Breast-i device for home breast examination

BREAST-i

Update

BREAST-i is now available for export. Enquiries from distributors are welcome. We are also looking for a licensee to manufacture and market BREAST-i in North America. Contact us to register interest. A new retail web site is now under construction. The technology has progressed from BreastChecker to Breastlight and now to BREAST-i.

Message from Manuela in South America:
“I have to tell you that we started to use BREAST-i on patients and people are really impressed with it. I do have some pictures that I want you to see that I will send to you later today or tomorrow, and I want you to know that we are working now on a corporate video with the BREAST-i that as soon as is ready I will send it to you with subtitles…”
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 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…”
Importer to Malaysia:
“Initial impression - very impressive… the packaging, manual… very nicely done. BREAST-i looks very good and robust… am charging it now…”
Nikoletta, Cyprus:
“We liked the product! It's very simple to use and the light is strong! It makes much more easier the daily checkup at home…”
Frank, Ghana:
“The new versions are perfect…”
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…”
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…”
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…”
Breast-i device held in a hand
The handheld BREAST-i device.
Packaging diagram for Breast-i device
Packaging for BREAST-i.
See a video interview with Dr Frank Ghartey on Ghana's Joy News, introducing BREAST-i.

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:

Breast-i home use device for breast examination
BREAST-i home use device with advanced sensor technology.

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 Self Examination Using BREAST-i

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.

diagram showing Breast-i usage
How the BREAST-i test is carried out in the home, with the user looking down at the breast or into a mirror.

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.

Normal breast image
Fig A: image captured with BREAST-i showing a normal breast with veins, appearing mainly bright in contrast to the following image. The areolar is dark in African women.
Breast with mass
Fig B: breast with mass about 4cm x 2cm recorded using BREAST-i. The angiogenesis and blood vessels feeding it are obvious.

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.

Testing of BREAST-i in Africa

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.

Performance of BREAST-i

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:

Comparison of relative luminosity between devices
Comparison of relative luminosity between BREAST-i, BreastChecker and Breastlight.

History of Research & Development Leading to New BREAST-i

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:

Breastlight and Breast-i devices
Breastlight produced by PWB Health Ltd and Wideblue Ltd under a license agreement with Highland Innovation Centre Ltd. Below it for comparison the new BREAST-i. The LEDs in BREAST-i are more efficient and do not require a large, complicated heat-absorbing mass. The battery box cover can be removed with the new design to replace a battery pack.

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.

Market Potential

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.

Recent Grant of European Patent & Design Copyright Including in China

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.

Historic Development

Two BreastCheckers, one Breastlight and one BREAST-i are shown here (left to right):

BreastChecker, Breastlight and Breast-i devices
The BreastCheckers, black and white versions (left), were forerunners of Breastlight. During 2014 we developed BREAST-i (extreme right) to overcome the limitations of Breastlight (second from right) and provide an enhanced performance.

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.

Patents

Registered Patents

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

Registered Designs

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

Other Intellectual Property

File patent listing 260314A

BREAST-i UK IPO Trademark UK00003036859

Subsequent Events

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).

Chinese copy of Breastlight called 'Breastangel'
On the left is the HIC version of the domestic BreastChecker and in the centre is the licenced PWB version, Breastlight. On the right is the unauthorised copy of Breastlight made in China and branded Breastangel.
Interior of Breastangel showing vibrator
Interior of Breastangel showing vibrator replacing battery.

Clinical Version of BreastChecker

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).

Clinical BreastChecker interface and graphs
The clinical BreastChecker interfaces to a computer and analyses the blood flow to the tumour or suspected tumour. Neovascularisation would indicate the presence of a cancer and in course of effective treatment the amplitude of signals would reduce or disappear.
BreastChecker integration with PC or Mac with amplifier
Here the mini amplifier allows the audio blood flow signal from the tumour to be heard as well as recorded and replayed. Software for PC and Apple computers has been already developed.

Examples of Images Using BreastChecker

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

Most images were obtained in Ghana.

read more about the clinical BreastChecker .

Breast Cancer: A Principal Health Concern For Women

The principle health concern of women today is breast cancer. Why?

X-ray Mammography & Breast Cancer Screening

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.

Why is screening and early detection so important?
“Early detection is the key to survival. Although we have made a great deal of progress in how we treat breast cancer, we do not know how to prevent breast cancer. If breast cancer can be detected early, when it is confined to the breast and has not spread to the lymph nodes, the five-year survival rate is 99 percent! If the breast cancer is detected at a later stage, the treatment is more invasive and the survival rate declines significantly…”
Susan G Komen, Komen Colorado

News & Comment On Breast Cancer

Role of BREAST-i

Professor Samuel Debrah, Head of Department of Surgery, University of Cape Coast, Ghana writes:

“Early detection of breast cancer saves lives and preserves breasts. Early detection has two components, namely breast awareness and breast screening. Techniques for mass screening includes Self Breast Examination (SBE) and Clinical Breast Examination (CBE), Mammography and its variants as Digital Mammography and Digital Breast Tomosynthesis which are used to improve the sensitivity, specificity and efficiency of mammography. MRI may be used to screen patients with a high risk of developing breast cancer such those with family history and genetic markers. In the future, genetic blood tests will provide a convenient means of screening for cancer.

At present the 'gold standard' for mass screening for breast cancer is mammography. There are however problems with even this gold standard. It picks up a significant number of cancers which are then treated even though the cancer will not cause any problems in the patient lifetime. Conventional mammography is not very good at picking up lesions in the younger, denser breast. It is associated with a small but significant risk of ionizing radiation.

In low income countries the greatest obstacle to mass mammographic screening is the cost of equipment and running the programs, including personnel. Breastlight which has been marketed as an adjunct to SBE and CBE offers low income countries an excellent chance for implementing mass breast screening. It is very affordable, user friendly, has no ionizing risk, and has sensitivity and specificity approaching that of mammography. In Ghana, peak age incidence is between 40 and 49 years. This implies screening should start from about 25 years. BREAST-i therefore offers a huge potential for mass screening of these younger, denser breasts for which mammography is not recommended…”

Read the article Breast-i Device To Detect Breast Cancer at Spy Ghana, Ghana's leading general news and information destination online.

References

  1. Labib N A., Ghobashi M M., Moneer M M., et al [2013] Asian Pacific J. of Cancer Prevention, vol 14, 4647 - 4650.
  2. Ghartey F and Watmough D. J. [2009] South and East Mediterranean College of Oncology, Second Annual Breast Cancer Conference 17- 19 March Evaluation of a new device Breastlight, for use as an adjunct to Breast Self Examination and Breast Awareness by Mammocare, Ghana.
  3. Brittenden J. Watmough D.J. Heys S.D. and Eremin O. [1995] Preliminary clinical evaluation of a combined optical Doppler ultrasound instrument for the detection of breast cancer. Brit. J. Radiol. 68, 1344 - 1348.
  4. Bundred N., Levack P., Watmough D.J., and Watmough J.A. [1986]. Preliminary results using computerised tele-Diaphanography for the investigation of breast disease. British J. Hospital Med. 37, 70-71.
  5. Watmough D.J., Quan K.M., Aspden R.M., and Mallard J.R. [1992] Phantom study of tissue compression: possible implications for the use of X- ray mammography as a method of imaging breast carcinoma. Europ. J. Surg. Oncol. 18, 538 - 544.
  6. Watmough D.J., and Quan K.M. (1992). X-Ray Mammography and breast compression. The Lancet, 340 (July 11, 1992), 122.
  7. Watmough D.J. [1982]. Diaphanography; Mechanism responsible for the images. Acta. Radiologica Oncol. 21, 11-15.
  8. Watmough D.J. [1983] Transillumination of breast tissues: Factors governing optical imaging of lesions. Radiology 147: 89-92, April 1983.
  9. Watmough D.J. [1989]. Son et Lumiere; a combined Optical Doppler ultrasound approach to detection of breast cancer. Rad. Magazine Jan. 1989.
  10. Watmough D.J., Quan K.M., and R.M. Aspden. [ 1993]. Breast compression; a preliminary study. J. Biomed. Eng. 15, No.2 121 - 126.
  11. Watmough D.J. [1983]. Diaphanography. Chapter 6 in the book Medical Imaging [Editor Daphne Jackson ] Surrey University Press, 217-225.
  12. Watmough D.J., [1981]. Breast transillumination using the Sinus Diaphanograph. Brit. Med. J. 284. 111-112.
  13. Hussey J.K., MacDonald A.F., Nichols D.M., and Watmough D.J. [1981]. Diaphanography; a comparison with mammography and thermography. Brit. J. Radiol. 54, 163 [abstract]
  14. Bhargava S, Watmough DJ, Syed F, Memnon A and EL-Gharbawy IF [1996] High detection rates do not necessarily lead to lower mortality. BMJ, 312, 24th February, 509.
  15. Watmough D.J. and Sharma P.N. [1995] Two sides of the same coin? Invited commentary. Medical Principles and Practice. [92-93 ], 3, 232 - 234.
  16. Watmough D.J. [1993] Interval Breast Cancers. American J Roentgenology July 1993, 161, 3.

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.