A vascular compression head cover that delivers vascular compression therapy to patients undergoing chemotherapy treatment

Abstract

Various devices and methods are useful in providing vascular compression to patients undergoing chemotherapy treatment.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 043,625, filed June 24, 2020, entitled "VASOCOMPRESSION DEVICES AND METHODS OF DELIVERING VASOCOMPRESSION THERAPY TO A PATIENT UNDERGOING CHEMOTHERAPY TREATMENT," which is incorporated by reference in its entirety herein. Incorporation by Reference

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

[0002]

[0003] Various embodiments to which the present application pertains are directed to devices and methods for mitigating or eliminating chemotherapy-induced alopecia (CIA), chemotherapy drug-induced hair loss, hair follicle death, and / or anagen effluvium. Additionally or optionally, the devices and methods may be used in conjunction with medications that aid in these goals. [Background technology]

[0003]

[0004] Chemotherapeutic drugs induce CIA by interfering with the transition between stages of hair follicle growth, stimulating follicular dystrophy, or inducing regression of immature hair follicles {Paus et al., 1994; Trueb, 2009; Yeager et al., 2011}. Telogen effluvium occurs when a greater proportion of anagen hairs progress prematurely to telogen; for example, cyclophosphamide causes CIA by this mechanism {Patel et al., 2014}. At any given time, up to 90% of scalp hairs are in anagen and occurs within days to weeks after administration of cytotoxic agents; anagen effluvium is the most common type of CIA {Olsen et al., 2011}, and it is stimulated by alkylating agents, antimetabolites, vinca alkaloids, topoisomerase inhibitors, anthracyclines, and taxanes {Espinosa et al., 2003; Yun et al., 2007}. As mentioned above, hair follicles are particularly sensitive to chemotherapy drugs because up to 90% of them are in anagen and their associated matrix keratinocytes represent the most rapidly dividing cell subset {Batchelor et al., 2001}, and therefore they are particularly targeted by cell replication targeting drugs.

[0004]

[0005] Scalp cooling, currently the only available technique to prevent chemotherapy-induced alopecia, may interfere with CIA by a variety of possible mechanisms. First, cooling causes vasoconstriction of blood vessels, which has been shown to reduce scalp blood flow to 20-40% of normal rates (Janssen et al., 2007). This has been suggested to result in less chemotherapy drug being delivered to the hair follicles (Bulow et al., 1985). Another possibility is that the rate of drug diffusion across cell membranes may be reduced by cooling, and thus less effective amount of drug may enter the cell (Lane et al., 1987). Also, when cell division is metabolically driven, this process may be slowed down by cooling, as temperature can particularly affect phases such as G1 and S (Watanabe and Okada, 1967), which may be particularly important for drugs that target specific phases of the cell cycle, such as microtubule-disrupting drugs that target mitosis. Also, a reduction in the metabolic activity of cells within the hair follicle may result in a more overall reduction in the cytotoxicity of chemotherapy drugs (Bulow et al., 1985). Indeed, a combination of these methods may play a role in the success of scalp cooling in reducing CIA.

[0005]

[0006] In any case, scalp cooling does not work in all cases and effectiveness may vary from person to person. Summary of the Invention [Problem to be solved by the invention]

[0006]

[0007] As a result, improvements are still needed in techniques used to alleviate, substantially eliminate, or aid in the treatment of chemotherapy drug-induced hair loss, hair follicle death, and / or anagen effluvium. [Means for solving the problem]

[0007]

[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 a leading edge, a trailing edge, a top, a left edge, and a right edge, a liner within the shell configured to at least partially contain the patient's hair, at least one vascular compression element within the outer shell, and a head cover retention system coupled to the shell.

[0008]

[0009] This and other embodiments may include one or more of the following features: The shell retention system may include a sub-chin strap connected to the shell. The shell retention system may include one or more of a rear strap, a front strap, or a neck strap connected to the shell. The shell retention system may include one or more adjustment elements. The at least one vascular compression element may be an expandable inner bag within the liner. The at least one vascular compression element may be coupled to the shell. The head cover may further include a pressure source in communication with the expandable inner bag. The head cover may further include a continuous perimeter connecting the leading edge, the trailing edge, the left edge, and the right edge. The at least one vascular compression element of the head cover 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. The at least one vascular compression element may be on the expandable layer. The at least one vascular compression element of the head cover may further include one or more raised features. The liner of the head cover, located within the shell and shaped to at least partially accommodate the patient's hair, may further include one or more features on the liner that engage 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 equally distributed protrusions having a linear or circular inflatable structure. The head cover retention system may further include a hook-and-loop fastener, a buckle, a quick release mechanism, or an adjustment feature. The head cover may further include a gas source in communication with the liner or at least one vascular compression element for inflation of 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 overpressurization of the inflatable element of the head cover. The gas source may be a manual pump mechanism, a bulb, an electric pump, or a pressurized tank, cartridge, or reservoir. The head cover may further include a control system to regulate the flow of gas from the gas source to maintain a desired pressure within the head cover.The desired pressure within the head cover may be sufficient to provide the results of vascular compression while minimizing discomfort or side effects to the patient or harm to surrounding structures. The head cover may further include a cooling gas source in communication with the liner or at least one vascular compression element, and a portion of the liner or at least one vascular compression element is adapted to provide cooling to the inner portion of the head cover. The head cover may further include one or more pressure sensors within the inner portion of the head cover. The one or more pressure sensors may provide an indication of the pressure to the control system. The one or more pressure sensors may be adapted to indicate the amount of pressure applied to the patient undergoing chemotherapy when the patient is wearing the head cover. The head cover may further include one or more sensors measuring skin perfusion (O2sat), or a Doppler blood flow monitor or an infrared pulse oximeter sensor. The sensor may be used to detect that blood flow in the vasculature undergoing vascular compression therapy is stopped or slowed down sufficiently to prevent exposure of hair follicles to chemotherapy drugs. The head cover may further include a continuous structure from the occipital region to the eyebrow or forehead. The head cover may further include a structure or an inflatable structure for compressing the eyebrow for a vascular compression effect at the eyebrow. The head cover may further include a timer and a control system adapted to provide an automatic deflation protocol when the timer expires or to deactivate any activated vascular compression element. The head cover may further include a timer and a control system adapted for programmed automatic inflation and deflation of the liner or one or more vascular compression elements or activation and deactivation of one or more vascular compression elements. The liner may be a rigid or semi-elastic layer configured for a precise fit against the patient to precisely fit the shape of the patient's head and hair. The head cover retention system may include a fastening system. The head cover may further include one or more selective pressure points arranged to compress one or more vessels of the patient's cranial circulatory system.The head covering may further include a vibration element coupled to the liner or the at least one vascular compression element. The liner and the at least one vascular compression element may be sized, shaped, or positioned relative to the head covering based on the patient's hairstyle.

[0009]

[0010] Generally, in one embodiment, a head covering for inducing vascular compression in the blood supply of a patient undergoing chemotherapy includes a cap having a leading edge, a trailing edge, a top, a left edge, and a right edge, a liner within the cap configured to at least partially contain the patient's hair, and at least one vascular compression element within the cap.

[0010]

[0011] This and other embodiments may include one or more of the following features: The cap may include a flexible, partially flexible, combination of semi-rigid and flexible, or adjustable structure sized to remain in place on the head when the at least one vascular compression element is activated. The at least one vascular compression element may be an expandable inner bladder within 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 in communication with the expandable inner bladder or the at least one vascular compression element. The head cover may further include a continuous perimeter connecting the leading edge, the trailing edge, the left edge, and the right edge. The at least one vascular compression element of the head cover may further include an expandable feature that expands away from the cap in response to a pressure source. The head cover may further include an expandable layer coupled to the liner, and the at least one vascular compression element may be on the expandable layer. The at least one vascular compression element of the head cover may further include one or more raised features. The liner within the shell of the head cover, which is shaped to at least partially accommodate the patient's hair, may further include one or more features on the liner that engage 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 equally distributed protrusions having a linear or circular inflatable structure. The head cover may further include a gas source in communication with the liner or at least one vascular compression element for inflation of 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 overpressurization of the inflatable element of the head cover. The gas source may be a manual pump mechanism, a bulb, an electric pump, or a pressurized tank, cartridge, or reservoir. The head cover may further include a control system that regulates the flow of gas from the gas source to maintain a desired pressure within the head cover.The desired pressure within the head cover may be sufficient to provide a vascular compression result while minimizing discomfort or side effects to the patient or harm to surrounding structures. The head cover may further include a cooling gas source in communication with the liner or at least one vascular compression element, and a portion of the liner or at least one vascular compression element is adapted to provide cooling to an inner portion of the head cover. The head cover may further include one or more pressure sensors within the inner portion of the head cover. The one or more pressure sensors may provide an indication of the pressure to the control system. The one or more pressure sensors may be adapted to indicate an amount of pressure applied to a patient undergoing chemotherapy when the patient is wearing the head cover. The head cover may further include one or more sensors measuring skin perfusion (O2sat), or a Doppler blood flow monitor or an infrared pulse oximeter sensor. The head cover may further include a continuous structure from the occipital region to the eyebrow or forehead. The head cover may further include a structure or an inflatable structure for compressing the eyebrow for a vascular compression effect at the eyebrow. The head cover may further include a timer and a control system adapted to provide an automatic deflation protocol when the timer has elapsed or to deactivate any active vascular compression element. The head cover may further include a timer and a control system adapted to programmed automatic inflation and deflation of the liner or activation and deactivation of one or more vascular compression elements. The liner may be a rigid or semi-elastic layer configured for a precise fit to the patient to precisely fit the shape of the patient's head and hair. The head cover retention system may include a fastening system. The head cover may further include one or more selective pressure points arranged to compress one or more vessels of the patient's cranial circulatory system. The head cover may further include a vibration element coupled to the liner or the at least one vascular compression element. The liner and the at least one vascular compression element may be sized, shaped, or positioned relative to the head cover based on the patient's hairstyle.

[0011]

[0012] Generally, in one embodiment, a method of inducing vascular compression in a cranial circulatory system of a patient undergoing chemotherapy includes the steps of: (1) placing a head cover around the patient's head; (2) inducing, at least in part, vascular compression in a portion of the patient's cranial circulatory system using a vascular compression element of the head cover; (3) initiating a chemotherapy session on the patient; (4) terminating the chemotherapy session on the patient; and (5) ceasing the step of at least inducing vascular compression in a portion of the patient's cranial circulatory system after the step of terminating the chemotherapy session when a period of time has elapsed sufficient to partially alleviate the effects of chemotherapy-induced alopecia in the patient.

[0012]

[0013] This and other embodiments may include one or more of the following features. The method may further include engaging the head cover retention system to secure the head cover against the patient's head. The period of time that has elapsed since the step of terminating the chemotherapy session may be up to 24 hours. The period of time that has elapsed since the step of terminating the chemotherapy session may be at least 1 hour. The period of time that has elapsed since the step of terminating the chemotherapy session may be at least 48 hours. The vascular compression element of the head cover may be a liner, 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 are performed. During the step of expanding the liner, the amount of vascular compression may increase in response to an increase in the force of the liner against the patient's scalp. During the step of contracting the liner, the amount of vasoconstriction may decrease in response to a decrease in the force of the liner against the patient's scalp. The vascular compression element of the head cover may be 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 are performed. During the step of expanding the liner, an amount of vascular compression may increase corresponding to an increase in force by the one or more features on the liner against the patient's scalp. During the step of contracting the liner, an amount of vascular compression may decrease corresponding to a decrease in force by the one or more features on the liner against the patient's scalp. The vascular compression element of the head cover may be an inflatable inner bladder, and a 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 in part to an amount of pressure in the inflatable inner bladder. The vascular compression element of the head cover may be an inflatable inner bladder, and a degree of vascular compression during the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system increases or decreases by increasing or decreasing pressure in the inflatable inner bladder against the skull.The vascular compression element of the head cover may be one or more features arranged on an inner surface of the head cover that are biased 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. The vascular compression element of the head cover may be one or more features arranged on an inner surface of the head cover that correspond to an arrangement of the patient's hair, the one or more features acting on the arrangement of the patient's hair to enhance the outcome 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 element of the head cover may compress a portion of the scalp including a plurality of hair follicles against a portion of the skull to at least partially vascularly compress the blood supply to the plurality of hair follicles. The portion of the skull may be one or more of the upper temporal line, the lower temporal line, the parietal bone, the squamosal suture, the temporal bone, the lambdoid suture, the occipital bone, the mastoid process, the sphenoid bone, a portion near the supraorbital foramen, the frontal bone, and the coronal suture. During the step of at least partially inducing vascular compression, the vascular compression element of the head cover may be arranged to at least partially vascularly compress an artery or vein of the patient's cranial circulatory system by compressing the artery or vein against a portion of the skull. The artery or vein of the cranial circulatory system may be a tributary of the external carotid artery or a tributary 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 the supratrochlear artery. The portion of the skull may be one or more of the superior temporal line, the inferior temporal line, the parietal bone, the squamosal suture, the temporal bone, the lambdoid suture, the occipital bone, the mastoid process, the sphenoid bone, a portion near the supraorbital foramen, the frontal bone, and the coronary suture. The step of at least partially inducing vascular compression in the portion of the cranial circulatory system may result from compression of a portion of the scalp including 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 the portion of the cranial circulatory system may be brought about by interaction between a vascular compression element of the head cover and blood vessels of the patient's cranial circulatory system.The step of at least partially inducing vascular compression in a portion of the cranial circulatory system of the method 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 follicle. During the engaging step, the vascular compression element of the head cover may be positioned against the patient's head such that the vascular compression element is positioned proximate to a specific vein or specific artery to at least partially vascularly compress the specific vein or specific artery of the patient's cranial circulatory system. The specific vein or specific artery may be any of the blood vessels described above. The method may further include delivery of a vasoconstrictor agent to the patient before, during, or after use of any of the methods or devices described herein. The vasoconstrictor agent may be one of an alpha-adrenergic receptor agonist, a vasopressin analog, epinephrine, norepinephrine, phenylephrine, dopamine, dobutamine, a migraine medication, a headache medication, a serotonin 5-hydroxytryptamine agonist, and a triptan. In any of the above methods or devices, the patient may receive chemotherapy by injection, infusion, targeted therapy, hormonal therapy, or immunotherapy. The patient may receive chemotherapy by intravenous, intrathecal, intraarterial, intracavitary, intramuscular, intralesional, or intracapsular methods. The patient may receive chemotherapy at home, at a health care provider's office, a doctor's office, an outpatient infusion center, a hospital infusion center, or in a hospital room.

[0013]

[0014] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings, in which: [Brief description of the drawings]

[0014] [Figure 1A]

[0015] FIG. 1 is an overhead view of a cancer patient at the beginning of chemotherapy treatment to treat a tumor or malignant lesion in the breast, including a pouch containing a chemotherapy drug at the start of the chemotherapy treatment session. [Figure 1B]

[0016] FIG. 1B is a close-up of a tumor or malignant lesion in the breast of the patient of FIG. 1A. [Figure 2A]

[0017] FIG. 1B is a diagram of the pouch of FIG. 1A showing the delivered and remaining amount of chemotherapy drug. [Figure 2B]

[0018] 1 is a graph showing the expected concentration curve of a chemotherapy drug in a patient's blood stream as a function of drug concentration (mg / L) and time (min). The triangles indicate the estimated concentration based on the amount of chemotherapy agent delivered as indicated by the visible fluid level in the pouch. [Figure 3A]

[0019] FIG. 1B is a diagram of the patient and pouch of FIG. 1A showing the delivered and remaining amount of chemotherapy drug as indicated by the decreasing level of fluid in the pouch. [Figure 3B]

[0020] 2B is a graph showing the expected concentration curve of the chemotherapy drug in the patient's blood stream as a function of drug concentration (mg / L) and time (min) for the patient's condition of FIG 3 A. The triangles indicate the estimated concentration based on the amount of chemotherapy agent delivered as indicated by the decrease in the visible fluid level in the pouch, which is approximately the peak or maximum drug concentration. [Figure 4]

[0021] FIG. 1B is a diagram of the state of the chemotherapy-induced necrotic process in the target tumor or malignant lesion of FIG. [Figure 5A]

[0022] FIG. 5A is a diagram of the patient and pouch of FIG. 3A showing the delivered and remaining amount of chemotherapy drug as indicated by the decreasing fluid level in the pouch. FIG. 5A is a diagram of the drug concentration (mg / L) vs. time (min) curve for the patient at, near, or above the maximum level. [Figure 5B]

[0023] FIG. 5 is a diagram of the progression of the process of chemotherapy-induced necrosis in the target tumors or malignant lesions of FIGS. 1B and 4. [Figure 5C]

[0024] FIG. 1 is a cross-sectional view of the scalp and hair follicle including its vascular bed before any chemotherapy drugs reach the vasculature of the skull, scalp, or hair vascular bed. [Figure 5D]

[0025] FIG. 5D is a cross-sectional view of the scalp and hair follicle vascular bed of FIG. 5C showing chemotherapy drug penetration and circulation. [Figure 6A]

[0026] FIG. 1B is a diagram of the end state of chemotherapy-induced necrosis in the target tumors or malignant lesions of FIG. 5B. [Figure 6B]

[0027] FIG. 5D is a diagram of the end state of widespread chemotherapy-induced necrosis in a patient's hair follicle, which began in FIG. 5D. [Figure 6C]

[0028] FIG. 1A is a side view of the widespread hair loss condition in the patient of FIG. 1A, FIG. 3A, and FIG. 5A, resulting from one or a combination of chemotherapy-induced alopecia, hair loss, hair follicle death, and / or anagen effluvium. [Figure 7A]

[0029] FIG. 1 is an overhead view of an area where the skin and scalp have been pulled back to reveal the layers of tissue that covered the bony portion of the skull. [Figure 7B]

[0030] FIG. 7B is a cross-sectional view of the portion of the skin and scalp of FIG. 7A that has been pulled out. [Figure 7C]

[0031] 7C is a cross-sectional view of the indicated area of ​​the skin and scalp of FIG. 7B. [Figure 8]

[0032] FIG. 1 is a cross-sectional view of a healthy scalp and hair follicle including its vascular bed. [Figure 9]

[0033] FIG. 1 is an overhead view of a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy. This view also shows a shell and an inner liner that are connected to an external pump or controller for one or more vascular compression elements within the head cover. Also visible in this view is a subchin strap connected to the shell. The head cover is configured to deliver vascular compression to the scalp and eyebrows. [Figure 10A]

[0034] FIG. 1 is an overhead view and partial interior view of a head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy. This view also shows a shell and an inner liner connected to a shell-mounted pump or controller for one or more vascular compression elements in the head cover. Also visible in this view is a subchin strap connected to the shell. The illustrated vascular compression elements are manifolds that extend inward, away from the shell, toward the scalp. The head cover is configured to deliver vascular compression to the scalp and eyebrows. [Figure 10B]

[0035] 1 is a cross-sectional view of a portion of a liner having a vascular compression element with one or more raised features having a rounded shape that faces a patient wearing the head covering. [Figure 10C]

[0036] 10C is a cross-sectional view of a portion of a liner having a vascular compression element with one or more raised features having a rectangular pyramid shape with a flat top section that faces the patient wearing the head covering. [Figure 11A]

[0037] FIG. 1 is a side view of a patient's head wearing a vascular compression element used to deliver vascular compression in the blood supply of a patient undergoing chemotherapy. The view also shows an inflatable liner connected to a pump or controller (not visible in this view). The inflatable liner vascular compression element is configured to deliver vascular compression to the scalp and eyebrows. [Figure 11B]

[0038] FIG. 11B is a side view of the patient of FIG. 11A showing the shell of a head cover and a sub-chin strap for inducing vascular compression in the blood supply of a patient undergoing chemotherapy using the vascular compression element of FIG. 11A to deliver vascular compression to the scalp and eyebrows. [Figure 12A]

[0039] FIG. 1 is a side view of a patient's head wearing a head cover including at least one vascular compression element used to deliver vascular compression. This is the patient's condition before or immediately after starting chemotherapy. A subchin strap connected to the shell of the head cover is also visible in this view. The head cover is configured to deliver vascular compression to the patient's scalp and eyebrows. [Figure 12B]

[0040] 12B is a cross-sectional view of a portion of the patient's hair, scalp, and hair follicles of FIG. 12A, showing the hair pressed against the scalp when the head covering is worn (FIG. 12A) and prior to delivering vascular compression. [Figure 12C]

[0041] 12C is a cross-sectional view of a portion of the patient's hair, scalp, and hair follicle of FIG. 12B, illustrating the expansion of one or more vascular compression elements in the head covering causing vascular compression in the vascular bed of the hair follicle. [Figure 12D]

[0042] FIG. 1 is an external view 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]

[0043] FIG. 13A is an illustration of the patient of FIGS. 12A-12D receiving vascular compression from the head cover during a nearly completed chemotherapy session, as indicated by a nearly empty pouch of chemotherapy drug.

[0044] Figure 13B is a graph showing the expected concentration curve of a chemotherapy drug in a patient's blood stream as a function of drug concentration (mg / L) and time (min) for the patient condition of Figure 13 A. The triangles indicate the estimated concentration based on the amount of chemotherapy agent delivered as indicated by the decreasing fluid level visible in the pouch of Figure 13 A. The arrows indicate the drug concentration amount is near or just beyond the peak or maximum drug concentration.

[0045] FIG. 13C is an illustration of the progression of the process of chemotherapy-induced necrosis in the target tumor or malignant lesion of the patient of FIGS. 12A, 12D, and 13A undergoing vascular compression during delivery of chemotherapy drugs.

[0046] Figure 13D is a cross-sectional view of the head covering, scalp, and hair follicles of the patient of Figures 12A, 12D, and 13A undergoing vascular compression during delivery of a chemotherapy agent (Figure 13B). This figure shows that the vascular bed is completely free or substantially free of any chemotherapy agent, or the level of chemotherapy agent reaching the vascular bed is maintained below a level that would harm the hair follicles. [Figure 14]

[0047] 13B is a side view of the patient of FIG. 13A in a period following delivery of chemotherapy with vascular compression. As a result of the beneficial effects of vascular compression, the patient has maintained hair on both the head and eyebrows. [Figure 15]

[0048] 1 is a flow chart of an exemplary method of providing vascular compression to a patient undergoing chemotherapy treatment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015]

[0049] 1A is an overhead view of a cancer patient 1 at the beginning of chemotherapy treatment to treat a tumor or malignant lesion 20 in the breast. The view includes an IV pouch 5 containing a chemotherapy drug 10, the amount of pouch 15 at the start of the chemotherapy treatment session.

[0016]

[0050] FIG. 1B is a close-up of a tumor or malignant lesion 20 in the breast of patient 1 of FIG. 1A.

[0051] FIG. 2A is a diagram of the IV pouch 5 of FIG. 1A showing the delivered and remaining amounts 15 of chemotherapy agent 10.

[0017]

[0052] 2B is a graph showing the expected concentration curve of chemotherapy agent 10 in a patient's blood stream as a function of drug concentration (mg / L) and time (min). Triangle 25 indicates the estimated concentration based on the amount of chemotherapy agent 10 delivered as indicated by the level of fluid 15 visible in pouch 5.

[0018]

[0053] FIG. 3A is an illustration of the patient and IV pouch 5 of FIG. 1A showing the delivered amount 15 and remaining amount of chemotherapy agent 10 as indicated by the decreasing level of fluid in the pouch.

[0054] Figure 3B is the graph of Figure 2B showing the expected concentration curve of chemotherapy drug 10 in the patient's blood stream as a function of drug concentration (mg / L) and time (min) for the patient condition of Figure 3 A. Triangle 25 shows the estimated concentration based on the amount of chemotherapy agent delivered as indicated by the decreasing fluid level visible in the pouch, which is approximately the peak or maximum drug concentration.

[0019]

[0055] FIG. 4 is a diagram of the state of the chemotherapy-induced necrotic process in the target tumor or malignant lesion of FIG. 1B.

[0056] Figure 5A is a diagram of the patient and pouch of Figure 3A showing the delivered amount 15 and remaining amount of chemotherapy drug 10 as indicated by the decreasing fluid level 15 in the IV pouch 5. The drug concentration (mg / L) vs. time (min) curve for the patient in Figure 5A is at, near, or above a maximum level (see, e.g., peak levels in Figure 3B).

[0020]

[0057] Figure 5B is an illustration of the progression of the process of chemotherapy-induced necrosis in the target tumor or malignant lesion 20 of Figures 1B and 4. A large amount of chemotherapy drug 10 has been delivered to the tumor or lesion 20 and is taken up by the tumor or lesion 20.

[0021]

[0058] Figure 5C is a cross-sectional view of the scalp and hair follicle similar to Figure 8. In this view, the vascular bed is shown before any chemotherapy agent 10 reaches the vasculature of the skull, scalp, or hair vascular bed.

[0022]

[0059] FIG. 5D is a cross-section 10 of the scalp and hair follicle vascular bed of FIG. 5C showing the penetration and circulation of chemotherapy agents within the vasculature 62.

[0060] FIG. 6A is an illustration of the end state of chemotherapy-induced necrosis in the target tumor or malignant lesion 20 of FIGS. 1B, 4, and 5B.

[0023]

[0061] Figure 6B is an illustration of the end state of widespread chemotherapy-induced necrosis in a patient's hair follicle that began in Figure 5D. Vasculature 62 contains chemotherapy drug 10 that is delivered to and catastrophic to bulb 64 and associated hair shaft 70. Introduction of chemotherapy drug into the vascular bed of the scalp and eyebrows results in the patient experiencing one or more of chemotherapy-induced alopecia (CIA), chemotherapy drug-induced hair loss, hair follicle death and / or anagen effluvium.

[0024]

[0062] Figure 6C is a side view of the widespread hair loss condition in the patient of Figures 1A, 3A, and 5A resulting from one or a combination of chemotherapy-induced alopecia, hair loss, hair follicle death, and / or anagen effluvium. The amount of hair 7 on the head 3 and eyebrows is less than that in the previous figures of Figures 1A, 3A, and 5A.

[0025]

[0063] The above-mentioned adverse effects can be largely mitigated or avoided using an embodiment of the device and method described herein that prevents or prevents chemotherapy drugs from reaching hair follicles.As used herein, vascular compression refers to a force applied to the patient's head that is sufficient to overcome the filling pressure 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, thereby preventing chemotherapy drugs in the blood stream in chemotherapy from reaching hair follicle blood supply.

[0026]

[0064] 7A is an overhead view of the head 3 of a patient 1 with the skin 30 and scalp removed to reveal the layers of tissue that cover the bony portions of the skull. Shown beneath the skin 30 is connective tissue 32, the aponeurosis or cranial layer 34, and loose areolar tissue 36. Below the loose areolar layer 36 is the pericranium 38, and then bone 40.

[0027]

[0065] Figure 7B is a cross-sectional view of the pulled-out portion of the skin and scalp of Figure 7A. Figure 7C is a cross-sectional view of the indicated area of ​​the skin and scalp of Figure 7B. This view shows the relationship of the skin and dense connective tissue (30 / 32) to the galeal aponeurosis 34, the loose areolar connective tissue 36, and the periosteum 38 and bone 40.

[0028]

[0066] 8 is a cross-sectional view of a healthy scalp and hair follicle including its vascular bed. The blood supply 62 includes arteries and veins that provide nutrients to the individual hair follicle. The hair shaft 70 and bulb 64 are shown in relation to the dermal papilla cells 60 and blood supply 62. The sebaceous gland 68 and arrector pili muscle 66 are also shown in this view.

[0029]

[0067] FIG. 9 is a perspective left side view of one embodiment of a head cover 100 for inducing vascular compression in the blood supply of a patient 1 undergoing chemotherapy. This view also shows the shell 110 with the leading edge 112, the top 113, the left edge 116, and the trailing edge 114. This view also shows a portion of the inside of the head cover with a portion of the liner 120 and one or more vascular compression elements 130 visible. The one or more vascular compression elements 130 are connected to an external pump or controller 180 using a suitable connector 185. The pump or controller 180 is used to perform the desired vascular compression therapy on the patient using the one or more vascular compression elements 130 in the head cover 100. Also visible in this view is a subchin strap connected to the shell. The head cover 100 has a shell 110 adapted and configured to deliver vascular compression to the scalp, with the leading edge 112 selected to provide vascular compression to the eyebrows. In one embodiment, one or more vascular compressible elements 130 may be placed continuously along the liner or inside of the shell to address the scalp / hair 7 and eyebrows 9, as well as the space on the forehead between the hairline and the eyebrows. Additionally or optionally, separate vascular compressible elements 130 are used for the eyebrows and hair, with no elements 130 in the forehead area between the hairline and the eyebrows.

[0030]

[0068] FIG. 10A is a perspective right side view and partial inside view of one embodiment of a head cover 100 for inducing vascular compression in the blood supply of a patient 1 undergoing chemotherapy. This view also shows a shell 110 with a top 113, a leading edge 112, a trailing edge 114, and a right edge 118. The shell 110 is shown as transparent to show the position of the vascular compression elements 130 aligned to deliver vascular compression therapy to the hair / scalp 7 and eyebrows 9 of the patient 1. This view also shows the inner portion of the liner 120 adjacent the left edge 116. In this embodiment of the head cover, a pump or controller 190 is mounted directly onto the head cover 100 (e.g., to a portion of the shell 110). The pump or controller 190 (such as pump or controller 180) is suitably connected to one or more vascular compression elements 130 in the head cover 100. The mounted pump or controller 190 is used to implement the desired vascular compression therapy to the patient using one or more vascular compression elements 130 in the head cover 100. Also visible in this view is a subchin strap 145 connected to the shell 110. The illustrated vascular compression element 130 is an inwardly expanding manifold, facing inward (away from the shell 110) towards the scalp. The head covering 100 is configured to deliver vascular compression to the scalp and eyebrows 9, as can be seen by the size, orientation, and location of the vascular compression element 130 positioned adjacent the scalp, as well as another separate or spaced apart vascular compression element 130 positioned to engage the eyebrows 9.

[0031]

[0069] 10B is a cross-sectional view of a portion of the liner 120 having a vascular compression element 130 with one or more raised features 170. In this exemplary embodiment, the raised features 170 have a rounded shape that faces the patient wearing the head covering 100.

[0032]

[0070] 10C is a cross-sectional view of a portion of a liner 120 having a vascular compression element 130 with one or more raised features 170. In this exemplary embodiment, the raised features 170 have a rectangular pyramid shape with a flat top section that faces the patient wearing the head covering 100.

[0033]

[0071] FIG. 11A is a left side view of a patient's head 3 wearing a vascular compression element used to deliver vascular compression in the blood supply of a patient undergoing chemotherapy. The outer shell 110 of the head cover 100 has been removed in this view (but can be seen in the view of FIG. 11B). An array of vascular compression elements 130 of different sizes and shapes is visible in this view. Additionally or optionally, one or more elements 130 may be configured as an inflatable liner connected to a pump or controller 180 / 190 (not visible in this view). In this configuration, the inflatable liner vascular compression elements 130 are configured to deliver vascular compression to the scalp 7 and eyebrows 9.

[0034]

[0072] FIG 11B is a left side view of the patient of FIG 11A showing the complete head cover 100 with the shell 110 in place. The head cover 100 is held to the head 3 using an exemplary subchin strap 140. FIG 11B shows an exemplary position of the head cover 100 on the head 3 to induce vascular compression in the blood supply of a patient 1 undergoing chemotherapy using the vascular compression element configuration of FIG 11A. In one embodiment, the head cover 110 delivers vascular compression for protection of the scalp 7 and eyebrows 9.

[0035]

[0073] There are several variations and alternatives to the head covering 100 shown and described in Figures 9, 10, 11A, and 11B. We now turn to some further details regarding the features and operation of the various head covering 100 embodiments.

[0036]

[0074] In one embodiment, a head cover 100 for inducing vascular compression in the blood supply of a patient undergoing chemotherapy is provided having a shell with a leading edge, a trailing edge, a top, a left edge, and a right edge. Within the shell is a liner configured to at least partially contain the patient's hair. Also included is at least one vascular compression element within the outer shell, and a head cover retention system coupled to the shell.

[0037]

[0075] In one aspect, the head covering retention system 140 may include a sub-chin strap connected to the shell 110. Optionally, the head covering retention system 140 may include one or more of a rear strap, a front strap, or a neck strap connected to the shell. In some embodiments, the shell retention system comprises one or more adjustment elements. Optionally, the head covering retention system 140 may include a hook and loop fastener, a buckle, a quick release mechanism, or an adjustment feature.

[0038]

[0076] In an additional aspect, the at least one vascular compression element is an expandable inner bladder 150 within the liner 120. In a further aspect, the at least one vascular compression element is coupled to the shell. There may also be a pressure source 160 in communication with the expandable inner bladder. Additionally or optionally, a continuous perimeter 160 may be provided connecting the leading edge 112, the trailing edge 114, the left edge 116, and the right edge 118. Furthermore, in one embodiment, the head cover 100 is a continuous structure from the occipital region to the eyebrows or the forehead. Still further, a structure or an inflatable structure is provided to compress the eyebrows for a vascular compression effect at the eyebrows. It should be understood that the pressure source may be used alone or as part of a control system such as that configured by the control system 180 and connector 185 of FIG. 9 or by the control system 190 as configured in FIG. 10A. In one embodiment, the pressure source 160 is in communication with the components of the head cover 100 using a suitable connector 185 as shown in FIG. 9. In another embodiment, the pressure source 160 is mounted on the head cover 100 as shown in the configuration of the control system 190 in FIG. 10A.

[0039]

[0077] In additional embodiments, the at least one vascular compression element includes an expandable feature that expands away from the shell in response to the pressure source 160. An expandable layer coupled to the liner may be provided, with the at least one vascular compression element on the expandable layer. Additionally or optionally, the at least one vascular compression element includes one or more raised features. A liner within the shell that is shaped to at least partially accommodate the patient's hair may include one or more features on the liner that engage with the patient's hair. Still further, the liner or at least one vascular compression element may include an array of evenly distributed protrusions that are smooth, textured, have an irregular shape, or have a straight or circular semi-rigid, flexible, or expandable structure.

[0040]

[0078] In yet another aspect, a gas source is included in communication with the liner or at least one vascular compression element for inflation of a portion of the liner or at least one vascular compression element. The system may include at least one relief valve to prevent overpressurization of the inflatable element of the head cover 100. In various embodiments, the gas source is a manual pump mechanism, a bulb, an electric pump, or a pressurized tank, cartridge, or reservoir. Optionally, the gas source may be worn or carried by the patient. Still further, the head cover 100 may include a fitting or connector for use with household gas, clean dry air, or other building-supplied gas source. Additionally or optionally, a control system may be provided, such as control system 180 or control system 190, configured to regulate the flow of gas from the gas source to maintain a desired pressure within the head cover 100.

[0041]

[0079] In still further embodiments, the control system 180 or the control system 190 may be a gas source and control system adapted and configured to include other additional functions such as those described herein. The desired pressure within the head cover 100 is sufficient to provide a result of vascular compression while minimizing discomfort or side effects to the patient or harm to surrounding structures. A cooling gas source in communication with the liner or at least one vascular compression element may also be included, and a portion of the liner or a portion of the at least one vascular compression element is adapted to provide cooling to the inner portion of the head cover 100. One or more pressure sensors within the inner portion of the head cover 100 may be included. The one or more pressure sensors may be appropriately selected and provided to generate a signal indicating the pressure to the control system 180 / 190. Still further, the one or more pressure sensors are adapted to indicate the amount of pressure applied to the patient when the patient undergoing chemotherapy is wearing the head cover 100. Additionally, the one or more sensors may be configured to measure skin perfusion (O2sat) or may be a Doppler blood flow monitor or an infrared pulse oximeter sensor. The sensors described herein may be adapted and configured to determine the blood flow rate in the vasculature undergoing vascular compression to determine that the flow is stopped or slowed sufficiently to prevent the flow of blood containing the chemotherapy drug. In one aspect, detection of significantly reduced or stopped blood flow may also be used as a trigger in the control system 180 / 190 to increase the amount of vascular compression by an additional margin to increase the certainty that the amount of vascular compression applied is sufficient. This additional margin of vascular compression may be included in a feedback loop performed by the control system 180 / 190 to measure the amount of blood flow, increase the vascular compression, measure the blood flow to determine if it has slowed or stopped, and then increase the vascular compression level, if necessary. A further step of increasing the vascular compression level after detecting stopped blood flow may then be added as a safety margin to ensure a temporary and reversible vascular compression-induced vascular closure.

[0042]

[0080] Additionally, the head cover 100 may be coupled to a timer and control system 180 / 190 adapted to provide an automatic deflation protocol when a timer has elapsed or to deactivate any active vascular compression elements. In one variation, the head cover 100 may be coupled to a timer and control system 180 / 190 adapted for programmed automatic inflation and deflation of the liner or one or more vasoconstriction elements, or activation and deactivation of one or more vasoconstriction elements. The system 180 / 190 may include a display and Bluetooth, near-field wireless communication, or other wireless or wired communication capabilities. Still further, the system may communicate status, programming, patient information, or other aspects of vascular compression therapy or operation to a mobile phone, network, remote network, or health information system. In yet other aspects, a display may be disposed on the head cover 100 to provide information to a health care provider or patient. Additionally or optionally, the display may be located on, within, within, or integral to a portion of the shell 110. One embodiment of the display may be on a moveable mount to allow the patient to view the display with the head cover. Additionally or optionally, the head cover may be fitted with appropriate 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 aspects, the head cover 100 may also include earphones, headphones, speakers, or other acoustic 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 while receiving chemotherapy or while using the head cover 100.

[0043]

[0081] Furthermore, with respect to the head cover 100 operating by the timer sequence of one embodiment of the control system 180 / 190, the timing may be adapted to correspond to the expected half-life or toxicity level of the chemotherapy agent at the time of use. In this way, the initiation of vascular compression therapy and the duration of vascular compression therapy may be related to the introduction of chemotherapy agent and the expected duration of vascular compression therapy to correspond to the lingering toxicity of the blood of the residual chemotherapy agent. Considering the drug concentration profile of FIG. 3B and FIG. 13B, the duration of vascular compression therapy is selected to that time duration when the drug concentration level is lower than the peak level and approaches zero or the pre-chemotherapy level of the blood. This amount may vary depending on the patient, as well as the specific toxicity profile and the half-life of the specific chemotherapy agent at the time of use. Thus, the timing function of the controller 180 / 190 may provide an automatic deflation protocol when a timer has elapsed that is selected to address the specifics of the patient and the agent used. Optionally, further timing margins may be added to provide further confidence that the toxic levels of chemotherapy drugs in the blood do not pose any further threat to the health of the scalp and hair structure (FIG. 8) or that the threat is significantly reduced. Additionally or optionally, once the timer has elapsed or any activated vascular compression elements have been deactivated, the control system may stage or stagger the interruption of vascular compression therapy to sequence the reintroduction of blood flow after vascular compression therapy. In one variation, the head cover 100 may be coupled to a timer and control system 180 / 190 adapted for programmed automatic inflation and deflation of the liner or one or more vasoconstriction elements, or activation and deactivation of one or more vasoconstriction elements, according to the guidelines described above.

[0044]

[0082] In yet another embodiment of the head covering 100 having a liner, the liner may be a rigid or semi-elastic layer configured for a precise fit to the patient so as to precisely fit the shape of the patient's head and hair.

[0045]

[0083] Various hair covering embodiments described herein may include one or more selective pressure points positioned to compress one or more vessels of the patient's cranial circulatory system. Additionally, other embodiments may include a vibration element coupled to the liner or at least one vascular compression element. In still further embodiments, the liner 120 and at least one vascular compression element 130 are sized, shaped, or positioned relative to the head covering 100 based on the patient's hairstyle.

[0046]

[0084] In yet another alternative embodiment of the head covering 100, there is a cap having a leading edge, a trailing edge, a top, a left edge, and a right edge. Within the cap is a liner configured to at least partially contain the patient's hair. Within the cap is at least one vascular compression element. In one alternative, the cap comprises a flexible structure, a partially flexible structure, a combination of semi-rigid and flexible structures, or an adjustable structure sized to remain in place on the head when the at least one vascular compression element is activated.

[0047]

[0085] In still other various alternative embodiments, the head cover 100 having a cap form factor may be adapted and configured to include any of the alternative, optional, and further variations and embodiments described above.

[0048]

[0086] In some embodiments, the one or more vascular compression elements are biased into contact with the scalp via a spring, a mechanical link, an electromechanical drive, or an electromagnetic device.

[0087] 12A-15, which are used to illustrate an exemplary method of providing vascular compression to a patient undergoing chemotherapy, it will be understood that the method and variations thereof may be modified for implementation using any of the head cover 100 embodiments or vascular compression element 130 described above.

[0049]

[0088] 12A is a left side view of a patient's head wearing a head cover 100 including at least one vascular compression element 130 used to deliver vascular compression. This is the patient's condition before or shortly after starting chemotherapy. Also visible in this view is a subchin strap 140 connected to the shell 110 of the head cover 100. The head cover 100 is configured to deliver vascular compression to the scalp 7 and eyebrows 9 of the patient.

[0050]

[0089] Figure 12B is a cross-sectional view of a portion of the patient's hair, scalp, and hair follicles of Figure 12A. The figure shows the hair 7 pressed against the scalp when the head covering 100 is worn (Figure 12A) and prior to delivery of vascular compression.

[0051]

[0090] Fig. 12C is a cross-sectional view of a portion of the patient's hair, scalp, and hair follicle of Fig. 12B, illustrating the expansion (in the direction of the arrow) of one or more vascular compression elements 130 in the head covering 100 causing vascular compression in the vascular bed 62 of the hair follicle.

[0052]

[0091] 12D is an external view of a patient 1 undergoing chemotherapy while vascular compression is being delivered by the head covering 100. The arrows indicate that vascular compression may be applied simultaneously or sequentially to multiple portions of the scalp 7, including the eyebrows 9.

[0053]

[0092] FIG. 13A is an illustration of the patient of FIGS. 12A-12D receiving vascular compression from the head cover during a nearly completed chemotherapy session, as indicated by a nearly empty IV pouch 5 of chemotherapy drug 10. FIG.

[0054]

[0093] Figure 13B is a graph showing the expected concentration curve of chemotherapy drug 10 in a patient's blood stream as a function of drug concentration (mg / L) and time (min) for the patient condition of Figure 13 A. Triangle 25 indicates the estimated concentration based on the amount of chemotherapy agent delivered as indicated by the decreasing fluid level visible in the pouch of Figure 13 A. Arrows indicate the drug concentration amount is near or just beyond the peak or maximum drug concentration.

[0055]

[0094] FIG. 13C is an illustration of the progression of the process of chemotherapy-induced necrosis in the target tumor or malignant lesion of the patient of FIGS. 12A, 12D, and 13A undergoing vascular compression during delivery of chemotherapy drugs.

[0056]

[0095] Figure 13D is a cross-sectional view of the head cover 100, scalp and hair follicles of the patient of Figures 12A, 12D and 13A undergoing vascular compression during delivery of chemotherapy agent 10 (Figure 13B). This figure shows that the vascular bed is completely or substantially free of any chemotherapy agent 10, or that the levels of chemotherapy agent 10 reaching the vascular bed are maintained below levels that would harm the hair follicles.

[0057]

[0096] In contrast to the catastrophic damage experienced by the unprotected patient of Figure 6B, a patient undergoing vascular compression during chemotherapy has vasculature 62 closed, preventing chemotherapy drug 10 from being delivered to or damaging bulb 64 and associated hair shaft 70. As a result of the advantageous prevention of chemotherapy drug introduction into the vascular bed of the scalp and eyebrows, a patient undergoing vascular compression as described herein in combination with chemotherapy avoids one or more of chemotherapy-induced alopecia (CIA), chemotherapy drug-induced hair loss, hair follicle death, and / or anagen effluvium.

[0058]

[0097] Figure 14 is a side view of the patient of Figure 13A at a period following delivery of chemotherapy using vascular compression. The patient has maintained hair 7 on both the head 3 and eyebrows 9 as a result of the beneficial effects of vascular compression.

[0059]

[0098] FIG. 15 is a flow chart of an exemplary method 1500 of providing vascular compression to a patient undergoing chemotherapy treatment.

[0099] A typical method for inducing vascular compression in the cranial circulatory system of a patient undergoing chemotherapy begins by placing the head cover 100 around the patient's head (step 1510).

[0060]

[0100] Next there is the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system using the vascular compression element of the head cover 100 (step 1520).

[0101] Next, there is a step of initiating a chemotherapy session for the patient (step 1530).

[0061]

[0102] Next, there is the step of terminating the chemotherapy session for the patient (step 1540).

[0103] Finally, there is a step of ceasing the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system when a period of time sufficient to partially alleviate the effects of chemotherapy-induced alopecia in the patient has elapsed after the step of terminating the chemotherapy session (step 1550).

[0062]

[0104] Optionally or additionally, the step of inducing vascular compression in a portion of the cranial circulatory system may be coordinated before, during, or after the step of initiating or terminating a chemotherapy session.

[0063]

[0105] The method 1500 may include engaging the head cover retention system 140 to secure the head cover 100 against the patient's head.

[0106] The period of time that has elapsed after the step of terminating the chemotherapy session may be 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, or more of a period of time that is relevant when the level of drug concentration in the patient's blood stream is below a level that will harm the hair follicles.

[0064]

[0107] In a further aspect of the method, the vascular compression element 130 of the head covering 100 is a liner 120, 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 are performed. Additionally or optionally, during the step of expanding the liner, the amount of vascular compression increases or decreases in response to an increase in force by the liner against the patient's scalp.

[0065]

[0108] In a further aspect of the method, a vascular compression element of the head covering is provided that 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 are performed. In yet a further aspect, during the step of expanding the liner, the amount of vascular compression increases in response to an increase in force by the one or more features on the liner against the patient's scalp. Additionally or optionally, during the step of contracting the liner, the amount of vascular compression decreases in response to a decrease in force by the one or more features on the liner against the patient's scalp.

[0066]

[0109] In yet another variation on the method, the vascular compression element 130 of the head cover is an inflatable inner bag, 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 in part to the amount of pressure within the inflatable inner bag.

[0067]

[0110] In yet another variation on the method, the vascular compression element 130 of the head cover is an inflatable inner bag, 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 is increased or decreased by increasing or decreasing the pressure within the inflatable inner bag against the skull.

[0068]

[0111] In yet another variation, the vascular compression element of the head covering is one or more features arranged on an inner surface of the head covering that are biased into contact with a portion of the patient's scalp having hair follicles during a step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system.

[0069]

[0112] Another variation includes the vascular compression element of the head covering being one or more features arranged on an inner surface of the head covering that correspond to the arrangement of the patient's hair, the one or more features acting on the arrangement of the patient's hair to enhance the outcome of the step of at least partially inducing vascular compression in a portion of the patient's cranial circulatory system.

[0070]

[0113] In yet another variation of the method, during the step of at least partially inducing vascular compression, a vascular compression element of the head cover compresses a portion of the scalp including a plurality of hair follicles against a portion of the skull to at least partially vascularly compress a blood supply to the plurality of hair follicles. Additionally or optionally, a step is provided in which the portion of the skull is one or more of the superior temporal line, the inferior temporal line, the parietal bone, the squamosal suture, the temporal bone, the lambdoid suture, the occipital bone, the mastoid process, the sphenoid bone, a portion near the supraorbital foramen, the frontal bone, and the coronal suture.

[0071]

[0114] In another alternative version of the 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 by compressing the artery or vein against a portion of the skull. Furthermore, the artery or vein of the cranial circulatory system is a tributary of the external carotid artery or a tributary of the internal carotid artery, the artery or vein of the cranial circulatory system is an ophthalmic artery, the artery or vein of the cranial circulatory system is a superficial temporal artery, the artery or vein of the cranial circulatory system is a posterior auricular artery, the artery or vein of the cranial circulatory system is an occipital artery, or the artery or vein of the cranial circulatory system is a supraorbital artery or a supratrochlear artery. Furthermore, optionally or in combination, the portion of the skull is one or more of the superior temporal line, the inferior temporal line, the parietal bone, the squamosal suture, the temporal bone, the lambdoid suture, the occipital bone, the mastoid process, the sphenoid bone, a portion near the supraorbital foramen, the frontal bone, and the coronary suture. It should be appreciated that the size, shape, and orientation in use of the shell 110, along with the size, shape, overall location, and relative positions of the leading edge 112, trailing edge 114, apex 113, left edge 116, and right edge 118 of the shell 110, may be advantageously selected, alone or in any combination with one or more embodiments of vascular compression elements described herein, to selectively apply active and controllable vascular compression to one or more of the arteries or veins of the cranial circulatory system listed above. In one particular example, given that the scalp receives a rich arterial supply via the external carotid and ophthalmic arteries (tributaries of the internal carotid), an embodiment of a vascular compression element or array of elements is provided that compresses nutrient vessels with a higher pressure (not tourniquet-like, but rather direct point pressure) than would otherwise be applied to the scalp / hair or eyebrow area.

[0072]

[0115] In a further variation, the method includes the step of at least partially inducing vascular compression in a portion of the cranial circulatory system resulting from compression of a portion of the scalp including blood vessels of the patient's cranial circulatory system against a portion of the patient's periosteum.

[0073]

[0116] In a further variation, the method includes the step of at least partially inducing vascular compression in a portion of the cranial circulatory system being brought about by interaction between a vascular compression element of the head cover and a blood vessel of the patient's cranial circulatory system.

[0074]

[0117] In yet another variation, the step of at least partially inducing vascular compression in a portion of the cranial circulatory system further comprises 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.

[0075]

[0118] In another alternative version of the method, during the engaging step, there is a step of positioning a vascular compression element of the head cover against the patient's head such that the vascular compression element is positioned proximate to a particular vein or particular artery for at least partially vascularly compressing the particular vein or particular artery of the patient's cranial circulatory system.

[0076]

[0119] Another alternative of the method includes delivery of a vasoconstrictor agent to the patient before, during, or after any of the methods described above. In one embodiment, the vasoconstrictor agent is one of alpha-adrenergic receptor agonists, vasopressin analogs, epinephrine, norepinephrine, phenylephrine, dopamine, dobutamine, migraine medications, headache medications, serotonin 5-hydroxytryptamine agonists, and triptans. Additionally, the above methods and devices, and all variations thereof, may be used to deliver vascular compression while the patient is receiving chemotherapy by injection, infusion, targeted therapy, hormonal therapy, or immunotherapy. Still further, these methods and devices that provide vascular compression may be used before or while the patient is receiving chemotherapy by intravenous, intrathecal, intraarterial, intracavitary, intramuscular, intralesional, or intracapsular methods. Additionally or optionally, these methods and devices for providing vascular compression are compact, portable, and capable of traveling with the patient, so that the methods and devices can be easily used whether the patient is receiving chemotherapy at home, a health care provider office, a clinic, an outpatient infusion center, a hospital infusion center, or a hospital room.

[0077]

[0120] Details of the construction of the head cover, shell, head cover retention features, or one or more vascular compression elements may be understood by reference to US Pat. No. 3,242,500 to Derr.

[0078]

[0121] Further details of potentially suitable materials, details of the construction of the head cover, shell, head cover retention features, or details of the construction of one or more vascular compression elements can be found by reference to U.S. Patent No. 9,743,701 to Javorek. By way of illustration and example, further aspects and alternatives are described herein for use with one or more head cover retention system embodiments having details relating to hook and loop fasteners, buckles, quick release mechanisms, or adjustment features, for example.

[0079]

[0122] Further details of potentially suitable materials, as well as details of the construction of one or more vascular compression elements, may be found by reference to US Design Patent No. 267,287 to Gooding.

[0123] Further details of potentially suitable materials, details of the construction of the head cover, shell, head cover retention features, or details of the construction of one or more vascular compression elements can be found by reference to U.S. Application Publication No. 2006 / 0070170 to Copeland.

[0080]

[0124] Further details of potentially suitable complementary compounds that may be used in combination with the devices and methods described herein, as well as information related to the treatment of chemotherapy-induced alopecia, may be found by reference to U.S. Patent Application Publication No. 2019 / 0240192 to Georgopoulos.

[0081]

[0125] In addition to those listed above, still further additional alternative embodiments and combinations of the inventive features described herein are possible to deliver the active, personalized, vascular compressible therapy described herein, for example, as follows:

[0082]

[0126] Selective vascular compression of critical portions of the blood supply to the scalp includes, for example, programmed sequences of applying compression to empty capillary beds or to occlude major blood vessels in the scalp / skull.

[0083]

[0127] In one aspect, the head cover is configured to include a set of separate vascular compression elements, one along the periphery of the head cover or shell, and the other within the interior of the shell. In one example, the arrangement is a peripheral vascular compression zone and a central vascular compression zone. It should be understood that these zones can be operated at different pressure levels or amounts of vascular compression by manual control or by use of the controller 180 / 190. These exemplary peripheral and central zones may be further divided, or additional other zones may be provided or incorporated into the head cover to more precisely deliver vascular compression therapy. Additionally or optionally, these zones can be operated at different pressure or vascular compression levels as needed to deliver a preselected or patient-specific vascular compression therapy profile.

[0084]

[0128] A single device for vascular compression for protection of all hair on the head is advantageous for protecting both hair on the scalp and hair on the eyebrows. Inclusion of the eyebrows can be provided by an additional vascular compressible element positioned, sized and adapted for this purpose (see, for example, Figures 10A and 11A).

[0085]

[0129] The custom-fit vascular compression device is adapted and configured to a patient's specific head shape and hairstyle. Further 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 a liner and shell adapted to the patient's comfort and the outcome of the vascular compression therapy session.

[0086]

[0130] An improved active control and / or feedback vascular compression control system 180 / 190 using integrated pressure sensors and other sensing devices within / integrated with the vascular compression device includes integration into a liner, expandable layer, or shell, including, for example, a stretch, strain, or other measurement system, built into one or more components of the head cover 100 to induce vascular compression in the patient.

[0087]

[0131] An embodiment of the personalized vascular compression device may include one or more pressure sensors within an inner portion of the head cover. The one or more pressure sensors may provide a pressure reading to the control system 180 / 190. The one or more pressure sensors may be adapted to indicate the amount of pressure applied to a patient undergoing chemotherapy when the patient is wearing the head cover. The head cover may further include one or more sensors measuring skin perfusion (O2sat), or a Doppler blood flow monitor or an infrared pulse oximeter sensor.

[0088]

[0132] The inner liner (adjacent the patient) may be a rigid or semi-elastic layer configured for a precise fit against the patient to precisely fit the shape of the patient's head and hair. The head cover retention system may include a fastening 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 vibration element coupled to the liner or the at least one vascular compression element. The liner and the at least one vascular compression element may be sized, shaped, or positioned relative to the head cover based on the patient's hairstyle.

[0089]

[0133] The head cover may further include a gas source in communication with the liner or at least one vascular compression element for inflation of a portion of the liner or at least one vascular compression element. The head cover may further include at least one relief valve to prevent overpressurization of the inflatable element of the head cover. The gas source may be a manual pump mechanism, a bulb, an electric pump, or a pressurized tank, cartridge, or reservoir. The head cover may further include a control system 180 / 190 for regulating the flow of gas from the gas source to maintain a desired pressure within the head cover. The desired pressure within the head cover may be sufficient to provide the results of vascular compression while minimizing discomfort or side effects to the patient or harm to surrounding structures.

[0090]

[0134] The head cover may further include a cooling gas source in communication with the liner or at least one vascular compression element, and a portion of the liner or at least one vascular compression element is adapted to provide cooling to an inner portion of the head cover. Additionally, the gas used for inflation of the vascular compression element may be cooled. The head cover may further include one or more pressure sensors within the inner portion of the head cover. The one or more pressure sensors may provide an indication of pressure to the control system 180 / 190. The one or more pressure sensors may be adapted to indicate an amount of pressure applied to a patient undergoing chemotherapy when the patient is wearing the head cover.

[0091]

[0135] The personalized vascular compression system may include improved communication connectivity. As a result of this feature, a user may use a personal vascular compression device with the functionality found on a smart device while receiving treatment. Additionally, noise canceling headphone or earphone functionality may be provided to enhance the user experience. The system may include a display and Bluetooth, near field communication, or other wireless or wired communication capabilities. Still further, the system may communicate status, programming, patient information or data, and / or any vascular compression device data related to all and any other aspects of the vascular compression therapy or operation to an on-board storage device, a mobile phone, a communication network, a remote network, or a health information system. In still other aspects, the display may be disposed on the head cover to provide information to a health care provider or the patient. In additional aspects, the head cover may include earphones, headphones, speakers, or other acoustic components adjacent to the patient's ears. In these embodiments, the system is also configured to provide noise canceling, music, media, or other entertainment to the patient while receiving chemotherapy or while using the head cover. Embodiments of the head cover may be externally powered by plugging into a suitable power source, or may be wirelessly powered, such as by use of an on-board battery system, or an on-board rechargeable battery system.

[0092]

[0136] It is understood that aspects of the components of the head covering 100 are modified and adapted for the presence of the patient's hair 7, as it is the intent to protect and preserve the hair through the use of various vascular compression devices and techniques. In further or alternative embodiments, further liners or modified vascular compression elements may include additional inherent conforming areas to conform and correspond to raised areas within the skull and areas where the hair is collected or arranged during use of the head covering 100. In particular, the design and use of the head covering 100 in delivering vascular compression therapy factors in the situation in which the patient's hair, amount, style, and placement against one or more vascular compression elements 130 compresses the (non-compressible) hair, which in turn compresses the scalp, thereby also contributing to vascular compression of the vasculature.

[0093]

[0137] Additionally or optionally, one or more surfaces of one or more vascular compression elements may be modified to have raised features of various cross-sectional shapes and tips or to have protrusions of various lengths to accommodate different areas or points in the particular shape of the patient's skull, such that the skull is treated appropriately uniformly in areas that are not on a uniform surface with the surrounding areas. Furthermore, a combination of liner features, vascular compression element features, and the alignment and placement of the patient's hair may also be used to accommodate the patient's particular cranial topography and shape, thereby improving the operation of the head cover and patient-specific outcomes and comfort.

[0094]

[0138] In this specification, when a feature or element is described as being "on" another feature or element, the feature or element may be directly on the other feature or element, or there may be intervening features and / or elements present. In contrast, when a feature or element is described as being "directly on" another feature or element, there are no intervening features or elements present. Also, when a feature or element is described as being "connected," "attached," or "coupled" to another feature or element, it will be understood that the feature or element may be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements present. In contrast, when a feature or element is described as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may apply to other embodiments. Additionally, it will be understood by one of ordinary skill in the art that a reference to a structure or feature being disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0095]

[0139] The terminology used herein is merely for the purpose of describing certain embodiments, and such terminology is not intended to be limiting of the present invention. For example, as used herein, the singular forms "a", "an", and "the" include the plural unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising" as used herein specify the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items, and may be abbreviated as " / ".

[0096]

[0140] Spatially relative terms, such as "below," "down," "below," "below side," "on," "above," and the like, may be used herein for ease of description to describe the relationship of one element or feature to another element or feature as shown in the figures. It will be understood that the spatially relative terms are intended to encompass various orientations of the device during use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, an element described as "below" or "directly below" another element or feature will be oriented "above" the other element or feature. Thus, the exemplary term "below" can encompass both an up and down orientation. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptions used herein will be interpreted accordingly. Similarly, the terms "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless specifically indicated otherwise.

[0097]

[0141] The terms "first" and "second" may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings of the present invention, a first feature / element described below may be referred to as a second feature / element, and similarly, a second feature / element described below may be referred to as a first feature / element.

[0098]

[0142] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "comprises" and "comprising" mean that various components may be used jointly in methods and articles (e.g., compositions and apparatus, including devices, and methods). For example, the term "comprising" will be understood to imply the inclusion of any described elements or steps, but not the exclusion of any other elements or steps.

[0099]

[0143] As used herein in the specification and claims, such as when used in the examples, unless otherwise expressly stated, all numbers may be read as if they were prefaced with the word "about" or "approximately", even if the term does not explicitly appear. The phrase "about" or "approximately" may be used when describing a size and / or location to indicate that the stated value and / or location is within a reasonable expected range of values ​​and / or locations. For example, a numerical value may have a value that is ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2% of the stated value (or range of values), ±5% of the stated value (or range of values), ±10% of the stated value (or range of values), etc. Any numerical value given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range recited herein is intended to include all subranges encompassed herein. It is also understood that when a value is disclosed, "less than or equal to" that value, "more than or equal to" that value, and possible ranges between these values ​​are also disclosed, as would be properly understood by one of ordinary skill in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "more than or equal to X" are also disclosed (e.g., where X is a numerical value). It is also understood that throughout this application, data is provided in several different formats, and this data represents end and starting points, as well as ranges for any combination of data points. For example, when a specific data point "10" and a specific data point "15" are disclosed, it is understood that greater than 10 and greater than 15, greater than or equal to 10 and greater than or equal to 15, less than 10 and less than 15, less than or equal to 10 and less than or equal to 15, and equal to 10 and 15 are disclosed and considered to be between 10 and 15. It is also understood that each unit between two specific units is also disclosed. For example, when 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0100]

[0144] Although various exemplary embodiments have been described above, any number of modifications may be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which the steps of the various described methods are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Thus, the foregoing description is provided primarily for purposes of illustration and should not be construed to limit the scope of the invention as set forth in the claims. The examples and illustrations contained herein set forth, by way of example and not limitation, specific embodiments in which the subject matter may be practiced. As noted above, other embodiments may be utilized, and structural and logical substitutions and changes may be made therefrom without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention, when in fact more than one is disclosed, may be referred to individually or collectively herein by the term "invention" merely for convenience, without any intention to spontaneously limit the scope of this application to any single invention or inventive concept. Thus, although specific embodiments have been illustrated and described herein, any arrangement designed to achieve the same purpose may be substituted for the specific embodiment illustrated. The present disclosure is intended to include any and all adaptations or variations of the various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

1. A head cover for inducing vascular compression in the blood supply of a patient undergoing chemotherapy, comprising: a shell having a leading edge, a trailing edge, a top, a left edge, and a right edge; a liner within the shell configured to at least partially contain the patient's hair; at least one vascular compression element within the shell; a head cover retention system coupled to the shell; one or more pressure sensors within an interior portion of the head cover; Equipped with the one or more pressure sensors are adapted to indicate an amount of pressure exerted on a patient undergoing chemotherapy when the patient is wearing the head covering. Head cover.

2. The head cover retention system includes an under-chin strap connected to the shell. The head cover according to claim 1.

3. the head cover retention system comprises one or more of a rear strap, a front strap, or a neck strap connected to the shell; The head cover according to claim 1.

4. the at least one vascular compression element is an expandable bladder within the liner; The head cover according to claim 1.

5. a pressure source in communication with the expandable bladder; The head cover according to claim 4.

6. a continuous perimeter connecting the leading edge, the trailing edge, the left edge, and the right edge; The head cover according to claim 1.

7. the head cover retention system further comprises a hook and loop fastener, a buckle, a quick release mechanism, or an adjustment feature; The head cover according to claim 1.

8. a gas source in communication with the liner or the at least one vascular compression element for inflation of a portion of the liner or a portion of the at least one vascular compression element; The head cover according to claim 1.

9. The gas source is a manual pump mechanism, a bulb, an electric pump, or a pressurized tank, cartridge, or reservoir. The head cover according to claim 8.

10. a control system for regulating the flow of gas from the gas source to maintain a desired pressure within the head cover; The head cover according to claim 8.

11. Further comprising a continuous structure from the occipital region to the eyebrow or forehead; The head cover according to claim 1.

12. The liner is a rigid or semi-elastic layer configured for a precise fit to the patient so as to precisely fit the shape of the patient's head and hair. The head cover according to claim 1.

13. and further comprising one or more selective pressure points positioned to compress one or more vessels of the patient's cranial circulatory system. The head cover according to any one of claims 1 to 12.

14. and further comprising a vibration element coupled to the liner or the at least one vascular compression element. The head cover according to any one of claims 1 to 13.

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