EP1030601A1 - Spatule medicale - Google Patents

Spatule medicale

Info

Publication number
EP1030601A1
EP1030601A1 EP98954593A EP98954593A EP1030601A1 EP 1030601 A1 EP1030601 A1 EP 1030601A1 EP 98954593 A EP98954593 A EP 98954593A EP 98954593 A EP98954593 A EP 98954593A EP 1030601 A1 EP1030601 A1 EP 1030601A1
Authority
EP
European Patent Office
Prior art keywords
blade
spatula
grip
cervical
spatula according
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP98954593A
Other languages
German (de)
English (en)
Inventor
Pieter Rousseau Fourie
Marius Van Der Merwe
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
HARWILL INDUSTRIES Pty Ltd
Harwill Ind Pty Ltd
Original Assignee
HARWILL INDUSTRIES Pty Ltd
Harwill Ind Pty Ltd
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 HARWILL INDUSTRIES Pty Ltd, Harwill Ind Pty Ltd filed Critical HARWILL INDUSTRIES Pty Ltd
Publication of EP1030601A1 publication Critical patent/EP1030601A1/fr
Withdrawn legal-status Critical Current

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

Definitions

  • This invention relates to a medical spatula.
  • the spatula finds particular application as a spatula 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 vaginal 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.
  • the spatula device in most common use is the wooden AYRE'S spatula. These devices are not without their disadvantages, the AYRE'S spatula being difficult to manipulate without causing discomfort or injury to the patient and giving less than satisfactory results in obtaining adequate endocervical cell samples.
  • spatula devices that are more flexible have been developed, one of which is the well-known CYTOBRUSH spatula.
  • the CYTOBRUSH is significantly better than the wooden spatula for collecting endocervical cells, but not significantly better for collecting and detecting metaplastic cells.
  • This invention provides a medical spatula comprising a grip and a substantially planar blade including an open 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.
  • the spatula in the preferred form of the invention, 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.
  • 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, in dependence on her age, the state of her pregnancy (if any) and the phase of her menstrual cycle.
  • the spatula blade is therefore shaped in essence, to conform to an idealised cervical os.
  • the flexibility of the blade is intended to assist in conforming the blade shape to any deviations from the idealised cervical shape that may be exhibited by an actual cervix when the spatula is used.
  • the blade is essentially triangular in plan outline, the end of the spatula being constituted by the apex of the triangular blade and the sides of the triangular blade arising from the apex being concave in plan outline.
  • All the plan outline corners of the triangular blade are rounded, the base corners being rounded more than the apex, in order to avoid possible discomfort or injury in use.
  • the bars making up the body of the blade may conveniently be constituted by a plurality of non- discrete lands spaced apart from one another by interposed grooves. Some or all of the grooves may be constituted by slots formed to extend through the plane of the blade.
  • all the grooves are constituted by slots.
  • the blade and preferably the entire spatula, being the grip and the blade, are integrally formed from a resiliently deformable material such as injection moulded plastics, preferably low density polyethylene.
  • the blade is adapted to flex in the plane of the blade.
  • the peripheral edges of the blade may be relatively sharp in cross section.
  • the grip may be longitudinally tapered from the hand grip end thereof to the point of attachment of the grip to the blade, the narrowing portion of the tapered grip being progressively more flexible up to the point of attachment of the grip to the blade. This is particularly appropriate for a spatula intended to be used as a cervical spatula.
  • Figure 1 is a diagrammatic isometric view of a cervical spatula according to the invention.
  • Figure 2 is a plan view of the spatula of Figure i;
  • Figure 3 is a side elevation of the spatula of Figure 1;
  • Figure 4 is a cross section through the blade on a line 4 - 4 in Figure 3 ;
  • Figure 5 is an enlarged view of one half of the section of Figure 4 (the circled area) ;
  • Figure 6 is a cross section on a line 6-6 in Figure 3;
  • Figure 7 is an isometric view of an alternative cervical spatula according to the invention.
  • Figure 8 is a diagrammatic isometric view of yet a further alternative cervical spatula according to the invention.
  • Figure 9 is a side elevation (partly in section) on a line 9-9 in Figure 8;
  • Figure 10 is an enlarged view of the area circled in Figure 9;
  • Figure 11 is a cross section through one half of the blade of the spatula of Figure 8 taken on a line 11-11 in Figure 8;
  • Figure 12 is a diagrammatic representation of the cervical spatula of the invention in use
  • Figure 13 is a diagrammatic representation illustrating the positioning of the spatula blade in the cervical os.
  • Figure 14 is a diagrammatic representation of the manner in which a cervical cytology sample collected with the spatula of the invention is deposited onto a glass slide.
  • the exfoliative cytology spatula illustrated in the drawings is a cervical spatula 10 that is intended for conducting PAP tests.
  • the CYTOBRUSH spatula includes a pair of flexible vanes extending on either side of a nose adapted for insertion into the cervical os during the conduct of the PAP test. Unfortunately, the flexibility of the vanes makes it difficult to obtain metaplastic cells.
  • the 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 substantial conformity with the shape of the cervical os during rotation of the spatula, but yet sufficient rigidity in the blade plane to perform an adequate scraping operation without hurting or injuring the patient.
  • the cervical spatula 10 of the invention includes a grip comprising a round hand grip 12 on the end of a thin insertion rod 14.
  • the grip 12 is provided with indentations 16 that serve as grip formations.
  • the insertion rod 14 is fluted by means of longitudinally extending indentations 18 which serve to enhance the rotational rigidity of the insertion rod 14 without sacrificing the longitudinal flexibility that is required for the proper conduct of PAP tests.
  • the spatula 10 is formed with a flat planar blade 20.
  • the spatula is integrally moulded from low density polyethylene.
  • the blade 20 is constituted by a grille or lattice of spaced apart bars 22 bounded by a closed loop 24 of material that defines the outer periphery of the blade 20.
  • the spaces 23 between the bars 22 are formed as open slots that extend through the body of the blade 20, as can be seen more clearly from the cross sections in Figures 4 and 5.
  • the blade 20 is symmetrical about a central axis (which is co-axial with the principal axis of the grip 14) and the blade 20 is essentially triangular in plan outline.
  • the insertion end 26 of the spatula is constituted by the apex of the triangular blade and the sides of the triangle arise from the apex to provide a heart-shaped or arrow head-shaped spatula blade 20.
  • the insertion end of the blade 20 is rounded in plan to define a nose 28 that is designed to enter the cervical os during sampling.
  • the peripheral rim 24 of the blade 20 curves symmetrically away from the nose 28 on either side thereof.
  • the concave curved areas 29 of the rim 24 is shaped to be complemental to the entrance and ecto- cervical area of the cervix. All surfaces of the blade 20 are rounded in order to minimise the risk of injury, pain and discomfort.
  • the angle of intersection is acute and the point of intersection is relatively sharp. This is to provide relatively sharp rim edges 25 that are designed to maximise cell accumulation during sampling. For the same reason, the same design is used along the lines of intersection between the principal plane of the blade 20 and the edges of the bars 22 to provide sharp edges 27 in these areas as well.
  • the cervical spatula 10.1 illustrated in Figure 7 is similar to the cervical spatula 10 described above with the exception of a smooth insertion rod 14.1 and hand grip 12.1.
  • the cervical spatula 10.2 illustrated in Figures 8, 9, 10 and 11 differs from the cervical spatula 10 and 10.1 described above in several respects. Not only are the insertion rod 14.2 and the hand grip 12.2 different in the spatula 10.2, but the blade 20.2 differs markedly.
  • the blade 20.2 is merely grooved so that the bars are constituted by a number of side-by-side lands 22.2 that are spaced apart from one another by grooves 23.2 interposed between the lands 22.2.
  • the spatula 10.2 will be more rigid than the spatulas 10 and 10.1 described above if similarly dimensioned and made from similar materials.
  • the biconcave triangular shape of the blade 20 is designed to permit selective acquisition of cells from the endocervical and ecto-cervical areas of the cervix.
  • the peripheral rim 24 of the blade 20 being constituted, essentially, by a loop of resiliently deformable material, is complaint enough to accommodate most variations in the shape of the cervix.
  • the blade 20 is substantially planar, but as can be seen from the side elevation of Figure 2 and the cross sections of Figures 4 and 5, the blade is tapered in two directions in cross section.
  • the blade 20 tapers towards the nose 28.
  • the opposing upper and lower plane surfaces of the blade converge from the thicker part of the blade 20, which is the end at which it is attached to the insertion rod 14 , towards the nose of 28.
  • the blade 20 In transverse cross section, the blade 20 is inversely tapered so that, in cross section, it is thinner in the middle than it is at the sides, the thickest areas of the blade 20 being the wings 30 that define the base of the blade 20.
  • the spatula grip which tapers from the hand grip 12, through the insertion rod 14 to the point of attachment to the blade 20, becomes progressively more flexible up to the point of attachment of the grip to the blade 20.
  • Figure 12 which illustrates the cervical spatula 10 of the invention in use.
  • the spatula 10 of the invention is inserted into the vagina of a patient through a speculum 32 that permits an unobstructed view of the cervix 34 of the patient.
  • the practitioner having inserted the blade 20 through the speculum 32 up to the point where the blade 20 is correctly positioned in the cervix 34, rotates the spatula 10 between her thumb and forefinger to collect a sample of cervical cells.
  • the insertion rod 14 flexes to accommodate the misalignment of the cervix and the vaginal passage.
  • the peripheral rim 24 of the blade 20 flexes during rotation in order to accommodate any variations in the shape of the cervix 34 that deviate from the shape of the blade 20.
  • the rim 24 flexes principally in the plane of the blade 20 with the bars 22 providing relatively little resistance to such flexing.
  • the bars 22 do not detract significantly from the compliance of the peripheral rim 24, yet they contribute to the collection of cells.
  • the blade 20 also flexes in the plane of the blade 20.
  • the degree of flexing is not great and the blade 20 is intended to twist ever so slightly about the principal axis of the spatula 10 in helical fashion.
  • FIG. 13 illustrates the location of the blade 21 within the cervix 34 in greater detail.
  • the tip of the blade 20 penetrates deep into the cervix 34 in order to collect endo-cervical cells.
  • the concave sides 29 of the blade 20 extend from within the cervix to the area adjacent to the entrance of the cervical os, to collect progressively less endo-cervical cells and progressively more ectocervical cells from the central regions of the blade 20 towards the wings 30 at the base of the blade 20.
  • the blade 20 is sufficiently compliant to accommodate nulli- and multigravidae cervixes.
  • the spatula 10 of the invention has additional advantages. Not only does it permit the selective acquisition of cells from the endocervical and ectocervical areas, but it allows deposition of the cells on a glass slide for instance, in a similar fashion.
  • the spatula 10 of the invention seeks to overcome this deficiency by permitting more effective deposition of the cells onto a glass slide 36 without the need for excess manipulation.
  • capillarity helps in drawing the sample from the blade 20 when, in depositing the collected cells on a glass slide, the practitioner draws the blade 20 longitudinally along the glass slide (in the direction of the arrows) .
  • the practitioner is not required to smear the sample.
  • This means that the blade can be drawn straight down the glass slide, depositing endocervical cells in the centre (40) of the sample and ectocervical cells on either side (42) thereof. This will allow the pathologist to examine the slide knowing that cells can be distinguished as to their origin.
  • the spatula 10 of the invention therefore has the advantage that it permits the selective acquisition of cells from the endocervical and ecto-cervical areas. In addition, it allows deposition of the cells in a similar fashion.

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)
  • Investigating Or Analysing Biological Materials (AREA)
  • Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)

Abstract

L'invention concerne une spatule médicale utile notamment en tant que spatule destinée à une cytologie exfoliative, comme un frottis cervical ou vaginal (test de Papanicolaou). La spatule de l'invention comprend une partie prise, constituée d'une poignée (12) et d'une tige d'insertion (14), ainsi qu'une lame sensiblement plane (20). Cette lame (20) comprend une boucle ouverte délimitant le flanc (24) de la lame (20) et un réseau de barres espacées les unes des autres (22), lesquelles saillent du flanc périphérique (24) et traversent le corps de la lame (20). Lorsque cette spatule (10) est conçue pour un usage cervical, la périphérie de la lame est formée de manière à épouser la forme d'un col moyen. Cette spatule (10) est formée monobloc à partir d'une matière pouvant se déformer de manière souple, comme des plastiques moulés par injection, de préférence un polyéthylène basse densité.
EP98954593A 1997-11-14 1998-11-13 Spatule medicale Withdrawn EP1030601A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ZA9710284 1997-11-14
ZA9710284 1997-11-14
PCT/GB1998/003431 WO1999025251A1 (fr) 1997-11-14 1998-11-13 Spatule medicale

Publications (1)

Publication Number Publication Date
EP1030601A1 true EP1030601A1 (fr) 2000-08-30

Family

ID=25586717

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98954593A Withdrawn EP1030601A1 (fr) 1997-11-14 1998-11-13 Spatule medicale

Country Status (10)

Country Link
EP (1) EP1030601A1 (fr)
JP (1) JP2001522683A (fr)
CN (1) CN1282229A (fr)
AU (1) AU1164999A (fr)
BR (1) BR9814190A (fr)
CA (1) CA2310254A1 (fr)
HU (1) HUP0100218A3 (fr)
ID (1) ID21307A (fr)
PL (1) PL340584A1 (fr)
WO (1) WO1999025251A1 (fr)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0015304D0 (en) 2000-06-23 2000-08-16 Cellpath Plc Improved medical sampler
GB2359257B (en) * 2001-02-06 2002-01-16 Platinum Feather Consultants L Spatula
GB0108554D0 (en) 2001-04-05 2001-05-23 George Samuel Health screening device
US6929926B2 (en) 2001-10-15 2005-08-16 Barry J. Marshall Composition for the detection of gastrointestinal disorders
US7540844B2 (en) * 2003-08-20 2009-06-02 Becton, Dickinson And Company Cell scraper
RU2240093C1 (ru) * 2004-01-21 2004-11-20 Московский научно-исследовательский институт глазных болезней им. Гельмгольца Минздрава РФ Офтальмологический шпатель
FR2881339B1 (fr) 2005-02-02 2009-07-10 Commissariat Energie Atomique Dispositif de prelevement moleculaire par contact
FR2903590B1 (fr) * 2006-07-13 2013-05-10 Commissariat Energie Atomique Dispositif de prelevement cellulaire par contact
CN103725594B (zh) * 2013-12-25 2015-07-29 广州洁特生物过滤股份有限公司 一种细胞刮刀
CN104825197A (zh) * 2015-05-18 2015-08-12 南京同仁医院 一种刨刀漏网式宫颈管搔刮器
RU189496U1 (ru) * 2018-04-11 2019-05-24 Научно-Производственный Кооператив "Синтакон" Медицинский шпатель для контейнера с транспортной средой, в частности консерванта
RU194902U1 (ru) * 2019-09-18 2019-12-26 Федеральное государственное бюджетное образовательное учреждение высшего образования "Курская государственная сельскохозяйственная академия имени И.И. Иванова" Шпатель для исследования ротовой полости, глотки и гортани у животных
EP4215121A4 (fr) * 2020-09-16 2024-08-14 Bionlifescience, Inc. Bâtonnet de collecte d'échantillon
EP4215122A4 (fr) * 2020-09-16 2024-10-23 Bionlifescience, Inc. Tige de collecte d'échantillon
CN116323905B (zh) * 2020-09-16 2025-10-17 生物生命科学股份有限公司 样本采集棒
US12558076B2 (en) * 2020-09-16 2026-02-24 Bionlifescience, Inc. Sample collection stick
JP7607326B2 (ja) * 2021-03-12 2024-12-27 株式会社北里コーポレーション 子宮内組織採取具

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2471088A (en) * 1947-10-01 1949-05-24 Clay Adams Company Inc Cervical scraper
GB1408140A (en) * 1971-12-09 1975-10-01 Levene M M Sampling device
ATE27680T1 (de) * 1982-09-14 1987-06-15 George Pistofidis Gynaekologischer spatel.
US4759376A (en) * 1984-05-29 1988-07-26 Nils Stormby Endocervical sampling brush and smear method
WO1993001749A1 (fr) * 1991-07-17 1993-02-04 Lonsten Pty. Limited Dispositif de prelevement de frottis vaginal
BR9307275A (pt) * 1992-10-23 1999-06-01 Lonsten Pty Ltd Sonda endocervical para extremidade dianteira de amostragem de esfregaço de papanicolaou

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9925251A1 *

Also Published As

Publication number Publication date
AU1164999A (en) 1999-06-07
WO1999025251A1 (fr) 1999-05-27
PL340584A1 (en) 2001-02-12
JP2001522683A (ja) 2001-11-20
CA2310254A1 (fr) 1999-05-27
BR9814190A (pt) 2000-10-03
CN1282229A (zh) 2001-01-31
HUP0100218A2 (hu) 2001-06-28
HUP0100218A3 (en) 2001-07-30
ID21307A (id) 1999-05-20

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