Cytological sampling method and device

• US 5,357,977 A
• Filed: 04/23/1993
• Issued: 10/25/1994
• Est. Priority Date: 04/23/1993
• Status: Expired due to Term

• Current Assignee: St. George'S Hospital Medical
• Original Assignee: St. George'S Hospital Medical
• Inventors: Michels, Ruth
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/052,407
• Time in Patent Office: 550 Days
• Field of Search: 128/749, 128/752, 128/758, 128/759, 604/317-319, 604/403, 604/404
• US Class Current: 600/571
• CPC Class Codes: A61B 10/0291 for uterus A61B10/0045 takes precedence
• CPC Class Codes: A61B 2217/005 with suction drainage system

Abstract

A method and device for collecting cytological samples is provided for suctioning material into a fixative container containing a sufficient amount of fixative so that collected cytological material is fixed substantially immediately after dislodgement. The sampling device includes a means for dislodging cytological material from the cervix uteri, a means for suctioning uterine cervical tissue under negative pressure, and a means for fixing collected cytological material. The sampling method and device is particularly useful for collecting cytological samples for morphological analysis and for collecting potentially HIV-infected cytological material without significant exposure to the healthcare worker.

Claims

1. A method for sampling cytologic material, comprising suctioning cytologic material directly into a container having fixative contained therein, such that said collected cytologic material is substantially immediately fixed.

2. The method of claim 1, wherein said step of suctioning comprises using a sampling instrument operatively attached to a source of negative pressure.

3. The method of claim 2, wherein said sampling instrument is suitably designed to contact mucous membrane tissue to dislodge desired cells.

4. The method of claim 3, wherein negative pressure is continually applied during said step of suctioning.

5. The method of claim 3, wherein said negative pressure is maintained at from about 20 mmHG to about 75 mmHG.

6. The method of claim 3, wherein said negative pressure allows the collection of a pre-determined amount of cytological material.

7. The method of claim 1, wherein said suctioned cytological material is contacted with fixative prior to said cytological material undergoing significant morphological changes due to exposure to air.

8. The method of claim 1, wherein said suctioned material is not exposed to the atmosphere outside of said fixative container prior to being fixed.

9. The method of claim 1, wherein said suctioned cytological material is contacted with said fixative within from about 0.5 seconds to about 5 seconds of said suctioning of said material.

10. The method of claim 1, wherein said fixative is selected from the group consisting of ethanol, acetone, methanol, osmiumtetroxide, mercuric chloride, formaldehyde, polypropylene glycol, polyethylene glycol, EDTA, or any combination thereof.

11. The method of claim 1, wherein said cytological material is sampled from mucous membrane tissue.

12. The method of claim 1, wherein said cytological material is sampled from the cervix uteri.

13. The method of claim 1, wherein said cytological material is sampled from tissue selected from the group consisting of the ectocervix, the squamocolumnar junction, and the endocervix.

14. The method of claim 1, further comprising analyzing said collected cytological material for the physical location and identification of intracellular and extracellular cell products.

15. The method of claim 1, further comprising analyzing said fixed material using an automated cytological specimen screening device.

16. The method of claim 1, wherein said suctioning is performed so as to collect a predetermined amount of cytological material.

17. A method for collecting cytological material that may be contaminated with infectious agents, comprising:

a) dislodging said cytological material using a sampling instrument suitably designed to contact mucous membrane tissue to dislodge desired cells;

b) suctioning said cytological material directly into a container containing a sufficient amount of fixative therein to fix said collected cytological material; and

c) contacting said cytological material with said fixative within about 0.5 seconds to about five seconds of collecting said cytological material.

18. The method of claim 17, wherein said collected cytological material is not removed from said container prior to analysis.

19. The method of claim 17, wherein said method for collecting does not involve any direct bodily contact with said collected cytological material by a healthcare worker following dislodgement of said cytological material.

20. A method for collecting cytological material that may be HIV-infected, comprising:

a) dislodging said cytological material using a sampling instrument suitably designed to contact mucous membrane tissue to dislodge desired cells;

b) suctioning said cytological material directly into a container containing fixative such that said collected cytological material is fixed within about 0.5 seconds to about five seconds of dislodging said cytological material; and

c) preparing said cytological material for analysis such that no direct bodily contact between a healthcare worker and said collected cytological material occurs following said step of dislodging said cytological material.

21. A method for collecting and fixing cytological material, comprising:

a) providing a means for dislodging cytological material from uterine cervical tissue;

b) contacting said dislodging means to said uterine cervical tissue under negative pressure such that said dislodged cytological material is contacted with cytological fixative substantially immediately and prior to the occurrence of any significant morphological change to said cells due to exposure to air, said cytological material transferred directly from said dislodging means into a container containing a predetermined amount of fixative.

22. A device for collecting cytological material, comprising:

a) a means for dislodging cytological material from uterine cervical tissue;

b) a means for suctioning said cytological material from said uterine cervical tissue under negative pressure, wherein said negative pressure is continually applied to allow collection of a pre-determined amount of cytological material, said suctioning means being operatively connected to said dislodging means; and

c) a container having a sufficient amount of cytological fixative contained therein to fix said collected cytological material, said cytological material being directly transported into said container after being dislodged.

23. The device of claim 22, wherein said distal end of said dislodging means is suitably designed to contact mucous membrane tissue and dislodge desired cells.

24. The device of claim 22, wherein said suctioning means comprises a source of negative pressure capable of providing at least about 20 mmHG to about 75 mmHG.

25. A device for collecting cytological material from the cervix uteri, comprising a sampling instrument having a channel passing lengthwise there through, operatively connected to a fixative container having therein a sufficient amount of fixative to fix said cytological material.

26. The device of claim 25, wherein said distal end of said sampling instrument is suitably designed to contact mucous membrane tissue and dislodge desired cells.