Wearable limb wraps for temperature-controlled therapy

Abstract

This invention relates to a compression pack and method for applying temperature-controlled pressure to a subject's arm, comprising a fluid sac including: a first element comprising two or more first flaps; a second element comprising one or more thumb flaps; and a third element comprising two or more second flaps, wherein the first and third elements are connected along a first edge, and the second element is connected to the first and third elements along a second edge. In one embodiment, the fluid sac includes an air chamber and a liquid chamber.

Description

Technical Field

[0001] This disclosure relates to the field of supportive care. Specifically, this disclosure relates to a compression wrap for providing heating or cooling to a limb. Background Technology

[0002] Compression refers to applying pressure to a body part by squeezing it within a device, wrapping, or cannula. Heating or cooling can sometimes be achieved simultaneously by circulating a temperature-controlled fluid within a sac contained in the device, wrapping, or cannula. For example, cooling can be performed simultaneously to achieve cryocompression, which applies pressure to a body part while lowering its temperature. Cryocompression has applications in various fields, including cosmetic and medical. For instance, cryocompression can be used to prevent and / or treat chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a serious dose-limiting side effect of several commonly used chemotherapy agents in cancer treatment. CIPN causes progressive and often irreversible pain / sensitivity in the hands and feet and affects cancer survival because it can lead to delays and interruptions in chemotherapy. Overall, CIPN affects a large number of cancer patients worldwide each year and contributes to long-term morbidity in cancer patients. CIPN also significantly increases the economic burden; it is estimated that cancer patients with CIPN incur $17,000 more medical costs than those without CIPN. CIPN also leads to lost work time, with a productivity loss of approximately 50 days under normal care.

[0003] The clinical need for systems, devices, and methods for the prevention / treatment of CIPN in cancer patients undergoing chemotherapy is unmet and increasing. Available treatments for CIPN are limited to symptom relief, such as paresthesia, hypoesthesia, and pain. Although several methods involving pharmaceutical agents, such as vitamin E or omega-3 supplementation, have been developed, none have been proven effective in large-scale clinical trials.

[0004] Limb cooling during chemotherapy has been shown to have neuroprotective effects by preventing / reducing the severity of CIPN. Studies have shown that the degree of neuroprotection depends on the efficiency of limb hypothermia, i.e., the degree of cooling achieved.

[0005] refer to Figure 1A and Figure 1BThe illustrations depict subjects receiving chemotherapy with and without limb hypothermia. Subjects can receive chemotherapy by introducing a neurotoxic chemotherapy drug (such as paclitaxel) into the arm. Systemic treatment of cancer with neurotoxic chemotherapy drugs has been shown to cause inflammation and nerve damage, for example, in the ulnar nerve (108). This nerve damage manifests as numbness and tingling in limbs such as the hand (112), a condition known as CIPN. Limb hypothermia (116) prevents CIPN by causing vasoconstriction in cooled areas such as the ulnar vein (120) and by reducing blood flow to that area, thus reducing the contact of the chemotherapy drug with the area. Limb hypothermia also reduces inflammation in the subject.

[0006] Of the various cryotherapy methods available, ice packs and commercially available gel bags are the most commonly used. Due to the risk of frostbite and subjects' intolerance to temperature, studies have recommended intermittent cooling protocols combining 30-minute cooling followed by 30-minute rewarming. However, this intermittent routine may not be effective, or worse, may be counterproductive due to blood flow rebound. Furthermore, ice packs can cause significant temperature fluctuations due to the phase change during melting.

[0007] Previously, cryogloves were used for limb cryotherapy in cancer patients. However, these gloves were unfriendly to operators, provided unstable cooling, and caused discomfort to subjects, thus limiting the duration of cryotherapy. Due to the incidence of frostbite, these gloves were eventually withdrawn from the market.

[0008] Existing devices utilizing a continuous, controlled flow of coolant employ outdated vapor compression technology, which is heavy and cumbersome, thus limiting subject mobility and the environment in which it is used, thereby restricting its application. While other cooling methods exist, these methods also have associated problems or limitations. For example, cooling using the Peltier effect cannot achieve the required cooling rate while maintaining portability. On the other hand, cooling using the magnetocaloric effect remains in the research stage and has not yet entered the market.

[0009] Other existing cooling solutions are either bulky, labor-intensive, and energy-inefficient, and are unsuitable for preventing CIPN in cancer patients. In particular, these cooling technologies lack suitable cooling attachments for use during chemotherapy administration, which requires intubation and monitoring of the subject's limbs.

[0010] Therefore, there is a need for accessories specifically designed for cancer patients undergoing chemotherapy to make the possible, optimal, and effective administration of cryotherapy. Summary of the Invention

[0011] One general aspect includes a compression wrap for applying temperature-controlled pressure to a subject's arm. The compression wrap also includes a fluid bladder that may include: a first element comprising two or more first flaps; a second element comprising one or more thumb flaps; and a third element comprising two or more second flaps, wherein the first and third elements are connected along a first edge, and the second element is connected to the first and third elements along a second edge.

[0012] The implementation may include one or more of the following features: a compression package, wherein a first element of the fluid sac is configured to cover at least the anterior half of the circumference of the subject's arm, and a third element of the fluid sac is configured to cover at least the posterior half of the circumference of the subject's arm. Each of two or more second flaps corresponds to one of two or more first flaps. Each of two or more second flaps is removably attached to a corresponding first flap. The two or more first flaps and the two or more second flaps extend vertically from a first edge. The two or more first flaps are separated from each other by a slit terminating within the first element. The two or more second flaps are separated from each other by a slit terminating within the third element. The fluid sac may include an air cavity and a liquid cavity. The air cavity may include 0.25 to 2 attachment points per square inch. The air cavity may include attachment points with a pitch-to-height ratio between 15 and 50 mm and a pitch-to-width ratio between 20 and 100 mm. The liquid cavity may include a liquid inlet and a liquid outlet, and the liquid cavity may include a channel extending through the liquid cavity from the liquid inlet to the liquid outlet. The channel extends along the periphery of each of two or more first flaps, one or more thumb flaps, and two or more second flaps. The liquid inlet is positioned on a first or second flap remote from the second element. The liquid cavity may include 3 to 8 attachment points per square inch. The liquid cavity may include attachment points with a pitch-to-height ratio between 5 and 40 mm and a pitch-to-width ratio between 5 and 40 mm. The liquid cavity may include three or more liquid pouches. The compression packing may include a fabric layer positioned against the liquid cavity and an insulating layer positioned against the air cavity.

[0013] One general aspect includes a method of applying temperature-controlled pressure to a subject's arm. The method of applying temperature-controlled pressure also includes providing a compression package, which may include: a fluid sac that may include: a first element that may include two or more first flaps; a second element that may include one or more thumb flaps; and a third element that may include two or more second flaps, wherein the first and third elements are connected along a first edge, and the second element is connected to the first and third elements along a second edge. The pressure also includes securing the compression package to the arm by attaching each of the two or more second flaps to a corresponding first flap. The pressure also includes injecting air and coolant into the fluid sac.

[0014] The implementation may include one or more of the following features: A method in which coolant is injected into a liquid chamber of a fluidized bag positioned against a subject; air is injected into an air chamber of the fluidized bag positioned above the liquid chamber; air is intermittently injected into and released from the air chamber to provide cyclic pressure on the subject. The method may include detaching and reattaching one of two or more second flaps from a corresponding first flap to monitor the subject. Attached Figure Description

[0015] The features, aspects, and advantages of this disclosure will be better understood with reference to the following description and accompanying drawings, wherein:

[0016] Figure 1A and Figure 1B The illustrations show subjects receiving chemotherapy with and without limb hypothermia.

[0017] Figure 2 This is a schematic diagram of a fluid capsule according to an embodiment of the present disclosure;

[0018] Figure 3 This is a schematic diagram of the end of the slit of a fluid capsule according to an embodiment of the present disclosure;

[0019] Figure 4 This is a schematic diagram of the cross-section of the fluid bladder between the fabric layer and the insulating layer according to an embodiment of the present disclosure;

[0020] Figure 5A This is a schematic diagram of the liquid cavity of a fluid capsule according to an embodiment of the present disclosure;

[0021] Figure 5B This is a schematic diagram of the channel wall of the liquid chamber and the direction of liquid flow within the liquid chamber of the fluid capsule according to an embodiment of the present disclosure;

[0022] Figure 6AThis is a schematic diagram of the air cavity of a fluid capsule according to an embodiment of the present disclosure;

[0023] Figure 6B This is a schematic diagram of the cavity wall of the air chamber of the fluid capsule according to an embodiment of the present disclosure;

[0024] Figure 7A This is a schematic diagram of the density of attachment points on a liquid cavity according to an embodiment of the present disclosure;

[0025] Figure 7B This is a schematic diagram of the density of attachment points on an air cavity according to an embodiment of the present disclosure;

[0026] Figure 8 This is a schematic diagram of the first and second flaps of a fluid sac 200 wrapped around the forearm of a subject according to an embodiment of the present disclosure;

[0027] Figure 9A This is a schematic diagram of a cannula for inserting a fluid bladder according to an embodiment of the present disclosure. Figure 9B This is a schematic diagram of the cannula that is fixed around the subject's arm;

[0028] Figure 10A and Figure 10B This is a schematic diagram of a subject with a compression pack secured around both arms according to an embodiment of this disclosure; and

[0029] Figure 11A and Figure 11B This is a schematic diagram of a first alternative compression package according to an embodiment of the present disclosure;

[0030] Figure 12 This is a schematic diagram of a second alternative compression package according to an embodiment of the present disclosure.

[0031] Identical or repeated or equivalent or similar structures, elements or parts appearing in one or more figures are generally designated with the same reference numerals, optionally with additional one or more letters to distinguish similar entities or variations thereof, and must not be repeatedly designated and / or described. References to previously presented elements are implied and need not be further referenced to the figures or descriptions in which they appear. Detailed Implementation

[0032] In the following detailed description, numerous specific details are set forth to provide a thorough understanding of the invention. However, those skilled in the art will understand that the invention can be practiced without these specific details. In other instances, well-known methods, procedures, components, modules, units, and / or circuits have not been described in detail so as not to obscure the invention.

[0033] The dimensions of the components and features shown in the figures are chosen for convenience or clarity and are not necessarily shown to scale or from a true perspective. For convenience or clarity, some elements or structures are not shown or are shown only partially and / or from different perspectives or angles.

[0034] While embodiments of the invention are not limited in this respect, the term "multiple" as used herein may include, for example, "a plurality" or "two or more". The term "multiple" may be used throughout the specification to describe two or more components, devices, elements, units, parameters, etc. Unless explicitly stated otherwise, the method embodiments described herein are not limited to a particular order or sequence. Furthermore, some of the described method embodiments or elements thereof may occur or be performed simultaneously, at the same time, or concurrently. Unless otherwise stated, the use of the conjunction "or" herein should be understood as inclusive (any or all of the stated options).

[0035] Referring now to the accompanying drawings in detail, it is emphasized that the details shown are exemplary and intended to illustrate embodiments of the present disclosure. In this regard, the description taken in conjunction with the drawings will enable those skilled in the art to readily understand how embodiments of the present disclosure can be practiced.

[0036] Figure 2 This is a schematic diagram of a fluid sac 200 according to an embodiment of the present disclosure. The fluid sac 200 may be flexible and may be made of plastic or any non-porous material. In some embodiments, the fluid sac 200 may be designed to secure the arm of a subject 202. In some embodiments, the fluid sac 200 may be designed to secure the forearm of a subject 202, including the forearm, palm, and fingers. In some embodiments, the fluid sac 200 may include a first element 204 for covering at least the front half of the circumference of the arm, a second element 206 for covering the thumb or finger, and a third element 208 for covering at least the rear half of the circumference of the arm, each of elements 204, 206, and 208 being connected to the other two elements. In some embodiments, the first element 204 and the second element 206 may have the same length and may be longitudinally connected to each other at any distance along a first edge 207. In some embodiments, the first edge 207 may extend over the entire length of the first element 204 and the second element 206. In some embodiments, the first edge 207 may extend over a portion of the length of the first element 204 and the second element 206. In some embodiments, the third element 208 may be longitudinally connected to the width of the first element 204 and the second element 206 along the second edge 209. The first element 204, the second element 206, and the third element 208 may be joined or connected using any method, including mechanical fastening, adhesives, solvent bonding, and welding.

[0037] According to some embodiments of this disclosure, the first element 204 may include two or more first flaps 210 arranged parallel to a first edge 207, the two or more first flaps 210 extending vertically from the first edge 207. In some embodiments, the first flaps 210 may be separated from each other by a slit 211 terminating within the first element 204, such that each first flap 210 can be manipulated independently of the other first flaps 210. In some embodiments, the slit 211 may define a gap or distance between adjacent first flaps 210.

[0038] According to some embodiments of this disclosure, the third element 208 may include two or more second flaps 212 arranged parallel to a first edge 207, the two or more second flaps 212 extending vertically from the first edge 207. In some embodiments, the second flaps 212 may be separated from each other by a slit 211 terminating within the third element 208, such that each second flap 212 can be manipulated independently of the other second flaps 212. In some embodiments, the slit 211 may define a gap or distance between adjacent second flaps 212.

[0039] According to some embodiments of this disclosure, the number and position of the second flaps 212 may correspond to the number and position of the first flaps 210. In some embodiments, the first flaps 210 and the second flaps 212 may be positioned, arranged, and sized such that each first flap 210 wraps around at least the front half of the circumference of the subject 202's arm, and the corresponding second flap 212 wraps around at least the rear half of the circumference of the subject 202's arm and overlaps with the first flap 210 to be removably secured to the first flap 210. In some embodiments, each second flap 212 may be removably attached or secured to the corresponding first flap 210 by any securing mechanism, including the use of a sleeve 406 having a hook-and-loop material (also known as Velcro). The second flaps 212 and the first flaps 210 may have flat or angled ends. Those skilled in the art will understand that the ends of the second flaps 212 and the first flaps 210 may be flat or angled to accommodate the tapered shape of the subject 202's arm and ensure a close fit. Preferably, there are five or more first flaps 210 and five or more second flaps 212. In some embodiments, there may be three first flaps 210 and three second flaps 212 covering the forearm region of the subject 202. In some embodiments, there may be two first flaps 210 and two second flaps 212 covering the palm and finger region of the subject 202. In some embodiments, the first flaps 210 may have equal or different lengths. In some embodiments, the second flaps 212 may have equal or different lengths. Preferably, the lengths of the first flaps 210 and the second flaps 212 correspond to the regions of the arm around which they are designed to wrap. Preferably, the length ratio of the second flaps 212 to the first flaps 210 may be between 3:1 and 2:1. Preferably, the length of the first flap 210, designed to wrap around the forearm region of the subject 202, can be between 80 and 130 mm, and ideally between 110 and 125 mm, while the length of the second flap 212, designed to wrap around the forearm, can be between 200 and 330 mm, and ideally between 235 and 260 mm. Preferably, the first flap 210 can be designed to wrap around the palm and finger region of the subject 202, and can have a length between 70 and 110 mm, and ideally between 80 and 100 mm, while the second flap 212 can be designed to wrap around the palm and finger region of the subject 202, and can have a length between 150 and 280 mm, and ideally between 170 and 220 mm. Those skilled in the art will understand that the first flap 210 and the second flap 212 can have any length, as long as the first flap 210 and the second flap 212 can completely wrap around the circumference of the subject 202's arm when connected to each other.

[0040] According to some embodiments of this disclosure, the second element 206 may include one or more thumb flaps 214. In some embodiments, the one or more thumb flaps 214 may be configured to fold backward and cover the thumb or finger of the subject 202, as shown in shaded area 203, and subsequently covered by the first element 204 and the third element 208 when the fluid sac 200 is used. In other embodiments, the first element 204 and the third element 208 may first be secured around the patient's arm, and then the one or more thumb flaps 214 may fold backward over the thumb or finger of the subject 202 and be secured to the first element 204 or the third element 208. In some embodiments, the length of the thumb flap 214 may be between 90 and 200 mm, and preferably 110 mm, and the width may be between 60 and 120 mm, and preferably 90 mm. In some embodiments, there may be two thumb flaps 214, each thumb flap 214 connected to the first element 204 or the third element 208. In some embodiments, one or more thumb flaps 214 may further include skin temperature sensors (not shown) positioned such that they come into contact with the subject 202 during use. The skin temperature sensors may also be positioned anywhere on the fluid sac 200, as long as they come into contact with the skin of the subject 202 when the fluid sac 200 is used.

[0041] refer to Figure 3 This is a schematic diagram of the end of the slit 211 of the fluid bladder 200 according to an embodiment of the present disclosure. In some embodiments, the end of the slit 211 separating the first flap 210, the thumb flap 214, and the second flap 212 may include a crimp weld 302. In some embodiments, the crimp weld 302 may be circular. The crimp weld 302 located at the end of the slit 211 has the advantages of expanding under torsional forces when the fluid bladder 200 is wrapped around the arm of the subject 202, the bending margin helping to alleviate some of the resulting pressure when the flat fluid bladder 200 is filled and molded into a 3D object wrapped around the arm of the subject 202, and the end of the slit 211 being reinforced to prevent flap tearing and other damage.

[0042] According to some embodiments of this disclosure, the fluid bladder 200 may include a plurality of attachment points 304 along its surface, the attachment points 304 connecting to the layers or walls including the fluid bladder 200. In some embodiments, the attachment points 304 may be weld points, and the weld points may be circular in shape, but other shapes may also be used. In some embodiments, the attachment points 304 may be formed by spot welding or thermal melting of the layers or walls including the fluid bladder 200. The plurality of attachment points 304 serve to prevent the fluid bladder 200 from expanding under pressurized liquid and / or air, which could otherwise lead to rupture.

[0043] refer to Figure 4 This is a schematic cross-sectional view of the fluid bladder 200 between the fabric layer 408 and the insulating layer 410 according to an embodiment of the present disclosure. Preferably, the fabric layer 408 and the insulating layer 410 may contact the fluid bladder 200, but optionally, gaps 418 may be present between the fabric layer 408 and the fluid bladder 200 and between the insulating layer 410 and the fluid bladder 200. In some embodiments, the fluid bladder 200 may include three walls 416a, 416b, and 416c forming two cavities, wherein wall 416b serves as a common wall. In some embodiments, wall 416 may be a plastic sheet or a plastic layer. In some embodiments, the two cavities may be an air cavity 402 formed by walls 416a and 416b, and a liquid cavity 404 formed by walls 416b and 416c, such that the air cavity 402 and the liquid cavity 404 share wall 416b as a common wall. In some embodiments, the liquid cavity 404 may receive coolant, while the air cavity 402 may receive air. In some embodiments, the coolant may be an organic salt-based antifreeze with a pH buffer. In some embodiments, the coolant may be any desired temperature above or below the subject's body temperature. In some embodiments, when the fluid capsule 200 is used to cool the subject's limbs, the coolant may have any temperature between 6 and 24°C. Preferably, the coolant has a density of 1.0 to 1.5 kg*m³ at 20°C. 2 This allows for smooth inflow and outflow of the liquid cavity 404 during application of the fluid bladder 200. In some embodiments, the coolant may comprise potassium formate (CAS No.: 590-29-4) (20-40%), dipotassium phosphate (CAS No.: 7758-11-4) (0.5-5%), and deionized water (CAS No.: 7732-18-5) (50-70%). In some embodiments, when the fluid bladder 200 is secured around the arm of the subject 202, the liquid cavity 404 may be positioned close to the skin of the subject 202, while the air cavity 402 may be positioned above the liquid cavity 404 such that when air is pumped into the air cavity 402, the air cavity 402 expands and compresses the liquid cavity 404 inward onto the skin of the subject 202. This creates pressure on the arm of the subject 202, which has been shown to increase the subject's tolerance to low temperatures, enabling the subject to tolerate lower temperatures when compression or pressure is applied simultaneously during cooling.

[0044] According to some embodiments of this disclosure, the fluid bladder 200 can be inserted into a sleeve 406 comprising two layers (a fabric layer 408 and an insulating layer 410). In other embodiments, the fluid bladder 200 can be secured to the fabric layer 408 and the insulating layer 410. In some embodiments, the fabric layer 408 can be positioned near the fluid cavity 404 and can be made of any fabric that is biocompatible when in contact with the skin of the subject 202. In some embodiments, the insulating layer 410 can be positioned near the air cavity 402 and can comprise any insulating material. Preferably, the insulating layer 410 comprises neoprene 414 sandwiched between two linings 412.

[0045] refer to Figure 5A This is a schematic diagram of the liquid cavity 404 of the fluid capsule 200 according to an embodiment of the present disclosure. Figure 5B This is a schematic diagram of the channel wall 502 of the liquid cavity 404 of the fluid capsule 200 and the direction of the liquid flow 508 within the liquid cavity 404. According to some embodiments, the liquid cavity 404 of the fluid capsule 200 may include a single channel 502 passing through the liquid cavity 404 (see [link to documentation]). Figure 5B Channel 502 ensures a constant flow of coolant during operation to maintain constant heat exchange.

[0046] According to some embodiments of this disclosure, the liquid cavity 404 of the fluid capsule 200 may include a liquid inlet 504 for receiving coolant and a liquid outlet 506 for discharging coolant. The liquid inlet 504 defines the beginning of a channel 502, and the liquid outlet 506 defines the end of a channel 502, such that coolant received at the liquid inlet 504 flows through the channel 502 within the liquid cavity 404 of the fluid capsule 200 and exits the liquid cavity 404 at the liquid outlet 506. Preferably, coolant is introduced into the liquid inlet 504 at a flow rate between 25 and 45 ml / s, and ideally between 35 and 40 ml / s. In some embodiments, the first element 204, the second element 206, and the third element 208 may be fluidly connected to each other and may each define a portion of the channel 502. The liquid inlet 504 and the liquid outlet 506 may be located anywhere along the liquid cavity 404. In some embodiments, the liquid inlet 504 and liquid outlet 506 may be located at the first flap 210 or the second flap 212, away from the second element 206, to wrap around the forearm region near the elbow of the subject 202. In some embodiments, the liquid inlet 504 may be located at the first flap 210 or the second flap 212 to wrap around the forearm region near the elbow of the subject 202, and the liquid outlet 212 may be located on either the first flap 210 or the second flap 212. Preferably, the liquid inlet 504 and liquid outlet 506 are located at the first flap 210a to wrap around the forearm region near the elbow of the subject 202. In some embodiments, channel 502 may extend from liquid inlet 504 on first fin 210a of first element 204 through each second fin 212 of third element 208, thumb fin 214 of second element 206, and each first fin 210 of first element 204, and then exit through liquid outlet 506 on first fin 210a of first element 204. Preferably, the wall of channel 502 includes press-fit welds 302, wherein a single channel 502 extends from the front fin to the rear fin. Preferably, attachment points 304 are present throughout the cavity wall of a single channel 502 to prevent expansion of the liquid cavity 404 and the generation of turbulence, which has proven to increase liquid flow rate. Examples of coolant flow direction through channel 502 include... Figure 5BAs indicated by arrow 508, although other flow directions are also possible. Preferably, as the fluid sac 200 wraps around the arm of the subject 202, the coolant flow 508 within the channel 502 moves down the subject's arm from the region of the forearm closest to the elbow to the fingertips, and then back up the forearm of the subject 202. This design ensures that cooling is tiered from the highest point of the arm, where there is a larger surface area, thus providing more opportunities to extract heat. As the coolant absorbs heat as it moves toward the subject's hand, a significant amount of heat is removed, and the coolant temperature is slightly higher when it reaches the subject's palm and fingertips. Since the subject may initially experience cold intolerance in the fingers, the fluid sac 200 increases the subject's tolerance by not exposing the limbs to the lowest temperatures, and thus increases the duration of limb cooling.

[0047] According to some embodiments of this disclosure, the channel 502 within the liquid cavity 404 may have a constant parametric width and rounded corners to ensure optimal flow rate of the coolant within the liquid cavity 404 without clogging or cutting off the coolant at corners. In some embodiments, the channel 502 may extend along the periphery of each of the first fin 210, the thumb fin 214, and the second fin 212. Preferably, each of the first fin 210, the thumb fin 214, and the second fin 212 has a partition wall 510 to maximize the width of the channel 502 (see [link]). Figure 5A ).

[0048] refer to Figure 6A It is a schematic diagram of the air cavity 402 of the fluid capsule 200 according to an embodiment of the present disclosure, and Figure 6B This is a schematic diagram of the air cavity wall 602 of the air cavity 402 of the fluid capsule 200. In some embodiments, the air cavity 402 may be a single cavity, with the cavity wall 602 along the periphery of the fluid capsule 200, including a single air inlet 604 for air inflow and outflow. The air inlet 604 can be used to control the air pressure within the air cavity 402. In some embodiments, the air cavity 402 may include multiple separate cavities, each including the air inlet 604, thereby allowing pressure to be applied differently based on each region of the subject's arm. In some embodiments, air can be injected into the air cavity 402 through the air inlet 604 to inflate the air cavity 402 and apply pressure to the subject 202. In some embodiments, air can be released from the air cavity 402 through the air inlet 604 to deflate the air cavity 402 and release pressure on the subject 202. In some embodiments, air injection and release may be configured to apply a constant pressure to the subject 202. In some embodiments, air injection and release may be performed intermittently to apply cyclic pressure to the subject 202. Preferably, the pressure applied to the subject 202 is cyclical, running at intervals of 50 seconds of compression and 10 seconds of decompression.

[0049] Now for reference Figure 7A It is a schematic diagram of the density of the attachment points 304 on the liquid cavity 404 according to an embodiment of the present disclosure, and Figure 7B This is a schematic diagram illustrating the density of attachment points 304 on the air cavity 402. Attachment points 304 on the liquid cavity 404 may be formed between walls 416b and 416c of the liquid cavity 404, while attachment points 304 on the air cavity 402 may be formed between walls 416a and 416 of the air cavity 402. Preferably, the attachment points 304 are arranged in an interlaced grid pattern relative to one axis of the grid. Preferably, the diameter of the attachment points 304 is between 3 and 10 mm, and ideally 5 mm. In some embodiments, the air cavity 402 and the liquid cavity 404 may have attachment points 304 with different densities. Preferably, the liquid cavity 404 may have a high density of attachment points 304 to generate turbulence, which will increase the liquid flow rate. Preferably, the air cavity 402 may have a low density of attachment points 304 because turbulence is not required, and the attachment points 304 on the air cavity 402 are only for structural purposes to prevent the expansion of the air cavity 402. Preferably, the density of attachment points 304 on the air cavity 402 can be between 0.25 and 2 attachment points 304 per square inch, and preferably 0.5 attachment points 304 per square inch. Preferably, the pitch ratio height of the attachment points 304 on the air cavity 402 can be between 15 and 50 mm, and ideally 34 mm, while the pitch ratio width can be between 20 and 100 mm, and ideally 80 mm. Preferably, the density of attachment points 304 on the liquid cavity 404 can be between 3 and 8 attachment points 304 per square inch, and preferably 5 attachment points 304 per square inch. Preferably, the pitch ratio height of the attachment points 304 on the liquid cavity 404 can be between 5 and 40 mm, and ideally 10 mm, while the pitch ratio width can be between 5 and 40 mm, and ideally 20 mm.

[0050] Now for reference Figure 8This is a schematic diagram of the first flap 210 and the second flap 212 of a fluid sac 200 wrapped around the forearm of a subject 202 according to an embodiment of the present disclosure. The combination of multiple flaps (first flap 210 and second flap 212) along the fluid sac 200 allows for a universal fluid sac 200. Furthermore, if intubation is required while the fluid sac is wrapped around the forearm of the subject 202, or if contact between the subject 202's skin and another monitoring device is required, the operator can release the flaps at the desired intubation or monitoring device location to perform intubation or attach the monitoring device without interfering with the compression process. In some embodiments, intubation of a vein 802 can be achieved by releasing the flap located above the desired intubation location to access the vein 802. The flaps (first flap 210 and second flap 212) can also be released during limb cooling to allow intermittent monitoring of the subject with minimal exposure and heat loss or heat increment during limb cooling.

[0051] Figure 9A This is a schematic diagram of a cannula 406 for inserting a fluid capsule 200 according to an embodiment of the present disclosure. Figure 9B This is a schematic diagram of the upper portion of the cannula 406 after it has been secured around the arm of the subject 202. The shape of the cannula 406 may resemble that of the fluid bladder 200, including a first element 1004 having a first flap 1010, a second element 1006 having a thumb flap 1014, and a third element 1008 having a second flap 1012. The fluid bladder 200 may be inserted into the cannula 406, wherein the second flap 212 of the fluid bladder 200 is inserted into the second flap 1012 of the cannula 406, the first flap 210 of the fluid bladder 200 is inserted into the first flap 1010 of the cannula 406, and the thumb flap 214 of the fluid bladder 200 is inserted into the thumb flap 1014 of the cannula 406. In some embodiments, each second flap 1012 of the sleeve 406 may be wrapped around the arm of the subject 202 and secured to the corresponding first flap 1010 of the sleeve 406 by any reversible fastening mechanism, including a hook-and-loop material 1016 commonly referred to as Velcro. The thumb flap 1014 of the sleeve 406 may then be folded and secured to either the second flap 1012 or the first flap 1010 covering the fingers of the subject 202. In other embodiments, the thumb flap 1014 may be folded over the fingers of the subject 202 before the second flap 1012 is folded over and secured to the corresponding first flap 1010.

[0052] Figure 10A and Figure 10BThis is a schematic diagram of a subject 202 having a cryogenic compression package 1110 fixed around both arms according to an embodiment of the present disclosure. The cryogenic compression package 1110 may include a fluid bladder 200 within a sleeve 406. Alternatively, the cryogenic compression package 1110 may include a fluid bladder 200 fixed between an insulating layer 410 and a fabric layer 408. In some embodiments, the cryogenic compression package 1110 may be connected to a cryogenic compression device 1112 via a liquid inlet 504, a liquid outlet 506, and an air inlet 604. The cryogenic compression device 1112 supplies coolant to the liquid chamber 404 of the fluid bladder 200 and controls the air pressure in the air chamber 402 of the fluid bladder 200. In some embodiments, one or more cryogenic compression packages 1110 may be connected to and controlled by the cryogenic compression device 1112. Preferably, two cryogenic compression packages 1110 are connected and controlled by the cryogenic compression device 1112. In some embodiments, the second flap 1012, located above the dorsal vein or metacarpal dorsal vein, can remain open for cannulation and monitoring without exposing too much skin or interfering with limb cooling of other areas of the patient's limb (see [link to relevant documentation]). Figure 10B ).

[0053] Figure 11A and Figure 11BThis is a schematic diagram of a first alternative compression wrap 1200 according to an embodiment of the present disclosure. Similar to the fluid bag 200 and the cannula 406, the compression wrap 1200 includes a first element 1204 for covering at least the front half of the circumference of the subject 202's arm, a second element 1206 for covering the fingers, and a third element 1208 for covering at least the rear half of the circumference of the subject 202's arm, each of elements 1204, 1206, and 1208 being connected to the other two elements. In some embodiments, the first element 1204 may include three first flaps 1210 covering the subject 202's arm: a first flap 1210a covering the fingertips, a first flap 1210b covering the palm, and a first flap 1210c covering the forearm. In some embodiments, the second element 1206 may include a single thumb flap 1214 to wrap around the fingers. In some embodiments, the third element 1208 may include three second flaps 1212: a second flap 1212a covering the fingertips, a second flap 1212b covering the palm, and a second flap 1212c covering the forearm. In some embodiments, the liquid cavity 1404 of the compression pack 1200 may include three or more liquid packs 1416 to receive coolant. In some embodiments, the liquid cavity 1404 may include a first liquid pack 1416a covering the forearm region, a second liquid pack 1416b covering the palm region, and a third liquid pack 1416c covering the finger regions. In some embodiments, the three or more liquid packs 1416 may be fluidly separated from each other, with separate coolant inlet and outlet pipes connected to each liquid pack 1416.

[0054] According to some embodiments of this disclosure, the first alternative compression wrap 1200 may further include one or more temperature sensors 1218 to monitor the skin temperature of the subject 202 during limb hypothermia. The first flap 1210 and the second flap 1212 may be secured together using a loop material 1220 commonly referred to as Velcro. In some embodiments, the first flap 1210 and the second flap 1212 may include openings 1224 for observation and / or intubation, such as when the compression wrap 1200 is secured around the arm of the subject 202. Figure 11B As shown.

[0055] Figure 12This is a schematic diagram of a second alternative compression pack 1200' according to an embodiment of the present disclosure. The second alternative compression pack 1200' is similar to the first alternative compression pack 1200, except that three or more liquid packs 1416' are fluidly connected. In some embodiments, a bottleneck design may be used to fluidly connect three or more liquid packs 1416' to each other to reduce flow rate and incrementally regulate temperature by different sections configured to cover different areas of the subject 202's arm. Coolant may first be introduced into the first liquid pack 1416a' covering the forearm area through liquid inlet 1504. The coolant may then be split into two streams: a first stream 1510 flows into the second liquid pack 1416b' covering the palm area, and a second stream 1514 flows into outlet pipe 1222 and exits the compression pack 1200' through liquid outlet 1506. In some embodiments, approximately 75% of the total coolant volume of the introduced liquid cryogenic package 1200 flows through the first stream 1510 into the second liquid package 1416b' covering the palm area, and the remaining 25% flows through the liquid outlet 1506 into the outlet pipe 1222 and out of the compressed package 1200'.

[0056] According to some embodiments of this disclosure, the coolant flowing into the liquid package 1416b' covering the palm area can then be further divided into two streams: a third stream 1518 flowing into the third liquid package 1416c' covering the finger area, and a fourth stream 1522 flowing out of the compressed package 1200' through the liquid outlet 1506 into the outlet pipe 1222. In some exemplary embodiments, approximately 50% of the total coolant volume introduced into the liquid cryogenic package 1200' flows into the third liquid package 1416c' covering the finger area. In some embodiments, all the coolant entering the third liquid package 1416c' covering the finger area can then flow into the outlet pipe 1222 through the fifth stream 1526 and out of the compressed package 1200' through the liquid outlet 1506. This significantly reduces the number of inlet and outlet pipes connected to the second alternative compressed package 1200' compared to the first alternative compressed package 1200. In some other alternative embodiments, the total coolant volume introduced into the second liquid package 1416b and the third liquid package 1416c may be further reduced to about 40% and about 20%, respectively. In still other alternative embodiments, the total coolant volume introduced into the second liquid package 1416b and the third liquid package 1416c may be further reduced to about 30% and about 10%, respectively.

[0057] This document discloses different embodiments. Features of certain embodiments may be combined with features of other embodiments; thus, some embodiments may be combinations of features of multiple embodiments. For purposes of illustration and description, the above description of embodiments of the invention has been given. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Those skilled in the art will understand that many modifications, variations, substitutions, alterations, and equivalents are possible in accordance with the above teachings. Therefore, it should be understood that the appended claims are intended to cover all such modifications and alterations falling within the true spirit of the invention.

[0058] While certain features of the invention have been described and illustrated herein, many modifications, substitutions, alterations, and equivalents will now occur to those skilled in the art. Therefore, it should be understood that the appended claims are intended to cover all such modifications and alterations falling within the true spirit of the invention.

Claims

1. A compression pack for applying pressure to a subject's arm under controlled temperature conditions, said compression pack comprising: Fluid capsule, the fluid capsule comprising: A first element, comprising two or more first flaps; The second element includes one or more thumb flaps; and A third element comprising two or more second flaps, wherein the first element and the third element are connected along a first edge, and the second element is connected along a second edge to the first element and the third element; A liquid chamber, the liquid chamber being configured to be placed close to the arm; and An air chamber configured to compress the liquid chamber onto the arm; The liquid cavity includes a liquid inlet and a liquid outlet, the liquid inlet being located on a first or second wing remote from the second element, the liquid cavity including a channel extending through the liquid cavity from the liquid inlet to the liquid outlet; the channel having a first surface area and a second surface area, the first surface area covering the region from the liquid inlet to the second element, and the second surface area covering the region after the third element to the liquid outlet; The first surface area is larger than the second surface area.

2. The compression pack of claim 1, wherein the first element of the fluid sac is configured to cover at least the front half of the circumference of the subject's arm, and the third element of the fluid sac is configured to cover at least the rear half of the circumference of the subject's arm.

3. The compression package according to claim 1, wherein each of the two or more second flaps corresponds to one of the two or more first flaps.

4. The compression package of claim 1, wherein each of the two or more second flaps is removably attached to a corresponding first flap.

5. The compression package of claim 1, wherein the two or more first flaps and the two or more second flaps extend vertically from the first edge.

6. The compression package of claim 1, wherein the two or more first flaps are separated from each other by a slit terminating within the first element.

7. The compression package of claim 1, wherein the two or more second flaps are separated from each other by a slit terminating in the third element.

8. The compressed package according to claim 1, wherein the density of attachment points on the air cavity is 0.25 to 2 per square inch.

9. The compressed package of claim 1, wherein the air cavity includes an attachment point with a pitch-to-height ratio between 15 and 50 mm and a pitch-to-width ratio between 20 and 100 mm.

10. The compression package of claim 1, wherein the channel extends along the periphery of each of the two or more first flaps, the one or more thumb flaps, and the two or more second flaps.

11. The compression package of claim 1, wherein the liquid cavity comprises 3 to 8 attachment points per square inch.

12. The compression package of claim 1, wherein the liquid cavity includes attachment points with a pitch-to-height ratio between 5 and 40 mm and a pitch-to-width ratio between 5 and 40 mm.

13. The compressed package of claim 1, wherein the liquid cavity comprises three or more liquid bags.

14. The compression package according to claim 1, further comprising a fabric layer positioned against the liquid cavity and an insulating layer positioned against the air cavity.

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