Redesigned biopsy device tray fits like a glove

Thermoformer’s choice of film provides contoured shape to protect Sanarus Medical’s handheld breast biopsy device.

Glove fit. The new form-fitting (below) tray provides a tighter, closer fit for the breast biopsy device, and for a specimen.
Glove fit. The new form-fitting (below) tray provides a tighter, closer fit for the breast biopsy device, and for a specimen.

A redesigned thermoformed tray made of Klöckner Pentaplast’s (www.kpfilms.com) Pentamed PETG film is used to hold a handheld large core breast biopsy device from Sanarus Medical Inc. The device is self-contained and disposable post-procedure.

The tray, which measures 15” x 6.5” x 2” deep, consists of two compartments: One for the biopsy device and the other for a sample tray used to hold the biopsy specimen. The device tray is heat-sealed with DuPont’s (www.dupont.com/packaging) 1073B Tyvek® lidding.

Sanarus Medical introduced the Cassi rotational core biopsy device in 2004. The device performs quickly and does not require setup time or capital equipment investment, which results in significant time and cost savings for physicians. A biopsy may be prescribed when the patient’s physician detects a breast lump or abnormality. The procedure involves taking tissue samples or cores from the suspicious area to determine if the lump is cancerous. When a suspicious breast lump is detected during a physician office visit, Cassi can be used to perform a biopsy immediately with only local anesthesia.

The device uses proprietary Stick Freeze Technology to deliver large, precise tissue samples with fewer passes. After being introduced into the breast lump or lesion, Cassi quickly immobilizes the lesion with a stick freeze that secures the targeted tissue to the biopsy needle. A cutting cannula rotates quickly over the needle to obtain the tissue sample.

Less bulk, less stress

Pleasanton, CA-based Sanarus Medical started to work on the packaging redesign in 2005. The original tray required internal padding and external foam caps for protection to pass shock and vibration shipping tests. The packaging configuration was not only costly and inefficient to assemble but also cumbersome for the customer to store, unpack, and dispose of the internal padding components.

Sanarus sought to streamline the packaging while preserving the integrity and sterility of the device during shipping.

The company began looking for a new thermoformer and awarded the packaging redesign project to Flexpak Corp. (www.flexpak.corp.com) based on the recommendation of Kent H. Landsberg Co. (www.landsberg.com). “When our engineers called on Sanarus, the company explained that the use of the internal padding and foam caps prevented the risk of any damage or cracking of the plastic tray during shipping,” explains Ed Berger, Flexpak’s vice president for business development. “We immediately recognized this issue from past experience. A phenomenon called birefringence was occurring in the thermoforming process under-taken by the previous vendor.”

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