Cytocore e2™ ceRvical cell collector

CytoCore partnered with Design Integrity to assist with the final design of the innovative SoftPAP® e2™ cervical cell collector for production launch. This new medical product design reduces the pain and discomfort associated with the Pap smear procedure, and it collects cells from the cervix, the endocervical canal, and the back side of the endocervical canal.

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Challenge

Pap smear tests have traditionally utilized plastic bristle brushes or spatula devices to scrape cells from the outer cervix (ectocervix) and the cervical canal (endocervix). These devices typically result in an uncomfortable experience for the patient, and they frequently lead to errors due to inadequate specimen sampling from the canal and the back side of the canal.

The CytoCore SoftPAP® e2™ cervical cell collector is an excellent example of how innovative new products can dramatically advance the state-of-the-art.

Solution

The SoftPAP® collector results in a quicker and more accurate cervical cell collection procedure with reduced likelihood of error. The device utilizes a silicone balloon and a spring-loaded stylus in the tip. After the tip of the balloon is inserted into the cervix, the activation button is depressed, releasing a low pressure air charge that inflates the balloon.

As the balloon is inflated, it collects cells from the endocervix and ectocervix with minimal discomfort for the patient. When the button is released, the air charge is vented to atmosphere, the balloon deflates, and the doctor removes the device for analysis.

Client benefit

Design Integrity worked in collaboration with the team at CytoCore to develop the design of the SoftPAP® e2™ Collector and handle from the industrial design concept development phase through engineering design, prototyping, engineering testing, tooling development, verification testing, FDA trials, and production launch.

The soft silicone balloon reduces the pain and discomfort associated with the Pap smear procedure, and it gathers cell samples from the ectocervix, the cervical canal, and the back side of the endocervical canal.

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