For vaginal fluid collect from sampling equipmentTechnical field
Present invention relates in general to screenings and healthy control field.More particularly, the present invention relate to vaginal fluid surveysExamination from sampling equipment, with detect for example with the relevant cervical carcinoma of virus, microorganism infection and pathological change.
Background
Pap smear, cervical smear or smear test are for detecting in uterine neck before potential cancer and the uterine neck of cancer disease processThe different names of screening method.Abnormal results are often followed by more sensitive diagnostic program, and if it is necessary, are followed by dryIn advance, which is intended to that cervical carcinoma is prevented to continue to develop.The laboratory point for the common type that sample material to being derived from vagina carries outAnalysis is the DNA analysis for HPV (human papilloma virus).Traditionally, cervical smear test is needed with sampling equipment (for example, scrapingKnife or brush) scrape women uterine neck.Usually by the medical professional in clinical setting, (such as gynaecologist helps for this samplingProduction scholar or nurse) it executes.Many women avoid this gynecologial examination now, and if sampling can be at home and/or by femaleProperty oneself carry out if, they can participate in this gynecologial examination.Therefore, self and family sample and will increase the participation of screening,And in this way, reduce the incidence of cervical carcinoma.2003/0028123 A1 of US disclose intravaginal from the thin of applicationBorn of the same parents' collecting device, but there is no snap-fit connection.US 5,445,164A are disclosed in the case of cervical tissue sampling equipmentQuick release attachment device, but the relieving mechanism is based on making sleeve slide lug and part until being engaged afterwards in an axial directionExposure.Then pin can be manually made to be detached from hole, to complete the separation of bar and axis.In addition to that mentioned above, it is also necessary to be used for DNAThe sampling system of analysis.Law enforcement official, patriarchy agent etc. often take DNA sample to help to solve crime, determine fatherDeng.Since the test result carried out to these samples significantly affects people’s lives, and may be needed in lawsuitAs evidence, sampling must be carried out in a manner of sample contamination is reduced or avoided.
One of the system suitable for self-test is described in the European patent EP 1903946B1 of Sweden Aprovix ABExample.The known system brings many advantages better than prior art solution.
Sample collection member is by snap-fit connection removedly with axis connection, and the snap-fit connection is by sampleThe protruding portion of the end of collection device is formed, and is suitable for snapping into the extension at the other end of axisIn slot in.With snapping fit attachment depending on the precise match between protruding portion and slot, so as to consistently for protruding portion and slotIt executes for sample collection member is remained connected to handle, and also allows when sample collection member is in salable unitWhen, sample collection member is detached with handle.This precise match needs the component (the i.e. handle and sample collection that have to being producedElement) measurement extensive quality system.Test is time-consuming and expensive, and therefore discards the portion produced in batchPart.
Using during being sampled from sampling equipment shown in EP1903946B1, there is risk slightly, i.e., excessivelyLateral force make the snap-lock between sample collection ontology and handle engagement be detached from, cause sampling when lose to sample collectionThe control of ontology.In addition, by the rotation of sample collection member, protruding portion is discharged from the slot in be contained in extension.However,At least to a certain extent, protruding portion usually also tends to grasp recess portion after rotation, is prevented from wherein being readily detached from.
Therefore, it is necessary to it is a kind of it is improved consistently executed from sampling equipment, and do not need extensive quality in productionTest.
It summarizes
The object of the present invention is to provide a kind of improved from sampling equipment, which alleviates disadvantages mentioned above.
According to the first aspect of the invention, by for the vaginal fluid (vaginal fluid) from user's vaginaRealize the purpose and other purposes from sampling equipment, it is described from sampling equipment include for being inserted into the elongated of user's vaginaThe first noumenon and for from user collect vaginal fluid sample sample collection ontology.Sample collection ontology can pass throughReleasable connecting device is attached to the inner end part of elongated the first noumenon.Elongated the first noumenon is configured so that it can be byUser's operation from vagina with the sample collection ontology for being attached to the first noumenon to collect fluid sample.Releasable connecting device packetThe first interlock on one be arranged in the first noumenon and sample collection ontology is included, and is arranged in elongated firstThe second interlock on another in body and sample collection ontology.First interlock is provided with axis, which defines substantiallyOn transverse to the first noumenon longitudinal axis rotation axis.Second interlock include the first hole or recess portion, first hole orRecess configuration is at receipts axis is received when the first and second interlocks connect, for making sample collection ontology relative to firstBody rotates between the first position and the second position around rotation axis, in first position, the longitudinal axis of sample collection ontologyIt is aligned with the longitudinal axis of the first noumenon, in the second position, the longitudinal axis of sample collection ontology surrounds rotation axis far from instituteState first position rotation preset distance.First and second interlocks be also respectively provided with corresponding first snap lock means andSecond snap lock means, first snap lock means and the second snap lock means are configured at first position, canThe engagement of release ground prevents the first interlock and the when snap lock means (snap-locking means) engagement each other, to work asRelative rotation between two interlocks.First and second interlocks are configured so that in the second position, the first interlockingDevice and the second interlock can removed from the first hole or recess portion in scheduled off-direction by axis and be detached from.AndAnd first interlock and the second interlock be configured so that in the first position, axis be limited in first hole orIn recess portion.
Axis and corresponding hole or recess portion provide the specific relative rotary motion between sample collection ontology and the first noumenon.Snap lock means by sample collection ontology for being maintained at first position during use so that by holding the first noumenonOuter end portion can control the movement of sample collection ontology and operate sample collection ontology and be sampled, just as above-mentionedUse described in EP1903946B1.The axis of first attached device limits the available freedom of sample collection ontology movementDegree so that it is only capable of the rotary motion clearly defined according to and is moved from its first position.Therefore, snap lock means are mainIt needs processing to be applied to the momentum of sample collection ontology, and relative translation motion need not be handled.Axis and snap lock meansThis combination provides lose the relatively low-risk of the control to sample collection ontology in sampling.The design can even useWeaker snap lock mechanism with the lasting control to the sample collection ontology in vagina.Using weaker mechanism provide compared withThe use of few material, and influenced to provide less environment.After sampling, sample collection ontology is taken out simultaneously from vaginaIt is inserted into small container to protect sample.After the insertion, apply momentum to rotate to sample collection ontology and the first noumenonThe second position.In the second position, the first noumenon is simply removed from sample collection ontology so that sample collection ontology due toThe gravity that acts on sample collection ontology and stay in a reservoir.Then the first noumenon is abandoned, and is for example sealed by lidContainer, to prepare the analysis for future.
Since the first interlock and the second interlock are in the second position (rather than in described first position)It is departing, firm holding is provided in first position, and provide in the second position and be readily detached from.Sample collection sheetBody can easily be detached with the handle with minimum power, and need not manually hold sample collection ontology with by its fromThe first noumenon pulls down.In addition, being well controlled in sampling period sample collection ontology.
In one embodiment, axis is arranged at the first proximal part of the first interlock.In addition, corresponding buckleFirst in locking device is arranged at the first distal portions of the first interlock.
The proximal part of corresponding interlock is such part, that is, the part is corresponding closest to being provided on itInterlock sample collection ontology or the first noumenon.By providing axis at the proximal part of the first attached device,Axis and on it setting axis sample collection ontology or the first noumenon between almost without distance, and therefore axis by rigidly attachedIt connects and immovable too many.This provides the more preferable of relative rotation/movement between the first noumenon and sample collection ontologyControl.Similarly, the distal side positioning of the first snap lock means provides snap lock means and attached with the first interlockThe distance of bigger between the sample collection ontology or the first noumenon that connect, and therefore can increase the soft of snap lock meansProperty.Increased flexibility allows snap lock mechanism being designed to that the main source of bias force is first interlock itself, toSimple and strong design is provided.
In order to further specify that the position of proximal part and distal portions, the first proximal part of the first interlock are neighbouringIt is provided with the first noumenon or sample collection ontology of the first interlock on it.Similarly, the first distal portions are closer than firstEnd part is further from the sample collection ontology or the first noumenon for being provided with the first interlock on it.
In embodiments, the first hole or recess portion laterally open so that when being detached from, axis can laterally be moved from the second positionGo out the first hole or recess portion.
Keep the first hole or recess portion laterally open so that axis lateral/radial remove the first hole or recess portion, rather than mustIt must be moved along the longitudinal axis of axis.
In embodiments, the first interlock includes fork-shaped ontology, which includes defining intermediate space togetherOpposite handle, the intermediate space along the first noumenon longitudinal axis extend.Axis prolongs from a handle across the intermediate spaceReach another handle.Second interlock includes the elongate bars in the intermediate space being adapted to fit between handle.In addition, secondFirst hole of interlock or recess portion are laterally open for receiving axis.
Keep the first hole or recess portion laterally open so that axis lateral/radial remove the first hole or recess portion, rather than mustIt must be moved along the longitudinal axis of axis.This allows axis to be fixed on both ends again, without interfering the first interlock and the second interlocking dressThe disengaging set.Fixing axle provides the strong fixation of axis at both ends, so as to use with the weaker of less materialAxis.It is advantageous using less material, because being equipment to be intended for single use, and therefore cost and environment influence from sampling equipmentIt is more important than long durability.
In one embodiment, the first hole or recess portion are laterally opened on the direction of the length along the second interlockIt puts.
This construction of first hole or recess portion makes once sample collection ontology is vertically oriented in a reservoir and the first structurePart is rotated to take sample collection ontology to the second position, then sample collection ontology is easily separated from.Since axis can be removed verticallyFirst hole or recess portion, then sample collection ontology therefore dropped down onto in container by free gravity.
In embodiments, axis is largely cylindrical, has at least one recess of the length along axis.ThisOutside, the first hole or recess portion have the cross-sectional shape of the circular middle portion with the full diameter corresponding to axis.The middle partDivide and is laterally outwardly opened in the form of the channel of the minimum widith with the diameter less than axis.In addition, the recess of axis definesProjected outline (projected profile) of the axis in the plane across the longitudinal axis of axis, wherein the projected outline is smallIn channel so that axis moves through the channel from the second position.
By providing such recess for axis, axis is stopped moving across except when axis is oriented at the second positionPath, in the second position axis expose its be less than channel projected outline.This allows the first interlock and the second interlocking dressEngagement is set always to allow relative rotation, and prevents relative translation when being not at the second position simultaneously, to limit axisSystem is in the first hole or recess portion.
In one embodiment, channel broadens outward far from circular middle portion.This construction that broadens in channel providesSurface for being directed to axis in assembled shaft in channel.So that manually and automatically assembly is easier and more may be usedPrediction.
In embodiments, the first hole or recess portion include auxiliary recess, and the auxiliary recess is from circular middle portionIt point far from channel and is partially toward the second snap lock means along the length of the second interlock and extends internally.It assists recessedIt is less than the diameter of middle section into the width of part.
The auxiliary recess inwardly further extended improves the elasticity of the second attachment device so that even if not describedThe second position, axis can also be forced into circular middle portion.This makes it possible to rapidly and easyly assemble the first noumenon and sample againThis collection ontology.Another advantage is, if biased engagement is interested, improved elasticity can realize axis and firstControlled bias between hole or recess portion.
In embodiments, in the contact site that corresponding snap lock means are arranged between bar and handle.
Snap lock means are provided in contact site between handle and bar enables the elasticity of handle to force corresponding buckleLocking device together, such as by forcing one or more protruding portions to enter one or more corresponding recess portions.This is providedRealize the simple mechanism of the desired bias capability of snap lock means.
In embodiments, the protruding portion of the first snap lock means is arranged on handle.In addition, snap lock means are extremelyA few recess portion is arranged in bar.In addition, the protruding portion of the first snap lock means includes front chamfered part (forwardlyChamfered portion), which is oriented when bar is inserted into chamfered part along the longitudinal axis of the first noumenonBetween when, make bar gradually push protruding portion separate.
Snap lock means this construction promotes be inserted into intermediate space along the longitudinal direction of the first noumenon in barThe quickly and easily assembling of the first noumenon when middle, wherein the risk of period of assembly damage protruding portion is reduced, because of chamfered sectionDividing makes bar be easier to push the protruding portion of snap lock means to separate in period of assembly, and thereby reduces the stress to protruding portion.The surface of deformation or damage on the protruding portion of snap lock means can increase the failure risk from sampling equipment, such as too looseBuckle is functional or the direct risk of the control to sample collection ontology is lost in sampling.
Reference numeral table
Brief description
Fig. 1-18 all shows first embodiment of the invention.
Fig. 1-7 is shown in which that sample collection ontology rotates to its second position to prepare and its remaining part from sampling equipmentThe view of separation.
Fig. 8-15 is shown in which that sample collection ontology, which is rotated to it, is ready for the view of the first position of sampling.
Fig. 1 and Fig. 9 is vertical view.
Fig. 2 and Figure 10 is rearview.
Fig. 3 and Figure 11 is side view.
Fig. 4 and Figure 12 is front view.
Fig. 5 and Figure 13 is cross sectional side view.
Fig. 6 and Figure 14 is diagonal perspective view seen from above.
Fig. 7, Fig. 8 and Figure 15 are the enlarged drawings of the first and second interlocks.
Figure 16 is the detail drawing for the amplification for showing the first interlock.
Figure 17 is the side view of sample collection ontology and the second interlock being arranged on sample collection ontology.
Figure 18 be also shown in Figure 17 sample collection ontology and the second interlock for being arranged on sample collection ontologyVertical view.
Detailed description
To hereinafter disclosed embodiment be described in greater detail with reference to the attached drawings, the invention is shown in the accompanying drawingsSome embodiments.However, the present invention can be embodied in many different forms, and should not be construed as limited to be explained hereinThe embodiment stated.But these embodiments are provided as example so that the disclosure will be complete and complete, andAnd it will fully express the scope of the present invention to those skilled in the art.Similar label reference is similar member in the textPart.
The present invention's represents the further development from sampling equipment described in EP1903946B1 from sampling equipment, andAnd it is used to collect sample in an identical manner, and be sent to by being posted in special small container/salable unit, withFor analyzing.Therefore, it is known from such use of sampling equipment, and this specification will focus on and be set from samplingThe standby new Curve guide impeller of itself.In sampling, it is operated to sample collection ontology from sampling equipment and surrounds its longitudinal axisIt rotates, while it laterally being pushed to the mucous membrane of vagina so that vaginal fluid is sticked in the recess portion of sample collection ontology.
Therefore, the present invention provides one kind from sampling equipment 1, can be by personal use, in sanitary condition from sampling equipment 1Under, easily and securely take at home or when accessing medical space be intended for subsequent lab analysis (such as butBe not limited to the DNA analysis to HPV) vaginal fluid sample.Sample can transport in small resealable container, without infectingThe risk of pollution or the propagation of property substance, and other immunologys or micro- (such as DNA analysis or are passed through by chemical method laterBiological method) it is analyzed.
Referring to Fig.1-18, it will be described below the first embodiment according to the present invention from sampling equipment 1.It is set from samplingStandby 1 includes the elongated the first noumenon for being inserted into the vagina of user, and for collecting vaginal fluid sample from userSample collection ontology 3.Sample collection ontology 3 could attach to the inner end of elongated the first noumenon by releasable connecting device 5Portion part 4.Inner end part be in use the first noumenon insertion vagina part, and the outer end portions of the first noumenon beThe part held by the user operated from sampling equipment in use.Therefore, the first noumenon is used as handle.
Elongated the first noumenon is configured so that it can be operated by user with the sample collection for being attached to the first noumenonOntology 3 collects vaginal fluid sample from vagina.This means that the first noumenon with length and shape appropriate to be grasped by individualMake executed in vagina from sampling.In the first embodiment, the length of the first elongate body is 145mm, wherein narrow circleCylindrical body part is 93mm long and the diameter with 4mm, and the width/diameter of wherein grip portion is 10mm, lengthFor 32mm.The rest part of first elongate body is occupied by the first interlock 6 as described below.
Releasable connecting device 5 includes the first interlock 6 being arranged on elongated the first noumenon and is arranged in sampleCollect the second interlock 7 on ontology 3.
First interlock 6 includes fork-shaped ontology, which includes opposite handle 16,17, and handle 16,17 defines togetherThe intermediate space 20 extended along the longitudinal axis 10 of the first noumenon.Axis 8 extends across the intermediate space 20 from a handle 16To another handle 17, for defining the rotation axis 9 for the longitudinal axis 10 for being generally transverse to the first noumenon.Therefore, axis 8Two opposed ends are attached/support.
Second interlock 7 includes the elongate bars 21 being adapted to fit in the intermediate space 20 between handle 16,17.Bar 21It is provided with through-hole, which receives axis 8 in the first interlock 6 and the connection of the second interlock 7, for making sampleThis collection ontology 3 is rotated relative to the first noumenon around rotation axis 9 between the first position and the second position, at firstIt sets, the longitudinal axis 18 of sample collection ontology 3 is aligned with the longitudinal axis of sample collection ontology 3, as shown in Fig. 9-15,The longitudinal axis 10 that two position samples collect ontology 3 rotates preset distance D around rotation axis 9 far from the first position, such asShown in Fig. 1-8.
First interlock 6 and the second interlock 7 are also respectively provided with corresponding first snap lock means and secondSnap lock means, first snap lock means and the second snap lock means are configured to release each other when at first positionIt engages with putting, to prevent the opposite rotation between the first interlock 6 and the second interlock 7 when snap lock means engageTurn.In the contact site that corresponding snap lock means 12,13 are arranged between bar 21 and handle 16,17, wherein opposite protruding portion12 extend inwardly into the intermediate space 20 between handle 16,17, and bar 21 is provided with corresponding to the opposite protruding portion 12Run through recess portion 13.
First interlock 6 and the second interlock 7 are configured so that in the first interlock of the second position 6 andTwo interlocks 7 are being removed from hole 11 on predetermined detaching direction 19 by axis 8 and can be detached from.Moreover, 6 He of the first interlockSecond interlock 7 is configured so that, in the first position, axis 8 is limited in first hole 11.
First hole 11 of the second interlock 7 laterally opens on the direction of the length along the second interlock 7.TheThis construction of one hole or recess portion make once sample collection ontology be vertically positioned in container and first component rotation withTake sample collection ontology to the second position, then sample collection ontology can be easily disengaged from.Since axis can vertically removeOne hole or recess portion, then sample collection ontology therefore dropped down onto in container by free gravity.It should be appreciated that in this specificationContext in, " lateral open " is finger-hole 11 in the square upward opening perpendicular to the rotation axis defined by hole 11, for example,Hole 11 be in the case of cylindrical or cone radially.When the first interlock 6 and the second interlock 7 connect,The rotation axis defined by hole 11 corresponds to the rotation axis 9 defined by axis 8.It should here be understood that hole 11 can take in addition toOther forms except cylinder, as long as 11 fitted shaft 8 of hole is rotated with supporting sample components to surround rotation axis 9.In general, hole11 need have at least three support surfaces, for controlling the rotary motion around axis 8 around the distribution of axis 8.
Most of axis 8 is two recesses 24 cylindrical, that there is the length along axis 8 to extend, and the part is setIt sets on the opposite side of the longitudinal axis of axis 8.Hole 11 has the cross-sectional shape with circular middle portion 23, circular middle portionDivide 23 full diameters for corresponding to axis 8.As shown in Figure 7, full diameter d3 is interpreted as in the case where not considering recess 24Axis 8 diameter.Opposite recess 24 is plane, but can have other shapes in other embodiments, such asOne or two side is bent upwards.Circular middle portion 23 can have other shapes, as long as it is used to support the second interlocking dress7 are set to surround the rotation of axis 8.
As shown in Fig. 7 and Figure 15, middle section 23 is opened outward in the form of channel 22, and channel 22, which has, is less than axis 8Full diameter d3 (see Figure 15) minimum widith d1.
The recess 24 of axis 8 defines axis 8 in detaching direction 19, longitudinal axis across axis 8 plane PProjected outline.The projected outline is less than channel 22 so that axis 8 is moveable from the second position across channel 22, exampleAs having the projected outline width d2 of the minimum widith d1 less than channel 22.
It should be appreciated that within the scope of the invention, many shapes in axis 8 and channel 22 are possible and important religionsLead is that axis 8 exposes projected outline of different shapes relative to the rotation in hole 11 so that in specific position (i.e. the second position), the throwingShadow contoured fit makes in the boundary for the homolographic projection profile that the channel 22 by the second interlock 7 exposes otherThe projected outline of position, axis 8 mismatches in the boundary of the projected outline exposed by channel 22.Therefore, in addition in the second position,Axis 8 is limited in hole 11, can directly be removed from hole 11 in the second position axis 8.This makes it possible in scheduled first behaviourIt is mutual to make in range the first interlock of control 7 and second (not in the second position, but between the second position and first position)Relative rotation between locking device 7, while when another opereating specification (that is, in second position) except the first opereating specificationWhen, additionally it is possible to so that the first interlock 6 and the second interlock 7 is freely disengaged.The first embodiment described in Fig. 1-15Construction be advantageous because it is strong (robust) and relatively simple injection moulding tool easy to use to manufacture.
Channel 22 broadens outward far from circular middle portion 23.This makes it easier to axis 8 being moved in channel 22.ThisOutside, hole 11 includes auxiliary recess 24, auxiliary recess 24 from middle section 23 along the length of the second interlock 7,It far from channel 22 and is partially toward the second snap lock means 13 and extends internally, during the width of auxiliary recess 25 is less thanBetween part 23 diameter.
In other embodiments, bar 21 and handle 16,17 can convert position so that handle 16,17 is arranged in sample collectionOn ontology and bar 21 is arranged on the first noumenon.
The recess portion of sample collection ontology should can absorb mucus fluid and cell therein, and from sampling equipment 1These materials are held in place during retraction.In the present embodiment, the size of sample collection ontology is slightly larger thanSize described in EP1903946B1, to allow to collect more sample materials and it to be deeper maintained at sample collectionIn the recess portion of ontology.
The first noumenon and sample collection ontology can be manufactured by any suitable material as needed.For example, these componentsIt can be formed by identical or different plastic material.In the first embodiment, the first noumenon is by such as polyacrylic plastics materialMaterial is made, which has bending modulus, assigns flexibility to first to follow the anatomical structure of vagina to reach the moonRoad portion (portio vaginalis) and arched roof vagina (fornix vaginalis) sufficiently rigid are enough to reach and at the same time havingClose contact between sample collection ontology and mucosal tissue ectocervix (mucous tissue ectocervix).
The appropriate method of manufacture the first noumenon and sample collection ontology is injection moulding, because it provides good repetitionProperty and low cost.
When in use, be moved to its first position from sampling equipment 1, wherein sample collection ontology be attached to the first noumenon/Handle/shaft 8.Hereafter, sample collection ontology is inserted into vaginal area and movement is to collect sample.Hereafter, it contracts from sampling equipment 1It returns, and sample collection ontology is inserted into sealable shipping container 26.Then, the first noumenon by a palmistry for sampleThis collection ontology rotates to the second position.Sample collection ontology is prevented from rotating by the container kept by another hand.It is logicalIt crosses that holding container is vertical, falls into sample collection ontological idea of freedom the deeper inside in container.