Cooling cap assembly and cooling unit

Abstract

To provide devices, systems and methods capable of cooling a head of a patient.SOLUTION: These systems and methods may comprise a cooling cap assembly 110 comprising a heat exchanger 120 configured to be wrapped around the head of the patient, and a compression assembly 145 releasably coupled to the heat exchanger. The compression assembly may comprise an enclosure and an inflatable member coupled to an internal surface of the enclosure. When coupled, the inflatable member 130 may be positioned between the enclosure and the heat exchanger. The heat exchanger may be separate from and moveable relative to the inflatable member.SELECTED DRAWING: Figure 1A

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

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

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

[0003] Alopecia is a common side effect of chemotherapy that may cause distress to some patients due to visible changes in appearance and loss of physical attributes. For some patients, chemotherapy-induced alopecia may lead to depression and therefore hinder the patient's recovery. In response, some patients undergoing chemotherapy undergo scalp cooling treatments. However, conventional techniques are not optimized for patient comfort and are typically performed at treatment centers where technicians ensure that the cooling devices are properly installed and used correctly. Thus, additional devices, systems, and methods for cooling the scalp may be desirable. Summary of the Invention

[0004] Herein, devices, systems, and methods are described for providing cooling to reduce or prevent chemotherapy-associated alopecia. These systems and methods can, for example, increase the contact area between the cooling element (e.g., heat exchanger) and the patient's scalp. This can, for example, improve cooling treatment efficiency. Furthermore, the devices and systems described herein can be compact and portable, allowing patients to perform cooling treatment at their own convenience (e.g., at home).

[0005] In some variations, the cooling cap assembly may 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 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.

[0006] In some variations, the expandable member may include a deflated configuration and an inflated configuration. Transitioning the expandable member from the deflated configuration to the inflated configuration may increase pressure applied to the patient's head. In some variations, a fluid pump may be coupled to the expandable member. In some variations, the housing may be configured to generate a counter pressure when the expandable member is in the inflated configuration. In some variations, the compression assembly may provide a pressure of about 0.1 lb / in against the head when the expandable member is in the inflated configuration. 2 ~about 10lb / in 2 The method may be configured to generate a compression of

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

[0008] In some variations, the heat exchanger may include a bottom portion, a top portion, a first side portion, and a second side portion. In some variations, the heat exchanger includes a fluid barrier set, and each fluid barrier of the set of fluid barriers is about 5 mm to about 15 mm from an adjacent fluid barrier in the fluid barrier set. In some barriers, each fluid barrier in the fluid barrier set 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 fluid barrier set. In some variations, at least one fluid barrier of the fluid barrier set includes a torus 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 variations, the top portion, the first side portion, and the second side portion each include a first lobe and a second lobe, and in some of these variations, 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 variations, each portion of the heat exchanger may include at least a portion of a fluid channel. In some variations, the length of the first side portion and the second side portion may be less than the length of the top portion. In some variations, the area of ​​either the first side portion or the second side portion relative to the area of ​​the top portion may be about 2:1 to about 0.5:1. In some variations, the top portion may define a longitudinal axis. The first side portion and the second side portion may extend from the bottom portion at an acute angle to the longitudinal axis. In some variations, one or more end portions of the heat exchanger may be configured to adjustably overlap to surround at least a portion of the head portion. In some variations, the heat exchanger may include a flexible material. In some variations, the heat exchanger may include a nonwoven fabric. In some variations, the heat exchanger may include a nonwoven fabric. In some variations, the heat exchanger may include a nonwoven fabric, each of about 9 mm. 2 ~ approx. 100mm 2 The fluid channel may include one or more fluid channels having a cross-sectional area of

[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, the one or more sensors may include a temperature sensor and a pressure sensor. In some of these variations, the heat exchanger may include at least one sensor in each portion of the heat exchanger. In some variations, the heat exchanger may include a fastener.

[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 expandable member. In some variations, the housing may define a cavity configured to surround at least a portion of the expandable 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 a fastener configured to couple to the expandable member. In some of these variations, the flexible cover may include a fastener. In some variations, the housing may define a cavity configured to receive the patient's head.

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

[0014] In some variations, a cooling unit may be fluidly coupled to the compression assembly. The cooling unit may include a fluid connection releasably coupled to the heat exchanger, the compressor, the reservoir, and the 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 a fluid through the heat exchanger. In some of these variations, the fluid may include one or more of water (e.g., liquid water, and ice) and salt, water and glycol, and water and alcohol, which may depress 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 be wrapped around a patient's head. The compression assembly may be 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 decoupled from and movable relative to the expandable member. Transitioning the expandable member from a contracted configuration to an expanded configuration may increase the contact area between the heat exchanger and the patient's head.

[0016] Also described herein are devices. In some variations, a method of cooling a scalp of a head to reduce chemotherapy-induced hair loss may include wrapping a heat exchanger around a portion of the scalp and placing a compression assembly on the head and over the wrapped heat exchanger. The compression assembly may include a semi-rigid outer member and an expandable inner member coupled to the outer member. The expandable member may be expanded to compress the heat exchanger between the expandable member and the scalp.

[0017] In some variations, the heat exchanger may be separate from and movable relative to the expandable member. In some variations, the expandable member may be transitioned from a contracted configuration to an expanded configuration to increase the pressure applied to the head. In some variations, a counter pressure may be created using an outer member when the expandable member is in the expanded configuration. In some variations, a pressure of about 0.1 lb / in against the head may be applied when the expandable member is in the expanded configuration. 2 ~about 10lb / in 2 A compression of 1000 psi may be generated. In some variations, the expandable member may include multiple independently expandable chambers. In some variations, a liner may be disposed about a portion of the scalp such that a heat exchanger may be positioned between the liner and the expandable 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 second side portion may be positioned over one another. The ends of the top portion may be positioned over the ends of the first side portion and the second side portion to surround at least a portion of the scalp.

[0019] In some variations, the expandable member may be inflated with a gas or liquid. In some variations, the expandable member may be inflated using a hand pump. In some variations, a fluid may be circulated through the heat exchanger. The fluid may include a temperature of about -10°C to about 5°C. In some variations, the heat exchanger may be removed from the scalp using a compression assembly. In some of these variations, the heat exchanger may be replaced on the scalp using a compression assembly. In some variations, a fastener may releasably attach the compression assembly to the scalp.

[0020] Also described herein are devices. 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 expandable member may include a pouch having an upper surface and a lower surface, the bottom surface being releasably coupled to the heat exchanger. The pump may be configured to inflate the pouch. The outer shell may be coupled to the upper surface of the pouch of the expandable member. The cooling unit may be fluidly coupled to the heat exchanger. The memory may include instructions for receiving a temperature from the temperature sensor and adjusting the output of the pump based on the temperature.

[0021] In some variations, the output of the pump can be an inflation pressure. In some variations, the temperature can be a scalp temperature. In some variations, the temperature sensor can be disposed on an exterior surface of the heat exchanger, within the heat exchanger, or within a fluid channel of the heat exchanger. In some variations, the heat exchanger can include one or more fluid channels that contain a circulating fluid. In some of these variations, the temperature can be a fluid temperature.

[0022] In some variations, the temperature sensor may include a temperature sensor set, the temperature may include a temperature set, and the pouch may include a chamber set. The memory may include instructions for independently adjusting the inflation pressure of each chamber of 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 releasable 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] Also described herein are methods. In some variations, a method of controlling scalp cooling of a chemotherapy patient's head includes applying a cooling cap to the head. The cooling cap can include a flexible heat exchanger including a temperature sensor. An expandable member can be releasably coupled to the heat exchanger. A shell can be coupled to the expandable member. The expandable member can include a pouch and a pump in fluid communication with the pouch to increase an inflation pressure of the pouch. The temperature can be measured using the temperature sensor. The inflation pressure of the pouch can be adjusted using the pump based on the measured temperature.

[0025] In some variations, the temperature may be a scalp temperature. In some variations, the temperature sensor may be on an exterior surface of the heat exchanger, within the heat exchanger, or within a fluid channel of the heat exchanger. In some variations, the heat exchanger may include one or more fluid channels that contain a circulating fluid. In some of these variations, the temperature may be a fluid temperature. In some variations, the temperature sensor may include a temperature sensor set, the temperature may include a temperature set, the pouch may include a chamber set, and the method includes independently adjusting the inflation pressure of each chamber of the pouch based on the temperature set.

[0026] In some variations, the heat exchanger may be separate from and movable relative to the expandable member. In some variations, transitioning the expandable member from the contracted configuration to the expanded configuration may increase the pressure applied to the head. In some variations, a shell may be used to create a counter pressure when the expandable member is in the expanded configuration. In some variations, a pressure of about 0.1 lb / in against the head may be applied when the expandable member is in the expanded configuration. 2 ~about 10lb / in 2 In some variations, the expandable member may include multiple independently expandable chambers.

[0027] In some variations, the liner may be disposed around a portion of the scalp such that the heat exchanger is between the liner and the expandable member. In some variations, the heat exchanger may include a bottom portion, a top portion, a first side portion, and a second side portion. The first side portion and the second side portion may be disposed one on top of the other. The top portion may be disposed over the first side portion and the second side portion so as to surround at least a portion of the scalp.

[0028] In some variations, the pouch may contain a fluid including a gas or a liquid. In some variations, the fluid may be circulated through a heat exchanger. The fluid may include a temperature of about -10°C to about 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 a patient's scalp, an expandable member releasably coupled to the heat exchanger, an outer shell coupled to the expandable member, a cooling unit fluidly coupled to the heat exchanger, the cooling unit configured to determine a power source and circulate a fluid through the heat exchanger, and a memory including 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 of an AC power source and a DC power source.

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

[0031] [Figure 1A] FIG. 4 is a block diagram of an exemplary variation of the cooling cap assembly. [Figure 1B] FIG. 13 is an exploded perspective view of an exemplary variation of the cooling cap assembly. [Figure 1C] FIG. 4 is a block diagram of an exemplary variation of the cooling cap assembly. [Figure 2A] FIG. 2 is a schematic diagram of an exemplary variation of a heat exchanger. [Figure 2B] FIG. 2 is a schematic diagram of an exemplary variation of a heat exchanger. [Figure 2C] 1 is a schematic diagram of an exemplary variation of a heat exchanger placed on a patient's scalp. [Figure 2D] 1 is a schematic diagram of an exemplary variation of a heat exchanger placed on a patient's scalp. [Figure 2E] FIG. 2 is a schematic diagram of an exemplary variation of a heat exchanger. [Figure 2F] FIG. 2 is a schematic diagram of an exemplary variation of a heat exchanger. [Figure 2G] FIG. 2 is a schematic diagram of an exemplary variation of a heat exchanger. [Figure 2H] 11A-11C are plan views of an exemplary variation of steps in assembling a heat exchanger. [Figure 2I] 11A-11C are plan views of an exemplary variation of steps in assembling a heat exchanger. [Figure 2J] 11A-11C are plan views of an exemplary variation of steps in assembling a heat exchanger. [Figure 2K] 11A-11C are plan views of an exemplary variation of steps in assembling a heat exchanger. [Figure 2L] 11A-11C are plan views of an exemplary variation of steps in assembling a heat exchanger. [Figure 2M] 4A-4C are plan views of exemplary variations in fluid flow patterns of a heat exchanger. [Figure 2N] 1 shows a schematic diagram of an exemplary variation of a fastener for a heat exchanger. [Figure 3A] 13A-13C are plan views of exemplary variations of the expandable member. [Figure 3B] 13A-13C are plan views of exemplary variations of the expandable member. [Figure 3C] 13A-13C are plan views of exemplary variations of the inflatable member and pump. [Figure 3D] 13A-13C are perspective views of exemplary variations of expandable members held within a housing. [Figure 4A] 13A and 13B are perspective views of an exemplary variation of the housing. [Figure 4B] 13A and 13B are perspective views of an exemplary variation of the housing. [Diagram 5] 13A and 13B are perspective views of exemplary variations of the flexible cover. [Figure 6] FIG. 1 is a schematic diagram of an exemplary variation of a portable cooling process. [Figure 7A] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 7B] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 7C] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 7D] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 7E] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 7F] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 8A] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 8B] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 8C] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 8D] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 8E] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 9A] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 9B] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 9C] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 9D] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 9E] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 9F] 11A-11C are perspective views of an exemplary variation of a cooling cap assembly process. [Figure 10] 11 is a set of plots of sensor and power measurements for an example variation of a cooling cap assembly. [Figure 11A] FIG. 2 is a schematic diagram of an exemplary variation of a heat exchanger. [Figure 11B] FIG. 2 is a schematic diagram of an exemplary variation of a heat exchanger. [Figure 11C] 1 is an image of an exemplary variation of a heat exchanger. [Figure 12A] 1A-1C are schematic diagrams of exemplary variations of expandable members. [Figure 12B] 13A-13C are bottom views of exemplary variations of expandable members held within housings in a first configuration. [Figure 12C] FIG. 13 is a bottom view of an exemplary variation of an expandable member retained within a housing in a second configuration. [Figure 12D] 1A-1C are images of exemplary variations of an expandable member in a first configuration and a second configuration. [Figure 13] FIG. 13 is a perspective view of an exemplary variation of the housing. [Figure 14A] 13A-13C are perspective views of an exemplary variation of the cooling cap. [Figure 14B] 13A-13C are perspective views of an exemplary variation of the cooling cap. [Figure 14C] 13A-13C are perspective views of an exemplary variation of the cooling cap. [Figure 14D] 13A-13C are perspective views of an exemplary variation of the cooling cap. [Figure 14E] 13A-13C are perspective views of an exemplary variation of the cooling cap. [Figure 14F] 13A-13C are perspective views of an exemplary variation of the cooling cap. [Figure 15A] FIG. 13 is an external view of an exemplary modified example of the cooling unit. [Figure 15B] FIG. 13 is an external view of an exemplary modified example of the cooling unit. [Figure 15C] FIG. 13 is an external view of an exemplary modified example of the cooling unit. [Figure 15D] FIG. 13 is an external view of an exemplary modified example of the cooling unit. [Figure 15E] FIG. 13 is an external view of an exemplary modified example of the cooling unit. [Figure 15F] FIG. 13 is an external view of an exemplary modified example of the cooling unit. [Figure 15G] FIG. 13 is an external view of an exemplary modified example of the cooling unit. [Figure 15H] FIG. 13 is an external view of an exemplary modified example of the cooling unit. [Figure 15I] FIG. 13 is an external view of an exemplary modified example of the cooling unit. [Figure 15J] FIG. 13 is an external view of an exemplary modified example of the cooling unit. [Figure 15K] FIG. 13 is an external view of an exemplary modified example of the cooling unit. [Figure 15L] FIG. 2 is an exploded perspective view of an exemplary variation of the cooling unit. [Figure 15M] FIG. 2 is an exploded perspective view of an exemplary variation of the cooling unit. [Figure 15N]FIG. 2 is an exploded perspective view of an exemplary variation of the cooling unit. [Figure 16A] FIG. 2 is an internal view of an exemplary variation of a cooling unit. [Figure 16B] FIG. 2 is an internal view of an exemplary variation of a cooling unit. [Figure 16C] FIG. 2 is an internal view of an exemplary variation of a cooling unit. [Figure 16D] FIG. 2 is an internal view of an exemplary variation of a cooling unit. [Figure 17] FIG. 1 is a phase diagram of an exemplary variation of a cooling process. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] Described herein are systems and devices for reducing the temperature of a patient's head, and in particular, systems and devices for cooling a patient's scalp using a cooling cap assembly. The cooling cap assembly may include, for example, a heat exchanger configured to remove heat from the patient's scalp, and a compression assembly separate from and releasably coupled to the heat exchanger. For example, the compression assembly may include an expandable member coupled to a rigid outer shell, which may expand to apply pressure to the heat exchanger and increase the contact area between the heat exchanger and the scalp. These systems and devices may generate sensor data for controlling one or more of the temperature of a cooling fluid and the force applied by a compression assembly disposed on the heat exchanger.

[0033] Also described herein are methods of assembling the cooling cap assembly and methods of using the cooling cap assembly to cool a patient's scalp. The method of assembling the cooling cap assembly may include wrapping a heat exchanger around a portion of the head and placing a compression assembly over the heat exchanger. The cooling cap assembly may be tailored to each patient to improve one or more of fit, comfort, and cooling effectiveness or heat transfer. In some variations, the assembled cooling cap assembly may form a friction fit with the compression assembly such that, upon completion of a treatment session, the cooling cap assembly may be removed from the patient's head as a single unit and, optionally, reapplied as a single unit for one or more subsequent treatment sessions. Generally, the method of using the cooling cap assembly includes circulating a fluid through a heat exchanger coupled to the patient's scalp and controlling an expansion pressure of an expandable 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. The patient may be able to adjust portions of the cooling cap assembly to personalize the fit and comfort of the cooling cap assembly. Additionally, the compression provided by the cooling cap assembly to the head may be adjusted for one or more of cooling effect and patient comfort. Some patients may use the cooling cap assemblies described herein to initiate a cooling therapy session within a clinical site (e.g., an infusion center). Additionally, the cooling cap assemblies may be portable so that the patient may perform a cooling therapy session outside of a clinical site (e.g., at home) and / or may initiate, continue, or terminate a cooling therapy session while traveling to or from a clinical site (e.g., while traveling from home to a clinical site or vice versa). The cooling cap assembly may generally include a liner, a flexible heat exchanger, a compression assembly, and a cover. The compression assembly may include an expandable member and a housing. For example, the heat exchanger may be separate from and movable relative to the expandable member. In some variations, the cooling cap assembly may include one or more sensors, which may be communicatively coupled (eg, wired or wirelessly) to a controller.

[0035] 1A is a block diagram of a variation of a cooling system (100) including a cooling cap assembly (110) and a cooling unit (150). The cooling cap assembly (110) may be configured to be removably placed on a patient's scalp to reduce a surface temperature of the scalp, for example during chemotherapy treatment. 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 expandable member (130) and a housing (140). The heat exchanger (120) may generally include fluid channels through which fluid may 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 to, for example, 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 the expanded configuration.

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

[0037] Returning to the cooling cap assembly (110), FIG. 1B is an exploded perspective view of a variation of the cooling cap assembly (110) configured to be placed on the scalp of a patient (101). The liner (112) may be placed on the scalp, and the heat exchanger (120) may be placed on the liner (112) such that a bottom or inner surface of the heat exchanger (120) may be removably coupled to the scalp via the liner (112). In some variations, the cooling cap assembly (110) may not include the liner (112), and the heat exchanger (120) may be placed directly on the scalp. The compression assembly (145) may be placed on top of the heat exchanger (120). More specifically, expandable member (130), which may be separate from and movable relative to heat exchanger (120), may be disposed on top of heat exchanger (120) (e.g., on top of the heat exchanger) such that a bottom or inner surface of expandable member (130) contacts a top or outer surface of heat exchanger (120). As mentioned above, housing (140) may be coupled to a top or outer surface of expandable member (130), such that housing (140) and expandable member (130) may be simultaneously positioned on a user's head.

[0038] In some variations, the cover (114) may be coupled to the housing (140) (e.g., to an exterior surface of the housing (140)) and may be placed on the user's head along with the housing (140) and the expandable member (130). In other variations, the cover (114) may be separate from the housing (140) and may be placed separately on the housing (140) and the user's head. The cover (114) may include fasteners that may releasably attach the cooling cap assembly to the head of the patient (101). In some variations, 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 coupled, the expandable member (130) may be disposed between the housing (140), which may include or otherwise function as an outer shell, and the heat exchanger (120). The heat exchanger (120) may be separate from and movable relative to the expandable member (130). In some variations, the expandable member (130) may comprise a pouch having a top surface and a bottom surface, and the bottom surface may be releasably coupled to the heat exchanger (120). The expandable member may be coupled to a pump (not shown), which may be configured to inflate the pouch. In some variations, the expandable member (130) may include multiple chambers, which may be coupled to a pump capable of inflating the chambers individually or simultaneously, as described in more detail herein. The expandable member (130) may include a set (144) of fluid conduits (e.g., fluid pressure lines) coupled to one or more valves (142). For example, in variations including multiple fluid conduits, each fluid conduit may include or be otherwise fluidly coupled to a valve. One or more valves (142) may be coupled to a pump (not shown).

[0040] In some variations, transitioning the expandable member (130) from the contracted configuration to the expanded configuration may increase the pressure exerted by the cooling cap assembly on the patient's head and the contact area between the heat exchanger (120) and the patient's head (101). In some variations, the compression assembly (145) may provide approximately 0.1 lb / in pressure against the head when the expandable member (130) is in the expanded configuration. 2 ~about 10lb / in 2 In some variations, the compression assembly (145) may be configured to generate a compression of about 0.1 lb / in against the head when the expandable member (130) is in the expanded configuration. 2 ~ approx. 8.0 lb / in 2 , about 0.1lb / in 2 ~ approx. 5.0 lb / in 2 , about 0.1lb / in 2 ~ approx. 3.0 lb / in 2 , about 0.1lb / in 2 ~ approx. 2.0 lb / in 2, about 0.1lb / in 2 ~ approx. 1.0 lb / in 2 , about 0.5lb / in 2 ~ approx. 8.0 lb / in 2 , about 0.5lb / in 2 ~ approx. 5.0 lb / in 2 , about 0.5lb / in 2 ~ approx. 3.0 lb / in 2 , about 0.5lb / in 2 ~ approx. 2.0 lb / in 2 , or approximately 0.5 lb / in 2 ~ approx. 1.0 lb / in 2 The method may be configured to generate a compression of

[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 the expandable member, a pump that circulates the cooling fluid, a cooling unit) may be altered based on information received from one or more sensors. For example, in some variations, the heat exchanger (132) may include multiple temperature sensors (132). The multiple temperature sensors (132) may be coupled (e.g., via a wired or wireless connection) to the controller (140) (e.g., a processor, memory). The controller may include and / or execute instructions to receive a temperature from the temperature sensor and adjust the output of one or both of the pump and / or compressor based on the temperature. 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 fluidly coupled to the controller (140).

[0042] heat exchanger In general, the heat exchangers described herein may be configured to remove heat from a patient's scalp via a cooling fluid circulating through one or more passages in 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 coverage area of ​​the heat exchanger with the circulating fluid may not be sufficient to provide a compressive force to uniformly cool the patient's scalp, such as when the patient moves his or her head. In some variations, the contact area between the heat exchanger and the scalp may be increased using the compression assemblies described herein, which may improve the effectiveness of the cooling treatment. In some variations, the shape and dimensions of the heat exchanger may be adjustable so that the heat exchanger can be properly adapted to multiple patients having different 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 of the patient's head. In some variations, the heat exchanger may include a surface that may 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] 2A and 2B are schematic top and bottom (e.g., exterior and interior) views, respectively, of a variation of a heat exchanger (200). 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 (270). The fluid connection (270) may be used to couple the heat exchanger (200) to a cooling unit and may be coupled to any suitable portion of the heat exchanger (200), for example, the bottom portion (210), the top portion (221), or either side portion (241). The fluid connection (270) may comprise fluid conduits, such as tubes, configured to couple to an inlet and outlet of a cooling unit. The top portion (221) may be configured to cover the top and / or front of the head, the bottom portion (210) may be configured to cover the back of the head and / or neck, and the first and second side portions (231, 241) may be configured to cover the left and right brain hemispheres of the head. The bottom portion (210) may have a generally rectangular shape and may extend away from the top portion (221).

[0044] In some variations, the top portion (221), the first side portion (231) and / or the second side portion (241) may include one or more arms or lobes, e.g., two, three, four or more. In some variations, the first side portion (231), the second side portion (241) and the top portion (221) may include only two lobes and the heat exchanger (200) may include only six lobes total (i.e., the bottom portion (210) has no lobes). The lobes of each portion of the heat exchanger may be sized and shaped to adjustably cover different portions of the patient's head. For example, the lobes may be generally elongated (e.g., longer than width) and each may have a curved or rounded distal end. One or more of the distal ends may include a fastener (e.g., hook, loop) used to secure the lobes together. Each lobe may extend from the bottom portion (210) and may be flexible to accommodate a patient's head and to allow for patient adjustment. In variations in which the top portion (221), first side portion (231), and second side portion (241) include multiple lobes, each lobe of each portion may be the same (e.g., same shape, length, width, surface area, and / or radius of curvature at the distal end) or each lobe may be different (e.g., different shape, length, width, surface area, and / or radius of curvature at the distal end). For example, in some variations, the top portion (221), the first side portion (231), and the second side portion (241) may each include two lobes, where the lobes (220, 222) of the top portion (221) have the same length and width as one another, and the length and width of the lobes (220, 222) of the top portion (221) may be different from the length and width of the lobes (230, 232, 240, 242) of the side portions (when the length and width of each lobe is 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 a mirror image of one or more lobes (240, 242) of the second side portion (241), and / or the lobes (220, 222) of the top portion (221) may be mirror images of one another.

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

[0046] 2A-2B, the top 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 length of the first lobes (230, 240) of the first portion (231) and the second portion (241) may be longer than the length of the second lobes (232, 242) of the first portion (231) and the second portion (241). Additionally or alternatively, the length of the first and second lobes of the first side portion (231) and the second side portion (241) may be less than the length of the first and second lobes of the top portion (221). In some variations, the ratio of the area of ​​either the first or second side portion to the area of ​​the top portion is from about 2:1 to about 0.5:1. In some variations, the heat exchanger (200) may include a length of from about 30 cm to about 50 cm, and a width of from about 35 cm to about 80 cm.

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

[0048] As shown at least in FIGS. 2A, 2B, and 2N, the heat exchanger (200) may include one or more releasable fasteners (280) (e.g., hook, loop, Velcro, combinations thereof, etc.) configured to form the heat exchanger (200) into a predetermined configuration and retain that configuration. For example, one or more end portions of the heat exchanger (200) may include fasteners having any suitable shape or size. FIGS. 2A and 2B show a set of fasteners (280) coupled to the distal ends of the lobes. For example, hemispherical loop fasteners may be disposed at the distal end of each lobe on a first side (FIG. 2A) of the heat exchanger (200). On a second side (FIG. 2B) of the heat exchanger (200) opposite the first side, hemispherical hook fasteners may be disposed on the four lobes. Additionally, loop fasteners may be disposed on a second side of the bottom portion (210). The multiple sections and / or lobes can be manipulated to wrap and secure the heat exchanger around the patient's scalp by overlapping and connecting the hooks and loops of different sections to one another.

[0049] In some variations, the heat exchanger (200) may comprise a flexible material, such as nylon, urethane coated nylon, woven polyester, polyvinyl chloride (PVC), loop cloth, nonwoven fabric, combinations thereof, etc. 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 and accommodate multiple patients with various head sizes. As shown in the side and front schematic views of Figures 2C and 2D, the heat exchanger (200) may be generally shaped to wrap around the patient's head. For example, one or more end portions of the heat exchanger may be configured to adjustably overlap to encircle at least a portion of the head, as described in more detail herein with respect to Figures 2H-2L.

[0050] The heat exchanger (200) may be formed from several layers that may be bonded together, one or more of which may form a fluid passage within the heat exchanger. FIG. 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, bottom layer (250), configured to face the patient, and a second layer, top layer (254), configured to face away from the patient (e.g., face the expandable member). The first layer (250) and the second layer (254) may form a cavity and / or one or more fluid channels (schematically shown as 252) between the first layer (250) and the second layer (254), which may receive a 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 together to form a circuitous and / or tortuous path for the 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 when no liner is used, the second layer (254) may include a soft fabric such as terry cloth and / or an absorbent fabric. Additionally or alternatively, in some variations, one or more portions of the heat exchanger (200) (e.g., the first layer (250) or a portion thereof, and / or the second layer (254) or a portion 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 into 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). Utilizing compressible materials can increase the stiffness of the heat exchanger (200), for example, increasing resistance to buckling from internal liquid pressure, and / or increasing 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 side views of the heat exchanger (200). For example, Figure 2E shows a first layer (250) that includes hook fasteners (260) and a second layer (254) that includes hook fasteners (260) and loop fasteners (262).

[0051] 11A and 11B are schematic diagrams of additional variations of a heat exchanger (1100) including designs configured for efficient cooling and fluid flow. As shown therein, the heat exchanger (1100) comprises a bottom portion (1110), a top portion (1121), a first side portion (1131) including a first arm (1130), a second side portion (1141) including a second arm (1140), and a fluid connection (1170). Additionally, one or more portions of the heat exchanger (1100) may include one or more fluid barriers (1150, 1152, 1154, 1156) (e.g., multiple fluid barriers, such as two, three, four, five, or more), one or more fasteners (1180) (e.g., multiple fasteners, such as two, three, four, five, or more), and one or more sensors (1182) (e.g., multiple sensors, such as two, three, four, five, or more). The fluid connection (1170) may be configured to couple the heat exchanger (1100) to a cooling unit (not shown) and may be coupled to any suitable portion of the heat exchanger (1100), such as the bottom portion (1110), the top portion (1121), or any of the side portions (1131, 1141). The fluid connections (1170) may include fluid conduits, such as tubes, configured to couple to the inlets and outlets of the cooling unit. The top portion (1121) may be configured to cover the top and / or front of the head, the bottom portion (1110) may be configured to cover the back of the head and / or neck, and the first and second side portions (1131, 1141) may be configured to cover the left and right brain hemispheres of the head. For example, the top portion (1121) may be generally circular or elliptical, the first and second side portions (1131, 1141) may have a generally elongated shape with rounded (e.g., bulbous) ends, and the bottom portion (1110) may have a generally tapered shape and extend away from the top portion (1121) and the side portions (1131, 1141).

[0052] In some variations, the top portion (1121), the first side portion (1131) and / or the second side portion (1141) may each include one or more, e.g., one, two, three, four, or more arms or lobes. In some variations, the first side portion (1131), the second side portion (1141), and the top portion (1121) may include a total of three arms or lobes, and the heat exchanger (1100) may include only a total of three arms or lobes (i.e., the bottom portion (1110) may have no arms). The arms of each portion of the heat exchanger may be sized and shaped to adjustably cover different portions of the patient's head. For example, the arms of each of the first and second side portions may be generally elongated (e.g., longer than they are wide) and each may have a curved or rounded distal end. The top portion (1121) may have a generally circular or oval shape in the shape of a head. One or more of the distal ends may include a fastener (e.g., hook, loop) used to secure the arms to one another. Each arm may extend outward in an opposite direction from the bottom portion (1110) and may be flexible to allow for conformance to the patient's head and adjustment by the patient. In variations in which the top portion (1121), first side portion (1131), and second side portion (1141) each include multiple arms, each arm of each portion may be the same (e.g., have the same shape, length, width, surface area, and / or radius of curvature at the distal end) or each arm may be different (e.g., have a different shape, length, width, surface area, and / or radius of curvature at the distal end).

[0053] As shown in FIGS. 11A-11C, for example, the top and side portions of the heat exchanger (1100) may generally form one or more of a human shape (e.g., a scarecrow), a T-shape, and / or a cross shape. In some variations, the top and bottom portions (1121) and (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 and second side portions (1131) and (1141) may extend from the bottom portion (1110) at an acute angle relative to the longitudinal axis. In some variations, the first and second side portions (1131) and (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 arcuate angles relative to the longitudinal axis. In some variations, one or more of the arms may be tapered (e.g., the proximal end has a wider width than the distal end, the distal end has a wider width than the proximal end, etc.). In some variations, the arms may either extend from another portion of the heat exchanger (e.g., a first arm (1130) extends from the bottom portion (1110) at an acute angle) or extend from another arm (e.g., a second arm (1132) extends from the top portion (1121)). For example, the first arm (1130) and the second arm (1132) may form an angle of about 0 degrees to about 80 degrees relative to the longitudinal axis. In some variations, the ratio of the length of the first arm to the length of the second arm may be 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 from about 2:1 to about 0.5:1.

[0054] In some variations, the heat exchanger (1100) may include a length of about 30 cm to about 50 cm, including all subranges and values ​​therebetween, for example, about 35 cm to about 45 cm. In some variations, the heat exchanger (1100) may include a width of about 35 cm to about 80 cm, including all subranges and values ​​therebetween. In some variations, the ratio of the arm length to the diameter of the top portion may be about 3:2 to about 3:4. For example, in some variations, the top portion (1121) may include a diameter of about 20 cm, the bottom portion (1110) may include a length of about 20 cm, and each side portion (1131, 1141) may include a length of about 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), the top portion (1121), the first side portion (1131), and the second side portion (1141). For example, in some variations, each portion of the heat exchanger (1100) may include at least a portion of a fluid path. The fluid path may have any size and shape suitable for circulating a cooling fluid through the portions of the heat exchanger (1100). In use, the fluid path may include a circulating fluid that may have a temperature lower than the temperature of the patient's scalp. FIGS. 11A and 11B show variations of the fluid flow patterns (1190, 1192) of the heat exchanger (1100). In the variation shown therein, fluid can enter (1190) and exit (1192) the heat exchanger (1100) through a bottom portion (1110) of the heat exchanger (1100) (e.g., a proximal end of the bottom portion (1110)). For example, fluid can flow sequentially in a generally counterclockwise direction through the bottom portion (1110), the second side portion (1141), the top portion (1120), the first side portion (1131), and exit through the bottom portion (1110).

[0056] In some variations, the heat exchanger (1100) may include fluid barriers configured to direct fluid flow through the heat exchanger (1100) and provide a predetermined shape to the heat exchanger (1100) in an expanded configuration. The fluid barriers described herein may help promote uniform and consistent cooling and may reduce fluid pooling within the heat exchanger (1100). For example, the fluid barriers may be configured to reduce turbulent fluid flow throughout the heat exchanger (1100) by defining predetermined fluid flow paths. Additionally, the fluid barriers may be configured to reduce expansion of one or more portions of the heat exchanger (1100). In some variations, the heat exchanger (1100) may include a set of fluid barriers (1150, 1152, 1154, 1156), including, but not limited to, punctate fluid barriers, elongated fluid barriers, rounded fluid barriers, and shaped fluid barriers. For example, the fluid barriers may be welded into an interior cavity of the heat exchanger (1100), including one or more side walls and not including walls that define the periphery (e.g., boundary) of the heat exchanger (1100). For example, each barrier may be bonded between opposing layers (e.g., top layer, bottom layer) of the heat exchanger (1100) such that when the heat exchanger (1100) is in an expanded configuration (e.g., filled with fluid), the heat exchanger (1100) does not "bulge" but rather may maintain a predefined thickness and shape throughout. As described in more detail herein, one or more of the fluid barriers may be formed by a welding process.

[0057] In some variations, the elongated fluid barriers (1152, 1153, 1155) may define fluid flow paths through one or more portions and / or arms of the heat exchanger (1100) and provide the heat exchanger (1100) with a predetermined shape. For example, FIG. 11A shows that the vertical elongated fluid barrier (1152) may bisect each of the bottom portion (1110) and the top portion (1121). Similarly, the horizontal elongated fluid barriers (1153, 1155) may bisect the first and second side portions (1131) and (1141), respectively, and the top portion (1121). In FIG. 11A, the vertical elongated fluid barrier (1152) may form a cross shape with each of the horizontal elongated fluid barriers (1153, 1155) to form a circuitous 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 disposed proximate to the intersections formed between the transverse and longitudinal elongated fluid barriers (1152, 1153, 1155) to reduce fluid backpressure (e.g., pooling) in those regions. The elongated fluid barriers (1154) may be approximately parallel or angled relative to the transverse or longitudinal elongated fluid barriers (1154).

[0058] FIG. 11B shows a curved elongated fluid barrier (1162), for example, configured to promote non-turbulent or laminar fluid flow near intersections and / or curved portions of the heat exchanger (1100). FIG. 11C is an image of the heat exchanger (1100) depicted in FIG. 11B. The elongated fluid barriers (1162, 1164) shown in FIGS. 11B and 11C may include one or more curves to reduce fluid back pressure and turbulence. The elongated fluid barriers may form a circuitous fluid path through the heat exchanger (1100). For example, FIG. 11B shows a first elongated fluid barrier (1162) that extends through the bottom portion (1110) and the second side portion (1141). The second elongated fluid barrier (1164) extends through the first side portion (1131) and the top portion (1120). The first and second elongated fluid barriers (1162, 1164) may be joined by a third elongated fluid barrier (1166). The lateral elongated fluid barrier (1165) may form a cross shape 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 disposed proximate 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., pooling) in those regions. The elongated fluid barriers (1154) may be approximately parallel or angled with respect to the elongated fluid barriers (1162, 1164, 1165, 1166).

[0059] In some variations, the fluid barrier set may include a fluid barrier pattern of spaced apart 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 may be approximately uniformly distributed throughout the cavity of the heat exchanger (1100). The center (e.g., hole) of the torus-shaped fluid barrier is not in fluid communication with the fluid within the heat exchanger. In some variations, one or more of the torus-shaped fluid barriers (1150) may include a diameter of about 5 mm to about 10 mm and may be spaced from other fluid barriers (1150) by about 5 mm to about 15 mm. For example, in some variations, one or more (e.g., a plurality, all) of the torus-shaped fluid barriers (1150) may include a diameter of about 7 mm and the spacing between the torus-shaped fluid barriers may be at least 10 mm (e.g., about 10 mm). In some variations, the set of tori (1150) may be generally uniformly spaced. Each fluid barrier of the fluid barrier set (1150) may have the same or different diameter. Additionally or alternatively, the fluid barrier set (1150) may include other shapes, such as hemispheres, rectangles, triangles, diamonds, trapezoids, and other polygons, or combinations thereof (e.g., a plurality of fluid barriers may include a first shape (e.g., a torus shape) and a plurality of fluid barriers may include a second, different shape (e.g., a solid circle)).

[0060] In some variations, one or more (e.g., multiple, two, three, four, or more) fluid barriers (e.g., fluid barrier (1154)) may include a barbell or dumbbell shape with a torus-like or circular fluid barrier (or point barrier) coupled to each end of the elongated fluid barrier. These fluid barriers (1154) may be configured to direct the flow of fluid in a predetermined manner. For example, the elongated fluid barriers (1152, 1154) may laminarize the fluid near intersections and sharp corners to reduce back pressure (e.g., pooling, still points) of the fluid. Relatively stagnant fluid within the heat exchanger (1100) may contain relatively high temperatures that may reduce one or more of the efficiency and performance of the cooling cap assembly. Thus, the elongated fluid barriers may 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 include a width less than or equal to the diameter or width of the fluid barrier end (eg, torus-shaped fluid barrier, point barrier).

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

[0062] Additionally, in some variations, the heat exchanger (1100) may include one or more releasable fasteners (1180) (e.g., hook, loop, Velcro, combinations thereof, etc.) configured to form and hold the heat exchanger (1100) in a predetermined configuration. For example, one or more end portions of the heat exchanger (1100) may include fasteners (1180) having any suitable shape or size. FIGS. 11A and 11B show a set of fasteners (1180) coupled to the distal ends of arms. For example, hemispherical loop fasteners may be disposed at the distal end of each arm on a first side of the heat exchanger (1100). On a second side of the heat exchanger (1100) opposite the first side, hemispherical hook fasteners may be disposed on the set of arms. Additionally, loop fasteners may be disposed on a second side of the bottom portion (1110). In some variations, the fasteners (1180) on the top portion (1120) may include a triangular shape that allows the top portion (1120) to form a concave or "bowl" shape when the heat exchanger (1100) is in an expanded configuration. For example, Figures 11A-11C show a set of four triangular fasteners (e.g., Velcro®) and three tab-type fasteners on the top portion (1120) of the heat exchanger (1100).

[0063] In some variations, the multiple sections and / or arms can be manipulated such that the hooks and loops of different sections overlap and couple to one another to wrap and secure the heat exchanger around the patient's scalp. For example, the fasteners (1180) on the distal ends (1130, 1140) of the side sections can be wrapped around the sides of the patient's head and meet (e.g., couple, overlap) on the patient's forehead. Tab-like fasteners (1180) protruding from the top section (1120) can then couple to the fasteners (1180) on the side sections (1131, 1141) to secure the top section (1120) to the side sections (1131, 1141).

[0064] In some variations, the heat exchanger (1100) may comprise a flexible material, such as nylon, urethane coated nylon, woven polyester, polyvinyl chloride (PVC), loop fabric, nonwoven fabric, combinations thereof, etc. This may allow one or more portions of the heat exchanger (1100) to be manipulated and adjusted (e.g., wrapped) to conform to the shape of a patient's head and accommodate patients with different head sizes.

[0065] In some variations, the heat exchanger (1100) may be formed from several layers that may be bonded together, one or more of which may form one or more fluid passages (e.g., fluid pathways) 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 the expandable member). In some variations, the layers of the heat exchanger may be radio frequency welded or heat welded together to form a circuitous fluid path for the circulating fluid and may be watertight. For example, radio frequency welding may include passing electricity through the portions of the heat exchanger to be welded using a manufacturing device. The localized heat and pressure applied by the manufacturing device may create a strong weld (e.g., bond). In some variations, the heat exchanger (1100) may include a fabric laminated with thermoplastic polyurethane (TPU).

[0066] In some variations, the heat exchanger (1100) may include a flexible material such as nylon and / or a nonwoven fabric. Additionally or alternatively, in some variations, one or more portions of the heat exchanger (1100) 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 into 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, for example, increase resistance to buckling from internal liquid pressure and / or reduce the risk of frostbite.

[0067] Compression Assembly The compression assembly described herein may be configured to increase the contact area between the heat exchanger and the patient's scalp (in some variations, the contact may be through a liner), which may increase the cooling efficiency of the cooling cap assembly. The compression assembly described herein may generally include an expandable member and a housing, and 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, e.g., detached or otherwise physically separated from the heat exchanger during application of the heat exchanger to the patient's scalp. In use, an inner surface of the expandable member may contact the heat exchanger and an outer surface of the expandable member may contact the housing. As the expandable member expands, the housing may be configured to resist deformation from the expandable member and to exert a counter force such that the compression assembly can apply a compressive force to the heat exchanger. This compressive force may increase the contact area between the heat exchanger and the scalp, e.g., by pressing the heat exchanger against the patient's scalp, so that the heat exchanger can better conform 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 fully contact all or a significant portion of the scalp unless pressure is applied to push the arms or lobes toward the scalp. The application of this pressure may enable reducing gaps, slippage, dimpling, etc. between the heat exchanger and the scalp. In some variations, the compression assembly may include one or more sensors.

[0068] Expandable Member The expandable members described herein can be configured to receive a fluid and transition from a contracted configuration to an expanded configuration to increase the force applied by the heat exchanger to the patient's head. Figures 3A and 3B are plan views of a variation of an expandable member (300). The expandable member (300) can include a bottom expandable portion (310), a top expandable portion (320, 322), a first expandable side portion (330, 332), and a second expandable side portion (340, 342). The bottom expandable portion (310) can be aligned with the patient's neck and / or back of the head, and the top expandable portion (321) can be placed over the top and / or front of the head. The side portions (331, 341) can cover the left and right brain hemispheres of the head when placed on the patient's head. Each portion can include at least one chamber configured to be filled with a fluid (e.g., liquid, gas (e.g., air)). For example, the expandable member may include multiple chambers (e.g., two, three, four, five, or more). For example, in one variation, the expandable member may include a front center chamber, a front left chamber, a front right chamber, an upper chamber, a rear center chamber, a rear right chamber, and a rear right chamber. In some variations, each of the multiple chambers may be independently inflatable. As discussed above, the expandable member (300) may include a deflated configuration and an inflated configuration. During use on a patient's head, transitioning the expandable member (300) from the deflated configuration to the inflated configuration may increase the pressure applied to the patient's head.

[0069] In some variations, the length of the first expandable side portion (330, 332) and the second expandable side portion (340, 341) may be less than the length of the top expandable portion (320, 322). As with the heat exchangers described herein, portions of the expandable member (300) may be configured to adjustably overlap to encircle at least a portion of the head. For example, Figures 3B and 3D are plan and perspective views of a variation of the expandable member (300) held within a housing (360). The side and top portions of the expandable member (300) may overlap each other to form an approximately hemispherical shape. In some variations, the expandable member (300) may be removably coupled to the housing (360). In other variations, the expandable member (300) may be fixed to the housing (360).

[0070] The inflatable member (300) can include one or more fluid connections (e.g., tubes) coupled to one or more inflation portions (310, 321, 331, 341). In some variations, the inflatable member (300) can further include a manual pump fluidly coupled to one or more chambers of the inflatable member (300) via a fluid connection. In other variations, the inflatable member can be fluidly coupled to a separate pump, e.g., an air pump included in a cooling unit, via one or more fluid connections. In some variations, one or more fluid conduits can include a valve that can be used to control or help control the inflation pressure.

[0071] FIG. 3C illustrates a variation of the inflatable member 300 that includes a fluid pump (e.g., air bulb) (350). The fluid pump (350), shown there as a manual hand pump (e.g., air pump bulb), can be coupled to a fluid connection (354) via flexible tubing (352). The flexible tubing (352) can fluidly couple one or more chambers in the expansion portion (310, 321, 331, 341) to the fluid pump (350) such 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), for example, with air and / or an inert gas. In some variations, the fluid pump (350) can be actuated by the patient, which can allow the patient to adjust the force applied to the patient's head by the compression assembly through the heat exchanger. This can allow for improved adaptability and comfort of the cooling cap assembly, and can allow some contact between the heat exchanger and the scalp. As mentioned 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 control the inflation pressure of the expandable member (300) manually (e.g., via user input) and / or dynamically (e.g., using sensor data) using the fluid pump (350).

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

[0073] The expandable member (1200) shown in FIGS. 12A-12D may include a bottom expandable portion (1210), a top expandable portion (1220) (e.g., top chamber (1221)), a first expandable side portion (1230) (e.g., left chamber (1231)), and a second expandable side portion (1240) (e.g., right chamber (1241)), a fluid barrier (1250), a fluid connection (1270), a notch or gap (1242), and a fastener (1280). The bottom expandable portion (1210) may be aligned with the neck and / or back of the patient's head, and the top expandable portion (1221) is placed over the top and / or front of the head. The expandable side portions (1230, 1240) may cover the left and right brain hemispheres of the head when positioned on the patient's head. Each portion 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 expandable member (1200) may include multiple chambers (e.g., two, three, four, five, or more). For example, in one variation, the expandable member (1200) may include a left chamber (1231), a right chamber (1241), and an upper chamber (1221). As discussed above, the expandable member (1200) may include a first deflated configuration, a second expanded configuration, and multiple partially expanded configurations therebetween. During use on the patient's head, transitioning the expandable member (1200) from the first deflated configuration to the second expanded configuration may increase the pressure applied to the heat exchanger and the patient's head.

[0074] In some variations, the top portion (1220) may have a generally oval or circular shape. The first and second side portions (1230, 1240) (e.g., wings, arms) may have a generally elongated shape that may be concave to form a "bowl" shape. The bottom portion (1210) may have a generally tapered shape and may extend away from the top portion (1220). In some variations, the length (along their respective longitudinal axes) of the first expandable side portion (1230) and the second expandable side portion (1240) may be longer than the length (along the longitudinal axis of the top expandable portion) of the top expandable portion (1220). As with the heat exchangers described herein, portions of the expandable member (1200) may be configured to adjustably overlap to surround at least a portion of the head. For example, Figures 12B and 12C are top views of a variation of an expandable member (1200) held within a housing (1260). The side portions (1230, 1240) and the top portion (1220) of the expandable member (1200) can overlap one another to form an approximately hemispherical shape. In some variations, the expandable member (1200) can be removably coupled to the housing (1260). In other variations, the expandable member (1200) can be fixed to the housing (1260). The expandable member (1260) can be configured to apply a substantially uniform amount of pressure to the patient's head when held in the housing (1260) in an expanded configuration. In some variations, the expandable member (1200) may include one or more notches (1242), gaps, or indentations to aid in the folding, molding, and / or overlapping of different portions of the expandable member (1200) within the housing (1260).

[0075] In some variations, the top portion (1220) and the bottom portion (1210) may define a common longitudinal axis that bisects the expandable member (1200). The first side portion (1230) and the second side portion (1240) may extend from the bottom portion (1210) at an acute angle to the longitudinal axis. For example, the first side portion (1230) and the second side portion (1240) may form an angle of about 0 degrees to about 80 degrees with respect to the longitudinal axis. In some variations, 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 portion and the second portion may be mirror images of each other. In some variations, 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 variations, the expandable member (1200) may include a length of about 25 cm to about 50 cm, including all subranges and values ​​therebetween, such as about 30 cm to about 40 cm. In some variations, the heat exchanger (1200) may include a width of about 35 cm to about 80 cm, about 50 cm to about 70 cm, about 60 cm to about 70 cm, including all subranges and values ​​therebetween.

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

[0078] In some variations, one or more portions of the expandable member (1200) may include one or more releasable fasteners (1280) (e.g., hooks, loops, Velcro®, combinations thereof, etc.) configured to form and hold the expandable member (1200) in a predetermined configuration. The expandable member (1200) may be manipulated such that the hooks and loops of different portions overlap and bind to one another to wrap and secure the expandable member within the housing. One or more edges of the expandable member (1200) may include fasteners (e.g., hooks, loops) used to fasten the portions together. Each side portion may extend from the bottom portion (1210) and may be flexible to allow for conformity to the patient's head and adjustment by the patient.

[0079] Fluid connection (1270) can be used to couple inflatable member (1200) to a pump (not shown) and can be coupled to any suitable portion of inflatable member (1200), such as bottom portion (1210), top portion (1220), or any of the side portions (1230, 1240). Fluid connection (1270) can include a fluid conduit, such as a tube, configured to couple to a pump. In some variations, inflatable member (1200) can further include a manual pump fluidly coupled to one or more chambers of inflatable member (1200) via a fluid connection. In other variations, inflatable member can 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 can include a valve that can be used to control or help control the inflation pressure.

[0080] In some variations, one or more chambers of the expandable member (1200) may be inflated to a predetermined pressure (inflation pressure), for example, with air and / or an inert gas. In some variations, the fluid pump may be patient-actuated, allowing the patient to adjust the force applied to the patient's head by the compression assembly through the heat exchanger. This may improve the adaptability and comfort of the cooling cap assembly, and may allow some contact between the heat exchanger and the scalp. As noted 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 expandable member (1200) using the fluid pump (1250), manually (e.g., via user input) and / or dynamically (e.g., using sensor data).

[0081] In some variations, the expandable member (1200) may comprise a flexible material, such as nylon, urethane coated nylon, woven polyester, polyvinyl chloride (PVC), loop cloth, nonwoven fabric, combinations thereof, etc. This may allow one or more portions of the expandable member (1200) to be manipulated and adjusted (e.g., wrapped) to conform to the shape of the patient's head and accommodate multiple patients with different head sizes. In some variations, the expandable member (1200) may comprise a flexible material, such as nylon and / or a nonwoven fabric.

[0082] In some variations, one or more expansion portions and / or chambers of the expandable member can be independently expanded and / or contracted. As shown in FIG. 1B, for example, the expandable member may include multiple segmented chambers that can be independently expanded and / or contracted. In these variations, a fluid conduit (144) can be coupled to each chamber of the expandable member (130) to allow independent control of the fluid pressure in each expandable portion and / or chamber of the expandable member. This can allow for more uniform cooling of the head by allowing individual adjustment of the expansion pressure of each expansion portion and / or chamber as needed. For example, after initial expansion of each chamber to a predetermined expansion pressure, temperature sensors coupled to each arm or lobe of the heat exchanger can measure temperature readings indicative of uneven cooling of the scalp. In response, the controller can increase the expansion pressure of the chambers corresponding to the arms or lobes with increased temperatures, for example, by increasing the output of pumps fluidly coupled to those chambers or otherwise directing additional fluid to those particular chambers.

[0083] Chassis In general, the housings described herein can include a surface configured to resist deformation when the expandable member transitions from a contracted configuration to an expanded configuration. The housings described herein can exert a counterforce on the expandable member as it expands, and when used with a heat exchanger, can allow the heat exchanger to exert a compressive force on the patient's head. The use of the housing as a counterforce against the expandable member in the expanded configuration allows the expandable member to maintain a uniform shape when in the expanded configuration and increases the contact area between the heat exchanger and the patient's scalp.

[0084] FIG. 13 is a perspective view of an exemplary variation of a housing (1300) including a shell (1310), straps (1312), chin straps (1314), strap fasteners (1316), shell fasteners (1318), expandable members (1320), and expandable member fasteners (1322). In some variations, the shell (1310) may be hemispherical or dome-shaped, or in the form of a helmet. For example, the shell (1310) may be constructed of a rigid (e.g., molded plastic) or semi-rigid material. For example, the shell (1310) may be more rigid than the expandable members (1320). As shown in FIG. 13, the shell (1310) may be configured to surround at least a portion of the expandable members (1320), and in some variations, the entire expandable members (1320). For example, the shell (1310) may define a cavity configured to surround at least a portion of the expandable member (1320) and / or receive a patient's head (not shown). In some variations, the shell (1310) may be surrounded 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 of the expandable members (1320) and a heat exchanger (not shown). The ports may be further configured to allow a wired connection to one or more sensors of the cooling cap assembly. In some variations, the shell (1310) may include one or more electronic components (e.g., processor, memory, PCB, battery, electrical leads, audio output device, haptic feedback device, visual output device) of the cooling cap assembly. For example, the shell (1310) may include an audio output device near an ear canal portion of the housing (1300) configured to provide audio notifications (e.g., operational status) related to the cooling treatment of the cooling cap assembly. As another example, the tactile feedback device may be configured to vibrate during a power state transition of a cooling unit coupled to the cooling cap.

[0085] In some variations, the housing (1300) may include one or more straps (1312) configured to secure the shell (1310) to the 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 soft components. For example, the chin strap (1314) may be threaded through one or more components of the cooling cap assembly. In some variations, the straps (1312) may include strap fasteners (1316) (e.g., loops) configured to fasten the straps (1312) to one or more of the shell (1310), the expandable member (1322), the cover, and the heat exchanger (not shown). In some variations, the shell fasteners (1318) and the expandable member fasteners (1322) can each include an opening configured to allow the strap fasteners (1316) to loop therethrough.

[0086] 14A-14F are perspective views of exemplary variations of a housing (e.g., a cooling cap). FIGS. 14A and 14C are side and rear views, respectively, of the housing. FIG. 14B is a bottom view of the housing with an inflatable member disposed within the housing. A manual pump is coupled to the inflatable member. FIGS. 14D and 14E show that the inflatable member and flexible cover can be releasably coupled (e.g., via Velcro®) to a more rigid shell of the housing. FIG. 14F is a detailed view of the chin strap of the housing. In some variations, a fastener (e.g., double-sided hook tape) can secure the shell of the housing to the inflatable member.

[0087] 4A and 4B are perspective views of the inside and outside of a variation of the housing (400). In some variations, the housing (400) may comprise a rigid material (e.g., molded plastic) or a semi-rigid material. For example, the housing (400) may be more rigid than the expandable member. As shown in FIGS. 4A-4B, the housing (400) may be configured to surround at least a portion of the expandable member. For example, the housing (400) may define a cavity configured to surround at least a portion of the expandable member and / or to receive the patient's head. In some variations, the housing may comprise a hemispherical shell (e.g., the housing may comprise a dome shape). Although not shown in FIGS. 4A and 4B, in some variations, the housing may comprise a fastener capable of reversibly coupling the housing (and the entire compression assembly) to the patient's head.

[0088] liner In general, the liners described herein can be configured to contact one or more of the patient's hair and scalp and to provide a barrier between the heat exchanger and the scalp. In some variations, the liners can be thin, flexible, and / or lightweight and can allow for heat transfer between the heat exchanger and the scalp. For example, the liners can include flexible and / or elastic materials such as knitted polyamide or knitted nylon. The liners can form a cavity configured to receive the patient's head, but unlike the housing, the liners can be malleable and devoid of any particular structure (e.g., soft and conformable). The liners can be applied and conformed to the patient's scalp. In some variations, the patient's hair can 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 can be adjusted to cover the patient's part line, which can help protect the patient's part line during cooling. In some variations, the liner can help hold the hair in a desired configuration. In some variations, a moisturizing lotion and / or hair conditioner may be applied to the scalp prior to application of the liner to improve conduction and / or prevent the hair from freezing during treatment. The liner may comprise a washable and reusable material. In some variations, the liner may be elastic. The liner may be disposed between the patient's scalp and the heat exchanger such that the heat exchanger is movable relative to the liner. In some variations, the liner may form a friction fit with the scalp such 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 include a liner.

[0089] cover Generally, when included in the cooling assemblies described herein, the cover can be configured to hold (e.g., secure, tether) the compression assembly to the patient. For example, the cover can be disposed on the housing of the cooling cap assembly and can include fasteners that can reversibly couple the cooling cap assembly to the patient. In this manner, the cooling cap assembly can be secured to the patient's head such that the cooling cap assembly exerts a predetermined pressure on the heat exchanger and the patient's head. As described in more detail above, the expandable member can be expanded to further increase compression on the head and the contact area between the heat exchanger and the patient's scalp. In some variations, the cover can include a flexible, resilient material such as neoprene, and the cover can be configured to expand as needed to hold the compression assembly in place on the head. In some variations, the cover can hold the compression assembly and the heat exchanger such that the compression assembly and the heat exchanger can be removed from the patient's head together. The cooling cap assembly (e.g., compression assembly and heat exchanger) can then be placed back onto the patient's head as a single piece during future use.

[0090] In some variations, the cover may be fixedly coupled to the compression assembly (e.g., the housing), and in other variations, the cover may be releasably coupled to the compression assembly. The cover assists the patient in placing the cooling cap assembly (e.g., the compression assembly) on the head and allows the cooling cap assembly to be secured to the head during use. In some variations, the heat exchanger may be separate from or releasably coupled to the compression assembly, as described in more detail herein. In these variations, the cover may also aid in removing, securing and reapplying the heat exchanger to the patient's head.

[0091] 5 is a perspective view of an exemplary variation of a flexible covering 500. As shown therein, the covering 500 (e.g., a stretchable cap) may include a fastener assembly (e.g., a chin strap 510) configured to wrap under the patient's chin.

[0092] Sensors In general, the sensors described herein may be configured to measure one or more parameters, such as, for example, temperature or force (e.g., pressure), and may be used to control one or more components of the cooling unit and / or the cooling cap assembly. As shown in FIG. 1B, in some variations, the cooling cap assembly may include one or more sensors (132). In this variation, the one or more sensors (132) may be coupled to the heat exchanger (120) and configured to measure one or more parameters of the cooling cap assembly, such as, for example, the temperature of a fluid circulating in the heat exchanger, the temperature of the scalp, and / or the force applied by the heat exchanger to the patient's scalp or vice versa. In some variations, 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 or force sensors.

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

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

[0095] In some variations, the inflation pressure of each chamber of the expandable member (130) may be independently adjusted based on the measured temperature of one or more of the respective chambers. In some variations, the measured temperature 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 temperature of the patient's scalp 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 the predetermined threshold and / or are outside the predetermined range, the controller may command or send a signal to one or more valves fluidly coupled to the chambers of the expandable member (130) and / or pumps fluidly coupled to the expandable member (130) to increase the inflation pressure in one or more chambers. Selectively increasing the inflation pressure in certain chambers may increase the contact area between the scalp and the heat exchanger at locations corresponding to those particular chambers. In this manner, the controller and one or more valves and / or pumps fluidly coupled to the expandable member (130) may be configured to dynamically control the inflation pressure.

[0096] Cooling unit As mentioned above, the cooling system described herein may include a cooling unit. The cooling unit may be configured to reduce the temperature of a cooling fluid and transfer the cooled cooling fluid to a cooling cap assembly (e.g., a heat exchanger) to reduce a patient's scalp temperature using the cooling cap assembly described herein. As shown in FIG. 1A, the cooling unit (150) may include a compressor and / or thermoelectric cooling mechanism (152) (e.g., a vapor compressor including a refrigerant), a reservoir (154), a sensor (156), and a pump (158) (e.g., a gear pump). The cooling unit (150) may be fluidly coupled to the heat exchanger (120) of the cooling cap assembly (110) and may be 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 about 5% to about 50%, about 5% to about 30%, about 20% to about 30%, and about 5% to about 25%, including all subvalues ​​and ranges therebetween. In some variations, the composition and ratio of the fluids can be determined based on the size of the reservoir and / or the volume of the fluid.

[0097] In some variations, the cooling unit (150) may be compact such that the cooling unit (150) is portable, allowing freedom of patient movement. Additionally, in some variations, the cooling unit (150) may include a portable power source (e.g., a battery), which may allow the patient to use the cooling system without access to an electrical outlet. As will become apparent from the description below, the cooling unit (150) allows the cooling systems described herein to be used without dry ice, thereby increasing safety and reducing operational complexity.

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

[0099] FIG. 1C is a block diagram of a variation of the cooling system (100) including the cooling cap assembly (110) and the 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). The compressor (152) may be configured to reduce the temperature of the circulating fluid returned from the heat exchanger (120). In some variations, the compressor (152) may be configured to compress a refrigerant used to cool the fluid passing through the expansion chamber. For example, the fluid (160) may be input to the compressor (152), which may be configured to output the fluid (164) at a temperature T3, which may be lower than the temperature T2. The 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) may be stored, and in some variations, the reservoir (154) may include ice. The flow meter (152) may be disposed in a fluid path between the compressor (152) and the reservoir (154) and may be configured to measure the flow of the fluid within the cooling unit (150). The pump (158) may be configured to circulate the fluid to and from the cooling cap assembly (110). For example, an output of the reservoir (154) may be fluidly coupled to the pump (158) configured to pump the fluid (162) to the cooling cap assembly (110) at a 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 variations, the sensor (156) may include one or more temperature sensors that 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), within 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 one or more temperature sensors may be configured to measure the temperature, e.g., temperatures T1, T2, and T3, of the fluid flowing into, through, or out of the cooling unit (150). 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 that 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), within 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 entering, passing through, or exiting the cooling unit (150). Additionally or alternatively, the sensor (156) may include, or be otherwise communicatively coupled to, a timer configured to count or determine, for example, the duration of a cooling therapy session based at least in part on one or more of the measurements of fluid flow, temperature, and power usage.

[0101] In some variations, cooling unit (150) may include a controller as described herein to control the flow rate and / or temperature of the circulating fluid, for example, based on sensor (156) measurements, sensors in the cooling cap assembly, and / or user input. For example, the controller may receive sensor data and modify the output of cooling unit components, such as pump (158) and / or compressor (152), based on the sensor data. As mentioned above, in some variations, sensor (156) of cooling unit (150) may include a fluid flow sensor (e.g., Hall effect sensor) configured to measure the flow rate of fluid circulating through cooling unit (150) and / or a temperature sensor (e.g., thermistor, thermocouple) configured to measure the temperature of the circulating fluid at various locations in the cooling system. In particular, in some cases, the controller may be configured to receive multiple temperature measurements from a temperature sensor (within the cooling unit and / or cooling cap assembly) and calculate a 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 measurements from the fluid flow sensor. The controller may be configured to compare the temperature measurements, calculated delta T, and / or flow measurements to target measurements (e.g., target temperature, target delta T, target flow rate) and / or target measurement ranges, and may adjust one or more components of the cooling unit (150) to achieve a desired result (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 may adjust the power delivered to the compressor (152) and / or the pump (158) to change (e.g., increase or decrease) or maintain the measured temperature, the measured flow rate, and / or delta T.By adjusting the power to the compressor (152), the temperature of the cooling fluid exiting the compressor (152) can be increased or decreased, while by adjusting the power to the pump (158), the flow rate of the cooling fluid in the system can be increased or decreased. A higher flow rate can generally be correlated with a lower delta T (as the faster the fluid is exchanged, the less time there is for heat exchange between the cooling fluid and the scalp). In some variations, the target temperature range of the cooling fluid at the cooling site (e.g., in the heat exchanger) can be about 2°C to about 4°C, and / or the target temperature range of the cooling fluid in the cooling unit can be about -2°C to about 2°C or about 0°C to about 2°C. In some variations, the controller can include a timer, and the controller can be configured to determine, for example, the duration of the 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 add or remove ice from the reservoir and / or modify the cooling fluid (e.g., change the ratio of water to alcohol) to modify the temperature of the cooling fluid. In some variations, the controller may adjust power to the compressor (152) and / or pump (158) in response to user input, for example, received via the graphical user interface. Although discussed above with respect to the cooling unit (150), it should be understood that in variations where the controller is a computing device (e.g., a smartphone, tablet, etc.), the controller may be separate from the cooling unit (150).

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

[0104] 15A-15K are external views of an exemplary variation of the cooling unit (1500). In some variations, the cooling unit (1500) may be self-contained, portable, reusable, and configured to be self-operated by the patient (e.g., without the assistance of a technician). As mentioned above, in some variations, the cooling unit (1500) may include a battery (not shown), allowing portability and freedom of movement for the patient. 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), for example, as described herein with respect to FIGS. 16A-16D. The handles (1540, 1542, 1544) and wheels (1504) of the cooling unit (1500) may allow for portability of the cooling unit (1500) as it allows the patient to easily move the cooling unit (1500) from one location (e.g., clinic, office, room) to another (e.g., transportation, home, another room) while performing continuous cooling therapy. In some variations, the cooling unit (1500) may include a height-adjustable handle (1540) and side handle (1542). The wheels (1504) may be configured to allow the cooling unit (1500) to rotate in any direction. In some variations, the cooling unit (1500) may be configured to fit into the floor of a car seat (e.g., behind the driver's or passenger's seat), or into the car seat itself. For example, the cooling unit (1500) may have a width of about 200 mm to about 500 mm, a length of about 400 mm to about 600 mm, and a height of about 350 mm to about 500 mm.

[0105] In some variations, the cooling unit (1500) may include a fluid reservoir (1510) releasably coupled to the housing (1502). In some variations, the fluid reservoir may be configured to hold between about 0.5 L and 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 between about 100 mm and about 300 mm, a length of between about 200 mm and about 300 mm, and a height of between about 50 mm and 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 variations, the cooling unit (1500) may include a latch (1512) configured to releasably engage the fluid reservoir (1510) to the housing (1502). As shown, for example, in Figures 15B-15G, the latch (1512) may comprise a hinge configured to transition between an engaged configuration and a disengaged configuration. The latch (1512) may cover the fluid reservoir (1510) in the engaged configuration to form a fluid seal over an opening of the fluid reservoir (1510). In some variations, the latch (1512) may further comprise an attachment sensor configured to generate an attachment 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 the attachment signal is not 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 located on an exterior surface of the housing (1502) to allow easy access and visualization 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 allow control of the cooling unit (1500).

[0107] 15L-15N are exploded perspective views of an exemplary variation of a cooling unit (1500). In particular, FIG. 15N shows a battery (1550), a condenser (1560), a system pump (1570), a cooling pump (1580), and a temperature sensor (1590).

[0108] 16A-16D are internal views of an example variation of a 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., circuit board, processor, memory), and a fluid input (1670). The condenser (1610) may be configured to condense a compressed gas into a liquid vapor. The pumps (1620, 1622) may include a cooling pump (1620) (e.g., a compressor) configured to reduce the temperature of a circulating fluid, and a system pump (1622) configured to circulate the fluid to and from a cooling cap assembly (not shown). In some variations, the cooling pump (1620) may be configured to compress a refrigerant used to cool the fluid passing through the expansion chamber. The fluid input (1670) may be configured to receive fluid from one or more of a fluid reservoir and a cooling cap assembly (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 variations, the sensors may include a fluid flow sensor (e.g., flow meter) (1650), a temperature sensor (1652), and / or a pressure sensor (1654). In some variations, the system may include a plurality of one or more of the above sensors. In variations including one or more flow sensors (1650), the flow meter (1650) may be configured to measure the flow of fluid within the cooling unit (1600). In variations including one or more temperature sensors, the temperature sensor (1652) may be configured to measure the temperature of fluid flowing into, through, or out of the cooling unit (1600). In some variations, the temperature sensor may be a thermistor or thermocouple housed in a liquid-impermeable fitting. In variations including one or more pressure sensors, pressure sensor (1654) may be configured to measure the pressure of fluid flowing into, passing through, or flowing out of 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, for example, based on cooling sensor measurements, sensors in the cooling cap assembly, and / or user input. For example, the controller (1660) may receive sensor data and modify the output of cooling unit components, e.g., pumps (1620, 1622), based on the sensor data. In particular, in some cases, the controller (1660) may be configured to receive multiple temperature measurements from temperature sensors (in the cooling unit and / or cooling cap assembly) and calculate a 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 in the cooling unit (150) and / or cooling cap assembly (110)). The controller (1660) may also be configured to receive fluid flow measurements from a fluid flow sensor. The controller may be configured to compare the temperature and / or flow rate measurements to target measurements and / or target measurement ranges and may adjust one or more components of the cooling unit (1600) to achieve a desired result (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 therapy session based at least in part on one or more of the measurements of fluid flow, pressure, temperature, and power usage.

[0111] In some variations, the controller (1660) can control a user interface to allow user adjustment of the flow rate and / or temperature of the circulating fluid. In some variations, the controller (1660) can provide instructions to a user via a graphical user interface, for example, to add or remove ice from the fluid reservoir and / or to modify the cooling fluid (e.g., change the ratio of water) to modify the temperature of the cooling fluid. In some variations, the controller can adjust power to the condenser (1610) and / or pumps (1620, 1622) in response to user input, for example, received via the user interface. Although described above with respect to the cooling unit (1600), it should be understood that in variations where the controller is a computing device (e.g., a smartphone, tablet, etc.), the controller may be separate from the cooling unit (1600).

[0112] FIG. 6 is a schematic diagram of a cooling system in use. As shown therein, a patient may use the portable cooling system in conjunction with a chemotherapy treatment session (600). For example, a patient may apply a cooling cap assembly to the patient's head and couple the cooling cap assembly to the cooling unit without the assistance of a medical professional (e.g., the patient himself / herself). In some embodiments, a patient may begin cooling treatment prior to receiving a chemotherapy infusion and continue cooling treatment while receiving a chemotherapy infusion. The cooling unit may be configured to be portable in a manner that allows the patient to perform basic activities (e.g., mobility, continence) while receiving cooling treatment. When the chemotherapy session is completed (602), the patient may continue to use the cooling system by transporting the cooling system to the patient's home or other destination. Thus, the patient need not remain at the treatment center to complete the cooling treatment session. The cooling unit may be sufficiently portable (e.g., having a suitable size and weight) for use by the patient, for example, while traveling between the patient's home and a chemotherapy treatment center (604). The patient can continue many of their daily activities uninterrupted outside of the chemotherapy treatment center (e.g., at home) while the cooling treatment is being administered 608. In some variations, the patient can control the cooling system using a graphical user interface on a computing device (e.g., a mobile phone, tablet, laptop, etc.).

[0113] Additionally or alternatively, the cooling unit may be placed in a medical cart, bag, carrying case, etc., which may include a handle for easy transport by the patient.

[0114] controller As described above, one or more of the cooling cap assembly and the cooling unit may include a controller. Additionally or alternatively, the system may further include a separate controller (e.g., a computing device) that may be used in combination with the cooling cap assembly and / or the cooling unit. In general, the computing device described herein may include a controller including a processor (e.g., a CPU) and a memory (which may include one or more non-transitory computer-readable storage media). The processor may incorporate data received from the memory and via a communication channel to control one or more components of the system (e.g., the cooling cap assembly (110), the cooling unit (150, 1600)). For example, in some embodiments, the processor may be configured to control a fluid pump coupled to the expandable member, the fluid pump (158, 1620, 1622) of the cooling unit (150, 1600), and / or the compressor (152) of the cooling unit (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 variations, the memory and the processor may be implemented on a single chip. In other variations, 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 (e.g., patient data, treatment data) from other sources (e.g., computing device, database, user input). The controller may be configured to control one or more of the inflation pressure of the expandable member, the circulating fluid temperature, and the flow rate based on the measured sensor data and / or other data (e.g., patient data, treatment data, user input). The controller may be configured to receive, process, compile, store, and access the data. In some variations, the computing device may be configured to access and / or receive data from different sources. The controller may be configured to receive input and / or measured data directly from the patient. Additionally or alternatively, the controller may be configured to receive data from a separate device (e.g., smartphone, tablet, computer) and / or storage medium (e.g., flash drive, memory card). The computing device may receive data via a network connection or via a physical connection with the device or storage medium (e.g., via a universal serial bus (USB), or any other type of port), as discussed in more detail herein. Computing devices may include any of a 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 reality / augmented reality headsets), televisions, set-top boxes (e.g., cable boxes, video players, video streaming devices), game consoles, etc.

[0116] The controller may be configured to receive various types of data. For example, the controller may be configured to receive the patient's personal data (e.g., gender, weight, birthdate, 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 a patient profile. The patient profile may include patient preferences and / or historical data regarding the treatment session (e.g., characteristics of the treatment session such as duration, location, time of day, day of week, or cooling parameters such as inflation pressure, cooling fluid temperature, scalp temperature, and cooling fluid flow rate from previous treatment sessions). The patient profile may additionally or alternatively include any of the patient-specific information described above. While the above-mentioned information may be received by the controller, in some variations, the controller may be configured to process any of the above data from the information the controller receives using software stored on the device itself or externally. Additionally, in some variations, the controller may be configured to adjust the inflation pressure of the expandable member, the temperature of the cooling fluid, the flow rate of the cooling fluid, the treatment session duration, or other treatment session characteristics or cooling parameters based on a combination of measurements received from the sensors described herein, as well as patient personal data, general health information, and / or a patient profile.

[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 the system, and / or networks associated therewith. The underlying device technology may be provided in a variety of 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 polymer, and metal-conjugated polymer-metal structures), mixed analog and digital technology, etc.).

[0118] In some variations, the memory may include a database (not shown) and may be, for example, a random access memory (RAM), a memory buffer, a hard drive, an erasable programmable read only memory (EPROM), an electrically erasable read only memory (EEPROM), a read only memory (ROM), a flash memory, etc. The memory may store instructions for causing the processor to execute modules, processes, and / or functions associated with cooling unit control, expansion control, and / or communication of the communication device. Some variations described herein relate to computer storage products having a non-transitory computer-readable medium (which may also be referred to as a non-transitory processor-readable medium) having instructions or computer code for performing various computer-implemented operations. The computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not include a transitory propagating signal (e.g., a propagating electromagnetic wave that carries information over a transmission medium such as space or cable) itself. The medium and the computer code (which may also be referred to as code or algorithm) may be designed and constructed for a specific purpose or for various purposes.

[0119] Examples of non-transitory 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 disks / digital video disks (CD / DVDs), compact disk read only memories (CD-ROMs) and holographic devices, magneto-optical storage media such as optical disks, semiconductor storage devices such as solid state drives (SSDs) and solid state hybrid drives (SSHDs), carrier wave 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 performed by software (executed 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 (executed on hardware) may be expressed in various software languages ​​(e.g., computer code), including 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 produced 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 enable a patient and / or a medical professional to control one or more components of the cooling unit and / or the 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) by a wired or wireless connection. In some variations, the controller may communicate with other devices over one or more wired and / or wireless networks. In some variations, the network interface may include a radio frequency receiver, transmitter, and / or an optical (e.g., infrared) receiver and transmitter configured to communicate with one or more devices and / or networks. The network interface may communicate wired and / or wirelessly.

[0122] The network interface may comprise RF circuitry configured to receive and transmit RF signals. The RF circuitry may convert electrical signals to / from electromagnetic signals and communicate with communication networks and other communication devices via electromagnetic signals. The RF circuitry may include known circuits for performing these functions, including, but not limited to, an antenna system, an RF transceiver, one or more amplifiers, a tuner, one or more oscillators, a digital signal processor, a CODEC chipset, a subscriber identity module (SIM) card, memory, etc.

[0123] Wireless communication via any of the computing and measurement devices may use any of a number of communication standards, protocols, and technologies, including, but not limited to, Global System 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, Wireless Fidelity (WiFi) ( For example, IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, IEEE 802.11n, etc.), Voice over Internet Protocol (VoIP), Wi-MAX, protocols for email (e.g., Internet Message Access Protocol (IMAP) and / or Post Office Protocol (POP)), instant messaging (e.g., Extensible Messaging and Presence Protocol (XMPP), Session Initiation Protocol for Instant Messaging and Presence Leverage Extension (SIMPLE), Instant Messaging and Presence Service (IMPS)), and / or Short Message Service (SMS), or any other suitable communication protocol. In some variations, devices herein may communicate directly with each other without transmitting data over a network (e.g., via NFC, Bluetooth, WiFi, RFID, etc.).

[0124] The communications device may further comprise a user interface configured to enable a user (e.g., the patient or a predefined contact such as a partner, family member, medical professional, etc.) to control the controller. The communications device may enable a user to directly and / or remotely interact with and / or control the controller. For example, the user interface of the controller may include an input device through which the user inputs commands and an output device through which the user receives output.

[0125] In some variations, the output device may include a display device including at least one of a light emitting diode (LED), a liquid crystal display (LCD), an electroluminescent display (ELD), a plasma display panel (PDP), a thin film transistor (TFT), an organic light emitting diode (OLED), an e-paper / e-ink display, a laser display, and / or a holographic display.

[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 comprise 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 an input device (e.g., a touch screen) and an output device (e.g., a display). For example, user control of the input device (e.g., a keyboard, buttons, touch screen) may be received by the user interface and then processed by the processor and memory for the user interface to output a control signal to the cooling unit (150). Some variations of the input device may include at least one switch configured to generate a control signal. For example, the input device may include a touch surface for a user to provide an input (e.g., a finger touch on the touch surface) corresponding to the control signal. For example, a user may input commands to start and stop cold therapy, increase or decrease inflation pressure, increase or decrease fluid temperature, and / or set a cold therapy session duration.

[0128] Input devices with touch surfaces can be configured to detect contact and movement on the touch surface using any of a number of touch sensitivity technologies, including capacitive, resistive, infrared, optical imaging, dispersive signal, acoustic pulse recognition, and surface acoustic wave technologies. In variations of input devices that include at least one switch, the switch can include, for example, at least one of a button (e.g., hard key, soft key), a touch surface, a keyboard, an analog stick (e.g., joystick), a directional pad, a mouse, a trackball, a jog dial, a step switch, a rocker switch, a pointer device (e.g., stylus), a motion sensor, an image sensor, and a microphone. The motion sensor can receive user movement data from the optical sensor and classify the user's gestures as control signals. The microphone can receive voice data and recognize the user's voice as a control signal.

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

[0130] network In some variations, the devices and systems described herein may communicate with other devices or networks (e.g., within the system, outside the system), for example, via one or more networks, each of which may be any type of network (e.g., wired network, wireless network). The communications may be encrypted or unencrypted. A wireless network may refer to any digital network that is not connected by any type of cable. Examples of wireless communications in a wireless network include, but are not limited to, cellular, radio, satellite, and microwave communications. However, a wireless network may connect with a wired network to interface with the Internet, other carrier voice and data networks, business networks, and personal networks. Wired networks are typically carried over copper twisted pair, coaxial cable, and / or fiber optic cable. There are many different types of wired networks, 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). Hereinafter, a network refers generally to any combination of wireless, wired, public, and private data networks interconnected via the Internet to provide 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 Also described herein are methods for assembling the cooling cap assembly and for cooling the scalp using the systems and devices described herein. The methods for cooling the scalp of the head described herein can help reduce, prevent, or prevent hair loss due to chemotherapy, for example. For example, the methods can increase heat transfer between the cooling cap assembly and the patient's scalp, thus improving the effectiveness of scalp cooling treatment. As another example, the methods can increase user compliance with a cooling treatment regimen. In some variations, the methods can 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 variations, the methods can include adjusting, for example, via a controller, one or more of the expansion pressure of the expandable member, the temperature of the cooling fluid, and the flow rate of the cooling fluid based on sensor measurements. Additionally or alternatively, the methods may include adjusting one or more of the above parameters based on user input.

[0133] Assembling the Cooling Cap Assembly Generally, a method of assembling a cooling cap assembly may include wrapping a heat exchanger around a portion of the head (e.g., scalp, scalp portion) and placing a compression assembly over the heat exchanger and on the head. FIGS. 2I-2L are plan views of one variation of the assembly steps for applying the heat exchanger (200) to a patient's scalp. The heat exchanger (200) is depicted separately from the patient's head for clarity. FIG. 2H shows the outside of the heat exchanger in an unfolded configuration, the inside of which may be placed on 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) resting on the top and / or front of the head. The side portions (231, 241) may cover the left and right brain hemispheres of the head when placed on the patient's head. As shown in FIG. 2I, the first and second lobes (220, 222) of the top portion (221) can be inverted 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 such that the side portions form an oval shape, as shown in FIG. 2J. As shown in FIG. 2K, the first lobe (220) of the top 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 FIG. 2L, the second side lobe (222) of the top portion can be folded over at least a portion of the top portion (220), the first side portion (230), and the second side portion (240). Fasteners can secure the overlapping portions together such that the heat exchanger forms a cap-like (e.g., hemispherical) shape that can generally conform to the patient's scalp. Additionally or alternatively, one or more of the assembly steps can be performed separately from the head, such as on a table or other surface, and the heat exchanger can be placed on the patient's head after being partially or fully assembled. Optionally, the patient can further adjust (e.g., tighten) parts of the heat exchanger to optimize contact area and comfort after placement on the head.

[0134] 7A-7F are schematic diagrams of variations of a method for assembling a cooling cap assembly. In the variations shown in FIGS. 7A-7F, the method may include forming a cooling cap assembly on a patient's head, for example, by 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 of 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., expandable member and housing) and the cover are shown as separate steps (704-708), it should be understood that in some variations, the compression assembly and the cover may be coupled together (e.g., using snaps, buckles, bonding, hook-and-loop fasteners, etc.) such that they may be applied in a single step.

[0135] More specifically, in variations in which the cooling cap assembly includes a liner, the method may begin by placing the liner around a portion of the head, for example, around the patient's scalp. A heat exchanger may be placed on top of the liner (702), and a compression assembly may be placed on the head and over the wrapped heat exchanger such that the heat exchanger is disposed between the liner and the compression assembly. In variations in which a liner is not used, the heat exchanger may be placed in direct contact with the patient's scalp and may be disposed between a surface of the patient's scalp and the compression assembly. In particular, an expandable member (e.g., outer member, outer shell), which may be coupled to the housing, may be placed over the heat exchanger (704) such that the heat exchanger is disposed between the expandable member and the liner or surface of the patient's scalp. In variations in which a cover is secured to the housing, the cover may be placed on the patient's head in combination with the expandable member and the housing. In other variations in which the cover is not inherently secured to the housing, the cover may be applied to the patient's head over the compression assembly. The method may further include releasably coupling the cooling cap assembly to the patient's head using fasteners (e.g., a chin strap with a buckle, hooks, Velcro, etc.) Figure 7F shows a partial cutaway cross section (710) of the cooling cap assembly after it has been applied or assembled to the patient's head.

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

[0137] In some variations, the heat exchanger may be separate from the compression assembly or may be releasably coupled. In these variations, the heat exchanger may be removed from the head using the compression assembly. That is, the heat exchanger may form a friction fit with the expandable member such that the compression assembly and the heat exchanger may be removed from the patient's head as a single piece. The heat exchanger may be placed back onto the scalp using the compression assembly during a future treatment session. In variations that include a cover, the cover may also aid in removing the heat exchanger from the patient's head and securing and reapplying it to the patient's head. In some variations, 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) to reduce the number of disassembly steps. For example, the heat exchanger, compression assembly, and cover may be removed from the patient's head together in a single piece, thereby leaving only the liner on the patient's scalp. This single-unit cooling cap assembly may then be placed back onto the patient's head and another cooling treatment session may be performed. Because the heat exchanger and expandable member are pre-aligned and attached to the patient's anatomy, the assembled cooling cap assembly can be easily positioned on top of the patient's head with minimal readjustment.

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

[0139] 9A-9F are perspective views of yet another variation of the cooling cap assembly process. FIGS. 9A and 9B show a liner (901) covering a patient (900) and a portion of the head (902). As shown in FIG. 9C, a heat exchanger (905) can be wrapped around the head (904) over the liner (901). The heat exchanger (905) can include multiple sensors (920) that can be communicatively coupled (e.g., wired, wireless) to a controller (950). An expandable member (907) can be disposed over the heat exchanger (906), and a fluid conduit set (908) can be coupled to the expandable member (908). As shown in FIGS. 9D and 9E, the expandable member (907) can include multiple independently expandable chambers. FIG. 9F is an exploded schematic view (910) of the cooling cap assembly process. The controller (950) may be configured to control the circulating fluid through the heat exchanger (905) and / or the inflation pressure of the expandable member (907). A fluid conduit (908) may be coupled between the expandable 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 FIG. 9F, the liner (901) may be placed directly on the scalp, and the heat exchanger (905) and expandable member (907) may be placed on the liner, either simultaneously or sequentially.

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

[0141] As described in more detail above, forming the 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 attached over the compression assembly, and the cover may be fastened to the patient using, for example, a chin strap. A cooling fluid conduit may be used to couple the heat exchanger to a cooling unit, and an inflation fluid conduit may be used to couple the inflatable member to a fluid pump (e.g., an air pump such as an air valve).

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

[0143] Circulating the cooling fluid through the cooling cap assembly may include circulating the fluid at a temperature of about -10°C to about 5°C through a heat exchanger using a cooling unit. In some variations, the fluid may be at about -2°C to about 2°C, or about -2°C to about 4°C. The fluid may be circulated through the heat exchanger for the duration of the treatment session. The treatment session may include a pre-cooling portion prior to administration of the chemotherapy treatment, a transition portion during which the patient is traveling to receive the chemotherapy treatment, a chemotherapy portion during which the patient is receiving the chemotherapy treatment, a second transition portion during which the patient is traveling from the chemotherapy treatment to another location (e.g., home), and a post-cooling portion during which the patient continues to cool the scalp for a period of time following the chemotherapy treatment. The patient may receive the cooling treatment over each portion of the treatment session. In some variations, the fluid may be circulated for about 45 minutes to 10 hours, about 1 hour to about 8 hours, about 1 hour to about 6 hours, or about 1 hour to about 4 hours. The cooling system may be plugged in during one or more portions of the treatment session (e.g., pre-cooling, chemotherapy, and post-cooling portions), but does not need to be plugged in during transitional portions. In other words, the cooling unit may be battery powered during transitional portions of the cooling treatment session (e.g., while the patient is moving from one location to another). After the patient has finished the cooling treatment session, the cooling cap assembly may be removed from the head and stored for later use. In some variations, the method may further include reapplying the cooling cap assembly to the scalp and recirculating the cooling fluid, as described above.

[0144] In some variations, the cooling unit may be operated in one of a number of operating states (e.g., full power, reduced power, battery power) with different capabilities based on the available power source. For example, when the cooling unit is connected to an AC power source, the pump and compressor may be on at full power, while when the cooling unit is in battery power mode, only the pump operates. FIG. 17 is a state diagram illustrating an exemplary method of controlling a cooling unit described herein. In some variations, 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 inhibited from circulating fluid and / or providing chilled fluid to the cooling cap assembly. The patient or user may input a power on signal (e.g., pressing a power button) to activate the cooling unit. In response, the controller may determine that the system transitions from the power off state (1702) to a power on state (1704) (e.g., a powered on state). In response to the power on state (1704), the system's controller can identify a valid power source to be used to energize the cooling unit. The system can determine 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 OK, AC power). The mains power source corresponds, for example, to a wall outlet from a power utility. In the full power state (1706), the cooling unit pump is on (e.g., running) and the cooling unit compressor can operate at full power. For example, the cooling unit can be operated without power limitations or loss of functionality (e.g., control loop active). For example, the active control loop can include a closed-loop temperature feedback. In some variations, the cooling unit's battery can be recharged while in the full power state (1706).

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

[0146] The system may determine to transition from the powered on state (1704) to the battery powered state (1710) when the system is receiving cooling unit battery power and is not receiving main or auxiliary power (1730) (e.g., battery OK, no main or auxiliary power). In the battery powered state (1710), the cooling unit pump is on (e.g., running) and the cooling unit compressor is off. Thus, fluid may circulate but is not being actively cooled by the cooling unit. In some variations, sensor measurements may be performed without active closed-loop control (e.g., control loop monitoring only).

[0147] The system may determine to transition from the partial power state (1708) to the full power state (1706) when the system is receiving primary power and not receiving auxiliary power (1730) (e.g., primary power OK, no auxiliary power). The system may determine to transition from the partial power state (1708) to the battery power state (1710) when the system is not receiving primary or auxiliary power (1728) (e.g., no primary or auxiliary power).

[0148] The system may determine to transition from the battery power state (1710) to the partial power state (1708) when the system is receiving auxiliary power and not receiving primary power (1724) (e.g., no primary power, auxiliary power OK). The system may determine to transition from the battery power state (1710) to the full power state (1706) when the system is receiving primary power (1722) (e.g., primary power OK). The system may determine to transition from the battery power state (1710) to the powered off state (1702) when the battery reaches a predetermined power level (1732) (e.g., low battery).

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

[0150] As mentioned 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 include a user interface through which the patient may 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 and / or 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 measurements including temperature, force, expansion pressure, and fluid flow rate generated by various sensors of the system.

[0151] In some variations, the controller can dynamically control the treatment time, inflation pressure, fluid temperature, and / or fluid flow rate. For example, the controller can command or send signals to the cooling unit (e.g., one or more pumps, compressor) to modify one or more cooling parameters (e.g., cooling fluid flow rate, cooling fluid temperature, inflation pressure of one or more of the chambers of the expandable member). In some variations, the patient may be notified when one or more temperature measurements exceed a predetermined threshold, and an option may be provided to adjust one or more cooling treatment parameters, for example, using a user interface of the computing device or cooling unit.

[0152] As an example, in one variation, the method may include circulating a fluid through a heat exchanger coupled to the patient's scalp and adjusting 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., inflation pressure, temperature of the cooling fluid, flow rate of the cooling fluid). In these variations, the patient may control one or more cooling parameters using a graphical user interface of a controller (e.g., 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 inflation pressure of the cooling cap assembly by manually activating 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 a display of the patient's computing device.

[0153] Additionally or alternatively, adjusting the cooling parameters may include using the 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) and a predetermined temperature and / or force threshold, maximum, target, or range. For example, in variations in which dynamic control is utilized, if the average measured temperature exceeds a predetermined temperature threshold, the controller may increase the inflation pressure of the inflatable member, e.g., using one or more fluid valves and / or fluid pumps coupled to the inflatable member, as described in more detail above. If the measured inflation pressure exceeds a predetermined pressure threshold, the controller may decrease the inflation pressure until the inflation pressure is within a suitable range. If the measured inflation pressure is within a target range, the controller may maintain the inflation 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, an average of several temperatures measured on or at a location on the patient's scalp, a delta T calculated between any of the aforementioned temperatures) are above or below a target value and / or outside a target range, the controller may adjust one or more parameters of the cooling system to adjust (e.g., increase or decrease) 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 a compressor of the cooling unit and / or adjust the flow rate of the cooling fluid by adjusting the output of a cooling fluid pump in the cooling unit until the temperature reaches a target value, exceeds a threshold, falls below a maximum value, or is within a target range. In some variations, the patient may be audibly and / or visually notified when the controller changes one or more of the inflation pressure, fluid temperature, and fluid flow rate to reduce surprise or anxiety.

[0154] In some variations, the method may further include independently adjusting the inflation pressure of one (e.g., each) of the multiple chambers of the expandable member based on the measured temperature set. For example, the inflation pressure in the chamber of the expandable member may be increased when the measured temperature or an average of the measured temperatures of the corresponding portion of the heat exchanger exceeds a predetermined maximum temperature. As another example, the measured temperature of a first arm or lobe of the heat exchanger may exceed a predetermined maximum temperature such that the controller can adjust one or more valves and / or fluid pumps to expand the chamber of the expandable member corresponding to the arm or lobe. In these variations, additional cooling can be precisely targeted to the patient's head. When the measured temperature of the arm or lobe falls below a predetermined threshold, the controller can maintain the pressure of 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 executed 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 impart a predetermined maximum compression to the heat exchanger and set the circulating fluid at a predetermined maximum flow rate to maximize heat transfer. In some variations, the patient may personalize the treatment protocol and / or the system may adjust a pre-set treatment protocol based on patient information entered into the system. The patient may further be provided with real-time control of treatment parameters such as treatment time, inflation pressure, fluid temperature, and fluid flow rate. Additionally, 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 and from 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 audible (e.g., voice) prompts instructing the user how to assemble the heat exchanger, how to assemble and / or disassemble the cooling cap assembly, and / or how to perform a cooling therapy session. EXAMPLES

[0156] FIG. 10 is a set of graphs of sensor and power measurements for one variation of the cooling cap assembly. As shown in FIG. 10, parameters including coolant flow (1000), temperature change (1002), and power (1004) (i.e., power extracted, power used) can be graphed against time. A temperature sensor array (1008) can be placed on the head and the temperature (1006) of each sensor can be graphed against time. At time A in FIG. 10, full pre-cooling power is applied. At time B, the cooling cap assembly powered with a 40W load can be applied to the patient's head. At time C, the expandable member of the cooling cap assembly can be expanded to increase the contact area between the heat exchanger and the patient's scalp. For example, the expandable member can be expanded to increase compression on 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 fluid through the heat exchanger may decrease while still maintaining at least the effectiveness of the cooling therapy. At point E, the system may be powered off. Between points C and E, a steady state may be achieved where all 40 W has been removed.

[0157] The specific examples and descriptions herein are exemplary in nature and modifications may be developed by those skilled in the art based on the material taught herein without departing from the scope of the present invention, which is limited only by the scope of the appended claims.

Claims

1. A scalp cooling system for reducing hair loss caused by chemotherapy, A heat exchanger configured to be placed on a portion of the user's scalp, The portable cooling unit comprises a portable cooling unit configured to circulate a fluid through the heat exchanger, and the portable cooling unit comprises a compressor configured to cool the fluid circulating through the heat exchanger. A scalp cooling system in which the portable cooling unit is movable by the user from a first position to a second position while the portable cooling unit is circulating a cooling fluid through the heat exchanger.

2. The scalp cooling system according to claim 1, wherein the portable cooling unit is configured to continuously circulate the cooled fluid to the heat exchanger.

3. The scalp cooling system according to claim 1, further comprising a compression assembly configured to be positioned on the user's scalp after the heat exchanger.

4. The scalp cooling system according to claim 3, wherein the portable cooling unit is further configured to circulate fluid through the compression assembly.

5. The scalp cooling system according to claim 4, wherein the compression assembly comprises an expandable member.

6. The scalp cooling system according to claim 3, further comprising an air pump capable of operating to increase the pressure applied by the compression assembly.

7. The scalp cooling system according to claim 1, wherein the portable cooling unit further comprises a fluid pump.

8. The scalp cooling system according to claim 7, wherein the fluid pump is a manual pump.

9. The scalp cooling system according to claim 1, wherein the portable cooling unit is movable in response to force applied to the handle of the portable cooling unit.

10. The scalp cooling system according to claim 9, wherein the portable cooling unit is further provided with wheels such that the portable cooling unit moves when force is applied.

11. The scalp cooling system according to claim 9, wherein the handle is configured to transition between a first collapsed state and a second expanded state.

12. The scalp cooling system according to claim 11, wherein the handle is in a second extended configuration while the user moves the portable cooling unit from the first position to the second position.

13. The scalp cooling system according to claim 1, wherein the portable cooling unit further comprises a housing connected to a fluid reservoir.

14. The aforementioned portable cooling unit further includes: Determine the power source for the aforementioned portable cooling unit, Based on the power supply determined above, the operating state of the portable cooling unit is selected. The scalp cooling system according to claim 1, comprising a processor configured as follows.

15. The scalp cooling system according to claim 14, wherein the fluid flow rate of the cooling fluid is determined based on the power supply.

16. The scalp cooling system according to claim 14, wherein the power source for the portable cooling unit is either an internal power source or an external power source.

17. The scalp cooling system according to claim 16, wherein the internal power supply is a DC power supply.

18. The scalp cooling system according to claim 17, wherein the DC power source is a battery.

19. The scalp cooling system according to claim 16, wherein the external power supply is an AC power supply.

20. The scalp cooling system according to claim 1, wherein the portable cooling unit circulates a cooling fluid through the heat exchanger at a temperature of approximately -10°C to approximately 5°C.

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