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EP-4203873-B1 - PORTABLE LIMB COMPRESSION SYSTEM

EP4203873B1EP 4203873 B1EP4203873 B1EP 4203873B1EP-4203873-B1

Inventors

  • SUNDAR, Raghav
  • BANDLA, Aishwarya
  • PAXMAN, NEIL
  • PAXMAN, GLENN
  • MOSES, RODNEY

Dates

Publication Date
20260506
Application Date
20211105

Claims (10)

  1. A compression apparatus for applying pressure to a subject, the compression apparatus comprising: a compression system (200); and one or more compression components (304) connected to the compression system (200) and secured around the subject, the one or more compression components (304) comprising an air cavity and a liquid cavity; the compression system (200) comprising: an air circuit 300 configured to introduce and release air from the air cavity cyclically based on a predetermined compression time and a predetermined decompression time until an operator-set treatment duration is reached; a liquid circuit (400) comprising a liquid pump (402) connected to a tank (406) comprising coolant, the liquid pump (402) configured to supply the coolant to the liquid cavity by way of an output channel; and a refrigeration circuit (500) connected to the tank (406) and configured to cool the coolant within the tank (406); wherein the liquid circuit (400) further comprises an overflow channel (408) disposed between and in fluidic communication with the output channel and the tank (406), the overflow channel (408) configured to allow at least some of the coolant leaving the liquid pump (402) to return to the tank (406) without entering the liquid cavity.
  2. The compression apparatus of claim 1, wherein the predetermined compression time is between 30 and 50 seconds.
  3. The compression apparatus of claim 1, wherein the predetermined decompression time is between 10 and 30 seconds.
  4. The compression apparatus of claim 1, wherein the operator-set treatment duration is between 2 and 5 hours.
  5. The compression apparatus of claim 1, wherein the air circuit (300) comprises one or more air pumps (308), one or more solenoid valves (310), and one or more pressure switches (312).
  6. The compression apparatus of claim 5, wherein the one or more air pumps (308) is configured to introduce air into the air cavity and the one or more solenoid valves (310) is configured to release air from the air cavity.
  7. The compression apparatus of claim 5, wherein the one or more pressure switches (312) are configured to release air from the air cavity when the pressure within the air cavity exceeds a set pressure
  8. The compression apparatus of claim 1, wherein the liquid cavity is configured to be positioned between the air cavity and the subject when secured around the subject.
  9. The compression apparatus of claim 1, wherein the refrigeration circuit (500) is configured to cool the coolant to a temperature predetermined by an operator
  10. The compression apparatus of claim 1, wherein the refrigeration circuit (500) is configured to cool the coolant to a temperature of between 6°C and 24°C.

Description

TECHNICAL FIELD The present disclosure relates to the application of pressure and cooling in the field of supportive care. In particular, the present disclosure relates to a compression system which may include cooling for various purposes, including the prevention of chemotherapy-induced peripheral neuropathy. BACKGROUND Compression is the squeezing of a body part in a device, wrap or sleeve to apply pressure to the body part. Cooling is sometimes 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 and/or 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. Studies have also shown that a patient is able to tolerate lower temperatures for longer periods of time if compression is applied concurrently when cooling. 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 may not be efficacious or, even worse, may be counter-productive owing 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. 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. Other existing cooling solutions are either bulky, manpower intensive, energy inefficient, and do not cater for use in preventing CIPN in cancer patients. Existing cryotherapy/cooling apparatuses utilising continuous-controlled coolant flow use dated vapour compression technology, which is heavy/cumbersome, restricting patient-mobility, 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 market accessible. US 2014/316314 discloses an apparatus for intermittently and sequentially compressing a body site for site specific treatment to achieve a desired