TISSUE OR MUCUS SAMPLING DEVICE

Abstract: An extremely simple cervical tissue or mucus sampling device (10) comprising an outer protective sleeve (11), a guard ring (15), a telescoping insertion tube (20), a stop ring (25) and a tissue or mucus sampling member (30) which enables a woman to obtain a sample of cervical tissue or mucus for examination and testing.

Description: Tissue or Mucus Sampling Device Background of the Invention The present invention relates to a sampling device for obtaining a tissue or mucus sample from the cervical os or from the upper region of the vagina (vaginal fornix) without undue contamination of the sample by vaginal fluids. Collection of cervical material in the form of tissue and mucus has been routinely performed for many years. Such retrieved samples are then tested for malignancy by the Pap test or examined for various purposes such as to determine whether ovulation has occurred. The probes or devices generally used to obtain such cervical samples for examination and testing have not been designed for self-use by women wishing to collect cervical specimens .at home. In most instances, skilled medical personnel obtain the required samples for testing. Some recent patents disclose sampling devices designed specifically for self-use by women. U.S. Patent 3,592,186 relates to an apparatus for self-use in the collection of cervical samples for evaluation. The apparatus comprises a substantially resilient scraper having a generally irregular heart-shape telescopically engaged within a protective cover. When the apparatus is disposed substantially within the female body at the vaginal opening, the scraper is extensible and rotatable by the individual from whom the sample is to be obtained. Λn indexer is provided to give external indication to the operator of the relative position of the scraper when in operation. U.S. Patent 3,776,219 discloses a cervical scraper unit designed particularly for utilization by the female herself. The scraper comprises a conical polyurethane foam head canti levered at the end of a hollow plastic tube and enveloped by a plurality of protective flexible petal-like appendages. The head is mounted to be exposed by the petals at the testing site, and to accommodate its collapse and flexion when it is rotated in situ against the entrance to the cervix. Subsequently, the petals are arranged to envelop and protect the head during withdrawal. The ability of the scraper to collapse and to flex, its resilient nature, and its conical shape, along with the protection of the sample by the petals, are all said to contribute to the efficiency and completeness of transfer of a 5 collected sample for examination. U.S. Patent 4,131,112 provides a probe for obtaining a sample of cervical mucus which comprises a syringe-like structure characterized by an outer barrel and an inner plunger capable of producing relative peristaltic motion. The cooperating forward 10. configurations of the outer barrel and the inner plunger defines therebetween the specimen cavity which, when it is caused to increase in volume with rearward motion of the plunger, receives a fluid specimen through the forward opening under suction and when it is caused to decrease in volume with forward motion of the plunger, 5 ejects the fluid specimen through the forward opening under pressure. U.S. Patent 4,157,709 and U.S. Patent 4,318,414 disclose probes for inserting a test element into the vaginal cavity while shielding it from intermediate vaginal contact, for positioning the test element in contact with the cervical os with the aid of a 0 reference foot, in order to collect a specimen of cervical material and for retrieving the test element and the specimen from the vaginal cavity while shielding them from intermediate vaginal contact. Other devices for collecting samples of cellular cervical material are disclosed in U.S. Patents 3,640,268 and 3,664,328. 5 Summary of the Invention The present invention relates to an extremely simple reusable tissue or mucus sampling device which enables a woman to obtain a sample of tissue or mucus from the cervical os or from the vaginal fornix for examination and testing. 0 The device comprises an outer protective sleeve, a guard ring on the protective sleeve to provide the user with a guide for proper depth of insertion and a telescoping insertion sleeve frictionally carrying a swab or scraper for collecting the sample. The device is extremely simple in design and easy to use. Description of the Drawings Figure 1 is a perspective view of the device of the present invention in an unassembled position; and Figure 2 is a side view, partly in section, of the device of Figure 1 in its "in use" position. Detailed Description of the Invention Referring now to the drawings, tissue or mucus sampling device 10 comprises an outer protective sleeve 11, a guard ring 15, a telescoping insertion tube 20, a stop ring 25 and a tissue or mucus sampling member 30. As used throughout the specification, the term "cervical" when used to refer to a mucus sample should be understood to include a mucus sample obtained from the upper region of the vagina (the vaginal fornix). Protective sleeve 11 is an elongate cylinder or tube, preierably formed of a semi-rigid polymer, such as polyvinyl chloride, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, Teflon or Nylon of relatively low liquid absorbency with a low coefficient of friction and non-irritating to the human skin. The protective sleeve 11 is preferably thermally treated to impart a gentle curvature along its length so that the tip 12 is inclined from the horizontal at an angle of from 15° to 45°. Inclination of tip 12 from the horizontal facilitates the process of obtaining a sample either from the cervical os or from the vaginal fornix due to the anatomy of the cervix relative to the vaginal cavity. In the thermal treatment process, sleeve 11 is drawn so that sleeve 11 is gently tapered along its length and tip 12 has a greatly reduced diameter, as clearly seen in the drawings. The resulting reduced diameter of tip 12 assists in minimizing contamination of the cervical mucus sample with vaginal fluids particularly during insertion of the device 10. Protective sleeve 11 can also be injection molded into the desired configuration. It will be appreciated that protective sleeve 11 can also be a straight cylinder or tube with only the tip portion inclined at the desired angle and such an arrangement is contemplated. Guard ring 15, formed of a suitable polymeric material, is tightly frictionally fitted onto protective sleeve 11 for sliding movement therealong. Since guard ring 15 functions to limit the depth of insertion of device 10 into the vaginal cavity, the sliding movement of guard ring 15 on sleeve 11 is accomplished only with some effor . Insertion sleeve 20 is also an elongate cylinder or tube formed of the same material as protective sleeve 11. As shown in the drawings, insertion sleeve 20 has an outer diameter slightly smaller than the inner diameter of protective sleeve 11 to permit it to telescopically fit and slide within protective sleeve 11. Stop ring 25, formed of a suitable polymeric material, is also tightly frictionally fitted onto insertion sleeve 20 in like manner as guard ring 15 on protective sleeve 11. Stop ring 25 serves to limit the degree of protrusion from tip 12 of the cervical tissue or mucus sampling member 30. As will be seen in Figure 2, cervical tissue or mucus sampling member 30 is illustrated as a double-ended swab comprising an elongate semi-rigid rod 31, the ends of which are covered with a flexible, soft, resilient fibrous material such as cotton, rayon, polyester or calcium alginate, forming specimen collecting tips 32. Only one of tips 32 is used for collecting a mucus sample. The other tip 32 serves to frictionally hold sampling member 30 firmly in the interior of insertion sleeve 20. It will be readily apparent to the reader that the end of sampling member 30 inserted into insertion sleeve 20 can take other forms than shown, e.g., the rod 31 can be of a larger diameter or an elastomeric col'lar can be placed over the rod end. When sampling member 30 is to be used to collect a tissue sample, the tip of sampling member would be in the form of a scraper. A handle member 35, shown as a ring, is affixed to one end of insertion sleeve 20 and is used to guide insertion sleeve 20 into protective sleeve 11 and also to manipulate the sampling member 30 in insertion sleeve 20 during use of device 10. After assembling device 10 by fitting a sampling member 30 into insertion sleeve 20 and placing insertion sleeve 20 into protective sleeve 11, stop ring 25 is moved along insertion sleeve 20 so that the tip 32 of sampling member 30 protrudes only slightly from tip 12. Insertion sleeve 20 is then withdrawn a short distance (approximately one-half to one inch) to avoid contamination of tip 32 with vaginal fluids. Device 10 is then inserted into the vaginal cavity until tip 12 contacts the cervical os. Guard ring 15 is then moved into contact with the vaginal orifice to prevent further insertion of device 10 into the vaginal cavity to avoid possible injury to the user. Of course, if device 10 has previously been used for collecting a cervical sample, guard ring 15 would already be in the desired position on protective sleeve 11. Insertion sleeve 20 is then pushed forwardly into protective sleeve 11 by handle member 35 until tip 32 of sampling member 30 is in the predetermined "in use" position shown in Figure 2. Handle member 35 can then be gently rotated to thus collect a mucus sample. Insertion sleeve 20 is retracted a short distance and device 10 is then withdrawn. Protective sleeve 11 shields the insertion sleeve 20 and particularly tip 32 of sampling member 30 during the entire insertion and removal process. Insertion sleeve 20 is completely withdrawn from protective sleeve 11 and the collected mucus sample is available for further processing for examination and testing. After each use, device 10 is completely cleaned by washing with soap and water and is ready for reuse. Sampling member 30, if the mucus collecting swab was used is discarded; if a scraper form was used, it is also washed for reuse.

Claims: What is claimed is: 1. A tissue or mucus sampling device for obtaining a tissue or mucus sample from the cervical os or the vaginal fornix comprising an elongate, cylindrical outer protective sleeve, a guard ring on said protective sleeve, an elongate, cylindrical insertion tube telescopically fitting within said protective sleeve, a stop ring on said insertion tube, a tissue or mucus sampling member at one end of said insertion tube and a handle member affixed to the other end of said insertion tube. 2. A tissue or mucus sampling device according to claim 1 wherein said protective sleeve is semi-rigid and is comprised of polyvinyl chloride, polypropylene, polyethylene terephthalate, polycarbonate, Teflon or Nylon. 3. A tissue or mucus sampling device according to claim 2 wherein said protective sleeve is gently curved along its length such that the tip thereof is inclined from the horizontal at an angle of from 15° to 45°. 4. A tissue or mucus sampling device according to claim 3, wherein said tip of said protective sleeve has a reduced diameter orifice. 5. A tissue or mucus sampling device according to claim 1 wherein said insertion tube is semi-rigid and is comprised of polyvinyl chloride, polypropylene, polyethylene terephthalate, polycarbonate, Teflon or Nylon. 6. A tissue or mucus sampling device according to claim 1 wherein said tissue or mucus sampling member comprises an elongate semi-rigid rod having a covering at one end thereof of a flexible, soft, resilient fibrous material of cotton, rayon, polyester or calcium alginate. 7. A tissue or mucus sampling device according to claim 1 wherein said tissue or mucus sampling member comprises an elongate semi-rigid rod having a scraper member affixed to one end thereof.

Inventors: FANSELOW DAN L, KO SU-SEN, FANSELOW, DAN, L., KO, SU-SEN
Applicants: MINNESOTA MINING & MFG, MINNESOTA MINING AND MANUFACTURING COMPANY
Application year: 1986
Main classification: A61B10
IPC codes: A61B10