BreastChecker Device for Domestic & Clinical Use

Two versions of the handheld BreastChecker have been developed by Highland Innovation Centre Ltd (HIC). The clinical version is shown here and the domestic light-only version below.

The domestic BreastChecker aims to allow the user to spot changes in the breast at an early stage and in such instances to seek advice from a General Practioner. The domestic version is for home use and is specifically designed to be non-diagnostic.

The hospital version is for use by doctors to monitor treatment of disease and is at an earlier stage of development requiring further clinical evaluation before being commercialised. The device seen here is the clinical BreastChecker, pictured with an Apple Mac running proprietry software developed specifically for use with the device.

The original Angiotracker.

The BreastChecker concept arose from work supported by a SMART grant from the Scottish government to develop an instrument which we called Angiotracker. This was designed to monitor cancers during treatment using antiangiogenic drugs such as Avastin (Avastin has not proved the wonder drug for breast cancer as at first thought).

“Dear David, it was a pleasure to meet with you yesterday to review the progress of your Angiotracker project now that is has been successfully completed. Your project has clearly achieved (and even surpassed) the objectives detailed in your original proposal, particularly in view of the additional development of the portable BreastChecker with combined optical and ultrasound Doppler probe. We were impressed both with the prototype Angiotracker device seen at our visit and the quality of the images that you have been able to produce. We certainly believe that your technology has the potential to offer substantial benefits to novel anti-angiogenic cancer treatments currently under development…”

A Reid, SMART Programme Executive

Brittenden et al (1995) had already noticed how changes in tumour size could be observed using light to image the cancer. The idea of getting rid of the desktop computer, screen, printer and television camera in a large instrument occurred to us. In making the first of many prototypes we reduced the cost of manufacture so that the instrument could be bought by women and used in the home. The Breastlight made under licence to PWB Health Ltd was a world first.

The prototype clinical BreastChecker is now greatly reduced in size and complexity. It utilises light and sound to detect angiogenesis.

Domestic / Personal Use

The domestic BreastChecker (BC) is a device designed to be used in the home as an aid to Breast Awareness or to regular breast self examination.

Light is transmitted through the breast tissues and in a preferably fully darkened room ( bedroom at night) the user observes brightness variations on the superior surface of the breast. Typically the BC is used once a month. Serial examinations using the handheld, battery powered unit, should show no changes from one month to the next*. A normal image does show superficial blood vessels as well as the nipple and areola dark against a mainly red background and this is normal.

The BreastChecker does not provide diagnostic information but may draw the attention of the user to a shadow which is indicative of the need to seek advice from a GP. Many observed abnormalities are caused by benign conditions. Use of the BreastChecker should be in addition to attending invitations to the National Breast Screening Programme which offers breast examination by X-Ray Mammography at 3 yearly intervals to women 50 years of age and over.

The Personal BreastChecker should run for approximately 30 minutes when fully charged but each particular examination (use) should last no more than 3 minutes. There are no user adjustments inside the Personal Breast Checker. The light level indicator gives a guide to the light intensity and for each individual should be used on the same setting as with previous examinations for serial comparison. The light level indicators will automatically switch off after about 10 seconds. The Personal Breast Checker is supplied with 4 rechargeable high power batteries these are mounted inside the unit and are charged via the charging socket on the base of the unit. A charger is also supplied with the unit.

The Personal Breast Checker is also fitted with several safety devices:

  1. A timer which will switch the unit off after about 2-3 minutes.
  2. A low battery warning light. This will flash when the battery is running low.
  3. An internal temperature cut-out which will switch the unit off should the internal temperature rise above a pre-set limit. This will reset automatically.

* The observed images are usually repeatable almost like finger prints but in late pregnancy and during lactation (breast feeding) the tissues are opaque to light and the device cannot be used.

Domestic BreastChecker (BC)
Appearance of normal breast while being examined with the BC.
A transparent demonstration version of BC. This shows the electronics which run the device and control / optimise the light intensity to match the tissue properties.
An earlier prototype of the BC which utilised 8 light emitting diodes rather than the three in the final version.

Clinical Use

The clinical BreastChecker (CBC) is a more sophisticated version of the domestic device. It is designed for use by clinicians to monitor the efficacy of treatment of breast tumours. Especially in the third world patients often present with advanced breast cancer with large tumours. Prior to surgery these tumours need to be reduced in size by chemotherapy or, in the near future, by treatment using antiangiogenic drugs. Like the domestic BreastChecker the CBC uses light to demonstrate the presence of the cancer. Associated tumour angiogenesis ( new blood vessels created by the cancer itself ) absorbs excess light thus creating the characteristic shadow.

The CBC has a second feature which allows interrogation of the angiogenesis. This is Doppler ultrasound which detects tumour blood flow. Effective treatment reduces tumour blood flow thereby reducing oxygen and nutrients which is necessary for rapid tumour growth. When the tumour is observed a click on the mode switches on the ultrasound feature. Audio data relating to blood flow can be heard via a small audio amplifier and captured for display and analysis by Apple or personal computer (PC).

Clinical BC showing audio amplifier and Apple laptop computer with software to analyse the data output from the device relating to tumour angiogenesis.
Close up image of exit pupil of CBC showing light emitting diodes together with transmit and receive ultrasound piezoelectric elements which interrogate tumour associated angiogenesis.

Results & Advantages

BreastChecker has been devised for use in both a clinical setting and in the home by women themselves in conjunction with breast self examination or breast awareness. The underlying technology has been tested in Ghana on a relatively large number of women with clinically detected or suspected breast symptoms. A high positive rate for cancer of 96% has been found. Light can demonstrate a cancer because of associated angiogenesis which greatly increases light absorption at 617 nm the wavelength employed in the BreastChecker device. Light away from the cancer is less absorbed and so a bright area surrounding a dark shadow indicates the possibility of a cancer.

The results shown in the images below which were recorded using a Nikon D 70 camera with 24 mm wide angle lens all set on a tripod to cope with relatively long exposure times [around 1 second or more]:

Focal abnormality, shadow at 11 o'clock.
Diffuse abnormality from 1 o'clock to 6 o'clock.
Small shadow adjacent to the nipple, possibly with enlarged blood vessels.
Marked abnormality at 12 o'clock extending to the nipple.
Circumscribed abnormality with suggestion of angiogenesis situated at 12 o'clock.
Normal image for comparison showing nipple areola and superficial blood vessels.

The use of BreastChecker brings a number of advantages with it, including:

  • Earlier detection, which should reduce the number of mastectomies in favour of breast conserving surgery.
  • Encourages women to examine their breasts so that possible disease can be caught at an early stage for further diagnosis and treatment measures.
  • The BreastChecker is small, safe, easy to use and is purposely chosen to be non-diagnostic. It involves no ionising radiation or breast compression.

The device developed by PWB Health Ltd under a licence from HIC and branded as Breastlight has been evaluated clinically in a leading NHS Hospital and the sensitivity for breast cancer detection among a group of 300 women was found to be 67%. This encouragingly high figure is achieved without any X radiation dose or tissue compression. The BreastChecker uses non ionising radiation in the far red part of the visible spectrum.

Highland Innovation Centre - Contact Us & Register Interest

Highland Innovation Centre Ltd (HIC) is a Scottish-based Medical Scientific device company that specialises in the design, development, and commercialisation of consumer, clinical, and research products.

Founded by Dr David Watmough, HIC is still driven by a desire to deliver healthcare solutions that not only raise the bar in terms of effectiveness, but also in terms of affordability.

HIC are looking for new partners interested in worldwide manufacture and marketing of this life-changing product - contact us.

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