CN101103931B - Device containing absorbent stuffing used for collecting clinical diagnose analyzing sample - Google Patents

Device containing absorbent stuffing used for collecting clinical diagnose analyzing sample Download PDF

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Publication number
CN101103931B
CN101103931B CN2006100993109A CN200610099310A CN101103931B CN 101103931 B CN101103931 B CN 101103931B CN 2006100993109 A CN2006100993109 A CN 2006100993109A CN 200610099310 A CN200610099310 A CN 200610099310A CN 101103931 B CN101103931 B CN 101103931B
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sample
fiberfill
fiber
layer
scopiform
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CN2006100993109A
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CN101103931A (en
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诺曼·沙普尔斯
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Copan Italia SpA
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MICRO RHEOLOGY HOLDING CO Ltd
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Abstract

The invention relates to an apparatus which is composed of absorptive fillers for collecting samples for clinical diagnosis and analysis. The component of the invention comprises a rod whose ends are covered with the absorptive fillers which is made from fibrous material with hydrophile property for easy absorbing the samples. The invention is characterized in that the layered and brush-shaped fiber is covered on the ends of the rod; the brushed fiber layer is formed in an electrostatic field, that is to say, the fiber is deposited to be formed in certain directions on the ends of the rod under the action of the electrostatic field.

Description

The device that is used for collecting clinical diagnose analyzing sample that comprises absorbent filler
Technical field:
The present invention relates to a kind of device that comprises absorbent filler, it is used to gather the clinical analysis of diagnosis Biosample, and preparation method thereof, and the workbox that comprises this device.
Background technology:
As everyone knows, in the clinical analysis of diagnosis field, the absorbent filler of gathering the tissue biological specimen is applied in the afterbody (being also referred to as the end) of bar usually, fiberfill that is wound such as natural fibers such as staple fibre or Cotton Gossypii have necessary water-wet behavior and can the fast Absorption sufficient amount be used to the sample gathering and test.Usually adopt glue that fiber is firm bonding along boom end.
Generally, if especially come the mode of cultivating microorganism to carry out under the situation of pattern detection by the sample that collects, behind sample collection, absorbent filler should be immersed in the test tube that contains culture medium immediately, at storage and/or during sample is transported to the laboratory so that sample is carried out appropriate preservation.
Usually; the end of bar is made by the materials such as plastics that certain degree of hardness is arranged; for example pressing mold is made; butt is arranged usually; if it makes that the end does not obtain under the situation of fine protection, the very difficult bar that will twine absorbent filler inserts in some patients that need extract sample cavity on one's body (in oral cavity, nasal cavity, eyes, rectum, urethra and the vagina).
Therefore, the hydrophilic fibre filler that is wrapped in the above-mentioned boom end that scabbles not only needs to have the sample (usually the quantity of needs are 100 microlitres) of abundant material to absorb desired amt, but also must have enough thickness and rounded, could protect the edge of truncated position end face like this, so as in collecting the sample process, to be unlikely to cause the patient other damage or make the patient feel uneasy.
Because above-mentioned reason; the rounded end that is wrapped in bar of fiberfill; typical shape is to be dome-shaped or similar shape so that at the thickening gradually of fiberfill on the cylindrical end winding direction in the end, could just in time reach maximum ga(u)ge like this and therefore produce best protection effect on the circumference of end, truncated position.The fiberfill of this shape, the protection patient exempt from the above-mentioned cylinder end face that blocks cause dangerous in, also caused many shortcomings.
One of major defect is the thickness of above-mentioned fiberfill, because the water-wet behavior of fiber, thereby the sample that causes gathering is penetrated in the fiberfill.
Consider based on practicality, when the needs analyzing samples, twining the boom end of absorbent filler and sliding along the Petri dish that culture medium is for example arranged (petridish) slightly by simple clamping, therefore soak in the fibrous material and expired liquid, in the actual mechanical process, usually sample is dispersed in (erasing) in the vessel, can not discharge the sample (for example quantity of 100ml) that obtains equal number even repeat such operation more carefully yet, because the part in the sample has penetrated into fiberfill inside, end, these samples can not be extruded on the surface of fiberfill, thereby also this part sample can't be discharged in slip extrusion process.
Because such shortcoming, the sample mean of collecting in the practical situation only have only 40% can recover to be used for to analyze.The reduction of sensitivity when so many inevitable sample losses has caused analyzing, and increased false negative.Notice these aspects, still have above-mentioned average sample loss amount after the method with reference to the erasing absorbent filler, only test the 40 μ l samples that from the 100 μ l samples of collecting at first, adopt erasing and discharge, whether can set up an effective negative test result and become difficulty, reason is owing to lack the microorganism that can search out, more definite reason be from absorbent filler do not transfer to the test panel or the sample size of shifting inadequate.
Also have a problem come from our known absorption filler the fiberfill volume bigger, especially in that to be used under urethra or the eyes situation problem more obvious.
In above-mentioned and other application-specific, in fact this problem will be a subject discomfort in the collected specimens process of making us more expecting to be solved that promptly can reduce the thickness of absorbent material filler and bring thus.
Summary of the invention:
The object of the invention is to address the above problem.
The present invention proposes a kind of device, it comprises the absorbent filler that is used to gather the clinical analysis of diagnosis sample, its form is the bar that the end has covered the above-mentioned filler of being made by fiber, thereby this fiber possess hydrophilic property can absorb above-mentioned sample, and above-mentioned fiber is deposited in order in described boom end successively according to orientation and becomes the scopiform layer to cover described end in electrostatic field.
Between described fibrous layer middle level and the layer is fully parallel, and perpendicular to the bar surface.Described end geometries is circular, is similar to sharp dome-shaped, and described fiberfill is arranged with identical thickness.
Described device is used to improve fluid sample or the collection of the sample be made up of cell improves.
Described fiber thickness scope is between 0.5 to 3mm.The weight range that described fiber has is 1.0 to 22.0 dtexs.The length of described fibrolaminar fiber and weight range are from the fine fleece of 0.5mm and 1.0 dtexs, to the long wool of 3mm and 22.0 dtexs.
Described fiber is selected from staple fibre, polyester, polyamide, carbon fiber or alginate, and natural material is as cotton, silk material, perhaps cotton, silk composite material.
The present invention also provides a kind of workbox of gathering and transporting biological sample, and it includes the test tube and the aforesaid device of culture medium.
The present invention also provides the preparation method of the fiberfill of described device, and it is bonding to comprise the steps: to use binding agent to carry out fibrous layer at described boom end; Place the electrostatic field fiber to form the scopiform layer with certain orientation sequential aggradation successively described fiber in described end.
The above-mentioned fiber that becomes according to orientation sequential aggradation successively can play the capillary effect of enhancing, and this capillarity is improved the ability that absorbs liquid state or cell class sample.
The fibrolaminar erasing effect of scopiform has also improved the collection effect of the sample of being made up of cell, and Ding Xiang fiber can be caught cell fully in this case, and improves and finally separate out the effect of cell from said apparatus.
Description of drawings:
Fig. 1 has shown that wherein said scopiform fibrous layer is shown schematically among the figure based on the longitudinal sectional view of the boom end of the device that comprises absorbent filler of the present invention;
The thin portion of Fig. 1 enlarged drawing when Fig. 2 display device is used to collect liquid sample;
Fig. 3 display device is thin portion enlarged drawing when being used to collect the sample of being made up of cell.
The specific embodiment:
In order to understand the features and advantages of the present invention better, with reference to the accompanying drawings and following non-limiting example.The example of being told about is suitable for collecting simultaneously and store the situation of the absorbent filler of biological sample, and such as a kind of built-in test tube of culture medium, the microorganism that is suitable for having gathered will be immersed in the culture medium in the absorbent material after the collection.
With reference to above-mentioned accompanying drawing, shown based on the present invention device comprise: be located at the absorbent filler 20 of the end 16 of bar 14, the form of absorbent material is the stratiform scopiform, and it is formed sequential aggradation end successively by fiber alignment in electrostatic field.Therefore absorbent filler 20 has been carried, the promptly above-described fibrous layer that is used for the collection analysis sample in the end 16 of bar 14.In the example, described boom end 16 its geometries are rounded, are similar to Gothic arch shown in the figure, and described fiber 17 is changed to the layer of same thickness.
In detail drawing 2, how schematically shown described fiber 20 and be orientation sequential aggradation successively, parallel to each other and with respect to the boom end Surface Vertical, so just improved capillarity, make liquid sample 10 all be absorbed.
In detail drawing 3, how schematically shown above-mentioned brush shape fibrous layer 20 and be orientation sequential aggradation successively, each layer fiber all is parallel and with respect to the boom end Surface Vertical, the effect that the sample 11 (such sample can all be hunted down in the fiber of orientation) that improved collection is made up of cell is provided equally and has discharged when using subsequently.
Briefly say, according to basic feature of the present invention: the applying filler of above-mentioned possess hydrophilic property is in electrostatic field, fiber is according to certain orientation sequential aggradation successively in electrostatic field, it is vertical being preferably with the surface of boom end, and the boom end surface has adopted the method for soaking or spraying to apply binding agent before.
Fiber is anchored on the end surface, by binding agent it is maintained.
Binding agent is preferably aqua type, treat the binding agent drying after fiber can be anchored on the end securely, and can be wear-resistant.
Layers of absorbent material is by being exposed to thermal source or radio frequency source is dried then.
In the device of the present invention, boom end has covered one deck fiber, and it is 0.5 to 3mm that fiberfill preferably has its scope of uniform thickness.
Based on type and the characteristics such as selected layer thickness and fineness that are deposited as fibrous layer based on fiber of the present invention, and the mode that can absorb 100 μ l samples is determined the consumption of fiber.
Consumption based on the purposes fiber that installs is preferably in 2000 to 100000 unit scopes.
The consumption of fiber is weight in other words, is preferably between 1.0 to 22.0 dtexs (Dtex), and Dtex (decitex) is a kind of unit of measuring fiber or yarn weight, and it is 1 gram that 1Dtex is equivalent to the long fibre weight of every 10000m.Especially, 0.5mm fiber long and 1.0Dtex is used to obtain superior fine fleece, and length surpasses 3mm and weight and can be used for obtaining long wool above the fiber of 22.0Dtex, thereby corresponding layer thickness and fineness characteristic are provided in scope defined above.In such scope, yet increasing fineness, reduces thickness, on the contrary also anti-.
In so wide in range estimation of fibres scope, the makeshift that we should consider according to purpose of the present invention be keep fiber be arranged in order order, layer with layer between fully parallel, preferably vertical for the boom end surface, avoid when the fine fleece fiber is long contingent any overlapping phenomenon between the fiber.In fact, each layer fiber all has capillarity in this sample loading mode, by the capillarity fiber can finish absorb and precipitated phase with the task of number of samples, and fiber is without prejudice, the maintenance corresponding function.
According to purpose of the present invention, can be from having of providing by selecting used fiber the very large-scale material of capillary effect performance hydrophilic, these materials for example: synthetic material or artificial material such as staple fibre, polyester, polyamide, carbon fiber or alginate, natural material is as cotton, silk material, perhaps cotton, silk composite material etc.
Experimental example:
According to the present invention, provide the example that some include the device of absorbent filler below.These examples are not inclined to and limit this scope of invention.
Example 1
A kind of absorbent filler that uses plastic bar is suitable for the clinical collection of human body, and the plastic bar diameter is 2.5mm, and the section diameter that length surpasses 6cm is reduced to 1mm.
Have the end immersion or the spraying of minimum diameter to go up binding agent, bar is placed vertically at the vessel that are arranged in electrostatic field so that the deposition Fypro then.
Length is the Fypro of 0.7mm, 1.7 Dtex, allows to absorb on every 2mm length the sample of 0.5 μ l, and by covering the long above-mentioned boom end of 10mm, the sample size of absorption can reach 40Pi like this.
According to example 1, used bar with bamboo chip shape end, be suitable for gathering the sample in the patient oral cavity.Used in this example that 1mm is long, the dacron of 1.7 Dtex is as fiberfill.
According to example 1 and example 2, used the dacron of long 2mm, 2.5Dtex.
Again to sum up, it is calculated that in the present invention by the erasing absorbent filler can discharge absorb 90% of sample size.The absorbent filler of the prior art of comparing adopts this mode can significantly improve the sensitivity of test, can eliminate thoroughly especially almost that test causes false negative result the test panel because of by halves the sample that collects being precipitate into from absorbent filler.
In addition according to the present invention, can form any thickness even very thin fibrous layer but not the masses of fibres layer that formed in the process in the past covers the end around boom end, this fact means circle that absorbent filler is required to be, and does not just have the edge.Absorbent filler needn't rely on a large amount of fibers again then depend on the end shape of bar, so that preferably do the end of bar is circular, as the aforementioned shown in example and the accompanying drawing.
Particularly under some specific situations, require absorbent filler to have the thin thickness of most probable, when for example being used to gather the sample of urethra and eyes, this has further represented the advantage of determining more than the known absorption filler.In fact, because absorbent material shape variable thereby can have the shape of rounded ends.Can gather enough quantitative analysis samples according to the present invention on the one hand round the sedimentary thin fiber layer of rounded ends, on the other hand can minimum absorption packing volume the best part (lunging the part of urethra) thus reduce the discomfort that the patient stands in the gatherer process and feel.
According to the type of set collection sample, the shape of end of given absorbent filler can not alter a great deal (when gathering sample in people's the oral cavity) profile even can have been scabbled or have the edge when grab type allows.
According to the present invention, the characteristic of the type of the type of adhesive, fiber and fiber such as length and metering under any circumstance can be selected in the scope of broad, purpose is to obtain desirable and clear and definite sign for the discriminating microbiological specimens, no matter the method for differentiating is by direct diagnostic techniques, immunoassay, perhaps molecular biotechnology polymerase chain reaction for example also has other known cultivation, concentrates or the selectivity technology.
Usually form by antibacterial, virus, DNA, RNA or above-mentioned mixture with the sample that the used absorbent filler of the present invention is gathered.

Claims (7)

1. device that is used for collecting clinical diagnose analyzing sample, it comprises that the end is coated with the bar of hydrophilic fibre filler, so that absorb described sample, it is characterized in that: described fiberfill is deposited in order in described end formation scopiform layer successively according to certain orientation and covers described boom end in electrostatic field, described fiberfill is perpendicular to the bar surface, described scopiform layer has same thickness to absorb described sample by capillary effect, described fiberfill thickness range is between 0.5 to 3mm, and described fiberfill weight range is 1.0 to 22.0 dtexs.
2. device as claimed in claim 1 is characterized in that: described end geometries is circular.
3. device as claimed in claim 2 is characterized in that: described end geometries is sharp dome-shaped.
4. device as claimed in claim 1 is characterized in that: described device is used to improve fluid sample or the collection of the sample be made up of cell.
5. device as claimed in claim 1 is characterized in that: described fiberfill is selected from staple fibre, and the natural material that is selected from cotton, silk, perhaps cotton, silk composite material.
6. be used to gather and transport the workbox of biological sample, it is characterized in that: it includes arbitrary described device among the test tube of culture medium and the claim 1-5.
7. as the fiberfill preparation method in arbitrary described device among the claim 1-5, it is bonding to it is characterized in that comprising the steps: to use binding agent to carry out fibrous layer at boom end; Described fiberfill is placed electrostatic field, and fiberfill forms the scopiform layer in described end with certain orientation sequential aggradation successively.
CN2006100993109A 2006-07-13 2006-07-13 Device containing absorbent stuffing used for collecting clinical diagnose analyzing sample Ceased CN101103931B (en)

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CN101103931B true CN101103931B (en) 2011-09-28

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Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2499665A (en) * 2012-02-27 2013-08-28 Exmoor Innovations Ltd A device for obtaining cell block samples
US10935555B2 (en) 2016-12-22 2021-03-02 Qiagen Sciences, Llc Determining candidate for induction of labor
US10656164B2 (en) 2016-12-22 2020-05-19 Qiagen Sciences, Llc Screening asymptomatic pregnant woman for preterm birth

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1070850A (en) * 1992-09-03 1993-04-14 刘福元 Normal temperature electrostatic flocking method and equipment
CN2183735Y (en) * 1993-12-08 1994-11-30 梅兹坎得·Ab Sampling tool
CN2274936Y (en) * 1996-07-12 1998-02-25 周东桥 Disposable sampling device for cell
CN2460050Y (en) * 2001-01-18 2001-11-21 江苏苏云医疗器材有限公司 Medical sampling swab
CN2479505Y (en) * 2001-03-30 2002-02-27 王佑雄 Microbial teting box
CN2554995Y (en) * 2002-08-05 2003-06-11 宁波美生医疗器材有限公司 Sampler for uterine cervix

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1070850A (en) * 1992-09-03 1993-04-14 刘福元 Normal temperature electrostatic flocking method and equipment
CN2183735Y (en) * 1993-12-08 1994-11-30 梅兹坎得·Ab Sampling tool
CN2274936Y (en) * 1996-07-12 1998-02-25 周东桥 Disposable sampling device for cell
CN2460050Y (en) * 2001-01-18 2001-11-21 江苏苏云医疗器材有限公司 Medical sampling swab
CN2479505Y (en) * 2001-03-30 2002-02-27 王佑雄 Microbial teting box
CN2554995Y (en) * 2002-08-05 2003-06-11 宁波美生医疗器材有限公司 Sampler for uterine cervix

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Address after: Brescia Italy

Patentee after: Kepan Enfu Laike Technology Co.,Ltd.

Address before: 14 masti street, Brescia, Italy

Patentee before: MICRO RHEOLOGY HOLDING Co.,Ltd.

TR01 Transfer of patent right

Effective date of registration: 20201216

Address after: Brescia Italy

Patentee after: COPAN ITALIA S.P.A.

Address before: Brescia Italy

Patentee before: Kepan Enfu Laike Technology Co.,Ltd.

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Decision date of declaring invalidation: 20220429

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Granted publication date: 20110928

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Volume: 39