Device to Aid Early Detection Breast Cancer

Page 1



Smallest structural and functional unit of an organism

Cells grow and divide to make new cells as the body needs them.

Cells die when they get too old or damaged.

New cells take their place.


Normal Cells

Cancer Cells

Cancer begins when genetic changes interfere with this orderly process.

Cells start to grow uncontrollably.

These cells may form a mass called a tumor. A tumor can be malignant or benign.

Malignant, meaning it can grow and spread to other parts of the body.

A benign tumor means the tumor can grow but will not spread.

Cancer cells Growing through normal tissue


(Broadly Classified)

• Carcinomas A carcinoma begins in the skin or the tissue that covers the surface of internal organs and glands. •

Sarcomas

A sarcoma begins in the tissues that support and connect the body. •

Leukemia

Leukemia is a cancer of the blood. •

Lymphomas

Lymphoma is a cancer that begins in the lymphatic system.


•

Breast cancer is the most commonly occurring cancer in women and the second most common cancer overall. There were over 2 million new cases in 2018.

PERCENTAGE

•

AGE (YEARS)

http://www.breastcancerindia.net/statistics/trends.html


Most 'symptomatic' cancers are stage 2B and beyond (significant numbers in stages 3 and 4) In the West, majority of breast cancers (read more than 75%) present in stages 1 and 2, resulting in good survival; and there is an ever increasing numbers of patients presenting with mammography detected cancer, with no symptoms India needs to reach this achievement, and it is only with aggressive promotion of screening and awareness and proper treatment that India will achieve this; and will take at least a few decades to reproduce similar results.


Breast cancers can start from different parts of the breast.

Most breast cancers begin in the ducts that carry milk to the nipple (ductal cancers).

Some start in the glands that make breast milk (lobular cancers).


The cancer can be classified according to the site and the extent of its spread and the site or origin: • Invasive breast cancer • Invasive lobular breast cancer

• Triple negative breast cancer • Ductal carcinoma in Situ (DCIS) • Lobular carcinoma in Situ (LCIS) • Male breast cancer

Ductal carcinoma in Situ

Lobular carcinoma in Situ



• • •

– Low-dose x-ray that allows doctors called radiologists to look for changes in breast tissue. Drawbacks: Expose the breasts to small amounts of radiation. The benefits outweigh any possible harm from the radiation exposure. Compression of the breasts causes discomfort and can also be painful for some women.

https://www.cancer.org/cancer/breast-cancer/screening-tests-and-early-detection/mammograms/mammogram-basics.html


Breast ultrasound uses sound waves to make a computer picture of the inside of the breast. Ultrasound is widely available, easy to have, and does not expose a person to radiation. It also costs less than a lot of other options.

Breast MRI is often used in women who already have been diagnosed with breast cancer, to help measure the size of the cancer, look for other tumors in the breast, and to check for tumors in the opposite breast.

https://www.cancer.org/cancer/breast-cancer/screening-tests-and-early-detection/mammograms/mammogram-basics.html


Done by a physician

Done by women themselves

https://www.pinkcaravan.ae/images/bse_women_1.jpg


During a biopsy, a doctor will remove cells from the suspicious area so they can be looked at in the lab to see if cancer cells are present.

https://www.cancer.org/cancer/breast-cancer/screening-tests-and-early-detection.html


• Optical imaging tests • Molecular breast imaging (MBI) • Positron Emission Mammography (PEM) • Electrical impedance imaging (EIT) • Elastography

https://www.cancer.org/cancer/breast-cancer/screening-tests-and-early-detection/experimental-breast-imaging.html



i • Available in India, made by UE Life Sciences • Cloud Based system • Mostly installed in Hospitals. • The iBE device was developed as a 16 finger array with a rapid wireless mobile processor algorithm and durable battery powered hand piece. • Uses tactile sensor technology originally invented at Drexel University in Philadelphia. The specialized ceramic material (patented), enables the device to assess tissue elasticity from the surface of the breast. INR 70/- (villages) INR 1000 – 1500 (high end hospitals) $ 8000-10000 (market cost) Pay per scan basis

• Developed to be operated by a technician or health care worker.

https://economictimes.indiatimes.com/small-biz/startups/features/backed-by-gehealthcare-this-startups-handheld-device-is-a-revolutionary-cancer-detectiontech/articleshow/62276845.cms


Available in U.S.

Used a breast pump-like device and a micro filter, to extract and collect tiny amounts of fluid.

Analyzed the cells from that fluid directly on the micro filter.

Hyperplasia mutations.

FDA approved.

Difficult for self-examination.

Difficult to take Nipple fluid sample.

and

other

abnormalities,

cancer,

genetic


• Available in Poland. • It works on the basis of contact thermography. Patented themographic matrix detects abnormal changes in breast. • The examination is performed in accordance with instructions on the mobile app.

• Difficult to understand Thermographic image. • Need to rely on App for performing the screening.


The principle of trans-illumination is simple: • A light source is placed behind the breast, and the light transmitted through the breast tissue is viewed. • As light passes through living tissue, it is reflected, scattered and absorbed.

https://pubs.rsna.org/doi/pdf/10.1148/radiographics.4.6.989


Inr 45,000/- (Amazon) INR 11000 – 15000/- (Supplier) • • •

Available in UK Uses led light to trace shadows of abnormalities Can be used at home


Acrylic Lens Red LED Capacitive Sensor

Brightness Control Display Power

Charging Socket



• Most of these devices take less than 10 minutes for a complete scan • They all have intensity settings for variable density of tissues. • Some are provided with displays for better interaction. • They all come with rechargeable batteries.


• Not readily available in Indian Market. • Higher cost range for most devices. • Most of the devices above have an application to work with and hence have a learning curve and preferred to be used by a physician. • Not all the above devices have the same efficiency.

• The devices tend to heat up due to poor heat sink. • A good heat sink tends to increase the overall weight of the device.



Dr. Max Cutler was one of America's pioneers in the campaign against cancer. He first did experiments using infra red light for checking breast tissue in 1929

How does it work? •

Light falling on the breasts undergoes scattering, absorption and reflection.

When light hits the blood vessels it is absorbed by haemoglobin in the blood, this causes them to appear as shadows.

Malignant lumps have increased blood supply (angiogenesis) to feed them and hence they appear as shadows too.

Fluid filled cysts and fibrosis let the light pass.

Can be used with higher intensity for denser breasts


Mammography is a Gold Standard Test for breast screening. Drawbacks of Mammography •

Peak age incidence age for breast cancer is 40 – 45 years and above, hence screening needs to begin at 25.

Mammography is not prescribed for younger age groups as breast tissue is dense.

Small but significant risk of ionizing radiation.

Picks up significant changes in breasts – even non cancerous ones.

Equipment cost is high.

Lack of skilled radiologists and technicians.


To design a self scanning device for early detection of breast abnormalities using the technology of Trans - Illumination.

It should be a medical grade infra red Leds.

Should work with same efficiency for all skin tones and breast sizes.

The device should be simple and easy to use by the women themselves.

There should interface to communicate the battery level, intensity, last scan date and power.

It should have an Ergonomic grip.

The device should be easy to clean.

Since the device does not have a regular use, it should have a proper storage provision.

It should come with a manual to guide the user and facilitate efficient use.



Red LEDs – Near Infra Red LEDs.

Wavelength – 615 – 680 nm (medical grade).

Rechargeable battery with accessible compartment.

LEDs (CSP / COB Type) developed to give more light and less heat.

Light weight heat sink.

Sensors to suppress light unless device is in contact with the skin.

Sensors to remember the intensity of light used so breasts appear same each time.

User Interface.


Heating up of the LEDs

• Heat causes o Reduction in light output o Color changes by altering the wavelength o Decreased life expectancy o Worst case – Failure •

Good heat sink increases the weight of the device

Intensity of light varies with decrease in charge.

Wide intensity adjustment needed to cater to different skin tones and tissue density. Low Resistance Thermal Plastic


• • • •

Weight of the device Use of opposite hand Time taken – 5-7 mins Interface

• • •

Use of the device in the dark Use of mirror Light intensity adjustments

In case of obesity



Replaceable batteries

Infra red LEDs On / Off Switch

– • • • •

4 LEDs of 1 watt each 200 lumens – 50 lumens each Wavelength – 620 – 625nm Temporary battery source


On / Off Switch

Charging Socket Infra red LEDs

– • • • •

4 LEDs of 4 watt each 200 lumens – 50 lumens each Wavelength – 620 – 630nm Rechargeable battery source


Sample Size – 18 Age of users – 20 – 40 years •

Insufficient intensity for some subjects

Availability and proximity of the mirror

Heating of device

Loss of light from the sides hindering vision when reflected in the mirror

Lack of feedback from the device

Provision for capturing and storing images for future reference and comparison





• • •


•


•


•


•


•


•




https://www.google.com/search?q=flexi+cord+lamp&tbm=isch&tbs=rimg:CXdQlfczevl5IjhzEXxHCaq0ftD

Keeping a track of previous scans.

In case of discrepancy sending images to the physician.

Pictures can be sent to devices like mobile phones using the Bluetooth.


• •

For the purpose of easy viewing. Solving the problem of proximity. Travel friendly.


• •

Wireless charging to prevent use of chord. Common usb can function as charger and for connecting camera.


Brainstorming involved understanding the function that was needed to be achieved and in how many ways can it be done.



Uses suction to create pressure which helps in adhesion to the skin. • • • • •

The LEDs on the periphery Suction needed to facilitate adhesion. Suction causes pressure on the skin causing discomfort. No easy adjustment. Portable


Uses glue to be adhered to the skin. The patch is made of silicone with the led unit snap fitted on it. • • • •

Glue helps adhesion and can be reused around 50 times. Patch is made in silicone and can be replaced. Heat sink cannot be provided. Portable


The device is mounted on a plane surface such as a table using suction. One needs to place the breast on it to use the device.

• • • •

Flat surface is needed for mounting. Portability is an issue (size and weight). Will require multiple height and size adjustments. Can have a good heat sink


The device is held in the hand and operated manually as it is pressed against the skin for better visibility. • • • • •

Device has to be held in the hand. Can be moved around to adjust. Portable. Heat sink can be provided. Easy to use and


.. . …. …. … ..

… …. . …. …. …

. . …. . …. ….

…. …. …. ….. …. ….








• •



Your At-Home Breast Scan Device


Your At-Home Breast Scan Device


Display Intensity Contact Strip (Charging)

Settings Power

Display Interface

Light Emitting Surface

Capacitive Sensor Red/Orange Leds

Acrylic lens


Back-lit Buttons


Light Emission on Contact



Battery Level

Display

Settings Intensity Adjustment / Navigation Power Contact Strip (Charging)


Turn on the device using the power button.


Choose an option best suited.


3. New user for someone who is using the device for the first time.


The device will generate a user number. Set the intensity and use the device. Modify the intensity if needed.


Save the setting for next use.


On pressing save on previous step the device will update the last scan date. On saving now the settings will be saved for next use.


You may now turn off the device or go to options to repeat the above process.


For users who have used the device before.


Select the user number given by the device on last usage. Use the intensity / navigation key to navigate through saved users.


Adjust intensity if needed and use the device. Save the settings after use.


Return to home. The device can now be turned off.


If the device gets overheated the power light will turn red and blink thrice before the device shuts down until it cools. The device can then be turned on and used normally. This is a safety feature even though there are rare chances of such heating occurrences.



Display Interface

PCB Front Cover Heat Sink (Aluminum) Censor Red / Orange Leds

Battery Back Cover


Front Cover Acrylic Lens Sensor PCB

Heat Sink (Aluminum) Battery

Back Cover



Storage for Charger

Considering the fact the device was not designed for everyday use, the packaging had to be something that can help store the device in good condition. The packaging designed functions as a dock for charging the device as well as a storage case not just for the device but also the charging adapter and chord.


Charger

Charging Cable

Connection to the Charging Strip


Charging Strip

Glow in the Dark Strip




Most women look out for changes in their breasts – both by feeling for lumps and looking at them carefully. It is recommend that women make an effort to know how their breasts look and feel normally. This is called “breast awareness”. In addition to lumps, one should look out for the following changes as well:

A change in the size or shape of the breast

A change in the skin – particularly dimpling or puckering

A change in the appearance of the nipple or a discharge from the nipple

Breast pain that does not go away after a period

Lumpy areas or thickening of the breast tissue

https://cdn3.vectorstock.com/i/1000x1000/47/32/breast-cancer-awareness-month-pink-ribbon-vector-22274732.jpg


B-Care is a health and wellbeing product for women. It helps women notice any changes in their breasts over time. B-Care shines a powerful light through the breast tissue so that one can see some of the details inside. That way one can get to know what’s normal and spot any changes. B-Care is a simple and easy to use product. Important things to remember are: •

Charge the B-Care before using it.

Make the room as dark as possible.

Hold B-Care under one of the breasts and look down.

Keep the device pressed tightly against the skin.

Use a mirror for better visibility.

Check all areas – including under the arms and high on the chest.


‌ Veins and other blood vessels as dark lines in the breast. These are totally normal. Around the nipple, a circle of small dots – these are part of mammary glands. These are also totally normal. Over a number of months the women will learn what their breasts look like when lit by B-Care. This internal view will become as familiar as the look and feel of the breasts on the outside. As with all the aspects of breast awareness, the important thing is to look out for any changes.

Image generated for graphical purpose


The brightness setting indicator shows the level of brightness that is selected. There are four settings to choose from.

The battery charge symbol will show how much battery life is left and will flash red when the battery needs charging.

Battery Level User Number Intensity of Light

• •

The Power symbol will turn red and blink thrice only if the product has overheated. In this unlikely event the unit will cut out, the symbol will flash until B-Care has cooled down sufficiently and is ready to use again.

Date of previous Scan

Save Settings

The last scan indicator shows the date on which the previous scan was done. After the device is used the settings can be saved until next use.

Settings Intensity Adjustment / Navigation Power

Contact Strip (Charging)


Find a room in the house where you can turn off the lights and make it as dark as possible. The darker the room, the easier it is to use B-Care. It is good to be able to see yourself in a mirror as you use the product – so make sure there is one in the room that you can see. Make yourself comfortable – sitting or standing are both fine.


Right

Turn off the lights and wait for a couple of minutes to allow your eyes to get used to the dark. Turn on your B-Care . The light will turn on only when it is in contact with your skin. Hold B-Care underneath one of your breasts and push it firmly against the skin. If you have a good light seal there will be no significant escape of light from under the breast and the breast itself will suddenly appear brighter. The dark lines are veins and other blood vessels in silhouette.

Wrong


There are four different brightness settings. Generally larger or firmer breasts will require a higher brightness setting. Try all the brightness settings until you find the setting that is right for you. If the light is too low then you will not be able to see the veins in your breast. If it is too high you won’t be able to see the fine details.

Too Dark

Correct level

Too Bright

Images generated for graphical purpose

https://www.breastlight.com/breast-screening-device/


Slowly move the device around and you will be able to see other parts of your breast. You should continue to do this until you have seen as much as you can. As you move around you may find it easier to switch hands as you change position. The breast tissue goes right around under the arms and high up on the chest toward your shoulder – so be sure to look here as well.

By either looking down on your breast or at the reflection in the mirror you will get a good view of all these areas. Take time to check all areas of your breast, including the area just behind the nipple. There is no set way to complete the examination. There is quite a variation in breast shapes and sizes and you know yourself best. Just make sure that you have a good look around.


Healthy Breast

Shadow

Shadow

Shadow

? When you are looking at your breasts with B-Care you may see some dark spots or shadowy areas. It is possible that these are abnormalities in the breast. If you see these you should go to your doctor for advice. These pictures are some examples of what to look out for.

Image generated for graphical purpose

https://www.breastlight.com/breast-screening-device/


B-Care is designed to aid breast awareness, however it is not capable of detecting all sizes, positions and types of breast abnormalities. It is not intended for use as a diagnostic device. B-Care should be used as an additional part of a normal breast awareness routine. It is not a replacement. Women who are invited for a routine breast screening are strongly advised to attend. B-Care is not a substitute for mammogram screening. It may highlight a potential abnormality that subsequently turns out to be normal or requires minimal medical intervention. For example blood filled cysts and haemotomas will appear as dark areas. However it is recommend that any suspicious signs are investigated by a doctor. B-Care is not suitable for use when breast feeding. B-Care can be used by women with implants.


• Awareness regarding one’s own body.

• Chances of Survival by helping early detection.

• Easy availability of this device to boost awareness

• Better ergonomics, portability and storage of device post use.

• Device with simple and effective interaction with minimum learning curve.

• Better use in the dark while the scanning is being done.

• Risk of buying cheaper devices that do not have a sound backing of research. • The battery size to make the device more compact. • Heat sink designed to work for the battery life provided to reduce the weight.

• Hassles of remembering the setting used last time. • Keeping a track of the last scan date.


Tremendous Learning – first time working on a Medical device

Enabled me to experiment and visualise the various aspects of product design - research, ideation, prototyping, and manufacturing.

Opportunity to understand empathic design

Awareness on important issues like Breast Cancer and Breast Awareness.


Sr. No

Link

Accessed on

3

Breast Cancer facts and Figures 2015-2016 https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-andstatistics/breast-cancer-facts-and-figures/breast-cancer-facts-and-figures-2015-2016.pdf

8.02.2019 , 10.50PM

4

Cancer Research UK http://www.cancerresearchuk.org/about-cancer/what-is-cancer

11.02.2019 , 11.34PM

5

Breast Anatomy http://www.webmd.com/women/picture-of-the-breasts#1

12.02.2019, 4.11PM

6

Breast Cancer trends in India http://www.breastcancerindia.net/statistics/trends.html

12.02.2019, 6:15PM

7

https://www.womenfitness.org/breast-cancer-rising-india/

12.02.2019, 6:30PM

8

https://www.cancer.org/cancer/breast-cancer/screening-tests-and-early-detection/mammograms/mammograbasics.html

15.02.2019, 11:50 AM

9

https://www.ncbi.nlm.nih.gov/books/NBK22310/

14.02.2019, 1:30 AM

10

https://www.spiedigitallibrary.org/conference-proceedings-of-spie on

1/29/2019, 10.30 AM

11

https://www.forbes.com/sites/suparnagoswami/2016/12/12/this-handheld-breast-scan-is-revolutionizing-how-indiansdetect-cancer/#6e7365593b34

16.08.2018, 3.45 PM


Sr. No

12

Link

Accessed on

https://www.medgadget.com/2013/03/testing-breast-cancer-interview-with-atossa-genetics-ceo-steven-quay-md-

16.08.2018, 4.30 PM

phd.html

13

https://www.braster.eu/en/technology

16.08.2018, 4.45 PM

14

https://www.indiegogo.com/projects/meik-global-breast-cancer-awareness-campaign#/

16.08.2018, 5.10 PM

15

https://www.breastlight.com/

18.08.2018, 6.30 PM

16

https://pubs.rsna.org/doi/pdf/10.1148/radiographics.4.6.989

18.08.2018, 7.15 PM

17

https://www.csail.mit.edu/news/using-ai-predict-breast-cancer-and-personalize-care

21.08.2018, 3.30 PM

Sr. No

Title

1

Taber's Cyclopedic Medical Dictionary

2

Gray's Anatomy

Author

Edition Edition 21st

Elsevier, Churchill and Livingstone

Edition 39th 6



Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.