Methods for delivering vascular compression therapy to patients receiving vascular compression devices and chemotherapy.

Abstract

Various devices and methods useful for providing vascular compression to patients undergoing chemotherapy are described. Some devices include a helmet with an inflatable bladder, a facepiece attached to the helmet, and one or more face tiles positioned inside the facepiece. In addition, structures capable of providing vascular compression reaction force may be present to increase the comfort of patients undergoing chemotherapy protocols while receiving vascular compression therapy. During use, the patient may perform one or more of the following: change the pressure of the inflatable bladder, adjust one or more straps attached to the facepiece, or change the position or characteristics of one or more face tiles.

Description

Technical Field

[0001] (Cross - Reference to Related Applications)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 490,487, filed Mar. 15, 2023, entitled “VASOCOMPRESSION DEVICES AND METHODS OF DELIVERING VASOCOMPRESSION THERAPY TO A PATIENT UNDERGOING CHEMOTHERAPY TREATMENT,” which is incorporated herein by reference in its entirety.

[0002] (Incorporation by Reference)

[0002] All publications and patent applications cited herein are incorporated herein by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference.

[0003]

[0003] Various embodiments related to this application are directed to devices and methods for reducing or eliminating chemotherapy - induced alopecia (CIA), chemotherapy - drug - induced hair loss, follicular death, and / or telogen effluvium. Additionally, or optionally, the devices and methods may be used with therapeutic agents that assist in these objectives.

Background Art

[0004]

[0004] Chemotherapy agents induce CIA by interfering with the transition between stages of hair follicle development, stimulating abnormal hair follicle development, or inducing premature hair follicle degeneration {Paus et al., 1994; Trueb, 2009; Yeager et al., 2011}. Telogen effluvium occurs when the majority of hair in the growth phase enters the resting phase prematurely, and cyclophosphamide, for example, causes CIA by this mechanism {Patel et al., 2014}. Anagen effluvium is the most common type of CIA, as up to 90% of the hair is in the growth phase at any given time and occurs within days to weeks after administration of cytotoxic agents {Olsen et al., 2011}, and is stimulated by alkylating agents, antimetabolites, vinca alkaloids, topoisomerase inhibitors, anthracyclines, and taxanes {Espinosa et al., 2003; Yun et al., 2007}. As mentioned above, up to 90% of hair follicles are in the growth phase {Batchelor et al., 2001}, and the associated matrix keratinocytes represent the most rapidly dividing cell subset. Therefore, hair follicles are particularly susceptible to the effects of chemotherapy drugs because they are especially targeted by drugs that target cell replication.

[0005]

[0005] Currently, scalp cooling is the only available method for preventing chemotherapy-induced alopecia and can prevent CIA through various possible mechanisms. Firstly, cooling has been shown to cause vasoconstriction, thereby reducing blood flow in the scalp to 20-40% of the normal rate (Janssen et al., 2007). As a result, it is thought that less chemotherapy drug is delivered to the hair follicles (Bulow et al., 1985). Another possibility is that cooling can reduce the rate of drug diffusion across the cell membrane, thus allowing for a more substantial drug dose entering the cell (Lane et al., 1987). Furthermore, since cell division is driven by metabolism, temperature may particularly affect stages such as G1 and S, and cooling may be able to slow down this process (Watanabe and Okada, 1967), which can be particularly important for drugs that target specific stages of the cell cycle, such as microtubule disruptors that target mitosis. Furthermore, a decrease in the metabolic activity of cells within hair follicles may lead to a more overall reduction in the cytotoxicity of chemotherapy drugs (Bulow et al., 1985). In practice, a combination of these methods is likely to be involved in the success of CIA reduction by scalp cooling.

[0006]

[0006] In any of these cases, scalp cooling does not necessarily work in all instances, and its effectiveness varies from person to person.

[0007]

[0007] As a result, there is still a need for improvements in techniques used to reduce, substantially eliminate, or support the treatment of chemotherapy-induced alopecia, hair follicle death, and / or anagen alopecia. [Overview of the Initiative] [Means for solving the problem]

[0008]

[0008] Generally, in one embodiment, a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy includes a shell having an anterior edge, a posterior edge, a apex, a left lateral edge, and a right lateral edge; a liner located inside the shell and shaped to at least partially accommodate the patient's hair; at least one vascular compression element located inside the outer shell; and a head cover retaining system coupled to the shell.

[0009]

[0009] The other embodiments described above may include one or more of the following features: The shell retention system may include a submandibular strap connected to the shell. The shell retention system may include one or more posterior straps, anterior straps, or cervical straps connected to the shell. The shell retention system may include one or more adjustment elements. At least one vascular compression element may be an expandable bladder located inside the liner. At least one vascular compression element may be coupled to the shell. The head cover may further include a pressure source communicating with the expandable bladder. The head cover may further include a continuous perimeter connecting the anterior, posterior, left, and right edges. The head cover of at least one vascular compression element may further include an expandable feature that expands away from the shell in response to the pressure source. The head cover may further include an expandable layer coupled to the liner. At least one vascular compression element may be located in the expandable layer. The head cover of at least one vascular compression element may further include one or more raised features. The head cover of the liner, located inside the shell and shaped to accommodate at least partially the patient's hair, may further include one or more features on the liner for engaging with the patient's hair. The liner or at least one vascular compression element may be smooth. The liner or at least one vascular compression element may include an array of uniformly distributed projections having a linear or circular inflatable structure. The head cover retention system may further include hook and loop fasteners, buckles, quick-release mechanisms, or adjustment features. The head cover may further include a gas source communicating with the liner or at least one vascular compression element to inflate a portion of the liner or a portion of at least one vascular compression element. The head cover may further include at least one relief valve to prevent overpressure of the inflatable elements of the head cover. The gas source may be a manual pump mechanism, a valve, an electric pump, or a pressurized tank, cartridge, or reservoir.The head cover may further include a control system for regulating the flow of gas from a gas source to maintain a desired pressure inside the head cover. The desired pressure inside the head cover can be sufficient to produce a vascular compression result while minimizing patient discomfort or side effects or damage to surrounding structures. The head cover may further include a cooling gas source communicating with a liner or at least one vascular compression element, and a portion of the liner or at least one portion of the vascular compression element is adapted to provide cooling inside the head cover. The head cover may further include one or more pressure sensors inside the head cover. One or more pressure sensors can provide pressure indications to the control system. One or more pressure sensors can be adapted to indicate the amount of pressure applied to a patient receiving chemotherapy when the patient is wearing the head cover. The head cover may further include one or more sensors for measuring skin perfusion (O2 saturation) or monitoring Doppler blood flow or sensing with an infrared pulse oximeter. Sensors may also be used to detect that blood flow in a vascular structure receiving vascular compression therapy has been sufficiently stopped or slowed to prevent exposure of hair follicles to chemotherapeutic agents. The head cover may further include a continuous structure from the occipital region to the eyebrows or forehead. The head cover may further include a structure or inflatable structure for compressing the eyebrows for vascular compression action on the eyebrows. The head cover may further include a timer and control system, which is adapted to provide an auto-contraction protocol to stop the operation of the vascular compression element when the timer has elapsed or when it is in any active state. The head cover may further include a timer and control system adapted for programmed auto-inflation and deflation of the liner or one or more vascular compression elements, or for activation and deactivation of one or more vascular compression elements. The liner may be a rigid or semi-elastic layer configured for a tight fit for the patient so as to fit tightly to the shape of the patient's head and hair. The head cover retention system may include a tightening system.The head cover may further include one or more selective pressure points positioned to compress one or more vessels in the patient's cranial circulatory system. The head cover may further include a vibrating element coupled to a liner or at least one vascular compression element. The liner and at least one vascular compression element may be sized, shaped, or positioned relative to the head cover based on the patient's hairstyle.

[0010]

[0010] Generally, in one embodiment, a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy includes a cap having a front edge, a rear edge, a top edge, a left edge, and a right edge; a liner located inside the cap and shaped to at least partially accommodate the patient's hair; and at least one vascular compression element located inside the cap.

[0011]

[0011] The other embodiments described above may include one or more of the following features: The cap may include a flexible structure, a partially flexible structure, a combination of a semi-rigid structure and a flexible structure, or an adjustable structure, sized to remain in a fixed position on the head when at least one vascular compression element is active. The at least one vascular compression element may be an expandable bladder located inside the cap or liner. The at least one vascular compression element may be coupled to the cap or liner. The head cover may further include a pressure source communicating with the expandable bladder or at least one vascular compression element. The head cover may further include a continuous perimeter connecting the anterior edge, posterior edge, left edge, and right edge. The head cover of at least one vascular compression element may further include an expandable feature to expand away from the cap in response to the pressure source. The head cover may further include an expandable layer coupled to the liner, and at least one vascular compression element may be located in the expandable layer. The head cover of at least one vascular compression element may further include one or more raised features. The head cover of a liner located inside the shell and shaped to at least partially accommodate the patient's hair may further include one or more features on the liner for engaging with the patient's hair. The liner or at least one vascular compression element may be smooth. The liner or at least one vascular compression element may include an array of uniformly distributed protrusions having a linear or circular inflatable structure. The head cover may further include a gas source communicating with the liner or at least one vascular compression element to inflate a portion of the liner or a portion of the at least one vascular compression element. The head cover may further include at least one relief valve to prevent overpressure of the inflatable elements of the head cover. The gas source may be a manual pump mechanism, a valve, an electric pump, or a pressurized tank, cartridge, or reservoir. The head cover may further include a control system for regulating the flow of gas from the gas source to maintain a desired pressure inside the head cover.The desired pressure inside the head cover can be sufficient to produce a vascular compression result while minimizing patient discomfort or side effects or damage to surrounding structures. The head cover may further include a cooling gas source communicating with a liner or at least one vascular compression element, and a portion of the liner or at least one portion of the vascular compression element may be adapted to provide cooling inside the head cover. The head cover may further include one or more pressure sensors inside the head cover. One or more pressure sensors may provide pressure indications to a control system. One or more pressure sensors may be adapted to indicate the amount of pressure applied to a patient receiving chemotherapy when the patient is wearing the head cover. The head cover may further include one or more sensors for measuring skin perfusion (O2 saturation) or monitoring Doppler blood flow or sensing with an infrared pulse oximeter. The head cover may further include a continuous structure from the occipital region to the eyebrows or forehead. The head cover may further include a structure or inflatable structure for compressing the eyebrows for a vascular compression effect on the eyebrows. The head cover may further include a timer and control system, which is adapted to provide an auto-contraction protocol to stop the operation of any active vascular compression element when the timer has elapsed or when any active vascular compression element has stopped. The head cover may further include a timer and control system adapted for programmed auto-inflation and deflation of the liner, or for activation and deactivation of one or more vascular compression elements. The liner may be a rigid or semi-elastic layer configured for a tight fit for the patient, so as to fit tightly to the shape of the patient's head and hair. The head cover retention system may include a tightening system. The head cover may further include one or more selective pressure points positioned to compress one or more vessels in the patient's cranial circulatory system. The head cover may further include a vibrating element coupled to the liner or at least one vascular compression element. The liner and at least one vascular compression element may be sized, shaped, or positioned relative to the head cover based on the patient's hairstyle.

[0012]

[0012] Generally, in one embodiment, a method for inducing vascular compression in the cranial circulatory system of a patient receiving chemotherapy includes: (1) placing a head cover around the patient's head; (2) using the vascular compression elements of the head cover to at least partially induce vascular compression in a portion of the patient's cranial circulatory system; (3) initiating a chemotherapy session for the patient; (4) completing a chemotherapy session for the patient; and (5) ending the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system after a sufficient period of time has elapsed to partially mitigate the effects of chemotherapy-induced alopecia in the patient.

[0013]

[0013] The other embodiments described above may include one or more of the following features. The method may further include engaging a head cover retention system to secure the head cover to the patient's head. The period elapsed after the step of completing the chemotherapy session may be up to 24 hours. The period elapsed after the step of completing the chemotherapy session may be at least 1 hour. The period elapsed after the step of completing the chemotherapy session may be at least 48 hours. The vascular compression element of the head cover may be a liner, and a step of expanding the liner or a step of contracting the liner may be performed during a step of at least partially inducing vascular compression in a portion of the patient's cranial circulation. An increase in the amount of vascular compression may occur during the step of expanding the liner in response to an increase in the force of the liner on the patient's scalp. A decrease in the amount of vasoconstriction may occur during the step of contracting the liner in response to a decrease in the force of the liner on the patient's scalp. The vascular compression element of the head cover can be a liner having one or more features, and a step of expanding or contracting the liner is performed during a step of at least partially inducing vascular compression in a portion of the patient's cranial circulation. An increase in the amount of vascular compression can be produced during the liner expansion step in response to an increase in the force pressing one or more features of the liner against the patient's scalp. A decrease in the amount of vascular compression can be produced during the liner contraction step in response to a decrease in the force pressing one or more features of the liner against the patient's scalp. The vascular compression element of the head cover can be an inflatable bladder, and the degree of vascular compression during the step of at least partially inducing vascular compression in a portion of the patient's cranial circulation corresponds at least partially to the amount of pressure inside the inflatable bladder. The vascular compression element of the head cover can be an inflatable bladder, and the degree of vascular compression during the step of at least partially inducing vascular compression in a portion of the patient's cranial circulation is increased or decreased by increasing or decreasing the pressure in the inflatable bladder against the skull.The vascular compression elements of the head cover may be one or more features located on the inner surface of the head cover that come into contact with the portion of the patient's scalp containing hair follicles during the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system. The vascular compression elements of the head cover may be one or more features located on the inner surface of the head cover that correspond to the composition of the patient's hair, and one or more features act on the composition of the patient's hair to facilitate the execution of the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system. During the step of at least partially inducing vascular compression, the vascular compression elements of the head cover can compress the portion of the scalp containing multiple hair follicles against a portion of the skull, thereby at least partially compressing the blood supply to the multiple hair follicles. This portion of the skull may be one or more of the superior temporal line, inferior temporal line, parietal bone, squamous suture, temporal bone, lambdoid suture, occipital bone, mastoid process, sphenoid bone, portion adjacent to the supraorbital foramen, frontal bone, and coronal suture. During the step of inducing vascular compression at least partially, the vascular compression element of the head cover can be positioned to compress an artery or vein of the patient's cranial circulatory system at least partially by compressing the artery or vein against a portion of the skull. The artery or vein of the cranial circulatory system may be a branch of the external carotid artery or a branch of the internal carotid artery. The artery or vein of the cranial circulatory system may be the ophthalmic artery. The artery or vein of the cranial circulatory system may be the superficial temporal artery. The artery or vein of the cranial circulatory system may be the posterior auricular artery. The artery or vein of the cranial circulatory system may be the occipital artery. The artery or vein of the cranial circulatory system may be the supraorbital artery or supratrochlear artery. This portion of the skull may be one or more of the superior temporal line, inferior temporal line, parietal bone, squamous suture, temporal bone, lambdoid suture, occipital bone, mastoid process, sphenoid bone, portion adjacent to the supraorbital foramen, frontal bone, and coronal suture. The step of inducing at least partial vascular compression in a portion of the cranial circulatory system can be attributed to compression of a portion of the scalp containing the blood vessels of the patient's cranial circulatory system against a portion of the patient's periosteum.The step of at least partially inducing vascular compression in a portion of the cranial circulatory system can be brought about by interaction between the vascular compression element of the head cover and the blood vessels of the patient's cranial circulatory system. The method of the step of at least partially inducing vascular compression in a portion of the cranial circulatory system may further include compressing a portion of the scalp against a portion of the periosteum to induce vascular compression in a portion of the vascular bed of the hair follicles. The vascular compression element of the head cover can be positioned relative to the patient's head, and during the engagement step, the vascular compression element is positioned in close proximity to a specific vein or artery to at least partially compress a specific vein or artery of the patient's cranial circulatory system. The specific vein or artery may be any of the blood vessels described above. This method may further include the delivery of a vasoconstrictor to the patient before, during, or after the use of any method or device described herein. The vasoconstrictor may be one of the following: alpha-adrenergic receptor agonists, vasopressin analogs, epinephrine, norepinephrine, phenylephrine, dopamine, dobutamine, migraine medications, headache medications, serotonin 5-hydroxytryptamine agonists, and triptans. With any of the methods or devices described above, the patient can receive chemotherapy by injection, infusion, targeted therapy, hormone therapy, or immunotherapy. The patient can receive chemotherapy via intravenous, subarachnoid, intra-arterial, intracavitary, intramuscular, intralesional, or intravesical methods. The patient can receive chemotherapy at home, in a medical provider's office, clinic, outpatient infusion center, hospital infusion center, or hospital ward.

[0014]

[0014] Generally, in one embodiment, a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy includes a shell having an anterior edge, a posterior edge, a vertex, a left edge, and a right edge; a liner located inside the shell and shaped to at least partially accommodate the patient's hair; at least one vascular compression element located inside the shell or liner; a head cover holding system including a full-face support structure that surrounds the mandibular body and mandibular ramus and extends to at least partially cover them across the zygomatic, maxillary, and frontal bones of the patient's skull, with openings for the patient's eyes, nose, and mouth inside the full-face support structure; a cushion located between the inner wall of the full-face support and the patient along the inner wall of the full-face support; and one or more straps located between the head cover and the full-face support.

[0015]

[0015] The other embodiments described above may include one or more of the following features: The cushion head cover may further include a plurality of tile face cushions arranged along the inner wall of the full face support, and the size, shape, hardness, and compression coefficient characteristics of each of the plurality of tile face cushions may be selected based on its location inside the full face support while vascular compression therapy is being delivered and the load characteristics of that location.

[0016]

[0016] The head cover may further include a plurality of tile face cushions arranged along the inner wall of a full face support, wherein each of the plurality of tile face cushions may include a post, and a plurality of openings located inside the full face support, wherein the location of each opening can be adapted and configured to correspond to a post of a tile face cushion adjacent to the opening.

[0017]

[0017] One or more straps may further include at least two front support straps extending from the front edge of the shell to the top edge of the full-face support, or at least two right-side support straps extending from the right side of the full-face support structure to the right side of the shell, or at least two left-side support straps extending from the left side of the full-face support structure to the left side of the shell, or any combination of the above.

[0018]

[0018] The liner can be an expandable liner.

[0019]

[0019] The inflatable liner may have an internal section of the liner and an external section that engages with the patient.

[0020]

[0020] A separation section can be provided between the internal section and the external section. The separation section can form a perimeter corresponding to the perimeter of the shell. The separation section can maintain its shape during the inflation and deflation of the inflatable liner. Each of the multiple tile face cushions may include an internal surface contoured to fit a portion of the face, an external surface contoured to engage with a portion of the full face support, and an intermediate portion between the internal and external surfaces.

[0021]

[0021] The middle section of each face tile can be one or a combination of gel, foam, silicone, uniform durometer material, mixed durometer material, or expansion section. Each face tile may have a post for aligning each face piece tile with the corresponding opening in the full face cover.

[0022]

[0022] Each face tile may have a shaft and knob for mechanically adjusting the distance from the inner surface of the full face cover to the inner surface of the face tile, or a valve for adjusting the pressure inside the face tile.

[0023]

[0023] Generally, in one embodiment, a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy includes a shell having a front edge, a rear edge, a top, a left edge, and a right edge, an inflatable liner located inside the shell, a head cover retention system adapted to maintain the position of the shell and the inflatable liner relative to the patient's head, a face cover coupled to the shell, and at least one pad support located inside the face cover.

[0024]

[0024] The other embodiments can include one or more of the following features. The face cover can include a plurality of connection points providing access for a plurality of support pads located inside the face cover.

[0025]

[0025] The at least one pad support can be a plurality of individual pads adapted and configured to be at least partially conformal with the patient's bone structure.

[0026]

[0026] The plurality of individual pads can be controllable using a mechanical adjustment system when applying pressure to a portion of the patient's face.

[0027]

[0027] The plurality of individual pads can be controllable using an electronic adjustment system when applying pressure to a portion of the patient's face.

[0028]

[0028] The electronic adjustment system can further include a time-based or user-selected program for increasing or decreasing the pressure applied to a portion of the patient's face by the pads.

[0029]

[0029] The user-selected program can be controlled using a control interface, remote device, smart device, or app selected by the user based on pre-set pressure settings, previous chemotherapy sessions, or time-based adjustments for alleviating intermittent fatigue while using the vascular compression device.

[0030]

[0030] The head cover can further include a blood vessel compression reaction force structure, and the blood vessel compression reaction force structure can be a ring having an inner diameter of 2.54 cm (1 inch) to 10.16 cm (4 inches).

[0031]

[0031] The blood vessel compression reaction force structure can have a frustum shape having a base with an outer diameter of 15.24 cm (6 inches) to 20.32 cm (8 inches) and an upper surface having a ring with a diameter of 2.54 cm (1 inch) to 10.16 cm (4 inches).

[0032]

[0032] The blood vessel compression reaction force structure can have a base, a mandrel, and an upper support surface. The diameter of the base can be 2.54 cm (1 inch) to 7.62 cm (3 inches). The blood vessel compression reaction force structure can have a base, an elongated mandrel, and a square upper support surface.

[0033]

[0033] The blood vessel compression reaction force structure can have a frustum shape having a base with an outer diameter of 15.24 cm (6 inches) to 20.32 cm (8 inches) and an upper ring supporting the base, an elongated mandrel, and an upper support surface.

[0034]

[0034] Generally, in one embodiment, a head cover for inducing blood vessel compression in the blood supply of a patient undergoing chemotherapy includes a shell having a front edge, a rear edge, a top, a left side edge, and a right side edge, at least one blood vessel compression element located inside the shell, a head cover holding system adapted to maintain the position of the shell and the liner with respect to the patient's head, and a blood vessel compression reaction force structure coupled to the shell.

[0035]

[0035] The other embodiments can include one or more of the following features. The blood vessel compression reaction force structure can be a ring having an inner diameter of 2.54 cm (1 inch) to 10.16 cm (4 inches).

[0036]

[0036] The vascular compression reaction structure may have a frustoconical shape with a base having an outer diameter of 15.24 cm (6 inches) to 20.32 cm (8 inches) and an upper surface having a ring with a diameter of 2.54 cm (1 inch) to 10.16 cm (4 inches).

[0037]

[0037] The vascular compression reaction structure may have a base, a core, and an upper support surface, and the diameter of the base is 2.54 cm (1 inch) to 7.62 cm (3 inches).

[0038]

[0038] The vascular compression reaction structure may have a base, an elongated core, and a rectangular upper support surface.

[0039]

[0039] The vascular compression reaction structure may have a frustoconical shape, an elongated spindle with a base having an outer diameter of 15.24 cm (6 inches) to 20.32 cm (8 inches) and an upper ring supporting the base, as well as an upper support surface.

[0040]

[0040] Generally, in one embodiment, a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy includes a shell having an anterior edge, a posterior edge, a apex, a left side edge, and a right side edge; a liner located inside the shell and shaped to at least partially accommodate the patient's hair; at least one vascular compression element located inside the shell; a head cover holding system including a submandibular rigid support extending from the left side of the mandibular body, around the mental protuberance, to the right side of the mandibular body; a cushion located on the submandibular rigid support; a left anterior support strap extending from the anterior edge of the shell to the submandibular rigid support; a right anterior support strap extending from the anterior edge of the shell to the submandibular rigid support; a left support strap extending from the left side edge of the shell to the left end of the submandibular rigid support; and a right support strap extending from the right side edge of the shell to the right end of the submandibular rigid support.

[0041]

[0041] The other embodiments described above may include one or more of the following features: The cushion may extend over the submandibular rigid support and beyond the left and right ends of the submandibular rigid support.

[0042]

[0042] The cushion can be a foamed filler located inside the structure of the submandibular rigid support.

[0043]

[0043] The submandibular rigid support can extend from a position close to the left corner of the mandible, around the mental protuberance along the left side of the mandibular body, and along the right side of the mandibular body to a position close to the right corner of the mandible.

[0044]

[0044] The head cover may further include a vascular compression reaction structure having a dynamic facepiece.

[0045]

[0045] The head cover may further include a vascular compression reaction structure or a dynamic facepiece.

[0046]

[0046] The head cover retention system may include one or more of the rear strap, front strap, or neck strap connected to the shell.

[0047]

[0047] The shell retention system may include one or more adjustment elements.

[0048]

[0048] At least one vascular compression element can be an expandable bladder located inside the liner.

[0049]

[0049] At least one vascular compression element can be coupled to the shell.

[0050]

[0050] The head cover may further include a pressure source in communication with an expandable bladder.

[0051]

[0051] The head cover may further include a continuous perimeter connecting the front edge, rear edge, left edge, and right edge.

[0052]

[0052] The head cover of at least one vascular compression element may further include an expandable feature that expands away from the shell in response to a pressure source.

[0053]

[0053] The head cover may further include an expandable layer bonded to the liner, and at least one vascular compression element is located in the expandable layer.

[0054]

[0054] The head cover of at least one vascular compression element may further include one or more raised features.

[0055]

[0055] The liner located inside the shell can be shaped to accommodate at least partially the patient's hair, and the liner may further include one or more features for engaging with the patient's hair.

[0056]

[0056] The liner or at least one vascular compression element can be smoothed.

[0057]

[0057] The liner or at least one vascular compression element may include an array of uniformly distributed projections having a linear or circular inflatable structure.

[0058]

[0058] The head cover retention system may further include hook and loop fasteners, buckles, quick-release mechanisms, or adjustment features.

[0059]

[0059] The head cover may further include a gas source in communication with the liner or at least one vascular compression element to inflate a portion of the liner or a portion of at least one vascular compression element.

[0060]

[0060] The head cover may further include at least one relief valve to prevent overpressure of the inflatable element of the head cover.

[0061]

[0061] The gas source can be a manual pump mechanism, a valve, an electric pump, or a pressurized tank, cartridge, or reservoir.

[0062]

[0062] The head cover may further include a control system for adjusting the flow of gas from the gas source to maintain a desired pressure inside the head cover.

[0063]

[0063] The desired pressure inside the head cover can be sufficient to produce a vascular compression result while minimizing patient discomfort, side effects, or damage to surrounding structures.

[0064]

[0064] The head cover may further include a cooling gas source communicating with a liner or at least one vascular compression element, and a portion of the liner or at least one portion of the vascular compression element may be adapted to provide cooling inside the head cover.

[0065]

[0065] The head cover may further include one or more pressure sensors inside the head cover.

[0066]

[0066] One or more pressure sensors can provide pressure signals to the control system.

[0067]

[0067] One or more pressure sensors can be adapted to indicate the amount of pressure applied to a patient receiving chemotherapy when the patient is wearing a head cover.

[0068]

[0068] The head cover may further include one or more sensors for measuring skin perfusion (O2 saturation), monitoring Doppler blood flow, sensing with an infrared pulse oximeter, or confirming that blood flow in a blood vessel under compression has been sufficiently stopped or slowed.

[0069]

[0069] The head cover may further include a continuous structure from the occipital region to the eyebrows or forehead.

[0070]

[0070] The head cover may further include a structure for compressing the eyebrows or an inflatable structure for compressing the blood vessels in the eyebrows.

[0071]

[0071] The head cover may further include a timer and control system, which is adapted to provide an autocontraction protocol to stop the operation of the vascular compression element when the timer has elapsed or when the vascular compression element is in any active state.

[0072]

[0072] The head cover may further include a timer and control system adapted for programmed automatic inflation and deflation of the liner or one or more vascular compression elements, or for activation and deactivation of one or more vascular compression elements.

[0073]

[0073] The liner can be a rigid or semi-elastic layer configured for a tight fit for the patient so as to fit precisely to the shape of the patient's head and hair.

[0074]

[0074] The head cover retention system may further include a tightening system.

[0075]

[0075] The head cover may further include one or more selective pressure points positioned to compress one or more vessels of the patient's cranial circulatory system.

[0076]

[0076] The head cover may further include a vibrating element coupled to a liner or at least one vascular compression element.

[0077]

[0077] The liner and at least one vascular compression element can be sized, shaped, or positioned relative to the head cover based on the patient's hairstyle.

[0078]

[0078] Generally, in one embodiment, a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy includes a cap having a front edge, a rear edge, a top edge, a left edge, and a right edge; a liner located inside the cap and shaped to at least partially accommodate the patient's hair; and at least one vascular compression element located inside the cap.

[0079]

[0079] The other embodiments described above may include one or more of the following features: The liner may further include a first layer adjacent to the inner surface of the cap, a second layer fitted and configured to engage with the patient's head, and a separation section separating the first layer from the second layer, the separation section having a perimeter corresponding to the edge of the cap.

[0080]

[0080] The cap may include a flexible structure, a partially flexible structure, a combination of a semi-rigid structure and a flexible structure, or an adjustable structure, sized to remain in place on the head when at least one vascular compression element is active.

[0081]

[0081] At least one vascular compression element can be an expandable bladder located inside the cap or liner.

[0082]

[0082] At least one vascular compression element can be coupled to a cap or liner.

[0083]

[0083] The head cover may further include a pressure source communicating with an expandable bladder or at least one vascular compression element.

[0084]

[0084] The head cover may further include a continuous perimeter connecting the front edge, rear edge, left edge, and right edge.

[0085]

[0085] At least one vascular compression element may include an expandable feature such that it expands away from the cap in response to a pressure source.

[0086]

[0086] The head cover may further include an expandable layer bonded to the liner, and at least one vascular compression element may be located in the expandable layer.

[0087]

[0087] At least one vascular compression element may further include one or more raised features.

[0088]

[0088] A liner located inside the shell and shaped to contain at least partially the patient's hair may further include one or more features for engaging with the patient's hair.

[0089]

[0089] The liner or at least one vascular compression element can be smoothed.

[0090]

[0090] The liner or at least one vascular compression element may include an array of uniformly distributed projections having a linear or circular inflatable structure.

[0091]

[0091] The head cover may further include a gas source in communication with the liner or at least one vascular compression element to inflate a portion of the liner or a portion of at least one vascular compression element.

[0092]

[0092] The head cover may further include at least one relief valve to prevent overpressure of the inflatable element of the head cover.

[0093]

[0093] The gas source can be a manual pump mechanism, a valve, an electric pump, or a pressurized tank, cartridge, or reservoir.

[0094]

[0094] The head cover may further include a control system for adjusting the flow of gas from the gas source to maintain a desired pressure inside the head cover.

[0095]

[0095] The desired pressure inside the head cover can be sufficient to produce a vascular compression result while minimizing patient discomfort, side effects, or damage to surrounding structures.

[0096]

[0096] The head cover may further include a cooling gas source communicating with the liner or at least one vascular compression element. A portion of the liner or a portion of at least one vascular compression element may be adapted to provide cooling inside the head cover.

[0097]

[0097] The head cover may further include one or more pressure sensors inside the head cover.

[0098]

[0098] One or more pressure sensors can provide pressure signals to the control system.

[0099]

[0099] One or more pressure sensors can be adapted to indicate the amount of pressure applied to a patient receiving chemotherapy when the patient is wearing a head cover.

[0100]

[0100] The head cover may further include one or more sensors for measuring skin perfusion (O2 saturation) or monitoring Doppler blood flow or sensing with an infrared pulse oximeter.

[0101]

[0101] The head cover may further include a continuous structure from the occipital region to the eyebrows or forehead.

[0102]

[0102] The head cover may further include a structure or inflatable structure for compressing the eyebrows for a vascular compression effect on the eyebrows. The head cover may further include a timer and control system, which is adapted to provide an automatic contraction protocol to stop the operation of the vascular compression element when the timer has elapsed or when the vascular compression element is in any active state.

[0103]

[0103] The head cover may further include a timer and control system adapted for programmed automatic inflation and deflation of the liner, or for activation and deactivation of one or more vascular compression elements.

[0104]

[0104] The liner can be a rigid or semi-elastic layer configured for a tight fit for the patient, so as to fit precisely to the shape of the patient's head and hair.

[0105]

[0105] The head cover retention system may include a tightening system.

[0106]

[0106] The head cover may further include one or more selective pressure points positioned to compress one or more vessels of the patient's cranial circulatory system.

[0107]

[0107] The head cover may further include a vibrating element coupled to a liner or at least one vascular compression element.

[0108]

[0108] Generally, in one embodiment, a method for inducing vascular compression in the cranial circulatory system of a patient undergoing chemotherapy includes: (1) positioning a head cover around the patient's head; (2) using the vascular compression elements of the head cover to at least partially induce vascular compression in a portion of the patient's cranial circulatory system; (3) inducing a reaction force applied to a head cover that is sized and induced to counteract at least a portion of the force introduced to the patient's head as a result of the step of at least partially inducing vascular compression; (4) initiating a chemotherapy session for the patient; (5) completing a chemotherapy session for the patient; and (6) ending the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system after the step of completing the chemotherapy session, when a sufficient period has elapsed to partially mitigate the effects of chemotherapy-induced alopecia in the patient.

[0109]

[0109] The other embodiments described above may include one or more of the following features: The step of inducing a reaction force applied to the head cover can be carried out by the force acting directly on the shell of the head cover.

[0110]

[0110] The step of inducing a reaction force applied to the head cover can be carried out by the force acting on a vascular compression reaction force structure coupled to the shell of the head cover.

[0111]

[0111] This method may further include engaging a head cover retention system to secure the head cover to the patient's head.

[0112]

[0112] The period elapsed after the step of completing a chemotherapy session may be a maximum of 24 hours.

[0113]

[0113] The period elapsed after the step of completing the chemotherapy session may be at least one hour.

[0114]

[0114] The period elapsed after the step of completing the chemotherapy session may be at least 48 hours.

[0115]

[0115] The vascular compression element of the head cover may be a liner, and during the step of inducing vascular compression in at least partially a portion of the patient's cranial circulatory system, a step of expanding or contracting the liner is performed.

[0116]

[0116] In response to the increased force of the liner on the patient's scalp, an increase in vascular compression can be caused during the step of expanding the liner.

[0117]

[0117] In response to the decrease in the force of the liner on the patient's scalp, a decrease in the amount of vasoconstriction can be caused during the step of contracting the liner.

[0118]

[0118] The vascular compression element of the head cover can be a liner having one or more features, and a step of expanding the liner or a step of contracting the liner can be performed during the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system.

[0119]

[0119] In response to an increase in the force pressing one or more features of the liner against the patient's scalp, an increase in vascular compression can be made during the step of expanding the liner.

[0120]

[0120] In response to a decrease in the force pressing one or more features of the liner against the patient's scalp, a decrease in the amount of vascular compression can be made during the step of contracting the liner.

[0121]

[0121] The vascular compression element of the head cover can be an inflatable bladder, and the degree of vascular compression during the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system corresponds at least partially to the amount of pressure inside the inflatable bladder.

[0122]

[0122] The vascular compression element of the head cover can be an inflatable bladder, and the degree of vascular compression during the step of inducing vascular compression in at least partially a portion of the patient's cranial circulatory system can be increased or decreased by increasing or decreasing the pressure in the inflatable bladder against the skull.

[0123]

[0123] The vascular compression element of the head cover may be one or more features located on the inner surface of the head cover that come into contact with the portion of the patient's scalp containing hair follicles during the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system.

[0124]

[0124] The vascular compression elements of the head cover may be one or more features located on the inner surface of the head cover that correspond to the composition of the patient's hair, and one or more features act on the composition of the patient's hair to facilitate the execution of a step that at least partially induces vascular compression in a part of the patient's cranial circulatory system.

[0125]

[0125] During the step of inducing vascular compression at least partially, the vascular compression element of the head cover can compress a portion of the scalp containing multiple hair follicles against a portion of the skull, thereby at least partially compressing the blood supply to the multiple hair follicles.

[0126]

[0126] This part of the skull may be one or more of the following: the superior temporal line, the inferior temporal line, the parietal bone, the squamous suture, the temporal bone, the lambdoid suture, the occipital bone, the mastoid process, the sphenoid bone, the part adjacent to the supraorbital foramen, the frontal bone, and the coronal suture.

[0127]

[0127] During the step of inducing vascular compression at least partially, the vascular compression element of the head cover can be positioned to compress an artery or vein of the patient's cranial circulation system at least partially by compressing the artery or vein against a portion of the skull.

[0128]

[0128] The arteries or veins of the cranial circulatory system may be branches of the external carotid artery or branches of the internal carotid artery.

[0129]

[0129] The arteries or veins of the cranial circulatory system may be the ophthalmic arteries.

[0130]

[0130] The artery or vein of the cranial circulatory system may be the superficial temporal artery.

[0131]

[0131] The arteries or veins of the cranial circulatory system can be the posterior auricular arteries.

[0132]

[0132] The arteries or veins of the cranial circulatory system may be the occipital arteries.

[0133]

[0133] The arteries or veins of the cranial circulatory system may be the supraorbital arteries or supratrochlear arteries.

[0134]

[0134] This part of the skull may be one or more of the following: the superior temporal line, the inferior temporal line, the parietal bone, the squamous suture, the temporal bone, the lambdoid suture, the occipital bone, the mastoid process, the sphenoid bone, the part adjacent to the supraorbital foramen, the frontal bone, and the coronal suture.

[0135]

[0135] The step of inducing vascular compression in at least partially a portion of the cranial circulatory system can be caused by compression of a portion of the scalp containing the blood vessels of the patient's cranial circulatory system against a portion of the patient's periosteum.

[0136]

[0136] The step of inducing vascular compression, at least partially, in a portion of the cranial circulatory system can be brought about by the interaction between the vascular compression element of the head cover and the blood vessels of the patient's cranial circulatory system.

[0137]

[0137] A method for at least partially inducing vascular compression in a portion of the cranial circulatory system may include compressing a portion of the scalp against a portion of the periosteum to induce vascular compression in a portion of the vascular bed of a hair follicle.

[0138]

[0138] The vascular compression element of the head cover can be positioned relative to the patient's head, and during the engagement step, the vascular compression element can be positioned in close proximity to a specific vein or artery so as to compress at least partially a specific vein or artery of the patient's cranial circulatory system.

[0139]

[0139] A specific vein or artery can be any of the above blood vessels.

[0140]

[0140] This method may further include the delivery of a vasoconstrictor to the patient before, during, or after any of the steps.

[0141]

[0141] The vasoconstrictor may be one of the following: α-adrenergic receptor agonists, vasopressin analogs, epinephrine, norepinephrine, phenylephrine, dopamine, dobutamine, migraine medications, headache medications, serotonin 5-hydroxytryptamine agonists, and triptans.

[0142]

[0142] Patients may receive chemotherapy via injection, intravenous infusion, targeted therapy, hormone therapy, or immunotherapy.

[0143]

[0143] Patients can receive chemotherapy via intravenous, subarachnoid, intra-arterial, intraluminal, intramuscular, intralesional, or intravesical methods.

[0144]

[0144] Patients can receive chemotherapy at home, in the office of a healthcare provider, in a clinic, outpatient infusion center, hospital infusion center, or in a hospital ward.

[0145]

[0145] Generally, in one embodiment, a method for comfortably fitting a headgear to protect against hair loss during chemotherapy includes: (1) positioning a helmet with a facepiece attached via a plurality of straps over the user's head and face; (2) adjusting the plurality of straps to form contact between the plurality of tiles of the facepiece and the user's face; (3) inflating the balloon liner of the helmet; (4) adjusting one or more of the plurality of straps until vascular compression of the blood supply to the user's hair follicles is achieved, (i) pressure from the contact between the plurality of tiles and the user's face, (ii) pressure from the inflated balloon liner of the helmet on the user's head, and (iii) until vascular compression of the blood supply to the user's hair follicles is achieved; (5) initiating a chemotherapy session for the user; and (6) continuing to adjust the pressure from the contact between the plurality of tiles on the face and the user, the pressure from the inflated balloon liner of the helmet on the user's head, and one or more of the plurality of straps for the user's comfort during the chemotherapy session.

[0146]

[0146] The other embodiments described above may include one or more of the following features: The tiles may have an outer surface facing the inside of the facepiece and an inner surface facing the user's face.

[0147]

[0147] The balloon liner can be inflated via an air adapter connected to an inflation line and an inflation source.

[0148]

[0148] The step of adjusting the pressure from contact between multiple tiles of the facepiece may include engaging with a knob having multiple protrusions, each having a smooth edge and a serrated edge, wherein the smooth edge may indicate a first rotational direction for increasing the contact pressure between the multiple tiles and the user's face by moving one or more of the multiple tiles toward the user's face, and the serrated edge may indicate a second rotational direction for decreasing the contact pressure between the multiple tiles and the user's face by moving one or more of the multiple tiles toward away from the user's face.

[0149]

[0149] The knob can work in conjunction with the padding and support piece to increase or decrease one or more of (i) the distance between the padding / support piece and the patient's face, and (ii) the pressure on the patient's face, and the padding can be a low durometer silicone pad having 5 to 20 Shore A units.

[0150]

[0150] The inflatable balloon liner may have a first section configured to be linked with the patient's head, a second section configured to be linked with the inner surface of the helmet, and a boundary layer between the first section and the second section, the second section and the boundary layer each having a durometer higher than the durometer of the first section of the balloon liner.

[0151]

[0151] The first section can have a thickness of 10 to 100 microns, and the second section can have a thickness of 50 to 300 microns.

[0152]

[0152] The boundary layer can have a consistent width of 20 to 40 mm between the first and second sections around the helmet.

[0153]

[0153] The positions of one or more of the facepieces and multiple tiles can be pre-contoured to match the user's facial topography before attaching the facepiece to the user's face.

[0154]

[0154] This method may further include a waiting period to confirm vascular compression of the blood supply to the user's hair follicles before initiating a chemotherapy session for the user.

[0155]

[0155] This method may further include the step of offsetting loads and pressures on the user's head or face by placing one or more of the helmet and facepiece worn by the user against a support surface to generate a desired reaction force vector.

[0156]

[0156] The method may further include steps of manually or automatically adjusting, before or during a chemotherapy session, the pressure from contact between a plurality of tiles on the face and the user, the pressure on the user's head from the inflated balloon liner (inflated state) of the helmet, and one or more of a plurality of straps via a graphical user interface (GUI) of a computer-implemented application or a web application, the GUI may adjust one or more of the plurality of tiles, one or more of the plurality of straps, and the inflated state of the balloon liner.

[0157]

[0157] The GUI can adjust the inflation state of one or more of the multiple tiles, one or more of the multiple straps, and the balloon liner via sensors and valves on the helmet, balloon liner, facepiece, multiple tiles, and pressure source, and the combined control and delivery system of chemotherapy and vascular compression therapy can respond to the user's user prescription and treatment preferences, chemotherapy session history, and electronic medical records (EMR).

[0158]

[0158] Generally, in one embodiment, a method for comfortably fitting a headgear to protect a user from hair loss during chemotherapy includes: (1) the step of arranging a headband around the user's head; (2) the step of arranging a helmet with a facepiece and headband attached over the user's head and face via a plurality of straps, such that the headband is between the helmet and the facepiece; (3) the step of adjusting the plurality of straps to form contact between (i) the plurality of tiles of the facepiece and the user's face, and (ii) the headband and the circumference of the user's head; and (4) the balloon of the helmet. The steps include (5) inflating the Ina, (i) adjusting the pressure from the contact between the multiple tiles and the user's face, (ii) the pressure from the inflated balloon liner of the helmet to the user's head, and (iii) adjusting one or more of the multiple straps until (6) vascular compression of the blood supply to the user's hair follicles is achieved, (7) continuing to adjust the pressure from the contact between the multiple tiles and the user's face, the pressure from the inflated balloon liner of the helmet to the user's head, and one or more of the multiple straps for the user's comfort during the chemotherapy session.

[0159]

[0159] The other embodiments described above may include one or more of the following features: The multiple straps may include one or more of straps, bands, and adhesives, and the headband is configured to perform one or more of the following: (i) stabilizing the helmet during inflation and deflation of the balloon liner, (ii) offsetting the load on the helmet, and (iii) further restricting blood circulation to the patient's hair follicles.

[0160]

[0160] The headband can be placed separately on the user's forehead and positioned to fit in the gap between the helmet and the facepiece.

[0161]

[0161] Generally, in one embodiment, a device for protecting against hair loss during chemotherapy includes a helmet having an inflatable balloon liner and a plurality of helmet connection points, a facepiece having a plurality of facepiece connection points around the facepiece, and a plurality of straps for connecting the facepiece to the helmet via a plurality of helmet connection points and facepiece connection points.

[0162]

[0162] The other embodiments described above may include one or more of the following features: The device may further include a headband attached to a helmet.

[0163]

[0163] The device may further include an inflatable balloon liner, the inflatable balloon liner having a first section which can be configured to be linked with the patient's head, a second section which can be configured to be linked with the inner surface of a helmet, wherein the first section may have a durometer lower than the durometer of the second section of the balloon liner, and a boundary section between the first section and the second section which can be traced around the helmet.

[0164]

[0164] The facepiece may have multiple tiles, which may consist of one or more of the following materials: foam, foam composite, gel, and air, and one or more of the tiles may be configured to be adjusted via a mechanical or pneumatic mechanism.

[0165]

[0165] In various other alternative embodiments, the various methods described above may be carried out using any of the vascular compression devices described above or elsewhere in this specification.

[0166]

[0166] Generally, in one embodiment, a computer controller can be adapted and configured to control the pressure applied to the patient's scalp and face using any one or a combination of the above devices, before, during, and after a chemotherapy session, using any of the methods described above.

[0167]

[0167] The graphical user interface can be adapted and configured to interact with a computer controller which can enable selection of one or more inflatable elements or pressure-applying elements which may be increased or decreased.

[0168]

[0168] The computer controller or graphical user interface may be further configured to control, monitor, initiate, interrupt, or otherwise control the delivery of the chemotherapy protocol to the patient.

[0169]

[0169] A computer controller or graphical user interface may be adapted and configured to be used with or to implement the devices described above or below in this specification.

[0170]

[0170] Novel features of the present invention are described in detail in the following claims. A further understanding of the features and advantages of the present invention can be obtained by referring to the following detailed description, which describes exemplary embodiments in which the principles of the present invention are utilized, and to the accompanying drawings. [Brief explanation of the drawing]

[0171] [Figure 1]

[0171] Figure 1A is a perspective view of a cancer patient at the start of chemotherapy treatment for a tumor or malignant lesion in the breast. The figure includes a bag containing chemotherapy agents, the amount in the bag being the amount at the start of the chemotherapy treatment session.

[0172] Figure 1B is a magnified view of the tumor or malignant lesion in the breast of the patient shown in Figure 1A. [Figure 2]

[0173] Figure 2A is a diagram of the bag in Figure 1A showing the amount of chemotherapeutic agent delivered and the remaining amount.

[0174] Figure 2B is a graph showing the expected concentration curve of the chemotherapeutic agent in the patient's bloodstream as drug concentration (mg / L) and time (minutes). The triangles indicate the estimated concentration based on the amount of chemotherapeutic agent delivered, indicated by the fluid level visible in the bag. [Figure 3]

[0175] Figure 3A is a diagram of the patient and bag in Figure 1A, showing the amount of chemotherapeutic agent delivered and the remaining amount, indicated by the reduced fluid level in the bag.

[0176] Figure 3B is a graph from Figure 2B showing the expected concentration curves of the chemotherapeutic agent in the patient's bloodstream in relation to the patient's condition in Figure 3A, with respect to drug concentration (mg / L) and time (minutes). The triangles indicate the estimated concentration based on the amount of chemotherapeutic agent delivered, indicated by the decreased fluid level visible in the bag where the drug concentration is near its peak or maximum. [Figure 4]

[0177] Figure 1B shows the state of the chemotherapy-induced necrosis process in the target tumor or malignant lesion. [Figure 5A]

[0178] Figure 5A is a diagram of the patient and bag from Figure 3A, showing the delivered and remaining amounts of chemotherapeutic agent, indicated by the decreased fluid level in the bag. The curves for drug concentration (mg / L) and time (min) for the patient in Figure 5A should be at, near, or above the highest level.

[0179] Figure 5B shows the progression of the chemotherapy-induced necrosis process in the target tumors or malignant lesions shown in Figures 1B and 4.

[0180] Figure 5C is a cross-sectional view of the scalp and hair follicle, including the vascular bed, before the chemotherapeutic agent reaches the vascular structure of the hair, scalp, or vascular bed.

[0181] Figure 5D is a cross-sectional view of the scalp and hair follicle vascular bed in Figure 5C, showing the penetration and circulation of chemotherapeutic agents. [Figure 6]

[0182] Figure 6A shows the final state of chemotherapy-induced necrosis in the target tumors or malignant lesions of Figures 1B, 4, and 5B.

[0183] Figure 6B shows the final state of widespread chemotherapy-induced necrosis in the hair follicles of a patient, which began in Figure 5D.

[0184] Figure 6C is a side view of widespread alopecia in the patients of Figures 1A, 3A, and 5A, resulting from one or a combination of chemotherapy-induced alopecia, hair loss, hair follicle death, and / or anagen alopecia. [Figure 7]

[0185] Figure 7A is a perspective view in which a portion of the skin and scalp has been pulled back to show the tissue layers above the bony portion of the skull.

[0186] Figure 7B is a cross-sectional view of the retracted portion of the skin and scalp shown in Figure 7A.

[0187] Figure 7C is a cross-sectional view of the area of ​​skin and scalp shown in Figure 7B. [Figure 8]

[0188] This is a cross-sectional view of healthy scalp and hair follicles, including the vascular bed. [Figure 9]

[0189] This is a perspective view of a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy. The figure also shows a shell and internal liner connected to an external pump or controller for one or more vascular compression elements located inside the head cover. A submandibular strap connected to the shell is also visible in this figure. The head cover is configured to deliver vascular compression to the scalp and eyebrows. [Figure 10A]

[0190] This figure shows a perspective view and a partial internal view of a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy. The figure also shows the shell and internal liner connected to a shell-mounted pump or controller for one or more vascular compression elements located inside the head cover. A submandibular strap connected to the shell is also visible in this figure. The vascular compression element shown is a manifold that expands inward, with the inward end moving away from the shell toward the scalp. The head cover is configured to deliver vascular compression to the scalp and eyebrows. [Figure 10BC]

[0191] Figure 10B is a cross-sectional view of a portion of a liner having a vascular compression element with one or more raised features. The raised features have a rounded shape facing the patient wearing the head cover.

[0192] Figure 10C is a cross-sectional view of a portion of a liner having a vascular compression element with one or more raised features. The raised features have a square pyramidal shape with a flat top facing the patient wearing the head cover. [Figure 11]

[0193] Figure 11A is a side view of the head of a patient wearing a vascular compression element used to deliver vascular compression in the blood supply of a patient undergoing chemotherapy. This figure also shows an inflatable liner connected to a pump or controller (not visible in this figure). The inflatable liner vascular compression element is configured to deliver vascular compression to the scalp and eyebrows.

[0194] Figure 11B is a side view of the patient in Figure 11A, showing the shell and submandibular strap of a head cover for inducing vascular compression in the blood supply of a chemotherapy patient, using the vascular compression elements of Figure 11A to deliver vascular compression to the scalp and eyebrows. [Figure 12AB]

[0195] Figure 12A is a lateral view of the head of a patient wearing a head cover containing at least one vascular compression element used to deliver vascular compression. This is the patient's condition before or immediately after the initiation of chemotherapy. A submandibular strap connected to the shell of the head cover is also visible in this figure. The head cover is configured to deliver vascular compression to the patient's scalp and eyebrows.

[0196] Figure 12B is a cross-sectional view of a portion of the patient's hair, scalp, and hair follicles in Figure 12A. This figure shows the hair pressed against the scalp before the delivery of vascular compression when the head cover is fitted (Figure 12A). [Figure 12CD]

[0197] Figure 12C is a cross-sectional view of a portion of the hair, scalp, and hair follicles of the patient in Figure 12B. This figure shows the expansion of one or more vascular compression elements in the head covering that cause vascular compression within the vascular bed of the hair follicle.

[0198] Figure 12D is a visual representation of a patient undergoing chemotherapy and vascular compression, with arrows indicating that vascular compression may be applied to multiple areas of the scalp, including the eyebrows. [Figure 13]

[0199] Figure 13A is a diagram of the patient in Figures 12A–12D receiving vascular compression from a head cover during a nearly completed chemotherapy session, as indicated by the nearly empty chemotherapeutic drug bag.

[0200] Figure 13B is a graph showing the expected concentration curve of the chemotherapeutic agent in the patient's bloodstream in relation to the patient's condition in Figure 13A, with respect to drug concentration (mg / L) and time (minutes). The triangles indicate the estimated concentration based on the amount of chemotherapeutic agent delivered, indicated by the decreased fluid level visible in the bag in Figure 13A. The arrows indicate that the drug concentration is near the peak or maximum drug concentration, or slightly above it.

[0201] Figure 13C illustrates the progression of the chemotherapy-induced necrosis process in the target tumor or malignant lesion of the patients in Figures 12A, 12D, and 13A who are experiencing vascular compression during delivery of chemotherapeutic agents.

[0202] Figure 13D is a cross-sectional view of the head covering, scalp, and hair follicles of the patients in Figures 12A, 12D, and 13A who are experiencing vascular compression during delivery of the chemotherapeutic agent (Figure 13B). This figure shows that the chemotherapeutic agent is completely or substantially absent from the vascular bed, or that the level of the chemotherapeutic agent reaching the vascular bed is kept below a level that would harm the hair follicles. [Figure 14]

[0203] Figure 13A is a side view of the patient during the period following delivery of chemotherapy with vascular compression. The patient retains hair on both the scalp and eyebrows as a result of the beneficial effect of vascular compression. [Figure 15]

[0204] This is a flowchart illustrating a typical method for providing vascular compression to patients undergoing chemotherapy. [Figure 16]

[0205] This is a front view of a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy. A partial submandibular rigid support extends continuously from the left portion of the mandibular body, the mental protuberance or jaw, and the right portion of the mandibular body. An oversized cushion is positioned between the patient's jaw and the rigid support. The rigid support is attached to the shell above the eyebrows and two anterior attachment points. The rigid support is attached to the left and right sides of the shell from attachment points located at the left and right ends of the support. [Figure 17]

[0206] This is a front view of a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy. Similar to Figure 16, a submandibular rigid support is attached to the shell. In contrast to Figure 16, the support extends continuously from the left portion of the mandibular body at the left corner of the mandible to the right corner of the mandible along the genioprotuberance or the right portion of the jaw and mandibular body. A cushion of similar size to the rigid support is positioned between the patient's jaw and the rigid support. The rigid support is attached to the shell above the eyebrows and two anterior attachment points adjacent to the jaw. The rigid support is attached to the shell on the left and right sides from attachment points at the left and right ends of the support. [Figure 18]

[0207] This is a front view of a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, including a full-face support structure. The full-face support structure surrounds the mandibular body and mandibular ramus, extending to at least partially cover them across the zygomatic, maxillary, and frontal bones of the skull. The full-face support structure has openings for the eyes, nose, and mouth. A cushion of similar size and shape to the full-face support structure is positioned between the patient and the full-face support. The full-face support is attached to the shell above the eyes and two anterior upper attachment points. A rigid support is attached to the shell on the left and right sides from attachment points at the left and right ends of the support, along locations adjacent to the upper surfaces of the mandibular body and mandibular ramus. The full-face support has additional unused attachment points in the center of the forehead, on the left and right sides adjacent to the nose, and on the left and right sides adjacent to the jaw, etc. One or more of the additional attachment points may be used to further adjust the distribution of forces generated during vascular compression. [Figure 19A]

[0208] This is a front view of a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, including a full-face support structure. The full-face support structure surrounds the mandibular body and mandibular ramus, extending to at least partially cover them across the zygomatic, maxillary, and frontal bones of the skull. Openings for the eyes, nose, and mouth are present in the full-face support structure. The series of openings in the full-face support structure allows for the use of an array of independently selectable cushion tiles to be added to the full-face support structure. Figures 20–25 show various configurations of cushion tiles adapted for use with the full-face support. In various figures of Figures 19A, 19B, and 19C, the cushion tiles are not shown. The full-face support is attached to the shell at nine points, three each along the forehead, right side, and left side. Along the forehead, one is located above each eye, and one is located in the center of the forehead above the nose. A pair of upper attachment points are located near the temples. The left and right lower attachment points are located below the ear, adjacent to the mandibular ramus. Each attachment point is a D-shaped connector sized to receive a loop, which is part of a strap attached to an adjustable connection point on the shell. Each of the straps and associated connectors may be adjusted to increase comfort during use, while adapting to the patient, by the distribution of force generated during vascular compression. [Figure 19B]

[0209] Figure 19A is a right side view of the head cover used to induce vascular compression. In this figure, the three upper mounting points are visible, along with a pair of upper right and lower right mounting points. [Figure 19C]

[0210] Figure 19A is a left side view of the head cover used to induce vascular compression. In this figure, two of the three upper mounting points are visible, along with a pair of upper left and lower left mounting points. [Figure 19D]

[0211] Figure 19A is a rear view of the head cover designed to induce vascular compression. This figure shows multiple mounting points on the shell. Additionally, air connections and lines at the rear of the shell are visible. [Figure 20]

[0212] This is a top isometric view of one embodiment of a plurality of tile face cushions, adapted for use with the embodiments shown in Figures 19A to 19D. The full face shield and straps are omitted from this figure. Each tile has a plug that is aligned with and sized and positioned to receive corresponding openings in the face shield. The cushioning properties of each face shield may be adapted by selecting cushion tiles of the desired shape, size, and composition, as well as by arranging specific tiles in the face shield in a location and orientation that improves the comfort of the patient undergoing vascular compression therapy. [Figure 21A]

[0213] Figures 19A–19D are side views of the vascular compression device, with the face shield removed to show the positions of exemplary multiple tile face cushions. In these figures, the patient is in a prone position, and the shell is positioned relative to the support structure, resulting in force vectors indicated by arrows. The force vectors are used to provide additional comfort to the patient receiving vascular compression therapy by offsetting a portion of the forces generated during the application of vascular compression therapy. In this embodiment, the reaction force is directed from the point of contact with the support structure towards the upper mounting point and the patient's nose. [Figure 21B]

[0214] Figure 21A is a side view of the vascular compression device, with the face shield removed to show the positions of exemplary multiple tiled face cushions. In this figure, the patient is in a prone position, and the shell is positioned relative to the support structure, resulting in force vectors indicated by arrows. The force vectors are used to provide additional comfort to the patient receiving vascular compression therapy by offsetting a portion of the forces generated during the application of vascular compression therapy. In this embodiment, the reaction force is directed from the point of contact with the support structure towards the upper mounting point, over the ears, and under the patient's chin. [Figure 21C]

[0215] Figure 21A is a side view of the vascular compression device, with the face shield removed to show the positions of exemplary multiple tile face cushions. In this figure, the patient is in a prone position, and the shell is positioned relative to the support structure, resulting in force vectors indicated by arrows. The force vectors are used to provide additional comfort to the patient receiving vascular compression therapy by counteracting a portion of the forces generated during the application of vascular compression therapy. In this embodiment, the reaction force is directed from the point of contact with the support structure towards the upper mounting point, over the ears, and over the patient's chin. [Figure 21D]

[0216] Figure 21A is a side view of the vascular compression device, with the face shield removed to show the positions of exemplary multiple tile face cushions. In this figure, the patient is standing, and an external force is applied to the shell, resulting in force vectors indicated by arrows. The force vectors are used to provide additional comfort to the patient receiving vascular compression therapy by counteracting a portion of the forces generated during the application of vascular compression therapy. In this embodiment, the reaction force is directed from the contact point towards the upper mounting point, over the ears, and towards the line between the patient's nose and chin. [Figure 22]

[0217] Figure 21A is a side view of the vascular compression device, with the face shield removed to show the positions of the exemplary multiple tile face cushions. The support ring is shown in cross-section on the shell at a point that is the center of the reaction force vector shown in Figure 21D. When in use, the support ring should be positioned to contact a support structure or other device used to apply the reaction force. The ring should be used to distribute the force over a larger area of ​​the head cover. [Figure 23]

[0218] Figure 21A is a rear perspective view of the vascular compression device with the face shield removed, showing the positions of exemplary multiple tile face cushions. The support ring is shown in place on the head cover. The support ring has a frustoconical shape and a base with a larger diameter relative to the shell surface. The flat upper ring surface may be used to receive and distribute reaction forces. Optionally, the upper support ring may be used as a support base for other or additional support structures, as shown in Figure 26. [Figure 24A]

[0219] Figure 21A is a side view of the vascular compression device, with the face shield removed to show the positions of exemplary multiple tile face cushions. The support structure is shown in place on the head cover. The support structure comprises a base, a spindle, and an upper support surface. The base may be sized to distribute reaction forces across a larger portion of the shell, and the orientation and contour of the spindle and upper support surface may be configured to engage with the corresponding support surface. [Figure 24B]

[0220] This is a front perspective view of the embodiment shown in Figure 24A. [Figure 25]

[0221] Figure 21A is a side view of the vascular compression device, with the face shield removed to show the positions of exemplary multiple tiled face cushions. [Figure 26]

[0222] Figure 26A is a left side view of one embodiment of a vascular compression device having a stabilizing weight and a head support on an adjustable sliding mount.

[0223] Figure 26B is a front view of the vascular compression device shown in Figure 26A. [Figure 27]

[0224] Figure 27A is a bottom perspective view of the inside of the head cover showing the shell and inflatable liner. Behind the shell, an air adapter and connection for adjusting the pressure inside the balloon liner are also shown.

[0225] Figure 27B is a cross-sectional view of the head cover in Figure 27A, showing the arrangement of the shell, liner, and air adapter and connections. [Figure 28]

[0226] Figure 28A is a front view and a rear view of one embodiment of the head cover shown in Figures 27A and 27B, showing its fixed position on the head. Figure 28B is a front view and a rear view of one embodiment of the head cover shown in Figures 27A and 27B, showing its fixed position on the head. A series of mounting points are shown extending from the upper corner of Figure 28A to the rear along the rear shown in Figure 28B. [Figure 29AB]

[0227] Figure 29A is a bottom perspective view of the balloon liner. Figure 29B is a left perspective view of the balloon liner. [Figure 29C] Figure 29C is a left perspective view of the balloon liner. [Figure 30]

[0228] Figure 30A is a cross-sectional view of an inflatable bladder or balloon.

[0229] Figure 30B is a rear perspective view of the inflatable bladder or balloon shown in Figure 30A. [Figure 31]

[0230] This is a cross-sectional view of an inflatable bladder joint for a helmet having an expansion port. [Figure 32]

[0231] This is a cross-sectional view of a head cover for inducing a vascular compression embodiment similar to that shown in Figure 19C, with a tile cushion in place. A detailed cross-sectional view of the shell shows the presence of a secondary material layer between the outer wall of the expandable liner and the inner wall of the shell. [Figure 33A]

[0232] This is a left-side perspective view of the balloon liner inside the helmet. [Figure 33BC]

[0233] Figure 33B is a bottom perspective view of the inner balloon liner of a helmet with a headrest. Figure 33C is a left perspective view of the inner balloon liner of a helmet with a headrest. [Figure 34]

[0234] Figures 33A to 33C are right side views of one embodiment of the head cover, showing its fixed position on the head. [Figure 35AB]

[0235] Figure 35A is a bottom view of the six air cells around the jaw.

[0236] Figure 35B is a top view of the air cell shown in Figure 35A. [Figure 35CDE]

[0237] Figure 35C is a cross-sectional view of the air cell located inside the support structure shown in Figure 35A.

[0238] Figure 35D is a side view of the air cell / pad in Figure 35A, with an exemplary inflation tube connected to one of the air cells / pads.

[0239] Figure 35E is a bottom view of the exemplary size and placement of inflatable air cells / pads around the jaw. [Figure 36A]

[0240] This is a front isometric view of a face shield having eight individual pad adjustment sections, with knobs on the face shield in relation to the helmet / shell. [Figure 36B]

[0241] Figure 36A is a front view of the face shield. [Figure 36C]

[0242] This is a frontal isometric view of Figure 36A showing only the face shield, without the helmet. [Figure 36D]

[0243] This is a front view of the face shield in Figure 36A without the helmet. [Figure 36E]

[0244] Figure 36D is a rear (inner) view of the face shield, showing the shape and position of each individual pad, which can be controlled by the operation of a dedicated pad adjustment knob. [Figure 37A]

[0245] This is an isometric view of a helmet having a movable support and a dynamic pressure-adjusting facepiece. [Figure 37B]

[0246] Figure 37A is an exploded view of a vascular compression device. [Figure 37C]

[0247] Figure 37A is a front view of the vascular compression device. [Figure 37D]

[0248] Figure 37A is a rear view of the vascular compression device. [Figure 37E]

[0249] Figure 37A is a side view of the vascular compression device. [Figure 38A]

[0250] This is a right side view of the head cover and facial support for inducing vascular compression before the straps are connected to the head cover and facial support. [Figure 38B]

[0251] This is a left side view of a head cover and facial support for inducing vascular compression, with straps connecting the head cover and facial support, as well as an optional headband. [Figure 39A]

[0252] This is an isometric view of a dynamic facepiece with 18 independently controlled support pads. [Figure 39B]

[0253] Figure 39A is an internal view of the dynamic facepiece. [Figure 39C]

[0254] Figures 39A and 39B show cross-sectional views of the dynamic facepiece, which has a movable support and pads of various shapes. [Figure 39DE]

[0255] Figure 39D is an isometric front view showing an exploded view of the pad adjustment knob relative to the pad and pad support.

[0256] Figure 39E is an exploded view of an embodiment of tactile feedback for a pad adjustment knob. [Figure 39F]

[0257] Figure 39B is an isometric view of the internal surface of the dynamic facepiece. [Figure 40]

[0258] This is a flowchart illustrating a method for delivering chemotherapy with a rigid facepiece that provides vascular compression and controllable, adjustable pressure relief. [Figure 41]

[0259] This is a perspective view of the anatomical landmarks and structure of the mandible. [Figure 42]

[0260] Figure 42A is a left-side view of the bones of the face and skull. Figure 42B is a frontal view of the bones of the face and skull. [Figure 43]

[0261] This is a diagram illustrating an exemplary graphical user interface (GUI) for controlling pressure in the head cover and face cover. [Figure 44]

[0262] This is a diagram illustrating an exemplary graphical user interface (GUI) for controlling individual tiles on a face cover. [Figure 45]

[0263] This is a block diagram of an exemplary computer controller for operating a system that combines chemotherapy and vascular compression therapy. [Figure 46A]

[0264] This is a block diagram showing how to comfortably wear headgear to protect against hair loss during chemotherapy. [Figure 46B] This is a block diagram showing how to comfortably wear headgear to protect against hair loss during chemotherapy. [Figure 47A]

[0265] This block shows another way to comfortably wear headgear to protect against hair loss during chemotherapy. [Figure 47B] This block shows another way to comfortably wear headgear to protect against hair loss during chemotherapy. [Modes for carrying out the invention]

[0172]

[0266] Figure 1A is a perspective view of a cancer patient 100 at the start of chemotherapy treatment for a tumor or malignant lesion 120 in the breast. The figure includes an IV bag 105 containing a chemotherapy agent 110, the amount in the bag 115 being the amount at the start of the chemotherapy treatment session. The patient's hair 107 and eyebrow area 109 are also shown. The patient's head 103 is also shown.

[0173]

[0267] Figure 1B is a magnified view of the tumor or malignant lesion 120 in the breast of patient 101 shown in Figure 1A.

[0174]

[0268] Figure 2A is a diagram of IV bag 205, corresponding to IV bag 105 from Figure 1A, showing the delivered amount of chemotherapy agent 210 and the remaining amount 215.

[0175]

[0269] Figure 2B is a graph showing the expected concentration curve of the chemotherapeutic agent 210 in the patient's bloodstream according to drug concentration (mg / L) 230 and time (minutes) 235. The triangle 225 indicates the estimated concentration based on the amount of chemotherapeutic agent 210 delivered, indicated by the fluid level 215 visible in the bag 205.

[0176]

[0270] Figure 3A is a diagram of the patient and IV bag 305 from Figure 1A, showing the delivered amount 315 and remaining amount of chemotherapeutic agent 310, indicated by the reduced fluid level in the bag. The patient's hair follicles 303 and back region 301 are also shown here.

[0177]

[0271] Figure 3B is a graph from Figure 2B showing the expected concentration curves of the chemotherapeutic agent 310 in the patient's bloodstream, corresponding to the patient's condition in Figure 3A, drug concentration (mg / L) 330, and time (minutes) 335. The triangle 325 indicates the estimated concentration based on the amount of chemotherapeutic agent delivered, indicated by the decreased fluid level visible in the bag, which is near the peak or maximum drug concentration.

[0178]

[0272] Figure 4 shows the state of the chemotherapy-induced necrosis process 410 in the target tumor or malignant lesion 420 of Figure 1B.

[0179]

[0273] Figure 5A is a diagram of the patient and bag from Figure 3A showing the delivered amount 515 and remaining amount of chemotherapeutic agent 510, indicated by the reduced fluid level 515 in the IV bag 505. The curves of drug concentration (mg / L) and time (min) for the patient in Figure 5A should be at, near, or above the highest level (see, for example, the peak level in Figure 3B). The patient's hair 507 and scalp 503 are also shown.

[0180]

[0274] Figure 5B shows the progression of the chemotherapy-induced necrosis process 510 in target tumors or malignant lesions 520, corresponding to tumors / malignant lesions 120 and 420 in Figures 1B and 4, respectively. A large amount of chemotherapy agent 510 is delivered to the tumor or lesion 520 and absorbed by the tumor or lesion 520.

[0181]

[0275] Figure 5C is a cross-sectional view of the scalp and hair follicle similar to that in Figure 8. This figure shows the vascular bed before the chemotherapy agent 510 reaches the skull 560, scalp, or vascular bed of the hair 568, the hair bulb 564, the hair shaft 570, and the vascular structure 562, the periosteum 538, and the bone 540.

[0182]

[0276] Figure 5D is a cross-sectional view of the scalp and hair follicle vascular bed of Figure 5C, showing the penetration and circulation of the chemotherapeutic agent 510 within the vascular structure 562. In this case as well, the hair shaft 570, the vascular bed of the hair 568, the hair bulb 564, and the vascular structure 562 are shown.

[0183]

[0277] Figure 6A shows the final state of chemotherapy-induced necrosis in target tumor or malignant lesion 620, corresponding to tumors or malignant lesions 120, 420, and 520 in Figures 1B, 4, and 5B, respectively.

[0184]

[0278] Figure 6B is a diagram of the final state of extensive chemotherapy-induced necrosis in the hair follicles of a patient, which began in Figure 5D. The vascular structure 662 contains the chemotherapy agent 610 that was delivered to the hair bulb 664 and the associated hair shaft 670, destroying them. The introduction of the chemotherapy agent 610 into the vascular bed of the scalp and eyebrow results in one or more chemotherapy-induced alopecia (CIA), chemotherapy-induced hair loss, hair follicle death, and / or anagenous alopecia in the patient. The periosteum 638 and bone 640 are also shown.

[0185]

[0279] Figure 6C is a side view of the widespread alopecia condition in the patients of Figures 1A, 3A, and 5A, resulting from one or a combination of chemotherapy-induced alopecia, hair loss, hair follicle death, and / or anagen alopecia. The amount of hair 607 in the scalp 603 and eyebrows is less than in the earlier figures of Figures 1A, 3A, and 5A. The eyebrow region 609 is also shown.

[0186]

[0280] The adverse consequences described above may be significantly mitigated or avoided by using one embodiment of the devices and methods described herein that interfere with or prevent chemotherapeutic agents from reaching the hair follicles. Hereinafter, vascular compression refers to the application of sufficient force to the patient's head to overcome the filling or systolic pressure in the arterial supply to the scalp. In other words, vascular compression achieved by the various embodiments and methods described herein blocks the arterial blood supply to the scalp, thus preventing chemotherapeutic agents in the bloodstream during chemotherapy from reaching the hair follicle blood supply.

[0187]

[0281] Figure 7A is a perspective view of the head 703 of patient 701, with the skin 730 and a portion of the scalp pulled back to show the tissue layers above the bony portion of the skull. Beneath the skin 730 of the head 703, connective tissue 732, aponeurosis or cranial layers 734, and loose annular tissue 736 are shown. Beneath the loose annular layer 736, the periosteum 738 and then the bone 740 are present. The eyebrow region 709 is also shown.

[0188]

[0282] Figure 7B is a cross-sectional view of the retracted portion of the skin and scalp shown in Figure 7A.

[0189]

[0283] Figure 7C is a cross-sectional view of the area of ​​skin and scalp shown in Figure 7B. This figure shows the relationship between the skin and dense connective tissue 730 / 732 to the galea aponeurotica 734, loose annular connective tissue 736, and periosteum 738 and bone 740. The hair shaft 770 and scalp / hair 707 are also shown.

[0190]

[0284] Figure 8 is a cross-sectional view of healthy scalp and hair follicles, including the vascular bed. The blood supply 862 includes arteries and veins that supply nutrients to individual hair follicles. The hair shaft 870 and hair bulb 864 are shown in relation to the dermal papilla cells 860 and the blood supply 862. The hair shaft 870 is the part of the hair that is visible above the scalp. The hair bulb 864 is the living part of the hair that surrounds the dermal papilla cells 860. Here the cells divide faster than anywhere else in the body. The dermal papilla cells 860 contain tiny blood vessels called capillaries that nourish the cells at the base of the hair follicle. The figure also shows the sebaceous glands 868 and arrector pili muscles 866. The sebaceous glands 868 produce sebum, which conditions the hair and skin. The arrector pili muscles 866 make the hair stand up and cause the sebaceous glands 868 to secrete oil.

[0191]

[0285] Figure 9 is a left side perspective view of one embodiment of a head cover 900 for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, such as patient 100 from Figure 1A. The figure also shows the shell 910 with its anterior edge 912, apex 913, left lateral edge 916, and posterior edge 914. The figure also shows part of the interior of the head cover, showing a liner 920 and a portion of one or more vascular compression elements 930. One or more vascular compression elements 930 are connected to an external pump or controller 980 using a suitable connector 985. The pump or controller 980 is used to perform the desired vascular compression therapy on the patient using one or more vascular compression elements 930 in the head cover 900. A submandibular strap connected to the shell 910 is also visible in this figure. The head cover 900 has a shell 910 fitted and configured to deliver vascular compression to the scalp, with the anterior edge 912 selected to provide vascular compression to the eyebrows. In one embodiment, one or more vascular compression elements 930 may be arranged continuously along the liner or interior of the shell 910 to treat the scalp / hair 107 and eyebrows 109 (from Figure 1A) as well as the space in the forehead between the hairline and eyebrows. In addition, or optionally, separate vascular compression elements 930 are used for the eyebrows and hair, and no elements 930 are present in the forehead area between the hairline and eyebrows. A head cover retention system 940 is also shown.

[0192]

[0286] Figure 10A is a right side perspective view and a partial internal view of one embodiment of a head cover 1000 for inducing vascular compression in the blood supply of patient 100 from Figure 1A undergoing chemotherapy. The figure also shows a shell 1010 having a top 1013, anterior edge 1012, posterior edge 1014, and right edge 1018. The shell 1010 is shown as transparent to indicate the location of vascular compression elements 1030 aligned to deliver vascular compression therapy to the hair / scalp 107 and eyebrows 109 of patient 100 from Figure 1A. The figure also shows the interior of a liner 1020 adjacent to the left edge 916 from Figure 9. In this embodiment of the head cover, a pump or controller 1090 is mounted directly to the head cover 1000, such as a portion of the shell 1010. The pump or controller 1090 is appropriately connected to one or more vascular compression elements 1030 in the head cover 1000, such as a pump or controller 980 (from Figure 9). The attached pump or controller 1090 is used to perform the desired vascular compression therapy on the patient using one or more vascular compression elements 1030 in the head cover 1000. A submandibular strap 1040 connected to the shell 1010 is also visible in this figure. The vascular compression element 1030 shown is a manifold that expands inward, with the inward end being the end that moves away from the shell 1010 toward the scalp. The head cover 1000 is configured to deliver vascular compression to the scalp 107 and eyebrows 109 (from Figure 1A), as can be seen by the size, orientation, and location of the vascular compression element 1030 positioned adjacent to the scalp, and another separate or separated vascular compression element 1030 positioned to engage with the eyebrows 109 (from Figure 1A).

[0193]

[0287] Figure 10B is a cross-sectional view of a portion of a liner 1020 having a vascular compression element / expandable bladder 1050B having one or more raised features 1070. In this exemplary embodiment, the raised features 170 have a rounded shape facing the patient wearing the head cover 100.

[0194]

[0288] Figure 10C is a cross-sectional view of a portion of a liner 1020 having a vascular compression element / expandable bladder 1050B having one or more raised features 1070. In this exemplary embodiment, the raised features 1070 have a square pyramidal shape with a flat top facing the patient wearing a head cover, for example, head cover 900 from Figure 9 or head cover 1000 from Figure 10A.

[0195]

[0289] Figure 11A is a left side view of the head 1103 of a patient wearing vascular compression elements used to deliver vascular compression in the blood supply of a patient undergoing chemotherapy. In this figure, the outer shell 1110 of the head cover 1100 has been removed (although it can be seen in the figure of Figure 11B). An array of vascular compression elements 1130 of different sizes and shapes is visible in this figure. In addition, or optionally, one or more elements 1130 may be configured as inflatable liners connected to a pump or controller 980 / 1090 (not visible in this figure, see Figures 9 and 10A, respectively). In this configuration, the inflatable liner vascular compression elements 1130 are configured to deliver vascular compression to the scalp 107 and eyebrows 109 from Figure 1A.

[0196]

[0290] Figure 11B is a left side view of the patient in Figure 11A showing a complete head cover 1100 with a shell 1110 in place. The head cover 1100 is held in place on the head 1103 using an exemplary submandibular strap 1140. Figure 11B shows an exemplary position of the head cover 1100 on the head 1103 to induce vascular compression in the blood supply of a patient 1101 undergoing chemotherapy, using the vascular compression element configuration of Figure 11A. In one embodiment, the head cover 1110 delivers vascular compression for protection of the scalp 1107 and eyebrows 1109.

[0197]

[0291] The head covers 900, 1000, and 1100, illustrated and described in Figures 9, 10, 11A, and 11B respectively, are capable of multiple modifications and alternatives. Several additional details of the features and operation of various embodiments of the head covers are referred to below.

[0198]

[0292] In one embodiment, a head cover 900 is provided for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, the head cover 900 having a shell 910 having an anterior edge, a posterior edge, a apex, a left edge, and a right edge. Inside the shell is a liner shaped to at least partially accommodate the patient's hair. Also included are at least one vascular compression element located inside the outer shell, and a head cover retention system coupled to the shell.

[0199]

[0293] In one embodiment, the head cover retention system 940 (from Figure 9) may include a chin strap connected to the shell 910. Optionally, the head cover retention system 940 may include one or more rear straps, front straps, or neck straps connected to the shell 910. In some embodiments, the shell retention system 940 comprises one or more adjustment elements. Optionally, the head cover retention system 940 may include hook-and-loop fasteners, buckles, quick-release mechanisms, or adjustment features.

[0200]

[0294] In an additional embodiment, as shown in Figures 10B-10C, at least one vascular compression element is an expandable bladder 1050B located inside the liner 1020. In an additional embodiment, at least one vascular compression element is coupled to the shell 1010. A pressure source (not shown) communicating with the expandable bladder 1050B may be present. In addition, or optionally, a continuous perimeter (not shown) connecting the anterior edge 912, posterior edge 914, left edge 916, and right edge 918 may be provided in Figure 9. In addition, in one embodiment, the head cover 900 is a continuous structure from the occipital region to the eyebrows or forehead. Furthermore, a structure or expandable structure for compressing the eyebrows is provided for vascular compression action on the eyebrows. It will be understood that the pressure source may be used alone or as part of a control system configured according to the control system 980 and connector 985 in Figure 9, or according to the control system 1090 configured in Figure 10A. In one embodiment, a pressure source (not shown) communicates with components of the head cover 900 using a preferred connector 985 shown in Figure 9. In another embodiment, a pressure source (not shown) is attached to the head cover 1000 as shown in the configuration of the control system 1090 in Figure 10A.

[0201]

[0295] In additional embodiments, at least one vascular compression element includes an expandable feature that expands away from the shell in response to a pressure source. Alternatively, an expandable layer may be provided bonded to the liner, and at least one vascular compression element is located in the expandable layer. In addition, or optionally, at least one vascular compression element includes one or more raised features. A liner located inside the shell and shaped to at least partially accommodate the patient's hair may also include one or more features in the liner for engaging with the patient's hair. Furthermore, the liner or at least one vascular compression element may be smooth, textured, or have an irregular shape, and may include an array of uniformly distributed protrusions having a linear or circular semi-rigid, flexible, or expandable structure.

[0202]

[0296] In yet another embodiment, a gas source communicating with the liner or at least one vascular compression element is included to inflate a portion of the liner or a portion of at least one vascular compression element. The system may also include at least one relief valve to prevent overpressure of the inflatable elements of the head cover 1000. In various embodiments, the gas source is a manual pump mechanism, a valve, an electric pump, or a pressurized tank, cartridge, or reservoir. Optionally, the gas source may be fitted or carried by the patient. Furthermore, the head cover 1000 may include fittings or connectors for use with a gas source supplied by indoor gas, clean dry air, or other structures. In addition, or optionally, a control system may be provided, such as a control system 980 or a control system 1090, configured to regulate the flow of gas from the gas source to maintain a desired pressure inside the head covers 900 and 1000 from Figures 9 and 10A, respectively.

[0203]

[0297] In further embodiments, control system 980 or control system 1090 may be a gas source and control system adapted and configured to include other additional capabilities, such as those described herein. The desired pressure inside the head cover 1000 is sufficient to produce a vascular compression result while minimizing patient discomfort or side effects or damage to surrounding structures. A cooling gas source communicating with the liner or at least one vascular compression element may be included, and a portion of the liner or at least one portion of the vascular compression element may be adapted to provide cooling inside the head cover 1000. One or more pressure sensors may be included inside the head cover 1000. One or more pressure sensors may be appropriately selected and provided to generate pressure instruction signals to control systems 980 / 1090. Furthermore, one or more pressure sensors may be adapted to indicate the amount of pressure applied to a patient receiving chemotherapy while the patient is wearing the head cover 1000. In addition, one or more sensors may be configured for measuring skin perfusion (O2 saturation) or monitoring Doppler blood flow or sensing with an infrared pulse oximeter. The sensors described herein may also be adapted and configured to determine the blood flow in a vascular structure under compression and to determine whether the flow has been sufficiently stopped or slowed to prevent the flow of blood containing chemotherapeutic agents. In one embodiment, the detection of substantially reduced or stopped blood flow may also be used as a trigger within the control system 180 / 190 to increase the amount of compression, with an additional margin to increase confidence that the amount of compression applied is sufficient. This additional compression margin may be included in a feedback loop that measures blood flow, increases compression, and is performed by the control system 180 / 190 to determine whether to increase it as needed in the case of a slowed or stopped level of compression. Subsequently, an additional step of increasing the compression level after detection of stopped blood flow may be added as a safety margin to ensure transient, reversible vascular occlusion induced by the compression.

[0204]

[0298] In addition, the head cover 1000 may be coupled to a timer and control system 180 / 190 adapted to provide an auto-contraction protocol to stop the operation of a vascular compression element when a timer has elapsed or when the vascular compression element is in any active state. In one variation, the head cover 1000 may be coupled to a timer and control system 980 / 1090 adapted for programmed auto-inflation and deflation of a liner or one or more vascular compression elements, or for activation and deactivation of one or more vascular compression elements. The system 980 / 1090 may also include a display and Bluetooth, short-range, or other wireless or wired communication capabilities. Furthermore, the system may communicate the status of vascular compression therapy or surgery, programming, patient information, or other aspects to a mobile phone, network, remote network, or health information system. In yet another embodiment, the display may be positioned on the head cover 1000 to provide information to a healthcare provider or patient. In addition, or optionally, the display may be located on top of, in the middle of, inside the shell 1010, or integrated into a part of the shell 1010. One embodiment of the display may be positioned on a movable mount to allow observation of the display by a patient using the head cover. In addition, or optionally, the head cover may be adapted to suitable mounts, connectors, or connectivity to allow a smartphone or other separate electronic device to be attached to the head cover and configured for electronic communication, interaction, and control of the components of the head cover. In additional embodiments, the head cover 1000 may also include earphones, headphones, speakers, or other audio components adjacent to the patient's ears. In these embodiments, the system is also configured to provide noise cancellation, music, media, or other entertainment to a patient undergoing chemotherapy or using the head cover 1000.

[0205]

[0299] In addition, in relation to the head cover 100 operated by a timer sequence in one embodiment of the control system 980 / 1090, the timing may be adapted to correspond to the expected half-life or toxicity level of the chemotherapeutic agent being used. Thus, the initiation and duration of vascular compression therapy may be related to the introduction of the chemotherapeutic agent and the expected duration of vascular compression therapy to correspond to the prolonged toxicity of residual chemotherapeutic agents in the blood. Considering the drug concentration profiles in Figures 3B and 13B, the duration of vascular compression therapy should be selected to the duration at which the drug concentration level in the blood falls below the peak level and approaches zero or pre-chemotherapeutic levels. This amount may vary depending on the patient and the specific toxicity profile and half-life of the particular chemotherapeutic agent being used. Therefore, the timing function of the controller 980 / 1090 may provide an automated contraction protocol selected to address patient and drug-specific details when the timer time has elapsed. Optionally, an additional timing margin may be added to provide additional confidence that the toxic levels of the chemotherapeutic agent in the blood do not pose a further threat, or that the threat to the health of the scalp and hair structure (Figure 8) has been significantly reduced. In addition, or optionally, after the timer has elapsed, or to stop the operation of any active vasoconstrictor element, the control system may step-by-step or adjust the pause of vasoconstriction therapy to sequentially reintroduce blood flow after vasoconstriction therapy. In one modification, the head cover 100 may be coupled to a timer and control system 980 / 1090 adapted for programmed automatic inflation and deflation of the liner or one or more vasoconstrictor elements, or for activation and deactivation of one or more vasoconstrictor elements, in accordance with the guidelines discussed above.

[0206]

[0300] In yet another embodiment of the head cover 1000 having a liner, the liner may be a rigid or semi-elastic layer configured for a tight fit for the patient so as to fit snugly to the shape of the patient's head and hair.

[0207]

[0301] The various embodiments of the hair cover described herein may also include one or more selective pressure points positioned to compress one or more vessels in the patient's cranial circulatory system. In addition, other embodiments may include a vibrating element coupled to the liner or at least one vascular compression element. In further embodiments, the liner 1020 and at least one vascular compression element 1030 are sized, shaped, or positioned relative to the head cover 1000 based on the patient's hairstyle.

[0208]

[0302] In yet another alternative embodiment of the head cover 1000, there is a cap having an anterior edge, a posterior edge, a apex, a left edge, and a right edge. Inside the cap is a liner shaped to at least partially accommodate the patient's hair. Inside the cap is at least one vascular compression element. In one alternative embodiment, the cap includes a flexible structure, a partially flexible structure, a combination of a semi-rigid structure and a flexible structure, or an adjustable structure, sized to remain in place on the head when at least one vascular compression element is active.

[0209]

[0303] In various other alternative embodiments, the head cover 1000 having a cap shape factor may also be adapted and configured to include any of the alternative forms, optional additional modifications, and embodiments described above.

[0210]

[0304] In some embodiments, one or more vascular compression elements are brought into contact with the scalp via springs, mechanical couplings, electromechanical drives, or electromagnetic arrangements.

[0211]

[0305] Referring next to Figures 12A–15, Figures 12A–15 are used to illustrate exemplary methods for providing vascular compression to patients undergoing chemotherapy. It will be understood that these methods and their variations may be modified to be implemented using either the embodiment of the head cover 1000 or the vascular compression element 1030 described above.

[0212]

[0306] Figure 12A is a left side view of the head of a patient wearing a head cover 1200 that includes at least one vascular compression element, such as vascular compression element 1230 from Figure 12B, for delivering vascular compression. This is the patient's condition before or immediately after the start of chemotherapy the patient is receiving. The submandibular strap 1240 connected to the shell 1210 of the head cover 1200 is also visible in this figure. The head cover 1200 is configured to deliver vascular compression to the patient's scalp 1207 and eyebrows 109 (from Figure 1).

[0213]

[0307] Figure 12B is a cross-sectional view of a portion of the hair 1207, scalp, and hair follicles of the patient of Figure 12A. This figure shows the hair 1207 pressed against the scalp before the delivery of vascular compression when the head cover 1200 is worn (Figure 12A). Also shown are the vascular structures, hair bulbs 1264, as well as the vascular structure 1262, periosteum 1238 / bone 1240, vascular compression element 1230, and shell 1210 with respect to the skull 1260, scalp 1207, or vascular bed of the hair 1268.

[0214]

[0308] Figure 12C is a cross-sectional view of a portion of the hair, scalp, and hair follicles of the patient of Figure 12B. There is a rigid outer shell 1210. This figure shows the inflation (a manifold expanding inward in the direction of arrow 1211) of one or more vascular compression elements 1230 in the head cover 1200 that causes vascular compression inside the vascular bed 1262 of the hair follicle. The scalp 1207 and periosteum 1238 / bone 1240 are also shown.

[0215]

[0309] Figure 12D is an external view of a patient 1200 receiving chemotherapy when vascular compression is being delivered by the head cover 1200. The submandibular strap 1240 connected to the shell 1210 of the head cover 1200 is also visible in this figure. The arrows indicate that vascular compression may be applied simultaneously or sequentially to multiple portions of the scalp 1207 including the eyebrows 109 (from Figure 1A).

[0216]

[0310] FIG. 13A is a diagram of a patient of FIGS. 12A - 12D who is undergoing vascular compression from a head cover during a nearly completed chemotherapy session, as indicated by a nearly empty IV bag 1305 of chemotherapeutic agent 1310, and the amount of fluid in bag 1315. The head cover 1300 is also shown.

[0217]

[0311] FIG. 13B is a graph showing the expected concentration curve of chemotherapeutic agent 1310 in the patient's bloodstream according to drug concentration (mg / L) 1330 and time (minutes) 1335 for the patient's condition of FIG. 13A. Triangle 1325 indicates the estimated concentration based on the amount of delivered chemotherapeutic agent indicated by the decreasing fluid level visible in the bag of FIG. 13A. The arrow indicates that the drug concentration amount is at or slightly above the approximate peak or maximum drug concentration.

[0218]

[0312] FIG. 13C is a diagram of the progress of the chemotherapy-induced necrosis process in the target tumor or malignant lesion 1320 of the patients of FIGS. 12A, 12D, and 13A who are undergoing vascular compression during delivery of the chemotherapeutic agent.

[0219]

[0313] FIG. 13D is a cross-sectional view of the head cover 1300, scalp, and hair follicles of the patients of FIGS. 12A, 12D, and 13A who are undergoing vascular compression during delivery of chemotherapeutic agent 1310 (FIG. 13B). This figure shows that there is no or substantially no chemotherapeutic agent 1310 in the vascular bed, or that the level of chemotherapeutic agent 1310 reaching the vascular bed is maintained below a level that would harm the hair follicles. As shown herein, there are present head cover 1300, shell 1310, manifold 1330, as well as vascular bed 1362, periosteum 1338 / bone 1340.

[0220]

[0314] In contrast to the severe losses experienced by unprotected patients in Figure 6B, patients who experience vascular compression during chemotherapy have vascular structures 662 closed to prevent the chemotherapeutic agent 10 from being delivered to or damaged by the hair follicles 664 and associated hair shafts 670. As a result of the advantageous prevention of the introduction of the chemotherapeutic agent into the vascular beds of the scalp and eyebrows, patients who experience vascular compression as described herein in combination with chemotherapy avoid one or more of chemotherapy-induced alopecia (CIA), chemotherapy-induced hair loss, hair follicle death, and / or anagen effluvium.

[0221]

[0315] Figure 14 is a side view of patient 1401 of Figure 13A during the period following delivery of chemotherapy with vascular compression. The patient retains hair 1407 on both the scalp 1403 and eyebrows 1409 as a result of the beneficial effect of vascular compression.

[0222]

[0316] Figure 15 is a flowchart of 1500 typical methods for providing vascular compression to patients undergoing chemotherapy.

[0223]

[0317] A typical method for inducing vascular compression in the cranial circulation of a patient undergoing chemotherapy begins by placing a head cover 100 around the patient's head (step 1510).

[0224]

[0318] Next, there is a step (step 1520) in which the vascular compression element of the head cover 100 is used to induce at least partial vascular compression in a portion of the patient's cranial circulatory system.

[0225]

[0319] Next, there is a step to initiating chemotherapy sessions for the patient (step 1530).

[0226]

[0320] Next, there is a step to complete the chemotherapy session for the patient (step 1540).

[0227]

[0321] Finally, after the step of completing the chemotherapy session, when a sufficient period has elapsed to partially mitigate the effects of chemotherapy-induced alopecia in the patient, there is a step of at least partially inducing vascular compression in a portion of the patient's cranial circulation (step 1550).

[0228]

[0322] Optionally, or in addition, a step to induce vascular compression in a portion of the cranial circulation may be adjusted before, during, or after the step of initiating or completing a chemotherapy session.

[0229]

[0323] Method 1500 may also include the step of engaging the head cover retaining system 940 to secure the head cover 900 (from Figure 9) to the patient's head.

[0230]

[0324] The time elapsed after the step that completes the chemotherapy session is greater than 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, or the time period when the drug concentration level in the patient's bloodstream falls below the level that harms hair follicles.

[0231]

[0325] In an additional embodiment of this method, as shown in Figure 9, the vascular compression element 930 of the head cover 900 is a liner 920, and a step of expanding or contracting the liner is performed during a step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system. In addition, or optionally, an increase or decrease in the amount of vascular compression occurs during the step of expanding the liner in response to an increase in the force of the liner on the patient's scalp.

[0232]

[0326] In an additional embodiment of this method, a vascular compression element of a head cover, which is a liner having one or more features, is provided, and a step of expanding the liner or contracting the liner is performed during a step of at least partially inducing vascular compression in a portion of the patient's cranial circulation. In a further embodiment, an increase in the amount of vascular compression occurs during the step of expanding the liner in response to an increase in the force pressing one or more features of the liner against the patient's scalp. In addition, or optionally, a decrease in the amount of vascular compression occurs during the step of contracting the liner in response to a decrease in the force pressing one or more features of the liner against the patient's scalp.

[0233]

[0327] In yet another variation of this method, the vascular compression element 930 of the head cover is an inflatable bladder, and the degree of vascular compression during the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system corresponds at least partially to the amount of pressure inside the inflatable bladder.

[0234]

[0328] In yet another variation of this method, the vascular compression element 930 of the head cover is an inflatable bladder, and the degree of vascular compression during the step of inducing vascular compression in at least partially a portion of the patient's cranial circulatory system is increased or decreased by increasing or decreasing the pressure in the inflatable bladder against the skull.

[0235]

[0329] In yet another variation, the vascular compression element of the head cover is one or more features located on the inner surface of the head cover that come into contact with the portion of the patient's scalp containing hair follicles during a step that at least partially induces vascular compression in a portion of the patient's cranial circulatory system.

[0236]

[0330] In another variation, the vascular compression element of the head cover is one or more features located on the inner surface of the head cover, corresponding to the composition of the patient's hair, and the one or more features act on the composition of the patient's hair to facilitate the performance of a step that at least partially induces vascular compression in a portion of the patient's cranial circulatory system.

[0237]

[0331] In yet another variation of this method, during the step of at least partially inducing vascular compression, the vascular compression element of the head cover compresses a portion of the scalp containing multiple hair follicles against a portion of the skull, thereby at least partially compressing the blood supply to the multiple hair follicles. In addition, or optionally, the step is provided in which that portion of the skull is one or more of the superior temporal line, inferior temporal line, parietal bone, squamous suture, temporal bone, lambdoid suture, occipital bone, mastoid process, sphenoid bone, portion adjacent to the supraorbital foramen, frontal bone, coronal suture.

[0238]

[0332] In another alternative variation of this method, during the step of at least partially inducing vascular compression, the vascular compression element of the head cover is positioned to at least partially vascularly compress an artery or vein of the patient's cranial circulatory system against a portion of the skull by compressing the artery or vein. Further, the artery or vein of the cranial circulatory system is a branch of the external carotid artery or the internal carotid artery, the artery or vein of the cranial circulatory system is the ophthalmic artery, the artery or vein of the cranial circulatory system is the superficial temporal artery, the artery or vein of the cranial circulatory system is the posterior auricular artery, the artery or vein of the cranial circulatory system is the occipital artery, the artery or vein of the cranial circulatory system is the supraorbital artery or the supratrochlear artery. In addition, optionally or in combination, that portion of the skull is one or more of the superior temporal line, the inferior temporal line, the parietal bone, the squamous suture, the temporal bone, the lambda suture, the occipital bone, the mastoid process, the sphenoid bone, the portion adjacent to the supraorbital foramen, the frontal bone, the coronal suture. Referring to FIG. 10A, the size, shape, and orientation of the shell 1010 during use are such that, together with the size, shape, overall position, and relative position of the front edge 1012, the rear edge 1014, the top 1013, the left edge 916 (from FIG. 9), and the right edge 1018 of the shell 1010, selective application of controllable vascular compression to one or more of the arteries or veins of the cranial circulatory system listed above is advantageously selected either alone or in any combination with embodiments of one or more vascular compression elements described herein. In one particular example, considering the scalp that receives a rich arterial supply via the external carotid artery and the ophthalmic artery (a branch of the internal carotid artery), an embodiment of the configuration of a vascular compression element or elements (not a tourniquet, but direct point pressure) that compresses the supply vasculature at a pressure higher than the pressure that would normally be applied to the scalp / hair or eyebrow region is provided.

[0239]

[0333] In an additional variation, the step of at least partially inducing vascular compression in a portion of the cranial circulatory system is due to compression of that portion of the scalp of the patient that includes the blood vessels of the patient's cranial circulatory system against a portion of the patient's periosteum.

[0240]

[0334] In an additional variation, the step of inducing vascular compression, at least partially, in a portion of the cranial circulatory system is brought about by the interaction between the vascular compression elements of the head cover and the blood vessels of the patient's cranial circulatory system.

[0241]

[0335] In yet another variation, the step of inducing vascular compression in at least partially a portion of the cranial circulation system further includes compressing a portion of the scalp against a portion of the periosteum to induce vascular compression in a portion of the vascular bed of the hair follicle.

[0242]

[0336] In another alternative modification of this method, there is a step in which the vascular compression element of the head cover is positioned relative to the patient's head, and during the engagement step, the vascular compression element is positioned in close proximity to a specific vein or artery so as to compress at least partially a specific vein or artery of the patient's cranial circulatory system.

[0243]

[0337] Another alternative form of this method involves the delivery of a vasoconstrictor to the patient before, during, or after any of the methods described above. In one embodiment, the vasoconstrictor is one of the following: alpha-adrenergic receptor agonists, vasopressin analogs, epinephrine, norepinephrine, phenylephrine, dopamine, dobutamine, migraine medications, headache medications, serotonin 5-hydroxytryptamine agonists, and triptans.

[0244] In addition, the methods and devices described above, and all their variations, may be used to deliver vascular compression while a patient is receiving chemotherapy by injection, infusion, targeted therapy, hormone therapy, or immunotherapy. Furthermore, these methods and devices for providing vascular compression may be used before or during chemotherapy administered by intravenous, subarachnoid, intra-arterial, intracavitary, intramuscular, intralesional, or intravesical methods. In addition, or optionally, because these methods and devices for providing vascular compression are small, portable, and can be moved with the patient, they may be readily used whether the patient is receiving chemotherapy at home, in a healthcare provider's office, clinic, outpatient infusion center, hospital infusion center, or hospital ward.

[0245]

[0338] In another alternative modification of this method 1500, a step is provided in which a reaction force is applied to a head cover to be used to counteract the force introduced into the patient's head as a result of vascular compression therapy. The reaction force may be applied directly to a preferred location on the shell of the head cover based on the patient's position and a desired vector of the reaction force, as illustrated and described in relation to Figures 21A–21D. In addition, or optionally, a support structure may be positioned on the shell of the head cover and releasably coupled to the shell of the head cover to facilitate the repeatable or controllable application of the generated reaction force, as illustrated and described in relation to embodiments of Figures 22–26. In this method, and the amount of vascular compression reaction force applied may vary during a vascular compression therapy session. The amount of reaction force and the direction of application of the reaction force may also change during a session or differ in subsequent sessions, based on the patient's comfort and the vascular compression forces generated during the chemotherapy session. In one embodiment, the criteria for the selection and application of a particular embodiment of vascular compression reaction force are the patient's preference and comfort.

[0246]

[0339] Figures 16 and 17 utilize a mandibular support attached to the helmet to distribute force along the jawbone (see Figure 41). The use of a facepiece with padding or tiling alone in any of the modifications is fitted and configured to distribute force along the skull and face as well as the jawbone (see Figures 41, 42A, and 42B). According to certain embodiments, the mandibular support may be part of the facepiece.

[0247]

[0340] Figure 16 is a front view (1600) of a head cover (helmet / shell) for inducing vascular compression in the blood supply of a patient undergoing chemotherapy. A partial submandibular rigid support or partial mandibular frame 1602 extends continuously from the left portion of the mandibular body, the chin prominence or jaw, and the right portion of the mandibular body. An oversized cushion or full mandibular padding 1604 is shown, positioned between the patient's jaw and the rigid support 1602. The rigid support 1602 is attached to the helmet / shell 1610 via straps 1608 on the eyebrows and two anterior mounting points or strap adjusters and connectors 1606A on the anterior strap support frame 1606. The rigid support 1602 is attached to the shell 1610 on the left and right sides from mounting points or strap connectors on the mandibular frame 1602A located at the left and right ends of the support 1602. A rear strap support frame 1612 is also present, and the rear strap support frame 1612 may also have attachment points for the strap 1608.

[0248]

[0341] Figure 17 is a front view of a head cover (shell) for inducing vascular compression in the blood supply of a patient undergoing chemotherapy (1700). Similar to Figure 16, a submandibular rigid support 1702 is attached to the shell 1710. The submandibular rigid support 1702 may be a rigid jaw support structure located inside a complete mandibular support frame. In contrast to Figure 16, the support 1702 extends continuously from the left portion of the mandibular body at the left corner of the mandible to the right corner of the mandible along the genioprotuberance or the right portion of the jaw and mandibular body. A cushion 1704 of similar size to the rigid support is positioned between the patient's jaw and the rigid support, and the cushion 1704 may be a soft foam filler positioned along the complete mandibular support frame 1702. The rigid support 1702 is attached to the shell 1710 on two anterior attachment points adjacent to the jaw, such as the eyebrows and a strap connector on the mandibular frame 1702A. The rigid support 1702 is attached to the shell 1710 on the left and right sides from mounting points at the left and right ends of the support, such as the strap adjuster and connector 1706A on the front strap support frame 1706. A rear strap support frame 1712 is also present. The strap 1708 connects the rigid support 1702 to the shell 1710 via the front strap support frame 1706 on the shell 1710, the strap connector on the mandibular frame 1702A, and the strap adjuster and connector 1706A, as well as mounting points on the rear strap support frame 1712.

[0249]

[0342] Figure 18 is a front view (1800) of a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, including a full-face support structure. The full-face support structure 1802 surrounds the mandibular body and mandibular ramus and extends to at least partially cover them across the zygomatic, maxillary, and frontal bones of the skull. The full-face support structure 1802 has openings 1802O for the eyes, nose, and mouth. A cushion 1804 of similar size and shape to the full-face support structure 1802 is positioned between the patient and the full-face support 1802. The full-face support 1802 is attached to the shell 1810 over the eyes and two anterior upper attachment points or anterior strap support connectors 1806A. The rigid support 1802 is attached to the shell 1810 on the left and right sides from the left and right end attachment points of the support 1802 along the mandibular body and locations adjacent to the upper surface of the mandibular ramus, such as the strap connectors on the facial support 1802A. The full-face support 1802 has additional unused attachment points 1802B in the center of the forehead, on the left and right sides adjacent to the nose, and on the left and right sides adjacent to the chin, etc. One or more of the additional attachment points may be used to further adjust the distribution of forces generated during vascular compression by connecting additional unused strap support connector sockets 1806B. Lateral and posterior strap support connectors 1812 are also present on the lateral and posterior sides of the shell 1810. The straps 1808 connect the full-face support structure 1802 to the shell 1810 via attachment points on the anterior strap support connector 1806A on the shell 1810, the strap connector on the facial support 1802A, and the lateral and posterior strap support connectors 1812.

[0250]

[0343] Figure 19A is a front view (1900) of a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, including a full-face support structure. The full-face support structure 1902 surrounds the mandibular body and mandibular ramus and extends to at least partially cover them across the zygomatic, maxillary, and frontal bones of the skull. The full-face support structure has openings 19020 for the eyes, nose, and mouth. A series of sockets or openings 1902oo in the full-face support structure allows for the use of an array of independently selectable cushion tiles or other local support structures to be added to the full-face support structure 1902. Figures 20–26 show various configurations of cushion tiles adapted for use with the full-face support. In various figures of Figures 19A, 19B, and 19C, the cushion tiles are not shown. According to a particular embodiment, the full-face support 1902 is attached to the shell 1910 at nine points, three each along the forehead 1902F, the right side 1902R, and the left side 1902L. Along the forehead, one is located above each eye and one is located in the center of the forehead above the nose. A pair of upper attachment points 1902U are located near the temples. Lower left and lower right attachment points are located below the ears, adjacent to the mandibular ramus. Each of the attachment points 1902F / 1902U / 1902R / 1902L on the facial support is a D-shaped connector sized to receive a loop which is part of a strap 1908 attached to an adjustable connection point / strap support connector 1906A of the shell 1910. Each of the straps 1908 and their associated connectors 1902F / 1902U / 1902R / 1902L / 1906A may be adjusted to enhance comfort during use, while adapting to the patient, based on the distribution of force generated during vascular compression.

[0251]

[0344] Figure 19B is a right side view (1925) of the head cover for inducing vascular compression as shown in Figure 19A. In this figure, the three upper mounting points 1902T are visible, along with a pair of upper right mounting points 1902RU and lower right mounting point 1902RL. An inflation line 1925I and inflation adapter 1925A (see Figure 31) that connect to the shell 1910 are also present. Sockets for arranging local support structures / strap connectors on the facial support 1902oo, strap connectors on the facial support 1902A, strap 1908, and strap support connector 1906A on the shell 1910 are also shown.

[0252]

[0345] Figure 19C is a left side view (1950) of the head cover for inducing vascular compression as shown in Figure 19A. In this figure, two of the three upper mounting points 1902T are visible, along with a pair of upper left mounting points 1902LU and lower left mounting point 1902LL. Sockets for positioning local support structures / strap connectors on the facial support 1902oo, strap connectors on the facial support 1902A, strap 1908, and strap support connector 1906A on the shell 1910 are also shown.

[0253]

[0346] Figure 19D is a rear view of the head cover for inducing vascular compression shown in Figure 19A (1975). In this figure, multiple mounting points are shown on the shell 1910. In addition, the air connection (inflation adapter) 1900A and inflation line 1900I at the rear of the shell 1910 are visible. The strap support connector 1906A on the shell 1910 is also visible.

[0254]

[0347] According to certain embodiments, the headband 1900H may be connected to the head cover / shell / helmet 1910 via a band, strap 1908A, or other structure in an adjustable gap between the helmet 1910 and the facial support 1902, which is adjusted by a strap 1908. During or before / after inflation of the helmet 1910 via an inflation line 1900I, which may be coupled to an inflation source, the headband 1900H may stabilize the helmet 1910. In some embodiments, the patient may put on the headband 1900H first, then the helmet 1910, and subsequently the facial support 1902.

[0255]

[0348] Figure 20 is a top isometric view of one embodiment of a plurality of tile face cushions adapted for use with the embodiments in Figures 19A–19D (2000). The full face shield, as well as the straps and connectors, are omitted from this figure. As shown herein, the helmet 2010 is transparent to show the location of the inflatable structure 2020 (see also Figures 27A, 27B, 29A, 29B, 29C, 30A, 30B, and 31). A rigid face support structure 2002 is also shown and is transparent to show the location of the tile elements / support tiles 2002ST. Each tile 2002ST has a plug that is aligned with the corresponding opening in the face shield and sized and positioned to be received by those openings. To achieve load distribution, the cushioning characteristics of each face shield may be adapted by selecting cushion tiles 2002ST of the desired shape, size, and composition, as well as by arranging specific tiles in the face shield in a location and orientation that improves the comfort of the patient undergoing vascular compression therapy. According to certain embodiments, in order to further achieve load distribution, the tile 2002ST may have different stiffness, durometer, flexibility, contour, and other properties based on its position in the facial support 2002, adjacent anatomical bone structures, and patient comfort (see Figures 41 and 42A-42B).

[0256]

[0349] Figures 21A to 21D illustrate the fluctuations in forces acting on the helmet to produce reactive forces on the user's head and face in order to reduce the degree of discomfort experienced during treatment.

[0257]

[0350] Figure 21A is a side view of the vascular compression device of Figures 19A–19D (2100), with the face shield removed and showing the positions of the exemplary multiple tile face cushions. In this figure, the patient is in a prone position and the shell 2110 is positioned relative to the support structure 2100SS, resulting in a reaction force vector indicated by arrow 2100F1. The reaction force vector 2100F1 is used to provide additional comfort to the patient receiving vascular compression therapy by offsetting a portion of the forces generated during the application of vascular compression therapy. In this embodiment, the reaction force 2100F1 is directed from the contact point 2100CP1 with the support structure 2100SS toward the upper mounting point and the patient's nose 2101N.

[0258]

[0351] Figure 21B is a side view of the vascular compression device of Figure 21A (2125), with the face shield removed to show the position of the exemplary multiple tile face cushions. In this figure, the patient is in a prone position and the shell 2110 is positioned relative to the support structure 2100SS, resulting in a reaction force vector 2100F2 indicated by the arrow. The force vector 2100F2 is used to provide additional comfort to the patient receiving vascular compression therapy by offsetting a portion of the forces generated during the application of vascular compression therapy. In this embodiment, the reaction force 2100F2 is directed from the contact point 2100CP2 with the support structure 2100SS toward the upper mounting point, over the ears, and under the patient's chin 2101C.

[0259]

[0352] Figure 21C is a side view of the vascular compression device of Figure 21A (2150), with the face shield removed to show the position of the exemplary multiple tile face cushions. In this figure, the patient is in a prone position and the shell 2110 is positioned relative to the support structure 2100SS, resulting in a force vector indicated by arrow 2100F3. The force vector 2100F3 is used to provide additional comfort to the patient receiving vascular compression therapy by offsetting a portion of the forces generated during the application of vascular compression therapy. In this embodiment, the reaction force 2100F3 is directed from the contact point with the support structure 2100CP3 toward the upper mounting point, over the ears, and onto the patient's chin 2101C.

[0260]

[0353] Figure 21D is a side view of the vascular compression device of Figure 21A (2175), with the face shield removed to show the positions of the exemplary multiple tile face cushions. In this figure, the patient is standing and an external force is applied to the shell 2110, resulting in a force vector indicated by arrow 2100F4. The force vector 2100F4 is used to provide additional comfort to the patient receiving vascular compression therapy by counteracting a portion of the forces generated during the application of vascular compression therapy. In this embodiment, the reaction force 2100F4 is directed from the contact point 2100CP4 toward the upper mounting point, over the ears toward the line between the patient's nose 2101N and chin 2101C.

[0261]

[0354] Figures 22–25 show several different support structures to assist force distribution by varying the contact area or additional location of the weighted structure to provide comfort during treatment.

[0262]

[0355] Figure 22 is a side view of the vascular compression device of Figure 21A (2200), with the face shield removed to show the positions of the exemplary multiple tile face cushions. The support ring 2200R is shown in a cross-section on the shell 2210 at a point that is the center of the reaction force vector 2100F4 shown in Figure 21D. When in use, the support ring 2200R should be positioned to contact a support structure or other device used to apply the reaction force, such as the support structure 2100SS shown in Figure 21C. The ring 2200R should be used to distribute the force over a larger area of ​​the head cover.

[0263]

[0356] Figure 23 is a rear perspective view (2300) of the vascular compression device of Figure 21A, with the face shield removed and showing the positions of exemplary multiple tile face cushions. The support ring 2300R is shown in place on the head cover 2310. The support ring 2300R has a frustoconical shape and a base 2300LDB with a larger diameter relative to the surface of the shell 2310. The flat upper ring surface may be used to receive and distribute reaction forces, such as a counterweight rim 2300CW. Optionally, the upper support ring 2300R may be used as a contact section / second support base 2300CZ to other or additional support structures, as shown in Figure 26.

[0264]

[0357] Figure 24A is a side view of the vascular compression device of Figure 21A (2400), with the face shield removed to show the positions of the exemplary multiple tile face cushions. The support structure 2400SS is shown in place on the head cover 2410. The support structure 2400SS comprises a base 2400SB, a spindle 2400SST, and an upper support surface 2400SSUS. The base 2400SB may be sized to distribute reaction forces across a larger portion of the shell 2410, and the orientation and contours of the spindle 2400SST and the upper support surface 2400SSUS may be configured to engage with the corresponding support surfaces.

[0265]

[0358] Figure 24B is a front perspective view (2450) of the embodiment of Figure 24A. Similar to Figure 24A, Figure 25B shows a support structure 2400SS positioned at the upper rear of the head cover 2410, near the crown of the head of a patient 2401 wearing the head cover 2410. Similar to the embodiment of Figure 24A, the support structure has a base 2400SB. In contrast to the embodiment of Figure 24A, the embodiment shown in Figure 25B includes an elongated spindle 2400ESST and a relatively larger upper support surface 2400LSSUS. The base 2400SB may be sized to distribute reaction forces over a larger portion of the shell 2410, and the orientation and contour of the elongated spindle 2400ESST and the upper support surface 2400LSSUS may be configured to engage with the corresponding support surface. According to certain embodiments, the upper support surface 2400LSSUS may have a non-slip surface or grip treatment for improved contact and stability with the corresponding support surface.

[0266]

[0359] Figure 25 is a side view of the vascular compression device of Figure 21A (2500), with the face shield removed to show the positions of exemplary multiple tile face cushions. The support ring 2500R, shown in position on the head cover, is similar to the embodiment in Figure 23. The support ring 2500R has a frustoconical shape and a base 2500SB with a larger diameter than the surface of the shell 2510. The base 2500SB may be contoured to fit with the upper surface of the counterweight rim / ring 2500CW or 2300CW on the shell 2310 (see Figure 23). The flat upper ring surface 2500SSUS may be used to receive and distribute reaction forces and is supported by the helmet support / column 2500SST. In this figure, the upper support ring 2500R is used as the support base 2500SB for the support structure shown in Figures 25A and 25B. The combination is advantageous because the elongated core and support surface allow for a wider distribution of reaction forces while enabling better containment by the support structure.

[0267]

[0360] Figures 26A and 26B provide a wide range of variations for adjusting fit and providing comfort. One or more of the adjustable or user-determined aspects, such as the variable positioning platform at the top of the helmet, the internal pressure of the balloon liner / bladder, the individual straps around the facepiece, as well as the user / patient-customizable adjustable tiles inside the facepiece, and the overall shape and size of the facepiece, may be used alone or in combination to provide comfort or to adjust the application of force used to induce vascular compression.

[0268]

[0361] Figure 26A is a left side view of one embodiment of a vascular compression device having a stabilizing weight 2600CW and a head support / headrest 2600SSUS on an adjustable sliding mount 2600SR which may be used to adjust the angle of the headrest. As shown herein, there is also an outer shell having an internal compression balloon 2600OSICB, which may be inflated via an inflation valve / pump 2600IP to the balloon and adjustment strap 2608.

[0269]

[0362] Figure 26B is a front view of the vascular compression device shown in Figure 26A. The adjustment strap 2608, facial support 2602, and facial padding 2604 are shown here.

[0270]

[0363] Figure 27A is a bottom perspective view of the inside of the head cover showing the helmet / shell 2710 and the inflatable balloon liner 2720. Behind the shell 2710, an air adapter 2700AA and connection for adjusting the pressure inside the balloon liner 2720 are also shown (see also Figure 31).

[0271]

[0364] Figure 27B is a cross-sectional view of the head cover in Figure 27A, showing the arrangement of the shell 2710, liner 2720, and air adapter 2700AA and connections.

[0272]

[0365] Figures 28A and 28B are front and rear views of one embodiment of the head cover shown in Figures 27A and 27B, showing its position on the head. Figure 28A shows a series of mounting points 2800AT for various accessories, connectors, and supports, extending from the upper corner of the helmet 2810 in the figure to the rear along the rear shown in Figure 28B. The balloon liner 2820 in Figure 28A and the air adapter 2800AA in Figure 28B are also shown.

[0273]

[0366] Figures 29A and 29B are bottom perspective and left perspective views of the balloon liner, respectively. As shown here, there is a balloon liner 2920 having a rim 2920R and an interior 2920I. An air adapter 2900AA is also shown.

[0274]

[0367] Figure 29C is a left perspective view of the balloon liner. As shown here, the balloon liner 2920, rim 2920R, and interior 2920I are present. Behind the balloon liner 2920, connections such as the inflation / air adapter 2900AA and inflation line 2900I for adjusting the pressure inside the balloon liner 2920 are also shown.

[0275]

[0368] Figure 30A is a cross-sectional view of an inflatable bladder. In one embodiment, the inflatable bladder 3050B is formed from an elastomer having a first durometer 3050D1 adjacent to the inner wall of the head cover and a second durometer 3050D2 adjacent to the patient's hair / scalp. The bladder material may be selected from latex, silicone, polyurethane, or any other flexible polymer. In some embodiments, the second durometer is lower than the first durometer. In yet another embodiment, the durometer range is 5 to 55 Shore A. In addition, or optionally, the thickness of the inflatable bladder 3050B adjacent to the inner wall of the head cover is greater than the thickness of the inflatable bladder 3050B adjacent to the patient's scalp. In one embodiment, the thickness of the inflatable bladder 3050B adjacent to the patient's scalp is 20 to 80 microns. In yet another embodiment, the inflatable bladder 3050B is a single-piece bladder having various wall thicknesses, for example, 30 to 100 micrometers on the scalp side and 100 to 300 micrometers on any other side. According to a particular embodiment, the inflatable bladder 3050B is connected to an inflation source 3050IS.

[0276]

[0369] Figure 30B is a rear perspective view of the inflatable bladder of Figure 30A. As shown here, the outer surface of the inflatable bladder 3050B is coupled to the inflatable core 3050IST and the inflatable port 3050IP.

[0277]

[0370] Figure 31 is a cross-sectional view of an inflatable bladder joint for a helmet having an inflation port. As shown here, an internal side wall 3100SW of the inflation bladder 3151B is present. An inner block 3100IB and a liner 3100L on the inner block 3100IB for engaging with the bladder side wall 3100SW are further shown. An inflation line 3100IL and an outer block 3100OB for engaging with the inner block 3100IB via a locking screw 3100LS are also present, and the locking screw 3100LS may also secure the neck 3151N of the inflatable bladder 3151B for passage of the inflation line 3100IL.

[0278]

[0371] Figure 32 is a cross-sectional view of a head cover for inducing an embodiment of vascular compression similar to that in Figure 19C, with a tile cushion in place. A detailed cross-sectional view of the shell shows the presence of a secondary material layer between the outer wall 3200OWL of the inflatable liner and the inner wall 3200IWL of the shell. Material 3200M may be any suitable solution, particle suspension, composite material, gel, aerogel, or other material suitable for the force distribution or absorption of vascular compression force between the inner wall 3200IWL of the shell and the outer wall 3200OWL of the inflatable liner.

[0279]

[0372] Figure 33A is a left-side perspective view of the balloon liner inside the helmet. As shown here, there is a helmet 3310 with a balloon liner rim 3320R and interior 3320I, and a strap connector 3306A. The inflation line 3300IL is also shown.

[0280]

[0373] Figures 33B and 33C are bottom and left perspective views, respectively, of the inner balloon liner of a helmet with a headrest. As shown here, there is the balloon liner rim 3320R and interior 3320I, the helmet 3310 with strap connector 3306A, and the inflation line 3300I. A head support / headrest 3300SSUS is shown on an adjustable sliding mount 3300SR, which may be used to adjust the angle of the headrest.

[0281]

[0374] Figure 34 is a right side view of one embodiment of the head cover shown in Figures 33A-33C, positioned on the head. A helmet 3410 with a strap connector 3406A and an inflation line 3400I are shown here.

[0282]

[0375] Figures 35A to 35E show various facepiece tile structures using variable density materials, or structures in which individual tiles are increased or decreased using pneumatic pressure. These may all include a foam interior, or a composite of foam, gel, and a structure of variable hardness, or may be air-filled or adjustable air-filled via a control valve and air / inflation system, or part of an air / inflation system, used to control the pressure, expansion, and contraction of a balloon liner. According to certain embodiments, tiles may be bonded to or contoured to a pad, some or all tiles may be mechanically or pneumatically adjusted to counteract the pressure on the facial bones, and tiles may be divided into various tile sections to correspond to various facial bone structures.

[0283]

[0376] Figure 35A is a bottom view of the six air cells around the chin. The helmet 3510, the filling port / connector 3500FP, and the air-inflated pad 3504, as well as the transparent rigid face cover 3502 for aligning the air pad 3504 and the filling port 3500FP, are shown here.

[0284]

[0377] Figure 35B is a top view of the air cell in Figure 35A. Other air cells have been omitted for clarity. The filling port / connector 3500FP inside the opening, the air-inflated pad 3504, and the rigid face cover 3502 are shown here.

[0285]

[0378] Figure 35C is a cross-sectional view of the air cell located inside the support structure shown in Figure 35A.

[0286]

[0379] Figure 35D is a side view of one of the air cells / pads 3504 in Figure 35A, with an exemplary inflation tube 3500IT connected to it.

[0287]

[0380] Figures 35A and 35D may show tubes, ports, etc., for inflating or deflating individual tiles.

[0288]

[0381] Figure 35E is a bottom view of the exemplary size and placement of the inflatable air cells / pads 3504 around the jaw.

[0289]

[0382] Figure 36A is a front isometric view of a face shield having eight individual pad adjustment sections, with a knob 3600K on the face shield 3602 in relation to a helmet / shell 3610. The straps have been removed for clarity. A strap connection point 3606A on the helmet / shell 3610 and a strap connection point 3602A on the face shield 3602 are also shown, and according to some embodiments, the face shield 3602 may be a facepiece support 3602.

[0290]

[0383] Figure 36B is a front view of the face shield shown in Figure 36A, exhibiting the same features.

[0291]

[0384] Figure 36C is a frontal isometric view of the face shield only, as shown in Figure 36A, without the helmet / shell 3610. The rigid facepiece support 3602 and pad adjustment knob 3600K are shown here.

[0292]

[0385] Figure 36D is a front view of the face shield / facepiece support 3602 of Figure 36A without the helmet. The patient's head and straps have also been removed for better visibility.

[0293]

[0386] Figure 36E is a rear (internal) view of the face shield of Figure 36D, showing the individual pad shapes and positions, each controllable by the operation of a dedicated pad adjustment knob 3600K, which may be coupled to a drive shaft 3600DS. The pad 3604 has a pad support 3604S. According to a particular embodiment, each pad 3604 or a group of pads 3604 may be sized, contoured, and structured with variable hardness, durometer, and / or stiffness for a specific location on the face and its bone structure.

[0294]

[0387] Figure 37A is an isometric view of a helmet having a movable support and a dynamic pressure-adjusting facepiece. The facepiece 3702 has a pad 3704 having a pad support 3704S and a pad adjustment knob 3700K. The helmet / shell 3710 has a movable support base 3700SB, and a head support / headrest or movable support 3700SSUS is located on an adjustable sliding mount / sliding rail for a movable support 3700SR which may be used to adjust the angle of the headrest.

[0295]

[0388] Figure 37B is an exploded view of the vascular compression device of Figure 37A. As shown here, there is a helmet / shell 3710 having a pad adjustment knob 3700K on a dynamic facepiece 3702, a strap 3708, and a helmet strap clip 3706A. In this case as well, the helmet / shell 3710 has a head support / headrest or movable support 3700SSUS, and the headrest is shown on an adjustable sliding mount / sliding rail for the movable support 3700SR which may be used to adjust the angle of the headrest. As shown with the sliding support structure in Figures 26A and 26B, the helmet / shell 3710 may include various mounts, and it will be understood that a wide range of different support structures (see Figures 22-25) or other additional attachments or connection points may be used without distinction.

[0296]

[0389] Figure 37C is a front view of the vascular compression device of Figure 37A. The vascular compression device has a full helmet / shell 3710 with a movable support 3700SB and a dynamic facepiece 3702. As shown here, there is a helmet / shell 3710 with a pad adjustment knob 3700K on the dynamic facepiece 3702, a strap 3708, and a helmet strap clip 3706A. In this case as well, the movable support 3700SSUS is shown on an adjustable sliding mount / sliding rail for the movable support 3700SR, which may be used to adjust the angle of the headrest.

[0297]

[0390] Figure 37D is a rear view of the vascular compression device of Figure 37A. The facepiece 3702 has a pad adjustment knob 3700K. The helmet / shell 3710 has a movable support base 3700SB, and the head support / headrest or movable support 3700SSUS is located on an adjustable sliding mount / sliding rail for the movable support 3700SR, which may be used to adjust the angle of the headrest. A helmet strap clip 3706A, an air adapter 3700A, and an inflation line 3700I are also shown.

[0298]

[0391] Figure 37E is a side view of the vascular compression device of Figure 37A. The facepiece 3702 has a pad adjustment knob 3700K. The helmet / shell 3710 has a movable support base 3700SB, and the head support / headrest or movable support 3700SSUS is located on an adjustable sliding mount / sliding rail for the movable support 3700SR, which may be used to adjust the angle of the headrest. A helmet strap clip 3706A, a strap 3708, an air adapter 3700A, and an inflation line 3700I are also shown.

[0299]

[0392] Figure 38A is a right side view of the head cover and face support for inducing vascular compression before the straps connect the head cover and face support. As shown here, there is a strap support connector 3806A and an inflation line 1900I on the head cover / shell / helmet 3810, and a strap connector 3802A and knob 3800K on the face support 3802.

[0300]

[0393] Figure 38B is a left side view of a head cover and face support for inducing vascular compression, in which straps connect the head cover and face support as well as an optional headband. As shown here, there is a strap support connector 3806A on the head cover / shell / helmet 3810, an inflation line 3800I, and a strap connector 3802A and knob 3800K on the face support 3802, with a strap 3808 connecting the strap support connector 3806A on the helmet 3810 to the strap connector 3802A on the face support 3802.

[0301]

[0394] Figure 39A is an isometric view of a dynamic facepiece having 18 independently controlled support pads. The strap 3908 and strap connection point on facepiece 3902A are also shown.

[0302]

[0395] Figure 39B is an internal view of the dynamic facepiece of Figure 39A. Independently controlled support pads 3904 are shown here. As previously stated, each pad 3904 or a group of pads 3904 may be sized, contoured, and structured with variable hardness, durometer, and / or stiffness for specific locations of the face and its bone structure.

[0303]

[0396] Figure 39C is a cross-sectional view of the dynamic facepiece of Figures 39A and 39B, which has a movable support and pads of various shapes. In this case as well, a pad 3904, a pad support 3904S, and a pad adjustment knob 3900K coupled to a drive shaft 3900DS are shown.

[0304]

[0397] Figure 39D is an isometric front view showing an exploded view of the pad adjustment knob 3900K relative to the pad 3904 and pad support 3904S, with a threaded shaft 3900TS coupled to the pad support 36904S, and the threaded shaft 3900TS may be part of the drive shaft 3900DS from Figure 39C.

[0305]

[0398] Figure 39E shows an exploded view of an embodiment of tactile feedback for a pad adjustment knob. According to a particular embodiment, tactile feedback features may be present on one, more or all of the pad adjustment knobs 3900K, such tactile feedback features may include a smooth edge 3900KS which may correspond to a direction that strengthens or increases the pressure of the pad 3904 on the patient's face via the drive shaft 3900DS, and a serrated edge 3900KJ which may correspond to a direction that releases or decreases the pressure of the pad 3904 on the patient's face via the drive shaft 3900DS. According to yet another embodiment, these directions corresponding to the smooth edge 3900KS and the serrated edge 3900KJ may be reversed.

[0306]

[0399] Figure 39F is an isometric internal view of the dynamic facepiece shown in Figure 39B. The independently controlled support pad 3904, pad support 3904S, and control knob 3900K are shown here. The specific pair of pad 3904 / pad support 3904S combinations varies depending on the location.

[0307]

[0400] During use, individual tiles may be individually adjusted by adjusting the pad control knob to increase or decrease the pressure of the tile on the face. In additional embodiments, pad adjustment may be achieved using any of a variety of mechanical, electric, pneumatic, or electromechanical direct, remote, wired, or wireless control methods. In addition, electronic user interfaces and computer controllers may be used, as will be discussed later in relation to Figures 43, 44, and 45.

[0308]

[0401] Figure 40 is a flowchart of a method for delivering chemotherapy with a rigid facepiece that provides vascular compression and controllable, adjustable pressure relief.

[0309]

[0402] Firstly, in step 4010, a head cover and facepiece are placed around the head of the patient who is about to receive chemotherapy treatment.

[0310]

[0403] Next, in step 4015, the head cover is secured to the patient's head.

[0311]

[0404] Next, in step 4020, the padded facepiece is secured to the head cover over the patient's face.

[0312]

[0405] Subsequently, step 4025 is performed, in which vascular compression is at least partially induced in a portion of the patient's cranial circulatory system using the vascular compression elements of the head cover.

[0313]

[0406] Next, the step of initiating a chemotherapy session for the patient is performed (step 3730).

[0314]

[0407] During the step of providing vascular compression, a step is taken to adjust the pressure applied to the patient's face by one or more pads of a padded facepiece, either initially, after a certain period of time, or to alleviate the patient's discomfort. This step may be performed according to the program, in response to the patient's request for pressure reduction, or in response to instructions from another clinic or patient (step 4035).

[0315]

[0408] Subsequently, the step of completing the chemotherapy session for the patient is performed (step 4040).

[0316]

[0409] Next, in step 4045, after the step of completing the chemotherapy session, when a sufficient period has elapsed to partially mitigate the effects of chemotherapy-induced alopecia in the patient, the process of at least partially inducing vascular compression in a portion of the patient's cranial circulation is completed.

[0317]

[0410] Finally, in step 4050, the process of removing the helmet and facepiece from the patient is carried out.

[0318]

[0411] Figure 41 is a perspective view of the anatomical landmarks and structures of the mandible. The mandibular ramus 4102 joins the mandibular body 4104 at an angle known as the mandibular angle 4104A. The left and right mandibular bodies 4104 are joined by the mental protuberance 4106, commonly called the jaw. The mental tubercle 4106A, mental foramen 4106B, alveolar process 4106C, mandibular body 4104B, and diagonal line 4104C are also shown. The mandibular condyle 4152, pterygoid fossa 4154, mandibular neck 4156, mandibular foramen 4158, condylar process 4160, mandibular notch 4162, uncinate process 4164, lesser lingula 4166, mylohyoid groove 4168, sublingual fossa 4170, mylohyoid line 4171, and submandibular fossa 4172 are also shown.

[0319]

[0412] Figures 42A and 42B show left and front views of the facial bones and skull, respectively. It will be understood that various embodiments of the support pads for the durometer, with different shapes, sizes, contours, structures, and other features, may be designed to interact with one or more specific anatomical structures, as these structures are capable of withstanding the forces introduced during vasoconstriction therapy. As an example, and not an limitation, one or more or an array of support pads may be fitted, contoured, and configured to engage with one or more of the following: the frontal bone 4201, the zygomatic bone 4203, the maxilla 4206 having the infraorbital foramen 4206A and the anterior nasal spine 4206B, the mandible 4204 having the mental foramen 4204A and the mandibular ramus 4202, and the sphenoid bone 4208 having the greater wing 4208A and the lesser wing 4208B, the lacrimal bone 4210, the temporal bone 4212, the nasal bone 4214, the vomer 4216, the inferior nasal concha 4218, and the ethmoid bone 4220 including the orbital plate 4220A, the middle nasal concha 4220B, and the vertical plate 4220C. Other combinations are also possible, and the pad may be configured to engage with one or more regions of the bone shown in Figure 41 or Figures 42A-42B, and to distribute force across one or more regions of the bone. For example, Figure 42A shows a left lateral view of the bones of the face and skull, and herein are shown the occipital bone 4254, the temporal bone 4212 with the external auditory canal 4212A, the parietal bone 4252, the sphenoid bone 4208 with the coronal suture 4256 and greater wing 4208A, the frontal bone 4201, the ethmoid bone 4220 including the orbital plate 4220A, the nasal bone 4214, the lacrimal bone 4210, the zygomatic bone 4203, the maxilla 4206 with the infraorbital foramen 4206A and anterior nasal spine 4206B, the mental foramen 4204A, the mandibular ramus 4202, and the uncinate process 4204B. The support pads may also be contoured and customized to match variations in the patient's facial bones, facial muscles, and fat pads.

[0320]

[0413] Figure 43 shows an exemplary graphical user interface (GUI) 4300 for controlling pressure in the head cover and face cover. The user may intuitively interact with the GUI 4300 via the display 4301 of a smartphone or controller 4302 to select an inflatable liner 4302A or one or more facepiece styles 4302B. The user may then adjust the amount of counteracting pressure applied by the vascular compression system using + / - or up, down arrows, or increase, decrease icons 4303. Settings may exist to control the range or amount of increase or decrease for patient safety. In addition, the system may control the amount of adjustment to ensure that vascular compression to the scalp and eyebrow area is maintained.

[0321]

[0414] Figure 44 shows an exemplary graphical user interface (GUI) 4402 for controlling individual tiles in a face cover. In this example, the user has a selected tile 2 4402A. In this interface, a + icon 4402B may be used to increase the pressure applied by tile 2 4402A. A - icon 4402C may be used to decrease the pressure applied by tile 2 4402A.

[0322]

[0415] Figure 45 is a block diagram of an exemplary computer controller for operating a system combining chemotherapy and vascular compression therapy. The vascular compression control system 4502 includes computer components, memory, and interfaces suitable for the interaction and control of sensors, valves, pressure sources 4502A, and other elements of an inflatable liner. In addition, the system also interacts with each of the tile elements on the facepiece and controls their positioning, for example, via individual tile sensors and tile motion controllers 4502B. It will be understood that the system may operate in a mode that follows the previous user session and settings / session history 4502F, or in a mode (user select) 4502F that allows the user to control throughout the entire session. In addition, or optionally, the system may operate in a combined mode, with an automated program running, along with interaction with the patient for fine-tuning of pressure intervals or to indicate where adjustments are needed, and such adjustments may be incorporated into subsequent interval adjustments. The chemotherapy control system 4503 interacts with the chemotherapy delivery system 4504 described in Figures 1A to 3B to deliver prescribed medications according to a desired protocol. The system may also be used to automate all or part of the steps of Method 1500 or 3700. A patient or healthcare worker may interact with the system in Figure 45 using exemplary interfaces such as those in Figures 43 and 44, or other suitable interfaces including voice, mouse, or other computer interfaces suitable for the purpose of providing interaction between the patient and the system 4505 combining vascular compression and chemotherapy.

[0323]

[0416] In addition, the system shown in Figure 45 may provide and receive from the patient electronic medical record information (EMR) 4502F regarding the patient's prescription 4502F, therapy 4502F, session duration, and session history 4502F, or other information used by the control system to accurately deliver chemotherapeutic agents and perform chemotherapy procedures.

[0324]

[0417] Figures 37A, 38B, 44, and 45 are some examples of embodiments that provide a wide range of variations for adjusting fit and providing comfort. One or more of the adjustable or user-determined embodiments, such as a variable positioning platform at the top of the helmet, internal pressure of the balloon liner / bladder, individual straps around the facepiece, and user / patient-customizable adjustable tiles inside the facepiece (see Figures 20–25), as well as the overall shape and size of the facepiece, may be used alone or in combination to provide comfort or to adjust the application of force used to induce vascular compression. Other adjustable structures may include an additional band 3808A (see Figure 38B), along with adjustments via a controller (see Figures 43, 44), manually (see Figure 45), or a combination thereof.

[0325]

[0418] Figures 46A and 46B are block diagrams showing comfortable ways to wear headgear to protect against hair loss during chemotherapy.

[0326]

[0419] Methods 4600-4601 begin with block 4605 in Figure 46A, in which a helmet with a facepiece attached via multiple straps is positioned over the user's head and face.

[0327]

[0420] Next, in block 4610, methods 4600-4601 continue by adjusting multiple straps to form contact between multiple tiles of the facepiece and the user's face.

[0328]

[0421] Next, in block 4615, the helmet's balloon liner is inflated.

[0329]

[0422] Methods 4600-4601 involve continuing to adjust (i) pressure from contact between multiple tiles and the user's face, (ii) pressure from the helmet's inflated balloon liner onto the user's head, and (iii) one or more of the multiple straps until vascular compression of the blood supply to the user's hair follicles is achieved in block 4620.

[0330]

[0423] In block 4625, methods 4600-4601 continue to describe initiating a chemotherapy session for the user.

[0331]

[0424] Methods 4600-4601 continue to adjust, for the comfort of the user during a chemotherapy session, the pressure from contact between multiple tiles and the user's face, the pressure on the user's head from the helmet's inflated balloon liner, and one or more of the multiple straps, as shown in block 4630 of Figure 46B.

[0332]

[0425] Figures 47A and 47B are block diagrams showing alternative methods for comfortably wearing headgear to protect against hair loss during chemotherapy (4700–4701).

[0333]

[0426] Methods 4700-4701 begin in block 4705 of Figure 47A, where a helmet with a facepiece and headband attached is positioned over the user's head and face via multiple straps.

[0334]

[0427] Next, in block 4710, methods 4700-4701 continue to adjust multiple straps so as to form contact between (i) multiple tiles of the facepiece and the user's face, and (ii) the circumference of the headband and the user's head.

[0335]

[0428] Next, in block 4715, the helmet's balloon liner is inflated.

[0336]

[0429] Methods 4700-4701 continue to adjust (i) pressure from contact between multiple tiles and the user's face, (ii) pressure from the helmet's inflated balloon liner onto the user's head, and (iii) one or more of the multiple straps until vascular compression of the blood supply to the user's hair follicles is achieved in block 4720.

[0337]

[0430] In block 4725, methods 4700-4701 continue to initiate a chemotherapy session for the user.

[0338]

[0431] Methods 4700-4701 continue to adjust, for the comfort of the user during a chemotherapy session, the pressure from the contact between the multiple tiles and the user's face, the pressure exerted on the user's head from the helmet's inflated balloon liner, and one or more of the multiple straps, as shown in block 4730 of Figure 47B. In additional alternative embodiments, any of the vascular compression head covers illustrated and described in relation to Figures 9, 10A, 10B, 10C, 11A, 11B, 12A, and 12D may be used according to the method of applying vascular compression reaction force shown in Figures 21A-21D. In addition, or optionally, these embodiments may also be adapted for use with a rigid mandibular support shown in Figures 16 and 17, a full-face support shown in Figures 18-20, or one embodiment of the reaction force support base shown in Figures 22-25.

[0339]

[0432] For convenience, many different embodiments have been described as using a nylon strap connected between two components and then adjusted using a conventional D-ring arrangement to adjust patient comfort. Various embodiments of the present invention are not limited in this way. It will be understood herein that the strap may also include other configurations of the connector used to maintain the relative position between two components of the system. Thus the strap may also include elastic bands, non-elastic bands, and springs, in different forms, either together with or in combination with other elements, that connect to the two components and fill the gap between them.

[0340]

[0433] Further details regarding potentially suitable additional materials, the head cover, shell, head cover retention features, or the structure of one or more vascular compression elements will be understood by referring to U.S. Patent No. 3,242,500 by Derr.

[0341]

[0434] Further details regarding potentially suitable additional materials, structural details of the head cover, shell, head cover retention features, or one or more vascular compression elements will be understood by referring to U.S. Patent No. 9,743,701 by Javorek. Additional and alternative embodiments for use with one or more embodiments of the head cover retention system are described herein, along with details relating, for example, to hook and loop fasteners, buckles, quick-release mechanisms, or adjustment features, as described and illustrated.

[0342]

[0435] Further details regarding the addition of potentially suitable materials and the structure of one or more vascular compression elements will be understood by referring to U.S. Design Patent No. 267,287 by Gooding.

[0343]

[0436] Further details regarding potentially suitable additional materials, structural details of the head cover, shell, head cover retaining features, or one or more vascular compression elements will be understood by referring to U.S. Patent Application Publication No. 2006 / 0070170 by Copeland.

[0344]

[0437] Further details regarding potentially suitable complementary compounds that may be used in combination with the devices and methods described herein, as well as information relating to the treatment of chemotherapy-induced alopecia, will be understood by referring to U.S. Patent Application Publication No. 2019 / 0240192 by Georgopoulos.

[0345]

[0438] In addition to those listed above, further additional alternative embodiments and combinations of the innovative features described herein are possible to deliver the effective personalized vascular compression therapy described herein, for example, as follows:

[0346]

[0439] Selective vascular compression of major parts of the blood supply to the scalp, including programmed sequences that apply compression to empty the capillary bed or block the major blood vessels of the scalp / skull.

[0347]

[0440] In one embodiment, the head cover is configured to include a pair of separate vascular compression elements, such as one inside the shell along the periphery of the head cover or shell and other vascular compression elements. In one example, this arrangement would be a peripheral vascular compression section and a central vascular compression section. It will be understood that these sections may be operated at different levels of pressure or amount of vascular compression by manual control or via the use of controllers 980 / 1090 (from Figures 9 to 10A, respectively). To deliver vascular compression therapy more precisely, these exemplary peripheral and central sections may be further divided, or additional other sections may be provided and incorporated into the head cover. In addition, or optionally, these sections may be operated at different pressures or levels of vascular compression as pre-selected or as needed to deliver a specific vascular compression therapy profile to the patient.

[0348]

[0441] A single device for prophylactic vascular compression of all hair on the head, which is advantageous for protecting both scalp hair and eyebrows. For this purpose, eyebrow inclusion may be provided by positioning, sizing, and fitted additional vascular compression elements (see, for example, Figures 10A and 11A).

[0349]

[0442] A specially fitted vascular compression device configured to conform to the patient's specific head shape and hairstyle. Additional embodiments include the use of 3D imaging or scanning of the patient's head and hairstyle, including the hairstyle used during chemotherapy sessions, to ensure the fit of the liner and shell for patient comfort and performance during vascular compression therapy sessions.

[0350]

[0443] Advanced and effective control and / or feedback of vascular compression control systems 980 / 1090 (from Figures 9 to 10A, respectively) by integrated pressure sensors and other detection devices located inside / integrated with the vascular compression device, including integration into a liner, expandable layer, or shell, including stretch, strain, or other measurement systems integrated into one or more components of a head cover 1000 (from Figure 10A) for inducing vascular compression in a patient.

[0351]

[0444] Embodiments of a personal vascular compression device may include one or more pressure sensors inside a head cover. One or more pressure sensors can provide pressure indications to a control system 180 / 190. One or more pressure sensors can be adapted to indicate the amount of pressure applied to a patient receiving chemotherapy while the patient is wearing the head cover. The head cover may further include one or more sensors for measuring skin perfusion (O2 saturation) or monitoring Doppler blood flow or sensing with an infrared pulse oximeter.

[0352]

[0445] The inner liner (behind the patient) may be a rigid or semi-elastic layer configured for a tight fit for the patient, so as to fit snugly to the shape of the patient's head and hair. The head cover retention system may include a tightening system. The head cover may further include one or more selective pressure points positioned to compress one or more vessels of the patient's cranial circulatory system. The head cover may further include a vibrating element coupled to the liner or at least one vascular compression element. The liner and at least one vascular compression element may be sized, shaped, or positioned relative to the head cover based on the patient's hairstyle.

[0353]

[0446] The head cover may further include a fluid source containing a liquid or gas, communicating with the liner or at least one vascular compression element, to inflate a portion of the liner or a portion of at least one vascular compression element. The head cover may further include at least one relief valve to prevent overpressure of the inflatable elements of the head cover. The fluid source may be a manual pump mechanism, a valve, an electric pump, or a pressurized tank, cartridge, or reservoir. The head cover may further include a control system 980 / 1090 (from Figures 9 to 10A, respectively) for regulating the flow of fluid from the fluid source to maintain a desired pressure inside the head cover. The desired pressure inside the head cover may be sufficient to produce a vascular compression result while minimizing patient discomfort or side effects or damage to surrounding structures.

[0354]

[0447] The head cover may further include a cooling fluid source communicating with a liner or at least one vascular compression element, wherein a portion of the liner or at least one portion of the vascular compression element is adapted to provide cooling to the interior of the head cover. In addition, the fluid used to inflate the vascular compression element may also be cooled. The head cover may further include one or more pressure sensors inside the head cover. One or more pressure sensors can provide pressure indications to control systems 980 / 1090 (from Figures 9 to 10A, respectively). One or more pressure sensors can be adapted to indicate the amount of pressure applied to a patient receiving chemotherapy when the patient is wearing the head cover.

[0355]

[0448] The personal vascular compression system may also include advanced communication connectivity. As a result of this feature, the user may use a personal vascular compression device with features found in smart devices while receiving therapy. In addition, noise-canceling headphones or earphones may be provided to enhance the user experience. The system may also include a display and Bluetooth, short-range, or other wireless or wired communication capabilities. Furthermore, the system may communicate status, programming, patient information or data, and / or any vascular compression device data relating to any other aspect of vascular compression therapy or surgery to an internal storage device, mobile phone, communication network, remote network, or health information system. In yet another embodiment, the display may be positioned on the head cover to provide information to the healthcare provider or patient. In an additional embodiment, the head cover may also include earphones, headphones, speakers, or other audio components adjacent to the patient's ears. In these embodiments, the system is also configured to provide noise cancellation, music, media, or other entertainment to the patient undergoing chemotherapy or using the head cover. The head cover embodiment may be powered externally by plugging it into a suitable power source, or it may be powered wirelessly by using a built-in battery system or a built-in rechargeable battery system.

[0356]

[0449] Since the use of various vascular compression devices and techniques is intended to protect and maintain hair, it will be understood that the configurations of the head cover 1000 (from Figure 10A) components are modified and adapted to the presence of the patient's hair 107 (from Figure 1A). In additional or alternative embodiments, additional liners or modified vascular compression elements may include specific additional conforming areas to correspond conformally to higher areas in the skull as well as areas where hair is collected or arranged during the use of the head cover 1000. In particular, the design and use of the head cover 1000 in the delivery of vascular compression therapy results in a situation where the patient's hair, volume, hairstyle, and placement relative to one or more vascular compression elements / manifolds 1330 (from Figure 13D) compresses the hair (non-compressible), which then compresses the scalp, thereby contributing to vascular compression of the vascular structure.

[0357]

[0450] In addition, or optionally, one or more surfaces of one or more vascular compression elements may be modified by a wide range of different cross-sectional shapes and apical protrusions, or to have projections of different lengths, to correspond to different areas or points of specific shape of the patient's skull, even within areas that are not uniform in surface area and the surrounding area, provided the treatment is appropriate. In addition, combinations of liner features, vascular compression element features, and the composition and arrangement of the patient's hair may also be used to accommodate the patient's specific cranial topography and shape to improve the operation of the head cover and the patient's specific performance and comfort.

[0358]

[0451] According to various embodiments, the adjustment cycle during chemotherapy treatment is a trade-off between pressures within the balloon liner / bladder for different parts of the face and head. User / patient or support or pressure compensation programs (Figures 43, 44, and 45) may be used alone or in combination with tightening or loosening one or more straps between the helmet and facepiece, or between the helmet and facepiece and intermediate pressure straps such as strap 3808A connected to headband 3808H (Figure 38B), along with adjusting the stiffness or softness of one or more face styles or adjustable face styles (see Figures 20–25).

[0359]

[0452] Various embodiments are intended to provide distraction and comfort to patients receiving treatment and wearing a helmet. Discomfort resulting from inducing vascular compression may be provided in various different ways, including by manipulating different components of the system, moving or adjusting the helmet relative to the support structure (Figures 21A-22D), as well as by individual or local adjustments of the helmet straps, tiles, or pressure adjustments.

[0360]

[0453] In this specification, when a feature or element is described as being located "on top of" another feature or element, it may mean that there are features and / or elements that can directly contact or interpose with the other feature or element. In contrast, when a feature or element is described as being located "directly on top of" another feature or element, there are no interposing features or elements. When a feature or element is described as being "connected," "attached," or "joined" to another feature or element, it will also be understood that it may mean that there are features or elements that can directly connect, attach, or combine with the other feature or element, or that there are interposing features or elements. In contrast, when a feature or element is described as being "directly connected," "directly attached," or "directly joined" to another feature or element, there are no interposing features or elements. Although described or illustrated in relation to one embodiment, features and elements described or illustrated in this way may also be applicable to other embodiments. It will also be understood by those skilled in the art that a reference to a structure or feature located "adjacent" to another feature may mean that there are portions that overlap with or lie beneath the adjacent feature.

[0361]

[0454] The terminology used herein is intended solely to describe specific embodiments and is not intended to limit the invention. For example, unless otherwise explicitly indicated by the context, singular “a,” “an,” and “the” are intended to include plural forms as well. The terms “comprises” and / or “comprising,” when used herein, specify the presence of the described features, steps, actions, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, actions, elements, components, and / or groups thereof. In this specification, the term “and / or” includes any combination of one or more of the items listed in relation, and may be abbreviated as “ / .”

[0362]

[0455] Spatially relative terms such as “under,” “below,” “lower,” “over,” and “upper” may be used herein to facilitate descriptions of the relationship between one element or feature shown in a figure and another element or feature. It will be understood that spatially relative terms are intended to encompass not only the orientation shown in the figure but also different orientations of the device in use or operation. For example, if the device in the figure is inverted, an element described as being located “under” or “beneath” another element or feature should be oriented “over” the other element or feature. Thus, the exemplary term “under” can encompass both over and under orientations. The device may be oriented in other ways (rotated 90 degrees or in other directions), and the spatially relative descriptive terms used herein will be interpreted accordingly. Similarly, unless otherwise specifically indicated, terms such as “upwardly,” “downwardly,” “vertical,” and “horizontal” are used herein for descriptive purposes only.

[0363]

[0456] The terms “first” and “second” may be used herein to describe various features / elements (including steps), but unless otherwise indicated in the context, these features / elements should not be limited by these terms. These terms may also be used to distinguish one feature / element from another. Thus, without departing from the teachings of the invention, the first feature / element discussed below may also be called the second feature / element, and similarly, the second feature / element discussed below may also be called the first feature / element.

[0364]

[0457] Throughout this specification and the following claims, unless otherwise required by context, the word “comprise,” and variations such as “comprises” and “comprising,” mean that various components may be used together in methods and articles (e.g., compositions and apparatus including devices and methods). For example, the term “comprising” will be understood to suggest the inclusion of any described element or step, rather than the exclusion of any other element or step.

[0365]

[0458] In this specification and in the claims, unless otherwise expressly designated, including when used in examples, all numbers may be read as if preceded by the words “about” or “approximately,” even when the term is not expressly stated. The phrases “about” or “approximately” may be used to indicate that a stated value and / or location is within a reasonable predictable range of the value and / or location when describing size and / or location. For example, a number may have values ​​such as ±0.1% of the stated value (or range of value), ±1% of the stated value (or range of value), ±2% of the stated value (or range of value), ±5% of the stated value (or range of value), ±10% of the stated value (or range of value), etc. Any number described herein should also be understood to include its value about or approximately unless otherwise indicated in the context. For example, if the value “10” is disclosed, “about 10” is also disclosed. Any numerical range described herein is intended to include all subranges within that range. Those skilled in the art will understand that when a value is disclosed, it is also understood that it is "less than or equal to" that value, "greater than or equal to" that value, and the possible range between values. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (for example, if X is a number) are also disclosed. Throughout this application, data is provided in multiple different forms, and it is also understood that this data represents a range of endpoints and starting points, as well as any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it will be understood that it is disclosed that they are greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than or equal to 10 and 15, equal to 10 and 15, and between 10 and 15. It will also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0366]

[0459] While various illustrative embodiments are disclosed above, any of several modifications can be made to these embodiments without departing from the scope of the invention as described in the claims. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional functions of the various device and system embodiments may be included in some embodiments but not in others. Therefore, the above description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as described in the claims.

[0367]

[0460] The examples and illustrations included herein are illustrative and not limiting to specific embodiments that can carry out the subject matter. As stated above, other embodiments are also available and can be derived therefrom, allowing for structural and logical substitutions and modifications without departing from the scope of this disclosure. Such embodiments of the subject matter of the present invention may be referred to herein, individually or collectively, as “inventions,” simply for convenience, without intending to spontaneously limit the scope of this application to any single invention or inventive concept when multiple inventions or inventive concepts are actually disclosed. Thus, while specific embodiments are illustrated and described herein, any configuration intended to achieve the same objective may be used in place of the specific embodiments shown. This disclosure is intended to cover all modifications or variations of various embodiments. Combinations of the embodiments described above and other embodiments not specifically described herein will be apparent to those skilled in the art upon consideration of the above description.

Claims

1. A head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, A shell having a front edge, a rear edge, a apex, a left edge, and a right edge, A liner located inside the shell and shaped to contain at least partially the patient's hair, At least one vascular compression element located inside the shell or liner, A full-face support structure surrounds the mandibular body and mandibular ramus, extending to at least partially cover them across the zygomatic, maxillary, and frontal bones of the patient's skull, and having openings within the full-face support structure for the patient's eyes, nose, and mouth, Head cover retention system, A cushion positioned between the inner wall of the full-face support and the patient, along the inner wall of the full-face support, A head cover comprising one or more straps positioned between the head cover and the full-face support.

2. The aforementioned cushion, The head cover according to claim 1, further comprising a plurality of tile face cushions arranged along the inner wall of the full face support, wherein the size, shape, hardness, and compression coefficient characteristics of each of the plurality of tile face cushions may be selected based on its location inside the full face support and the load characteristics of that location while vascular compression therapy is being delivered.

3. A plurality of tile face cushions arranged along the inner wall of the full face support, wherein each of the plurality of tile face cushions is provided with a post, A plurality of openings located inside the full-face support, wherein the location of each opening is adapted and configured to correspond to a post of a tile face cushion adjacent to the opening, and The head cover according to claim 1, further comprising:

4. The one or more straps mentioned above At least two front support straps extending from the front edge of the shell to the top edge of the full-face support, or At least two right-side support straps extending from the right side of the full-face support structure to the right side of the shell, or The head cover according to claim 1, further comprising at least two left-side support straps extending from the left side of the full-face support structure to the left side of the shell, or any combination thereof.

5. The head cover according to claim 1, wherein the liner is an expandable liner.

6. The head cover according to claim 5, wherein the inflatable liner has an internal section of the liner and an external section for engaging with the patient.

7. The head cover according to claim 6, wherein a separation section is provided between the internal section and the external section, and the separation section forms a perimeter corresponding to the perimeter of the shell.

8. The head cover according to claim 6, wherein the separation section maintains its shape during the expansion and contraction of the expandable liner.

9. The head cover according to claim 3, wherein each of the plurality of tile face cushions comprises an inner surface contoured to fit a portion of the face, an outer surface contoured to engage with a portion of the full face support, and an intermediate portion between the inner surface and the outer surface.

10. The head cover according to claim 9, wherein the intermediate portion of each face tile is one or a combination of gel, foam, silicone, uniform durometer material, mixed durometer material, or expansion section.

11. The head cover according to claim 9, wherein each face tile has a post for aligning each face tile with a corresponding opening in the full face cover.

12. The head cover according to claim 9, wherein each face tile has a shaft and knob for mechanically adjusting the distance from the inner surface of the full face cover to the inner surface of the face tile, or a valve for adjusting the pressure inside the face tile.

13. A head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, A shell having a front edge, a rear edge, a apex, a left edge, and a right edge, An expandable liner located inside the aforementioned shell, A head cover retaining system adapted to maintain the position of the shell and the inflatable liner relative to the patient's head, A face cover attached to the aforementioned shell, A head cover comprising at least one pad support located inside the face cover.

14. The device according to claim 13, wherein the face cover includes a plurality of connection points that provide access for a plurality of support pads located inside the face cover.

15. The device according to claim 14, wherein the at least one pad support is a plurality of individual pads that are fitted and configured to be at least partially conformal to the bone structure of the patient.

16. The device according to claim 15, wherein the plurality of individual pads are controllable when applying pressure to a portion of the patient's face using a mechanical adjustment system.

17. The device according to claim 15, wherein the plurality of individual pads are controllable when applying pressure to a portion of the patient's face using an electronic adjustment system.

18. The device according to claim 17, wherein the electronic adjustment system further comprises a time-based or user-selectable program for increasing or decreasing the pressure applied by the pad to a portion of the patient's face.

19. The device according to claim 18, wherein the user selection program is controlled using a control interface, remote device, smart device, or app selected by the user, based on a pre-set pressure setting, previous chemotherapy session, or time-based adjustments to alleviate intermittent fatigue while using the vascular compression device.

20. The head cover according to any one of claims 13 to 19, further comprising a vascular compression reaction structure, wherein the vascular compression reaction structure is a ring having an inner diameter of 2.54 cm (1 inch) to 10.16 cm (4 inches).

21. The head cover according to claim 20, wherein the vascular compression reaction structure has a frustoconical shape having a base having an outer diameter of 15.24 cm (6 inches) to 20.32 cm (8 inches) and an upper surface having a ring having a diameter of 2.54 cm (1 inch) to 10.16 cm (4 inches).

22. The head cover according to claim 20, wherein the vascular compression reaction structure has a base, a core, and an upper support surface, and the diameter of the base is 2.54 cm (1 inch) to 7.62 cm (3 inches).

23. The head cover according to claim 20, wherein the vascular compression reaction structure has a base, an elongated core, and a rectangular upper support surface.

24. The head cover according to claim 20, wherein the vascular compression reaction structure has a truncated cone shape, an elongated spindle having a base with an outer diameter of 15.24 cm (6 inches) to 20.32 cm (8 inches) and an upper ring supporting the base, and an upper support surface.

25. A head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, A shell having a front edge, a rear edge, a apex, a left edge, and a right edge, The shell comprises at least one vascular compression element located inside the shell, A head cover retaining system adapted to maintain the position of the shell and liner relative to the patient's head, A head cover comprising a vascular compression reaction structure coupled to the aforementioned shell.

26. The head cover according to claim 25, wherein the vascular compression reaction force structure is a ring having an inner diameter of 2.54 cm (1 inch) to 10.16 cm (4 inches).

27. The head cover according to claim 25, wherein the vascular compression reaction structure has a frustoconical shape with a base having an outer diameter of 15.24 cm (6 inches) to 20.32 cm (8 inches) and an upper surface having a ring with a diameter of 2.54 cm (1 inch) to 10.16 cm (4 inches).

28. The head cover according to claim 25, wherein the vascular compression reaction structure has a base, a core, and an upper support surface, and the diameter of the base is 2.54 cm (1 inch) to 7.62 cm (3 inches).

29. The head cover according to claim 25, wherein the vascular compression reaction structure has a base, an elongated core, and a rectangular upper support surface.

30. The head cover according to claim 25, wherein the vascular compression reaction structure has a truncated cone shape, an elongated spindle having a base with an outer diameter of 15.24 cm (6 inches) to 20.32 cm (8 inches) and an upper ring supporting the base, and an upper support surface.

31. A head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, A shell having a front edge, a rear edge, a apex, a left edge, and a right edge, A liner located inside the shell and shaped to contain at least partially the patient's hair, The shell comprises at least one vascular compression element located inside the shell, A submandibular rigid support extending from the left side of the mandibular body, around the mental protuberance, to the right side of the mandibular body. A head cover holding system equipped with, A cushion located in the submandibular rigid support, A left anterior support strap extending from the anterior edge of the shell to the submandibular rigid support, A right anterior support strap extending from the anterior edge of the shell to the submandibular rigid support, A left-side support strap extending from the left-side edge of the shell to the left end of the submandibular rigid support, A head cover comprising a right-side support strap extending from the right-side edge of the shell to the right end of the submandibular rigid support.

32. The head cover according to claim 31, wherein the cushion extends over the submandibular rigid support and beyond the left and right ends of the submandibular rigid support.

33. The head cover according to claim 31, wherein the cushion is a foamed filler located inside the structure of the submandibular rigid support.

34. The head cover according to claim 31, wherein the submandibular rigid support extends from a position close to the left corner of the mandible, along the left side of the mandibular body, around the mental protuberance, and along the right side of the mandibular body to a position close to the right corner of the mandible.

35. A head cover according to any one of claims 31 to 34, further comprising a vascular compression reaction force structure according to any one of claims 25 to 30, having a dynamic facepiece according to any one of claims 13 to 24.

36. A head cover according to any one of claims 1 to 12, further comprising a vascular compression reaction force structure according to any one of claims 25 to 30, or a dynamic facepiece according to any one of claims 13 to 24.

37. The head cover according to any one of claims 1 to 34, wherein the head cover retention system comprises one or more of a rear strap, a front strap, or a neck strap connected to the shell.

38. The head cover according to claim 37, wherein the shell retaining system comprises one or more adjustment elements.

39. The head cover according to claim 37, wherein the at least one vascular compression element is an expandable bladder located inside the liner.

40. The head cover according to claim 37, wherein the at least one vascular compression element is coupled to the shell.

41. The head cover according to claim 39, further comprising a pressure source in communication with the expandable bladder.

42. The head cover according to claim 37, further comprising a continuous perimeter connecting the front edge, the rear edge, the left edge, and the right edge.

43. The head cover according to claim 37, wherein the at least one vascular compression element further comprises an expandable feature such that it expands away from the shell in response to a pressure source.

44. The head cover according to claim 37, further comprising an expandable layer bonded to the liner, wherein the at least one vascular compression element is located in the expandable layer.

45. The head cover according to claim 37, wherein the at least one vascular compression element further comprises one or more raised features.

46. The head cover according to claim 37, wherein the liner, located inside the shell and shaped to at least partially accommodate the patient's hair, further comprises one or more features for engaging with the patient's hair.

47. The head cover according to claim 37, wherein the liner or the at least one vascular compression element is smooth.

48. The head cover according to claim 37, wherein the liner or the at least one vascular compression element comprises an array of uniformly distributed protrusions having a linear or circular inflatable structure.

49. The head cover according to claim 37, wherein the head cover retaining system further comprises hook and loop fasteners, buckles, quick-release mechanisms, or adjustment features.

50. The head cover according to any one of claims 1 to 34, further comprising a gas source communicating with the liner or the at least one vascular compression element for inflating a portion of the liner or a portion of the at least one vascular compression element.

51. The head cover according to claim 50, further comprising at least one relief valve for preventing overpressure of the inflatable element of the head cover.

52. The head cover according to claim 50, wherein the gas source is a manual pump mechanism, a valve, an electric pump, or a pressurized tank, cartridge, or reservoir.

53. The head cover according to claim 50, further comprising a control system for adjusting the flow of gas from the gas source to maintain a desired pressure inside the head cover.

54. The head cover according to claim 53, wherein the desired pressure inside the head cover is sufficient to produce a vascular compression result while minimizing discomfort or side effects or damage to surrounding structures in the patient.

55. The head cover according to claim 50, further comprising a cooling gas source communicating with the liner or the at least one vascular compression element, wherein a portion of the liner or a portion of the at least one vascular compression element is adapted to provide cooling inside the head cover.

56. The head cover according to claim 50, further comprising one or more pressure sensors inside the head cover.

57. The head cover according to claim 56, wherein one or more pressure sensors provide a pressure signal to the control system according to claim 19.

58. The head cover according to claim 56, wherein one or more pressure sensors are adapted to indicate the amount of pressure applied to a patient receiving chemotherapy when the patient is wearing the head cover.

59. Skin perfusion (O ２ The head cover according to claim 50, further comprising one or more sensors for measuring saturation, monitoring Doppler blood flow, sensing an infrared pulse oximeter, or confirming that blood flow in a blood vessel under compression has been sufficiently stopped or slowed.

60. The head cover according to any one of claims 1 to 34, further comprising a continuous structure from the occipital region to the eyebrows or forehead.

61. The head cover according to claim 60, further comprising a structure for compressing the eyebrows or an inflatable structure for compressing the blood vessels in the eyebrows.

62. The head cover according to claim 60, further comprising a timer and a control system, wherein the timer and control system are adapted to provide an auto-contraction protocol to stop the operation of a vascular compression element when the timer has elapsed or in any active state.

63. The head cover according to claim 60, further comprising a timer and control system adapted for programmed automatic inflation and deflation of the liner or the one or more vascular compression elements, or for activation and deactivation of the one or more vascular compression elements.

64. The head cover according to claim 60, wherein the liner is a rigid or semi-elastic layer configured for a tight fit for the patient so as to fit tightly to the shape of the patient's head and hair.

65. The head cover according to claim 64, wherein the head cover holding system comprises a tightening system.

66. The head cover according to claim 60, further comprising one or more selective pressure points positioned to compress one or more vessels of the patient's cranial circulatory system.

67. The head cover according to claim 60, further comprising a vibrating element coupled to the liner or the at least one vascular compression element.

68. The head cover according to claim 60, wherein the liner and the at least one vascular compression element are sized, shaped, or positioned relative to the head cover based on the patient's hairstyle.

69. A head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, A cap having a front edge, a rear edge, a top, a left edge, and a right edge, A liner located inside the cap and shaped to contain at least partially the patient's hair, A head cover comprising at least one vascular compression element located inside the cap.

70. The head cover according to claim 69, wherein the liner further comprises a first layer adjacent to the inner surface of the cap, a second layer fitted and configured to engage with the patient's head, and a separation section separating the first layer from the second layer, the separation section having a perimeter corresponding to the edge of the cap.

71. The head cover according to claim 69, wherein the cap comprises a flexible structure, a partially flexible structure, a combination of a semi-rigid structure and a flexible structure, or an adjustable structure, sized to remain in a fixed position on the head when the at least one vascular compression element is active.

72. The head cover according to claim 69, wherein the at least one vascular compression element is an expandable bladder located inside the cap or the liner.

73. The head cover according to claim 69, wherein the at least one vascular compression element is coupled to the cap or the liner.

74. The head cover according to any one of claims 69 to 73, further comprising a pressure source communicating with the expandable bladder or the at least one vascular compression element.

75. The head cover according to claim 69, further comprising a continuous perimeter connecting the front edge, the rear edge, the left edge, and the right edge.

76. The head cover according to claim 69, further comprising an expandable feature such that the at least one vascular compression element expands away from the cap in response to a pressure source.

77. The head cover according to claim 69, further comprising an expandable layer bonded to the liner, wherein the at least one vascular compression element is located in the expandable layer.

78. The head cover according to claim 69, wherein the at least one vascular compression element further comprises one or more raised features.

79. The head cover according to claim 69, wherein the liner, located inside the shell and shaped to at least partially accommodate the patient's hair, further comprises one or more features for engaging with the patient's hair.

80. The head cover according to claim 69, wherein the liner or the at least one vascular compression element is smooth.

81. The head cover according to claim 69, wherein the liner or the at least one vascular compression element comprises an array of uniformly distributed protrusions having a linear or circular inflatable structure.

82. The head cover according to claim 69, further comprising a gas source communicating with the liner or the at least one vascular compression element for inflating a portion of the liner or a portion of the at least one vascular compression element.

83. The head cover according to claim 82, further comprising at least one relief valve for preventing overpressure of the inflatable element of the head cover.

84. The head cover according to claim 82, wherein the gas source is a manual pump mechanism, a valve, an electric pump, or a pressurized tank, cartridge, or reservoir.

85. The head cover according to claim 82, further comprising a control system for adjusting the flow of gas from the gas source to maintain a desired pressure inside the head cover.

86. The head cover according to claim 85, wherein the desired pressure inside the head cover is sufficient to produce a vascular compression result while minimizing discomfort or side effects or damage to surrounding structures for the patient.

87. The head cover according to claim 69, further comprising a cooling gas source communicating with the liner or the at least one vascular compression element, wherein a portion of the liner or a portion of the at least one vascular compression element is adapted to provide cooling inside the head cover.

88. The head cover according to claim 69, further comprising one or more pressure sensors inside the head cover.

89. The head cover according to claim 88, wherein one or more pressure sensors provide a pressure signal to the control system according to claim 50.

90. The head cover according to claim 88, wherein one or more pressure sensors are adapted to indicate the amount of pressure applied to a patient receiving chemotherapy when the patient is wearing the head cover.

91. Skin perfusion (O ２ The head cover according to claim 69, further comprising one or more sensors for measuring saturation, monitoring Doppler blood flow, or sensing an infrared pulse oximeter.

92. The head cover according to claim 69, further comprising a continuous structure from the occipital region to the eyebrows or forehead.

93. The head cover according to any one of claims 69 to 72, further comprising a structure for compressing the eyebrows or an inflatable structure for compressing the blood vessels in the eyebrows.

94. The head cover according to claim 69, further comprising a timer and a control system, wherein the timer and control system are adapted to provide an auto-contraction protocol to stop the operation of a vascular compression element when the timer has elapsed or when the vascular compression element is in any active state.

95. The head cover according to claim 69, further comprising a timer and control system adapted for programmed automatic inflation and deflation of the liner, or for activation and deactivation of one or more vascular compression elements.

96. The head cover according to claim 69, wherein the liner is a rigid or semi-elastic layer configured for a tight fit for the patient so as to fit tightly to the shape of the patient's head and hair.

97. The head cover according to claim 96, wherein the head cover retaining system comprises a tightening system.

98. The head cover according to any one of claims 69 to 97, further comprising one or more selective pressure points positioned to compress one or more vessels of the patient's cranial circulatory system.

99. The head cover according to claim 98, further comprising a vibrating element coupled to the liner or the at least one vascular compression element.

100. A method for inducing vascular compression in the cranial circulatory system of a patient undergoing chemotherapy, The head cover is placed around the patient's head, Using the vascular compression element of the head cover, to induce vascular compression in at least partially a portion of the patient's cranial circulatory system, To induce a reaction force applied to the head cover, which is sized and induced to counteract at least a portion of the force introduced to the patient's head as a result of the step of at least partially inducing the vascular compression, To initiate chemotherapy sessions for the aforementioned patient, To complete the chemotherapy sessions for the aforementioned patient, A method comprising the step of inducing at least partial vascular compression in a portion of the cranial circulatory system of the patient, after a sufficient period of time has elapsed following the step of completing the chemotherapy session to partially mitigate the effects of chemotherapy-induced alopecia in the patient.

101. The method according to claim 100, wherein the step of inducing a reaction force applied to the head cover is carried out by the force acting directly on the shell of the head cover.

102. The method according to claim 100, wherein the step of inducing a reaction force applied to the head cover is carried out by the force acting on a vascular compression reaction force structure coupled to the shell of the head cover.

103. The method according to claim 100, further comprising engaging the head cover retaining system to secure the head cover to the head of the patient.

104. The method according to claim 100, wherein the period elapsed after the step of completing the chemotherapy session is a maximum of 24 hours.

105. The method according to claim 100, wherein the period elapsed after the step of completing the chemotherapy session is at least one hour.

106. The method according to claim 100, wherein the period elapsed after the step of completing the chemotherapy session is at least 48 hours.

107. The method according to claim 100, wherein the vascular compression element of the head cover is a liner, and during the step of inducing vascular compression at least partially in a portion of the cranial circulatory system of the patient, a step of expanding the liner or a step of contracting the liner is performed.

108. The method according to claim 107, wherein an increase in the amount of vascular compression occurs during the step of expanding the liner in response to an increase in the force of the liner on the scalp of the patient.

109. The method according to claim 107, wherein a decrease in the amount of vasoconstriction occurs during the step of contracting the liner in response to a decrease in the force of the liner on the scalp of the patient.

110. The method according to claim 100, wherein the vascular compression element of the head cover is a liner having one or more features, and during the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system, a step of expanding the liner or a step of contracting the liner is performed.

111. The method according to claim 110, wherein an increase in the amount of vascular compression occurs during the step of expanding the liner in response to an increase in the force applied to press one or more features of the liner against the scalp of the patient.

112. The method according to claim 110, wherein a reduction in the amount of vascular compression occurs during the step of contracting the liner in response to a reduction in the force pressing one or more features of the liner against the scalp of the patient.

113. The method according to claim 100, wherein the vascular compression element of the head cover is an inflatable bladder, and the degree of vascular compression in the step of at least partially inducing vascular compression in a portion of the cranial circulatory system of the patient at least partially corresponds at least partially to the amount of pressure inside the inflatable bladder.

114. The method according to claim 100, wherein the vascular compression element of the head cover is an inflatable bladder, and the degree of vascular compression in the step of at least partially inducing vascular compression in a portion of the cranial circulatory system of the patient is increased or decreased by increasing or decreasing the pressure in the inflatable bladder against the skull.

115. The method according to claim 100, wherein the vascular compression element of the head cover is one or more features located on the inner surface of the head cover that are brought into contact with a portion of the patient's scalp having hair follicles during the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system.

116. The method according to claim 100, wherein the vascular compression element of the head cover is one or more features disposed on the inner surface of the head cover corresponding to the composition of the patient's hair, and the one or more features act on the composition of the patient's hair to facilitate the carrying out of the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system.

117. The method according to claim 100, wherein, in the step of at least partially inducing the vascular compression, the vascular compression element of the head cover compresses a portion of the scalp containing a plurality of hair follicles against a portion of the skull, thereby at least partially compressing the blood supply to the plurality of hair follicles.

118. The method according to claim 117, wherein the portion of the skull is one or more of the superior temporal line, inferior temporal line, parietal bone, squamous suture, temporal bone, lambdoid suture, occipital bone, mastoid process, sphenoid bone, portion adjacent to the supraorbital foramen, frontal bone, and coronal suture.

119. The method according to claim 100, wherein, in the step of at least partially inducing the vascular compression, the vascular compression element of the head cover is positioned to at least partially compress an artery or vein of the patient's cranial circulatory system by compressing the artery or vein against a portion of the skull.

120. The method according to claim 119, wherein the artery or vein of the cranial circulatory system is a branch of the external carotid artery or a branch of the internal carotid artery.

121. The method according to claim 119, wherein the artery or vein of the cranial circulatory system is the ophthalmic artery.

122. The method according to claim 119, wherein the artery or vein of the cranial circulatory system is the superficial temporal artery.

123. The method according to claim 119, wherein the artery or vein of the cranial circulatory system is the posterior auricular artery.

124. The method according to claim 119, wherein the artery or vein of the cranial circulatory system is the occipital artery.

125. The method according to claim 119, wherein the artery or vein of the cranial circulatory system is a supraorbital artery or a supratrochlear artery.

126. The method according to claim 119, wherein the portion of the skull is one or more of the superior temporal line, inferior temporal line, parietal bone, squamous suture, temporal bone, lambdoid suture, occipital bone, mastoid process, sphenoid bone, portion adjacent to the supraorbital foramen, frontal bone, and coronal suture.

127. The method according to claim 100, wherein the step of at least partially inducing vascular compression in a portion of the cranial circulatory system is due to compression of a portion of the scalp containing blood vessels of the patient's cranial circulatory system on a portion of the patient's periosteum.

128. The method according to claim 100, wherein the step of at least partially inducing vascular compression in a portion of the cranial circulatory system is brought about by an interaction between the vascular compression element of the head cover and the blood vessels of the patient's cranial circulatory system.

129. The method according to claim 100, wherein the step of at least partially inducing vascular compression in a portion of the cranial circulatory system further includes compressing a portion of the scalp against a portion of the periosteum to induce vascular compression in a portion of the vascular bed of a hair follicle.

130. The method according to claim 100, wherein the vascular compression element of the head cover is positioned relative to the patient's head, and during the engagement step, the vascular compression element is positioned in close proximity to a specific vein or artery so as to at least partially compress a specific vein or artery of the patient's cranial circulatory system.

131. The method according to claim 130, wherein the specific vein or the specific artery is one of the blood vessels described in any one of claims 120 to 125.

132. The method of claim 100, further comprising delivering a vasoconstrictor to the patient before, during, or after any of the steps of claim 66.

133. The method according to claim 130, wherein the vasoconstrictor is one of α-adrenergic receptor agonists, vasopressin analogs, epinephrine, norepinephrine, phenylephrine, dopamine, dobutamine, migraine treatments, headache treatments, serotonin 5-hydroxytryptamine agonists, and triptans.

134. The method according to any one of claims 100 to 133, wherein the patient is receiving chemotherapy by injection, intravenous infusion, targeted therapy, hormone therapy, or immunotherapy.

135. The method according to claim 134, wherein the patient is receiving chemotherapy via an intravenous, subarachnoid, intra-arterial, intracavitary, intramuscular, intralesional, or intravesical approach.

136. The method according to claim 134 or 135, wherein the patient is receiving chemotherapy at home, in a medical facility's office, clinic, outpatient infusion center, hospital infusion center, or in a hospital ward.

137. A comfortable way to wear headgear to protect against hair loss during chemotherapy, The helmet, with a facepiece attached via multiple straps, is positioned over the user's head and face. Adjusting the multiple straps so as to form contact between the multiple tiles of the facepiece and the user's face, Inflating the balloon liner of the aforementioned helmet, Until vascular compression of the user's hair follicles is achieved, (i) pressure from contact between the plurality of tiles and the user's face, (ii) pressure on the user's head from the inflated balloon liner of the helmet, and (iii) adjustment of one or more of the plurality of straps, Initiating a chemotherapy session for the aforementioned user, A method for adjusting, for the comfort of the user during the chemotherapy session, the pressure from the contact between the plurality of tiles on the face and the user, the pressure on the user's head from the inflated balloon liner of the helmet, and one or more of the plurality of straps.

138. The method according to claim 137, wherein the plurality of tiles have an outer surface facing the inside of the facepiece and an inner surface facing the user's face.

139. The method according to claim 137, wherein the balloon liner is inflated via an air adapter connected to an inflation line and an inflation source.

140. The method according to claim 137, wherein adjusting the pressure from the contact between the plurality of tiles on the facepiece involves engaging with a knob having a plurality of protrusions, each having a smooth edge and a jagged edge, wherein the smooth edge is configured to indicate a first direction of rotation for increasing the pressure of the contact between the plurality of tiles and the user's face by moving one or more of the plurality of tiles toward the user's face, and the jagged edge is configured to indicate a second direction of rotation for decreasing the pressure of the contact between the plurality of tiles and the user's face by moving one or more of the plurality of tiles toward away from the user's face.

141. The method according to claim 137, wherein the knob, in conjunction with the padding and support piece, increases or decreases one or more of the following: (i) the distance between the padding / support piece and the patient's face, and (ii) the pressure exerted on the patient's face, and the padding is a low durometer silicone pad having 5 to 20 Shore A units.

142. The method according to claim 137, wherein the inflatable balloon liner has a first section configured to be linked with the patient's head, a second section configured to be linked with the inner surface of the helmet, and a boundary layer between the first section and the second section, the second section and the boundary layer each having a durometer higher than the durometer of the first section of the balloon liner.

143. The method according to claim 137, wherein the first section has a thickness of 10 to 100 microns, and the second section has a thickness of 50 to 300 microns.

144. The method according to claim 143, wherein the boundary layer has a consistent width of 20 to 40 mm between the first section and the second section around the helmet.

145. The method according to claim 137, wherein the positions of one or more of the facepieces and the multiple tiles are pre-contoured to match the topography of the user's face before the facepieces are attached to the user's face.

146. The method of claim 137, further comprising a waiting period to confirm vascular compression of the blood supply to the hair follicles of the user before initiating the chemotherapy session for the user.

147. The method according to claim 137, further comprising applying one or more of the helmet and facepiece worn by the user to a support surface to generate a desired reaction force vector, thereby offsetting the load and pressure on the user's head or face.

148. The method according to claim 137, further comprising, before or during the chemotherapy session, manually or automatically adjusting the pressure from the contact between the plurality of tiles on the face and the user, the pressure on the user's head from the inflated balloon liner (inflated state) of the helmet, and one or more of the plurality of straps via a graphical user interface (GUI) of a computer-implemented application or a web application, wherein the GUI adjusts one or more of the plurality of tiles, one or more of the plurality of straps, and the inflated state of the balloon liner.

149. The method according to claim 148, wherein the GUI adjusts the inflation state of one or more of the multiple tiles, one or more of the multiple straps, and the balloon liner via sensors and valves on the helmet, balloon liner, facepiece, multiple tiles, and pressure source, thereby coordinating with a combined chemotherapy and vascular compression therapy control and delivery system, and further the combined chemotherapy and vascular compression therapy control and delivery system responds to the user's user prescription and treatment preferences, chemotherapy session history, and electronic medical records (EMR).

150. A comfortable way to wear headgear to protect the user from hair loss during chemotherapy, The headband is positioned around the user's head, A helmet, with a facepiece and headband attached via multiple straps, is positioned so that the headband is between the helmet and the facepiece. (i) adjusting the plurality of straps to form contact between the plurality of tiles of the facepiece and the user's face, and (ii) between the headband and one or more of the circumference of the user's head, Inflating the balloon liner of the aforementioned helmet, Until vascular compression of the user's hair follicles is achieved, (i) pressure from the contact between the plurality of tiles and the user's face, (ii) pressure on the user's head from the inflated balloon liner of the helmet, and (iii) adjustment of one or more of the plurality of straps, Initiating a chemotherapy session for the aforementioned user, A method for ensuring the user's comfort during the chemotherapy session, comprising: the pressure from the contact between the plurality of tiles and the user's face; the pressure exerted on the user's head by the inflated balloon liner of the helmet; and continuing to adjust one or more of the plurality of straps.

151. The method according to claim 150, wherein the plurality of straps comprises one or more of straps, bands, and adhesives, and the headband is configured to perform one or more of the following: (i) stabilizing the helmet during inflation and deflation of the balloon liner, (ii) offsetting the load on the helmet, and (iii) further restricting blood circulation to the patient's hair follicles.

152. The method according to claim 150, wherein the headband is placed separately on the user's forehead and positioned to be positioned in the gap between the helmet and the facepiece.

153. A device for protecting against hair loss during chemotherapy, A helmet having an inflatable balloon liner and multiple helmet connection points, A facepiece having multiple facepiece connection points around the facepiece, A device comprising a plurality of helmet connection points and a plurality of straps for connecting the facepiece to the helmet via the facepiece connection points.

154. The device according to claim 153, further comprising a headband attached to the helmet.

155. The inflatable balloon liner is further provided, and the inflatable balloon liner is A first section configured to be linked to the patient's head, The device according to claim 154, comprising: a second section configured to be linked with the inner surface of the helmet, wherein the first section has a durometer lower than the durometer of the second section of the balloon liner; and a boundary section between the first section and the second section, the boundary section following the periphery of the helmet.

156. The device according to claim 155, wherein the facepiece has a plurality of tiles, the tiles are made of a material comprising one or more of foam, foam composite, gel, and air, and one or more of the tiles are configured to be adjusted via a mechanical or pneumatic mechanism.

157. The method according to any one of claims 100 to 136, 137 to 149, or 150 to 152, which is carried out using the device according to claim 36, or any one of claims 36, 37, or 50, or any one of claims 69 to 99, or any one of claims 153 to 156.

158. A computer controller adapted and configured to control the pressure applied to the patient's scalp and face using one or a combination of the above devices, before, during, and after chemotherapy sessions, using any of the methods described above.

159. A graphical user interface adapted and configured to interact with the computer controller according to claim 158, enabling a selection of one or more inflatable elements or pressure-applying elements which may be increased or decreased.

160. A computer controller according to claim 158 or a graphical user interface according to claim 159, further configured to control, monitor, initiate, interrupt, or otherwise control the delivery of a chemotherapy protocol to a patient.

161. A computer controller or graphical user interface according to any one of claims 158, 159, or 160, adapted and configured to be used with a device or to implement the method described in claim 157.

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