Reusable Core Needle Biopsy Device for Low-Resource Settings

Abstract

Purpose The core needle biopsy (CNB) procedure is an essential part of breast cancer diagnosis. Current CNB devices on the market are not suitable for low-resource settings, which makes early breast cancer diagnosis inaccessible for women in these areas. Disposable CNB devices are the gold standard of breast cancer diagnostic tools in high-income countries, but the single-use cost—approximately $40 to $200—is unaffordable in low- and middle-income countries. Existing reusable devices are susceptible to internal contamination as blood travels back through the coaxial needle into the driver and thus requires laborious cleaning procedures. Methods After conducting more than 100 interviews with stakeholders at 18 hospitals in the United States, South Africa, and Peru, we devised criteria for the device. The device must prevent internal driver contamination and match the standard tissue sample size. We report the design and development of a reusable CNB device with disposable needles that trap contamination. To demonstrate where blood travels in current reusable devices and prove that internal contamination can be completely eliminated, we created an external attachment that interfaces with the Bard Magnum, an existing reusable driver that yields internal contamination. To prove our concept, we evaluated contamination rates by placing water-indicating tape inside the Bard driver and firing the device into a plastic test tube that was filled with blood-mimicking solutions and covered with a latex glove. Results When we fired the existing Bard Magnum device without our attachment, contaminants entered the internal compartment of the device both times, as shown by the water-indicating tape; however, when the device was fired with our external needle attachment, the water-indicating tape was completely clean, which verified that there was no internal contamination. Conclusion We can conclude from our contamination testing that blood enters the device as a result of contaminants traveling back between the faces of the needle and sheath into the device’s driver and that our external attachment eliminates this risk. Using these insights, we are currently developing a full reusable driver device with novel disposable needles that trap contamination to remove safety concerns associated with reusable devices, lower procedural cost, and increase access to breast cancer diagnostic tools in low-resource settings. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/site/ifc . Megan Callanan Employment: Stryker Spine Patents, Royalties, Other Intellectual Property: Ithemba LLC Laura Hinson Patents, Royalties, Other Intellectual Property: Ithemba LLC Madeline Lee Patents, Royalties, Other Intellectual Property: Ithemba LLC Sophia Triantis Patents, Royalties, Other Intellectual Property: Ithemba LLC Amir Manbachi Research Funding: Siemens Healthineers (Inst) Susan Harvey Honoraria: Hologic Inc, IBM Watson Imaging Consulting or Advisory Role: IBM Watson, Hologic Inc Research Funding: IBM Watson