Website for BreastChecker Device Developed for Domestic & Clinical Use | Developed by Highland Innovation Centre

Introduction Two versions of the hand held BreastChecker have been developed by Highland Innovation Centre Ltd . The clinical version is shown on the right 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 on the right is the clinical BreastChecker , pictured with an Apple Mac running proprietry software developed specifically for use with the device. Jump ahead to the following sections of this webpage or read at your leisure: Domestic Version Clinical Version Results Contact Us Additional Information References / Patents

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The Breastlight was previously manufactured and sold under a licence from Highland Innovation Centre Ltd (HIC) but now HIC are looking for a new partner(s) for the manufacture and marketing of the product world wide. Contact us.

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.

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).

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.

• From July 2007 to December 2008 a total of 6085 women were clinically examined

• Of these 475 were found to have breast symptoms or suspects symptoms

• Among this group 49 have had breast cancer confirmed

• The number with benign disease was 379.

• 47 (96%) of 49 cancers were positive using Breast Checker.

• In all 47 cases the women themselves confirmed that they could see the shadow causes by presence of the tumour.

• Among 60 cases of benign disease 20 (33%) showed no shadow or other indication of abnormality.

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.

HIC are looking for new partners interested in world wide manufacture and marketing of this life changing product.

Breast Cancer: A Principal Health Concern For Women

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

• Breast cancer is the most common cause of death for women under 50.

• In the United Kingdom, 41,000 new cases are diagnosed each year and this figure is rising.

• There are 13,000 deaths per year from breast cancer in the UK.

• 5 year survival rate of 73%. This means 1 in 4 women die within 5 years of diagnosis.

• The appropriate management of patients with early disease reduces mortality.
   

About Highland Innovation Centre

The Highland Innovation Centre Ltd (HIC) is a Scottish-based
Medical / Scientific device company, established 10 years ago,
that specialises in the design, development, and commercialisation of
consumer, clinical, and research products.


Founded in 1998 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.

Other HIC developments are described at www.ultrastethoscope.com and www.oregondisease.com

References

(1) 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.
(2) 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.
(3) 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.
(4) 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.
(5) Watmough D.J., and Quan K.M. (1992). X-Ray Mammography and breast compression. The Lancet, 340 (July 11, 1992), 122.
(6) Watmough D.J. [1982]. Diaphanography; Mechanism responsible for the images. Acta. Radiologica Oncol. 21, 11-15.
(7) Watmough D.J. [1983] Transillumination of breast tissues: Factors governing optical imaging of lesions. Radiology 147: 89-92, April 1983.
(8) Watmough D.J. [1989]. Son et Lumiere; a combined Optical Doppler ultrasound approach to detection of breast cancer. Rad. Magazine Jan. 1989.
(9) Watmough D.J., Quan K.M., and R.M. Aspden. [ 1993]. Breast compression; a preliminary study. J. Biomed. Eng. 15, No.2 121 - 126.
(10) Watmough D.J. [1983]. Diaphanography. Chapter 6 in the book Medical Imaging [Editor Daphne Jackson ] Surrey University Press, 217-225.
(11) Watmough D.J., [1981]. Breast transillumination using the Sinus Diaphanograph. Brit. Med. J. 284. 111-112.
(12) 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]
(13) 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, 24 th.February, 509.
(14) 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.
(15) Watmough D.J. [1993] Interval Breast Cancers. American J Roentgenology July 1993, 161, 3.
 

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