Design of an Innovative Medical Device to Improve Quality of Life in

Lymphedema Patients

Katherine Wang

and Angeliki Kopsini

Department of Mechanical Engineering, University College London, Torrington Place, London WC1E 7JE, U.K.

Medical and Scientific Affairs and Healthcare Development Department, Roche Diagnostics Hellas, Athens, Greece

Keywords: Lymphedema, Medical Device, Breast Cancer, Rehabilitation.

Abstract: Lymphedema is a disease that is a common side effect of breast cancer, affecting up to 70% of breast cancer

patients. Currently there is no known curative treatment; management of the disease is based on symptomatic

therapy such as Complete Decongestive Therapy (CDT). Current devices and compression garments used in

CDT are often heavy and cause discomfort and bacterial infections due to poor skin care. Along with the long-

term physical problems, it also causes serious psychological and social problems for patients, affecting their

quality of life significantly. There is an urgent need for innovative approaches for the treatment of lymphedema.

In this paper we propose a novel solution in the form of a light portable pneumatic device “Lymphmotion”, along

with a complimentary compression garment designed to reduce bacterial infection to address this problem.

1 INTRODUCTION

Lymphedema is a disease caused by the inability of

the lymphatic system to transport lymph fluid out of

the affected area, causing accumulation of fluid in

interstitial tissues that results in swelling of the

affected area (Taghian et al., 2014). Breast Cancer

Related Lymphedema (BCRL) is a common side

effect of breast cancer treatment, affecting up to 70%

of breast cancer patients. The number of individuals

coping with this disease continues to increase,

estimated to affect more than 120 million individuals

worldwide (International Lymphedema Framework,

ILF).

It is a leading cause of disability worldwide, yet it

remains underdiagnosed, under-researched, and

underfunded in most health systems (Douglass and

Kelly-Hope, 2019; Keast et al., 2015). The disparity

between diagnosis, treatment and funding could be

due to a lack of public awareness of the condition,

insufficient education and knowledge on

management, and limited financial coverage to

support appropriate methods and materials. It is

suggested that lymphedema may be a common and

under-reported morbidity.

https://orcid.org/0000-0002-6900-3213

htps://orcid.org/0000-0003-2310-2117

Lymphedema patients have chronic, progressive

swelling, recurrent infections, and significantly

decreased quality of life that affects both physical and

psychological aspects of a patient’s life. The

progressive nature means that the swelling can lead to

disfigurement, disability, decreased limb strength,

mobility, pain, heaviness, and in some cases even

death (Cemal et al., 2011; Keast et al., 2015; Taghian

et al., 2014). Anxiety and frustration are well

documented in patients with secondary lymphedema

(Hayes et al., 2009). Reduced productivity of the

patient, and higher cost of treatment is also a

significant socioeconomic burden; treatment cost of

breast cancer survivors with lymphedema

demonstrated a $10,000 increase in annual treatment

costs compared breast cancer survivors without

(Brahma and Yamamoto, 2019; Cemal et al., 2011;

Shih et al., 2009).

Treatment of lymphedema is largely palliative,

with no cure. The gold standard is Complete

Decongestive Therapy (CDT), a treatment programme

that includes pneumatic devices. Currently there is no

portable pneumatic device for the treatment of

lymphedema, and both researchers and physicians

agree that there is an urgent

need for innovative

Wang, K. and Kopsini, A.

Design of an Innovative Medical Device to Improve Quality of Life in Lymphedema Patients.

DOI: 10.5220/0009369703230328

In Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2020) - Volume 1: BIODEVICES, pages 323-328

ISBN: 978-989-758-398-8; ISSN: 2184-4305

323

approaches in the treatment of lymphedema.

In this paper, we will give a brief review into the

current state of the art treatment and market overview

for lymphedema, and the patient perspective. We will

also introduce a solution to the current issues with

treatment patients face, in the form of a lightweight

portable pneumatic compression device and garment

named ‘Lymphmotion’.

2 STATE OF THE

ARTTREATMENT AND

PATIENT PERSPECTIVES

2.1 State of the Art

Non-invasive Treatments: First line treatment for

lymphedema, involves two phases: the reduction

therapy and the maintenance therapy. The first one

involves Complete Decongestive Therapy (CDT)

which is administered by a certified lymphedema

therapist, whose goal is to decrease symptoms and

limb volume. It is individualized for each patient, but

it typically includes Manual Lymphatic Drainage

(MLD), aerobic exercise, skin care, patient education

and compression strategies; such as using an

advanced decongestive pump and compression

garments.

Pneumatic devices used in CDT are often heavy

and can cause discomfort to the patient; who has to use

the devices at least twice per week for 50 minutes per

session (Kayõran et al., 2017). Once minimized limb

volume is achieved with CDT, after several weeks,

maintenance therapy begins. This may include self or

caregiver-administered MLD, compression garments,

exercise, wound prevention, and skin care. (Gillespie,

2018, Shaitelman, 2015)

While non-invasive treatment remains the

standard of care for BCRL, surgical management is

another avenue to treat persistent lymphedema,

particularly for patients who do not respond to non-

invasive treatments. Lymph Venous anastomosis

(LVA) is one such method but they are out of scope

of this paper.

2.2 Clinical Motivation: The Patient

Perspective

Aside from the long-term physical problems,

lymphedema also causes serious psychological and

social problems for patients. Affected women may

have decreased self-confidence resulting from a

distorted body image and negative emotions are often

reported including anxiety, frustration, sadness, anger,

fear, and increased self-consciousness (Taghian,

2014). As a result, in the last decade there is an

increased focus on the quality of life (QoL) and Patient

Reported Outcome Measures (PROMs). Most of the

Arm Symptom-Specific Questions in Questionnaires

on Quality Of Life as well as the ICHOM Breast

Cancer Reference guide refer pain, heaviness,

swelling/ tightness, loss of strength,

tingle/burning/pins and skin problems, elevation of

the arm and movement difficulties and the ability of

wearing clothes of choice as major everyday problems

(Cornelissen, 2018 and ICHOM Breast Cancer Data

Collection Reference Guide, 2017)

The necessity to wear compression sleeves are

viewed as barriers to daily life and the current

products are described as “terrible daily armour", one

sized, uncomfortable, tight, affecting clothes wearing

and patients’ discomfort is described by adjectives

such as “aching,” “heaviness,” and “pulling” (Hayes

et al., 2009, O'Toole, 2013). Numbness, dehydration

with chapping or sweating with itching, and risk of

bacterial or fungal infection are the most frequently

mentioned problems concerning the skin because of

the absence of pH-neutral moisturizer and

antibacterial layer in existent devices (Buragadda,

2015).

We had the chance to work closely with a 24-year-

old cancer survivor, who is a representative of the

Young Cancer Patient Association Sweden (Ung

Cancer). The association was founded in 2010 and

supports young cancer patients and survivors, aged

between 16-30 years old, as well as young people who

have a relative suffering or has died from cancer.

Through several discussions and a presentation by

patient representative, we were able to better

understand some everyday challenges that the young

cancer patients are facing. Given the relationship that

we had developed and our interest in the patients’

perspective we kindly asked the representative to

conduct a small research through the association

concerning breast cancer survivors who are suffering

from lymphedema. The research included two

questions: ‘’Describe your feelings and challenges

living with lymphedema’’ and “Would you use the

device we have designed’’.

Responses received from the community to the

first question were all arguing with the findings from

the literature while answers concerning our solution,

were all positive. Participants highlighted the need for

something innovative.

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2.3 Lymphedema Market Overview

and Economic Burden

According to the first overview of reported direct and

indirect patient-borne as well as society-borne costs

specifically associated with the treatment of BCRL in

literature; BCRL imposes a substantial economic

burden which is often neglected. Direct costs include

medical and therapeutic consultations, compression

garments, medications etc., while indirect costs refer

to productivity losses, values of lost income, unpaid

help and lost unpaid work. Mean direct costs per year

borne by patients ranged between USD$2306 and

USD$2574. Indirect costs borne by patients ranged

between USD$3325 and USD$5545 per year. Mean

direct treatment costs after 1 year of CDT ranged

between

€799 (= USD$1126.60) and USD$3165 (De

Vrieze, 2019). This amount of money mainly depicts

what is happening outside the EU and it is difficult to

be transferred. However, it remains a strong evidence

of BCRL economic burden. Therefore, we need more

high-quality, standardized health economic analyses

in order to have a clear view of the EU landscape and

push to acquire reimbursement.

There is only 1 industrial company per 10 million

that is dedicated to lymphedema products in Europe

and developing countries are virtually depleted of

industrial companies in this field (Schulze, 2018). At

the same time Alibaba.com offers 3390 lymphatic

drainage air pressure machine products.

We have conducted a small market research to

identify some of our direct competitors. FlexiTouch,

4 Chamber Arm Garment and LymphaPress have

been identified as the major ones. FlexiTouch, Tactile

System Technology, Minneapolis (USA,North

America), has an FDA approval and numerous

garment and program options but needs a continuous

connection to a large external device, it has a non-

ergonomic size and non-thermoregulated garment

and it costs around 1000€. 4 Chamber Arm Garment,

BioCompression Systems, NewJersey (USA,North

America), has similar advantages with FlexiTouch.

However, the cost varies between 914-3.450€ while

the external device has an outdated design, the

garment is made of an uncomfortable material and

there is an unreliable cable connection. Finally,

MegoAFEK Ltd., Afek (Israel, Middle East) is the

world’s leading innovator in pneumatic compression

therapy. LymphaPress is considered the leader in

lymphedema and venous insufficiency treatment and

it has strong clinical evidence with peer-reviewed

publications. Although it has proven positive results

its use is limited because of the large in size garment,

its heavy weight, lots of wire connection cables and

lack of patients’ mobility.

After listening carefully patients’ needs and

taking in mind the current market solutions, we have

concluded that we need a solution that is more

compact and non-dependent to external devices in

order to reduce fatigue, increase independence and

self-confidence.

3 PROPOSAL OF AN

INNOVATIVE PRODUCT

3.1 Specifications for Solution

Our solution consists of a device called

‘LymphMotion’ which comprises of two factors that

can be used in conjunction:

A portable pneumatic compression device (PCD)

in the form of a sleeve, ‘LymphMotion’ which the

patient can use at home in place of going into a

specialized clinic for pneumatic compression

(Pressure therapy) or a therapist for manual lymphatic

drainage (MLD). The PCD sleeve provides a gentle

massage movement to facilitate lymph fluid away

from the affected limb.

A complimentary compression garment that is

infused with microencapsulated aloe vera and

antimicrobial nanoparticles, in order to reduce

dryness and prevent bacterial or fungal infection. The

compression garment is to be used daily while the

patient is awake and during exercise.

During the conception-development procedure of

LymphMotion we kept in mind the IEC 62366 MD-

Application of usability engineering to medical

devices.

Intended Use: Alleviation of lymphedema in breast

cancer survivors who have undergone mastectomy,

and prevention of the disease to progress to more

serious stages or develop more serious complications

such as infections or cancer.

Intended User: Breast cancer survivors, who have

undergone mastectomy (ages 30-80).

User Environment: At home during the day and

during exercise.

3.2 Description of LymphMotion

The portable pneumatic compression device (PCD),

LymphMotion consists of a sleeve that is worn over the

affected limb (such as the arm) that includes a network

of 3D printed pockets designated in zones that can

inflate and deflate via air pressure. The network of

pockets acts as individual massage actuators. One-

Design of an Innovative Medical Device to Improve Quality of Life in Lymphedema Patients

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way air pumps and air valves which controls air flow

into the next zone of the sleeve in a controlled manner

using a microprocessor, in the direction of lymphatic

drainage. Air flow enters from the most distal point of

the limb away from the body (e.g. wrist on the arm)

and is released at the end of the sleeve closest to the

body – this direction ensures that the lymph fluid is

being drained away from the limb into the blood

circulatory system and to be eliminated via natural

processes (i.e. urination). A schematic of this can be

found in Figure 1. The device would be made in

different sizes to accommodate the patient.

Silicone can be used to make the pocket as it is a

low-cost, soft, durable material with a high elastic

modulus and power to weight ratio. They make safe

actuators for direct human interaction owed to their

lightweight and lack of rigid parts (Al-Fahaam et al.,

2018). This network of silicone pockets can be

manufactured using 3D printing methods. One such

method is a technique called Rapid Liquid Printing

(RLP) (Hajash et al., 2017; Papadopoulou et al.,

2017).

A piezoelectric pressure sensor that provides a

feedback loop to the microprocessor is used to ensure

the correct amount of pressure (mmHg) – depending

on which stage of lymphedema the patient is at, is

used during the massage on the patient, preventing

insufficient or dangerous levels of applied pressure

(Elwenspoek and Wiegerink, 2001; Meyer et al.,

2006). Gyroscope sensors are used to detect whether

the movement of the device is due to patient

movement or device inflation; this allows the user to

move while wearing the device while not

compromising on applied pressure; making the

device portable. The device can be powered by

rechargeable Lithium ion (Li-ion) batteries, with a

lifetime of 2000 cycles – enough cycles to last

approximately 5.5 years (Coyle et al., 2010;

Gorlatova et al., 2014).

3.3 Description of Compression

Garment

Compression garments are used by patients daily

from the first moment they wake up, for the duration

of the day, and during exercise. A common

complication of constantly wearing compression

garments is risk of bacterial and fungal infection that

results in dermatitis, or if there is a wound in the skin,

wound infections. Another issue is that compressive

garments can be uncomfortable and result in dry,

itchy, cracking skin (Lim and Davies, 2014; Vignes

and Arrault, 2009; Xiong and Tao, 2018). The

LymphMotion compression garment aims to reduce

these issues with current compressive garments in the

market.

The complimentary LymphMotion compression

garment (CG) addresses these two problems by

incorporating Anti-bacterial nanoparticles (ABNPs)

and encapsulated aloe vera into the fabric of the

compression garment. ABNPs exhibit antibacterial

and anti-inflammatory effects that can significantly

inhibit bacterial growth and reproduction. The

integration of NPs in the fabric can reduce the risk of

wound infection or accelerate wound healing should

the skin be injured. Combinations of nanosilver,

chitosan (CS), tungsten, and copper have been used in

production of textiles that is antibacterial. Fibre

fabrication methods such pressurized gyration

(Illangakoon et al., 2017; Wang et al., 2017) can be

used to create such fibres. Aloe Vera (AV) is

stabilized and encapsulated by immersing the fabric

into an AV micro-emulsion and inducing ultrasonic

waves to encapsulate and load the AV extract onto the

fabric (Ghayempour, Montazer and Mahmoudi Rad,

2016).

3.4 Regulatory Aspects

Lymph Motion is an active, non-invasive, non-

Figure 1: Schematic of the proposed pneumatic compression device LymphMotion and how it works.

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implantable Medical Device (MD) that complies with

the EC Regulation 2017/745/EU of May 5, 2017 on

Medical Devices. According to Article 52, Section 6

and Annex VIII, Rule 9, Section 6.1 of the MDR

2017/745/EU the above-mentioned MD is considered

as Class IIa MD.

As our product includes software that collects

patients’ pressure data, we need to comply with the

GDPR (General Data Protection Regulation) EU

2016/679. In collaboration with a DPO (Data

Protection Officer) we will take action to reduce data

volume collected, the recipients of these data and

especially for the clinical studies part, reduce the

duration of the process. We will also need to comply

with ISO/IEC 27032:2012 Guidelines for

cybersecurity.

4 CONCLUSIONS

Lymphedema continues to be clinically and

economically underestimated. The current available

treatment is insufficient, and data on the improvement

of patients’ quality of life is missing if not negative.

The burden is physical, social and psychological and it

is these dimensions that our solution tries to cover.

To bring our idea further, we will need funding to

create a prototype. In addition, according to the MDR

2017/745/EU and the new requirements on the Clinical

Evaluation of a Medical Device, in order to

demonstrate safety and performance requirements of

the device when used in accordance with the intended

purpose provided by the manufacturer, we will need to

proceed with biocompatibility and usability studies and

if the results are positive we should continue with a

Clinical Investigation. Further issues that would need

to be addressed would be the challenge of developing

Lymphmotion on an industrial scale. A business model

canvas is under development. Further options are under

consideration.

ACKNOWLEDGEMENTS

We would like to extend our thanks to Dr. Maria

Hagglund for hosting the immersive experience at

Uppsala University Hospital as well as the cancer

specialists for their invaluable knowledge. We thank

Emilya Bislimova, and the Young Cancer Patient

Association Sweden for their patient perspectives. We

also thank our teammates at the 2019 EIT Clinmed

Summer School Tiberiu Niță Mihai and Marta Tallon.

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