Air compression therapy device

Abstract

A medical device comprising an air bladder (or multiple air bladders), an attachment mechanism, a fluid inlet, a fluid outlet, a compressor, a pressure regulation system, and a perfusion sensor, the medical device being compressed against perfused tissue (unbroken skin or cavity surface tissue) for the purpose of minimizing blood perfusion to prevent drug delivery to non-target sites.

Description

Technical Field

[0001] The present invention relates to a pneumatic device configured to reduce the potential for chemotherapy-induced side effects in subjects including, but not limited to, chemotherapy-induced alopecia (CIA), infertility, and peripheral neuropathy.

Background Art

[0002] Chemotherapy is one of the most widely used treatments for cancer, and an estimated 9.8 million patients worldwide were treated with chemotherapy regimens in 2018. Chemotherapy works by targeting rapidly growing and proliferating cells, which are a known characteristic of cancer cells. This not only explains the effectiveness of chemotherapy in cancer treatment but also accounts for some of the side effects of chemotherapy treatment resulting from the systemic delivery of chemotherapeutic drugs.

[0003] Many non-cancerous cells that normally exist in the body share the property of rapid division. This results in some well-recognized side effects of cancer treatment, such as, among others, chemotherapy-induced alopecia (CIA), chemotherapy-induced peripheral neuropathy (CIPN), and chemotherapy-induced infertility (CII). The use of chemotherapy is predicted to grow by 53% by 2040, creating an urgent need to address the side effects of this central element of cancer treatment.

[0004] Chemotherapy-induced alopecia (CIA) affects at least 4.5 million people annually and is considered by patients to be one of the most traumatic aspects of cancer treatment. CIA is a visible physical symptom of cancer treatment, which is associated with a negative psychological impact on patients and constantly reminds them of their illness. For example, 47% of female breast cancer patients consider CIA to be one of the most traumatic aspects of chemotherapy.

[0005] Each year, 2.5 million women undergo treatments that could potentially cause CIA, with over 1 million in this group receiving treatment for breast cancer and another 1.2 million for solid tumors. With increasing awareness among patients and clinicians of the need for CIA treatment, there is growing attention on developing preventative solutions.

[0006] A method to prevent CIA has been on the market for over 20 years in the form of "cold cap" treatment, which uses dry ice / gel and a cap that covers the head to cause constriction of scalp blood vessels, preventing the destructive effects of chemotherapy drugs on hair follicles. In recent years, "scalp cooling" technology has been developed, which is a more modern model, FDA approved, and is a machine-based cooling treatment. Using the same operating principle, scalp cooling has become increasingly popular because it shortens treatment time and is relatively easier to use compared to cold caps.

[0007] Cold caps and scalp cooling caps are generally caps that cover the head, either filled with dry ice in the case of manual caps, or connected to a circulating cooling system in the case of scalp coolers. The intended mechanism of action is that the reduced tissue temperature in local blood vessels causes vasoconstriction, restricting blood flow to the hair follicles. Furthermore, the reduced temperature further causes a decrease in the metabolic rate of cells in the scalp area. This combined effect causes a reduced level of chemotherapeutic action in the hair follicles, thus reducing hair loss. Examples of scalp cooling technology can be seen in Patent Documents 1 and 2.

[0008] Patent Document 3 describes a wound treatment device that conforms to the shape of the scalp. A hollow tube is configured to receive air or a gaseous liquid pumped up as part of a temperature control system. The tube is arranged in a series of loops or similar configurations and is positioned to allow any type of fluid to be pumped through the system, providing a large contact area with the scalp for the purpose of providing temperature changes or maintaining the temperature of the scalp surface. Patent Document 4 describes a cooling and pressurizing device for relieving migraines. The device consists of a tube wrapped around the scalp in a hemispherical shape. Patent Document 5 describes a cap used to cover a scalp cooling device, which may act as a mechanism for attaching the scalp cooling device to the wearer. Patent Document 6 describes a therapeutic vibrator that may use a flexible air bladder. In this case, the air bladder is used to secure the device to the wearer's head. A vibrating element is always present between the wearer and the air bladder, so that the air bladder does not make direct contact for therapeutic effect. Compression is not used here for therapeutic effect; its function is simply to secure the device in place. Patent Document 7 describes a scalp blood flow perfusion device that uses pressure to increase blood flow in order to promote hair growth and combat androgenetic alopecia, commonly known as pattern alopecia.

[0009] Current treatment methods have several problems. Scalp cooling technology is very uncomfortable for patients. Clinical data published by manufacturers of commercially available scalp cooling systems shows that 42% of patients complain of headaches, and 74% report scalp pain induced by the cooling. The desire for a more tolerable treatment method is a major driving force among all relevant stakeholders for a disruptive solution to this need. Treatment centers suffer from lost opportunities due to the length of the additional treatment time required. The booking situation for time slots for scalp cooling treatment can be a limiting factor in the number of additional chemotherapy patients that outpatient clinics can treat.

[0010] Tourniquet systems modeled after surgical tourniquets that apply pressure to the scalp were investigated in the 1970s and 1980s before being discontinued due to obsolescence, insufficient effectiveness, potential discomfort, and patient risks, as the system applies pressure to a single point at a very high level.

[0011] The transmission of infection poses further problems. The scalp cooling cap encloses the patient's jaw area. This means that bodily fluids remaining in the unwashable cap pose a risk of worsening the health of immunocompromised patients. This also presents maintenance challenges for medical staff. The effectiveness and reliability of current solutions are being questioned by stakeholders in treatments abandoned or failed due to issues such as improper cap installation. Thus, there is no widely available CIA solution that is comfortable and minimizes treatment time.

[0012] CIPN is a widely reported side effect of many chemotherapy treatments that causes peripheral motor control in addition to loss of sensation and chronic pain. CIPN can cause varying levels of disability in patients and may lead to the discontinuation or reduction of chemotherapy treatment plans, which can increase cancer morbidity and mortality. CIPN is reported in as many as 68% of chemotherapy patients. The additional healthcare system cost burden for patients with CIPN is estimated to be over $17,000 per patient. The mechanism of CIPN development is not fully understood, but it is known to be triggered by cytotoxic chemotherapy drugs that are frequently used, such as paclitaxel, which causes damage to long myelinated fibers in peripheral pathways, leading to demyelination.

[0013] While solutions to prevent CIPN are not widely used clinically, several solutions have been described in the literature, including the use of hypothermia therapy techniques similar to those used to prevent CIA (e.g., Patent Document 8), and the use of compositions or other pharmaceutical approaches that attempt to prevent and reverse CIPN through chemical processes. However, there are currently no solutions widely available to patients or clinicians for preventing the onset of CIPN.

[0014] CII is caused by chemotherapy drugs that interact with the reproductive systems of both men and women, leading to premature ovarian failure and infertility in women, and decreased or stopped sperm production in men. Although the exact overall prevalence of CII is unknown, the fertility risks associated with chemotherapy side effects should be considered in cancer treatment for all men and women who wish to have children after completing chemotherapy. In some cases, chemotherapy that induces infertility can be irreversible, causing high levels of psychological stress and mental health problems. The global population of people considered to be at risk of CII is estimated to be about 1 million per year.

[0015] There are no widely used or well-documented solutions to prevent CII in male patients. In female patients, several clinical trials have analyzed the effects of gonadotropin-releasing hormone agonists (GnRHa) on maintaining ovarian function in breast cancer patients. While this method has been successful in slowing ovarian function (aimed at reducing the risk and severity of damage from chemotherapy), the overall benefit to infertility has not been clinically proven. In addition, the potential effectiveness of this approach for other cancers is unclear. In clinical practice, existing solutions for male patients focus on sperm preservation, while female patients can pursue cryopreservation of ovarian tissue through surgical procedures, in vitro fertilization, or intrauterine insemination. In both cases, current treatment options are very expensive, with 64% of male patients reporting expenses of over $15,000, while for female patients, the cost can be expected to range from $7,000 to $30,000 per patient.

[0016] The object of the present invention is to overcome at least one of the above-mentioned problems. [Prior art documents] [Patent Documents]

[0017] [Patent Document 1] International Publication No. 2019 / 222044 [Patent Document 2] U.S. Patent No. 10478637 [Patent Document 3] U.S. Patent No. 7744640 [Patent Document 4] UK Patent Application Publication No. 2417423 [Patent Document 5] International Publication No. 03 / 047479 [Patent Document 6] U.S. Patent Application Publication No. 2019 / 262223 [Patent Document 7] International Publication No. 96 / 10983 [Patent Document 8] International Publication No. 2014 / 120090 [Overview of the project]

[0018] Chemotherapy-induced side effects in disease-free tissues are caused by the unintended destruction of rapidly dividing healthy cells by chemotherapy drugs. For example, CIA (Chronic Acute Alopecia) is caused by the unintended destruction of rapidly dividing hair cells by chemotherapy drugs. The exact pharmacological mechanism of this effect is still not well understood. Therefore, most efforts to prevent hair loss during chemotherapy have focused on preventing or significantly reducing drug delivery and / or uptake by hair follicles.

[0019] In one embodiment, a pneumatic device and method are provided for preventing chemotherapy-induced side effects by local, upstream, or both vascular compression therapy, thereby reducing drug delivery and / or drug uptake by hair follicles.

[0020] The method of the invention according to the claims (local microvascular compression therapy) is related to the application of a little pressure (between about 10 mmHg and about 200 mmHg, preferably between about 15 mmHg and about 190 mmHg, more preferably between about 20 mmHg and about 180 mmHg, optionally between about 20 mmHg and about 150 mmHg, and between about 20 mmHg and about 100 mmHg, ideally between about 25 mmHg and about 75 mmHg, and in one aspect, between about 40 mmHg and about 60 mmHg) to the entire tissue surface on the target microvascular system, which is related to collapsing the local capillaries in that area and expelling the blood in the local blood vessels. The pneumatic pressure device and method described herein utilize this effect to attach a pneumatic pressure device to the target area of a subject and apply a constant pressure to the entire surface of the target tissue to inhibit drug delivery to the target tissue.

[0021] In one aspect, the invention described herein relates to a pneumatic pressure or compression device. The device of the invention according to the claims (e.g., a pneumatic pressure cap or device) is related to the application of a little pressure (between about 20 mmHg and about 100 mmHg, ideally between about 25 mmHg and about 75 mmHg, and in one aspect between about 40 mmHg and about 60 mmHg) to the entire surface on the bone prominence, which is related to collapsing the local capillaries in that area and expelling the blood in the local blood vessels. The device described herein utilizes this effect to, for example, attach a pneumatic pressure device to the head of a subject and apply a constant and / or uniform pressure to the entire surface of the scalp to inhibit drug delivery to the hair follicles. The device described herein also utilizes this effect to inhibit drug delivery to external limbs such as fingers and toes, and areas such as the vaginal cavity.

[0022] An air compression device is provided for use in preventing or treating chemotherapy-induced alopecia in a subject undergoing chemotherapy treatment. The device (1) comprises a headband member (2), a first layer (3), a second layer (4), an outer mesh layer (6), at least one main airbag (5), and a control element (9). The at least one main airbag (5) is located between the first layer (3) and the second layer (4) and is configured to inflate with air or gas at ambient temperature, and when the airbag (5) is inflated, a compressive pressure is applied to the scalp of the subject.

[0023] In one aspect, an air pressure device (1) is provided for use in preventing or treating chemotherapy-induced alopecia in a subject undergoing chemotherapy treatment. The device (1) comprises a headband member (2) adapted to attach the device (1) to the head of the subject. The headband member (2) is connected to a first layer (3), a second layer (4), and at least one main airbag (5) sandwiched therebetween. The at least one main airbag (5) is attached to the second layer (4) along its inner edge (5a), attached to the first layer (3) along its outer peripheral surface (5b), and attached to the headband member (2) along its lower end surface (5c). The first layer (3) is wrapped by an outer mesh layer (6) attached to the headband member (2). The at least one main airbag (5) is configured to inflate with air or gas at ambient temperature, and when the airbag (5) is inflated, a compressive pressure is applied to the scalp of the subject.

[0024] In one aspect, an air compression device (1,100) is provided for use in preventing or treating chemotherapy-induced alopecia or chemotherapy-induced peripheral neuropathy (CIPN) in a subject undergoing chemotherapy treatment. The device (1,100) comprises an attachment member (2), a first layer (3) connected to the attachment member (2), at least one main airbag (5), and a fluid inlet (12). The at least one main airbag (5) is configured to inflate with fluid at ambient temperature, and when the airbag (5) is inflated, a compressive pressure is applied to a non-treatment area of the subject to minimize blood perfusion and prevent chemotherapy delivery to the non-treatment area.

[0025] In one embodiment, the air compressor (1, 100) further comprises a control element (9).

[0026] An air compressor (100) is provided for use in preventing or treating chemotherapy-induced peripheral neuropathy (CIPN) in the hands or feet of subjects undergoing chemotherapy, the apparatus (100) comprising a mounting member (2), a first layer (3), at least one main air bag (5), and a control element (9), the at least one main air bag (5) being located between the first layer (3) and the subject's hand or foot and configured to inflate with air or gas at ambient temperature, and when the air bag (5) is inflated, it applies compressive pressure to the subject's hand or foot.

[0027] In one embodiment, at least one main air bladder (5) is configured to have a plurality of sockets (108) for accommodating the fingers or toes of the subject.

[0028] In one embodiment, at least one main air bladder (5) is configured to form a single socket that accommodates the entire hand or foot of the subject.

[0029] In one embodiment, the air compressor (100) further comprises a first fixing member (102) for fixing the device (100) in a predetermined position.

[0030] In one embodiment, the air compressor (100) further comprises a second fixing member (103) for fixing the device (100) in a predetermined position.

[0031] An air compressor (200) is provided for use in preventing or treating chemotherapy-induced infertility (CII) in subjects receiving chemotherapy, the compressor (200) comprising at least one main air bag (205), an applicator (202) adapted to house at least one main air bag (205), and a cap (204) configured to house at least one main air bag (205) within the applicator (202) when deflated, the at least one main air bag (205) located within the applicator (202) being configured to inflate with air or gas at ambient temperature, and applying compression pressure when the air bag (205) is inflated.

[0032] In one embodiment, the applicator (202) is coupled to form a housing (214) comprising an outer shell (210) and an inner shell (212) that houses at least one main air bladder (205).

[0033] In one embodiment, the air compressor (200) further comprises a support means (208) housed inside an applicator (202) and communicating with a cap (204). When at least one main air bladder inflates, the cap is released from the applicator and pushed upward while being supported by the support means. The support means divides at least one main air bladder into two, which, when inflated, enclose the support means.

[0034] In one embodiment, the cap (204) is reversibly connected to the applicator (202) and is released from the applicator (202) when at least one main air bladder (205) is inflated.

[0035] In one embodiment, the cap (204) is fixed to the applicator (202) and further comprises an opening (206) through which at least one main air bladder (205) is pushed before inflation.

[0036] In one embodiment, the control element or control system includes a pump, at least one vent (12) for accessing the inflow of air or gas and for allowing air or gas to exit the device, and a tactile on / off switch (14).

[0037] In one embodiment, at least one main air bag (5) further comprises a plurality of air bag compartments, each air bag compartment operating independently of the others.

[0038] In one embodiment, at least one main air bag (5) further comprises a plurality of air bag compartments, each of which is in fluid communication with an air bag compartment adjacent to it.

[0039] In one embodiment, at least one main air bag (5) or more air bag compartments are connected to a pump, which has a two-way valve structure that controls the inflow and outflow of air or gas.

[0040] In one embodiment, the apparatus (1, 100, 200) further comprises a pressure sensor. Preferably, the pressure sensor is in communication with at least one main air bladder (5).

[0041] In one embodiment, the apparatus (1, 100, 200) further comprises a tissue perfusion sensor.

[0042] In one embodiment, the apparatus (1) further comprises an outer mesh layer (6) surrounding the second layer (4).

[0043] In one embodiment, the device (1) further comprises an inner membrane (7) which forms the inner layer of the device (1) and is located between the second layer (4) and the scalp of the subject.

[0044] In one embodiment, the device (1) further comprises a secondary air bag (11), which is configured to be attached to the mounting member (2) such that the secondary air bag (11) is in contact with the head of the subject.

[0045] In one embodiment, the apparatus (1) further comprises a first clamping system (16) configured to prevent the outer mesh layer (6) from moving outwards.

[0046] In one embodiment, the device (1) further comprises a second tightening system (17) adapted to tighten the attachment member (2) onto the head of the subject.

[0047] In one embodiment, when the device (1, 100, 200) is activated, it applies a compressive pressure to the subject's scalp ranging from approximately 30 mmHg to approximately 350 mmHg, or up to approximately 200 mmHg. Preferably, the compressive pressure is between approximately 30 mmHg and approximately 150 mmHg, or between approximately 20 mmHg and 100 mmHg, ideally between approximately 25 mmHg and approximately 75 mmHg, and in one embodiment, between approximately 40 mmHg and approximately 60 mmHg.

[0048] In one embodiment, the compressive pressure is applied in an increasing manner.

[0049] In one embodiment, the compressive pressure is applied uniformly or non-uniformly.

[0050] In one embodiment, the mounting member (2) further comprises at least one status indicator light (13).

[0051] In one embodiment, the device (1) further comprises at least one adjustable strap (10) for securing the device under, around, or over the chin of a subject.

[0052] In one embodiment, a method is provided for preventing or treating chemotherapy-induced injury to a region distant from the patient's body, the method comprising applying increasing compressive pressure to the distant region (e.g., an air compressor located in situ at the target site). The target site can be either a protected tissue site (in the case of the scalp) or a vascular structure upstream of a protected tissue (e.g., targeting the uterine arteries that supply the female reproductive tract through the vaginal cavity). The method comprises adjusting the applied pressure to balance unwanted drug delivery with avoiding occlusion and hypoxic damage to the tissue of the protected site.

[0053] As the air compressor applies increasing compression pressure to the occluded site, the compression system pressure increases in a stepwise manner in an electronically or mechanically controlled manner, so that the occluded site should begin to partially occlude. The applied pressure should reach a peak between 20 mmHg and about 200 mmHg (preferably between about 20 mmHg and about 100 mmHg, ideally between about 25 mmHg and about 75 mmHg, and in one embodiment between about 40 mmHg and about 60 mmHg), depending on the application site, and this pressure is maintained once a specific threshold (40–60 mmHg) is reached where localized blood flow is reduced by at least 60%, for the comfort of the user. The pressure is maintained in a uniform distribution at each point of the occluded site for a specified period related to the half-life of the drug used to treat the patient, and this period is controlled electronically or mechanically by the control system. When the pressure reaches its peak, the local vascular and microvascular systems are almost completely occluded at the occluded site. This occlusion reduces or avoids drug delivery through the vascular system to the protected site, ultimately preventing side effects at the protected site. After a specified period of pressure application, the pressure is slowly reduced in a manner controlled electronically or mechanically by a control system to avoid sudden reperfusion of the tissue.

[0054] The air compressor operates for a predetermined period based on the half-life of the drug intervention being used.

[0055] Upon completion, the air compressor begins to reduce the applied pressure to allow for a safe, gradual increase in blood perfusion at the effect site, while avoiding reperfusion injury at both the occluded and protected sites.

[0056] Upon completion, the air compressor begins to pulsately reduce the applied pressure, causing a significant pressure reduction for 5 seconds, followed by a re-application for 5 seconds, and then further short-term depressurization. In this embodiment, a safe increase in blood perfusion at the affected site is permitted, while simultaneously increasing blood flow to expel toxins from that site.

[0057] In one embodiment, a decrease in perfusion at the target site and application site is monitored by sensing one of the following parameters: SpO2, red blood cell count, or hemoglobin concentration.

[0058] In one embodiment, the compressive force is modified based on sensed parameters so that an ideal amount of compressive force is applied independently of the user.

[0059] In one embodiment, the device further comprises a foam layer inserted into one or more airbags, or a set of airbags. The foam is a low-density polymer material, such as low-density polyurethane. In this embodiment, a pump connected to an air inlet is connected to a reverse pole and sucks air out of the airbag. The pump sucks fluid (and thus pressure) in an increasing manner, creating a vacuum in the airbag. This causes the outer first layer and the airbag to collapse in the foam layer, compressing the foam layer. When compressed, the foam layer exerts a reaction force through the airbag into the scalp, feet, hands, or cavity, creating the level of compression necessary to restrict blood flow.

[0060] In one embodiment, the tightening system or adjustment member allows for greater force to be used to tighten the device against the surface of the scalp, foot, or hand. The pressure level required for the therapeutic effect is obtained through a drawstring mechanism that tightens the device against the surface of the scalp / foot / hand.

[0061] In one embodiment, a fluid or solid that takes a viscous form at ambient pressure but a solid form at pressures lower than atmospheric pressure is inserted into one or more air bladders or a group of air bladders. In this embodiment, a pump connected to an air inlet is connected to a reverse pole and sucks air out of the air bladders, creating a vacuum inside the air bladders. As the pressure inside the air bladders decreases, the substrate hardens, creating a modifiable compressive force against the tissue (scalp, feet, hands, or cavity).

[0062] In one embodiment, an inflated air bag or a group of air bags is inflated using an air vent to a predetermined pressure level lower than the target therapeutic pressure level. Compression pressure is applied to the air bag using a tightening system or adjustment member (such as a drawstring or hook and fastener strap) to reduce the volume of the air bag in a modifiable manner. This reduction in the volume of the air bag causes an increase in the internal pressure within the air bag, resulting in a modifiable pressure level as the target therapeutic range applied to the tissue (scalp, foot, hand, or cavity).

[0063] In one embodiment, an air bag or a set of air bags is provided at a predetermined pressure level and is not modified by an air vent.

[0064] In one embodiment, a method is provided for preventing or treating chemotherapy-induced alopecia in a subject receiving chemotherapy, the method comprising the steps of attaching the above-described air compressor (1) to the subject and activating a switch (14) located on the rear of the attachment member (2) to initiate inflation of at least one main air bag (5) for a specified time.

[0065] In one embodiment, when switch (14) is activated, the device inflates as described above, applying increased pressure to the user's scalp. The device maintains uniform pressure across the entire scalp surface for a predetermined period. Once this period is complete, the device deflates the air bladder within the device in a predetermined, controlled decreasing manner to avoid reperfusion injury to the user.

[0066] In one embodiment, the method further includes tightening the device (1) around the scalp of the subject by activating the first tightening system 16.

[0067] In one embodiment, the method further includes tightening the air compressor (1) to the scalp of the subject by activating a second tightening system 17.

[0068] In one embodiment, the method further includes securing an adjustable strap (10) under the subject's chin.

[0069] In one embodiment, once the period is complete and the air bladder has deflated, the user may remove the device by loosening the tightening system.

[0070] In one embodiment, a method is provided for preventing or treating chemotherapy-induced peripheral neuropathy in a subject receiving chemotherapy, the method comprising the steps of attaching the above-mentioned air compressor (100) to the subject and activating a switch of a control element to start inflating at least one main air bag 5 for a specified time.

[0071] In one embodiment, the method further includes tightening the device (100) to the foot or hand of the subject by activating a first fastening means, a second fastening means, or a combination of both.

[0072] In one embodiment, a method is provided for preventing or treating chemotherapy-induced infertility in a subject receiving chemotherapy, the method comprising the steps of attaching the above-mentioned air compressor to the subject and activating a switch of a control element to initiate inflation of at least one main air bag (205) for a specified time.

[0073] In one embodiment, a method is provided for controlling vascular drug delivery to a target site in the body, the method comprising: mechanically compressing the skin / surface tissue of a target tissue site with a predetermined compressive force to block upstream blood vessels; maintaining the compressive force for a predetermined period of time (so that drugs circulating in the vascular system do not reach the target site); and releasing the compressive force applied to the tissue of the target site at a predetermined rate and in a predetermined geometric pattern (releasing the compressive force includes reducing the mechanical compressive force so that long-term tissue damage and ischemia-reperfusion injury can be avoided).

[0074] When blood vessels are blocked, it can lead to occlusion of the local microvascular system and superficial arteries, resulting in a limited possibility of drug delivery to the target tissue site or organ sites downstream of the target tissue site.

[0075] In one embodiment, when a compressive force is applied to a tissue site upstream of the intended site of effect, this means that compressive pressure is applied to the target blood vessel at a point different from the intended site of protective effect.

[0076] In one embodiment, a compressive force is applied to the skin / surface tissue of the target site at a rate of approximately 20 mmHg to approximately 100 mmHg.

[0077] In one embodiment, the applied compressive force is configured to mechanically block the microvascular system and local arterial supply vessels near the surface of the tissue.

[0078] In one embodiment, the compressive pressure is applied uniformly to the entire tissue site being treated.

[0079] In one embodiment, the compressive force is maintained for a period of 30 minutes to 7 hours.

[0080] In one embodiment, the compressive force is applied to different regions of the tissue, allowing larger blood vessels to be filled with a greater level of compression.

[0081] In one embodiment, the compressive force is applied in a pulsating manner.

[0082] One embodiment provides a method for controlling drug delivery to a target site in the body, followed by a period of reactivating blood flow to ensure long-term tissue survival, comprising: mechanically compressing the skin / surface tissue of the target site with a predetermined compressive force to cause occlusion of a local microvascular system with limited potential for drug delivery; maintaining the microvascular occlusion for a predetermined period so that the drug circulating through the vascular system does not reach the target site; releasing the occlusion in a manner controlled by a predetermined rate and a predetermined geometric pattern so as to avoid long-term tissue damage and ischemia-reperfusion injury; sensing physiological parameters; adjusting the mechanical compression applied to the tissue site based on the sensed physiological parameters; and applying pulsatile compressive force to the skin tissue to promote blood flow to remove unwanted drugs from the local vascular system.

[0083] In one embodiment, the perceived physiological parameter is hemoperfusion in the tissue site being treated. Hemoperfusion within tissue is typically measured by magnetic resonance imaging (MRI), positron emission tomography (PET), and laser Doppler imaging. MRI is a non-invasive technique that directly measures blood flow by utilizing arterial blood as an endogenous tracer. PET scans require the introduction of a radioactive tracer into the blood supply. Laser Doppler flowmetry (LDF) is an established surface technique for measuring the movement of red blood cells at tissue surfaces in real time. LDF and laser Doppler imaging (LDI) work by irradiating the tissue with a laser. Perfusion measurements are obtained from the product of the average velocity and the concentration of red blood cells in the volume of tissue being measured. Perfusion is measured at the tissue surface and is given only as a relative value.

[0084] definition In this specification, the term “healthy” should be understood to mean that an individual or patient is free from underlying medical conditions, infections, inflammatory responses, diseases, or other symptoms.

[0085] In this specification, the term “cancer” should be understood to mean cancer selected from the group consisting of lymph node-negative, ER-positive breast cancer and lymph node-negative, ER-positive breast cancer. Early stage, lymph node-positive breast cancer, multiple myeloma, prostate cancer, glioblastoma, lymphoma, fibrosarcoma; myxosarcoma; liposarcoma; chondrosarcoma; osteogenic sarcoma; chordoma; angiosarcoma; endosarcoma; lymphangiosarcoma; lymphangiosarcoma; endolymphatic sarcoma; synoviomas; mesothelioma; Ewing’s tumor; leiomyosarcoma; rhabdomyosarcoma; colon cancer; pancreatic cancer; breast cancer; ovarian cancer; squamous cell carcinoma; basal cell carcinoma; adenocarcinoma; sweat gland carcinoma; Sebaceous carcinoma; papillary carcinoma; papillary adenocarcinoma, cystadenocarcinoma; medullary carcinoma; bronchogenic carcinoma; renal cell carcinoma; liver carcinoma; cholangiocarcinoma; choriocarcinoma; seminoma; embryonal carcinoma; Wilms' tumor; cervical carcinoma; uterine carcinoma; testicular carcinoma; lung carcinoma; small cell lung carcinoma; bladder carcinoma; epithelial carcinoma; glioma; astrocytoma; medulloblastoma; cephalopharyngioma; ependymoma; pinealoma; hemangioblastoma; acoustic neuroma, oligodendroglioma; meningioma; melanoma; retinoblastoma. And also includes selected metastases from the group including bone metastases; lung metastases; liver metastases; bone marrow metastases; breast metastases; and brain metastases.

[0086] In this specification, the terms “individual,” “subject,” or “patient” should be understood to mean all mammals, such as humans, primates, non-human primates, livestock (including pigs, horses, goats, sheep, cattle (including bulls, bulls, virgin cows, etc.), donkeys, reindeer, etc.), veterinary mammals (including dogs, cats, rabbits, hamsters, guinea pigs, mice, rats, ferrets, etc.), domesticated mammals (including lions, tigers, elephants, zebras, giraffes, pandas, rhinos, hippos, etc.), and other mammals and higher mammals to which the use of the present invention is applicable.

[0087] In this specification, the term “treatment” should be understood to mean prohibiting, preventing, suppressing, delaying, halting, or reversing the progression or severity of, for example, chemotherapy-induced alopecia (CIA), chemotherapy-induced peripheral neuropathy (CIPN), and chemotherapy-induced infertility (Cll).

[0088] In this specification, the term “vasoconstriction” should be understood to mean narrowing of blood vessels, particularly the muscular walls of large arteries and small arterioles, resulting in reduced blood flow in the vessels, for example, to the scalp to limit hair loss, or to reduce the delivery of chemotherapy drugs. The major arteries of the scalp are the supratrochlear artery, supraorbital artery, superficial temporal artery, and occipital artery. The major veins, on the other hand, are the superficial temporal, posterior auricular, and occipital veins. The major arteries of the limbs are the radius, ulna, humerus, dorsum of the foot, anterior tibia, lateral calcaneus, medial calcaneus, lateral plantar, and medial plantar. The major arteries of the pelvic cavity are the superior vaginal artery, uterine artery, and ovarian artery.

[0089] In this specification, the term “air bag” should be understood, in relation to the apparatus of the claimed invention, to mean a sealed bag that can be filled with a fluid and is configured to withstand a pressure of up to 500 mmHg.

[0090] In this specification, the term “fluid” should be understood to mean a substance that does not have a fixed shape, flows readily, and readily submits to external pressure. Examples of fluids include gases, air, or liquids.

[0091] In this specification, the term “shell” should be understood to mean a shell or protective packaging that can be made of a hard, soft, or flexible (malleable) material. Examples of hard materials include hard plastics, metals (aluminum, stainless steel, etc.), glass fiber, carbon fiber, graphene, acrylonitrile butadiene styrene (ABS), polylactic acid (PLA), and similar materials. Examples of soft materials include cotton, linen, silk, foam, polyurethane (PU) gel / foam, silicone, latex, polyvinyl chloride (PVC), polyethylene (PE), polyester, bamboo cloth, etc. Examples of flexible materials include rubber, shape memory foam, etc. Other components that can be embedded with the soft or flexible materials described above include antimicrobial agents such as silver, copper, and zinc.

[0092] In this specification, the term “pressure sensor” should be understood to mean a device for measuring the fluid pressure inside an air bag. Typically, sensors consist of resistive, capacitive, or inductive sensing elements and are capable of measuring pressures from 0 to about 100 kPa, preferably from about 0 to about 80 kPa, more preferably from about 0 to about 50 or about 60 kPa, and ideally from about 0 to about 40 kPa.

[0093] In this specification, the term “tissue perfusion sensor” should be understood to mean a device for measuring the level of blood perfusion in tissue, such as scalp tissue. Typically, the sensor comprises a non-invasive convective blood perfusion probe that adapts to the shape of the area being treated. For example, in the case of scalp compression, the sensor is circular and placed on the surface of the scalp. Perfusion measurements are obtained from the product of the average velocity and the concentration of red blood cells in the volume of tissue being measured. The measurement range is typically about 1, 2, 3, 4, or 5 mm in tissue depth below the probe.

[0094] In this specification, the term "air" should be understood to mean the use of gas or air operated under pressure.

[0095] In this specification, the term “ambient temperature” should be understood to mean the average temperature around something (such as a person). Typically, this means “room temperature,” which, depending on climatic conditions, means a dry, clean, and well-ventilated place with temperatures ranging from 15° to 25°C (59° to 77°F), or up to 30°C.

[0096] In this specification, the term “cavity” should be understood to mean the nasal cavity, cheek cavity, and pelvic cavity (including the genitals, vaginal cavity, bladder, distal ureter, proximal urethra, terminal sigmoid colon, rectum, and anal canal, and in females, the uterus, fallopian tubes, ovaries, and (upper) vagina occupy the area between the other viscera).

[0097] In this specification, the term “non-treatment area” should be understood to mean a non-target area of ​​the body that is not affected by the cancer being treated.

[0098] In this specification, the terms “control element” and “control system” are interchangeable and should typically be understood to house a pump, at least one air or gas vent for accessing the inflow of air or gas and allowing air or gas to flow back, at least one pressure sensor, and a tactile on / off switch. At least one pressure sensor may be located within at least one main air bag, or on the tissue-facing side of at least one main air bag, and may remain connected to the control element / system. This control element or system further comprises a control electronic architecture for reading inputs from the pump and at least one pneumatic sensor. The pump is powered by a battery housed within the control element / system.

[0099] The present invention will be better understood from the following description of embodiments, which are shown merely as examples, with reference to the accompanying drawings. [Brief explanation of the drawing]

[0100] [Figure 1] This is a perspective view of the air compressor according to the claimed invention. [Figure 2] This is a diagram showing the air compressor in Figure 1, with a portion of the device's layers cut out. [Figure 3] Figure 3A shows a control element of the claimed invention for use with the air compressor of Figure 1. Figure 3B shows a control element attached to the rear of the device of the claimed invention. When the scalp compression device of Figure 1 is used, (a) the device is placed on the patient's head, (b) a dial on the back of the device is turned to tighten and position the device on the patient's head, and (c) a pressure sensor activates an electric dial on the front of the device to gradually apply and control the pressure inside the device to produce the desired compression. [Figure 4] This figure shows a rear perspective view of the device, with the auxiliary air bladder, indicated by the dotted line, shown at the top. [Figure 5] This figure shows the apparatus of the claimed invention for use on the hands of subjects undergoing chemotherapy. [Figure 6] This figure shows a cross-sectional view of the apparatus in Figure 5, along with the outer layer, revealing the main air bladder located underneath. [Figure 7] Figures 5 and 6 show the apparatus in a cross-sectional view. [Figure 8] This figure shows the device of the claimed invention, to be used for use on the feet of patients undergoing chemotherapy. [Figure 9] This figure reveals the main air bladder located beneath it and shows the apparatus in Figure 8 in a cross-sectional view, along with the outer layer. [Figure 10A] This diagram shows a device that is in vivo (in situ) but has not yet been deployed. [Figure 10B] This is a diagram showing the device in the process of being deployed. [Figure 10C] This is a diagram showing the fully deployed device. [Figure 10D] Figure 10C shows a cross-sectional view of the fully unfolded device, revealing its internal elements. [Figure 11A] This diagram shows a device that is in vivo (in situ) but has not yet been deployed. [Figure 11B] This is a diagram showing the device in the process of being deployed. [Figure 11C] Figure 11B shows a cross-sectional view of the apparatus, illustrating its internal elements. [Figure 11D] This is a diagram showing the fully deployed device. [Figure 12] This graph shows the decrease in tissue perfusion compared to baseline perfusion at a target site (in the case of the scalp) in eight human volunteers when various levels of compression pressure are used and applied to the apparatus of the claimed invention. Tissue perfusion is measured in relative perfusion units provided by a Moor Instruments laser Doppler monitor. [Modes for carrying out the invention]

[0101] Local microvascular compression therapy has been applied to prevent CIA, CIN, CH, and other drug side effects such as dry skin and mucositis. The air compression device of the claimed invention modulates localized drug delivery to protect off-target tissue. The air compression device applies tissue and / or vascular compression to unbroken (unruptured) skin or internal structures (such as within the vaginal cavity) from air compression to occlude local blood vessels in the range of 20 mmHg to 200 mmHg (preferably about 20 mmHg to about 100 mmHg), resulting in partially or completely reduced blood perfusion at the protected site and reduced drug delivery at the effect site (or protected tissue site).

[0102] Firstly, the air compressor applies pressure over a wide area to reduce blood perfusion to the protected tissue. This wide-area approach allows for lower pressure levels (20–100 mmHg) compared to conventional tourniquets (which apply high pressure to a narrow area). This larger pressure footprint allows for greater patient comfort during treatment. Secondly, the applied pressure is adjusted during treatment to mitigate or avoid perfusion-related damage to the tissue at the occluded or protected site. Post-treatment pressure reduction is controlled to avoid reperfusion injury.

[0103] The above-described air compressor can significantly reduce off-target drug-related damage to other tissues and organs, including the skin, peripheral nerve endings, ovaries, or bladder.

[0104] This invention provides an air compression device designed to apply uniform or non-uniform incremental pressure to a subject's area for the therapeutic purpose of preventing damage from chemotherapy drugs. Before chemotherapy infusion, the device can be attached to the subject's head, feet, hands, or cavity, secured in place (where appropriate), and then activated. The device can be used for any size or shape of head, feet, hands, or cavity, and can be used for all age groups (from infants to adults), offering flexibility and ease of use. The internal air bladder mechanism inflates incrementally at room temperature using a fluid to apply pressure (uniformly / non-uniformly) to an area of ​​interest, such as the scalp. When this level of air pressure is applied before, during, or after chemotherapy treatment, the device causes local vasoconstriction of blood vessels, reducing tissue perfusion in the area of ​​interest and thus preventing drug delivery to, for example, hair follicles or other non-target areas.

[0105] Referring here to the drawings, Figure 1 shows a general embodiment of the air compressor of the present invention for use on a subject's scalp. Specifically, Figure 1 shows a perspective view of the air compressor of the present invention mounted on a subject's head, and is generally referred to by reference numeral 1. The apparatus 1 of the illustrated embodiment comprises a mounting member 2 adapted to mount the apparatus 1 on a subject's head. The mounting member 2 is connected to a first layer 3, a second layer 4 (see Figure 2), and at least one main air bag 5 (see Figure 2) sandwiched between them. The mounting member 2 acts as an anchor for the other elements of the apparatus 1. At least one main air bag 5 is attached to the second layer 4 along its inner edge 5a, and at least one main air bag 5 is attached to the first layer 3 along its outer peripheral surface 5b and to the mounting member 2 along its lower end surface 5c. At least one main air bag 5 is inflated, preferably at room temperature, using a fluid, preferably air or gas. The first layer 3 is typically wrapped in an outer mesh layer 6, which is also attached to the mounting member 2. Mounting component 2 is typically rigid.

[0106] When inflated, at least one main air bladder 5 is only capable of expanding toward the scalp, thus expanding and applying pressure to the scalp. The outer mesh layer 6 prevents any outward expansion of the device 1 away from the scalp. One of the functions of the outer mesh layer 6 is to restrain the main air bladder 5 so that the air pressure within the main air bladder 5 is applied to the scalp. When a series of interconnected main air bladder 5 or a series of air bladder compartments are used, pressures of varying magnitudes can be applied to the same or different areas of the scalp.

[0107] Device 1 further comprises an inner membrane 7. The inner membrane 7 ensures that Device 1 fits comfortably to the subject. In one embodiment, the inner membrane 7 works in conjunction with the attachment member 2, i.e., wraps around the subject's head. The inner membrane 7 forms a seal around the subject's scalp. In one embodiment, the inner membrane 7 forms the innermost layer of Device 1, located between the second layer 4 and the subject's head, and substantially envelops the entire area of ​​the scalp when Device 1 is attached to the subject. The inner membrane 7 is typically a soft or malleable (compliant) material that is comfortable for the wearer.

[0108] The inflatable main air bladder 5 is configured to connect to a pump that inflates the main air bladder 5 with air or gas when the device 1 is switched on. The pump and any associated electronic control architecture are housed in a removable control element 9 mounted in a slot 20 located in a mounting member 2 at the rear of the device 1. The main air bladder 5 is constrained in place by both the mounting member 2 and the outer mesh layer 6, and is therefore able to apply an incremental compressive force to the head of the person wearing the device 1.

[0109] During use, the device 1 is positioned on the subject's scalp and secured in place by a plurality of adjustable straps 10 attached to the mounting member 2, either above, around, or below the subject's chin (see Figure 2). In one embodiment, the adjustable straps can be replaced with a drawstring structure attached to the side of the device 1. In one embodiment, the device 1 is secured to the scalp by a secondary air bladder 11 located on the inner surface of the mounting member 2 so as to contact the subject's chin, temples, and nape of the neck (see Figures 1 and 4). When a fluid, preferably air or gas, is supplied to the secondary air bladder 11, the secondary air bladder 11 inflates to form a seal against the subject's forehead, temples, and the base of the head or nape of the neck.

[0110] Referring here to Figures 3A and 3B, the control element 9 is shown in an isolated state (Figure 3A) and in a state within the slot 20 (Figure 3B). The control element 9 typically includes a pump, at least one air or gas vent 12 for accessing the inflow of air or gas and allowing air or gas to flow back, at least one pressure sensor, and a tactile on / off switch 14. The at least one pressure sensor may be located inside at least one main air bag 5, or on the scalp-facing side of at least one main air bag 5, and may remain connected to the control element 9. The control element 9 further comprises a control electronic architecture for reading inputs from the pump and at least one air pressure sensor. The pump is powered by a battery housed within the control element 9 of the device 1. The battery may be a rechargeable battery or a disposable battery.

[0111] The headband member 2 also incorporates at least one status indicator light 13 (see Figure 1) that communicates with the control element 9. The status indicator light 13 communicates with the control element 9 via the mounting member 2 and via a wired connection to the control element 9. The at least one indicator light 13 is used to indicate whether the device 1 is on and functioning, off, or malfunctioning.

[0112] Any incremental change in pressure is measured by at least one air pressure sensor connected to at least one main air bladder 5. The compression pressure applied to the scalp by the device 1 ranges from about 20 mmHg to 350 mmHg, or about 200 mmHg, but preferably between about 20 mmHg and about 150 mmHg, more preferably between about 20 mmHg and about 100 mmHg, and ideally between about 25 mmHg and about 75 mmHg. Typically, the applied compression pressure is between about 40 mmHg and 60 mmHg. When activated, a pump housed within the device 1 inflates at least one main air bladder 5 to the specified compression pressure, acting like a pneumatic device. This compression pressure causes local vasoconstriction and a decrease in the perfusion level of skin tissue, hindering drug delivery to the hair follicles. Once chemotherapy treatment is complete, the device 1 is deflated using a valve structure or using a reverse-polarity pump.

[0113] In one embodiment, the device 1 comprises several air pressure sensors located at several points within the device 1. When the pressure reaches a certain threshold, either low (e.g., 30 mmHg or 40 mmHg) or high (e.g., between approximately 60 mmHg and approximately 200 mmHg) at one or more points measured by the pressure sensors, the pump is activated to either pump more air (fluid) into at least one main air bag 5 to result in more scalp compression, or to remove air from at least one main air bag 5 to result in reduced scalp compression, as needed. In one embodiment, at least one main air bag 5 comprises several individual air bag compartments, each air bag compartment corresponding to a different area of ​​the device 1 and a different part of the subject's scalp. Each air bag compartment is connected to its own pump and pressure sensor in a control element 9.

[0114] In one embodiment, a tissue perfusion sensor, such as a laser Doppler blood flow sensor, is incorporated into or on the scalp-facing surface of the second layer 4 or mounting member 2. The tissue perfusion sensor analyzes the blood flow level while the scalp tissue is compressed. This information, controlled by an architecture of control elements 9 using an embedded software system, is used to activate a pump to increase or decrease the pressure in at least one main air bladder 5 or air bladder compartment.

[0115] Tissue perfusion sensors can be incorporated in several ways. In one embodiment, the tissue perfusion sensor is incorporated into the hollow of the material constituting the second layer 4 so that the sensor is in contact with the subject's scalp. In one embodiment, at least two tissue perfusion sensors are incorporated within a mounting member 2 so that the positions of the tissue perfusion sensors correspond to the temple regions on both sides of the user's head. In another embodiment, there are multiple tissue perfusion sensors configured to be patterned around the scalp by being bonded to or inside at least one main air bladder 5 in a specific pattern, or inside or on both poles of the air bladder compartment, ensuring that the perfusion sensors are scattered around and covering the scalp region. In a further embodiment, multiple tissue perfusion sensors are incorporated into the inner shell 4 so as to be in direct contact with the subject's scalp. The use of one, two, or more tissue perfusion sensors limits the user to determining blood flow at different points on the subject's scalp and the pressure required to constrict blood vessels to obstruct blood flow at points on the scalp.

[0116] In one embodiment, the sensors (air pressure, tissue perfusion) and pump further comprise a power supply, a circuit for measuring its resistance, and means for controlling the sensors and pump and recording readings. In other embodiments of any embodiments described herein, the air pressure sensor, tissue perfusion sensor and pump may further comprise wireless technology for exchanging data between the sensors and pump and the control element 9 of the device 1 at close range, for example, using short-wavelength UHF radio waves (such as Bluetooth®), other wireless data transmission methods such as wireless mesh networks for battery-powered devices of wireless control and monitoring applications (such as ZigBee®), local area network and internet access for the device (such as Wi-Fi®), and other wireless communication protocols using mesh networks that communicate appliance to appliance using low-energy radio waves (such as Z-Wave®). Typically, a remote application can be used on or with the device 1 to record readings from the air pressure sensor, tissue perfusion sensor and / or pump. In this way, the user can remotely control the inflation of at least one main air bag 5, a secondary air bag 11, and air bag compartments. Alternatively, the device 1 itself controls the expansion pressure based on feedback from the sensor to the control element 9. The sensor (air pressure and tissue perfusion) and the pump can also be physically connected to the control element 9 by wiring.

[0117] At the rear of the device 1 is a first tightening system 16 configured to tighten the outer mesh layer 6 to fasten the device 1 to the wearer's head (see Figure 3B). During use, to provide the initial tightening of the device 1 to the wearer's head, the wearer twists the first tightening system 16 in one direction (e.g., clockwise) to secure the outer mesh layer 6, and twists the first tightening system 16 in the opposite direction (e.g., counterclockwise) to loosen the outer mesh layer 6.

[0118] Similarly, the second tightening system 17 is used to tighten the attachment member 2 around the subject's temples, forehead, and nape. This allows the subject to position the device 1 in a comfortable position and to tighten the headband member 2 in a mechanical manner by first twisting the first tightening system 16 and / or the second tightening system 17 to ensure the device 1 is in the correct position for the subject, and then activating the on / off switch 14 to fill the auxiliary air bladder 11 and create a seal around the subject's chin, temples, and underside of the head to hold the device 1 in place.

[0119] The first and second tightening systems 16, 17 can be manually adjusted by the user and electronically adjusted by the architecture of the control element 9. The first and second tightening systems 16, 17 typically have motors within their structure that twist the fastening elements of systems 16, 17. It should be noted that the device 1 can be used without the first and second tightening systems 16, 17, or with only one of the first and second tightening systems 16, 17.

[0120] Referring here to the drawings, Figures 5 to 9 show general embodiments of the air compressor of the present invention for use on the hands or feet of a subject. Where elements of each embodiment are shared, the same reference numerals are used. Specifically, Figure 5 shows a perspective view of the air compressor of the present invention fixed to the hand of a subject, and is typically referred to as reference numeral 100. The device 100 comprises a first layer 3 in the shape of a glove or mitten that can be fixed to the hand of a user. The first layer 3 is fixed to the wearer using attachment members 2, and the device 100 is tightened against the wearer. Furthermore, first and second attachment members 102, 103 can also be used to fix the first layer 3 in place around the fingers of the user, respectively. At least one main air bag 5 connected by a single fluid inlet 12 is attached to the inner surface of the first layer 3 (see Figures 6 and 7). The at least one main air bag 5 is positioned so that each point on the skin of the wearer's fingers, wrist, and forearm is in contact with the main air bag 5. Next, the fluid inlet 12 is connected to a pump (not shown) and electronically coupled to a pressure regulation system / sensor. The pump delivers a fluid (air, oxygen, water, etc.) to the fluid inlet 12 and then to at least one main air bag 5. The main air bag can be configured to have multiple sockets 108 that accommodate the fingers and thumb of the user's hand (see Figures 6 and 7). Alternatively, a network of main air bags 5 is provided that can form contact with the individual fingers and thumb of the user. At least one main air bag 5 inflates and applies incremental compressive pressure to the wearer's skin. The device 100 is programmable to remain inflated until the pressure reduces skin perfusion of the user and hinders drug delivery. Once treatment is complete, the device 100 is deflated using the pump and fluid outlet (or conversely, the fluid inlet (12)).

[0121] In one embodiment, one or more perfusion sensors are positioned on the surface of a plurality of sockets 108 that form at least one main air bladder 5 and come into contact with the wearer's skin. Input from the perfusion sensors can be used to adjust the level of compression pressure applied to the wearer by at least one air bladder 5.

[0122] Referring here to Figure 8, a general embodiment of the air compressor of the present invention for use on a subject's foot is shown. Where elements of each embodiment are shared, the same reference numerals are used. Specifically, Figure 8 shows a perspective view of the air compressor of the present invention fixed to a subject's foot, and is typically referred to as reference numeral 100. The first layer 3 is formed in the shape of a sock that can be fixed over the user's foot. In this embodiment, at least one main air bag 5 is positioned so that each skin surface of the user's toes, foot, and ankle is in contact with at least one main air bag 5. In one embodiment, a network of main air bags 5 is provided that can form contact with the foot and ankle as well as the user's individual toes. The at least one main air bag 5, connected by a single fluid inlet 12, is attached to the inner surface of the first layer 3 (see Figure 9).

[0123] A sterile contact layer is placed between at least one main air bladder 5 and the wearer's skin surface. This sterile contact layer is typically made of a biocompatible, sterilizable plastic such as polyethylene. The first layer 3 is secured to the wearer using mounting members 2 that tighten the device 100 to the wearer. Furthermore, first and second fixing members 102, 103 can also be used to secure the first layer 3 in place around the user's foot, respectively. Next, the fluid inlet 12 is connected to a pump (not shown) electrically coupled to a pressure adjustment system / sensor, i.e., a control system (as described for device 1). The pump delivers a fluid (such as air, oxygen, or water) to the fluid inlet 12 and then to at least one main air bladder 5. A network of main air bladder 5 is provided, capable of forming contact with the individual toes, heels, balls of the feet, and ankles of the user. At least one main air bladder 5 inflates, applying increasing compressive pressure to the wearer's skin. The device 100 is programmable to remain inflated until the pressure reduces skin perfusion to the user and hinders drug delivery. Once treatment is complete, the device 100 is deflated using the pump and fluid outlet (or conversely, the fluid inlet (12)).

[0124] In one embodiment, one or more perfusion sensors are positioned on the surface of a plurality of sockets 108 that form at least one main air bladder 5 that comes into contact with the wearer's skin. Input from the perfusion sensors can be used to adjust the level of compression pressure applied to the wearer by at least one air bladder 5.

[0125] Referring here to Figures 10 and 11, a general embodiment of the air compressor of the present invention for use in a subject's cavity is shown. Where elements of each embodiment are shared, the same reference numerals are used. Specifically, Figure 10A shows a perspective view of the air compressor of the present invention in situ in a subject's vaginal cavity, and is typically referred to as reference numeral 200. The device 200 comprises an applicator 202 having at least one main air bladder 205, an outer shell 210 and an inner shell 212 forming a housing 214 housing the at least one main air bladder 205, and a cap 204 located on top of the applicator 202. The applicator 202 delivers at least one main air bladder 205 to a tissue target in the lumen, as shown in the vaginal cavity in Figures 10 and 11. When the user is correctly positioned in the cavity, at least one main air bladder 205 is pushed from the housing 214 into the vagina by a support shaft 208 (see Figure 10D). The cap 204 communicates with the support shaft 208 and detaches from the end of the applicator 202 when activated (see Figures 10B and 10D). When at least one main air bladder 205 is outside the housing 214 of the applicator 202, at least one or more main air bladder 205 are inflated using a pump through the inlet 12 via the control system, and as described above for devices 1 and 100, at least one or more main air bladder 205 expand to compress against the walls of the cavity (see Figures 10C and 10D).

[0126] At least one main air bladder 205 inflates, applying increasing compressive pressure to the wearer's skin. The device 200 is programmable to remain inflated until the pressure reduces tissue perfusion in the user and hinders drug delivery. Once treatment is complete, the device 200 is deflated using the pump and fluid outlet (or conversely, the fluid inlet (12)).

[0127] In one embodiment, one or more perfusion sensors are positioned on the surface of at least one or more main air bags 205 that are in contact with the tissue of the cavity. Input from the perfusion sensors can be used to adjust the level of compression pressure applied to the user by at least one or more main air bags 205.

[0128] Referring to Figure 11 in more detail, the cap 204 located above the applicator 202 further comprises an opening 206. The opening 206 is configured to guide at least one main air bladder 205 from the housing 214 into the cavity. When the user acts on the support shaft 208, at least one main air bladder 205 exits the opening 206 and enters the cavity (see Figure 11B). The cap 204 is disengaged from the support shaft 208 and remains in communication with the top of the applicator 202. The support shaft 208 remains engaged with at least one main air bladder 205 (see Figure 11C). When at least one main air bladder 205 is outside the housing 214 of the applicator 202, at least one or more main air bladder 205 are inflated via the control system using a pump through the inlet 12, and as described above for devices 1 and 100, at least one or more main air bladder 205 expand to compress against the walls of the cavity (see Figure 11D).

[0129] At least one main air bladder 205 inflates, applying increasing compressive pressure to the wearer's skin. The device 200 is programmable to remain inflated until the pressure reduces tissue perfusion in the user and hinders drug delivery. Once treatment is complete, the device 200 is deflated using the pump and fluid outlet (or conversely, the fluid inlet (12)).

[0130] In one embodiment, one or more perfusion sensors are positioned on the surface of at least one or more main air bags 205 that are in contact with the tissue of the cavity. Input from the perfusion sensors can be used to adjust the level of compression pressure applied to the user by at least one or more main air bags 205.

[0131] material and method Devices 1, 100, and 200 are operated by the wearer in a clinical setting, as described below. 1. Devices 1, 100, and 200 are provided in a loosened, detached state. 2. In the case of the scalp The clinician or user loosely places the device 1 over the subject's head and secures the device 1 in place with straps using the fixing method 10 and the auxiliary air bladder 11, the first tightening system 16 or the second tightening system 17, or a combination thereof. 3. Device 1 is switched on by pressing the ON button 14 located on the rear of Device 1. Device 1 then begins to inflate, and the status light 13 indicates that Device 1 has been switched on and that at least one main air bladder 5 has begun to inflate. 4. When device 1 reaches the target pressure application, the status light 13 indicates that device 1 is currently in "active" mode. Device 1 remains active for a pre-programmed period. 5. In the case of hands or feet, The clinician or user loosely places the device 100 on the subject's hand or foot and secures the device 100 in place with straps using the first fixing member 2, the second fixing member 102, or the third tightening member 103, or a combination thereof. 6. The device 100 is switched on by pressing a button on a control system that incorporates a pump electrically coupled to a pressure regulating system / sensor. The pump then begins to inflate at least one main air bag 5, and a status light on the control system indicates that the device 100 has been switched on and at least one main air bag 5 has begun to inflate. 7. When the device 100 reaches the target pressure application, the status light indicates that the device 100 is currently in "active" mode. The device 100 remains active for a pre-programmed period. 8. In the case of a cavity, The clinician or user places the device 200 into the cavity. 9. The device 200 is switched on by pressing a button on a control system that incorporates a pump electrically coupled to a pressure regulating system / sensor. The pump then begins to inflate at least one main air bag 205, and a status light on the control system indicates that the device 200 has been switched on and at least one main air bag 5 has begun to inflate. 10. When the device 200 reaches the target pressure application, the status light indicates that the device 200 is now in "active" mode. The device 200 remains active for a pre-programmed period. 11. Subsequently, the clinician can begin the chemotherapy infusion process. 12. Once the chemotherapy infusion is complete, the patient can freely leave the clinical setting while still wearing devices 1, 100, and 200. 13. When the active chemotherapy period ends, the status indicator light indicates the completion of treatment. The control element 9 or control system further comprises a timing system which can be set to a specific time at which the devices 1, 100, 200 inflate to apply pressure to the user's scalp / hands / feet / cavities. The timing system can be set to the amount of time at which chemotherapy is being administered, or the control element 9 or control system can be connected to the chemotherapy treatment delivery device (physically connected via plug-and-play wiring configuration or wirelessly) to reflect the time taken for treatment. When this time has expired, the user can press the off button (14), or when the off button (14) is automatically released by the control element 9 or control system, which activates a pump that draws fluid from at least one main air bag 5,205 (or from multiple air bag compartments 5,205) and releases the fluid through vents that slowly release pressure from the devices 1, 100, 200. 14. Once the pressure is released, devices 1, 100, and 200 will complete the shutdown procedure, after which the user is free to loosen or remove and store devices 1, 100, and 200. 15. The user shall bring devices 1, 100, and 200 to the clinic at their next appointment.

[0132] conclusion Devices 1, 100, and 200 can be attached before, during, and after chemotherapy treatment for a specified period. The expected attachment time is up to approximately 30 minutes before chemotherapy infusion, continuous attachment during chemotherapy infusion, and an additional 60 to 120 minutes, preferably 90 minutes, after the infusion is complete. The main advantage of this solution is that there is no need to spend additional time at the infusion center where devices 1, 100, and 200 are attached after the infusion treatment is completed, and the patient can leave the infusion ward while still wearing devices 1, 100, and 200.

[0133] The apparatus 1, 100, 200 of the invention described in the claims is a refined, comfortable, and portable solution for preventing hair loss during chemotherapy. The apparatus 1, 100, 200 is designed to fit into existing clinical workflows and avoids the problems of capital cost, infection control, and patient discomfort associated with existing products.

[0134] The use of air bladders in devices 1, 100, and 200 essentially involves them spreading to fill the surrounding empty space. This is a highly advantageous characteristic in devices 1, 100, and 200 because it provides ample room for spreading, meaning the air bladders system will expand to conform to any shape of the head, hands, feet, or cavity, and apply the same pressure evenly to all surfaces.

[0135] Devices 1, 100, and 200 regulate drug delivery at the microvascular level at low pressure to avoid problems caused by insufficient blood flow to most of the body. This is shown in Figure 12, demonstrating a reduction in tissue perfusion at the target site to a significantly lower level from the “baseline” quiescent state when compression is applied using Device 1. This graph shows the average reduction in tissue perfusion at a depth of 1.5 mm (as measured using a laser Doppler flowmeter) at the target site while using Device 1 across eight healthy human volunteers. Existing devices of the prior art utilize vasoconstriction induced by low temperatures, while existing compression devices primarily focus on increasing blood flow.

[0136] In this specification, the terms “equip, include, constitute, and constitute” or variations thereof are considered to be fully interchangeable, and all of them should be given the broadest possible interpretation, and vice versa.

[0137] The present invention is not limited to the embodiments described herein and can be modified in both structure and detail.

Claims

1. An air compression therapy device (1,100) for use in preventing or treating chemotherapy-induced alopecia or chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving chemotherapy, A mounting member (2) for attaching the device (1,100) to the subject, A first layer (3) is connected to the mounting member (2) and forms the outer layer of the device (1,100), A main air bladder (5) is provided between the first layer and the subject, The device (1,100) includes a fluid inlet (12) that allows air or gas to enter and exit the device, The at least one main air bladder (5) is configured to inflate with fluid at ambient temperature, and when the at least one main air bladder (5) inflates, it applies compressive pressure to the non-treatment area of ​​the subject, hindering blood perfusion and preventing the delivery of chemotherapy drugs to the non-treatment area. An air compression therapy device (1,100) further comprising a secondary air bag (11), the secondary air bag (11) being attached to the mounting member (2) and the secondary air bag (11) in contact with the tissue of the subject.

2. The air compression therapy device (1) according to claim 1, further comprising an inner lining (7), wherein the inner lining (7) forms the inner layer of the device (1).

3. An outer mesh layer (6) disposed on the outside of the first layer (3), A first tightening system (16) is configured to fix the device (1) to the head of the subject by tightening the outer mesh layer (6), The air compression therapy device (1) according to claim 1 or 2, further comprising:

4. The air compression therapy device (1) according to claim 3, further comprising a second tightening system (17) adapted for tightening the mounting member (2) on the subject.

5. The air compression therapy device (1) according to any one of claims 2 to 4, wherein the at least one main air bag (5) is attached to the first layer (3) along its outer surface (5b) and to the attachment member (2) along its lower end (5c).

6. The air compression therapy device (1) according to any one of claims 1 to 5, further comprising at least one adjustable strap for securing it under the chin of the subject.

7. The air compression therapy device (100) according to claim 1, wherein the at least one main air bladder (5) is configured to have a plurality of sockets (108) for accommodating the fingers or toes of the subject.

8. The air compression therapy device (100) according to claim 1, wherein the at least one main air bladder (5) is configured to be a single socket for accommodating the entire hand or the entire foot of the subject.

9. The air compression therapy device (100) according to any one of claims 1, 7, or 8, further comprising a first fixing member (102) for fixing the device (100) in a predetermined location.

10. The air compression therapy device (100) according to claim 9, further comprising a second fixing member (103) for fixing the device (100) in a predetermined location.

11. Further comprising a control element (9) including a pump and at least one pressure sensor, The air compression therapy device (1,100) according to any one of claims 1 to 10, wherein the control element (9) is configured to operate the pump based on the pressure measured by the at least one pressure sensor.

12. The air compression therapy device (1,100) according to claim 11, further comprising at least one tissue perfusion sensor for the control element (9).

13. The air compression therapy device (1,100) according to claim 11, wherein the at least one pressure sensor is in communication with the at least one main air bag (5).

14. The air compression therapy device (1,100) according to any one of claims 1 to 13, wherein the at least one main air bag (5) further comprises a plurality of air bag compartments, and each air bag compartment operates independently of the other compartments.

15. The air compression therapy device (1,100) according to any one of claims 1 to 13, wherein the at least one main air bag (5) further comprises a plurality of air bag compartments, and each of the plurality of air bag compartments communicates with an air bag compartment arranged in parallel thereto.

16. The air compression therapy device (1,100) according to claim 14 or 15, wherein the at least one main air bag (5) or the plurality of air bag compartments are connected to a pump and the pump has a two-way valve structure that controls the inflow and outflow of fluid.

17. When activated, the device (1,100) applies a compression pressure of approximately 20 mmHg to approximately 100 mmHg to the subject, as described in any one of claims 1 to 16.

18. The air compression therapy device (1,100) according to claim 17, wherein the applied compression pressure is between approximately 25 mmHg and approximately 75 mmHg.

19. The air compression therapy device (1,100) according to claim 17 or 18, wherein the applied compression pressure is between approximately 40 mmHg and approximately 60 mmHg.

20. The air compression therapy device (1,100) according to any one of claims 1 to 19, wherein the at least one main air bag (5) or the plurality of air bag compartments are inflated to a predetermined pressure level lower than the target therapeutic pressure level before the user uses the device (1,100).

21. The air compression therapy device (1,100) according to any one of claims 1 to 20, wherein the at least one main air bag (5) or the plurality of air bag compartments are supplied at a predetermined pressure level and do not inflate beyond that level.

22. The air compression therapy device (1,100) according to any one of claims 1 to 21, wherein the mounting member (2) comprises at least one indicator light (13).

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