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US5713369A Expired / Lapsed US ⏱️ 0.0 years remaining

Uterine endometrial tissue sample brush

Assignee: Indiana University Research and Technology Corp
•
Filing: 1995-09-13
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Granted: 1998-02-03
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Expires: 2015-09-13
📄 Original PDF 🌐 Google Patents

Abstract

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.

Inventors

  • 👤 Liang-Che Tao
  • 👤 John A. Maksem

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-08 09:28
CPC Classifications
A; A61; A61B; A61B10/00; A61B10/02; A61B10/0291; A61B2010/0216

Claims Analysis

Total Claims: 31
Claim 1
Independent Claim 143 words
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).
Claim 2
Dependent Claim 143 words
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).
Claim 3
Dependent Claim 40 words
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.
Claim 4
Dependent Claim 29 words
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.
Claim 5
Dependent Claim 27 words
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.
Claim 6
Dependent Claim 27 words
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.
Claim 7
Dependent Claim 23 words
The brush (10) according to claim 3, wherein the center of each bristle (20) is offset from the axis of the core (12).
Claim 8
Dependent Claim 24 words
The brush (10) according to claim 1, further comprising a sheath (24) adapted to slidably receive the core (12) and brush member (18) therein.
Claim 9
Dependent Claim 22 words
The brush (10) according to claim 7, wherein the sheath (24) has an outside diameter of no more than about 2.8 mm.
Claim 10
Dependent Claim 21 words
The brush (10) according to claim 7, wherein the sheath (24) is adapted to compressively contain the brush member (18) therein.
Claim 11
Dependent Claim 18 words
The brush (10) according to claim 1, wherein the distal core end (16) includes an atraumatic tip (26).
Claim 12
Dependent Claim 17 words
The brush (10) according to claim 1, wherein the brush member (18) is about 3.5 cm long.
Claim 13
Dependent Claim 25 words
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.
Claim 14
Dependent Claim 16 words
The brush (10) according to claim 1, wherein the bristles (20) include perpendicular end surfaces (32).
Claim 15
Dependent Claim 16 words
The brush (10) according to claim 1, wherein the brush member (18) is cylindrical in shape.
Claim 16
Dependent Claim 22 words
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.
Claim 17
Dependent Claim 17 words
The brush (10) according to claim 15, wherein the bristles (20) are about 0.127 mm in diameter.
Claim 18
Dependent Claim 23 words
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.
Claim 19
Dependent Claim 21 words
The brush (10) according to claim 17, wherein the free outside diameter of the brush member (18) is about 5.97 mm.
Claim 20
Dependent Claim 59 words
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).
Claim 21
Dependent Claim 27 words
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).
Claim 22
Dependent Claim 227 words
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).
Claim 23
Dependent Claim 227 words
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).
Claim 24
Independent Claim 211 words
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).
Claim 25
Independent Claim 211 words
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).
Claim 26
Dependent Claim 134 words
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).
Claim 27
Dependent Claim 35 words
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.
Claim 28
Dependent Claim 42 words
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.
Claim 29
Dependent Claim 108 words
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).
Claim 30
Dependent Claim 183 words
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).
Claim 31
Dependent Claim 183 words
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).

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2001-02-02 2001-08-04 2002-02-03 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2005-02-02 2005-08-04 2006-02-03 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2009-02-02 2009-08-04 2010-02-03 $7700.00 Window Closed / Lapsed

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