Vance Products Inc.

Cook Urological, Inc.

John A Maksem

Rodney W Bosley, Jr

Liang-Che Tao

Kathren J Sips

A medical device for collecting both endocervical cells and exocervical cells from a human or veterinary patient includes an elongate handle having first and second handle ends and an elongate foam portion carried by one of the handle ends or and a disk-like foam portion carried by either the same or the opposite handle end or The device includes at least one base plate or connected to the handle to which the elongate and disk-like foam portions and are affixed. The elongate foam portion can be cylindrical in shape, while the disk-like portion can be a convex disk or a generally flat disk or . The first foam portion is positioned about a tip or carried by the first handle end , for example, connected to the first base plate The first and second foam portions and can be carried on opposite ends and of the handle or can be unitarily formed as a single foam portion carried by the first handle end . The foam portions and/or comprise an open cell, reticulated foam (such as a polyester polyurethane foam of relatively large mean pore diameter, for example, 1 mm or larger) which is sufficiently pliant to take the shape of the internal and external surfaces of the cervix and is sufficiently abrasive to scrape an acceptably large number of cells from the internal and external surfaces of the cervix during use. In an alternative embodiment, the handle includes a lumen defined therein which is dimensioned to receive an endocervical brush or other structure or object therein, such as a guide wire, an endoscope, an optical fiber or a sensor. The device can include the brush or other object . The foam portion in that embodiment is preferably a perforate disk . The device enjoys a superior combination of cell capture and relative patient comfort.

Endocervical and exocervical cell collection device

A uterine endometrial tissue sample brush 10 includes a flexible core 12 having a distal core end 16 and a cylindrical brush member 18 carried adjacent the distal core end 16. The core 12 is formed from a spirally wrapped pair of wires 22 and includes an atraumatic tip 26. The brush member 18 is about 3 to 5 cm long and has a free outside diameter, preferably about 5.08 to 7.62 mm (0.2 to 0.3 in.), suited to maintain patient comfort yet comprehensively contact the undilated uterine canal 38. The brush member 18 includes a plurality of resilient bristles 20 axially spaced about 0.5 to 1.5 mm apart. The bristles 20 have a stiffness equivalent to that possessed by nylon-6,12 at a diameter of about 0.076 to 0.152 mm (0.003 to 0.006 in.). This stiffness is critical and unexpectedly gives the brush 10 good exfoliating and collecting abilities simultaneously, in contrast to prior devices which may possess either good exfoliating or good collecting abilities, but not both abilities at the same time. The bristles 20 are preferably composed of nylon-6,12 of about 0.127 mm (0.005 in.) diameter, and are retained between the pair of wires 22 so that they are spirally arrayed. The brush 10 also preferably includes a flexible sheath 24 adapted to slidably receive the core 12 and brush member 18 therein, to prevent the collection of undesired exocervical or vaginal fluid or material during introduction or removal of the brush 10. The brush 10 especially useful for routinely and repeatedly collecting samples for cancer screening or for monitoring ongoing estrogen replacement therapy.

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Waukee, IA, United States of America

John A Maksem