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WO2001097693A1 - Improved medical sampler - Google Patents

Improved medical sampler Download PDF

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Publication number
WO2001097693A1
WO2001097693A1 PCT/EP2001/007167 EP0107167W WO0197693A1 WO 2001097693 A1 WO2001097693 A1 WO 2001097693A1 EP 0107167 W EP0107167 W EP 0107167W WO 0197693 A1 WO0197693 A1 WO 0197693A1
Authority
WO
WIPO (PCT)
Prior art keywords
stem
head
sampler
spatula
cervical
Prior art date
Application number
PCT/EP2001/007167
Other languages
French (fr)
Inventor
Philip Webber
Peter James Webber
Original Assignee
Cellpath Plc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cellpath Plc filed Critical Cellpath Plc
Priority to AU2002215481A priority Critical patent/AU2002215481A1/en
Publication of WO2001097693A1 publication Critical patent/WO2001097693A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0291—Instruments for taking cell samples or for biopsy for uterus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B2010/0074—Vaginal or cervical secretions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0216—Sampling brushes

Definitions

  • This invention relates to a medical sampler.
  • the sampler finds particular application as a sampler for exfoliative cytology and it will be described with reference to a cervical spatula by way of example.
  • PAP test named after the Greek-American physician George Papanicolaou who developed the cervical smear test in 1928 to diagnose cervical cancer, is probably the most widely used example of exfoliative cytology. PAP tests are normally performed using a hand held scraper or spatula that is used to scrape off the outer cells of the cervix prior to a transfer of the cells to a glass slide for microscopic evaluation.
  • sampling devices There are many sampling devices in common use. These devices can however give less than satisfactory results in obtaining adequate endocervical and ectocervical cell samples due to the rigidity of both the sampling head and the stem.
  • spatula devices that are more flexible have been developed, one of which is the well-known CYTOBRUSH spatula; others are the Medscand Accelor Combi and the Cervitula produced by Harwill Medical.
  • Medical samplers which comprise a grip and a substantially planar blade including a loop of a resiliently deformable material extending about the outer periphery of the blade and a lattice of spaced apart bars of a resiliently deformable material that arise from the peripheral loop and transect the body of the blade.
  • This spatula is adapted for use as a cervical spatula in that the periphery of the blade is shaped to conform to the shape of the average cervical os.
  • Samplers have also been developed with sleeves on the stem of the spatula, which can be slid along the stem to collapse the flexible head to enhance the transfer of samples from the head to a slide.
  • An example of such a spatula is the Accellor Combi Cervical Biosampler marketed by Medscand.
  • the head is a flexible quadrangle mounted on the stem by means of a polypropylene hinge so the head can move in a direction perpendicular to the axis of the stem.
  • Samplers have also been developed with a head readily removable from the stem. In this way the head with the sample thereon may be broken from the stem into a bottle of sterile liquid which may then be analysed. This provides an alternate method to the tradition analysis of samples on microscope slides.
  • the CYTOBRUSH was developed. It includes a 360° circular brush head. However this does not adjust angularity with the cervical os during the conduct of the PAP test.
  • the stem/handle cervical spatula of the invention was developed, the intention being to provide a spatula with sufficient deformability in or parallel to the principal axis of the spatula to permit total conformity with the shape of the cervical os during rotation of the spatula head of any type, but yet sufficient rigidity in the blade plane to perform an adequate scraping operation without hurting or injuring the patient.
  • the sampling head is linked to the stem by means of a universal joint whereby the head may be freely rotated with variable angular disposition to the stem. In this way through rotation of the stem the head can be brought into contact with all, or substantially all, of the external os surface area thus reducing the likelihood of missing abnormal cells.
  • the present invention provides a medical sampler comprising a sampling head linked to a stem or grip by a universal joint whereby the head may be rotated with variable angular disposition in relation to the stem.
  • the invention is applicable to samplers using any type of sampling head such as those described in European Patent 106461 and PCT publications 93/01749; 94/09704 and 99/25251 or the head employed in the Accellor Combi Cervical Biosampler marketed by Medscand AB or the sampler described in United Kingdom Patent Application 9928842.5.
  • the head be flexible so that in use it can conform to the size and shape of the cervix being sampled.
  • the head be provided with sampling protrusions.
  • the head can be readily removed from the stem either by cutting or bending to break so that once samples have been taken the head can be quickly removed and placed in a transport solution within a container for subsequent analysis.
  • the universal joint may be formed in any suitable way.
  • the joint may be formed in the moulding process.
  • the joint may be formed by crimping as in the production of drinking straws. We have found that a product such as the bendy drinking straw as is an excellent stem for the samplers of the present invention.
  • the sampler comprises a flexible head, which will conform to the cervix being sampled, the head being provided with sampling protrusions.
  • the universal joint is provided by a crimped region in a hollow stem similar to a bendy drinking straw with the head being very near to the crimp.
  • the stem also is so constructed that the head can be removed from the stem either by cutting or bending so that if can be readily placed in a sample jar once the sample have been taken. This may be achieved by making the stem from materials that are readily cut or by providing a weakness in the stem. Where a weakness is provided in the stem it is preferred that the weakness be close to the universal joint and on the side of the joint nearer to the sampler head.
  • FIG. 1 shows an assembled sampler, consisting of a flexible head 1) which is a loop 2) of flexible plastic preferably nylon provided with sampling protrusions 3) and 4).
  • the loop is such that it can be compressed against the os during sampling.
  • the loop is provided with a stem 5) which is preferably provided with ribs 6).
  • the head then fits into the top 7) of a tube such as a bendy straw provided with a concertinaed ribbed section 8) to allow angular rotation of the head in relation to the stem of the tube 9).
  • the stem may be provided with a weakened section 10) to allow ready removal of the head.
  • the sampler has great flexibility in operation due to the combination of the compressibility of the sampler loop and the ability to rotate the sampler head relative to the stem.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

A medical sampler particularly for exfoliative cytology consists of a sampler head (1) linked to a stem (5) or grip by a universal joint (8) that allows rotation of the head with varied angular disposition to the stem.

Description

IMPROVED MEDICAL SAMPLER
This invention relates to a medical sampler.
The sampler finds particular application as a sampler for exfoliative cytology and it will be described with reference to a cervical spatula by way of example.
The so-called PAP test, named after the Greek-American physician George Papanicolaou who developed the cervical smear test in 1928 to diagnose cervical cancer, is probably the most widely used example of exfoliative cytology. PAP tests are normally performed using a hand held scraper or spatula that is used to scrape off the outer cells of the cervix prior to a transfer of the cells to a glass slide for microscopic evaluation.
There are many sampling devices in common use. These devices can however give less than satisfactory results in obtaining adequate endocervical and ectocervical cell samples due to the rigidity of both the sampling head and the stem.
To address these problems, spatula devices that are more flexible have been developed, one of which is the well-known CYTOBRUSH spatula; others are the Medscand Accelor Combi and the Cervitula produced by Harwill Medical.
Medical samplers are known which comprise a grip and a substantially planar blade including a loop of a resiliently deformable material extending about the outer periphery of the blade and a lattice of spaced apart bars of a resiliently deformable material that arise from the peripheral loop and transect the body of the blade.
This spatula is adapted for use as a cervical spatula in that the periphery of the blade is shaped to conform to the shape of the average cervical os.
Samplers have also been developed with sleeves on the stem of the spatula, which can be slid along the stem to collapse the flexible head to enhance the transfer of samples from the head to a slide. An example of such a spatula is the Accellor Combi Cervical Biosampler marketed by Medscand. In this spatula the head is a flexible quadrangle mounted on the stem by means of a polypropylene hinge so the head can move in a direction perpendicular to the axis of the stem.
Samplers have also been developed with a head readily removable from the stem. In this way the head with the sample thereon may be broken from the stem into a bottle of sterile liquid which may then be analysed. This provides an alternate method to the tradition analysis of samples on microscope slides.
It is appreciated that the shape of the cervical os varies widely from woman to woman and that the shape and consistency of the tissue of the cervical os tends to vary, within the same woman. Various shapes and designs of spatula heads have been proposed for improving the taking of samples. Examples of such heads are described in European Patent 106461 , and PCT publications 93/01749; 94/09704 and 99/25251.
One of the difficulties faced by the practitioner in conducting PAP tests is to be found in the fact that the cervical passage, in most women, enters the vaginal passage at an angle. However, the practitioner is obliged to insert and manipulate the cervical spatula coaxially with the vaginal passage and to make the best of keeping the insertion end of the spatula in constant engagement with the cervical os.
This is very difficult to achieve during the sampling process, since rotation of the spatula is required.
As a result, the angular deviation of the cervical and vaginal passages makes it difficult to obtain endocervical cells when conducting PAP tests with rigid spatulas.
In an attempt to overcome this difficulty, the CYTOBRUSH was developed. It includes a 360° circular brush head. However this does not adjust angularity with the cervical os during the conduct of the PAP test.
It is with these difficulties in mind that the stem/handle cervical spatula of the invention was developed, the intention being to provide a spatula with sufficient deformability in or parallel to the principal axis of the spatula to permit total conformity with the shape of the cervical os during rotation of the spatula head of any type, but yet sufficient rigidity in the blade plane to perform an adequate scraping operation without hurting or injuring the patient.
In the sampler of the present invention the sampling head is linked to the stem by means of a universal joint whereby the head may be freely rotated with variable angular disposition to the stem. In this way through rotation of the stem the head can be brought into contact with all, or substantially all, of the external os surface area thus reducing the likelihood of missing abnormal cells.
Accordingly the present invention provides a medical sampler comprising a sampling head linked to a stem or grip by a universal joint whereby the head may be rotated with variable angular disposition in relation to the stem.
The invention is applicable to samplers using any type of sampling head such as those described in European Patent 106461 and PCT publications 93/01749; 94/09704 and 99/25251 or the head employed in the Accellor Combi Cervical Biosampler marketed by Medscand AB or the sampler described in United Kingdom Patent Application 9928842.5. We prefer however that the head be flexible so that in use it can conform to the size and shape of the cervix being sampled. In addition we prefer that the head be provided with sampling protrusions. We also prefer that the head can be readily removed from the stem either by cutting or bending to break so that once samples have been taken the head can be quickly removed and placed in a transport solution within a container for subsequent analysis.
To enable the head to be rotated in relation to the stem the universal joint may be formed in any suitable way. For example if the product is formed in moulded plastic the joint may be formed in the moulding process. Alternatively the joint may be formed by crimping as in the production of drinking straws. We have found that a product such as the bendy drinking straw as is an excellent stem for the samplers of the present invention.
In a preferred embodiment of the present invention the sampler comprises a flexible head, which will conform to the cervix being sampled, the head being provided with sampling protrusions. The universal joint is provided by a crimped region in a hollow stem similar to a bendy drinking straw with the head being very near to the crimp. The stem also is so constructed that the head can be removed from the stem either by cutting or bending so that if can be readily placed in a sample jar once the sample have been taken. This may be achieved by making the stem from materials that are readily cut or by providing a weakness in the stem. Where a weakness is provided in the stem it is preferred that the weakness be close to the universal joint and on the side of the joint nearer to the sampler head.
The present invention is illustrated but in no way limited by reference to the accompanying drawing Figure 1 which shows an assembled sampler, consisting of a flexible head 1) which is a loop 2) of flexible plastic preferably nylon provided with sampling protrusions 3) and 4). The loop is such that it can be compressed against the os during sampling. The loop is provided with a stem 5) which is preferably provided with ribs 6). The head then fits into the top 7) of a tube such as a bendy straw provided with a concertinaed ribbed section 8) to allow angular rotation of the head in relation to the stem of the tube 9). The stem may be provided with a weakened section 10) to allow ready removal of the head.
As can be seen, the sampler has great flexibility in operation due to the combination of the compressibility of the sampler loop and the ability to rotate the sampler head relative to the stem.

Claims

1. A medical sampler according comprising a sampling head linked to a stem or grip by a universal joint whereby the head may be rotated in relation to the stem.
2. A medical sampler according to Claim 1 in which the head is flexible.
3. A medical sampler according to Claim 1 or Claim 2 in which the head is provided with sampling protrusions.
4. A medical sampler according to any of the preceding claims in which the stem is plastic and the universal joint is a ball and socket joint formed in the moulding.
5. A medical sampler according to any one of Claims 1 to 3 in which the universal joint is provided by crimping the stem.
6. A medical sampler according to Claim 5 in which the stem is hollow.
7. A medical sampler according to any of the preceding claims in which the sampling head is detachable from the stem.
PCT/EP2001/007167 2000-06-23 2001-06-25 Improved medical sampler WO2001097693A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002215481A AU2002215481A1 (en) 2000-06-23 2001-06-25 Improved medical sampler

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0015304.9 2000-06-23
GB0015304A GB0015304D0 (en) 2000-06-23 2000-06-23 Improved medical sampler

Publications (1)

Publication Number Publication Date
WO2001097693A1 true WO2001097693A1 (en) 2001-12-27

Family

ID=9894183

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2001/007167 WO2001097693A1 (en) 2000-06-23 2001-06-25 Improved medical sampler

Country Status (3)

Country Link
AU (1) AU2002215481A1 (en)
GB (1) GB0015304D0 (en)
WO (1) WO2001097693A1 (en)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7223345B2 (en) 2001-04-09 2007-05-29 Steinert Electromagnetbau Gmbh High-gradient magnetic filter and method for the separation of weakly magnetisable particles from fluid media
EP1913878A2 (en) 2006-10-19 2008-04-23 Cheuk-Him, NG Raymond Rotary device to gather mucous for testing
WO2014207254A1 (en) * 2013-06-28 2014-12-31 Commissariat A L'energie Atomique Et Aux Energies Alternatives Device for in vivo sampling of biological species
EP2925234A4 (en) * 2012-11-30 2016-07-13 Eve Medical Inc DEVICE AND NECESSARY FOR SAMPLING
CN106872218A (en) * 2015-12-10 2017-06-20 核动力运行研究所 A kind of adjustable flowing steam sampling structure in direction
CN111297408A (en) * 2020-04-03 2020-06-19 杭州布封科技有限公司 A sample collection device
KR102346252B1 (en) * 2021-07-05 2022-01-04 (주)바이오다인 exfoliative cell collection device for uterus examination

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3554185A (en) * 1968-02-29 1971-01-12 Gerald C Kohl Cervical biopsy-sampling instrument
EP0106461A2 (en) 1982-09-14 1984-04-25 George Pistofidis Gynaecological spatula
US5031635A (en) * 1982-03-01 1991-07-16 Accu-Med Corporation Plastic molded biological sample collection swab
WO1991016855A1 (en) * 1990-05-10 1991-11-14 Medscand Ab Instrument for endo- and ectocervical sampling
WO1993001749A1 (en) 1991-07-17 1993-02-04 Lonsten Pty. Limited Pap smear sampling device
WO1994009704A1 (en) 1992-10-23 1994-05-11 Lonsten Pty. Limited Endocervical probe for pap smear sampling head
WO1999025251A1 (en) 1997-11-14 1999-05-27 Harwill Industries (Pty.) Ltd. Medical spatula
GB2349826A (en) 1999-05-13 2000-11-15 Samuel George Speculum

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3554185A (en) * 1968-02-29 1971-01-12 Gerald C Kohl Cervical biopsy-sampling instrument
US5031635A (en) * 1982-03-01 1991-07-16 Accu-Med Corporation Plastic molded biological sample collection swab
EP0106461A2 (en) 1982-09-14 1984-04-25 George Pistofidis Gynaecological spatula
WO1991016855A1 (en) * 1990-05-10 1991-11-14 Medscand Ab Instrument for endo- and ectocervical sampling
WO1993001749A1 (en) 1991-07-17 1993-02-04 Lonsten Pty. Limited Pap smear sampling device
WO1994009704A1 (en) 1992-10-23 1994-05-11 Lonsten Pty. Limited Endocervical probe for pap smear sampling head
WO1999025251A1 (en) 1997-11-14 1999-05-27 Harwill Industries (Pty.) Ltd. Medical spatula
GB2349826A (en) 1999-05-13 2000-11-15 Samuel George Speculum

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7223345B2 (en) 2001-04-09 2007-05-29 Steinert Electromagnetbau Gmbh High-gradient magnetic filter and method for the separation of weakly magnetisable particles from fluid media
EP1913878A2 (en) 2006-10-19 2008-04-23 Cheuk-Him, NG Raymond Rotary device to gather mucous for testing
EP1913878A3 (en) * 2006-10-19 2009-06-03 Cheuk-Him, NG Raymond Rotary device to gather mucous for testing
US10182796B2 (en) 2012-11-30 2019-01-22 Eve Medical Inc. Specimen collection device and kit
EP2925234A4 (en) * 2012-11-30 2016-07-13 Eve Medical Inc DEVICE AND NECESSARY FOR SAMPLING
WO2014207254A1 (en) * 2013-06-28 2014-12-31 Commissariat A L'energie Atomique Et Aux Energies Alternatives Device for in vivo sampling of biological species
FR3007634A1 (en) * 2013-06-28 2015-01-02 Commissariat Energie Atomique DEVICE FOR IN VIVO COLLECTION OF BIOLOGICAL SPECIES AND AUTOMATED METHOD FOR ANALYZING BIOLOGICAL SPECIES CAPTURED BY MEANS OF SUCH A DEVICE
US10149668B2 (en) 2013-06-28 2018-12-11 Commissariat A L'energie Atomique Et Aux Energies Alternatives Device for in vivo sampling of biological species
CN106872218A (en) * 2015-12-10 2017-06-20 核动力运行研究所 A kind of adjustable flowing steam sampling structure in direction
CN106872218B (en) * 2015-12-10 2023-10-20 核动力运行研究所 Direction adjustable mobile steam sampling structure
CN111297408A (en) * 2020-04-03 2020-06-19 杭州布封科技有限公司 A sample collection device
KR102346252B1 (en) * 2021-07-05 2022-01-04 (주)바이오다인 exfoliative cell collection device for uterus examination
WO2023282432A1 (en) * 2021-07-05 2023-01-12 (주)바이오다인 Exfoliative cell collection device for uterus examination

Also Published As

Publication number Publication date
GB0015304D0 (en) 2000-08-16
AU2002215481A1 (en) 2002-01-02

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