Cooling cap assembly and cooling unit

Abstract

The devices, systems, and methods herein relate to cooling a patient's head. These systems and methods may include a cooling cap assembly including a heat exchanger configured to be wrapped around the patient's head and a compression assembly releasably coupled to the heat exchanger. The compression assembly may include a housing and an expandable member coupled to an inner surface of the housing. When coupled, the expandable member may be positioned between the housing and the heat exchanger. The heat exchanger may be separate from and movable relative to the expandable member.

Description

Cross-reference of related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 856,691, filed on 3 June 2019, and U.S. Provisional Patent Application No. 62 / 882,429, filed on 2 August 2019, the contents of which are incorporated herein by reference in their entirety. [Technical Field]

[0002] The devices, systems, and methods described herein relate to lowering the temperature of a patient's scalp. [Background technology]

[0003] Alopecia is a common side effect of chemotherapy, and the visible changes in appearance and loss of physical attributes can cause distress to some patients. For some patients, chemotherapy-induced alopecia can lead to depression, which can hinder their recovery. In response, some patients undergoing chemotherapy receive scalp cooling treatment. However, conventional techniques are not optimized for patient comfort and are usually performed in a treatment center where a technician ensures that the cooling device is properly installed and used correctly. Therefore, additional devices, systems, and methods for cooling the scalp may be desirable. [Overview of the Initiative]

[0004] This section describes devices, systems, and methods for providing cooling to alleviate or prevent alopecia associated with chemotherapy. These systems and methods can, for example, increase the contact area between the cooling element (e.g., a heat exchanger) and the patient's scalp. This can, for example, improve the efficiency of the cooling treatment. Furthermore, the devices and systems described herein can be compact and portable so that the patient can perform the cooling treatment at their convenience (e.g., at home).

[0005] In some variations, the cooling cap assembly can include a heat exchanger configured to be wrapped around a patient's head and a compression assembly releasably coupled to the heat exchanger. The compression assembly can include a housing and an expandable member coupled to an inner surface of the housing. When coupled, the expandable member can be positioned between the housing and the heat exchanger. The heat exchanger can be separated from the expandable member and movable relative to the expandable member.

[0006] In some variations, the expandable member can include a contracted configuration and an expanded configuration. Transitioning the expandable member from the contracted configuration to the expanded configuration can increase the pressure applied to the patient's head. In some variations, a fluid pump can be coupled to the expandable member. In some variations, the housing can be configured to generate a counterpressure when the expandable member is in the expanded configuration. In some variations, the compression assembly can be configured to generate a compression of from about 0.1 lb / in 2 to about 10 lb / in 2 on the head when the expandable member is in the expanded configuration.

[0007] In some variations, the inflatable member may include a plurality of chambers. In some of these variations, each of the plurality of chambers may be independently inflatable. In some variations, the inflatable member may include an upper inflatable portion, a first inflatable side portion, and a second inflatable side portion. Each portion may include a chamber. In some of these variations, the length of the first inflatable side portion and the length of the second inflatable side portion may each be longer than the length of the upper inflatable portion. In some variations, the length of the first inflatable side portion and the length of the second inflatable side portion may each be shorter than the length of the upper inflatable portion. In some variations, the inflatable side portions of the inflatable member may be configured to adjustably overlap so as to surround at least a portion of the head. In some variations, the inflatable member may include a fluid barrier. In some variations, the inflatable member may include one or more cuts. In some variations, the inflatable member may include at least three chambers. In some variations, the inflatable member may include one or more fasteners.

[0008] In some variations, the heat exchanger may include a bottom portion, an upper portion, a first side portion, and a second side portion. In some variations, the heat exchanger may include a set of fluid barriers, and each fluid barrier of the set of fluid barriers is from about 5 mm to about 15 mm from an adjacent fluid barrier within the set of fluid barriers. In some barriers, each fluid barrier within the set of fluid barriers may include a diameter of about 5 mm to about 10 mm. In some variations, the temperature sensor may be positioned within an opening of at least one fluid barrier of the set of fluid barriers. In some variations, at least one fluid barrier of the set of fluid barriers includes a toroidal shape. In some variations, the first side portion may include a first arm, and the second side portion may include a second arm.

[0009] In some of these modifications, the upper portion, the first side portion, and the second side portion each include a first lobe and a second lobe. In some of these modifications, the length of the first lobe of the first portion and the second portion may be longer than the length of the second lobe of the first portion and the second portion.

[0010] In some modifications, each part of the heat exchanger may include at least a portion of the fluid channel. In some modifications, the lengths of the first and second side portions may be shorter than the length of the top portion. In some modifications, the area of ​​either the first or second side portion to the area of ​​the top portion may be about 2:1 to about 0.5:1. In some modifications, the top portion may define the longitudinal axis. The first and second side portions may extend from the bottom portion at an acute angle to the longitudinal axis. In some modifications, one or more end portions of the heat exchanger may be configured to overlap flexibly so as to surround at least a portion of the head. In some modifications, the heat exchanger may include a flexible material. In some modifications, the heat exchanger may include a nonwoven fabric. In some modifications, the heat exchanger may have approximately 9 mm each. 2 ~approximately 100mm 2 It may include one or more fluid channels containing the cross-sectional area of ​​the fluid.

[0011] In some variations, one or more sensors may be coupled to the heat exchanger and configured to measure one or more properties of the compression assembly. In some of these variations, one or more sensors may include temperature sensors and pressure sensors. In some of these variations, the heat exchanger may have at least one sensor in each part of the heat exchanger. In some variations, the heat exchanger may include fasteners.

[0012] In some variations, the housing may include a rigid or semi-rigid material. In some variations, the housing may be configured to surround at least a portion of the inflatable member. In some variations, the housing may define a cavity configured to surround at least a portion of the inflatable member. In some variations, the housing may include a hemispherical shell. In some variations, the housing may include a helmet. In some of these variations, the housing may further include a flexible cover. In some variations, the housing may include fasteners configured to connect to the inflatable member. In some of these variations, the flexible cover may include fasteners. In some variations, the housing may define a cavity configured to receive a patient's head.

[0013] In some modifications, the liner may be configured to be positioned between the heat exchanger and the patient's scalp. Fasteners may be releasably coupled to the compression assembly and the patient. In some of these modifications, the liner may include a flexible material.

[0014] In some variations, the cooling unit may be fluidly coupled to the compression assembly. The cooling unit may comprise a heat exchanger, compressor, reservoir, and fluid connections releasably coupled to a pump. In some of these variations, the cooling unit may include a housing, a battery, and a fluid reservoir releasably coupled to the housing. In some of these variations, the cooling unit may be configured to circulate fluid through the heat exchanger. In some of these variations, the fluid may include one or more of the following: water (e.g., liquid water and ice) and salt, water and glycol, and water and alcohol, which can lower the freezing point of the fluid. In some variations, the ratio of water to alcohol may be about 20:1 to about 5:1.

[0015] In some variations, the cooling cap assembly may include a heat exchanger configured to wrap around the patient's head. A compression assembly may be releasably coupled to the heat exchanger. The compression assembly may comprise a housing and an inflatable member coupled to the inner surface of the housing. When coupled, the inflatable member may be positioned between the housing and the heat exchanger. The heat exchanger may be separated from the inflatable member and movable relative to the inflatable member. Transitioning the inflatable member from a contracted configuration to an expanded configuration may increase the contact area between the heat exchanger and the patient's head.

[0016] The device is also described here. In some variations, a method of cooling the scalp to reduce hair loss caused by chemotherapy may involve wrapping a heat exchanger around a portion of the scalp and placing a compression assembly on top of the head and the wrapped heat exchanger. The compression assembly may include a semi-rigid outer member and an inflatable inner member coupled to the outer member. The inflatable member can be inflated to compress the heat exchanger between the inflatable member and the scalp.

[0017] In some modifications, the heat exchanger may be separated from the expandable member and movable relative to the expandable member. In some modifications, the expandable member can be transitioned from a contracted configuration to an expanded configuration to increase the pressure applied to the head. In some modifications, when the expandable member is in the expanded configuration, a back pressure may be generated using the outer member. In some modifications, when the expandable member is in the expanded configuration, approximately 0.1 lb / in pressure is applied to the head. 2 ~about 10lb / in 2 Compression can be generated. In some modifications, the inflatable member may include multiple independently inflatable chambers. In some modifications, the liner may be positioned around the scalp portion so that a heat exchanger can be positioned between the liner and the inflatable member.

[0018] In some variations, the heat exchanger may include a bottom portion, a top portion, a first side portion, and a second side portion. The ends of the first side portion and the ends of the second side portion may be arranged to overlap each other. The ends of the top portion may be positioned on top of the ends of the first side portion and the ends of the second side portion so as to surround at least the scalp portion.

[0019] In some variations, the inflatable member can be inflated with gas or liquid. In some variations, the inflatable member can be inflated using a manual pump. In some variations, a fluid can be circulated through a heat exchanger. The fluid can contain temperatures from about -10°C to about 5°C. In some variations, the heat exchanger can be removed from the scalp using a compression assembly. In some of these variations, the heat exchanger can be returned to the scalp using a compression assembly. In some variations, fasteners can be used to releasably attach the compression assembly to the scalp.

[0020] The device is also described here. In some variations, the cooling cap assembly may include a flexible heat exchanger configured to remove heat from the patient's scalp. The heat exchanger may include a temperature sensor. The inflatable member may include a pouch having an upper and lower surface, the lower surface being releasably coupled to the heat exchanger. A pump may be configured to inflate the pouch. An outer shell may be coupled to the upper surface of the pouch of the inflatable member. A cooling unit may be fluidly coupled to the heat exchanger. Memory may receive temperature from the temperature sensor and include instructions for adjusting the pump output based on this temperature.

[0021] In some variations, the pump output may be expansion pressure. In some variations, the temperature may be scalp temperature. In some variations, the temperature sensor may be located on the outside of the heat exchanger, inside the heat exchanger, or within the fluid channels of the heat exchanger. In some variations, the heat exchanger may include one or more fluid channels containing a circulating fluid. In some of these variations, the temperature may be fluid temperature.

[0022] In some variations, the temperature sensor may include a set of temperature sensors, the temperature may include a set of temperature sensors, and the pouch may include a set of chambers. The memory may include instructions for independently adjusting the expansion pressure of each chamber in the pouch based on the temperature set.

[0023] In some variations, the cooling unit may be portable. In some variations, the cooling unit may include a releaseable fluid reservoir. In some variations, the fluid reservoir may include a handle. In some variations, the cooling unit may include an adjustable handle. In some variations, the cooling unit may include a battery.

[0024] The method is also described here. In some variations, a method for controlling the cooling of the scalp of a chemotherapy patient involves applying a cooling cap to the head. The cooling cap may include a flexible heat exchanger containing a temperature sensor. An inflatable member may be releasably coupled to the heat exchanger. A shell may be coupled to the inflatable member. The inflatable member may include a pouch and a pump in fluid contact with the pouch to increase the inflation pressure of the pouch. The temperature may be measured using a temperature sensor. The inflation pressure of the pouch may be adjusted using the pump based on the measured temperature.

[0025] In some variations, temperature may be scalp temperature. In some variations, temperature sensors may be on the outer surface of the heat exchanger, inside the heat exchanger, or within the fluid channels of the heat exchanger. In some variations, the heat exchanger may include one or more fluid channels containing a circulating fluid. In some of these variations, temperature may be fluid temperature. In some variations, temperature sensors may include a set of temperature sensors, temperature may include a set of temperatures, pouch may include a set of chambers, and the method includes independently adjusting the expansion pressure of each chamber of the pouch based on the set of temperatures.

[0026] In some modifications, the heat exchanger may be separated from the expandable member and movable relative to the expandable member. In some modifications, transitioning the expandable member from a contracted configuration to an expanded configuration may increase the pressure applied to the head. In some modifications, when the expandable member is in the expanded configuration, a back pressure may be generated using the shell. In some modifications, when the expandable member is in the expanded configuration, approximately 0.1 lb / in pressure is applied to the head. 2 ~about 10lb / in 2 Compression can be generated. In some variations, the inflatable member may include multiple independently inflatable chambers.

[0027] In some modifications, the liner may be positioned around the scalp portion such that the heat exchanger is located between the liner and the inflatable member. In some modifications, the heat exchanger may include a bottom portion, a top portion, a first side portion, and a second side portion. The first and second side portions may be positioned overlapping. The top portion may be positioned on top of the first and second side portions so as to surround at least the scalp portion.

[0028] In some variations, the pouch may contain a fluid, including gas or liquid. In some variations, the fluid may circulate through a heat exchanger. The fluid may have a temperature range of approximately -10°C to approximately 5°C. In some variations, the compression assembly may be attached to the scalp using fasteners.

[0029] In some variations, the cooling cap assembly may include a flexible heat exchanger configured to remove heat from the patient's scalp, an inflatable member releasably coupled to the heat exchanger, an outer shell coupled to the inflatable member, a cooling unit fluid-coupled to the heat exchanger, a cooling unit configured to determine a power source and circulate fluid through the heat exchanger, and a memory containing instructions for adjusting the fluid flow rate of the cooling unit based on the determined power source. In some variations, the power source may include one or more AC and DC power sources.

[0030] In some variations, a method for controlling the cooling of the scalp of a chemotherapy patient may include applying a cooling cap to the head. The cooling cap may include a flexible heat exchanger, an inflatable member releasably coupled to the heat exchanger, and a shell coupled to the inflatable member. The method may include the steps of circulating a temperature-controlled fluid through the heat exchanger using a cooling unit having multiple operating states, identifying a power source for the cooling unit, and selecting an operating state for the cooling unit based on the identified power source. [Brief explanation of the drawing]

[0031] [Figure 1A] This is a block diagram of an exemplary and modified cooling cap assembly. [Figure 1B] This is an exploded perspective view of an exemplary modified cooling cap assembly. [Figure 1C] This is a block diagram of an exemplary and modified cooling cap assembly. [Figure 2A] This is a schematic diagram of an exemplary and modified heat exchanger. [Figure 2B] This is a schematic diagram of an exemplary and modified heat exchanger. [Figure 2C] This is a schematic diagram of an exemplary modified example of a heat exchanger placed on a patient's scalp. [Figure 2D] This is a schematic diagram of an exemplary modified example of a heat exchanger placed on a patient's scalp. [Figure 2E] This is a schematic diagram of an exemplary and modified heat exchanger. [Figure 2F] This is a schematic diagram of an exemplary and modified heat exchanger. [Figure 2G] This is a schematic diagram of an exemplary and modified heat exchanger. [Figure 2H] This is a plan view of an exemplary modified example of the steps involved in assembling a heat exchanger. [Figure 2I] This is a plan view of an exemplary modified example of the steps involved in assembling a heat exchanger. [Figure 2J] This is a plan view of an exemplary modified example of the steps involved in assembling a heat exchanger. [Figure 2K] This is a plan view of an exemplary modified example of the steps involved in assembling a heat exchanger. [Figure 2L] This is a plan view of an exemplary modified example of the steps involved in assembling a heat exchanger. [Figure 2M] This is a plan view of an exemplary modified example of a fluid flow pattern in a heat exchanger. [Figure 2N] This diagram shows a schematic example of a modified fastener for a heat exchanger. [Figure 3A] This is a plan view of an exemplary and modified example of an expandable member. [Figure 3B] This is a plan view of an exemplary and modified example of an expandable member. [Figure 3C] This is a plan view of an exemplary and modified example of an expandable member and a pump. [Figure 3D] This is a perspective view of an exemplary and modified example of an expandable member held within a housing. [Figure 4A] This is a perspective view of an exemplary and modified example of the enclosure. [Figure 4B] This is a perspective view of an exemplary and modified example of the enclosure. [Figure 5] This is a perspective view of an exemplary and modified example of a flexible cover. [Figure 6] This is a schematic diagram illustrating an exemplary variation of a portable cooling process. [Figure 7A] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 7B] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 7C] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 7D] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 7E] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 7F] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 8A] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 8B] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 8C] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 8D] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 8E] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 9A] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 9B] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 9C] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 9D] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 9E] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 9F] This is a perspective view of an exemplary and modified example of the cooling cap assembly process. [Figure 10] This is a set of plots of sensor and power measurements for exemplary and modified cooling cap assemblies. [Figure 11A] This is a schematic diagram of an exemplary and modified heat exchanger. [Figure 11B] This is a schematic diagram of an exemplary and modified heat exchanger. [Figure 11C] These are images of exemplary and modified heat exchangers. [Figure 12A] This is a schematic diagram of an exemplary modified example of an expandable member. [Figure 12B] This is a bottom view of an exemplary modified example of an inflatable member held within the housing in the first configuration. [Figure 12C] This is a bottom view of an exemplary modified example of an inflatable member held within the housing in the second configuration. [Figure 12D] These are images of exemplary and modified examples of the expandable members in the first and second configurations. [Figure 13] This is a perspective view of an exemplary modified example of the enclosure. [Figure 14A] This is a perspective view of an exemplary and modified cooling cap. [Figure 14B] This is a perspective view of an exemplary and modified cooling cap. [Figure 14C] This is a perspective view of an exemplary and modified cooling cap. [Figure 14E] This is a perspective view of an exemplary and modified cooling cap. [Figure 14F] This is a perspective view of an exemplary and modified cooling cap. [Figure 15A] This is an external view of an exemplary modified example of a cooling unit. [Figure 15B] This is an external view of an exemplary modified example of a cooling unit. [Figure 15C] This is an external view of an exemplary modified example of a cooling unit. [Figure 15D] This is an external view of an exemplary modified example of a cooling unit. [Figure 15E] This is an external view of an exemplary modified example of a cooling unit. [Figure 15F] This is an external view of an exemplary modified example of a cooling unit. [Figure 15G] This is an external view of an exemplary modified example of a cooling unit. [Figure 15G] This is an external view of an exemplary modified example of a cooling unit. [Figure 15H] This is an external view of an exemplary modified example of a cooling unit. [Figure 15I] This is an external view of an exemplary modified example of a cooling unit. [Figure 15J] This is an external view of an exemplary modified example of a cooling unit. [Figure 15K] This is an external view of an exemplary modified example of a cooling unit. [Figure 15L] This is an exploded perspective view of an exemplary modified cooling unit. [Figure 15M] This is an exploded perspective view of an exemplary modified cooling unit. [Figure 15N]This is an exploded perspective view of an exemplary modified cooling unit. [Figure 16A] This is an internal diagram of an exemplary modified cooling unit. [Figure 16B] This is an internal diagram of an exemplary modified cooling unit. [Figure 16C] This is an internal diagram of an exemplary modified cooling unit. [Figure 16D] This is an internal diagram of an exemplary modified cooling unit. [Figure 17] This is a diagram illustrating an exemplary variation of the cooling process. [Modes for carrying out the invention]

[0032] This section describes systems and devices for lowering the temperature of a patient's head, particularly systems and devices for cooling a patient's scalp using a cooling cap assembly. The cooling cap assembly may comprise, for example, a heat exchanger configured to remove heat from the patient's scalp, and a compression assembly separate from the heat exchanger and releasably coupled to it. For example, the compression assembly may include an inflatable member coupled to a rigid outer shell, which can expand to apply pressure to the heat exchanger and increase the contact area between the heat exchanger and the scalp. These systems and devices can generate sensor data for controlling one or more of the following: the temperature of the cooling fluid and the force applied by the compression assembly positioned on the heat exchanger.

[0033] This section also describes a method for assembling a cooling cap assembly and a method for using a cooling cap assembly to cool a patient's scalp. The method for assembling a cooling cap assembly may include wrapping a heat exchanger around a portion of the head and placing a compression assembly on top of the heat exchanger. The cooling cap assembly can be tailored to each patient to improve fit, comfort, and one or more of the cooling effect or heat transfer. In some variations, the assembled cooling cap assembly may form a friction fit with the compression assembly, allowing the cooling cap assembly to be removed from the patient's head as a single unit upon completion of a treatment session and optionally reapplied as a single unit for one or more subsequent treatment sessions. Generally, the method of using a cooling cap assembly involves circulating a fluid through a heat exchanger coupled to the patient's scalp and controlling the expansion pressure of an inflatable member coupled to the heat exchanger based on one or more temperature and / or force (e.g., pressure) measurements.

[0034] Cooling cap assembly The cooling cap assemblies described herein can be configured to be placed on a patient's head to remove heat from the patient's scalp. Patients may be able to adjust the parts of the cooling cap assembly to personalize its fit and comfort. Furthermore, the compression provided to the head by the cooling cap assembly can be adjusted for one or more of the following: cooling effect and patient comfort. Some patients may be able to initiate cooling therapy sessions in a clinical setting (e.g., an infusion center) using the cooling cap assemblies described herein. Furthermore, the cooling cap assemblies can be made portable so that patients can conduct cooling therapy sessions outside of a clinical setting (e.g., at home) and / or initiate, continue, or terminate cooling therapy sessions while traveling to and from a clinical setting (e.g., while traveling from home to a clinical setting, or vice versa). Cooling cap assemblies may generally include a liner, a flexible heat exchanger, a compression assembly, and a cover. The compression assembly may include an inflatable member and a housing. For example, the heat exchanger may be separate from the inflatable member and movable relative to the inflatable member. In some variations, the cooling cap assembly may include one or more sensors, which may be coupled to a controller in a way that allows them to communicate (e.g., wired or wirelessly).

[0035] Figure 1A is a block diagram of a modified cooling system (100) including a cooling cap assembly (110) and a cooling unit (150). The cooling cap assembly (110) may be removably positioned on the patient's scalp and configured to lower the surface temperature of the scalp, for example, during chemotherapy. As shown therein, the cooling cap assembly (110) may include a liner (112), a flexible heat exchanger (120), and a compression assembly (145), a cover (114), and one or more sensors (132). The compression assembly (145) may include an inflatable member (130) and a housing (140). The heat exchanger (120) may generally include fluid channels through which a fluid can circulate to remove heat from the patient's scalp. The compression assembly (145) may be configured to apply a predetermined force to the heat exchanger, for example, to increase the contact area between the heat exchanger and the patient's scalp, which may increase heat transfer between the scalp and the fluid circulating within the heat exchanger. For example, the housing may provide a reaction force to the expandable member when the expandable member is in an expanded configuration.

[0036] The cooling unit described herein can be fluid-coupled to the cooling cap assembly described herein to cool a cooling fluid and circulate the cooled fluid to a heat exchanger. For example, the cooling unit may include components for cooling, storing, and pumping a fluid (e.g., water, alcohol, glycol, or a combination thereof) into and out of the cooling cap assembly. Returning to Figure 1A, as shown therein, the cooling unit (150) may comprise a compressor (152), a reservoir (154), one or more sensors (156), and a pump (158). The compressor (152) may be configured to lower the temperature of the cooling fluid, and the pump (158) may be configured to circulate the cooling fluid through the cooling cap assembly (110) (i.e., through the heat exchanger). One or more sensors (156) may be coupled to a controller for communication (e.g., wired or wireless). As will be discussed in more detail herein, the cooling unit (150) may be fluidly coupled to the cooling cap assembly (110) by, for example, a fluid conduit or tube assembly.

[0037] Returning to the cooling cap assembly (110), Figure 1B is an exploded perspective view of a modified version of the cooling cap assembly (110) configured to be placed on the scalp of a patient (101). A liner (112) may be placed on the scalp, and a heat exchanger (120) may be placed on the liner (112) such that the bottom or inner surface of the heat exchanger (120) may be removably bonded to the scalp via the liner (112). In some modifications, the cooling cap assembly (110) may not include a liner (112), and the heat exchanger (120) may be placed directly on the scalp. A compression assembly (145) may be placed on top of the heat exchanger (120). More specifically, an expandable member (130) that is separate from the heat exchanger (120) and movable relative to the heat exchanger (120) may be positioned on top of the heat exchanger (120) (e.g., on the top of the heat exchanger) such that the bottom or inner surface of the expandable member (130) is in contact with the top or outer surface of the heat exchanger (120). As described above, the housing (140) can be coupled to the top or outer surface of the expandable member (130), so that the housing (140) and the expandable member (130) can be positioned simultaneously on the user's head.

[0038] In some modifications, the cover (114) may be coupled to the housing (140) (for example, to the outer surface of the housing (140)) and may be positioned on the user's head together with the housing (140) and the inflatable member (130). In other modifications, the cover (114) may be separate from the housing (140) and may be positioned separately on the housing (140) and the user's head. The cover (114) may include fasteners that allow the cooling cap assembly to be releasably attached to the patient's (101) head. In some modifications, the cooling cap assembly may not include the cover (114), and the housing (130) may include releasable fasteners for coupling the cooling cap assembly to the patient's head (101).

[0039] When combined, the inflatable member (130) can be disposed between a housing (140) that includes or can function as an outer shell, and a heat exchanger (120). The heat exchanger (120) is separated from the inflatable member (130) and can be movable relative to the inflatable member (130). In some variations, the inflatable member (130) can include a port having a top surface and a bottom surface, and the bottom surface can be releasably coupled to the heat exchanger (120). The inflatable member can be coupled to a pump (not shown), and the pump can be configured to inflate the port. In some variations, the inflatable member (130) can include a plurality of chambers, as described in more detail herein, and these chambers can be coupled to a pump that can inflate the chambers individually or simultaneously. The inflatable member (130) can include a set (144) of fluid conduits (e.g., fluid pressure lines) coupled to one or more valves (142). For example, in variations that include a plurality of fluid conduits, each fluid conduit can include a valve or be fluidly coupled to a valve. The one or more valves (142) can be coupled to a pump (not shown).

[0040] In some variations, by transitioning the inflatable member (130) from a contracted configuration to an inflated configuration, the pressure applied to the patient's head by the cooling cap assembly, and the contact area between the heat exchanger (120) and the patient's head (101) can increase. In some variations, the compression assembly (145) can be configured to generate a compression of about 0.1 lb / in 2 to about 10 lb / in 2 on the head when the inflatable member (130) is in the inflated configuration. In some variations, the compression assembly (145) can be configured to, when the inflatable member (130) is in the inflated configuration, apply a pressure of about 0.1 lb / in 2 to about 8.0 lb / in 2 , about 0.1 lb / in 2 to about 5.0 lb / in 2 , about 0.1 lb / in 2 to about 3.0 lb / in 2 , about 0.1 lb / in 2 to about 2.0 lb / in 2, about 0.1lb / in 2 ~Approximately 1.0 lb / in 2 , about 0.5lb / in 2 ~Approximately 8.0 lb / in 2 , about 0.5lb / in 2 ~Approximately 5.0 lb / in 2 , about 0.5lb / in 2 ~Approximately 3.0 lb / in 2 , about 0.5lb / in 2 ~Approximately 2.0 lb / in 2 , or approximately 0.5 lb / in 2 ~Approximately 1.0 lb / in 2 It can be configured to produce compression.

[0041] In some variations, the cooling system may be a closed-loop system such that one or more parameters of one or more components of the cooling system (e.g., a pump coupled to an expandable member, a pump circulating a cooling fluid, a cooling unit) can be modified based on information received from one or more sensors. For example, in some variations, a heat exchanger (132) may include a plurality of temperature sensors (132). The plurality of temperature sensors (132) may be coupled to a controller (140) (e.g., a processor, memory) (e.g., via a wired or wireless connection). The controller may receive temperatures from the temperature sensors and include and / or execute commands to adjust the output of one or both of the pumps and / or compressors based on these temperatures. In some variations, the controller (140) may be configured to adjust, or otherwise control, the fluid pressure of the expandable member (130) using a pump fluid-coupled to the controller (140).

[0042] heat exchanger In general, the heat exchangers described herein can be configured to remove heat from a patient's scalp via a cooling fluid circulating through one or more passages within the heat exchanger. Due to the shape of the patient's head and the shape of the heat exchanger, the contact area between the patient's scalp and the heat exchanger may be inconsistent and / or suboptimal. For example, the weight and covering area of ​​the heat exchanger with the circulating fluid may not be sufficient to provide sufficient compressive force to uniformly cool the patient's scalp, such as when the patient moves their head. In some modifications, the contact area between the heat exchanger and the scalp can be increased using the compression assemblies described herein, which may improve the effectiveness of the cooling treatment. In some modifications, the shape and dimensions of the heat exchanger can be configured to be adjustable so that the heat exchanger can be appropriately fitted to multiple patients with various head shapes and sizes, thereby also increasing the contact area between the heat exchanger and the patient's head and enhancing the effectiveness of the cooling treatment on the patient's head. In some modifications, the heat exchanger may include a surface that can be comfortably placed directly on the patient's scalp. For example, the inner surface of the heat exchanger may include a terry cloth surface.

[0043] Figures 2A and 2B are schematic top and bottom views (e.g., outside and inside) of a modified example of the heat exchanger (200), respectively. As shown therein, the heat exchanger (200) may comprise a bottom portion (210), a top portion (221), a first side portion (231), a second side portion (241), and a fluid connection portion (270). The fluid connection portion (270) may be used to connect the heat exchanger (200) to a cooling unit and may be connected to any preferred portion of the heat exchanger (200), e.g., the bottom portion (210), the top portion (221), or any of the side portions (241). The fluid connection portion (270) may comprise fluid conduits, such as tubes, configured to connect to the inlet and outlet of the cooling unit. The upper portion (221) may be configured to cover the apex and / or foremost part of the head, the bottom portion (210) may be configured to cover the occipital region and / or neck, and the first and second lateral portions (231, 241) may be configured to cover the left and right hemispheres of the head. The bottom portion (210) may have a substantially rectangular shape and may extend away from the upper portion (221).

[0044] In some variations, the upper section (221), the first side section (231), and / or the second side section (241) may include one or more, e.g., two, three, four, or more arms or lobes. In some variations, the first side section (231), the second side section (241), and the upper section (221) may include only two lobes, and the heat exchanger (200) may include only six lobes in total (i.e., the bottom section (210) has no lobes). The lobes of each section of the heat exchanger may be sized and shaped to adjustably cover different parts of the patient's head. For example, the lobes may generally be elongated (e.g., length greater than width), and each may have a curved or rounded distal end. One or more of the distal ends may include fasteners (e.g., hooks, loops) used to secure the lobes together. Each lobe may extend from the bottom portion (210) and may be flexible to allow for adaptation to the patient's head and patient adjustment. In variations in which the top portion (221), first lateral portion (231), and second lateral portion (241) include multiple lobes, each lobe of each portion may be the same (e.g., the same shape, length, width, surface area, and / or radius of curvature at the distal end), or each lobe may be different (e.g., different shapes, lengths, widths, surface areas, and / or radii of curvature at the distal end). For example, in some variations, each of the upper portion (221), the first side portion (231), and the second side portion (241) may include two lobes, and the lobes (220, 222) of the upper portion (221) may have the same length and width as each other, and the length and width of the lobes (220, 222) of the upper portion (221) may differ from the length and width of the lobes (230, 232, 240, 242) of the side portion (230, 232) (when the length and width of each lobe are measured relative to the proximal end of the heat exchanger (200)). In some cases, one or more lobes (230, 232) of the first side portion (231) may be mirror images of one or more lobes (240, 242) of the second side portion (241), and / or the lobes (220, 222) of the upper portion (221) may be mirror images of each other.

[0045] For example, as shown in Figure 2A, the upper and side portions of the heat exchanger (200) may generally form a cactus-like shape or a set of outstretched fingers. In some modifications, the upper portion (221) and the bottom portion (210) may define a common longitudinal axis. The first side portion (231) and the second side portion (241) may extend from the bottom portion (210) at an acute angle with respect to the longitudinal axis. Multiple lobes of the side portion may have different acute angles with respect to the longitudinal axis. In some modifications, one or more lobes may be tapered. In some modifications, lobes may extend from another portion of the heat exchanger (e.g., the first lobe (230) extends at an acute angle from the bottom portion (210)) or from another lobe (e.g., the second lobe (232) extends from the first lobe (230)). In some variations, the ratio of the length of the first lobe to the length of the second lobe may be approximately 2:1 to approximately 0.5:1. In some variations, the ratio of the width of the first lobe to the width of the second lobe may be approximately 2:1 to approximately 0.5:1.

[0046] In the modified forms shown in Figures 2A-2B, the upper portion (221) may include a first lobe (220) and a second lobe (222), the first side portion (231) may include a first lobe (230) and a second lobe (232), and the second side portion (241) may include a first lobe (240) and a second lobe (242). As shown therein, the lengths of the first lobes (230, 240) of the first portion (231) and the second portion (241) may be longer than the lengths of the second lobes (232, 242) of the first portion (231) and the second portion (241). Additionally or alternatively, the lengths of the first and second lobes of the first and second side portions (231) and the second side portion (241) may be shorter than the lengths of the first and second lobes of the upper portion (221). In some modifications, the area of ​​either the first or second side portion to the area of ​​the upper portion is about 2:1 to about 0.5:1. In some modifications, the heat exchanger (200) may include a length of about 30 cm to about 50 cm and a width of about 35 cm to about 80 cm.

[0047] The heat exchanger (200) may generally comprise one or more fluid channels (not shown) that form a fluid path through at least one of the bottom portion (210), top portion (221), first side portion (231), and second side portion (241). For example, in some modifications, each portion of the heat exchanger (200) may comprise at least one portion of the fluid channels. In some cases, each portion of the heat exchanger (200) may comprise multiple (e.g., two, three, four, or more) fluid channels. The fluid channels may have any size and shape suitable for circulating the cooling fluid through the heat exchange portion. For example, each fluid channel may be approximately 9 mm 2 ~approximately 100mm 2 The cross-sectional area may include the following. During use, the fluid channels may contain a circulating fluid that may have a temperature lower than the temperature of the patient's scalp. Figure 2M shows one modified example of the fluid flow pattern of the heat exchanger (200). In the modified example shown therein, each lobe of the heat exchanger (200) may contain two fluid channels, and the fluid may enter (260) and exit (262) the heat exchanger (200) through the bottom portion of the heat exchanger (200).

[0048] As shown in at least Figures 2A, 2B, and 2N, the heat exchanger (200) may include one or more releasable fasteners (280) (e.g., hooks, loops, Velcro®, or combinations thereof) configured to form and maintain the heat exchanger (200) in a predetermined shape. For example, one or more end portions of the heat exchanger (200) may include fasteners of any preferred shape or size. Figures 2A and 2B show sets of fasteners (280) coupled to the distal ends of lobes. For example, hemispherical loop fasteners can be provided at the distal ends of each lobe on a first side of the heat exchanger (200) (Figure 2A). On a second side of the heat exchanger (200) opposite to the first side (Figure 2B), hemispherical hook fasteners can be provided on four lobes. Furthermore, loop fasteners can be provided on a second side of the bottom portion (210). These multiple sections and / or robes can be manipulated to wrap around and secure the heat exchanger to the patient's scalp, with the hooks and loops of the different sections overlapping and joining together.

[0049] In some variations, the heat exchanger (200) may include flexible materials such as nylon, urethane-coated nylon, polyester fabric, polyvinyl chloride (PVC), loop cloth, nonwoven fabric, or combinations thereof. This may allow one or more portions of the heat exchanger (200) to be manipulated and adjusted to conform to the shape of the patient's head, accommodating multiple patients with varying head sizes. As shown in the schematic side and front views of Figures 2C and 2D, the heat exchanger (200) may generally be molded to wrap around the patient's head. For example, one or more end portions of the heat exchanger may be configured to overlap in an adjustable manner to surround at least a portion of the head, as will be described in more detail herein with respect to Figures 2H–2L.

[0050] The heat exchanger (200) may be formed from several layers which can be joined together, one or more of which may form fluid passages within the heat exchanger. Figure 2G is a schematic cross-sectional view of a portion of one variation of the layers of the heat exchanger (200). The heat exchanger (200) may include a first layer, the bottom layer (250), configured to face the patient, and a second layer, the top layer (254), configured to face away from the patient (e.g., facing an expandable member). The first layer (250) and the second layer (254) may form cavities and / or one or more fluid channels (indicated schematically as 252) between the first layer (250) and the second layer (254), the fluid channels which may receive circulating fluid during use of the heat exchanger. In some variations, the layers of the heat exchanger may be radio frequency welded or heat welded to each other to form detours and / or winding paths for circulating fluid and may be watertight. In some variations, the first layer (250) and / or the second layer (254) may include a flexible material such as nylon. In some variations, for example, if no liner is used, the second layer (254) may include a soft fabric such as terry cloth and / or absorbent cloth. Additionally or alternatively, in some variations, one or more parts of the heat exchanger (200) (e.g., the first layer (250) or a part thereof, and / or the second layer (254) or a part thereof) may optionally include a compressible material (e.g., open-cell foam, closed-cell foam). In variations including a compressible material, the compressible material may be integrated or embedded in one or more layers of the heat exchanger and / or attached to the inner and / or outer surfaces of one or more layers of the heat exchanger (200). By utilizing compressible materials, the rigidity of the heat exchanger (200) can be increased, for example, to increase resistance to buckling from internal hydraulic pressure and / or to increase the distance between the first layer (250) of the heat exchanger (200) and the patient's scalp, which may reduce the risk of frostbite. Figures 2E and 2F are schematic cross-sectional views of the heat exchanger (200). For example, Figure 2E shows a first layer (250) including hook fasteners (260) and a second layer (254) including hook fasteners (260) and loop fasteners (262).

[0051] Figures 11A and 11B are schematic diagrams of additional modifications of the heat exchanger (1100), including a design configured for efficient cooling and fluid flow. As shown therein, the heat exchanger (1100) comprises a bottom section (1110), an upper section (1121), a first side section (1131) including a first arm (1130), a second side section (1141) including a second arm (1140), and a fluid connection section (1170). Furthermore, one or more portions of the heat exchanger (1100) may include one or more fluid barriers (1150, 1152, 1154, 1156) (e.g., two, three, four, five, or more fluid barriers), one or more fasteners (1180) (e.g., two, three, four, five, or more fasteners), and one or more sensors (1182) (e.g., two, three, four, five, or more sensors). A fluid connection (1170) may be configured to connect the heat exchanger (1100) to a cooling unit (not shown) and may be connected to any preferred portion of the heat exchanger (1100), for example, the bottom portion (1110), the top portion (1121), or any of the side portions (1131, 1141). The fluid connection section (1170) may include fluid conduits, such as tubes, configured to connect to the inlet and outlet of the cooling unit. The upper section (1121) may be configured to cover the crown and / or foremost part of the head, the bottom section (1110) may be configured to cover the back of the head and / or the neck, and the first and second lateral sections (1131, 1141) may be configured to cover the left and right hemispheres of the head. For example, the upper section (1121) may be generally circular or elliptical, the first and second lateral sections (1131, 1141) may have a generally elongated shape with rounded (e.g., bulbous) ends, and the bottom section (1110) may have a generally tapered shape and may extend away from the upper section (1121) and the lateral sections (1131, 1141).

[0052] In some variations, the upper section (1121), the first lateral section (1131), and / or the second lateral section (1141) may each include one or more, for example, one, two, three, four, or more arms or lobes. In some variations, the first lateral section (1131), the second lateral section (1141), and the upper section (1121) may include a total of three arms or lobes, while the heat exchanger (1100) may include only a total of three arms or lobes (i.e., the bottom section (1110) may not have any arms). The arms of each section of the heat exchanger may be sized and shaped to adjustably cover different parts of the patient's head. For example, each arm of the first and second lateral sections may generally be elongated (e.g., length greater than width) and each may have a curved or rounded distal end. The upper portion (1121) may have a head-like shape and be substantially circular or elliptical. One or more of the distal ends may include fasteners (e.g., hooks, loops) used to secure the arms together. Each arm may extend outward in the opposite direction from the bottom portion (1110) and may be flexible to allow for adaptation to the patient's head and patient adjustment. In variations in which each of the upper portion (1121), the first lateral portion (1131), and the second lateral portion (1141) includes multiple arms, each arm of each portion may be identical (e.g., identical shape, length, width, surface area, and / or radius of curvature at the distal end), or each arm may be different (e.g., having different shapes, lengths, widths, surface areas, and / or radii of curvature at the distal end).

[0053] As shown in Figures 11A-11C, for example, the upper and side portions of the heat exchanger (1100) can generally form one or more of the following shapes: human-shaped (e.g., scarecrow), T-shaped, and / or cruciform. In some modifications, the upper portion (1121) and the bottom portion (1110) may define a common longitudinal axis, and in some cases, the fluid barrier (1152) may generally extend along this common longitudinal axis (e.g., the fluid barrier (1152) may generally extend along the longitudinal axis of the heat exchanger (1100)). The first side portion (1131) and the second side portion (1141) may extend from the bottom portion (1110) at an acute angle to the longitudinal axis. In some modifications, the first side portion (1131) and the second side portion (1141) may form a generally curved shape relative to the bottom portion (1110). For example, the side portions may extend from the bottom portion (1110) at the same or different arc-shaped angles with respect to the longitudinal axis. In some modifications, one or more of the arms may be tapered (e.g., the proximal end is wider than the distal end, the distal end is wider than the proximal end, etc.). In some modifications, the arms may either extend from another part of the heat exchanger (e.g., the first arm (1130) extends at an acute angle from the bottom portion (1110)) or from another arm (e.g., the second arm (1132) extends from the top portion (1121)). For example, the first arm (1130) and the second arm (1132) may form angles with respect to the longitudinal axis from about 0 to about 80 degrees. In some modifications, the ratio of the length of the first arm to the length of the second arm may be from about 2:1 to about 0.5:1. In some variations, the ratio of the width of the first arm to the width of the second arm may be approximately 2:1 to approximately 0.5:1.

[0054] In some variations, the heat exchanger (1100) may include a length of approximately 30 cm to approximately 50 cm, encompassing all sub-part ranges and values ​​within that range, e.g., approximately 35 cm to approximately 45 cm. In some variations, the heat exchanger (1100) may include a width of approximately 35 cm to approximately 80 cm, encompassing all sub-part ranges and values ​​within that range. In some variations, the ratio of the arm length to the diameter of the upper part may be approximately 3:2 to approximately 3:4. For example, in some variations, the upper part (1121) may include a diameter of approximately 20 cm, the bottom part (1110) may include a length of approximately 20 cm, and each side part (1131, 1141) may include a length of approximately 25 cm.

[0055] The heat exchanger (1100) may generally include a fluid path (e.g., a fluid channel) through at least one of the bottom portion (1110), top portion (1121), first side portion (1131), and second side portion (1141). For example, in some modifications, each portion of the heat exchanger (1100) may include at least a portion of the fluid path. The fluid path may have any size and shape suitable for circulating a cooling fluid through the portion of the heat exchanger (1100). During use, the fluid path may contain a circulating fluid that may have a temperature lower than the temperature of the patient's scalp. Figures 11A and 11B show modified fluid flow patterns (1190, 1192) of the heat exchanger (1100). In the modified version shown therein, the fluid can enter (1190) and exit (1192) the heat exchanger (1100) through the bottom portion (1110) (e.g., the proximal end of the bottom portion (1110)). For example, the fluid can flow continuously in a nearly counterclockwise direction through the bottom portion (1110), the second side portion (1141), the top portion (1120), the first side portion (1131), and out through the bottom portion (1110).

[0056] In some modifications, the heat exchanger (1100) may include fluid barriers configured to direct the flow of fluid through the heat exchanger (1100) and, in an extended configuration, provide the heat exchanger (1100) with a predetermined shape. Fluid barriers described herein may help to promote uniform and consistent cooling and may reduce fluid retention within the heat exchanger (1100). For example, a fluid barrier may be configured to reduce turbulent fluid flow throughout the heat exchanger (1100) by defining a predetermined fluid flow path. Furthermore, a fluid barrier may be configured to reduce expansion of one or more portions of the heat exchanger (1100). In some modifications, the heat exchanger (1100) may include a set of fluid barriers (1150, 1152, 1154, 1156) that include, but are not limited to, point-shaped fluid barriers, elongated fluid barriers, rounded fluid barriers, and shaped fluid barriers. For example, a fluid barrier can be welded within the internal cavity of the heat exchanger (1100), including one or more side walls and not including walls that define the outer perimeter (e.g., boundary) of the heat exchanger (1100). For example, each barrier can be joined between opposing layers (e.g., top layer, bottom layer) of the heat exchanger (1100) so that the heat exchanger (1100) maintains a predefined thickness and shape throughout, rather than "bulging" when the heat exchanger (1100) is in an expanded configuration (e.g., filled with fluid). As will be described in more detail herein, one or more fluid barriers can be formed by a welding process.

[0057] In some variations, elongated fluid barriers (1152, 1153, 1155) can define fluid pathways through one or more sections and / or arms of the heat exchanger (1100) and provide the heat exchanger (1100) with a predetermined shape. For example, Figure 11A shows that a longitudinal elongated fluid barrier (1152) can bisect each of the bottom section (1110) and the top section (1121). Similarly, transverse elongated fluid barriers (1153, 1155) can bisect a first side section (1131) and a second side section (1141), as well as the top section (1121), respectively. In Figure 11A, the longitudinal elongated fluid barrier (1152) can form a cross with each of the transverse elongated fluid barriers (1153, 1155) to form a roundabout fluid path through the heat exchanger (1100). One or more elongated fluid barriers (1154) shorter than the longitudinal or transverse elongated fluid barriers (1152) may be placed very close to the intersections formed between the transverse and longitudinal elongated fluid barriers (1152, 1153, 1155) to reduce fluid back pressure (e.g., retention) in those areas. The elongated fluid barriers (1154) can be substantially parallel or angled to the transverse or longitudinal elongated fluid barriers (1154).

[0058] Figure 11B shows a curved, elongated fluid barrier (1162) configured to facilitate non-turbulent or laminar fluid flow near intersections and / or curved sections of a heat exchanger (1100). Figure 11C is an image of the heat exchanger (1100) schematically depicted in Figure 11B. The elongated fluid barriers (1162, 1164) shown in Figures 11B and 11C may include one or more curves to reduce fluid back pressure and turbulence. The elongated fluid barriers may form detour fluid paths through the heat exchanger (1100). For example, Figure 11B shows a first elongated fluid barrier (1162) extending through the bottom section (1110) and a second side section (1141). A second elongated fluid barrier (1164) extends through the first side section (1131) and a top section (1120). The first and second elongated fluid barriers (1162, 1164) may be connected by a third elongated fluid barrier (1166). A lateral elongated fluid barrier (1165) may form a cross with respect to the second elongated fluid barrier (1164). One or more elongated fluid barriers (1154) shorter than the first and second elongated fluid barriers (1162, 1164) may be placed very close to the intersections formed between the first, second, third, and lateral elongated fluid barriers (1162, 1164, 1165, 1166) to reduce fluid back pressure (e.g., retention) in those areas. The elongated fluid barriers (1154) may be substantially parallel or angled with respect to the elongated fluid barriers (1162, 1164, 1165, 1166).

[0059] In some modifications, the fluid barrier set may include a fluid barrier pattern of spaced-out fluid barriers (1150) configured to define fluid flow paths and provide a predetermined shape to the heat exchanger (1100). For example, Figures 11A and 11B show a fluid barrier set (1150) including torus-shaped (e.g., donut, dot, cylinder) shapes that can be distributed substantially uniformly throughout the cavity of the heat exchanger (1100). The centers (e.g., holes) of the torus-shaped fluid barriers are not in fluid communication with the fluid in the heat exchanger. In some modifications, one or more of the torus-shaped fluid barriers (1150) may have diameters of about 5 mm to about 10 mm and may be spaced about 5 mm to about 15 mm apart from the other fluid barriers (1150). For example, in some modifications, one or more (e.g., multiple, all) of the torus-shaped fluid barriers (1150) may have a diameter of approximately 7 mm, and the spacing between the torus-shaped fluid barriers may be at least 10 mm (e.g., approximately 10 mm). In some modifications, the set of tori (1150) may generally be uniformly spaced apart. Each fluid barrier in the fluid barrier set (1150) may have the same or different diameters. Additionally or alternatively, the fluid barrier set (1150) may include other shapes, such as hemispheres, rectangles, triangles, rhombuses, trapezoids, and other polygons, or combinations thereof (e.g., multiple fluid barriers may include a first shape (e.g., a torus shape), and multiple fluid barriers may include a second different shape (e.g., a solid circle)).

[0060] In some variations, one or more (e.g., several, two, three, four, or more) fluid barriers (e.g., fluid barrier (1154)) may include barbell or dumbbell shapes, having torus-shaped or circular fluid barriers (or point barriers) coupled to each end of an elongated fluid barrier. These fluid barriers (1154) may be configured to direct the fluid flow in a predetermined manner. For example, elongated fluid barriers (1152, 1154) can reduce fluid back pressure (e.g., storage, stationary point) by making the fluid laminar near intersections and sharp angles. Fluid that is relatively stagnant within the heat exchanger (1100) may contain relatively high temperatures that could reduce one or more of the efficiency and performance of the cooling cap assembly. Therefore, elongated fluid barriers can enable non-turbulent flow throughout the heat exchanger (1100). In some variations, the elongated fluid barriers (1152, 1153, 1154, 1162, 1164, 1165, 1166) may be linear or curved and may have a width less than or equal to the diameter or width of the fluid barrier ends (e.g., torus-shaped fluid barriers, point barriers).

[0061] As will be described in more detail herein, in some modifications, the heat exchanger (1100) may be equipped with one or more sensors (1182), for example, one or more sensors configured to measure temperature. For example, the sensors (1182) may be located in one or more (e.g., two, three, four, or more) predetermined locations within the heat exchanger (1100) in "donut holes" (e.g., through holes) inside the torus-shaped fluid barrier (1150), as shown in Figure 11B. In some modifications, a notification may be generated when one or more measured temperatures are outside a predetermined temperature range or other criteria. For example, in some modifications, a notification may be generated when the temperature of one sensor differs from that of one or more other sensors by a predetermined amount (e.g., a temperature difference of 2°C or more).

[0062] Furthermore, in some variations, the heat exchanger (1100) may include one or more releasable fasteners (1180) (e.g., hooks, loops, Velcro®, or combinations thereof) configured to form and hold the heat exchanger (1100) in a predetermined shape configuration. For example, one or more end portions of the heat exchanger (1100) may include fasteners (1180) of any preferred shape or size. Figures 11A and 11B show a set of fasteners (1180) coupled to the distal ends of the arms. For example, hemispherical loop fasteners may be provided on the first side of the heat exchanger (1100) at the distal end of each arm. On a second side of the heat exchanger (1100) opposite to the first side, hemispherical hook fasteners may be provided on the set of arms. Furthermore, loop fasteners may be provided on the second side of the bottom portion (1110). In some variations, the fasteners (1180) of the upper section (1120) may include a triangular shape, allowing the upper section (1120) to form a concave or “bowl” shape when the heat exchanger (1100) is in an extended configuration. For example, Figures 11A–11C show a set of four triangular fasteners (e.g., Velcro®) and three tab-type fasteners on the upper section (1120) of the heat exchanger (1100).

[0063] In some variations, these multiple parts and / or arms can be operated so that the hooks and loops of different parts overlap and connect with each other to wrap around and secure the heat exchanger to the patient's scalp. For example, the fasteners (1180) at the distal ends (1130, 1140) of the lateral parts can wrap around the sides of the patient's head and make contact (e.g., connect, overlap) on the patient's forehead. Then, tab-shaped fasteners (1180) protruding from the upper part (1120) can be connected to the fasteners (1180) of the lateral parts (1131, 1141) to secure the upper part (1120) to the lateral parts (1131, 1141).

[0064] In some variations, the heat exchanger (1100) may include flexible materials such as nylon, urethane-coated nylon, polyester fabric, polyvinyl chloride (PVC), loop cloth, nonwoven fabric, or combinations thereof. This may allow one or more parts of the heat exchanger (1100) to be manipulated and adjusted (e.g., wrapped) to conform to the shape of the patient's head, accommodating patients of various head sizes.

[0065] In some modifications, the heat exchanger (1100) may be formed from several layers that can be joined together, one or more of which may form one or more fluid passages (e.g., fluid paths) within the heat exchanger. For example, the heat exchanger (1100) may include a first layer configured to face the patient and a second layer configured to face away from the patient (e.g., facing an inflatable member). In some modifications, the layers of the heat exchanger may be high-frequency welded or thermal welded to each other to form detour fluid paths for circulating fluids and may be waterproof. For example, high-frequency welding may involve using a manufacturing device to energize the portion of the heat exchanger to be welded. The localized heat and pressure applied by the manufacturing device may create a strong weld (e.g., a joint). In some modifications, the heat exchanger (1100) may include a fabric laminated with thermoplastic polyurethane (TPU).

[0066] In some modifications, the heat exchanger (1100) may include flexible materials such as nylon and / or nonwoven fabric. Additionally or alternatively, in some modifications, one or more portions of the heat exchanger (1100) may optionally include compressible materials (e.g., open-cell foam, closed-cell foam). In modifications including compressible materials, the compressible material may be integrated or embedded in one or more layers of the heat exchanger and / or attached to the inner and / or outer surfaces of one or more layers of the heat exchanger (1100), which may increase resistance to buckling from internal hydraulic pressure and / or reduce the risk of frostbite.

[0067] Compressed assembly The compression assemblies described herein may be configured to increase the contact area between the heat exchanger and the patient's scalp (in some modifications, contact may occur via a liner), which may increase the cooling efficiency of the cooling cap assembly. The compression assemblies described herein may generally include an inflatable member and a housing, which may be separate from and movable relative to the heat exchanger. In other words, the compression assembly may be formed separately from the heat exchanger, for example, detached from or otherwise physically separated from the heat exchanger during application of the heat exchanger to the patient's scalp. During use, the inner surface of the inflatable member may be in contact with the heat exchanger, and the outer surface of the inflatable member may be in contact with the housing. When the inflatable member expands, the housing may be configured to resist deformation from the inflatable member and to act as a reaction force so that the compression assembly can impart a compressive force to the heat exchanger. This compressive force can increase the contact area between the heat exchanger and the scalp, for example by pressing the heat exchanger against the patient's scalp, so that the heat exchanger better conforms to the shape of the patient's scalp. For example, the contours and shape of the patient's scalp may be such that the arms or lobes of the heat exchanger do not make full or substantial contact with the scalp unless pressure is applied to push them toward the scalp. This application of pressure can reduce gaps, misalignments, depressions, etc., between the heat exchanger and the scalp. In some variations, the compression assembly may include one or more sensors.

[0068] Expandable member The inflatable member described herein can be configured to receive a fluid and transition from a deflated configuration to an inflated configuration in order to increase the force applied to the patient's head by the heat exchanger. Figures 3A and 3B are plan views of modified examples of the inflatable member (300). The inflatable member (300) may comprise a bottom inflatable portion (310), upper inflatable portions (320, 322), first inflatable side portions (330, 332), and second inflatable side portions (340, 342). The bottom inflatable portion (310) may be aligned with the patient's neck and / or occipital region, and the upper inflatable portion (321) may be placed over the apex and / or foremost part of the head. The side portions (331, 341), when positioned on the patient's head, may cover the left and right hemispheres of the head. Each portion may include at least one chamber configured to be filled with a fluid (e.g., liquid, gas (e.g., air)). For example, the inflatable member may include multiple chambers (e.g., two, three, four, five, or more). For example, in one modification, the inflatable member may include a front central chamber, a front left chamber, a front right chamber, an upper chamber, a rear central chamber, a rear right chamber, and a rear right chamber. In some modifications, each of the multiple chambers may be independently inflatable. As described above, the inflatable member (300) may include a deflated configuration and an inflated configuration. When the inflatable member (300) is used on a patient's head, transitioning from the deflated configuration to the inflated configuration may increase the pressure applied to the patient's head.

[0069] In some modifications, the lengths of the first inflatable side portions (330, 332) and the second inflatable side portions (340, 341) may be shorter than the length of the upper inflatable portion (320, 322). Similar to the heat exchangers described herein, portions of the inflatable member (300) may be configured to overlap in an adjustable manner so as to surround at least a portion of the head. For example, Figures 3B and 3D are plan and perspective views of modifications of the inflatable member (300) held within a housing (360). The side and upper portions of the inflatable member (300) can overlap each other so as to form a substantially hemispherical shape. In some modifications, the inflatable member (300) may be removably coupled to the housing (360). In other modifications, the inflatable member (300) may be fixed to the housing (360).

[0070] The inflatable member (300) may comprise one or more fluid connections (e.g., tubes) coupled to one or more inflatable sections (310, 321, 331, 341). In some modifications, the inflatable member (300) may further comprise a manual pump fluidly coupled to one or more chambers of the inflatable member (300) via the fluid connections. In other modifications, the inflatable member may be fluidly coupled via one or more fluid connections to a separate pump, such as an air pump included in a cooling unit. In some modifications, one or more fluid conduits may include valves that can be used to control or assist in controlling the expansion pressure.

[0071] Figure 3C shows a modified version of the inflatable member 300 including a fluid pump (e.g., an air bulb) (350). The fluid pump (350), shown therein as a manual hand pump (e.g., an air pump valve), can be coupled to a fluid connection (354) via a flexible tube (352). The flexible tube (352) can fluidly couple one or more chambers in the inflatable sections (310, 321, 331, 341) to the fluid pump (350) so that the fluid pump (350) can be actuated to fill one or more chambers of the inflatable member (300) to a predetermined pressure (inflation pressure) using, for example, air and / or an inert gas. In some modifications, the fluid pump (350) may be actuated by the patient, which may allow the patient to adjust the force applied to the patient's head by the compression assembly via the heat exchanger. This may allow for improved adaptability and comfort of the cooling cap assembly and may allow some degree of contact between the heat exchanger and the scalp. As described above, in some variations, the cooling unit may include a fluid pump (350). In these variations, the cooling system may further include a controller, which may be configured to use the fluid pump (350) to control the expansion pressure of the inflatable member (300) manually (e.g., via user input) and / or dynamically (e.g., using sensor data).

[0072] In some variations, the inflatable member may be configured to conform to the shape of a patient's head when inflated and held within a housing, such as a cooling cap. Figure 12A is a schematic diagram of another variation of the inflatable member (1200). Figure 12B is a bottom view of a variation of the inflatable member (1200) in a first configuration (e.g., non-inflatable configuration) when held within a housing. Figure 12C is a bottom view of an exemplary variation of the inflatable member in a second configuration (e.g., inflatable configuration) when held within a housing. Similarly, Figure 12D is an image of each exemplary variation of the inflatable member in the first and second configurations.

[0073] The inflatable member (1200) shown in Figures 12A-12D may include a bottom inflatable portion (1210), an upper inflatable portion (1220) (e.g., an upper chamber (1221)), a first inflatable side portion (1230) (e.g., a left chamber (1231)), and a second inflatable side portion (1240) (e.g., a right chamber (1241)), a fluid barrier (1250), a fluid connection (1270), a notch or gap (1242), and fasteners (1280). The bottom inflatable portion (1210) may be aligned with the patient's neck and / or occipital region, and the upper inflatable portion (1221) may be placed on the apex and / or foremost part of the head. The inflatable side portions (1230, 1240), when positioned on the patient's head, may cover the left and right hemispheres of the head. Each part may include at least one chamber configured to be filled with a fluid (e.g., a liquid, a gas such as air). For example, the inflatable member (1200) may include multiple chambers (e.g., two, three, four, five, or more). For example, in one variation, the inflatable member (1200) may include a left chamber (1231), a right chamber (1241), and an upper chamber (1221). As described above, the inflatable member (1200) may include a first deflated configuration, a second inflated configuration, and multiple partial inflated configurations between them. When used on a patient's head, transitioning the inflatable member (1200) from the first deflated configuration to the second inflated configuration may increase the pressure applied to the heat exchanger and the patient's head.

[0074] In some modifications, the upper portion (1220) may generally have an elliptical or circular shape. The first and second side portions (1230, 1240) (e.g., wings, arms) may generally have an elongated shape, which may be concave to form a “bowl” shape. The bottom portion (1210) may generally have a tapered shape and may extend away from the upper portion (1220). In some modifications, the lengths (along their respective longitudinal axes) of the first inflatable side portion (1230) and the second inflatable side portion (1240) may be longer than the length (along the longitudinal axis of the upper inflatable portion) of the upper inflatable portion (1220). Similar to the heat exchangers described herein, portions of the inflatable member (1200) may be configured to overlap in an adjustable manner so as to surround at least a portion of the head. For example, Figures 12B and 12C are top views of modified versions of an inflatable member (1200) held within a housing (1260). The side portions (1230, 1240) and top portion (1220) of the inflatable member (1200) can overlap each other to form a substantially hemispherical shape. In some modifications, the inflatable member (1200) may be detachably coupled to the housing (1260). In other modifications, the inflatable member (1200) may be fixed to the housing (1260). The inflatable member (1260) may be configured to apply a substantially uniform amount of pressure to the patient's head when held in the housing (1260) in an inflated configuration. In some variations, the inflatable member (1200) may include one or more notches (1242), gaps, or indentations to facilitate the folding, shaping, and / or overlapping of different portions of the inflatable member (1200) within the housing (1260).

[0075] In some modifications, the upper portion (1220) and the bottom portion (1210) may define a common longitudinal axis that bisects the inflatable member (1200). The first side portion (1230) and the second side portion (1240) may extend from the bottom portion (1210) at an acute angle with respect to the longitudinal axis. For example, the first side portion (1230) and the second side portion (1240) may form an angle of about 0 to about 80 degrees with respect to the longitudinal axis. In some modifications, the ratio of the length of the first portion to the length of the second portion may be about 2:1 to about 0.5:1. For example, the first and second portions may be mirror images of each other. In some modifications, the ratio of the width of the first portion to the width of the second portion may be about 2:1 to about 0.5:1.

[0076] In some modifications, the expandable member (1200) may include lengths of approximately 25 cm to approximately 50 cm, including all sub-ranges and values ​​within that range, for example, approximately 30 cm to approximately 40 cm. In some modifications, the heat exchanger (1200) may include widths of approximately 35 cm to approximately 80 cm, approximately 50 cm to approximately 70 cm, and approximately 60 cm to approximately 70 cm, including all sub-ranges and values ​​within that range.

[0077] In some variations, one or more portions of the inflatable member (1200) may include one or more fluid barriers (1250). In some variations, the inflatable member (1200) may include a set of fluid barriers (1210) (e.g., walls, welds) configured to provide the inflatable member (1200) with a predetermined shape in the inflatable configuration. The fluid barriers described herein may help to promote uniform and consistent inflation of the inflatable member (1200). For example, the fluid barriers may be configured to reduce the expansion of one or more portions of the inflatable member (1200). Each barrier may be bonded between opposing layers (e.g., top layer, bottom layer) of the inflatable member (1200) so that when the inflatable member (1200) is in the inflatable configuration (e.g., filled with fluid), the inflatable member (1200) maintains a predefined thickness and shape throughout, rather than "bulging." This may help patient comfort and improve cooling efficiency. One or more fluid barriers may be formed by the welding process described herein. In some modifications, one or more fluid barriers (1250) may be elongated and generally may extend through the midpoint of the chamber. That is, the fluid barriers (1250) may be located within the internal cavity of the inflatable member. For example, the fluid barriers (1250) may be linear and / or form a "V" shape.

[0078] In some variations, one or more portions of the inflatable member (1200) may include one or more releasable fasteners (1280) (e.g., hooks, loops, Velcro®, or combinations thereof) configured to form and hold the inflatable member (1200) in a predetermined shape. The inflatable member (1200) can be operated so that the hooks and loops of different portions overlap and connect with each other, thereby wrapping and securing the inflatable member within the housing. One or more edges of the inflatable member (1200) may include fasteners (e.g., hooks, loops) used to fasten multiple portions together. Each side portion may extend from the bottom portion (1210) and may be flexible to allow for adaptation to the patient's head and patient adjustment.

[0079] A fluid connection (1270) can be used to connect the inflatable member (1200) to a pump (not shown) and may be connected to any preferred portion of the inflatable member (1200), for example, the bottom portion (1210), the top portion (1220), or any of the side portions (1230, 1240). The fluid connection (1270) may include a fluid conduit, such as a tube, configured to connect to the pump. In some variations, the inflatable member (1200) may further include a manual pump fluidly coupled to one or more chambers of the inflatable member (1200) via the fluid connection. In other variations, the inflatable member may be fluidly coupled to an air pump included in a cooling unit via one or more fluid connections. In some variations, one or more fluid conduits may include valves that can be used to control or assist in controlling the expansion pressure.

[0080] In some variations, one or more chambers of the inflatable member (1200) may be inflated to a predetermined pressure (inflation pressure) with, for example, air and / or an inert gas. In some variations, the fluid pump may be operated by the patient, allowing the patient to adjust the force applied to the patient's head by the compression assembly via the heat exchanger. This can improve the adaptability and comfort of the cooling cap assembly and allow some degree of contact between the heat exchanger and the scalp. As described above, in some variations, the cooling unit may include a fluid pump. In these variations, the cooling system may further include a controller, which may be configured to control the inflation pressure of the inflatable member (1200) manually (e.g., via user input) and / or dynamically (e.g., using sensor data) using the fluid pump (1250).

[0081] In some variations, the inflatable member (1200) may include flexible materials such as nylon, urethane-coated nylon, polyester fabric, polyvinyl chloride (PVC), loop cloth, nonwoven fabric, or combinations thereof. This may allow one or more parts of the inflatable member (1200) to be manipulated and adjusted (e.g., wrapped) to conform to the shape of the patient's head, accommodating multiple patients with varying head sizes. In some variations, the inflatable member (1200) may include flexible materials such as nylon and / or nonwoven fabric.

[0082] In some modifications, one or more inflatable sections and / or chambers of the inflatable member can be inflated and / or deflated independently. As shown in Figure 1B, for example, the inflatable member may include multiple segmented chambers that can be inflated and / or deflated independently. In these modifications, fluid conduits (144) can be coupled to each chamber of the inflatable member (130) to allow independent control of the fluid pressure in each inflatable section and / or chamber of the inflatable member. This can allow for more uniform cooling of the head by allowing individual adjustment of the expansion pressure of each inflatable section and / or chamber as needed. For example, after each chamber has been initially inflated to a predetermined expansion pressure, temperature sensors coupled to each arm or lobe of the heat exchanger can measure temperature readings indicating uneven cooling of the scalp. Accordingly, the controller can increase the expansion pressure of the chambers corresponding to the heated arms or lobes, for example, by increasing the output of the pumps fluid-coupled to those chambers or by directing additional fluid to those particular chambers.

[0083] cabinet In general, the housing described herein may include a surface configured to resist deformation when the inflatable member transitions from a contracted configuration to an expanded configuration. The housing described herein can act as a reaction force on the inflatable member when it expands, and when used with a heat exchanger, allows the heat exchanger to apply a compressive force to the patient's head. By using the housing as a reaction force on the inflatable member in the expanded configuration, it is possible to maintain a uniform shape for the inflatable member when in the expanded configuration and to increase the contact area between the heat exchanger and the patient's scalp.

[0084] Figure 13 is a perspective view of an exemplary modification of the housing (1300), including a shell (1310), straps (1312), a chin strap (1314), strap fasteners (1316), shell fasteners (1318), an inflatable member (1320), and an inflatable member fastener (1322). In some modifications, the shell (1310) may be hemispherical or dome-shaped, or in the form of a helmet. For example, the shell (1310) may be made of a rigid (e.g., molded plastic) or semi-rigid material. For example, the shell (1310) may be more rigid than the inflatable member (1320). As shown in Figure 13, the shell (1310) may be configured to surround at least a portion of the inflatable member (1320), and in some modifications, the entire inflatable member (1320). For example, the shell (1310) may define a cavity configured to surround at least a portion of the inflatable member (1320) and / or to receive a patient's head (not shown). In some modifications, the shell (1310) may be enclosed by a flexible cover as described herein. The shell (1310) may include one or more ports (not shown) configured to allow one or more fluid connections to connect to one or more inflatable members (1320) and a heat exchanger (not shown). The ports may be further configured to allow wired connections to one or more sensors of the cooling cap assembly. In some modifications, the shell (1310) may include one or more electronic components of the cooling cap assembly (e.g., a processor, memory, PCB, battery, wires, audio output device, haptic feedback device, visual output device). For example, the shell (1310) may include an audio output device near the ear canal portion of the housing (1300) configured to provide audio notifications (e.g., operating status) related to the cooling treatment of the cooling cap assembly. As another example, a haptic feedback device may be configured to vibrate during power state transitions of a cooling unit coupled to a cooling cap.

[0085] In some variations, the housing (1300) may include one or more straps (1312) configured to secure the shell (1310) to a patient. The straps (1312) may include a chin strap (1314) configured to wrap under the patient's chin. In some variations, the chin strap (1314) may be adjustable for comfort and may include one or more rigid and flexible components. For example, the chin strap (1314) may pass through one or more components of the cooling cap assembly. In some variations, the strap (1312) may include a strap fastener (1316) (e.g., a loop) configured to fasten the strap (1312) to one or more of the shell (1310), an inflatable member (1322), a cover, and a heat exchanger (not shown). In some variations, the shell fastener (1318) and the inflatable member fastener (1322) may each include an opening, the opening being configured such that a strap fastener (1316) can loop through it.

[0086] Figures 14A–14F are perspective views of exemplary modifications of the housing (e.g., a cooling cap). Figures 14A and 14C are side and rear views of the housing, respectively. Figure 14B is a bottom view of the housing with the inflatable member installed inside. A manual pump is coupled to the inflatable member. Figures 14D and 14E show that the inflatable member and flexible cover can be releasably coupled to a more rigid shell of the housing (e.g., via Velcro®). Figure 14F is a detail view of the chin strap of the housing. In some modifications, fasteners (e.g., double-sided hook tape) can be used to secure the housing shell to the inflatable member.

[0087] Figures 4A and 4B are internal and external perspective views of modified versions of the housing (400). In some modifications, the housing (400) may include a rigid material (e.g., molded plastic) or a semi-rigid material. For example, the housing (400) may be more rigid than the inflatable member. As shown in Figures 4A-4B, the housing (400) may be configured to surround at least a portion of the inflatable member. For example, the housing (400) may define a cavity configured to surround at least a portion of the inflatable member and / or to receive the patient's head. In some modifications, the housing may include a hemispherical shell (e.g., the housing may include a dome shape). Although not shown in Figures 4A and 4B, in some modifications, the housing may include fasteners that allow the housing (and the entire compression assembly) to be reversibly connected to the patient's head.

[0088] liner Generally, the liners described herein can be configured to make contact with one or more of the patient's hair and / or scalp, and to provide a barrier between the heat exchanger and the scalp. In some modifications, the liner may be thin, flexible, and / or lightweight, and may allow heat transfer between the heat exchanger and the scalp. For example, the liner may contain flexible and / or elastic materials such as knitted polyamide or knitted nylon. The liner may form a cavity configured to receive the patient's head, but unlike the housing, the liner may be adaptable and lack a specific structure (e.g., soft and conformable). The liner can be applied to and fitted to the patient's scalp. In some modifications, the patient's hair may be spread evenly across the scalp before applying the liner to the head, thereby helping to provide more evenly distributed cooling to the scalp. For example, the patient's hair may be arranged to cover the patient's partial hairline, which may help protect the patient's partial hairline during cooling. In some modifications, the liner may help to hold the hair in place in the desired configuration. In some variations, a moisturizing lotion and / or hair conditioner may be applied to the scalp before applying the liner to improve conductivity and / or prevent hair from freezing during treatment. The liner may contain washable and reusable materials. In some variations, the liner may be elastic. The liner may be positioned between the patient's scalp and the heat exchanger so that the heat exchanger is movable relative to the liner. In some variations, the liner may form a friction fit with the scalp so that the liner can remain on the scalp when the cooling cap assembly is removed from the patient's head. As mentioned above, in some variations, the cooling cap assembly may not contain a liner.

[0089] cover In general, when included in the cooling assemblies described herein, the cover may be configured to hold (e.g., secure, fasten) the compression assembly to the patient. For example, the cover may be disposed on the housing of the cooling cap assembly and may include fasteners that can reversibly connect the cooling cap assembly to the patient. In this way, the cooling cap assembly can be secured to the patient's head so that the cooling cap assembly applies a predetermined pressure to the heat exchanger and the patient's head. As described in more detail above, the inflatable member can be inflated to further increase the compression to the head and the contact area between the heat exchanger and the patient's scalp. In some modifications, the cover may include a flexible and elastic material such as neoprene, and the cover may be configured to expand as needed to hold the compression assembly in place on the head. In some modifications, the cover may hold the compression assembly and heat exchanger so that the compression assembly and heat exchanger can be removed together from the patient's head. The cooling cap assembly (e.g., the compression assembly and heat exchanger) can then be returned to the patient's head as a single unit for future use.

[0090] In some modifications, the cover may be coupled and fixed to the compression assembly (e.g., the housing), and in other modifications, the cover may be releasably coupled to the compression assembly. The cover assists the patient in positioning the cooling cap assembly (e.g., the compression assembly) on their head and allows the cooling cap assembly to be secured to the head during use. In some modifications, as described in more detail herein, the heat exchanger may be detached from the compression assembly and releasably coupled. In these modifications, the cover can also assist in removing the heat exchanger from the patient's head and securing and reapplying it to the patient's head.

[0091] Figure 5 is a perspective view of an exemplary modification of the flexible cover (500). As shown therein, the cover (500) (e.g., an expandable cap) may include a fastening assembly (e.g., a chin strap (510)) configured to wrap around the underside of the patient's chin.

[0092] sensor In general, the sensors described herein may be configured to measure one or more parameters, such as temperature or force (e.g., pressure), and may be used to control one or more components of the cooling unit and / or cooling cap assembly. As shown in Figure 1B, in some modifications, the cooling cap assembly may include one or more sensors (132). In this modification, one or more sensors (132) can be coupled to a heat exchanger (120) and configured to measure one or more parameters of the cooling cap assembly, such as the temperature of the fluid circulating within the heat exchanger, the temperature of the scalp, and / or the force exerted on the patient's scalp by the heat exchanger or vice versa. In some modifications, the sensors may include one or more (e.g., two, three, four, five, or more) temperature sensors and / or one or more (e.g., two, three, four, five, or more) pressure sensors or dynamic sensors.

[0093] In some variations, the heat exchanger (120) may have at least one sensor (132) in each part of the heat exchanger (120). For example, each arm or lobe of the heat exchanger (120) may include one or more sensors (132) (e.g., one temperature sensor, one pressure sensor). In some variations, the temperature sensor may be located on the outer surface of the heat exchanger (120), inside the heat exchanger (120), or within the fluid channels of the heat exchanger (120). For example, the temperature sensor may be located inside the heat exchanger (120) (e.g., facing the scalp), and the pressure sensor may be located outside the heat exchanger. The sensor may be located at the distal end of an arm or lobe. In one example, the sensor may include six temperature sensors coupled to the heat exchanger and an ambient temperature sensor located outside the cooling cap assembly. In some variations, the temperature may be scalp temperature and / or fluid temperature. In some variations, one or more sensors (132) may include a radial pattern on the heat exchanger.

[0094] In some variations, one or more sensors can be coupled to a controller. The controller can be configured to receive and process sensor measurements (e.g., temperature, force) to control the cooling cap assembly. For example, the expansion pressure of an inflatable member can be adjusted by the controller based on temperature measurements.

[0095] In some variations, the expansion pressure in each chamber of the inflatable member (130) may be adjusted independently based on one or more measured temperatures in each chamber. In some variations, the measured temperatures may be compared to a predetermined threshold or target temperature, or a predetermined target temperature range. For example, in some variations, the target temperature range for the patient's scalp temperature may be about 3°C ​​to about 5°C, or about 16°C to about 18°C. If one or more of the scalp temperatures exceed a predetermined threshold and / or are outside a predetermined range, the controller can command or signal one or more valves and / or pumps fluidly coupled to the chambers of the inflatable member (130) to increase the expansion pressure in one or more chambers. Selectively increasing the expansion pressure in specific chambers may increase the contact area between the scalp and the heat exchanger at the locations corresponding to those specific chambers. In this way, the controller and one or more valves and / or pumps fluidly coupled to the inflatable member (130) may be configured to dynamically control the expansion pressure.

[0096] Cooling unit As described above, the cooling systems described herein may include a cooling unit. The cooling unit may be configured to lower the temperature of a cooling fluid and transfer the cooled cooling fluid to a cooling cap assembly (e.g., a heat exchanger) to lower the scalp temperature of a patient using the cooling cap assembly described herein. As shown in Figure 1A, the cooling unit (150) may comprise a compressor and / or thermoelectric cooling mechanism (152) (e.g., a vapor compressor containing a refrigerant), a reservoir (154), a sensor (156), and a pump (158) (e.g., a gear pump). The cooling unit (150) may be fluid-coupled to a heat exchanger (120) of the cooling cap assembly (110) and configured to circulate the cooling fluid through the heat exchanger (120). In some variations, the fluid may include water and alcohol, or liquid water, ice and salt. For example, the fluid may include a mixture of isopropyl alcohol and water. In some variations, the ratio of alcohol to water can be approximately 5% to 50%, 5% to 30%, 20% to 30%, and 5% to 25%, encompassing all sub-values ​​and ranges in between. In some variations, the composition and ratio of the fluid can be determined based on the size of the reservoir and / or the volume of the fluid.

[0097] In some modifications, the cooling unit (150) may be compact so that it is portable and allows for free movement of the patient. Furthermore, in some modifications, the cooling unit (150) may include a portable power source (e.g., batteries), which may allow the patient to use the cooling system without using an electrical outlet. As will be apparent from the following description, the cooling unit (150) enables the use of the cooling system described herein without dry ice, thereby increasing safety and reducing operational complexity.

[0098] As described above, the cooling unit (150) can be fluid-coupled to the cooling cap assembly (110). For example, the cooling unit may include a fluid conduit (not shown) releasably coupled to the heat exchanger (120). For example, the fluid conduit (e.g., a tube assembly, tubes) may include a set of flexible polymer tubes of a predetermined length, such as about 1 foot to about 15 feet. In some cases, the cooling unit (150) and / or the fluid conduit may include one or more valves that can help control the flow of the circulating cooling fluid. In some modifications, the fluid connection may include one or more of polyvinyl chloride (PVC) and thermoplastic polyurethane (TPU). In some modifications, the fluid connection may be covered by an external sheath that may include an elastic and / or laminated insulating cloth (e.g., neoprene).

[0099] Figure 1C is a block diagram of a modified cooling system (100), including a cooling cap assembly (110) and a cooling unit (150). A fluid (162) at a first temperature T1 (e.g., water, water, and alcohol) may be output from the cooling unit (150) to the cooling cap assembly (110). A fluid (160) at a second temperature T2 may be received by the cooling unit (150) from the cooling cap assembly (110). A compressor (152) may be configured to lower the temperature of the circulating fluid returned from the heat exchanger (120). In some modifications, the compressor (152) may be configured to compress a refrigerant used to cool the fluid passing through the expansion chamber. For example, a fluid (160) may be input to the compressor (152), and the compressor (152) may be configured to output a fluid (164) at a temperature T3 which may be lower than temperature T2. A reservoir (154) may be configured to hold the cooled fluid received from the compressor (152). For example, the reservoir (154) may include a container in which the fluid (164) can be stored, and in some modifications, the reservoir (154) may include ice. A flow meter (152) may be placed in the fluid path between the compressor (152) and the reservoir (154) and may be configured to measure the flow of fluid in the cooling unit (150). A pump (158) may be configured to circulate the fluid to and from the cooling cap assembly (110). For example, the output of the reservoir (154) may be fluid-coupled to a pump (158) configured to deliver the fluid (162) to the cooling cap assembly (110) at temperature T3.

[0100] The sensor (156) may be configured to measure one or more system parameters, such as duration of use, fluid flow, and / or temperature. For example, in some modifications, the sensor (156) may include one or more temperature sensors, which may be coupled to fluid flow paths between the cooling cap assembly (110) and the compressor (152) (e.g., above the inlet of the cooling unit (150), between the compressor (152) and the reservoir (154), inside the reservoir (154), between the reservoir (154) and the pump (158), on the outlet side of the pump (158), and / or between the outlet of the cooling unit (150) and the cooling cap assembly (110)). One or more temperature sensors may be configured to measure the temperature of the fluid flowing into, passing through, or out of the cooling unit (150), e.g., temperatures T1, T2, and T3. In some variations, the temperature sensor may be a thermistor or thermocouple housed in a liquid-impermeable fitting. Additionally or alternatively, the sensor (156) may include a fluid flow sensor, which may be coupled to a fluid flow path between the cooling cap assembly (110) and the compressor (152) (e.g., above the inlet of the cooling unit (150), between the compressor (152) and the reservoir (154), inside the reservoir (154), between the reservoir (154) and the pump (158), on the outlet side of the pump (158), and / or between the outlet of the cooling unit (150) and the cooling cap assembly (110)). The fluid flow sensor may be configured to measure the flow rate of fluid flowing into, through, or out of the cooling unit (150). Additionally or alternatively, the sensor (156) may include a timer configured to count or determine, for example, the duration of a cooling treatment session, based at least partially on one or more of the measurements of fluid flow, temperature, and power consumption, or otherwise be communicably coupled to the timer.

[0101] In some modifications, the cooling unit (150) may include a controller, such as those described herein, to control the flow rate and / or temperature of the circulating fluid based, for example, sensor (156) measurements, sensors within the cooling cap assembly, and / or user input. For example, the controller may receive sensor data and, based on that sensor data, modify the output of cooling unit components, such as the pump (158) and / or the compressor (152). As described above, in some modifications, the sensor (156) of the cooling unit (150) may include a fluid flow sensor (e.g., a Hall effect sensor) configured to measure the flow rate of the fluid circulating through the cooling unit (150), and / or a temperature sensor (e.g., a thermistor, thermocouple) configured to measure the temperature of the circulating fluid at various points in the cooling system. In particular, in some cases, the controller may be configured to receive multiple temperature measurements from temperature sensors (in the cooling unit and / or cooling cap assembly) and to calculate the temperature difference (i.e., delta T) between two or more of the temperature measurements (e.g., between a first temperature and a second temperature measured at different locations within the cooling unit (150) and / or cooling cap assembly (110)). The controller may also be configured to receive fluid flow measurement values ​​from a fluid flow sensor. The controller may be configured to compare the temperature measurements, the calculated delta T, and / or flow measurement values ​​with target measurements (e.g., target temperature, target delta T, target flow rate) and / or target measurement range, and to adjust one or more components of the cooling unit (150) to achieve desired results (e.g., lower cooling fluid temperature, higher cooling fluid temperature, lower scalp temperature (measured by a sensor in the cooling cap assembly), higher scalp temperature, lower flow rate, higher flow rate). For example, the controller can adjust the power delivered to the compressor (152) and / or pump (158) to change (e.g., increase or decrease) or maintain the measured temperature, measured flow rate, and / or delta T.By adjusting the power to the compressor (152), the temperature of the cooling fluid leaving the compressor (152) can be raised or lowered, while by adjusting the power to the pump (158), the flow rate of the cooling fluid in the system can be increased or decreased. Higher flow rates may generally correlate with lower delta T (because faster fluid exchange reduces the time for heat exchange between the cooling fluid and the scalp). In some modifications, the target temperature range of the cooling fluid in the cooling area (e.g., within the heat exchanger) may be about 2°C to about 4°C, and / or the target temperature range of the cooling fluid in the cooling unit may be about -2°C to about 2°C or about 0°C to about 2°C. In some modifications, the controller may include a timer, which may be configured to determine, for example, the duration of a cooling treatment session.

[0102] In some variations, the controller may display a graphical user interface to allow user adjustment of the flow rate and / or temperature of the circulating fluid. In some variations, the controller may provide instructions to the user via the graphical user interface to change the temperature of the cooling fluid by adding or removing ice from the reservoir and / or changing the cooling fluid (e.g., by changing the ratio of water to alcohol). In some variations, the controller may adjust the power to the compressor (152) and / or pump (158) in response to user input received, for example, via the graphical user interface. While the cooling unit (150) has been described above, it should be understood that in variations where the controller is a computing device (e.g., a smartphone, tablet, etc.), the controller may be separated from the cooling unit (150).

[0103] In some modifications, the cooling cap assembly (110) and cooling unit (150) may be configured to be self-contained, portable, reusable, and self-operated by the patient (e.g., without the assistance of a technician). As described above, in some modifications, the cooling unit (150) may be equipped with a battery to allow for patient portability and freedom of movement.

[0104] Figures 15A–15K show the appearance of exemplary modifications of the cooling unit (1500). In some modifications, the cooling unit (1500) may be configured to be self-contained, portable, reusable, and self-operated by the patient (e.g., without the assistance of a technician). As described above, in some modifications, the cooling unit (1500) may be equipped with a battery (not shown) to enable the patient's portability and freedom of movement. The cooling unit (1500) may include a housing (1502), wheels (1504), a fluid reservoir (1510), a latch (1512), a fluid connection port (1520), a user interface (1530), and handles (1540, 1542, 1544). The housing (1502) may enclose and protect the internal components of the cooling unit (1500), as described herein, for example with respect to Figures 16A–16D. The handles (1540, 1542, 1544) and wheels (1504) of the cooling unit (1500) may enable the portability of the cooling unit (1500) by allowing the patient to easily move the cooling unit (1500) from one location (e.g., a clinic, office, or room) to another location (e.g., public transport, home, or another room) while performing continuous cooling therapy. In some modifications, the cooling unit (1500) may include height-adjustable handles (1540) and side handles (1542). The wheels (1504) may be configured to allow the cooling unit (1500) to rotate in any direction. In some modifications, the cooling unit (1500) may be configured to fit on the floor of a car seat (e.g., behind the driver's or passenger's seat) or on the car seat itself. For example, the cooling unit (1500) may have a width of approximately 200 mm to approximately 500 mm, a length of approximately 400 mm to approximately 600 mm, and a height of approximately 350 mm to approximately 500 mm.

[0105] In some modifications, the cooling unit (1500) may include a fluid reservoir (1510) releasably coupled to a housing (1502). In some modifications, the fluid reservoir may be configured to hold about 0.5 L to about 4 L of fluid. For example, the fluid reservoir (1510) may be configured to hold about 3 L of fluid. In some embodiments, the fluid reservoir (1510) may have a width of about 100 mm to about 300 mm, a length of about 200 mm to about 300 mm, and a height of about 50 mm to about 150 mm. In some embodiments, the fluid reservoir may include a handle (1544) configured to allow a user to separate the fluid reservoir (1510) from the housing (1502) of the cooling unit (1500). In some modifications, the cooling unit (1500) may include a latch (1512) configured to releasably engage the fluid reservoir (1510) with the housing (1502). As shown, for example in Figures 15B-15G, the latch (1512) may include a hinge configured to transition between an engaged configuration and an unengaged configuration. The latch (1512) can cover the fluid reservoir (1510) in the engaged configuration to form a fluid seal over the opening of the fluid reservoir (1510). In some modifications, the latch (1512) may further include a mounting sensor configured to generate a mounting signal when the fluid reservoir (1510) is engaged with the latch (1512). The controller of the cooling unit (1500) may be configured to prevent operation if no mounting signal is received.

[0106] In some variations, the cooling unit (1500) may include a fluid connection port (1520). In some variations, the fluid connection port (1520) may include a fluid inlet and a fluid outlet configured to fluidly couple the cooling unit (1500) to a heat exchanger (not shown) of a cooling cap. In some variations, the fluid connection port (1520) may be mounted on the exterior surface of the housing (1502) to allow easy access and visual confirmation of fluid connection / disconnection by the patient. In some variations, the cooling unit (1500) may include a user interface (1530) configured to display cooling information and / or to allow control of the cooling unit (1500).

[0107] Figures 15L to 15N are exploded perspective views of exemplary modifications of the cooling unit (1500). In particular, Figure 15N shows the battery (1550), condenser (1560), system pump (1570), cooling pump (1580), and temperature sensor (1590).

[0108] Figures 16A–16D are internal diagrams of exemplary variations of the cooling unit (1600). In some variations, the cooling unit (1600) may include a condenser (1610), a cooling pump (1620), a system pump (1622), a battery (1630), a power input (1632), a heat exchanger (1640), sensors (1650, 1652, 1654), a controller (1660) (e.g., a circuit board, processor, memory), and a fluid input (1670). The condenser (1610) may be configured to condense compressed gas into liquid vapor. The pumps (1620, 1622) may include a cooling pump (1620) (e.g., a compressor) configured to lower the temperature of the circulating fluid and a system pump (1622) configured to circulate the fluid between the cooling cap assembly (not shown). In some variations, a cooling pump (1620) may be configured to compress a refrigerant used to cool the fluid passing through the expansion chamber. A fluid input (1670) may be configured to receive fluid from one or more of the fluid reservoir and / or cooling cap assemblies (not shown).

[0109] The sensors (1650, 1652, 1654) may be configured to measure one or more system parameters such as duration of use, fluid flow, temperature, and / or pressure. For example, in some modifications, the sensors may include a fluid flow sensor (e.g., a flow meter) (1650), a temperature sensor (1652), and / or a pressure sensor (1654). In some modifications, the system may comprise multiple of one or more of the above sensors. In a modification comprising one or more flow sensors (1650), the flow meter (1650) may be configured to measure the fluid flow within the cooling unit (1600). In a modification comprising one or more temperature sensors, the temperature sensor (1652) may be configured to measure the temperature of the fluid flowing into, passing through, or flowing out of the cooling unit (1600). In some modifications, the temperature sensor may be a thermistor or thermocouple housed in a liquid-impermeable fitting. In a modified version comprising one or more pressure sensors, the pressure sensor (1654) may be configured to measure the pressure of a fluid flowing into, passing through, or flowing out of the cooling unit (1600).

[0110] In some variations, the cooling unit (1600) may include a controller, as described herein, to control the flow rate, pressure, and / or temperature of the circulating fluid based, for example, cooling sensor measurements, sensors within the cooling cap assembly, and / or user input. For example, the controller (1660) may receive sensor data and, based on that sensor data, modify the output of cooling unit components, such as pumps (1620, 1622). In particular, in some cases, the controller (1660) may be configured to receive multiple temperature measurements from temperature sensors (within the cooling unit and / or cooling cap assembly) and to calculate the temperature difference (i.e., delta T) between two or more of the temperature measurements (e.g., between a first temperature and a second temperature measured at different locations within the cooling unit (150) and / or cooling cap assembly (110)). The controller (1660) may also be configured to receive fluid flow measurement values ​​from a fluid flow sensor. The controller may be configured to compare temperature and / or flow rate measurements with target measurements and / or target measurement ranges, and to adjust one or more components of the cooling unit (1600) to achieve desired results (e.g., lower cooling fluid temperature, higher cooling fluid temperature, lower scalp temperature (measured by a sensor in the cooling cap assembly), higher scalp temperature, lower flow rate, higher flow rate). In some variations, the controller (1660) may include a timer configured to count or determine, for example, the duration of a cooling treatment session based at least in part on one or more measurements of fluid flow, pressure, temperature, and power consumption.

[0111] In some modifications, the controller (1660) may control a user interface to allow user adjustment of the flow rate and / or temperature of the circulating fluid. In some modifications, the controller (1660) may provide instructions to the user via a graphical user interface to change the temperature of the cooling fluid, for example, by adding or removing ice from the fluid reservoir and / or by changing the cooling fluid (e.g., by changing the water ratio). In some modifications, the controller may adjust the power to the condenser (1610) and / or pumps (1620, 1622) in response to user input received via the user interface. While the cooling unit (1600) has been described above, it should be understood that in modifications where the controller is a computing device (e.g., a smartphone, tablet, etc.), the controller may be separated from the cooling unit (1600).

[0112] Figure 6 is a schematic diagram of a cooling system in use. As shown therein, a patient can use the portable cooling system in conjunction with a chemotherapy treatment session (600). For example, the patient can apply the cooling cap assembly to their head and connect the cooling cap assembly to the cooling unit without the assistance of a medical professional (e.g., by the patient themselves). In some embodiments, the patient can start the cooling treatment before receiving chemotherapy infusions and continue the cooling treatment while receiving chemotherapy infusions. The cooling unit may be configured to be portable in a manner that allows the patient to perform basic activities (e.g., movement, bladder control) while receiving the cooling treatment. When the chemotherapy session is completed (602), the patient can continue to use the cooling system by transporting it to the patient's home or other destination. Thus, the patient does not need to remain at the treatment center to complete the cooling treatment session. The cooling unit may be portable enough for the patient to use when traveling, for example, between the patient's home and the chemotherapy treatment center (604) (e.g., having a suitable size and weight). While the cooling treatment is being administered (608), patients can continue many of their daily activities outside the chemotherapy treatment center (e.g., at home) without interruption. In some variations, patients can control the cooling system using a graphical user interface on a computing device (e.g., a mobile phone, tablet, or laptop).

[0113] Additionally or alternatively, cooling units can be installed inside medical carts, bags, portable cases, etc., which may be equipped with handles to allow patients to easily transport them.

[0114] controller As described above, one or more of the cooling cap assemblies and cooling units may include a controller. Additionally or alternatively, the system may further include a separate controller (e.g., a computing device) which may be used in combination with the cooling cap assemblies and / or cooling units. Generally, the computing device described herein may include a controller comprising a processor (e.g., a CPU) and memory (which may include one or more non-temporary computer-readable storage media). The processor may incorporate data received from memory and via communication channels to control one or more components of the system (e.g., cooling cap assemblies (110), cooling units (150, 1600)). For example, in some embodiments, the processor may be configured to control fluid pumps coupled to inflatable members, fluid pumps (158, 1620, 1622) of the cooling units (150, 1600), and / or compressors (152) of the cooling units (150, 1600). The memory may further store instructions that cause the processor to execute modules, processes, and / or functions associated with the methods described herein. In some modifications, the memory and processor may be implemented on a single chip. In other modifications, they may be implemented on separate chips.

[0115] The controller may be configured to receive and process sensor data from the cooling system and other data from other sources (e.g., computing devices, databases, user inputs) (e.g., patient data, treatment data). The controller may be configured to control one or more of the following based on the measured sensor data and / or other data (e.g., patient data, treatment data, user inputs): the expansion pressure of an inflatable member, the circulating fluid temperature, and the flow rate. The controller may be configured to receive, process, compile, store, and access data. In some variations, the computing device may be configured to access data from different sources and / or receive data from different sources. The controller may be configured to receive data directly from the patient and / or measured data. Additionally or alternatively, the controller may be configured to receive data from separate devices (e.g., smartphones, tablets, computers) and / or storage media (e.g., flash drives, memory cards). The computing device may receive data via a network connection or via a physical connection to the device or storage media (e.g., via a Universal Serial Bus (USB) or any other type of port), as will be discussed in more detail herein. Computing devices can include a wide variety of devices such as mobile phones (e.g., smartphones), tablet computers, laptop computers, desktop computers, portable media players, wearable digital devices (e.g., digital glasses, wristbands, watches, brooches, armbands, virtual / augmented reality headsets), televisions, set-top boxes (e.g., cable boxes, video players, video streaming devices), and game consoles.

[0116] The controller may be configured to receive various types of data. For example, the controller may be configured to receive patient personal data (e.g., gender, weight, date of birth, age, height, medical certificate, etc.), general health information, or other relevant information. In some variations, the controller may be configured to create, receive, and / or store patient profiles. Patient profiles may include patient preferences and / or historical data about treatment sessions (e.g., characteristics of treatment sessions such as duration, location, time, day of the week, etc., or cooling parameters from previous treatment sessions such as inflation pressure, cooling fluid temperature, scalp temperature, and cooling fluid flow rate, etc.). Patient profiles may additionally or alternatively include any of the aforementioned patient-specific information. While the above information may be received by the controller, in some variations, the controller may be configured to process any of the above data from information received by the controller using the device itself or software stored externally. Furthermore, in some variations, the controller may be configured to adjust the expansion pressure of the inflatable member, the temperature of the cooling fluid, the flow rate of the cooling fluid, the duration of the treatment session, or other treatment session characteristics or cooling parameters based on a combination of patient personal data, general health information, and / or patient profile, in addition to measurements received from the sensors described herein.

[0117] The processor may be any suitable processing device configured to operate and / or execute a set of instructions or code, and may include one or more data processors, image processors, image processing units, physical processing units, digital signal processors, and / or central processing units. The processor may be, for example, a general-purpose processor, a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), etc. The processor may be configured to operate and / or execute application processes and / or other modules, processes and / or functions associated with a system, and / or networks associated therewith. The underlying device technology may be provided in various component types (e.g., metal-oxide-semiconductor field-effect transistor (MOSFET) technology such as complementary metal-oxide-semiconductor (CMOS), bipolar technology such as emitter-coupled logic (ECL), polymer technology (e.g., silicon-conjugated polymers, and metal-conjugated polymer-metal structures), analog and digital mixed technologies, etc.).

[0118] In some variations, the memory may include a database (not shown) and may be, for example, random access memory (RAM), memory buffers, hard drives, erasable programmable read-only memory (EPROM), electrically erasable read-only memory (EEPROM), read-only memory (ROM), flash memory, etc. The memory may store instructions for causing a processor to execute modules, processes, and / or functions associated with communication devices, such as cooling unit control, expansion control, and / or communication. Some variations described herein relate to computer storage products having a non-temporary computer-readable medium (sometimes also referred to as a non-temporary processor-readable medium) having instructions or computer code for performing various computer operations. The computer-readable medium (or processor-readable medium) is non-temporary in the sense that it does not contain transient propagating signals themselves (e.g., propagating electromagnetic waves that carry information on a transmission medium such as space or cable). The medium and computer code (which may also be referred to as code or algorithms) may be designed and constructed for a particular purpose or for various purposes.

[0119] Examples of non-temporary computer-readable media include, but are not limited to, magnetic storage media such as hard disks, floppy disks, and magnetic tapes; optical storage media such as compact discs / digital video discs (CDs / DVDs); magneto-optical storage media such as compact disc read-only memory (CD-ROMs) and holographic devices, optical discs; semiconductor storage devices such as solid-state drives (SSDs) and semiconductor hybrid drives (SSHDs); carrier signal processing modules; and hardware devices specifically configured to store and execute program code, such as application-specific integrated circuits (ASICs), programmable logic circuits (PLDs), read-only memory (ROMs), and random-access memory (RAM) devices. Other variations described herein relate to computer program products, which may include, for example, instructions and / or computer code disclosed herein.

[0120] The systems, devices, and / or methods described herein may be implemented by software (running on hardware), hardware, or a combination thereof. Hardware modules may include, for example, general-purpose processors (or microprocessors or microcontrollers), field-programmable gate arrays (FPGAs), and / or application-specific integrated circuits (ASICs). Software modules (running on hardware) may be expressed in various software languages ​​(e.g., computer code), such as C, C++, Java®, Python, Ruby, Visual Basic®, and / or other object-oriented, procedural, or other programming languages ​​or development tools. Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions such as those generated by a compiler, code used to generate web services, and files containing high-level instructions executed by a computer using an interpreter. Additional examples of computer code include, but are not limited to, control signals, encryption code, and compression code.

[0121] In some variations, the controller may further comprise a communication device configured to allow a patient and / or medical professional to control one or more components of the cooling unit and / or cooling cap assembly. The communication device may include a network interface configured to connect the controller to another system (e.g., the Internet, a remote server, a database) via a wired or wireless connection. In some variations, the controller may communicate with other devices via one or more wired and / or wireless networks. In some variations, the network interface may include a radio frequency receiver, transmitter, and / or optical (e.g., infrared) receiver and transmitter configured to communicate with one or more devices and / or networks. The network interface may communicate via wired and / or wireless.

[0122] A network interface may include RF circuits configured to receive and transmit RF signals. RF circuits can convert electrical signals to and from electromagnetic signals and communicate with communication networks and other communication devices via electromagnetic signals. RF circuits may include known circuits for performing these functions, and such circuits may include, but are not limited to, antenna systems, RF transceivers, one or more amplifiers, tuners, one or more oscillators, digital signal processors, CODEC chipsets, subscriber identification module (SIM) cards, memory, and the like.

[0123] Wireless communication via either computing or measuring devices may use any of several communication standards, protocols, and technologies, including, but not limited to, Global Systems for Mobile Communications (GSM), Enhanced Data GSM Environment (EDGE), High-Speed ​​Downlink Packet Access (HSDPA), High-Speed ​​Uplink Packet Access (HSUPA), Evolution, Data Only (EV-DO), HSPA, HSPA+, Dual-Cell HSPA (DC-HSPADA), Long-Term Evolution (LTE), Near Field Communication (NFC), Wideband Code Division Multiple Access (W-CDMA), Code Division Multiple Access (CDMA), Time Division Multiple Access (TDMA), Bluetooth, and Wireless Fidelity (WiFi). Examples include IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, IEEE 802.11n, etc.), Voice over Internet Protocol (VoIP), Wi-MAX, email protocols (e.g., Internet Message Access Protocol (IMAP) and / or Post Office Protocol (POP)), instant messaging (e.g., Extensible Message and Presence Protocol (XMPP), Session Initialization Protocol for Instant Message and Presence Leverage Extension (SIMPLE), Instant Message and Presence Service (IMPS)), and / or Short Message Service (SMS), or any other suitable communication protocol. In some variations, the devices described herein can communicate directly with each other without transmitting data over a network (e.g., via NFC, Bluetooth, WiFi, RFID, etc.).

[0124] The communication device may further include a user interface configured to allow a user (e.g., a patient, a partner, a family member, a designated contact such as a healthcare professional) to control the controller. The communication device may allow the user to interact with and / or control the controller directly and / or remotely. For example, the controller's user interface may include input devices for the user to enter commands and output devices for the user to receive outputs.

[0125] In some variations, the output device may include a display device comprising at least one of the following: light-emitting diodes (LEDs), liquid crystal displays (LCDs), electroluminescent displays (ELDs), plasma display panels (PDPs), thin-film transistors (TFTs), organic light-emitting diodes (OLEDs), electronic paper / electronic ink displays, laser displays, and / or holographic displays.

[0126] In some variations, a user can communicate with other users using an audio device and communication channel. For example, a patient may form an audio communication channel (e.g., a VoIP call) with a remote medical professional. In some variations, the audio device may include at least one of a speaker, a piezoelectric acoustic device, a magnetostrictive speaker, and / or a digital speaker.

[0127] In some variations, the user interface may include input devices (e.g., a touchscreen) and output devices (e.g., a display). For example, user control of an input device (e.g., a keyboard, buttons, a touchscreen) may be received by the user interface and then processed by a processor and memory so that the user interface outputs control signals to the cooling unit (150). Some variations of the input device may include at least one switch configured to generate control signals. For example, the input device may include a touch surface for the user to provide input (e.g., finger contact to a touch surface) corresponding to a control signal. For example, the user may input commands to start and stop cooling treatment, increase or decrease inflation pressure, raise or lower fluid temperature, and / or set the duration of a cooling treatment session.

[0128] Input devices with touch surfaces may be configured to detect contact and movement on the touch surface using one of several touch sensitivity technologies, including capacitive, resistive, infrared, optical imaging, dispersed signaling, acoustic pulse recognition, and surface acoustic wave technology. In a variation of an input device including at least one switch, the switch may include, for example, at least one of buttons (e.g., hard keys, soft keys), touch surfaces, keyboards, analog sticks (e.g., joysticks), directional pads, mice, trackballs, jog dials, step switches, rocker switches, pointer devices (e.g., styluses), motion sensors, image sensors, and microphones. A motion sensor can receive user movement data from an optical sensor and classify the user's gestures as control signals. A microphone can receive voice data and recognize the user's voice as control signals.

[0129] Haptic devices can be integrated into one or more input and output devices to provide additional sensory output (e.g., force feedback) to the user. For example, a haptic device may generate a tactile response (e.g., vibration) to confirm user input to an input device (e.g., a touch surface). As another example, haptic feedback may indicate that user input is being invalidated by the controller.

[0130] network In some variations, the devices and systems described herein may communicate with other devices or networks (e.g., within or outside the system) via one or more networks, each of which may be any type of network (e.g., wired network, wireless network). The communication may or may not be encrypted. A wireless network can refer to any digital network that is not connected by any type of cable. Examples of wireless communication in a wireless network include, but are not limited to, mobile phones, radio, satellite, and microwave communications. However, wireless networks may be connected to wired networks to interface with the Internet, other carrier voice and data networks, business networks, and personal networks. Wired networks are typically carried via copper twisted pair, coaxial cable, and / or fiber optic cable. Many different types of wired networks exist, including wide area networks (WANs), metropolitan area networks (MANs), local area networks (LANs), Internet area networks (IANs), campus area networks (CANs), internet-like global area networks (GANs), and virtual private networks (VPNs). Hereafter, the term "network" generally refers to any combination of wireless, wired, public, and private data networks interconnected via the Internet, providing an integrated networking and information access system.

[0131] Mobile communications can encompass technologies such as GSM, PCS, CDMA or GPRS, W-CDMA, EDGE or CDMA2000, LTE, WiMAX, and 5G networking standards. Some wireless network deployments combine networks from multiple mobile radio networks or use a mix of mobile radio, Wi-Fi, and satellite communications.

[0132] method This specification also describes a method for assembling a cooling cap assembly and a method for cooling the scalp using the systems and devices described herein. The methods for cooling the scalp of the head described herein can, for example, help reduce, prevent, or prevent hair loss caused by chemotherapy. For example, the method can increase heat transfer between the cooling cap assembly and the patient's scalp, and thus improve the effectiveness of scalp cooling therapy. As another example, these methods can improve user compliance with a cooling therapy regimen. In some modifications, the method may include the use of a cooling cap assembly and a cooling unit that can be configured to provide a closed-loop feedback system for responsive cooling. In these modifications, the method may include, for example, adjusting one or more of the following based on sensor measurements, via a controller: the expansion pressure of an inflatable member, the temperature of the cooling fluid, and the flow rate of the cooling fluid. Additionally or alternatively, the method may include adjusting one or more of the above parameters based on user input.

[0133] Assembly of the cooling cap assembly In general, the method of assembling the cooling cap assembly may include wrapping the heat exchanger around a portion of the head (e.g., scalp, portion of scalp) and positioning the compressed assembly on top of the heat exchanger and on the head. Figures 2I-2L are plan views of one modified assembly step for applying the heat exchanger (200) to the patient's scalp. The heat exchanger (200) is drawn separately from the patient's head for clarity. Figure 2H shows the outside of the heat exchanger in an expanded configuration, with the inside positioned on top of the patient's head. The bottom portion (210) may be aligned with the patient's neck and / or back of the head, with the top portion (221) positioned on the crown and / or front of the head. The side portions (231, 241), when placed on the patient's head, may cover the left and right hemispheres of the head. As shown in Figure 2I, the first and second lobes (220, 222) of the upper portion (221) can be turned inside out over the bottom portion (210). The ends of the first side portion (230) and the second side portion (240) can be overlapped and held together so that the side portions form an oval shape, as shown in Figure 2J. As shown in Figure 2K, the first lobe (220) of the upper portion can be folded over at least a portion of the first side portion (230) and the second side portion (240). Then, as shown in Figure 2L, the second side lobe (222) of the upper portion can be folded over the upper portion (220), the first side portion (230), and at least a portion of the second side portion (240). Fasteners can be used to fasten the overlapping portions together so that the heat exchanger forms a cap-like (e.g., hemispherical) shape that can generally fit the patient's scalp. Additionally or alternatively, one or more of the assembly steps can be performed separately from the head on a table or other surface, and the heat exchanger can be placed on the patient's head after it has been partially or completely assembled. Optionally, the patient may further adjust (e.g., tighten) parts of the heat exchanger to optimize the contact area and comfort after it has been placed on their head.

[0134] Figures 7A–7F are schematic diagrams of modified methods for assembling a cooling cap assembly. In the modifications shown in Figures 7A–7F, the method may include forming a cooling cap assembly on a patient's head by, for example, placing a liner on the patient's scalp (700), wrapping a heat exchanger around a portion of the scalp (702), and applying a compression assembly over the heat exchanger (704, 706). The method for forming the cooling cap assembly may further include applying a cover over the compression assembly (708). Although the application of the compression assembly (e.g., inflatable member and housing) and the cover is shown as separate steps (704–708), it should be understood that in some modifications, the compression assembly and the cover may be joined to each other (e.g., using snaps, buckles, bonding, hook-and-loop fasteners, etc.) so that they can be applied in a single step.

[0135] More specifically, in a modification in which the cooling cap assembly includes a liner, the method can be initiated by positioning the liner around a portion of the head, for example, around the patient's scalp. A heat exchanger may be positioned on top of the liner (702), and the compression assembly may be positioned on the head and on the wrapped heat exchanger so that the heat exchanger is positioned between the liner and the compression assembly. In modifications in which no liner is used, the heat exchanger may be positioned in direct contact with the patient's scalp and between the surface of the patient's scalp and the compression assembly. In particular, an inflatable member (e.g., an outer member, outer shell) that can be coupled to the housing may be positioned on top of the heat exchanger (704) so ​​that the heat exchanger is positioned between the inflatable member and the liner or the surface of the patient's scalp. In modifications in which the cover is fixed to the housing, the cover may be positioned on the patient's head in combination with the inflatable member and the housing. In other modifications in which the cover is not originally fixed to the housing, the cover may be applied to the patient's head on the compression assembly. The method may further include releasably attaching the cooling cap assembly to the patient's head using fasteners (e.g., a chin strap with a buckle, hook, Velcro®, etc.). Figure 7F shows a partial cutaway section (710) of the cooling cap assembly after it has been applied to or assembled on the patient's head.

[0136] As described above, in some variations, wrapping the heat exchanger around a portion of the scalp (702) may include fully or partially assembling the heat exchanger while the heat exchanger remains away from the patient's head, placing the fully or partially assembled heat exchanger on the head, and optionally adjusting the partially or fully assembled heat exchanger. In other variations, wrapping the heat exchanger around a portion of the scalp (702) may include partially or completely assembling the heat exchanger while the heat exchanger is on the patient's head.

[0137] In some modifications, the heat exchanger may be separated from the compression assembly or may be releasably coupled. In these modifications, the heat exchanger can be removed from the head using the compression assembly. That is, the heat exchanger may form a friction fit with an inflatable member so that the compression assembly and the heat exchanger can be removed from the patient's head as a single unit. The heat exchanger can be returned to the scalp using the compression assembly during a future treatment session. In modifications including a cover, the cover can also help remove the heat exchanger from the patient's head and secure and reapply it to the patient's head. In some modifications, to reduce the number of disassembly steps, there may be a friction fit between the compression assembly and at least one other component of the cooling cap assembly (e.g., heat exchanger, cover). For example, the heat exchanger, compression assembly, and cover can be removed together from the patient's head as a single unit, thereby leaving only the liner on the patient's scalp. This single-unit cooling cap assembly can then be returned to the patient's head to perform another cooling treatment session. Because the heat exchanger and expandable components are pre-adjusted and attached to the patient's anatomical structure, the assembled cooling cap assembly can be easily positioned over the patient's head with minimal readjustment.

[0138] Figures 8A–8E are perspective views of another modification of the cooling cap assembly process. In this modification, the cover can be opened to receive the compressed assembly (800). In particular, the housing or outer shell may be placed in the cavity of the cover (802). The inflatable member may be pre-formed and then placed in the outer shell, or may be formed by being placed in the outer shell (804). The heat exchanger may be assembled and placed in the cavity of the cover and housing adjacent to the inflatable member (808). As described above, the heat exchanger may include a bottom portion, a top portion, a first side portion, and a second side portion. During the assembly of the heat exchanger, the ends of the first side portion and the ends of the second side portion may be placed overlapping each other. Similarly, the ends of the top portion are placed on top of the side portions such that they surround at least a portion of the scalp when placed on top of the ends of the first and second side portions.

[0139] Figures 9A–9F are perspective views of yet another variation of the cooling cap assembly process. Figures 9A and 9B show a liner (901) covering a patient (900) and part of the head (902). As shown in Figure 9C, a heat exchanger (905) may be wrapped around the head (904) on the liner (901). The heat exchanger (905) may include several sensors (920) which may be communicatively coupled (e.g., wired, wirelessly) to a controller (950). An inflatable member (907) may be positioned on top of the heat exchanger (906), and a fluid conduit set (908) may be coupled to the inflatable member (908). As shown in Figures 9D and 9E, the inflatable member (907) may include several independently inflatable chambers. Figure 9F is an exploded schematic of the cooling cap assembly process (910). A controller (950) may be configured to control the circulating fluid through the heat exchanger (905) and / or the expansion pressure of the inflatable member (907). A fluid conduit (908) may be coupled between the inflatable member (907) and a valve (940) controlled by the controller (950). The valve (940) may be coupled to a pump (not shown). As shown in Figure 9F, the liner (901) may be positioned directly on the scalp, and the heat exchanger (905) and the inflatable member (907) may be positioned on the liner simultaneously or sequentially.

[0140] Use of cooling system In general, methods using the cooling cap assemblies or cooling systems described herein may include forming a cooling cap assembly on a patient's head, inflating an inflatable member, and circulating a cooling fluid through the cooling cap assembly (e.g., a heat exchanger). In some variations, the methods may further include controlling the inflation pressure of the cooling cap assembly, the temperature of the cooling fluid, and / or the flow rate of the cooling fluid. In some variations, a closed-loop feedback system may be used to dynamically control the fluid temperature, fluid flow rate, and / or inflation pressure (i.e., control compression) to optimize the cooling treatment.

[0141] As described in more detail above, forming a cooling cap assembly may include placing a liner on the patient's scalp, wrapping a heat exchanger around a portion of the scalp, and applying a compression assembly over the heat exchanger. A cover may be fitted over the compression assembly, which may be fastened to the patient, for example, using a chin strap. The heat exchanger may be connected to a cooling unit using a cooling fluid conduit, and the inflatable member may be connected to a fluid pump (e.g., an air pump such as an air valve) using an expansion fluid conduit.

[0142] An inflatable member can be expanded (i.e., transitioned from a contracted configuration to an expanded configuration) to compress the heat exchanger between the inflatable member and the scalp (e.g., via a liner). In some modifications, transitioning the inflatable member from a contracted configuration to an expanded configuration may increase the force (e.g., pressure) applied to the head by the heat exchanger. When the inflatable member is in the expanded configuration, the housing (e.g., outer member) can be used to generate a back pressure. When the inflatable member is in the expanded configuration, approximately 0.1 lb / in is applied to the head. 2 ~about 10lb / in 2 A compression of approximately 0.1 lb / in can be generated when the inflatable member is in an inflated configuration. 2 ~Approximately 8.0 lb / in 2 , about 0.1lb / in 2 ~Approximately 5.0 lb / in 2 , about 0.1lb / in 2 ~Approximately 3.0 lb / in 2 , about 0.1lb / in 2 ~Approximately 2.0 lb / in 2 , about 0.1lb / in 2 ~Approximately 1.0 lb / in 2 , about 0.5lb / in 2 ~Approximately 8.0 lb / in 2 , about 0.5lb / in 2 ~Approximately 5.0 lb / in 2 , about 0.5lb / in 2 ~Approximately 3.0 lb / in 2 , about 0.5lb / in 2 ~Approximately 2.0 lb / in2 , about 1.5lb / in 2 ~2.5lb / in 2 , or approximately 0.5 lb / in 2 ~Approximately 1.0 lb / in 2 Compression can be generated. The expandable member can be inflated with any suitable fluid, such as a gas (e.g., air) or a liquid (e.g., water). In some modifications, the expandable member may be inflated using a manual pump, and in other modifications, the expandable member may be inflated using an electric pump, for example in a cooling unit.

[0143] Circulating a cooling fluid through a cooling cap assembly may involve using a cooling unit to circulate the fluid through a heat exchanger at a temperature of approximately -10°C to approximately 5°C. In some modifications, the fluid may be approximately -2°C to approximately 2°C, or approximately -2°C to approximately 4°C. The fluid may be circulated through a heat exchanger throughout a treatment session. A treatment session may include a pre-cooling phase before the administration of chemotherapy, a transition phase as the patient moves to receive chemotherapy, a chemotherapy phase as the patient is receiving chemotherapy, a second transition phase as the patient moves from chemotherapy to another location (e.g., home), and a post-cooling phase as the patient continues to have their scalp cooled for a period after chemotherapy. The patient may receive cooling treatment throughout each part of a treatment session. In some modifications, the fluid may be circulated for approximately 45 minutes to 10 hours, approximately 1 hour to approximately 8 hours, approximately 1 hour to approximately 6 hours, or approximately 1 hour to approximately 4 hours. The cooling system may be plugged into an outlet during one or more parts of a treatment session (e.g., a pre-cooling part, a chemotherapy part, and a post-cooling part), but not during the transitional part. In other words, the cooling unit may be battery-operated during the transitional part of a cooling treatment session (e.g., while the patient is moving from one place to another). After the patient has completed the cooling treatment session, the cooling cap assembly can be removed from the head and stored for later use. In some modifications, the method may further include reapplying the cooling cap assembly to the scalp and recirculating the cooling fluid, as described above.

[0144] In some modifications, the cooling unit may operate in one of several operating states with different functions (e.g., full power, reduced power, battery power) based on the available power supply. For example, when the cooling unit is connected to AC power, the pump and compressor may be on in full power mode, while when the cooling unit is in battery power mode, only the pump operates. Figure 17 is a state diagram illustrating an exemplary method of controlling the cooling unit described herein. In some modifications, the cooling process (1700) may include a power-off state (1702) in which the pump and compressor of the cooling unit are off (e.g., not receiving power). As a result, the cooling unit may be prevented from circulating fluid and / or providing cooled fluid to the cooling cap assembly. A patient or user may activate the cooling unit by inputting a power-on signal (e.g., pressing a power button). In response, the controller may decide to transition the system from the power-off state (1702) to the power-on state (1704) (e.g., powered on). In response to the power-on state (1704), the system controller can identify an available power source to be used to supply energy to the cooling unit. The system may decide to transition from the power-on state (1704) to the full-power state (1706) when the system first receives mains power (1722) (e.g., mains power OK, AC power). Mains power corresponds to, for example, a wall outlet from the power company. In the full-power state (1706), the cooling unit pump is on (e.g., operating) and the cooling unit compressor can operate at full power. For example, the cooling unit can operate without power limitations or loss of function (e.g., with the control loop active). For example, the active control loop may include closed-loop temperature feedback. In some modifications, the cooling unit battery may be recharged while in the full-power state (1706).

[0145] The system may decide to transition from a power-on state (1704) or a full-power state (1706) to a partial-power state (1708) when the system is receiving auxiliary power but not mains power (1724) (e.g., auxiliary power OK). For example, a cooling unit in a partial-power state (1708) can receive auxiliary power from a DC source such as a car power supply. In a partial-power state (1708), the cooling unit pump is on (e.g., operating), and the cooling unit compressor may operate at a reduced power state (e.g., about 50% to about 80% of full power). For example, the cooling unit may operate up to a predetermined power level using closed-loop control.

[0146] The system may decide to transition from a power-on state (1704) to a battery-powered state (1710) when the system receives battery power for the cooling unit and does not receive mains power or auxiliary power (1730) (e.g., battery OK, no mains power or auxiliary power). In the battery-powered state (1710), the cooling unit pump is on (e.g., operating) and the cooling unit compressor is off. Thus, fluid may circulate but is not actively cooled by the cooling unit. In some modifications, sensor measurements may be performed without active closed-loop control (e.g., control loop monitoring only).

[0147] The system may decide to transition from a partial output state (1708) to a full output state (1706) when the system receives main power but not auxiliary power (1730) (e.g., main power OK, no auxiliary power). The system may decide to transition from a partial output state (1708) to a battery power state (1710) when the system does not receive main power or auxiliary power (1728) (e.g., no main power or auxiliary power).

[0148] The system may decide to transition from a battery-powered state (1710) to a partial output state (1708) when the system receives auxiliary power but not main power (1724) (e.g., no main power, auxiliary power OK). The system may decide to transition from a battery-powered state (1710) to a full output state (1706) when the system receives main power (1722) (e.g., main power OK). The system may decide to transition from a battery-powered state (1710) to a power-off state (1702) when the battery reaches a predetermined power level (1732) (e.g., low battery).

[0149] The system may decide to transition from the full output state (1706) to the battery power state (1710) when the system is not receiving main or auxiliary power (1728) (e.g., no main or auxiliary power). The system may decide to transition from any power state (except the power-off state) to the power-off state (1702) when the patient or user inputs a power-off signal (e.g., pressing the power button).

[0150] As described above, in some variations, the methods described herein may include controlling or adjusting (e.g., manually or automatically) the expansion pressure of the cooling cap assembly, the temperature of the cooling fluid, and / or the flow rate of the cooling fluid. In some variations, the cooling unit may have a user interface that allows the patient to control one or more of the cooling unit (e.g., the expandable member pump, the circulating fluid pump) and the cooling cap assembly. Additionally or alternatively, the patient may control the temperature and / or flow rate of the circulating fluid, as well as the expansion pressure of the compression assembly, using a graphical user interface (GUI) displayed on a computing device such as a smartphone or tablet. For example, the GUI may output sensor readings, including temperature, force, expansion pressure, and fluid flow rate, generated by various sensors in the system.

[0151] In some variations, the controller can dynamically control treatment time, expansion pressure, fluid temperature, and / or fluid flow rate. For example, the controller can command or signal a cooling unit (e.g., one or more pumps, compressors) to change one or more cooling parameters (e.g., flow rate of cooling fluid, temperature of cooling fluid, expansion pressure of one or more chambers of an expandable member). In some variations, the patient may be notified when one or more temperature readings exceed a predetermined threshold, and optional adjustments to one or more cooling treatment parameters may be provided, for example, using a computing device or the user interface of the cooling unit.

[0152] In one example and variation, the method may include circulating a fluid through a heat exchanger coupled to the patient's scalp and adjusting the cooling parameters of the cooling system based on one or more temperature and / or force measurements. In some variations, adjusting the cooling parameters may include manually adjusting the cooling parameters (e.g., expansion pressure, temperature of the cooling fluid, flow rate of the cooling fluid). In these variations, the patient can control one or more cooling parameters using a graphical user interface on a controller (e.g., a mobile phone, tablet). In some of these variations, the patient may be notified using the graphical user interface to manually change (e.g., increase) the expansion pressure of the cooling cap assembly by manually operating a pump in response to the measured temperature and / or force. For example, when the average measured temperature exceeds a predetermined temperature threshold, an animation of a hand gripping a pump may be displayed on the patient's computing device display.

[0153] Additionally or alternatively, adjusting cooling parameters may involve using a controller to dynamically (e.g., automatically) adjust one or more cooling parameters based on one or more of the measured temperature and / or force (e.g., a single temperature / force measurement, an average of multiple temperature / force measurements), as well as a given temperature and / or force threshold, maximum value, target value, or range. For example, in a modified example where dynamic control is utilized, if the average measured temperature exceeds a given temperature threshold, the controller may increase the expansion pressure of the expandable member, for example, using one or more fluid valves and / or fluid pumps coupled to the expandable member, as described in more detail above. If the measured expansion pressure exceeds a given pressure threshold, the controller may reduce the expansion pressure until it falls within a suitable range. If the measured expansion pressure is within a target range, the controller may maintain the expansion pressure within that range. Additionally or alternatively, if one or more temperatures (e.g., the temperature of the cooling fluid measured in the cooling unit, the temperature of the cooling fluid measured in the heat exchanger, the temperature measured on or at a location on the patient's scalp, the average of several temperatures measured on or at a location on the patient's scalp, or a delta T calculated between any of the aforementioned temperatures) are above or below a target value and / or outside the target range, the controller may adjust one or more parameters of the cooling system to adjust (e.g., increase or decrease) the heat transfer between the cooling cap assembly and the patient's scalp. For example, the controller may adjust the temperature of the circulating cooling fluid by adjusting the output of the compressor in the cooling unit and / or the flow rate of the cooling fluid by adjusting the output of the cooling fluid pump in the cooling unit until the temperature reaches a target value, exceeds a threshold, falls below a maximum value, or falls within the target range. In some variations, the patient may be notified audibly and / or visually when the controller changes one or more of the expansion pressure, fluid temperature, and fluid flow rate to reduce surprise or anxiety.

[0154] In some modifications, the method may further include independently adjusting the expansion pressure of one of several chambers of an inflatable member (e.g., each chamber) based on a measured set of temperatures. For example, if the measured temperature or the average of measured temperatures of a corresponding part of a heat exchanger exceeds a predetermined maximum temperature, the expansion pressure in the chamber of the inflatable member may increase. In another example, the measured temperature of a first arm or lobe of a heat exchanger may exceed a predetermined maximum temperature so that the controller can adjust one or more valves and / or fluid pumps to inflate the chamber of the inflatable member corresponding to the arm or lobe. In these modifications, the patient's head can be precisely targeted with additional cooling. When the measured temperature of the arm or lobe drops below a predetermined threshold, the controller can maintain the pressure in the chamber or deflate the chamber to a predetermined pressure.

[0155] In some variations, the method may further include generating a patient profile for each patient. The patient profile may include a set of cooling treatment protocols that can be performed for various patient scenarios. For example, a quiet treatment protocol may reduce the power consumption of the cooling unit so that noise is reduced. A maximum cooling treatment protocol may impose a predetermined maximum compression on the heat exchanger and set the circulating fluid to a predetermined maximum flow rate to maximize heat transfer. In some variations, the patient may be able to personalize the treatment protocol, and / or the system may be able to adjust a pre-configured treatment protocol based on patient information entered into the system. The patient may also be provided with real-time control of treatment parameters such as treatment time, expansion pressure, fluid temperature, and fluid flow rate. Furthermore, the GUI may include visual instructions on how to assemble or wrap the heat exchanger, how to assemble and disassemble the cooling cap assembly onto the patient's head, and how to operate the cooling unit to perform a cooling treatment session. For example, in some variations, the GUI may provide visual and / or auditory (e.g., voice) prompts that instruct the user on how to assemble the heat exchanger, how to assemble and / or disassemble the cooling cap assembly, and / or how to conduct a cooling therapy session. [Examples]

[0156] Figure 10 shows a set of graphs of sensor and power measurements for one modified cooling cap assembly. As shown in Figure 10, parameters including coolant flow (1000), temperature change (1002), and power (1004) (i.e., extracted power, consumed power) can be graphed against time. A temperature sensor array (1008) can be placed overhead, and the temperature (1006) of each sensor can be graphed against time. At time A in Figure 10, the full output of pre-cooling is applied. At time B, the cooling cap assembly, powered at a 40W load, can be applied to the patient's head. At time C, the inflatable member of the cooling cap assembly can be inflated to increase the contact area between the heat exchanger and the patient's scalp. For example, the inflatable member can be inflated to increase compression to the head. At time D, the compressor speed can be reduced to reduce noise and increase patient comfort. As the temperature of the fluid in the heat exchanger decreases and the contact area between the cooling cap and the scalp increases, the flow rate of the fluid through the heat exchanger may decrease while maintaining at least the effect of the cooling therapy. At time E, the system can be powered off. Between time C and E, a steady state can be achieved with all 40W removed.

[0157] The specific examples and descriptions herein are illustrative in nature, and modifications can be developed by those skilled in the art based on the materials taught herein without departing from the scope of the invention; however, the invention is limited only by the appended claims. The present invention provides, for example, the following items: (Item 1) A heat exchanger configured to be wrapped around the patient's head, A cooling cap assembly comprising a compression assembly releasably coupled to the heat exchanger, wherein the compression assembly includes a housing and an expandable member coupled to the inner surface of the housing, and when coupled, the expandable member is positioned between the housing and the heat exchanger, and the heat exchanger is separated from the expandable member and movable relative to the expandable member. (Item 2) The cooling cap assembly according to item 1, wherein the expandable member includes a contraction configuration and an expansion configuration, and when the expandable member is moved from the contraction configuration to the expansion configuration, the pressure applied to the patient's head increases. (Item 3) The cooling cap assembly according to item 1, further comprising a fluid pump coupled to the expandable member. (Item 4) The cooling cap assembly according to item 1, wherein the housing is configured to generate a back pressure when the expandable member is in the expanded configuration. (Item 5) The compression assembly, when the expandable member is in the expansion configuration, has a load of approximately 0.1 lb / in in relation to the head. 2 ~about 10lb / in 2 A cooling cap assembly as described in item 1, configured to generate compression. (Item 6) The expandable member is a cooling cap assembly according to item 1, comprising a plurality of chambers. (Item 7) The cooling cap assembly according to item 6, wherein each of the plurality of chambers is independently expandable. (Item 8) The cooling cap assembly according to item 1, wherein the expandable member includes an upper expandable portion, a first expandable side portion, and a second expandable side portion, each portion including a chamber. (Item 9) The cooling cap assembly according to item 8, wherein the length of the first inflatable side portion and the length of the second inflatable side portion are each longer than the length of the upper inflatable portion. (Item 10) The cooling cap assembly according to item 8, wherein the length of the first inflatable side portion and the length of the second inflatable side portion are each shorter than the length of the upper inflatable portion. (Item 11) The cooling cap assembly according to item 1, wherein the lateral expandable portion of the expandable member is configured to overlap in an adjustable manner so as to surround at least a portion of the head. (Item 12) The expandable member is the cooling cap assembly according to item 1, which includes a fluid barrier. (Item 13) The expandable member is the cooling cap assembly according to item 1, which includes one or more notches. (Item 14) The expandable member is a cooling cap assembly according to item 1, comprising at least three chambers. (Item 15) The inflatable member is a cooling cap assembly according to item 1, comprising one or more fasteners. (Item 16) The heat exchanger is a cooling cap assembly as described in item 1, including a bottom portion, an upper portion, a first side portion, and a second side portion. (Item 17) The cooling cap assembly described in item 1, wherein the heat exchanger includes a fluid barrier set, and each fluid barrier in the fluid barrier set is approximately 5 mm to approximately 15 mm from adjacent fluid barriers in the fluid barrier set. (Item 18) The cooling cap assembly according to item 17, further comprising a temperature sensor positioned within the opening of at least one fluid barrier of the fluid barrier set. (Item 19) At least one fluid barrier of the fluid barrier set is a cooling cap assembly according to item 17, which includes a torus shape. (Item 20) The cooling cap assembly according to item 1, wherein the first side portion includes a first arm, and the second side portion includes a second arm. (Item 21) The cooling cap assembly according to item 16, wherein the upper portion, the first side portion, and the second side portion each include a first lobe and a second lobe. (Item 22) The cooling cap assembly according to item 21, wherein the length of the first lobe of the first part and the second part is longer than the length of the second lobe of the first part and the second part. (Item 23) Each part of the heat exchanger includes at least a portion of the fluid channel, as described in item 16. (Item 24) The cooling cap assembly according to item 16, wherein the lengths of the first side portion and the second side portion are shorter than the length of the upper portion. (Item 25) The cooling cap assembly according to item 16, wherein the area of ​​either the first side portion or the second side portion is approximately 2:1 to approximately 0.5:1 relative to the area of ​​the upper portion. (Item 26) The cooling cap assembly according to item 16, wherein the upper portion defines a longitudinal axis, and the first and second side portions extend from the bottom portion at an acute angle with respect to the longitudinal axis. (Item 27) The cooling cap assembly according to item 16, wherein one or more end portions of the heat exchanger are configured to overlap in an adjustable manner so as to surround at least a portion of the head. (Item 28) The heat exchanger is a cooling cap assembly according to item 1, comprising a flexible material. (Item 29) The heat exchanger is a cooling cap assembly as described in item 1, including a nonwoven fabric. (Item 30) Each of the heat exchangers is approximately 9 mm 2 ~approximately 100mm 2 A cooling cap assembly as described in item 1, comprising one or more fluid channels including the cross-sectional area of ​​the following: (Item 31) The cooling cap assembly according to item 1, further comprising one or more sensors coupled to the heat exchanger and configured to measure one or more characteristics of the compression assembly. (Item 32) The cooling cap assembly described in item 31 includes one or more sensors, a temperature sensor and a pressure sensor. (Item 33) The cooling cap assembly according to item 31, wherein the heat exchanger comprises at least one sensor in each of the parts of the heat exchanger. (Item 34) The heat exchanger is a cooling cap assembly as described in item 1, including fasteners. (Item 35) The housing is a cooling cap assembly according to item 1, comprising a rigid material or a semi-rigid material. (Item 36) The cooling cap assembly according to item 1, wherein the housing is configured to surround at least a portion of the expandable member. (Item 37) The cooling cap assembly according to item 1, wherein the housing defines a cavity configured to surround at least a portion of the expandable member. (Item 38) The enclosure is a cooling cap assembly as described in item 1, including a hemispherical shell. (Item 39) The housing is the cooling cap assembly described in item 1, including the helmet. (Item 40) The housing is a cooling cap assembly according to item 35, further comprising a flexible cover. (Item 41) The cooling cap assembly according to item 1, wherein the housing includes fasteners configured to connect to the expandable member. (Item 42) The flexible cover is a cooling cap assembly as described in item 40, including fasteners. (Item 43) The housing is a cooling cap assembly according to item 1, which defines a cavity configured to receive the patient's head. (Item 44) A liner configured to be disposed between the heat exchanger and the patient's scalp, The cooling cap assembly according to item 1, further comprising the compression assembly and a fastener releasably connected to the patient. (Item 45) The liner is a cooling cap assembly according to item 44, comprising a flexible material. (Item 46) The cooling cap assembly according to item 1, further comprising a cooling unit fluidly coupled to the compression assembly, wherein the cooling unit includes a heat exchanger, a compressor, a reservoir, and a fluid connection portion releasably coupled to a pump. (Item 47) The cooling unit is a cooling cap assembly according to item 46, comprising a housing, a battery, and a fluid reservoir releasably coupled to the housing. (Item 48) The cooling unit is configured to circulate a fluid through the heat exchanger, as described in item 46. (Item 49) The cooling cap assembly according to item 48, wherein the fluid comprises one or more of the following: water and salt, water and glycol, and water and alcohol. (Item 50) A heat exchanger configured to be wrapped around the patient's head, A cooling cap assembly comprising a compression assembly releasably coupled to the heat exchanger, wherein the compression assembly includes a housing and an expandable member coupled to the inner surface of the housing, and when coupled, the expandable member is positioned between the housing and the heat exchanger, the heat exchanger is separated from the expandable member and is movable relative to the expandable member, and when the expandable member is moved from a contracted configuration to an expanded configuration, the contact area between the heat exchanger and the patient's head is increased. (Item 51) A method of cooling the scalp to reduce hair loss caused by chemotherapy, Wrapping a heat exchanger around a portion of the scalp, The compression assembly is positioned on the head and on the wrapped heat exchanger, wherein the compression assembly includes a semi-rigid outer member and an expandable inner member coupled to the outer member. A method comprising expanding the expandable member to compress the heat exchanger between the expandable member and the scalp. (Item 52) The method according to item 51, wherein the heat exchanger is separated from the expandable member and is movable relative to the expandable member. (Item 53) The method according to item 51, further comprising transitioning the expandable member from a contracted configuration to an expanded configuration to increase the pressure applied to the head. (Item 54) The method according to item 51, further comprising using the outer member to generate a back pressure when the expandable member is in an expanded configuration. (Item 55) When the inflatable member is in an inflated state, approximately 0.1 lb / in is applied to the head. 2 ~about 10lb / in 2 The method described in item 51, further comprising generating a compression of the same. (Item 56) The method according to item 51, wherein the inflatable member includes a plurality of independently inflatable chambers. (Item 57) The method according to item 51, further comprising positioning the liner around the portion of the scalp such that the heat exchanger is positioned between the liner and the expandable member. (Item 58) The heat exchanger includes a bottom portion, an upper portion, a first side portion, and a second side portion, with the ends of the first side portion and the ends of the second side portion overlapping each other. The method according to item 51, wherein the end of the upper portion is positioned to overlap the end of the first side portion and the end of the second side portion in order to surround at least the portion of the scalp. (Item 59) The method according to item 51, wherein the expandable member is expanded by a gas or liquid. (Item 60) The method according to item 51, wherein the inflatable member is inflated using a manual pump. (Item 61) The method according to item 51, further comprising circulating a fluid through the heat exchanger, wherein the fluid has a temperature of about -10°C to about 5°C. (Item 62) The method according to item 51, further comprising using the compression assembly to remove the heat exchanger from the scalp. (Item 63) The method according to item 62, further comprising using the compression assembly to return the heat exchanger to the scalp. (Item 64) The method according to item 51, further comprising using fasteners to releasably attach the compression assembly to the scalp. (Item 65) A cooling cap assembly, A flexible heat exchanger configured to remove heat from a patient's scalp, comprising a temperature sensor, An expandable member comprising a pouch having an upper surface and a lower surface, wherein the lower surface is releasably coupled to the heat exchanger, A pump configured to inflate the aforementioned pouch, The outer shell of the inflatable member is coupled to the upper surface of the pouch, A cooling unit fluidly coupled to the heat exchanger, A cooling cap assembly comprising: a memory that receives temperature from the temperature sensor and includes commands for adjusting the output of the pump based on the temperature. (Item 66) The output of the pump is the expansion pressure, as described in item 65 of the cooling cap assembly. (Item 67) The temperature is the scalp temperature, as described in item 65 of the cooling cap assembly. (Item 68) The cooling cap assembly according to item 65, wherein the temperature sensor is disposed on the outer surface of the heat exchanger, inside the heat exchanger, or within the fluid channel of the heat exchanger. (Item 69) The heat exchanger is a cooling cap assembly according to item 65, comprising one or more fluid channels containing a circulating fluid. (Item 70) The aforementioned temperature is the fluid temperature, as described in item 65 of the cooling cap assembly. (Item 71) The cooling cap assembly according to item 65, wherein the temperature sensor includes a temperature sensor set, the temperature includes a temperature set, and the pouch includes a chamber set, and the memory includes instructions for independently adjusting the expansion pressure of each chamber of the pouch based on the temperature set. (Item 72) The cooling unit is a portable cooling cap assembly as described in item 65. (Item 73) The cooling unit is a cooling cap assembly according to item 65, comprising a releasable fluid reservoir. (Item 74) The fluid reservoir is a cooling cap assembly according to item 65, comprising a handle. (Item 75) The cooling unit is a cooling cap assembly as described in item 65, comprising an adjustable handle. (Item 76) The cooling unit is a cooling cap assembly as described in item 65, including a battery. (Item 77) A method for controlling the cooling of the scalp of a chemotherapy patient, The application of a cooling cap to the head, wherein the cooling cap comprises a flexible heat exchanger including a temperature sensor, an expandable member releasably coupled to the heat exchanger, and a shell coupled to the expandable member, the expandable member comprising a pouch and a pump that fluidly communicates with the pouch to increase the expansion pressure of the pouch, The temperature is measured using the aforementioned temperature sensor, A method comprising adjusting the inflation pressure of the pouch using the pump based on the measured temperature. (Item 78) The method according to item 77, wherein the temperature is the scalp temperature. (Item 79) The method according to item 77, wherein the temperature sensor is on the outer surface of the heat exchanger, inside the heat exchanger, or in the fluid channel of the heat exchanger. (Item 80) The method according to item 77, wherein the heat exchanger includes one or more fluid channels containing a circulating fluid. (Item 81) The method according to item 80, wherein the temperature is the fluid temperature. (Item 82) The method according to item 77, wherein the temperature sensor includes a temperature sensor set, the temperature includes a temperature set, and the port includes a chamber set, and the method includes independently adjusting the expansion pressure of each chamber of the port based on the temperature set. (Item 83) The method according to item 77, wherein the heat exchanger is separated from the expandable member and is movable relative to the expandable member. (Item 84) The method according to item 77, further comprising shifting the expandable member from a contracted configuration to an expanded configuration to increase the pressure applied to the head. (Item 85) The method according to item 77, further comprising generating a counterpressure using the shell when the expandable member is in the expanded configuration. (Item 86) When the expandable member is in the expanded configuration, about 0.1 lb / in 2 ~ about 10 lb / in 2 The method according to item 77, further comprising generating compression of. (Item 87) The method according to item 77, wherein the expandable member includes a plurality of independently expandable chambers. (Item 88) The method according to item 77, further comprising arranging the liner around the portion of the scalp such that the heat exchanger is between the liner and the expandable member. (Item 89) The heat exchanger includes a bottom portion, an upper portion, a first side portion, and a second side portion. The first side portion and the second side portion are arranged to overlap each other, The method according to item 77, wherein the upper portion is positioned on top of the first and second side portions in order to surround at least the portion of the scalp. (Item 90) The method according to item 77, wherein the pouch contains a fluid including a gas or liquid. (Item 91) The method according to item 77, further comprising circulating a fluid through the heat exchanger, wherein the fluid has a temperature of about -10°C to about 5°C. (Item 92) The method according to item 77, further comprising attaching the compression assembly to the scalp using fasteners. (Item 93) A flexible heat exchanger configured to remove heat from the patient's scalp, An expandable member releasably coupled to the heat exchanger, The outer shell is coupled to the expandable member, A cooling unit fluid-coupled to the heat exchanger, configured to determine the power supply and to circulate fluid through the heat exchanger, A cooling cap assembly comprising a memory containing instructions for adjusting the fluid flow rate of the cooling unit based on the power supply determined above. (Item 94) The power supply is the cooling cap assembly described in item 93, which includes one or more AC power supplies and DC power supplies. (Item 95) Each fluid barrier in the fluid barrier set is a cooling cap assembly as described in item 17, with a diameter of approximately 5 mm to approximately 10 mm. (Item 96) A method for controlling the cooling of the scalp of a chemotherapy patient, The application of a cooling cap to the head, wherein the cooling cap comprises a flexible heat exchanger, an expandable member releasably coupled to the heat exchanger, and a shell coupled to the expandable member, Using a cooling unit that includes multiple operating states, a temperature-controlled fluid is circulated through the heat exchanger, Identifying the power supply of the cooling unit, A method comprising selecting the operating state of the cooling unit based on the identified power supply.

Claims

1. A heat exchanger configured to be placed on the head of a patient, wherein the heat exchanger consists of two or more overlapping portions, and at least one of the two or more overlapping portions includes a fastener configured at its distal end to hold the two or more overlapping portions of the heat exchanger in a working configuration. A cooling cap assembly comprising a compression assembly configured to be positioned at the head separately from the heat exchanger, wherein the compression assembly includes a housing and an expandable member coupled to the inner surface of the housing, and when positioned at the head, the expandable member is positioned between the housing and the heat exchanger, and the heat exchanger is separated from the expandable member and movable relative to the expandable member.

2. The cooling cap assembly according to claim 1, wherein the expandable member includes a contraction configuration and an expansion configuration, and when the expandable member is moved from the contraction configuration to the expansion configuration, the pressure applied to the patient's head increases.

3. The cooling cap assembly according to claim 1, further comprising a fluid pump coupled to the expandable member.

4. The cooling cap assembly according to claim 1, wherein the housing is configured to generate a reverse pressure when the expandable member is in the expanded configuration.

5. The cooling cap assembly according to claim 1, wherein the compression assembly is configured to generate a compression of approximately 0.6895 kPa to approximately 68.95 kPa with respect to the head when the expandable member is in the expansion configuration.

6. The cooling cap assembly according to claim 1, wherein the expandable member includes a plurality of chambers.

7. The cooling cap assembly according to claim 6, wherein each of the plurality of chambers is independently expandable.

8. The cooling cap assembly according to claim 1, wherein the expandable member includes an upper expandable portion, a first expandable side portion, and a second expandable side portion, each portion including a chamber.

9. The cooling cap assembly according to claim 8, wherein the length of the first inflatable side portion and the length of the second inflatable side portion are each longer than the length of the upper inflatable portion.

10. The cooling cap assembly according to claim 8, wherein the length of the first inflatable side portion and the length of the second inflatable side portion are each shorter than the length of the upper inflatable portion.

11. The cooling cap assembly according to claim 8, wherein the lateral expandable portions of the expandable member are configured to overlap each other in an adjustable manner so as to surround at least a portion of the head.

12. The cooling cap assembly according to claim 1, wherein the expandable member includes a fluid barrier.

13. The cooling cap assembly according to claim 1, wherein the expandable member includes one or more notches.

14. The cooling cap assembly according to claim 1, wherein the expandable member includes at least three chambers.

15. The cooling cap assembly according to claim 1, wherein the expandable member includes one or more fasteners configured to hold the expandable member in a predetermined shape.

16. The cooling cap assembly according to claim 1, wherein the two or more overlapping portions include a bottom portion, an upper portion, a first side portion, and a second side portion.

17. The cooling cap assembly according to claim 1, wherein the heat exchanger includes a fluid barrier set, and each fluid barrier in the fluid barrier set is approximately 5 mm to approximately 15 mm from adjacent fluid barriers in the fluid barrier set.

18. The cooling cap assembly according to claim 17, further comprising a temperature sensor disposed in at least one fluid barrier of the fluid barrier set.

19. The cooling cap assembly according to claim 17, wherein at least one fluid barrier of the fluid barrier set includes a torus shape.

20. The cooling cap assembly according to claim 16, wherein the first side portion includes a first arm, and the second side portion includes a second arm.

21. The cooling cap assembly according to claim 16, wherein the upper portion, the first side portion, and the second side portion each include an adjacent first lobe and a second lobe.

22. The cooling cap assembly according to claim 21, wherein the length of the first lobe of the first side portion is longer than the length of the second lobe of the first side portion, and the length of the first lobe of the second side portion is longer than the length of the second lobe of the second side portion.

23. The cooling cap assembly according to claim 16, wherein each part of the heat exchanger includes at least a portion of the fluid channel.

24. The cooling cap assembly according to claim 16, wherein the lengths of the first side portion and the second side portion are shorter than the length of the upper portion.

25. The cooling cap assembly according to claim 16, wherein the area of ​​either the first side portion or the second side portion is approximately 2:1 to approximately 0.5:1 with respect to the area of ​​the upper portion.

26. The cooling cap assembly according to claim 16, wherein the upper portion defines a longitudinal axis, and the first and second side portions extend from the bottom portion at an acute angle with respect to the longitudinal axis.

27. The cooling cap assembly according to claim 1, wherein the heat exchanger comprises a flexible material.

28. The heat exchanger is a cooling cap assembly according to claim 1, comprising a nonwoven fabric.

29. Each of the heat exchangers is approximately 9 mm ２ ~approximately 100 mm ２ The cooling cap assembly according to claim 1, comprising one or more fluid channels including the cross-sectional area of ​​the following:

30. The cooling cap assembly according to claim 1, further comprising one or more sensors coupled to the heat exchanger and configured to measure one or more characteristics of the compression assembly.

31. The cooling cap assembly according to claim 30, wherein the one or more sensors include a temperature sensor and a pressure sensor.

32. The cooling cap assembly according to claim 30, wherein the heat exchanger is provided with at least one sensor in each part of the heat exchanger.

33. The cooling cap assembly according to claim 1, wherein the housing comprises a rigid material or a semi-rigid material.

34. The cooling cap assembly according to claim 1, wherein the housing is configured to surround at least a portion of the expandable member.

35. The cooling cap assembly according to claim 1, wherein the housing defines a cavity configured to surround at least a portion of the expandable member.

36. The cooling cap assembly according to claim 1, wherein the housing includes a hemispherical shell.

37. The housing is the cooling cap assembly according to claim 1, including a helmet.

38. The cooling cap assembly according to claim 33, wherein the housing further includes a flexible cover bonded to the rigid or semi-rigid material.

39. The cooling cap assembly according to claim 1, wherein the housing includes a fastener configured to connect to the expandable member.

40. The cooling cap assembly according to claim 38, wherein the flexible cover includes fasteners configured to releasably attach the cooling cap assembly to the patient's head.

41. The cooling cap assembly according to claim 1, wherein the housing defines a cavity configured to receive the patient's head.

42. A liner configured to be disposed between the heat exchanger and the patient's scalp, The cooling cap assembly according to claim 1, further comprising a fastener configured to releasably connect the compression assembly to the patient.

43. The cooling cap assembly according to claim 42, wherein the liner comprises a flexible material.

44. The cooling cap assembly according to claim 1, further comprising a cooling unit, the cooling unit including a fluid connection portion releasably coupled to the heat exchanger, a compressor, a reservoir, and a pump.

45. The cooling cap assembly according to claim 44, wherein the cooling unit comprises a housing, a battery, and a fluid reservoir releasably coupled to the housing.

46. The cooling cap assembly according to claim 44, wherein the cooling unit is configured to circulate a fluid through the heat exchanger.

47. The cooling cap assembly according to claim 46, wherein the fluid comprises one or more of the following: water and salt, water and glycol, and water and alcohol.

48. A heat exchanger configured to be placed on the head of a patient, wherein the heat exchanger consists of two or more overlapping parts, and at least one of the two or more overlapping parts is a heat exchanger including a fastener at its distal end, A cooling cap assembly comprising: a compression assembly configured to be positioned on the head separately from the heat exchanger, wherein the compression assembly includes a housing and an expandable member coupled to the inner surface of the housing, and when positioned on the head, the expandable member is positioned between the housing and the heat exchanger, the heat exchanger is separated from the expandable member and is movable relative to the expandable member, and when the expandable member is moved from a contracted configuration to an expanded configuration, the contact area between the heat exchanger and the patient's head is increased.

49. The cooling cap assembly according to claim 17, wherein each fluid barrier in the fluid barrier set has a diameter of approximately 5 mm to approximately 10 mm.

50. The cooling cap assembly according to claim 1 or 48, wherein the expandable member comprises two or more overlapping chambers.

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