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Summary
During the summer of 2008, I worked with an international team of five at the International Development Design Summit. We invented a novel, low-cost, modification of a conventional nipple shield to be discretely used by HIV+ mothers to prevent MTCT during breastfeeding (patent pending). During the passage of breast milk through the shield, HIV will be killed by contact with the treated filter. The device could also be a new drug delivery method. The team is continuing to work together on the project as we are spread around the globe (Malawi, England, US, and wherever I happen to be).
The Need
Treatments to prevent mother-to-child transmission (MTCT) of HIV are available and effective during the perinatal period, but there is no good solution for HIV+ breastfeeding mothers in low-resource settings (Urdaneta, 2006). WHO recommends that, "when replacement feeding is acceptable, feasible, affordable, sustainable and safe, avoidance of all breastfeeding by HIV-infected mothers is recommended. Otherwise, exclusive breastfeeding is recommended during the first months of life,” (WHO, 2007). While HIV can infect about 15% of infants during breastfeeding, using formula in low-resource settings causes even more deaths, due to diarrhea and malnutrition (WHO, 2008). Giving anti-retroviral drugs to infants can protect them, but raises other safety issues (Kumwenda, 2008; Gray, 2008). Mothers need a way to kill HIV in breast milk that is practical and allows normal breastfeeding.
We have sought to analyze our market by contacting representative authorities in affected regions and gathering testimonials to provide an indication of the desirability and viability of proposed solutions. The anecdotal evidence gathered was from various regions in Sub-Saharan Africa, comprising Malawi, Tanzania and Zimbabwe.
The Product
The HIV nipple shield is a device designed to prevent mother-to-child transmission of HIV through breast feeding. The invention is a breast milk ‘filter’ in the form of a textile disk impregnated with sodium dodecyl sulfate and incorporated in a modified nipple shield. The invention can inactivate HIV in breast milk without greatly disrupting breast feeding. A mother would open a blister pack and insert a dry textile disk through the retention ring so that it is held in the tip of the nipple shield. The mother would then place the device over her breast and feed her baby. The textile disk would be replaced periodically, e.g. once or twice per day, depending on the exact parameters of the particular active agent and excipients.
In another application that we are researching, the textile disk may also be impregnated with therapeutic formulations, including but not limited to antibiotics, vitamins, minerals, etc. There are several advantages to a delivery mechanism of this type. For example, current administration of antibiotics is commonly done in syrups. However, preparing syrups for infants is expensive, time consuming, and typically leads to a much shorter half-life of drug stability compared to drugs in the dry state. With our device, a single dose of a drug, with various flavoring agents and sugar, could be impregnated onto a textile disk and dried, then easily dispensed by a pharmacist to a mother without the need for syrup preparation.
For more information on the team, project, technical and cultural research visit our website at:
