US-12622806-B2 - Wearable limb wraps for temperature-controlled therapy

US12622806B2US 12622806 B2US12622806 B2US 12622806B2US-12622806-B2

Abstract

A compression wrap and method for temperature-controlled application of pressure on an arm of a subject, comprising a fluid bladder comprising a first element comprising two or more first flaps; a second element comprising one or more digital 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 to the first element and the third element along a second edge.

Inventors

Raghav Sundar
Aishwarya BANDLA
Jonathan Rex BINDER
Patrick Burke
Ertu Unver

Assignees

NATIONAL UNIVERSITY HOSPITAL (SINGAPORE) PTE LTD
NATIONAL UNIVERSITY OF SINGAPORE
PAXMAN COOLERS LTD

Dates

Publication Date: 20260512
Application Date: 20211105
Priority Date: 20201105

Claims (18)

1 . A compression wrap for temperature-controlled application of pressure on an arm of a subject, the compression wrap comprising: a fluid bladder comprising: a first element comprising two or more first flaps; a second element comprising one or more digital flaps; 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 to the first element and the third element along a second edge; a fluid cavity configured to be deposed proximate to the arm; and an air cavity configured to compress the fluid cavity against the arm; wherein the liquid cavity comprises a liquid inlet and a liquid outlet, the liquid inlet disposed on a first flap or a second flap and away from the second element, the liquid cavity comprising a passageway that runs through the liquid cavity from the liquid inlet to the liquid outlet.
2 . The compression wrap of claim 1 , wherein the first element of the fluid bladder is configured to cover at least a first half of a circumference of the arm of a subject and the third element of the fluid bladder is configured to cover at least a second half of the circumference of the arm of a subject.
3 . The compression wrap of claim 1 , wherein each of the two or more second flaps corresponds to one of the two or more first flaps.
4 . The compression wrap of claim 1 , wherein each of the two or more second flaps is removably attached to a corresponding first flap.
5 . The compression wrap of claim 1 , wherein the two or more first flaps and the two or more second flaps extend perpendicularly from the first edge.
6 . The compression wrap of claim 1 , wherein the two or more first flaps are separated from each other with slits terminating within the first element.
7 . The compression wrap of claim 1 , wherein the two or more second flaps are separated from each other with slits terminating within the third element.
8 . The compression wrap of claim 1 , wherein the air cavity comprises between 0.25 and 2 attachment points per square inch.
9 . The compression wrap of claim 1 , wherein the air cavity comprises attachment points with a pitch ratio height of between 15 and 50 mm and a pitch ratio width of between 20 to 100 mm.
10 . The compression wrap of claim 1 , wherein the passageway runs along a perimeter of each of the two or more first flaps, the one or more digital flaps, and two or more second flaps.
11 . The compression wrap of claim 1 , wherein the liquid cavity comprises between 3 and 8 attachment points per square inch.
12 . The compression wrap of claim 1 , wherein the liquid cavity comprises attachment points with a pitch ratio height of between 5 and 40 mm and a pitch ratio width of between 5 and 40 mm.
13 . The compression wrap of claim 1 , wherein the liquid cavity comprises three or more liquid pockets.
14 . The compression wrap of claim 1 , further comprising a fabric layer positioned against the liquid cavity and an insulating layer positioned against the air cavity.
15 . A method of applying temperature-controlled pressure to an arm of a subject, the method comprising: providing a compression wrap, the compression wrap comprising: a fluid bladder comprising: a first element comprising two or more first flaps; a second element comprising one or more digital 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 to the first element and third element along a second edge; securing the compression wrap on the arm by attaching each of the two or more second flaps to a corresponding first flap; and injecting air and coolant into the fluid bladder; whereincoolant is injected into a liquid cavity of the fluid batter, the liquid cavity positioned against the subject, thenliquid cavity comprising a liquid inlet and a liquid outlet, the liquid inlet disposed on a first flap or second flap and away from the second element, the liquid cavity comprising a passageway that runs through the liquid cavity from the liquid inlet to the liquid outlet.
16 . The method of claim 15 , wherein air is injected into an air cavity of the fluid bladder, the air cavity positioned above the liquid cavity.
17 . The method of claim 16 , wherein air is injected into and released from the air cavity intermittently to provide cyclical pressure on the subject.
18 . The method of claim 15 , further comprising detaching and reattaching one of the two or more second flaps from the corresponding first flap to monitor the subject.

Description

TECHNICAL FIELD The present disclosure relates to the field of supportive care. In particular, the present disclosure relates to a compression wrap for providing heating or cooling to a limb. BACKGROUND Compression is the squeezing of a body part in a device, wrap or sleeve to apply pressure to the body part. Heating or cooling may sometimes be carried out simultaneously by circulating a temperature-controlled fluid within a bladder contained within the device, wrap or sleeve. For example, cooling may be simultaneously carried out to effect cryocompression, which is to simultaneously apply pressure to the body part while reducing the temperature of the body part. Cryocompression has uses in various fields, including the cosmetic and medical fields. For example, cryocompression may be used to prevent and/or treat chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a severe dose-limiting side-effect of several commonly used chemotherapeutic agents used in chemotherapy for cancer treatment. CIPN causes progressive and often irreversible pain/sensitivity in hands and feet and affects cancer survival rates as it may cause delay and discontinuation of chemotherapy. Overall, CIPN affects a significant number of cancer patients annually worldwide and contributes to long-term morbidity for cancer patients. CIPN also significantly increases economic burden, with healthcare costs estimated to be US$17,000 more in cancer patients with CIPN than those without CIPN. CIPN also causes patient work-loss, with a productivity loss of some 50 days with usual care. There is an unmet and increasing clinical need for systems, devices, and methods to prevent/treat CIPN in cancer patients receiving chemotherapy treatment. Available treatment methods for CIPN are limited to alleviating symptoms such as paraesthesia, dysesthesia, and pain. Although several methods involving pharmacological agents have been developed, such as supplementation with Vitamin E or omega-3, none have proven effective in large-scale clinical trials. Limb cooling during chemotherapy treatment has demonstrated a neuroprotective effect by preventing/reducing CIPN severity. Studies have shown that the extent of neuroprotection is dependent on the efficiency of limb hypothermia, i.e., the degree of cooling achieved. Reference is made to FIGS. 1A and 1B, which illustrate a subject receiving chemotherapy treatment with and without limb hypothermia respectively. A subject may receive chemotherapy through the introduction of neurotoxic chemotherapeutics 104, like Paclitaxel, into the arm. Systematic cancer treatment with neurotoxic chemotherapeutics has been shown to cause inflammation and nerve damage in, for example, the ulnar nerve 108. This nerve damage manifests as numbness and tingling sensation in the limbs such as hand 112 and is known as CIPN. Limb hypothermia 116 prevents CIPN by causing vasoconstriction of the cooled regions such as ulnar vein 120 and reduces exposure of the region to the chemotherapeutics by reducing blood flow to the region. Limb hypothermia also reduces inflammation in the subject. Among various cryotherapy modalities available for use, ice packs and commercially available gel packs are the most frequently used modalities. Due to risk of frost bite and subject intolerability of the temperature, studies have recommended intermittent cooling schedules of 30 minutes cooling coupled with 30 minutes of rewarming. However, such an intermittent routine might not be efficacious, or even worse, be counter-productive due to rebound blood flow. Furthermore, ice packs can cause extensive variations in temperature due to their phase change during melting. Gloves were previously used frozen to administer limb cryotherapy to cancer patients. However, these gloves were not operator-friendly, delivered unstable cooling and caused subject discomfort which limited the period of application of cryotherapy. These gloves were eventually withdrawn from the market due to incidences of frostbite. Existing apparatuses utilising continuous-controlled coolant flow use dated vapour compression technology, which is heavy and cumbersome, thus restricting subject-mobility and the environment of use, and consequently its range of applications. Although there are other methods for cooling, these have problems or restrictions associated. For example, cooling using the Peltier effect cannot achieve the required cooling rates whilst remaining portable. On the other hand, cooling using the Magnetocaloric effect is still at the research phase and is not yet market accessible. Other existing cooling solutions are either bulky, manpower intensive, energy inefficient, and do not cater for use in preventing CIPN in cancer patients. In particular, these cooling technologies do not have cooling accessories which are catered for use during chemotherapy administration, which requires the limb of the subject to be cannulated and monitored. There is therefore a need for accesso