A lesion is caused by any process that alters or damages tissue. A lesion can be defined as any pathological or traumatic discontinuity of tissue with partial loss of tissue function. The concept of a lesion includes wounds, sores, ulcers, tumors, cataracts and any other tissue damage. Lesions can range from the skin sores associated with eczema to the changes in lung tissue that occur in tuberculosis. Generally, a lesion can be characterized by the epithelium covering the connective tissue becoming fragile, leading to ulceration and bleeding.
Human papillomaviruses (HPV) are responsible for many cutaneous and mucosal lesions. Some viral genotypes are considered to be the causal agents of cervical cancer. Natural genital HPV infection seems to be poorly immunogenic because of its nonproductive and non-inflammatory characteristics and also because of mechanisms developed by the virus to counteract the immune response. Cervicovaginitis refers to inflammation of the squamous epithelium of the vagina and cervix caused by an inflammatory reaction to an infection. This damage leads to desquamation and ulceration, which can cause a reduction in the epithelial thickness due to loss of superficial and part of the intermediate layers of cells. In the deeper layers, the cells are swollen with infiltration of neutrophils in the intercellular space. The surface of the epithelium is covered by cellular debris and inflammatory mucopurulent secretions. The underlying connective tissue is congested with dilatation of the superficial vessels and with enlarged and dilated stromal papillae. Rare and uncommon cervical infections, due to tuberculosis, schistosomiasis and amoebiasis, cause extensive ulceration and necrosis of the cervix with symptoms and signs mimicking invasive cancer. Herpes simplex virus (HSV) can be present on the mucosal lining of the mouth or genitals. A large coalesced ulcer due to HSV can also mimic the appearance of invasive cancer. Chronic inflammation causing recurrent ulceration and healing of the cervix can result in a distortion of the cervix. Infections with the pathogenic fungi Cryptococcus neoformans, Histoplasma capsulatum, and Coccidioides immitis can be disseminated and some, e.g., C. neoformans, can result in pneumonia or meningitis. Longstanding viral, bacterial, fungal or protozoal infection and inflammation may lead to white or pink appearance as a result of fibrosis.
Previous devices to obtain a biopsy sample include brushes with rigid bristles that puncture and shear epithelial surfaces (U.S. Pat. No. 5,535,756 “Catheter with simultaneous brush cytology and scrape biopsy capability”, U.S. Pat. No. 6,258,044 “Apparatus and method for obtaining transepithelial specimen of a body surface using a non-lacerating technique”, U.S. Pat. No. 6,494,845 “Retractable brush for use with endoscope for brush biopsy” and U.S. Pat. No. 6,132,421 “Integrated epithelial removal tool”), single metal or plastic curettes that extend in a parallel direction to the applicator handle and are much larger than the innovation (U.S. Pat. No. 4,641,662 “Endocervical curette system” and U.S. Pat. No. 6,730,085 “Surgical biopsy instrument”), scalpels or similar bladed sharp cutting tools (U.S. Pat. No. 5,857,982 “Apparatus and method for removing tissue”, U.S. Pat. No. 5,800,362 “Cervical biopsy device”, U.S. Pat. No. 3,774,590 “Uterine Specimen Collecting Method”, U.S. Pat. No. 5,092,345 “Uterine cell sampler”, U.S.Pat. No. 4,061,146 “Tissue macerating instrument”, U.S. Pat. No. 5,868,668 “Surgical instrument”, U.S. Pat. No. 6,053,877 “Movable sample tube multiple biopsy sampling device”, U.S. Pat. No. 5,470,308 “Medical probe with biopsy stylet”, U.S. Pat. No. 7,137,956 “Endoscopic submucosal core biopsy device”, U.S. Pat. No. 4,168,698 “Endocervical strip biopsy instrument” and U.S. Pat. No. 4,757,826 “Endocervical biopsy instrument”; and U.S. Publication No. 2005/0059905 “Tissue extraction and maceration device” and U.S. Pat. No. 2007/0093727 “Cervical tissue biopsy system and methods of use”), or very large electrified metal loops used to produce excisional biopsies (U.S. Pat. No. 5,913,857 “Methods and devices for collection of soft tissue” and U.S. Pat. No. 5,951,550 “Endocervical conization electrode apparatus”). One device performs simultaneous brush cytology and scrape biopsy on structures with an organic duct (U.S. Pat. No. 5,535,756, “Catheter with simultaneous brush cytology and scrape biopsy capability”). U.S. Pat. No. 5,643,307 “Colposcopic Biopsy Punch with Removable Multiple Sample Basket” has also been proposed to obtain biopsy samples when examining the cervix.
USPTO Backgrounds
USPTO Backgrounds