inhibited. Apart from cytokine expression, cytokine receptors like those for TNF, IL-6, IL-17, IL-13 and IFN-y, were also down-regulated in monocytes. Further, pro-inflammatory pathways resulting in IL-6 or TNF production, like the NF-kB pathway, were inhibited. Pathways promoting monocyte migration were also downregulated, while the adaptive immune response and the circulating immune cell composition remained unchanged. This suggests that the treatment is safe and does not induce overall immune suppression. Intriguingly, splenic US is also tested as a COVID-19 treatment to decrease inflammation and reduce the length of hospitalization. A pilot clinical trial is set out to determine whether the US has a beneficial effect in severe COVID-19 infections (Trial number: NCT04803409). This may be a promising approach considering vagus nerve stimulation in an acute respiratory distress syndrome (ARDS) model decreased CXCL9 mRNA levels and the secretion of pro-inflammatory cytokines TNF-a and IL-1β while increasing IL-10 levels. Further, the treatment seemed to switch macrophage polarization from a pro-inflammatory M1 to an anti-inflammatory M2 phenotype.
Conventional ultrasound systems comprise multiple components, including—but not limited to—a transducer to direct ultrasonic waves into a subject's body, a handle or wand attached to the transducer, and a display screen. These ultrasound systems require a medical professional to operate and may utilize a conductive gel to fill air gaps between the transducer and the subject's body. In conventional ultrasound systems, the medical professional first applies the conductive gel to the subject's body, then holds the transducer in contact with the subject's body by continuously applying pressure through the handle or wand. The images produced are displayed in real time on the display screen. In order to position the transducer accurately, the medical professional moves the transducer across the subject's body until a target feature appears on the display screen. External measurement tools may sometimes be necessary to position the transducer accurately on the subject's body.
In some aspects, provided are wearable harnesses for securing and positioning an ultrasound transducer on a subject's body. The wearable harnesses provided herein can include two adjustable shoulder straps, an adjustable waist strap, a pocket for holding a power pack, and a securing portion for holding the transducer. In some embodiments, the pocket for holding the transducer is positioned over the subject's spleen.
The conventional ultrasound systems described above are typically used for medical imaging. In recent years, some ultrasound systems have additionally been modified for immunomodulation. During immunomodulation, the ultrasonic waves emitted by these ultrasound systems stimulate nerves, such as the splenic nerve, into modulating the immune system. Ultrasound immunomodulation may be desirable over other immunomodulation treatments because it is non-invasive and does not require drugs to modulate immune pathways.
Like conventional imaging ultrasound systems, the transducers of immunomodulatory ultrasound systems are typically positioned and operated by a medical professional during treatment. However, many subjects may desire to undergo at-home ultrasound treatment without requiring the presence of a medical professional for every treatment.
Accordingly, in certain aspects, the harnesses (e.g., garment or back brace) provided herein allow a subject to consistently position and operate the transducer over a target organ or nerve, such as the splenic nerve, without requiring the presence of a medical professional. Unlike the conventional handheld transducers described above, the transducers described herein are attached to a wearable harness that is fastened to a subject's body. The transducer is placed on the wearable harness with a securing portion/mechanism and positioned over the subject spleen, which contains the splenic nerve, by a medical professional. A separate pocket of the wearable harness holds a power pack for the transducer. Additionally, the wearable harness includes adjustable shoulder and waist straps so that a medical professional can adjust the harness to fit the subject's body and secure the transducer over the subject's spleen. In some embodiments, the harnesses described herein may be configured to position an ultrasonic transducer over a liver (sympathetic fibers from the celiac plexus and parasympathetic fibers from the anterior and posterior vagal trunks) or another organ or nerve. In some embodiments, a positioning grid may be provided on the adjustable straps and/or the transducer securing portion to assist in the positioning of the transducer. Once the straps are adjusted, the transducer will be positioned in the same location above the subject's spleen every time the harness is worn. Thus, the subject can wear, activate, and remove the harness without requiring a medical professional to readjust the harness before every ultrasound treatment. This enables the subject to receive at-home ultrasound treatment without the presence of a medical professional.
In some embodiments, the wearable harness may be in the form of a belt, vest, or patch, that allows for consistent stimulation of the target organ.
In some embodiments, the wearable harness stimulates the splenic nerve (by directly targeting the spleen) to reduce inflammatory markers in the body such as, but not limited to, TNF-alpha, IL6.
The wearable harness may be configured and used to stimulate any other nerve or organ to modulate physiological function. Advantageously, no medical professional is needed, and the ultrasound device can be worn directly on the skin, while the user goes about their normal daily activities.
In some embodiments, provided is a system for securing an ultrasound transducer over a spleen of a subject, the system comprising: a harness comprising: a front portion configured to hold a power pack; a rear portion connected to the front portion by a first shoulder strap and a second shoulder strap; an adjustable waist strap configured to wrap around a subject's waist and connect the front portion and the rear portion; and a transducer securing portion located on the adjustable waist strap and configured to be positioned over a spleen of a subject, wherein the transducer securing portion comprises a two-dimensional scale; and a treatment unit comprising: an ultrasound transducer configured to couple to the transducer securing portion of the harness; and a mechanical lens positioned between the ultrasound transducer and the subject, the mechanical lens comprising a plurality of concentric rings and configured to adjust ultrasonic waves emitted by the ultrasound transducer.
In some embodiments, provided a harness for positioning an ultrasound transducer to a subject, the harness comprising: a front portion configured to hold a power pack; a rear portion connected to the front portion by a first shoulder strap and a second shoulder strap; an adjustable waist strap configured to wrap around a subject's waist and connect the front portion and the rear portion; and a transducer securing portion located on the adjustable waist strap and configured to be positioned over a spleen of a subject, wherein the transducer securing portion comprises a two-dimensional scale.
In some embodiments, provided is a treatment unit comprising: an ultrasound transducer; and a mechanical lens comprising a plurality of concentric rings and configured to adjust ultrasonic waves emitted by the ultrasound transducer.
In some embodiments, provided is a system for securing an ultrasound transducer over a spleen of a subject, the system comprising: a harness comprising: a front portion configured to hold a power pack; a rear portion connected to the front portion by a first shoulder strap and a second shoulder strap; an adjustable waist strap configured to wrap around a subject's waist and connect the front portion and the rear portion; and a transducer securing portion located on the adjustable waist strap and configured to be positioned over a spleen of a subject, wherein the transducer securing portion comprises a two-dimensional scale, and an ultrasound transducer configured to couple to the transducer securing portion of the harness.
In some embodiments, provided is a harness for positioning an ultrasound transducer to a subject, the harness comprising: a transducer securing portion configured to receive an ultrasound transducer and secure the ultrasound transducer in a first location directly over a spleen of a subject.
In some embodiments, provided is a method of using a harness for positioning an ultrasound transducer to a subject, the method comprising: securing a treatment unit to a transducer securing portion of a harness; placing the harness on a subject such that the treatment unit is positioned over a spleen of the subject.
The invention will now be described, by way of example only, with reference to the accompanying drawings, in which:
In some aspects, provided are wearable harnesses positioning an ultrasound transducer to a subject's body. The wearable harnesses provided herein can include two adjustable shoulder straps, an adjustable waist strap, a pocket for holding a power pack, and a securing portion for holding the transducer. In some embodiments, the pocket for holding the transducer is positioned over the subject's spleen such that the ultrasound transducer may be positioned over the subject's spleen.
As explained above, conventional ultrasound systems are typically used for medical imaging. In recent years, some ultrasound systems are being used for immunomodulation. During immunomodulation, the ultrasonic waves emitted by these ultrasound systems stimulate nerves, such as the splenic nerve, into modulating the immune system in a non-invasive manner. Like conventional imaging ultrasound systems, the transducers of immunomodulatory ultrasound systems are typically positioned and operated by a medical professional during treatment.
Conversely, the harnesses provided herein allow a subject to consistently position and operate the transducer over a target, such as the splenic nerve, without requiring the presence of a medical professional. The transducers described herein are attached to a wearable harness that is fastened to a subject's body. The transducer is placed at a securing portion of the wearable harness that is configured to be positioned over the subject's spleen during proper fit and wear. When properly fit (e.g., adjusted) to the subject, the transducer can be positioned in the same location every time the harness is worn. Thus, the subject can wear, activate, and remove the harness without requiring a medical professional to readjust the harness before every ultrasound treatment. This enables the subject to receive at-home ultrasound treatment without the presence of a medical professional. In some embodiments, a harness can include commercially available and smart materials that can adapt to the body's shape, retain memory of the body, and ensure security of the ultrasound stimulator to provide continue ultrasound to a specific region of the target organ.
The wearable harnesses described herein can also be used to treat subjects shortly after an organ transplant. Unfortunately, only 20% of organ demand in the world is met. Even if a subject receives an organ transplant, one out of three subjects will reject their new organ. The current clinical standard is to put subjects on cocktails of immunosuppressant drugs, that have dangerous side-effects. No major advancements for the management of organ rejection have been seen for the past 40 years. Therefore, more personalized treatment is critical for the survival of these subjects.
Aspects and embodiments of the present invention can suppress the immune system via ultrasound stimulation of a target organ, such as the spleen, in a wearable device that the subject can use at home. Though the clinical effects are similar to the immune suppression observed with drugs, the typical dangerous side-effects are reduced as the system leverages the normal physiology of an individual which contains feedback mechanisms to prevent oversuppression. According to certain embodiments, by targeting the spleen and/or the splenic nerve, normal physiology can be controlled by inhibiting or enhancing its normal function. However, because the approach augments normal physiology, there is no risk for over-suppression as the body's normal feedback loop will be activated to prevent this side effect. According to certain aspects, the innovative design makes it possible for subjects to wear the device like a vest, without any knowledge of anatomy. As discussed in more detail below, according to certain examples, the device is configured to stimulate the spleen, the liver and nerves surrounding it with specific frequency or frequencies that have the desired effects. The wearable harness is fitted once at the clinic, and thereafter it can be modulated by the physician remotely with several parameters such as intensity, frequency, duration and more, depending on the subject response based on biomarker feedback that is taken periodically, e.g., once daily to once weekly, all personalized to the subject.
In some embodiments, the wearable harnesses described herein may, along with an ultrasound transducer, use low or high intensity focused ultrasound (LIFU/HIFU) to treat subjects with organ (e.g., kidney) transplants to prevent chronic or acute organ (e.g., kidney) rejection.
Embodiments of the wearable device are not limited to a wearable back brace, vest, or harness, but also include a patch design as well as a belt. Those skilled in the art, given the benefit of this disclosure, will appreciate that other wearable forms of the device may also be implemented. Regardless of the form or design of the wearable device, the device is configured such that it is fitted and rigid, so that it does not move during treatment.
Furthermore, embodiments of the wearable services and system disclosed herein allow clinics or hospitals to obtain monitored data from subjects. Any data collected during the wearable period may be collected. In some embodiments, the system may be used by subjects who suffer from acute or chronic organ (e.g., kidney) rejection; however, the system and methods of use disclosed herein can be applied to any other indication, not limited to kidney rejection. Embodiments may be used to treat any modulatory marker or any other biological function with the wearable device that can apply ultrasound stimulation to the body without any prior knowledge from the subject or person using it.
Embodiments of the device may be personalized to every single organ and subject. Embodiments of the device may replace all the immunosuppressant drugs, thus being able to deliver a personalized and home-based treatment approach that even has the potential to make studies into artificial kidney obsolete. Examples of advantages and value provided by embodiments of the device include the ability to provide opportunity to 1) reduce the cost of care (through fewer visits and early detection), 2) improve access to care (through home monitoring), and 3) improve outcomes (early detection and specific treatment means less organs wasted and therefore shorter organ transplant waiting list). Furthermore, the collection of data and the use of an artificial intelligence (AI) based cloud platform may allow for optimized and personalized care.
Unlike immunosuppressive drugs, where only the dosage can be adjusted, this technology has many parameters that can be personalized to the subject's need such as: location of stimulation, amplitude, pressure, and frequency of the stimulation, which can even be adjusted in real-time based on the monitored biomarkers. Furthermore, neuromodulation of the immune system via ultrasound stimulation of the splenic nerve may, over time, train the body to maintain a non-inflammatory state whereby the subject requires less immunosuppression via drugs or neuromodulation.
According to certain embodiments, the device can be compiled with companion monitoring devices as well as with artificial intelligence (through software algorithm, machine learning and/or other data processing methods) to predict and optimize the treatment regime. For example, embodiments of the wearable device described herein may include a communicator with a monitoring device (e.g., similar to a glucose monitor) to analyze the effect of the ultrasound stimulation, and either directly or through a cloud-based platform to provide optimization parameters to improve the stimulation.
A device according to certain embodiments is a closed-loop system that integrates biomarker monitoring with an ultrasound stimulator to evoke anti-inflammatory effects. Embodiments of the ultrasound stimulation device, packaged in the form of a wearable device, such as a belt, a patch or a back brace, for example. This technology is designed for the subject to bring home, which allows for the physician to treat subjects at home and adjust treatments remotely. Ultimately by treating subjects via bioelectronics, fewer organs will be fully rejected because they will be managed by the technology according to aspects and embodiments disclosed herein, and thereby resulting in a shorter organ waiting list. Bioelectronic medicine devices leverage the physiological mechanism, and thereby this treatment can never lead to a full suppression of the immune system unlike drugs, this therefore means that these subjects can taper off some of the immunosuppressant drugs with the most dangerous side effects, improving their quality of life significantly.
Data has shown that short periods of ultrasound stimulation of the spleen, vagus nerve, or the liver can reduce inflammatory cytokine markers in animal models and in humans. For example, one study shows that ultrasound stimulation of the spleen can be used to treat inflammatory arthritis in mouse models. Another study shows that ultrasound stimulation of the spleen reduces cytokine levels to the same levels as the more medically established procedure, implant-based vagus nerve stimulation. A third study shows that focused ultrasound on the porta hepatis can reduce cytokine markers in obese animals and reduce weight. A final study shows that ultrasound stimulation of the spleen lowers cytokines levels in humans.
Graft Rejection Mechanism: During allograft rejection, host immune cells, mostly T-cells and particularly CD4+ T-cells, recognize polymorphisms within the MHC and the minor histocompatibility complex. The T-cells can either be activated through direct allorecognition by recognizing intact donor MHC molecules on donor-derived APCs or they can be activated via indirect allorecognition by responding to processed donor-derived peptides bound to MHC molecules. Donor endothelial cells can also directly activate CD8+ T-cells, which can be a process constantly present after transplantation26. Embodiments of the wearable device according to aspects of the invention have been developed for the novice subject without any prior knowledge of the organs of interest. Therefore, only by placing the back brace, the patch or the belt, the device is fitted in such a way that it can modulate the above processes through targeting nerves connected to the spleen and the liver. Therefore, embodiments of the device may be crucial for the health of these subjects.
Referring to
Aspects and embodiments provide an individualized and adaptive system that integrates biomarker monitoring with ultrasound stimulation.
According to certain embodiments, the wearable device 100 has a built-in focused ultrasound device, that is adjusted and placed on the body to target the nerves on and around the spleen to dampen the immune system via the above mechanism of action also illustrated in
The system may further include a communications/monitoring module 300 that may be separate from the wearable device 100 or may be integrated with the wearable device 100. The communications module 300 allows remote communication, either directly or via a cloud platform or other intermediary, with the subject's (e.g., patient's) physician, and may allow for remote adjustment of one or more parameters of the device, as discussed above.
An example of the wearable device 100 implemented in a belt housing is shown in
An example of the wearable device 100 implemented as a patch device is shown in
As shown, adjustable shoulder straps 402 include two straps that may be supported by or positioned over the shoulders of the subject. The adjustable shoulder straps 402 may be connected to the front panel 406. The method of connection may be, for example, and without limitations, directly molding or sewing the adjustable shoulder straps 402 and the front panel 406 together, connecting by buckle, fastening by VELCRO®, etc. The adjustable shoulder straps 402 may include padding or other cushioning features to enhance the subject's comfort. In some embodiments, the adjustable shoulder straps 402 may be made of an elastic material, an inelastic material, or a combination of two or more materials. The material may be, for example, and without limitations, canvas, plastic, elastane, etc. In some embodiments, the shoulder straps can be antibacterially and/or antimicrobially coated. For example, the coating may comprise one or more of isothiazolinone treatments, zinc pyrithione, silver, and quaternary ammonium compounds. Any coating may also be used on other portions of the wearable harness as well. In some embodiments, the material of the shoulder straps is not stretchable. In some embodiments, the adjustable shoulder straps 402 may be removable and washable. In some embodiments, the two adjustable shoulder straps may be connected together. As shown in
As shown, elastic panel 404 includes a panel made of an elastic material that connects the adjustable shoulder straps 402 to each other and/or to the top of front panel 406. The method of connection may be, for example, and without limitations, directly molding or sewing the elastic panel 404 to the adjustable shoulder straps 402 and the front panel 406, connecting by buckle, fastening by VELCRO®, etc. The elastic panel 404 may be V-shaped, triangle-shaped, or another shape. In some embodiments, the elastic panel 404 may be removable and washable. In some embodiments, such as if the two adjustable shoulder straps 402 merge into a single strap before they attach to the front panel 406, the elastic panel 404 may not connect to the front panel 406 or may be absent entirely. In some embodiments, the elastic panel 404 allows the harness to be more easily adjustable to different sized subject. For example, the elastic panel 404 ensures that the harness will fit narrow- and wide-shouldered subjects, such that, regardless of body shape, the harness is tightly fitted and snug to the subject's body.
As shown, front panel 406 includes a panel that covers at least a portion of the front of the subject's torso. As used herein, “front panel” may also be referred to as “front portion.” In some embodiments, the front panel 406 may be made of an elastic material, an inelastic material, or a combination of two or more materials. The material may be, for example, and without limitations, canvas, plastic, elastane, etc. In some embodiments, the front panel 406 may be removable and washable. In some embodiments, the shape of the front panel 406 can be any shape that fits over the subject's torso, for example, but not limited to, a rectangular shape, a circular shape, a X-shape, a Y-shape, etc. The front panel 406 may be flat, or alternatively, it may be contoured to match the shape of the subject's body. In some embodiments, the front panel 406 may cover most of the subject's torso. Alternatively, in some embodiments, the front panel 406 may be shaped like a belt that provides minimal coverage of the subject's torso. Front panel 406 may include a power pocket 407.
As shown, power pocket 407 includes a pocket that can hold a power pack on the harness 400. The power pocket 407 may be sewn or otherwise attached onto the front panel 406. Alternatively, in some embodiments, power pocket 407 may not be attached to front panel 406 but may instead be attached to a different location on the harness, such as an adjustable shoulder strap 402, an adjustable waist strap 413, or a rear panel 516 (see
As shown, power pocket outlet 414 includes an opening through which a power cable can extend into power pocket 407. The size of this opening may vary, so long as it is large enough for the power cable to extend through but no larger than the size of the power pack. The power pocket outlet 414 may be located near the bottom, side, center, or another area of power pocket 407.
As shown, transducer securing portion 408 includes a pocket that can hold a transducer case assembly on the harness 400. In some embodiments, the transducer securing portion 408 secures the transducer case assembly in one position to prevent the transducer from moving or falling off the harness 400. In such embodiments, the transducer case assembly can be repositioned and resecured if necessary. The transducer securing portion 408 may be sewn or otherwise attached onto the adjustable waist strap 413. Alternatively, in some embodiments, transducer securing portion 408 may not be attached to adjustable waist strap 413 but may instead be attached to a different location on the harness, such as an adjustable shoulder strap 402, a front panel 406, or a rear panel 516 (see
As shown, transducer securing portion outlet 409 includes an opening through which a power cable can extend into transducer securing portion 408. The size of this opening may vary, so long as it is large enough for the power cable to extend through but no larger than the size of the transducer case assembly. The transducer securing portion outlet 409 may be located near the bottom, side, center, or another area of transducer securing portion 408.
As shown, adjustable waist strap 413 includes a horizontal strap that may be supported by or positioned over the waist. The adjustable waist strap 413 may be connected to the front panel 406 by waist strap buckle 412. Alternatively, the method of connection may be, for example, and without limitations, directly molding or sewing the adjustable waist strap 413 and the front panel 406 together, fastening by VELCRO®, etc. The adjustable waist strap 413 may include padding or other cushioning features to enhance the subject's comfort. In some embodiments, the adjustable waist strap 413 may be inelastic to ensure a consistent fit of the harness 400 along the subject's waist. In such embodiments, the adjustable waist strap 413 may be made of one or more inelastic materials. The material may be, for example, and without limitations, canvas, plastic, etc. so long as the material is inelastic. In some embodiments, the adjustable waist strap 413 may be removable and washable. In some embodiments, one or more adjustable horizontal straps may run parallel to the adjustable waist strap 413 to further adjust how the harness 400 fits on the subject's body. In these embodiments, the one or more adjustable horizontal straps may be connected to the adjustable waist strap 413 or may merge into a single strap before it attaches to the front panel 406 via the waist strap buckle 412. The adjustable waist strap 413 may be adjusted in length to fit subjects of different heights, sizes, and body shapes and can be replaced if necessary. For example, if the subject is too small or large for the harness 400 and adjustable waist strap 413 no longer fits the subject, it may be replaced by an adjustable waist strap 413 of a different length. In some embodiments, in order to cover a greater region of the patient's torso, such as the region including the spleen, one side of the adjustable waist strap 413 may be wider than the other side. Adjustable waist strap 413 may include a waist strap scale 410, a waist strap clip 411, and/or a waist strap buckle 412.
As shown, waist strap scale 410 includes a scale that extends lengthwise along the adjustable waist strap 413. This scale allows the adjustable waist strap 413 to be adjusted to a set length every time harness 400 is worn. The line markers of waist strap scale 410 may be printed, embroidered, etched, or otherwise attached to the adjustable waist strap 413. The waist strap scale 410 may use metric, imperial, or other units of distance measurement. In some embodiments, waist strap scale 410 extends in only one dimension. The waist strap scale 410 may extend across the entire length of adjustable waist strap 413, or alternatively, it may extend across only part of the length.
As shown, waist strap clip 411 includes a clip that attaches to adjustable waist strap 413 and holds the strap in place near the waist strap buckle 412. In some embodiments, the waist strap clip 411 is rectangular in shape and hollow in the middle so that the waist strap scale 413 is still visible. Alternatively, in some embodiments, the waist strap clip 411 may be any shape, for example, but not limited to, circular, triangular, organic, etc. In some embodiments, the waist strap clip 411 may include a clip pointer that extends partway along the middle so that the clip pointer can align with line markers of the waist strap scale 413. In such embodiments, the clip pointer can be used to read the waist strap scale 413. In some embodiments, more than one clip pointer may be attached to waist strap clip 411, such that the central axes of each clip pointer are parallel to the line markers of the waist strap scale 413 and parallel to each other.
As shown, waist strap buckle 412 includes a buckle that attaches the adjustable waist strap 413 to the front panel 406. The waist strap buckle 412 can be opened when the subject is putting on the harness 400, then closed to secure the harness 400 around the subject. In some embodiments, the waist strap buckle 412 may be a side release buckle. Alternatively, in some embodiments, the waist strap buckle 412 may be any type of fastener, for example, but not limited to, a tie buckle, snap buckle, roller buckle, ratchet buckle, cam buckle, etc. The material of waist strap buckle 412 may be, for example, and without limitations, metal, plastic, etc.
As shown, adjustable shoulder straps 502 include two straps that may be supported by or positioned over the shoulders of the subject 599. In some embodiments, the connection region between the adjustable shoulder straps 502 and the rear panel 516 may comprise adjustable clasps. In such embodiments, the adjustable clasps may include shoulder strap buckles 518. In such embodiments, the adjustable clasps may be configured to connect and disconnect and adjust the connection positions between the adjustable shoulder straps 502 and the rear panel 516. The connection positions may comprise an overlap region between the adjustable shoulder straps 502 and the rear panel 516. Alternatively, the connection positions may comprise no overlap region between the adjustable shoulder straps 502 and the rear panel 516. Alternatively, the method of connection may be, for example, and without limitations, directly molding or sewing the adjustable shoulder straps 502 and the rear panel 516 together, fastening by VELCRO®, etc. The adjustable shoulder straps 502 may include padding or other cushioning features to enhance the comfort of the subject 599. In some embodiments, the adjustable shoulder straps 502 may be made of an elastic material, an inelastic material, or a combination of two or more materials. The material may be, for example, and without limitations, canvas, plastic, elastane, etc. In some embodiments, the adjustable shoulder straps 502 may be removable and washable. In some embodiments, the two adjustable shoulder straps may be connected together. In some embodiments, one or more adjustable horizontal straps may connect the two adjustable shoulder straps 502 together to further adjust how the harness 500 fits on the body of subject 599. Alternatively, the two adjustable shoulder straps 502 may merge into a single strap before they attach to the rear panel 516. The adjustable shoulder straps 502 may be adjusted in length to fit subjects of different heights, sizes, and body shapes. However, in some embodiments, if the subject 599 is too small or large for the harness 500, the adjustable shoulder straps 502 may no longer be able to fit the subject.
As shown, shoulder strap buckles 518 include two buckles that attach the adjustable shoulder straps 502 to the rear panel 516. One end of each shoulder strap buckle 518 may be attached to an adjustable shoulder strap 502; the other end may be attached to the rear panel 516, so that when the buckle is closed, the adjustable shoulder straps 502 are attached to the rear panel 516. In some embodiments, one or both ends of each shoulder strap buckle 518 may be attached to a shoulder strap scale 520. In some embodiments, the shoulder strap buckles 518 may be side release buckles. Alternatively, in some embodiments, the shoulder strap buckles 518 may be any type of fastener, for example, but not limited to, tie buckles, snap buckles, roller buckles, ratchet buckles, cam buckles, etc. The material of shoulder strap buckles 518 may be, for example, and without limitations, metal, plastic, etc.
As shown, shoulder strap scales 520 include scales that extend lengthwise along the adjustable shoulder straps 502. These scales allow the adjustable shoulder straps 502 to be adjusted to a set length every time harness 500 is worn. The line markers of shoulder strap scales 520 may be printed, embroidered, etched, or otherwise attached to the adjustable shoulder straps 502. The shoulder strap scales 520 may use metric, imperial, or other units of distance measurement. In some embodiments, the shoulder strap scales 520 extend in only one dimension. In some embodiments, a shoulder strap scale 520 may be attached to a shoulder strap buckle 518. The shoulder strap scales 520 may extend across the entire length of adjustable shoulder straps 502, or alternatively, they may extend across only part of the length.
As shown, rear panel 516 includes a panel that covers at least a portion of the back of the subject's torso. As used herein, “rear panel” may also be referred to as “rear portion.” In some embodiments, the rear panel 516 may be inelastic to ensure a consistent fit of the harness 500 along the back of the subject's torso. In such embodiments, the rear panel 516 may be made of one or more inelastic materials. The material may be, for example, and without limitations, canvas, plastic, etc. so long as the material is inelastic. In some embodiments, the rear panel 516 may be removable and washable. In some embodiments, the shape of the rear panel 516 can be any shape that fits over the subject's torso, for example, but not limited to, a rectangular shape, a circular shape, a X-shape, a Y-shape, etc. The rear panel 516 may be flat, or alternatively, it may be contoured to match the shape of the subject's body. In some embodiments, the rear panel 516 may cover most of the subject's torso. Alternatively, in some embodiments, the rear panel 516 may be shaped like a belt that provides minimal coverage of the subject's torso. One end of each shoulder strap buckle 518 may be attached to the rear panel 516, so that when the buckle is closed, the adjustable shoulder straps 502 are attached to the rear panel 516.
As shown, adjustable waist strap 513 includes a horizontal strap that may be supported by or positioned over the waist. The adjustable waist strap 513 may be connected to the rear panel 516. The method of connection may be, for example, and without limitations, directly molding or sewing the adjustable waist strap 513 and the rear panel 516 together, connecting by buckle, fastening by VELCRO®, etc. The adjustable waist strap 513 may include padding or other cushioning features to enhance the subject's comfort. In some embodiments, the adjustable waist strap 513 may be inelastic to ensure a consistent fit of the harness 500 along the subject's waist. In suchsome embodiments, the adjustable waist strap 513 may be made of one or more inelastic materials. The material may be, for example, and without limitations, canvas, plastic, elastane, etc. so long as the material is inelastic. In some embodiments, the adjustable waist strap 513 may be removable and washable. In some embodiments, one or more adjustable horizontal straps may run parallel to the adjustable waist strap 513 to further adjust how the harness 500 fits on the subject's body. In these embodiments, the one or more adjustable horizontal straps may be connected to the adjustable waist strap 513 or may merge into a single strap before it attaches to the rear panel 516. The adjustable waist strap 513 may be adjusted in length to fit subjects of different heights, sizes, and body shapes and can be replaced if necessary. For example, if the subject is too small or large for the harness 500 and adjustable waist strap 513 no longer fits the subject, it may be replaced by an adjustable waist strap 513 of a different length. In some embodiments, in order to cover a greater region of the patient's torso, such as the region including the spleen, one side of the adjustable waist strap 513 may be wider than the other side. Adjustable waist strap 513 may include a waist strap scale, a waist strap clip, and/or a waist strap buckle.
As shown, transducer securing portion 508 includes a pocket that can hold a transducer case assembly on the harness 500. In some embodiments, the transducer securing portion 508 secures the transducer case assembly in one position to prevent the transducer from moving or falling off the harness 500. In such embodiments, the transducer case assembly can be repositioned and resecured if necessary. The transducer securing portion 508 may be sewn or otherwise attached onto the adjustable waist strap 513. Alternatively, in some embodiments, transducer securing portion 508 may not be attached to adjustable waist strap 513 but may instead be attached to a different location on the harness, such as an adjustable shoulder strap 502, a front panel 406 (see
As shown, transducer securing portion scale 522 includes a two-dimensional scale that extends lengthwise and heightwise along the exterior of the transducer securing portion 508. This scale may be used to align the transducer case assembly so that it may be placed in the same position inside the transducer securing portion 508 every time harness 500 is worn. The line markers of transducer securing portion scale 522 may be printed, embroidered, etched, or otherwise attached to the transducer securing portion 508. transducer securing portion scale 522 may use metric, imperial, or other units of distance measurement. The transducer securing portion scale 522 may extend across the entire exterior surface area of transducer securing portion 508, or alternatively, it may extend across only part of the surface area. In some embodiments, transducer securing portion scale 522 may extend farther in one dimension than the other. In some embodiments, the transducer securing portion scale 522 may be a grid that extends across the entire exterior surface area of the transducer securing portion 508.
As shown, adjustable shoulder straps 602 include two straps that may be supported by or positioned over the shoulders. Shoulder straps 602 can include any features of shoulder straps 402 of
As shown, elastic panel 604 includes a panel made of an elastic material that connects the adjustable shoulder straps 602 to each other and/or to the top of front panel 606. Elastic panel 604 can include any features of elastic panel 404 of
As shown, front panel 606 includes a panel that covers at least a portion of the front of the subject's torso. Front panel 606 can include any features of front panel 406 of
As shown, power pocket 607 includes a pocket that can hold a power pack on the harness 600. Power pocket 607 can include any features of power pocket 407 of
As shown, power pocket outlet 614 includes an opening through which a power cable can extend into power pocket 607. Power pocket outlet 614 can include any features of power pocket outlet 414 of
As shown, transducer securing portion 608 includes a pocket that can hold a transducer case assembly on the harness 600. Transducer securing portion 608 can include any features of transducer securing portion 408 of
As shown, adjustable waist strap 613 includes a horizontal strap that may be supported by or positioned over the waist. Adjustable waist strap 613 can include any features of adjustable waist strap 413 of
As shown, waist strap scale 610 includes a scale that extends lengthwise along the adjustable waist strap 613. Waist strap scale 610 can include any features of waist strap scale 410 of
As shown, waist strap clip 611 includes a clip that attaches to adjustable waist strap 613 and holds the strap in place near the waist strap buckle 612. Waist strap clip 611 can include any features of waist strap clip 411 of
As shown, waist strap buckle 612 includes a buckle that attaches the adjustable waist strap 613 to the front panel 606. Waist strap buckle 612 can include any features of waist strap buckle 412 of
As shown, adjustable shoulder straps 702 include two straps that may be supported by or positioned over the shoulders of the subject. Shoulder straps 702 can include any features of shoulder straps 402 of
As shown, shoulder strap buckles 718 include two buckles that attach the adjustable shoulder straps 702 to the rear panel 716. Shoulder strap buckles 718 can include any features of shoulder strap buckles 518 of
As shown, shoulder strap scales 720 include scales that extend lengthwise along the adjustable shoulder straps 702. Shoulder strap scales 720 can include any features of shoulder strap scales 520 of
As shown, rear panel 716 includes a panel that covers at least a portion of the back of the subject's torso. Rear panel 716 can include any features of rear panel 516 of
As shown, adjustable waist strap 713 includes a horizontal strap that may be supported by or positioned over the waist. Adjustable waist strap 713 can include any features of adjustable waist strap 413 of
As shown, transducer securing portion 708 includes a pocket that can hold a transducer case assembly on the harness 700. Transducer securing portion 708 can include any features of transducer securing portion 408 of
As shown, transducer securing portion scale 722 includes a two-dimensional scale that extends lengthwise and heightwise along the exterior of the transducer securing portion 708. Transducer securing portion scale 722 can include any features of transducer securing portion scale 522 of
As shown, adjustable shoulder straps 1002 include two straps that may be supported by or positioned over the shoulders. Shoulder straps 1002 can include any features of shoulder straps 402 of
As shown, shoulder strap buckles 1018 include two buckles that attach the adjustable shoulder straps 1002 to the rear panel 1016. Shoulder strap buckles 1018 can include any features of shoulder strap buckles 518 of
As shown, shoulder strap scales 1020 include scales that extend lengthwise along the adjustable shoulder straps 1002. Shoulder strap scales 1020 can include any features of shoulder strap scales 520 of
As shown, front panel 1006 includes a panel that covers at least a portion of the front of the subject's torso. Front panel 1006 can include any features of front panel 406 of
As shown, adjustable waist strap 1013 includes a horizontal strap that may be supported by or positioned over the waist. In some embodiments, the adjustable waist strap 1013 may connect the front panel 1006 to the rear panel 1016 on the left-hand side of the subject and/or on the right-hand side of the subject. Adjustable waist strap 1013 can include any features of adjustable waist strap 413 of
As shown, waist strap buckle 1012 includes a buckle that attaches the adjustable waist strap 1013 to the front panel 1006. Waist strap buckle 1012 can include any features of waist strap buckle 412 of
As shown, waist strap clip 1011 includes a clip that attaches to adjustable waist strap 1013 and holds the strap in place near the waist strap buckle 1012. Waist strap clip 1011 can include any features of waist strap clip 411 of
As shown, waist strap scale 1010 includes a scale that extends lengthwise along the adjustable waist strap 1013. Waist strap scale 1010 can include any features of waist strap scale 410 of
As shown, rear panel 1016 includes a panel that covers at least a portion of the back of the subject's torso. Rear panel 1016 can include any features of rear panel 516 of
As shown, transducer securing portion 1008 includes a pocket that can hold a transducer case assembly on the harness 1000. Transducer securing portion 1008 can include any features of transducer securing portion 408 of
As shown, transducer securing portion scale 1022 includes a two-dimensional scale that extends lengthwise and heightwise along the exterior of the transducer securing portion 1008. Transducer securing portion scale 1022 can include any features of transducer securing portion scale 522 of
As shown, scale 1342 includes a scale that extends lengthwise along the adjustable strap 1340. Scale 1342 can include any features of waist strap scale 410 of
As shown, clip 1344 includes a clip that attaches to adjustable strap 1340 and holds the strap in place near the buckle 1346. Clip 1344 can include any features of waist strap clip 411 of
As shown, clip pointer 1345 includes a thin pointer arm attached to clip 1344 that points towards scale 1342. In some embodiments, the clip pointer 1345 may extend partway through the middle of clip 1344 so that the clip pointer 1345 can align with line markers of the scale 1342. In some embodiments, the clip pointer 1345 can be used to read the scale 1342. In some embodiments, more than one clip pointer 1345 may be attached to clip 1344, such that the central axes of each pointer are parallel to the line markers of the scale 1342 and parallel to each other.
As shown, buckle 1346 includes a buckle that attaches the adjustable strap 1340 to another component of the harness. Buckle 1346 can include any features of waist strap buckle 412 of
Referring to
As shown in
Methods according to certain embodiments comprise the use of ultrasound waves in the low-intensity or low frequency range applied non-invasively to nerves, specifically the splenic nerve, and nerves surrounding the spleen to modulate, either inhibit or activate, the immune response. The ultrasound stimulation device may include one or several components that are commercially available or custom-made and generate the ultrasound waves, such as ultrasound emitters, transducers, piezo-electric transducers, composite transducers, capacitive micromachined ultrasound transducer or any other ultrasound emitting transducers, that could be single or multiple transducers and the waves could be in any shape both being focused and unfocused depending on the desired outcome that is needed. In certain examples, the ultrasound pressure ranges from 10 kPa to 800 kPa. The focused ultrasound may be emitted from a shallow ultrasound-focusing cone. In one embodiment, the ultrasound frequency exhibited to the body is <2.5 MHz. In certain examples, the ultrasound frequency may be in the range from 500 kHz to 2.5 MHz, with a pulse repetition ranging from 0.1 to 10 milliseconds (ms). The pulse length may range from 100 to 300 microseconds.
According to certain implementations, subjects may undergo treatment for from 1 minute to 30 minutes per day, for example, from 5 to 30 minutes per day, or from 10 to 15 minutes per day. The number of days of treatment may be determined by the subject's doctor, and may be up to the full lifetime of the subject. The number of days of treatment, and frequency of the treatment, may depend on health condition and disease state of the subject, and can range from daily to weekly to monthly.
Kidney transplant subjects can use the wearable device or harness according to various embodiments to deliver ultrasound stimulation to their spleens and reduce their cytokine levels, in addition to or instead of the cocktail of immunosuppressants which are currently the standard of care for subjects who have undergone a kidney transplantation. For kidney treatment, the ultrasound may be focused on the splenic region of the abdomen, as discussed above. However, in other applications, the ultrasound may be focused at different bodily regions, as appropriate.
Thus, aspects and embodiments provide a wearable harness for an ultrasound-emitting device that can be used to provide targeted ultrasound stimulation to one or more organs in a subject's body. For example, the wearable harness can be used with an ultrasound transducer that is applied non-invasively to the spleen. As discussed above, the wearable device/harness can be implemented in a form that is comfortable for the subject to wear and configured to be easy for the subject to correctly position the ultrasound emitter without requiring detailed knowledge of the organ location within the subject's body. The wearable device or harness can be used by the subject at home, without requiring the presence of a physician or another trained medical professional. Ultrasound stimulation/modulation provided by the ultrasound device of the harness may advantageously treat or improve a variety of medical conditions, as discussed above, including (but not limited to) reducing kidney transplant rejection through ultrasound applied to the spleen. Furthermore, as discussed above, embodiments of the device can be used to stimulate the splenic nerve and other nerves surrounding it to modulate other bodily functions beyond dampening the immune system in organ transplants. For example, Alzhiemer's disease (e.g., remyleination induction of the nerves), traumatic brain injury, chronic traumatic encephalopathy, autoimmune diseases such as lupus, dermatitis, eczema, psoriasis, psoriatic arthritis, endometriosis, scleroderma, Sjogren's, fibromyalgia, neuropathy, Wegener's granulomatosis, vascultities, temporal arteritis, celiac's disease, Crohn's disease, eczema, ulcerative colitis, inflammatory bowel disease, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, non-alcoholic fatty liver disease, alcoholic fatty liver disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, myocardial infarction, coronary artery disease, cardiovascular disease, reperfusion injury, diabetes types I and II, multiple sclerosis, depression, schizophrenia, bipolar disorder, autism spectrum disorder, major depression disorder, post-traumatic stress disorder, skin cancer, cellulitis, vitiligo, rosacea, cervicitis, herpes, HIV, menopause, aging, hair loss, hair greying, pelvic inflammatory disease, endometriosis, infertility, antiphospholipid syndrome, post and pre-transfusions, Rh incompatibility during pregnancy, post-plastic surgery, post-surgical interventions, sleep disorders, circadian rhythm disorders, insomnia, jet lag, hepatitis, and obesity.
In some embodiments, a treatment unit may comprise an ultrasound transducer only. In some embodiments, a treatment unit may comprise an ultrasound transducer and a mechanical lens.
The following enumerated embodiments are representative of some aspects of the invention.
1. A wearable ultrasound stimulation device configured to be worn by a patient in need thereof and comprising:
2. The wearable ultrasound stimulation device of embodiment 1 wherein the wearable housing is a belt configured to be worn around the chest of the patient.
3. The wearable ultrasound stimulation device of embodiment 1 wherein the wearable housing is a patch configured to be adhered to the back of the patient covering an area of the spleen.
4. The wearable ultrasound stimulation device of embodiment 1 wherein the wearable housing is a harness configured to the worn around the shoulders and waist of the patient.
5. The wearable ultrasound stimulation device of embodiment 4 wherein the harness includes:
6. The wearable ultrasound stimulation device of embodiment 5 wherein the ultrasound component holder includes a clip portion configured to fit over a portion of the rigid back brace component to frictionally secure the ultrasound component holder to the rigid back brace component.
7. The wearable ultrasound stimulation device of embodiment 5 wherein the shoulder straps are made of neoprene, rubber, or a flexible smart material.
8. The wearable ultrasound stimulation device of embodiment 5 further comprising an additional component holder attached to the rigid back brace component.
9. The wearable ultrasound stimulation device of any one of embodiments 1-8 wherein the target region is the spleen.
10. A system for securing an ultrasound transducer over a spleen of a subject, the system comprising:
11. The system of embodiment 10, wherein the transducer securing portion receives and secures an ultrasound transducer with a mechanism comprising a pop-lock, a magnet, VELCRO®, locking pins, clips, or a key-in arms mechanism.
12. The system of embodiment 10 or 11, wherein a connection region between the first shoulder strap and the rear portion and a connection region between the second shoulder strap and the rear portion comprise an adjustable clasp.
13. The system of any of embodiments 10-12, wherein the adjustable clasp is configured to connect and disconnect and adjust a connection position between the rear portion and the first shoulder strap or the rear portion and the second shoulder strap.
14. The system of any of embodiments 10-13, wherein the connection position comprises an overlap region between the first shoulder strap and the rear portion or the second shoulder strap and the rear portion.
15. The system of any of embodiments 10-14, wherein the connection position comprises no overlap region between the first shoulder strap and the rear portion or the second shoulder strap and the rear portion.
16. The system of any of embodiments 10-15, wherein the front portion is configured to be positioned over the subject's chest.
17. The system of any of embodiments 10-16, wherein the rear portion is configured to be positioned over the subject's back.
18. The system of any of embodiments 10-17, wherein the power pack is connected to the ultrasound transducer with a power cable.
19. The system of any of embodiments 10-18, wherein the mechanical lens is configured to adjust ultrasonic waves emitted by the ultrasound transducer to a specific focal distance.
20. The system of embodiment 19, wherein the focal distance is 0.2-20 cm
21. A harness for positioning an ultrasound transducer to a subject, the harness comprising:
22. The harness of embodiment 21, wherein the transducer securing portion is configured to receive a treatment unit such that the harness positions the treatment unit over the spleen of the subject.
23. The harness of embodiment 22, wherein the treatment unit comprises an ultrasound transducer.
24. The harness of embodiment 22 or 23, wherein the treatment unit comprises a mechanical lens comprising a plurality of concentric rings and configured to adjust ultrasonic waves emitted by the ultrasound transducer.
25. A treatment unit comprising:
26. The treatment unit of embodiment 25, wherein the mechanical lens is configured to adjust ultrasonic waves emitted by the ultrasound transducer to a specific focal distance.
27. The treatment unit of embodiment 25 or 26, wherein the focal distance is 1-3 cm.
28. A system for securing an ultrasound transducer over a spleen of a subject, the system comprising:
29. A harness for positioning an ultrasound transducer to a subject, the harness comprising:
30. The harness of embodiment 29, wherein the transducer securing portion comprises a two-dimensional scale for guiding the subject to reposition the ultrasound transducer in a second location identical to the first location.
31. A method of using a harness for positioning an ultrasound transducer to a subject, the method comprising:
32. The method of embodiment 31, wherein securing a treatment unit to a transducer securing portion of a harness comprises positioning the treatment unit to the transducer securing portion with the guidance of a two-dimensional scale on the transducer securing portion.
33. The method of embodiment 31 or 32, wherein securing a treatment unit to a transducer securing portion of a harness comprises a mechanism comprising a pop-lock, a magnet, VELCRO®, locking pins, clips, or a key-in arms mechanism.
34. The method of any of embodiments 31-33, wherein the treatment unit comprises an ultrasound transducer.
35. The method of embodiment 34, wherein the treatment unit comprises a mechanical lens comprising a plurality of concentric rings and configured to adjust ultrasonic waves emitted by the ultrasound transducer.
As used herein, and unless otherwise specified, the terms “treat,” “treating” and “treatment” contemplate an action that occurs while a subject is suffering from the specified disease, disorder or condition, which reduces the severity of the disease, disorder or condition, or retards or slows the progression of the disease, disorder or condition (“therapeutic treatment”). Disease, disorder, and condition are used interchangeably herein.
Embodiments of the present invention include the prophylactic use of the wearable harness before a subject begins to suffer from the specified disease, disorder or condition. As used herein, “prophylactic treatment,” “preventive treatment,” “prevent,” “preventing” or “prevention” contemplates an action that occurs before a subject begins to suffer from the specified disease, disorder or condition. In some embodiments, the terms encompass the inhibition or reduction of the seriousness, progression, or recurrence of a symptom of the particular disease, disorder or condition. As used herein, and unless otherwise specified, a “prophylactically effective amount” is an amount sufficient to prevent a disease, disorder or condition, or one or more symptoms associated with the disease, disorder or condition, or prevent its recurrence. A prophylactically effective amount means an amount which provides a prophylactic benefit in the prevention of the disease, disorder or condition. The term “prophylactically effective amount” can encompass an amount that improves overall prophylaxis or enhances the prophylactic efficacy of another prophylactic agent.
In some variations, a “subject” to which the use of the harnesses described herein and administration are contemplated is a human, who may be a male or female of any age group, e.g., a pediatric subject (e.g., infant, child, adolescent) or adult subject (e.g., young adult, middle-aged adult or senior adult).
As used herein, and unless otherwise specified, a “therapeutically effective amount” is an amount sufficient to provide a therapeutic benefit in the treatment of a disease, disorder or condition, or to delay or minimize one or more symptoms associated with the disease, disorder or condition. A therapeutically effective amount means an amount which provides a therapeutic benefit in the treatment of the disease, disorder or condition. The term “therapeutically effective amount” can encompass an amount that improves overall therapy, reduces or avoids symptoms or causes of disease or condition, or enhances the therapeutic efficacy of another therapeutic agent.
Having described above several aspects of at least one embodiment, it is to be appreciated various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to be part of this disclosure and are intended to be within the scope of the invention. It is to be appreciated that embodiments of the methods and apparatuses discussed herein are not limited in application to the details of construction and the arrangement of components set forth in the foregoing description or illustrated in the accompanying drawings. The methods and apparatuses are capable of implementation in other embodiments and of being practiced or of being carried out in various ways. Examples of specific implementations are provided herein for illustrative purposes only and are not intended to be limiting. Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use herein of “including,” “comprising,” “having,” “containing,” “involving,” and variations thereof is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. References to “or” may be construed as inclusive so that any terms described using “or” may indicate any of a single, more than one, and all of the described terms. Accordingly, the foregoing description and drawings are by way of example only, and the scope of the invention should be determined from proper construction of the appended claims, and their equivalents.
Although the disclosure and examples have been fully described with reference to the accompanying figures, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the disclosure and examples as defined by the claims. Finally, the entire disclosure of the patents and publications referred to in this application are hereby incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2023/060538 | 1/12/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63299131 | Jan 2022 | US |
