Letter from Professor John Mallard, FRSE:
“How very kind of you to send me your BREAST-i, so magnificently designed and made, and so wonderfully packaged. You must feel very proud of it…”
Letter from Scottish Government:
“I have therefore made both the First Minister and the Cabinet Secretary for Health and Sport aware of your product, BREAST-i…”
Importer to Colombia (female):
“I have to say that I did a try with the device and I'm really impressed with it, is perfect and easy to use…”
Importer to Ecuador:
“The packing is perfect. We were able to store the 'travel adapter' in the same box as the power supply and the Spanish manual within the case…”
BREAST-i designer wrote:
“My wife and several of her friends tried the device and they were amazed at what they could see with it. The light output is noticeably better than anything we have seen before. Contrast is good and discerning veins is easy…”
Importer to Malaysia:
“Initial impression - very impressive… the packaging, manual… very nicely done. BREAST-i looks very good and robust… am charging it now…”
One leading charity, Breakthrough Breast Cancer, has called for women to touch, look and check (TLC) their breasts to pick up any sign of lumps early, when cure is possible and likely. This website describes another way of looking at the breast by the woman herself and to encourage women to take advantage of national breast screening programs.
Highland Innovation Centre Ltd (HIC) has developed a light-based home use technology for detection of breast disease and are now working on a clinical version to monitor treatment of advanced breast cancer prior to surgery. The original prototype device was called BreastChecker. A list of granted patents, design copyright, trade mark and domain names is appended. The latest device, BREAST-i is shown here:
The motivation for the work is to provide women with a safe, easy to use device to check their breasts for any changes which indicates the need to get a medical opinion. About 1 in 8 women are diagnosed with breast cancer in their life time. A constraint was to keep the cost of manufacture low and the sensitivity of the instrument high. Breast-i is light-based, safe, (chosen to be) non-diagnostic and an adjunct to breast self examination. Keeping an eye on your breast - we believe touch, look and check is the best advice.
The woman undresses and in a darkened room, sitting leaning slightly forward, places the BREAST-i light source on the inferior surface of (underneath) the breast. She views the superior aspect (top surface) of each breast, which should be uniformly bright except for typically a few darker lines corresponding to superficial blood vessels.
A typical normal breast is shown in Fig A and another with pathology in Fig B (both images courtesy of Mammocare Ghana). The concept is to check one's breasts once per month and if any dark areas appear which were absent previously go to a GP and ask for a clinical examination and an opinion. The test using light in the domestic version is not diagnostic but the presence of angiogenesis (a group of new blood vessels) causes a dark shadow on the superior aspect of the breast in Fig B. The absorption of light by blood vessels around a cancer produce a shadow on the superior surface of the breast.
A blood-filled cyst or bruising can also cause similar appearances. The images remain the same over long periods (years) unless pathology intervenes. The user can view the superior aspect of her breast or use a mirror. A nurse or doctor can also use BREAST-i provided that they have a dark environment. A weak red light can be kept switched on without hindering the examination. The device will be available with an instruction book containing typical patterns of women with normal breasts and those with lumps.
Photographic records are only done to provide the examples for the booklet. Photography of the breast during an examination is quite difficult because the low light requires long exposure (half a second) and the subject will move, blurring the image. With experience one can use high ASA setting on the camera and bracket heavily to compensate for the use of red light. However it may be that the camera on mobile phones might, in due course, be capable of recording high definition images in low light conditions.
We discovered quite recently that light from a red bulb can be kept switched on in the corner of the room while carrying out the examination and even while photographing the breast. This red light actually helps in optimizing the camera settings in low light. It is important not to use light intensities from BREAST-i in excess of what will produce uniform brightness on the breast viewed from above or significant shadows may be 'washed out' by light scattering around a lesion.
The first BREAST-i was sent to a clinic in Africa, where to date 1,460 women have been examined. The sensitivity for cancers is estimated at 94.4% and after an initial charge of the batteries a series of 70 examinations could be carried out before the light intensity began to drop off. The precursors to BREAST-i, BreastChecker and Breastlight, have been used in over 8000 examinations at the same clinic. In some developing countries other techniques - like the gold standard for screening, X-ray mammography - are not available.
The BREAST-i is designed to be used by women with breasts of various sizes and pigmentation, using state-of-the-art light emitting diodes. The device is able to comfortably cope with Ghanaian women, many of whom have large breasts and dark skins. A comparative study of relative light intensities carried out independently is shown here:
On July 11th 2007 Highland Innovation Centre Ltd signed a license agreement with a newly created company PWB Health Ltd based in the West of Scotland to produce a commercial version of the original BreastChecker and to sell it worldwide. HIC transferred prototypes, clinical data, know-how and IP to PWB Health Ltd.
The staff of PWB Health Ltd had good electronic and good design experience and produced the Breastlight, shown together with the BREAST-i here:
It is aesthetically pleasing but in our opinion the the narrow swan neck design led to teething problems not initially foreseen. To image breast tissues high intensity light from 3 red light emitting diodes was required and these sources also generated heat which had to be conducted away to prevent burn out of the LEDs. An aluminium heat sink was bonded to the LEDs to keep the temperature low. It had to be made in a complicated shape to pass through the narrow swan neck and to have enough capacity it occupies a large portion of the handle not taken up by batteries and electronics. The complex shape of the heat absorber led to a high cost of tooling needed to make it.
The upshot was that the rechargeable batteries could not be replaced by most users. If the batteries failed the device had to be returned to the manufacturer. A second problem with the original version was that the device measured the time since last use (e.g. 31 days), which resulted in a constant current drain. Battery voltages of devices in storage dropped so low that in some cases the recharging circuitry failed.
Notwithstanding these limitations, Breastlight was subjected to a successful clinical trial in a NHS Hospital. The sensitivity in terms of detecting cancer was 67%, a surprisingly high figure bearing in mind that the tests were carried out by nurses not initially familiar with this technique, and the relatively low cost of the device. Subsequently a paper published in the Asian Pacific Journal of Cancer claims sensitivity for cancer detection of 93% in a study conducted in Cairo, Egypt. The high figure may be due to late presentation of women thus harboring larger tumors. Tumors larger than 10mm are easier to detect using light.
Independent Market research acknowledged that the principal health concern of women is breast cancer and predicted significant sales of BreastCheckers in the UK and as predicted, despite liquidation of the original PWB Health Ltd, a new company has sold Breastlights of value around one million pounds. The retail price of Breastlight was around £85 per unit and included lubricating oil which in our trials has never been required and makes the examination messy. The new BREAST-i has been developed for elegance, utility, sensitivity and to keep cost of manufacture as low as possible. With a good distribution network worldwide sales could take off rapidly.
European Patent application for 'improved BreastChecker' went to grant in May 2013 and covered the essential features of Breastlight but with priority from May 2005 before any agreements were signed. The main features of the patent are advanced sensor technology to suppress light unless the device is in contact with tissues which prevents the user looking directly at the high intensity LEDs, and also the device is programmed to remember light intensity at last use so that the user's breasts should look the same at every examination unless pathological changes have occurred in the interval.
We have not relied solely upon the patent for protection of IP but also taken out design registration in UK and China. We have also registered BREAST-i as a domain name and as a trademark.
With the grant of the crucial European patent HIC were able to raise a modest amount of private equity and a balancing grant from Highlands & Islands Enterprise. Instead of taking on staff we have used a specialist electronic company to develop the new BREAST-i with a view to improved technology and reduced manufacturing cost. We were thus able to work on a fixed price basis and control our costs.
The physical design of BREAST-i was carried out by a designer working for an internationally known company. The accessible battery compartment was a must. Pink has been incorporated as a design feature because of the connection to pink ribbon month when funds are raised for breast cancer charities. The performance of the LEDs incorporated in BREAST-i have improved giving more light while generating less heat so requiring a smaller uncomplicated heat absorber. This means lower tooling costs prior to manufacture. We kept the geometry of the exit pupil of the device virtually unchanged and chose the same light wavelength, so that previous clinical testing is applicable.
Two BreastCheckers, one Breastlight and one BREAST-i are shown here (left to right):
The two BreastCheckers were developed prior to the licensing agreements with Wideblue Ltd then PWB Health Ltd. In the last year the LED technology has improved allowing more light if required for less unwanted heat. Thus BREAST-i allows larger denser breasts to be examined.
Highland Innovation Centre has always been careful not to over-hype the devices and to recognise that their use encourages breast awareness. We also point out that BREAST-i is not alternative to breast cancer screening by X-Ray mammography however in the intervals between screenings keeping an eye out for interval cancers is recommended. Younger women with dense or lumpy breasts are not called for breast cancer screening and BREAST-i may have a role here.
In parts of Africa, India and China X-Ray mammography is not available and our belief is that BREAST-i may have an important role in developing countries.
X-ray mammography can pick up tiny cancers sometimes indicated only by flecks of calcification in breast tissues. The irony is that for some time now the best treatment for minute cancers is not known, since some may grow to become life threatening, others may remain dormant and some might disappear. Any cancer detected by BREAST-i is highly likely to be life threatening since it is detected by associated angiogenesis implying that it is already in the exponentially growing phase. It must be realised that X-rays and light are monitoring different features of the breast, tissue density and neovascularisation, respectively.
|Description||Jurisdiction & Registration Number|
|Portable non-diagnostic domestic apparatus for self-checking female breasts or testicular tissues to detect the occurrence of breast or testicular diseases||United Kingdom Patent Office GB 2375672 B|
|Apparatus for in vivo monitoring of the effect of antiangiogenic drugs on cancers||German Patent Office EP1253856|
|Apparatus for in vivo monitoring of the effect of antiangiogenic drugs on cancers||United Kingdom Patent Office EP1253856|
|Apparatus for in vivo monitoring of the effect of antiangiogenic drugs on cancers||French Patent Office EP1253856|
|Apparatus for examining a body of living tissues (improved BreastChecker)||European Patent Office EPO5741888.1 (ex PCT/GB2005/001777)|
|Apparatus for examining a body of living tissues (improved BreastChecker)||United Kingdom Patent Office (IPO) P3032EPGB|
|Apparatus for examining a body of living tissues (improved BreastChecker)||French Patent Office P3032EPFR|
|Apparatus for examining a body of living tissues (improved BreastChecker)||German Patent Office (IPO) P3032EPDE|
|Description||Jurisdiction & Registration Number|
|Breast Checker||Community Design (OHIM) 000723036-0001|
|BREAST-i||Community Design (OHIM) Applic. 4034270|
|BREAST-i||Community Design China - details awaited|
File patent listing 260314A
BREAST-i UK IPO Trademark UK00003036859
A 'credit' to the designers of Breastlight was the making of an unauthorised Chinese copy, complete with copied packaging and copied breast images, which we discovered and purchased on the Internet. Unfortunately the batteries were removed and a vibrator installed to replace them. The device is mains operated and the firm doing the copying ought to know that vibrating a malignant tumour is most dangerous as it could cause metastases (secondary tumours).
The clinical version of the BreastChecker is shown in the figures above and depends on the combined use of light and ultrasound. Software to analyse the Doppler ultrasound signals has been developed and is obtained in real time on a laptop (Apple or PC Computer).
Most images were obtained in Ghana.
The principle health concern of women today is breast cancer. Why?
X-ray mammography is the gold standard for breast cancer screening and diagnosis. In the UK a breast cancer screening programme was set up in 1987 following publication of the Forrest Report in 1986. After a positive response to an invitation, mammographic screening takes place when women reach the age of 50 years, then at 3 yearly intervals until they reach 70 years.
Diagnostic X-ray mammography is carried out on women with breast lumps or other breast symptoms. The consensus view is that the earlier a cancer is found, the more likely treatment is to be effective and lead to a cure.
Now the technology is so good that some microscopic cancers are detected for which their future course is uncertain. They may lie dormant, or disappear or grow to become life threatening. The treatment options range from mastectomy to watchful waiting.
Some controversy has so far surrounded the use of light, despite the fact it was an American surgeon Max Cutler who first described its use. Light does not and cannot compete with mammography in terms of sensitivity. X-ray images relate to tissue density. Images showing a breast abnormality produced using light demonstrate angiogenesis around a cancer, or blood in a blood-filled cyst or even bruising. Abnormalities observed using BREAST-i are therefore not diagnostic.
The advantages of examination with BREAST-i is that there are no X-rays and no requirement for breast compression.
Cancer charities recommend being 'breast aware', and to touch, look, check. We believe that BREAST-i is just another way of looking, by means of transmitted light travelling through the breast tissues and showing up any changes. In the developing world where there is a lack of technology, we believe BREAST-i will have an even more important role.
HIC strongly recommends taking advantage of breast screening by mammography as offered by the UK NHS Screening programme.
Read the article Breast-i Device To Detect Breast Cancer at Spy Ghana, Ghana's leading general news and information destination online.
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.