Uterine endometrial tissue sample brush

• US 5,713,369 A
• Filed: 09/13/1995
• Issued: 02/03/1998
• Est. Priority Date: 09/13/1995
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Vance Products Incorporated (Cook Group Incorporated)
• Inventors: Tao, Liang-Che, Maksem, John A.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/527,838
• Time in Patent Office: 874 Days
• Field of Search: 128/748, 128/756, 128/757, 128/759
• US Class Current: 600/569
• CPC Class Codes: A61B 10/0291 for uterus A61B10/0045 takes precedence
• CPC Class Codes: A61B 2010/0216 Sampling brushes

Abstract

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.

Claims

1. A uterine endometrial tissue sample brush (10) comprising:

a flexible core (12) having a proximal core end (14) and a distal core end (16); and

a brush member (18) carried adjacent the distal core end (16);

wherein the brush member (18) is about 3 to 5 cm long and has a free outside diameter suited to maintain patient comfort yet comprehensively contact the undilated uterine canal (38); and

wherein the brush member (18) comprises a plurality of resilient bristles (20) axially spaced about 0.5 to 1.5 mm apart, each of the bristles (20) having a stiffness equivalent to that possessed by nylon-6,12 at a diameter of about 0.076 to 0.152 mm;

whereby the brush (10) simultaneously possesses good ability to exfoliate endometrial tissue without trauma to the uterine canal and good ability to collect the exfoliated endometrial tissue on the brush member (18).

2. The brush (10) according to claim 1, wherein the core (12) comprises a spirally wrapped pair of wires (22), and wherein the bristles (20) are retained between the pair of wires (22) so that the bristles (20) are spirally arrayed.

3. The brush (10) according to claim 1, wherein alternating rows (28 and 30) of axially spaced bristles (20) have differing stiffnesses and thereby possess differing exfoliating and collecting abilities.

4. The brush (10) according to claim 3, wherein the alternating rows (28 and 30) of axially spaced bristles (20) have differing diameters, thereby giving them differing stiffnesses.

5. The brush (10) according to claim 3, wherein the alternating rows (28 and 30) of axially spaced bristles (20) have differing lengths, thereby giving them differing stiffnesses.

6. The brush (10) according to claim 3, wherein the center of each bristle (20) is offset from the axis of the core (12).

7. The brush (10) according to claim 1, further comprising a sheath (24) adapted to slidably receive the core (12) and brush member (18) therein.

8. The brush (10) according to claim 7, wherein the sheath (24) has an outside diameter of no more than about 2.8 mm.

9. The brush (10) according to claim 7, wherein the sheath (24) is adapted to compressively contain the brush member (18) therein.

10. The brush (10) according to claim 1, wherein the distal core end (16) includes an atraumatic tip (26).

11. The brush (10) according to claim 1, wherein the brush member (18) is about 3.5 cm long.

12. The brush (10) according to claim 1, wherein the bristles (20) have a stiffness equivalent to that possessed by nylon-6,12 of about 0.127 mm diameter.

13. The brush (10) according to claim 1, wherein the bristles (20) include perpendicular end surfaces (32).

14. The brush (10) according to claim 1, wherein the brush member (18) is cylindrical in shape.

15. The brush (10) according to claim 1, wherein the bristles (20) are composed of nylon-6,12 about 0.076 to 0.152 mm in diameter.

16. The brush (10) according to claim 15, wherein the bristles (20) are about 0.127 mm in diameter.

17. The brush (10) according to claim 1, wherein the free outside diameter of the brush member (18) is about 5.08 to 7.62 mm.

18. The brush (10) according to claim 17, wherein the free outside diameter of the brush member (18) is about 5.97 mm.

19. The brush (10) according to claim 2, wherein the bristles (20) retained between the pair of wires (22) comprise a series (110) of first bristles (120) possessing a first stiffness equivalent to that possessed by nylon-6,12 at a diameter of about 0.076 to 0.152 mm, and a plurality of second bristles (122) between each of the first bristles (120).

20. The brush (110) according to claim 19, wherein the second bristles (122) possess a second stiffness different from the first stiffness possessed by the first bristles (120).

21. A uterine endometrial tissue sample brush (10) comprising:

a flexible core (12) having a proximal core end (14) and a distal core end (16), the core (12) comprising a spirally wrapped pair of wires (22), and the distal core end (16) including an atraumatic tip (26);

a cylindrical brush member (18) carried adjacent the distal core end (16), the brush member (18) being about 3.5 cm long and having an outside diameter of about 5.97 mm;

wherein the brush member (18) comprises a spiral array of resilient bristles (20) axially spaced about 1 mm apart, the bristles (20) being retained between the spirally wrapped pair of wires (22), and the bristles (20) comprising a series (110) of first bristles (120) possessing a first stiffness equivalent to that possessed by nylon-6,12 at a diameter of about 0.076 to 0.152 mm, and a plurality of second bristles (122) between each of the first bristles (120), the second stiffness being different from the first stiffness; and

a sheath (24) having an outside diameter of about 2.8 mm, adapted to slidably receive the core (12) and brush member (18) therein and to compressively contain the brush member (18) therein;

whereby the brush (10) simultaneously possesses good ability to exfoliate endometrial tissue without trauma to the uterine canal and good ability to collect the exfoliated endometrial tissue on the brush member (18).

22. A method for sampling uterine endometrial tissue, comprising the steps of:

providing a uterine endometrial tissue sample brush (10) comprising a flexible core (12) having a proximal core end (14) and a distal core end (16), and a brush member (18) carried adjacent the distal core end (16);

wherein the brush member (18) is about 3 to 5 cm long and has a free outside diameter suited to maintain patient comfort yet comprehensively contact the undilated uterine canal (38); and

wherein the brush member (18) comprises a plurality of resilient bristles (20) axially spaced about 0.5 to 1.5 mm apart, each of the bristles (20) having a stiffness equivalent to that possessed by nylon-6,12 at a diameter of about 0.076 to 0.152 mm;

whereby the brush (10) simultaneously possesses good ability to exfoliate endometrial tissue without trauma to the uterine canal (38) and good ability to collect the exfoliated endometrial tissue on the brush member (18);

introducing the brush (10) into the uterine canal (38);

rotating and simultaneously moving the brush member (18) distally in the uterine canal (38) so as to exfoliate endometrial tissue from the uterine canal (38) and collect the exfoliated endometrial tissue on the brush member (18); and

withdrawing the brush (10) from the uterine canal (38).

23. The method according to claim 22, wherein the providing step is carried out with a brush (10) further comprising a sheath (24) adapted to slidably receive the core (12) and brush member (18) therein;

and wherein the method comprises the additional steps of;

sliding the brush member (18) into the sheath (24) before introducing the brush (10) into the uterine canal (38);

partially withdrawing the sheath (24) after introducing the brush (10) into the uterine canal (38) and before rotating and moving the brush member (18) in the uterine canal (38), so as to free the brush member (18) from the sheath (24); and

holding the sheath (24) stationary while the brush member (18) is rotated and moved in the uterine canal (38), until the brush member (18) is received in the sheath (24).

24. The method according to claim 23, wherein the steps of the method are carried out with a brush (10) in which the sheath (24) has an outside diameter of no more than about 2.8 mm.

25. The method according to claim 22, wherein the steps of the method are carried out with a brush (10) in which alternating rows (28 and 30) of axially spaced bristles (20) have differing stiffnesses and thereby possess differing exfoliating and collecting abilities.

26. The method according to claim 22, wherein the steps of the method are carried out with a brush (10) in which the core (12) comprises a spirally wrapped pair of wires (22), in which the brush member (18) comprises a spiral array of the resilient bristles (20) retained between the pair of wires (22), and in which the bristles (20) retained between the pair of wires (22) comprise a series (110) of first bristles (120) possessing a first stiffness equivalent to that possessed by nylon-6,12 at a diameter of about 0.076 to 0.152 mm, and a plurality of second bristles (122) between each of the first bristles (120).

27. A uterine endometrial tissue sample brush (10) comprising:

a flexible core (12) having a proximal core end (14) and a distal core end (16), the core (12) comprising a spirally wrapped pair of wires (22), and the distal core end (16) including an atraumatic tip (26);

a cylindrical brush member (18) carried adjacent the distal core end (16), the brush member (18) being about 3.5 cm long and having an outside diameter of about 5.97 mm;

wherein the brush member (18) comprises a spiral array of resilient bristles (20) axially spaced about 1 mm apart, the bristles (20) being composed of nylon-6,12 of about 0.127 mm diameter and being retained between the spirally wrapped pair of wires (22); and

a sheath (24) having an outside diameter of about 2.8 mm, adapted to slidably receive the core (12) and brush member (18) therein and to compressively contain the brush member (18) therein;

whereby the brush (10) simultaneously possesses good ability to exfoliate endometrial tissue without trauma to the uterine canal and good ability to collect the exfoliated endometrial tissue on the brush member (18).