Specific embodiment
Disclosed herein is embodiment of the present invention, it should be understood, however, that disclosed embodiment is only of the inventionExample, the present invention can be realized by different modes.Therefore, this disclosure is not to be construed as restricted, andIt is the basis only as claim, and how basis of the invention is used as teaching those skilled in the art.
Embodiment of the disclosure is described in detail now with reference to accompanying drawing, for convenience of statement, a side of follow-up all Proximity operation personsNear-end is defined as, and distal end is defined as away from a side of operator.
Fig. 1-3 illustrate in detail the structure composition that one embodiment of the invention takes sundries tool 10.Briefly, thing is takenApparatus 10 includes specimen bag 200, spreading mechanism 20, conduit tube component 30, Handleset 40 and binding 50 successively from distal end to near-end.Conduit tube component 30 includes hollow conduit 33 and the modular catheter portion 31 and modular catheter portion 32 being combined together fixed thereto.It is differentUnder clinical practice situation, the external diameter of the hollow conduit 33 is different, and typical diameters are roughly divided into 5mm, 8mm, 10mm, 12mm and15mm.Handleset 40 includes the finger ring 42 and hollow drive rod 41 that are proximally sequentially connected to distal end, and the drive rod 41 is determinedPosition can move axially in hollow conduit 33 relative to the hollow conduit 33, with retracted mode (Fig. 1) and deployed conditionMobile spreading mechanism 20 and specimen bag 200 between (Fig. 2).
Spreading mechanism 20 includes elastomer 21 and the connecting shaft 22 being connected with the near-end of elastomer 21, and the elastomer 21 is wrappedTwo generally flexible or elasticity elastic webbings 23 and elastic webbing 24 are included, the elastic webbing 23 is roughly the same with the shape of elastic webbing 24And be symmetrical arranged along connecting shaft 22.The elastic webbing 23 and elastic webbing 24 include proximally-located straightway 23b and straightway 24bAnd the stretch section 23a and stretch section 24a, the stretch section 23a and stretch section 24a of distal end have flexible and shape memory work(Can, by the deformable storage of external force, removing external force can strut automatically.The straightway 23b near-ends setting mounting hole 23c is described straightLine segment 24b near-ends set mounting hole 24c, and the connecting shaft 22 is with mounting hole 24c and mounting hole 23c correspondence positions are provided with axis holeBe riveted in connecting shaft 22 for elastic webbing 23 and elastic webbing 24 by rivet 25 simultaneously by 22a.The near-end insertion of the connecting shaft 22 is drivenThe distal end of lever 41, and be bonded by glue, the mode such as threaded connection or welding is connected.Those skilled in the art can be withExpect, the elastomer 21 and the connected mode of connecting shaft 22 can also be welding, the pin connection or elastomer 21 is directFixation is attached with the distal end of drive rod 41.
The specimen bag 200 includes the sack 220 that can be opened and draw in, and the envelope extended from the sack 220The bag 230 for closing.The sack 220 is included around the tunnel 222 of sack, and the tunnel 222 is used to accommodate the He of spreading mechanism 20Binding 50.With reference to Fig. 2-3, the distal end of the binding 50 includes slip joint 51, and the distal end of the binding 50 passes through tunnel 211 and itNear-end 53 passes through the slip joint 51, forms the binding ring 52 roughly the same with mouth size.The elastomer 21 inserts describedIn tunnel 222.Described taking after sundries tool 10 completes assembling (refers to Fig. 2), is generally wrapped on elastomer 21 simultaneously specimen bag 200It is accommodated within hollow conduit 33 (refer to Fig. 1).The various windings for taking sundries tool are disclosed in U.S. patent Nos US8986321With storage mode, other take sundries tool patent with also disclose it is various wind and storage mode, a those skilled in the art coupleIts slightly adaptation, you can be applied to the present invention.
In the present embodiment, the elastomer 21 has shape memory function, in the winding for taking sundries tool 10 and receiptsThe mode of receiving can convenient Automatic-expanding.Operator promotes drive rod 41 by the specimen bag 200 in retracted mode (Fig. 1) and strutsMechanism 20 is released to outside hollow conduit 33, and elastomer 21 has shape memory function and restores automatically, so as to by specimen bag 200Automatically open up (Fig. 2).Those skilled in the art is it is contemplated that can also set the elastic webbing 23 of elastomer 21 and elastic webbing 24Realize strutting effect into linkage.The spreading mechanism 20 that a kind of typical case takes sundries tool 10 has been described in this implementation,Conduit tube component 30 and Handleset 40, in addition, those skilled in the art is it is contemplated that by by U.S. patent NosSpreading mechanism 20 in US5465731, US6383197, US8721658 etc. and this implementation, conduit tube component 30 and Handleset 40Combination is replaced, is also protection scope of the present invention.
The associative operation for taking the clinical practice of sundries tool 10 can substantially be divided into following several stages：
First stage：Preproduction phase.In retracted state to take sundries tool inserted into the patient via puncture cannula and extendTo target area.Second stage：Take sundries tool stages of deployment.Operation handle component 40 controls drive rod 41 by proximate phaseMoved axially for hollow conduit 33, until the spreading mechanism 20 and specimen bag 200 are completely exposed in the hollow conduit 33Outside, elastomer 21 has shape memory function and restores automatically, so as to specimen bag 200 be automatically opened up (Fig. 2).3rd rankSection：Wipe out the sample stage.Deployed condition is taken into sundries tool 10 under the cooperation such as endoscope, pathological tissues or organ position is navigated toLower section is put, in wiping out pathological tissues or organ and drop into specimen bag 200 by operating scissors.Fourth stage, sample takes out rankSection.With reference to Fig. 4-5, first operation handle component 40 takes out spreading mechanism 20 via puncture cannula, while pulling the near of binding 50End 53 so that slip joint 51 is slided and reduces binding ring 52, so as to the sack 201 of specimen bag 200 be drawn in.Then binding is pulled50 take out specimen bag 200 and its sample for containing via puncture cannula or via skin incision.During this, covered due to puncturingBore or Minimally Invasive Surgery otch are smaller, and when larger tissue or organ is cut off, specimen bag 200 is subject to very big extruding force.ThoughThe right various structures and application mode for taking sundries tool are had nothing in common with each other, but its function and are mainly substantially the same using step.The present inventionThe clinical application method for taking sundries tool 10, also refer to associated description in US5465731 and understand, to be better understood by this hairBright purposes.
Fig. 7 depicts a kind of typical specimen bag 100 of prior art.The specimen bag 100 is generally by monolithic thin film (pieceMaterial) doubling is overlapped and is welded, or two panels film (sheet material) is overlapped and is welded.The material of film includes but is not limited to poly- secondAlkene, polyvinyl chloride, polypropylene, nylon, Teflon, thermo-setting elastomer and thermoplastic elastomer (TPE) (such as polyurethane).Film is weldedThe technique for connecing includes but is not limited to heating welding, ultrasonic bonding, high-frequency welding, radiation welding, pulse welding etc..It is a kind of existingIn implementation, the specimen bag 100 is heated after being overlapped by the doubling of monolithic polyurethane 101 and is welded.The film 101Wherein one end crimp and weld to form tunnel 111.The film 101 is several along the direction for being approximately perpendicular to the tunnel 111What axis of symmetry 102 is folded to form the bag face 103 and bag face 104 for overlapping substantially.Along the bag face 103 and bag face 104The outward flange shape of overlap carries out heating welding (abbreviation heat seal) and forms heat seal weld seam 105.The bag face 103, bag face 103 and weld seam105 bags 120 for limiting sack 110 and the closing extended from the sack 110.The tunnel 111 is along describedSack 110 is approximate circumferentially distributed.
Fig. 6 describes a kind of representative heat welding (referred to as heat seal) process of the existing manufacturing technology of specimen bag.Heat-sealing machine 60Comprising the pedestal 66 and connected fuselage 67 fixed with ground installation, and it is connected and can vertically moves with fuselage 67Dynamic upper heat seal dynamic model 64 and the lower heat seal cover half 65 being connected with fuselage 67.The heat seal process of the specimen bag 100 can letterSingly it is expressed as, first adjusts heat seal parameter (mainly including heat-seal temperature, heat sealed time and heat seal pressure), then by the weight of film 101Fold and be placed on lower heat seal cover half 65, finally start the heat seal welding that heat-sealing machine completes specimen bag 100.
One those skilled in the art is to be understood that the film heat seal (welding), i.e., in the molten state, filmThe polymer segment phase counterdiffusion by heat seal region surface, infiltration, mutually winding so that biplate (or multi-disc) film welding existsTogether.With reference to Fig. 7, the mutual welding in bag face 103 and bag face 104 forms the specimen bag 100 comprising heat seal seam 105.Fig. 8 is depictedThe schematic partial sectional view of the optional position of heat seal seam 105, i.e., it is (thin that described specimen bag 100 finer can be divided into film substrate 131Film base material 151), transitional region 132 (transitional region 152) and welding area 133 (welding area 153).During film heat seal,In the presence of heat seal pressure, the film in molten condition in heat seal region is set to be calendered extrusion, so as to form the transitionRegion 132 (transitional region 152).The film thickness of the transitional region 132 (152) is less than the film substrate 131 (151)Thickness.
Generally, it is different with failure mode with the heat sealing strength of transitional region according to welding area, can be by the heat seal seamIt is divided into underheat conjunction, three classifications of standard heat seal and excessive heat seal.The underheat is closed, i.e. the surface in heat seal region is melted, ginsengWith the thinner thickness of the film of heat seal, failure mode when heat sealing strength is tested is peeled off for welding area, and test result is less thanDesired value.The standard heat seal, the i.e. thickness of film that the surface in heat seal region is melted, participating in heat seal is moderate, and fail mouldFormula is peeled off for welding area, and heat sealing strength test result reaches desired value.The surface quilt of the excessive heat seal, i.e. heat seal regionThe thickness of fusing, participation heat seal film is too many, causes the thickness of the transitional region significantly thinning so that transitional regionStructural strength be significantly lower than the peel strength of the welding area, this phenomenon is often referred to simply as " root is cut ", and the mould that failsFormula is broken for transitional region, and heat sealing strength test result is less than desired value.In other standard heat seal, claim heat sealing strength test value mostBig heat seal seam is optimal heat seal seam.One those skilled in the art is appreciated that using different heat seal parameters, determinesThe heat seal seam 105 is that underheat is closed, standard heat seal or excessively heat seal.
One those of ordinary skill is readily apparent that, the optimal heat seal parameter needed for can obtaining standard heat seal by experiment.FoodProduct are packed with medical package field, particularly in blood product packaging bag manufacture field, plastic sheeting heat seal have been carried out greatlyQuantity research.It is disclosed the prior art indicate that, usual heat-seal temperature, the comprehensive function of heat seal pressure and heat sealed time determines modelingExpect the heat sealing quality of film, and heat-seal temperature is maximum for the influence of heat sealing quality, and heat seal pressure and heat sealed time are to describedThe influence of heat sealing quality is relatively small or negligible.
In packaging for foodstuff and medical package field, optimal heat-seal temperature is generally obtained with experimental method.Generally presetOne heat sealing strength receives standard (i.e. desired value), then heat seal of the method for testing specified according to authoritative standard to test specimenIntensity is tested, and test result satisfaction receives standard and then assert that the heat-seal temperature is reasonable temperature or optimum temperature.For example it is rightIn peelable packaging bag (the free-hand packaging bag torn during convenient use), generally according to American Society Testing and Materials《ASTMF88 flexible barrier material sealing intensity test methods》Tested, dominant failure mode during sample test is shelled for heat seal regionFrom (Fig. 9), its test result is essentially identical to the true heat sealing strength of sample.And for bags of blood, bag filter etc. can notPackaging bag (without the free-hand packaging bag torn when using) is peeled off, generally according to American Society Testing and Materials《ASTMF2029 determines flexible material heat seal capability thermal weld code of practice by measuring sealing intensity》Tested, sample testWhen dominant failure mode for heat seal region peel off (Fig. 9) or transitional region fracture (Figure 10).The transitional region phenomenon of rupture,Being primarily due to local excessive heat seal causes the thickness of corresponding transitional region significantly thinning, so as to cause local intensity significantly to dropIt is low.Failure mode when sample test for transitional region be broken when, its test result is strong less than the true heat seal of sampleDegree.But, as long as test result meets receives standard, still assert that the heat-seal temperature is reasonable temperature or optimum temperature.ShouldParticularly point out, the establishment of the optimum temperature depends primarily on its method of testing and receives standard, therefore optimal heat-seal temperatureThe heat sealing strength for being not intended that its heat seal seam is optimal.When heat sealing strength test failure mode for heat seal region peel off rather thanWhen transitional region is broken, and during heat seal region peeling force maximum, referred to as optimal heat seal, and the heat-seal temperature of its sample is called optimalHeat-seal temperature, more accurately, commonly referred to as this optimum temperature parameter is theoretical optimum temperature or preferable optimum temperature.
When generally obtaining optimal heat-seal temperature with experimental method, not by clamping apparatus error, by heat-sealing film error and environmentThe factors such as error introduce overall merit.And during actual production manufacture, due to film thickness error, film out-of-flatness, heat seal work folderTool error, the combined influence of unequal factor of being heated is more long with the poor material of sealability (for example especially for heat seal seamThermoplastic elastomer (TPE)), heat seal (welding) is carried out using theoretical optimum temperature and easily Local residues space, i.e. heat seal seam occursSealing integrity is not up to standard.Or heat sealing performance poor product more long for heat seal seam, the sealing integrity of heat seal seam andHeat sealing strength is conflicting, to ensure that sealing integrity generally has to that using excessively heat-sealing, i.e., heat sealing strength must be sacrificed.In packaging for foodstuff and medical package field, the sealing integrity of its packaging is the most critical index must being fulfilled for, and heat sealing strengthIt is secondary index.Packaging for foodstuff and medical package field are usual to meet sealing integrity as most critical index, in this premise barRelatively low heat-seal temperature is selected under part to obtain preferable heat sealing strength, the optimal heat-seal temperature that it is used is usually above theory mostGood temperature.When carrying out heat seal with this optimal heat-seal temperature, most of region of usual same heat seal seam belongs to the standard hotClose and its regional area belongs to the excessive heat seal.
Up to the present, disclosed, less, mesh is studied in the heat seal for laparoscope dedicated specimen of the present invention bagThe experience in packaging for foodstuff and medical package field is generally continued to use in the preceding specimen bag batch heat seal when manufacturing, i.e., using higher than theoryOptimum temperature carry out heat seal with simultaneously obtain sealing integrity and preferable heat sealing strength, inevitably, the formation it is sameMost of region of one heat seal seam belongs to the standard heat seal and its regional area belongs to the excessive heat seal.With reference to Fig. 7, figure8 and Figure 11, such as described specimen bag 100 in heat seal under the conditions of optimal heat-seal temperature, most of area of the heat seal seam 105Domain belongs to standard heat seal (its heat seal seam figure is referring to Fig. 8), and the regional area of heat seal seam 105 belongs to excessive heat seal (its heatSplice grafting stitches figure referring to Figure 11).With reference to Figure 11, as it was noted above, the local excessive heat seal causes the transitional region 132 localIt is significantly thinning, so as to cause local intensity to significantly reduce.
With reference to Fig. 4-5, as it was noted above, by the pathological tissues or organ of specimen bag and its splendid attire via puncture cannula or warpWhen being taken out by skin incision, because puncture cannula internal diameter or Minimally Invasive Surgery otch are smaller, specimen bag is subject to very big extruding force, holdsIt is easily caused and takes thing bag rupture.And intensity significantly reduces the rupture wind that just greatly increased specimen bag caused by local excessive heat sealDanger.One those skilled in the art is readily apparent that increasing film thickness can increase the intensity of specimen bag, but when specimen bag is used forForegoing when taking in sundries tool, because the size of conduit is limited, increasing film thickness and typically result in specimen bag cannot be accommodated in conduitInterior or specimen bag cannot be released from conduit.Simultaneously as specimen bag is generally used for containing pathological tissues or organ, it has been sealedWhole property is also of equal importance, any work for revealing the risk or follow-up cleaning treatment of increase that may all increase patient's inadvertent contaminationMeasure.The hot bonding method for obtaining sealing integrity and the hot bonding method for obtaining optimal heat sealing strength are conflicting, to currentUntill also solve this conflict without good method.
In view of the size-constrained system of film thickness, and very big extruding force is subjected to during specimen bag clinical practice, thus it is rightIt is no upper limit in the pursuit of specimen bag intensity, intensity is the bigger the better.And broken in up to the present specimen bag clinical practiceThe case split still happens occasionally.Those skilled in the art may be it will be appreciated that most have generation what this area maintained the leading positionThe product of table, i.e., with trade nameEndo CatchTMWithA large amount of production and sales and use take sundriesTool, there is also a certain degree of cracking probability.Up to the present, specimen bag rupture cannot almost be avoided in use, andGenerally there is the transitional region in commissure in rupture；Disclosed control measure generally include to select more preferable thin-film materialWith preferably welding control Heat-seal parameter, these measures a certain degree of can reduce weld seam slip gradient, but still need to continue to changeEnter.
One those skilled in the art is it should be understood that when two sheet metals are welded to each other, its welding point form is numerous, pressesJoint form can be roughly divided into banjo fixing butt jointing, edge joint, corner joint, T connector, cruciform joint, lap joint and crimpingThe types such as joint.Although the intensity of different welding points is variant, but different welding point forms are mainly adaptation product shapeThe need for shape and structure.For plastic sheeting (sheet material) welding, can also be connect using various welding methods and welding in theoryCapitiform formula, due to very thin thickness and overall softness freely deformable, film solder field does not consider the welding point of complexity generallyForm.What is be widely used at present is that to be soldered two films overlapped, then is welded along its overlapping edge, when will be overlapped thinFilm water horizontal drawing is opened, the edge-flange joint that the shape of its welding point is welded similar to metal, and the film solder of this type is defined hereinJoint is edge-flange joint (referring to Figure 18-19).Up to the present, the disclosed specimen bag in this area and commercialized sampleThe welding point of bag is nearly all edge-flange joint.Moreover, packaging for foodstuff, it is disclosed in medical package and other fieldFor film welded research, mostly just studied for crimping welding joint style；The welding point of other formsResearch and application are very rare.Wherein one of the main reasons is edge-flange joint Type of Welding most simple and be easy to automatic metaplasiaProduce, the second is the overall softness freely deformable based on film, have no reason also not have using the welding point of other forms is aobviousIt is necessary.
Research shows the specimen bag for this area, welds its intensity using lap joint and is welded much larger than using edge-flange jointConnect.The lap joint is that only its seam edge is mutually overlapped between two soldered films, and the substrate area of film does not overlap,With reference to Figure 12-14 and Figure 20-21.This scheme is appreciated that, it is necessary to enough Elasticity, plastoelasticity and plastic material are specialIt is not the knowledge background of thermoplastic elastomer (s), is explaining the beneficial effect of this scheme with an experiment case study first.
Experiment case study 1：It is the tensile strength difference that contrast edge-flange joint welding and lap joint connect, from same materialMaterial, process equipment, machined parameters, test equipment and method of testing are carried out, to exclude other disturbing factors.It is finer, selectThe film of RxT85A polyurethane materials and the 0.1 ± 0.02mm thickness produced with rolling process, is cut into 200mm × 200mmSample carry out heat seal welding.Welding parameter：180 ± 2 DEG C of welding temperature, 0.2 ± 0.01Mpa of welding pressure, weld interval 1 ±0.2s, 3 ± 0.2mm of weld width.The method specified using ASTM F2029-08 is tested, test result such as following table：
The edge-flange joint of table 1 and the weld strength contrast test table of lap joint
Be can be seen that for this experiment from the test result of table 1, the drawing of the tensile strength much larger than edge-flange joint of lap jointStretch intensity.Different materials or essentially identical using the test result of different welding parameters are changed, is no longer gone to live in the household of one's in-laws on getting married herein to save lengthState.This test result seems not meeting the judgement that daily experience is made, but but meets materialogy and theory of mechanics.It is ripeThe technical staff for knowing plastic material and Elasticity is to be understood that：First, plastic material particularly thermoplastic elastomer (s)Generally belong to anisotropic material, and plastic sheeting is typical anisotropic material, it is strong along the material in film surface directionIntensity of the degree much larger than its thickness direction；Second, in the Tensile Fracture Process of film, elastic elongation and become in thickness direction firstIt is thin, then there is plastic deformation to more than material limits fracture, the place that elongation strain and thinning most serious occur is materialWeakest link.For edge-flange joint form welding sample extension test when, the adjacent domain (i.e. transitional region) of weld seam is mainTo be acted on by shearing force and bending force, and the intensity of the thickness direction of film is relatively poor in itself, therefore relatively easy generation is disconnectedSplit.For lap joint form weld seam sample extension test when, because the weld seam of lap joint has self booster action so thatThe elongation strain of weld seam and its transitional region is smaller, and the nearer region in the position of distance test fixture fixation sample, due to answeringPower is concentrated and film elongation is thinning serious, is broken to more than material limits in generation plastic deformation as weakness zone.To sum upDescribed, when welding specimen bag using edge-flange joint mode, the intensity for increasing thin-film material can not significantly solve foregoing ruptureProblem.And when welding specimen bag using lap joint mode, weld seam and its close region have not been weak links, specimen bagClose to the intensity of thin-film material, increasing the intensity of thin-film material can significantly increase the intensity of the specimen bag to actual strength.
Figure 12-15 illustrate in detail the structure and composition of first embodiment of the present invention specimen bag 200.The specimen bag200 include the sack 220 that can open and draw, and the closing from the extension of the sack 220 bag 230.The bagMouth 220 is included around the tunnel 222 of sack, and the tunnel 222 is used to accommodate spreading mechanism 20 and binding 50.Of the invention oneIndividual aspect, welds to form the bag 230 using lap joint mode.
In a kind of scheme, the specimen bag 200 is folded by monolithic polyurethane 210 and is welded.It is described with reference to Figure 12Film 210 includes top margin 211 and base 213 corresponding thereto；The one end of first overlap edge 212 connects top margin 211 and its other endConnection base 213；The one end of second overlap edge 214 connects top margin 211 and its other end connects base 213.With reference to Figure 12-13, topSide 211 folds along notional fold line 223 and welds to form weld seam 225, and the weld seam 225 limits tunnel 222.
With reference to Figure 13, the film 210 is turned up along notional fold line 216 and notional fold line 218, so that will be described thinFilm 210 is divided into three parts：First bag of face 215, second bag of face 217 and the 3rd bag of face 219.With reference to Figure 13-14, first overlap jointThe overlap edge 214 of side 212 and second is overlapped, usual overlapping region width B scopes:1mm≤B≤5mm.Along its overlapping regionCarry out welding and form lap joint weld seam 233 so as to first bag of face 215 and the 3rd bag of face 219 are connected into an entirety.As schemed14-15, welds along the outward flange on the base 213, forms edge-flange joint weld seam 235 so as to by first bag of face 215, second bagFace 217 and the 3rd bag of face 219 link into an integrated entity.First bag of face 215, second bag of face 217, the 3rd bag of face 219, lap joint weld seam233 and edge-flange joint weld seam 235 collectively form bag 230.The tunnel 222 limits sack 220.
The method of the lap joint welding and edge-flange joint welding is completely different.With reference to Fig. 6-8, the edge-flange jointDuring welding, it is positioned over after the two panels film (sheet material) of composition welding point is overlapped on lower weldering mould, then upper weldering mould is moved downStart welding after to stroke end, weld to form weld seam 105 along the outward flange of two overlap templates.With reference to Figure 14, Figure 16, Figure 20And Figure 21, when the lap joint is welded, two panels film only its welding edge for constituting welding point is overlapped, and two panels is thinThe base material of film is not overlapped (in the opposite direction).And be not to place specimen bag during the lap joint welding of specimen bag 200On lower mould, but lower mould is interspersed in inside specimen bag and under the lap in two panels film, then will be upperMould starts welding after being displaced downwardly to stroke end, welds to form weld seam 233 along overlapping region.Figure 21 depicts the weld seamThe schematic partial sectional view of 233 optional positions, i.e., described specimen bag 200 finer can be divided into (the film substrate of film substrate 241251), transitional region 242 (transitional region 252) and welding area 243 (welding area 253).It is similar to edge-flange joint, it is described to takeConnect the thickness of the film thickness less than the film substrate 241 (251) of the transitional region 242 (252) of weld.
Those skilled in the art is to be understood that the bag 120 of the specimen bag 100 can disposably be welded intoType, and the bag 230 of the specimen bag 200 generally cannot disposable welding fabrication because lap joint welding may causeIts weld seam 233 cannot constitute the bag being fully sealed together with soldered film, therefore generally need to carry out second crimpingWelding point is welded.The other notional fold line 216 and notional fold line 218 exist only in the welding process of lap jointIn, not obvious virtual broken line in the finished product of specimen bag 200.
Intensity of the specimen bag 200 for the specimen bag 100 during its clinical practice is significantly improved.With reference to figure18-19, when enough samples or tissue are put into the specimen bag 100, the specimen bag 100 becomes approximately conical, andThe weld seam 105 shows as typical edge-flange joint weld seam (Figure 19), when the specimen bag 100 equipped with a large amount of pathological tissues from patientWhen small otch is pulled out (Figure 17), the transitional region 132 (152) of flanged edge weld is easy to hair by large curved power and shearing forceRaw fracture.With reference to Figure 20-21, when enough samples or tissue are put into the specimen bag 200, the specimen bag 200 becomesApproximately conical, the weld seam 233 shows as typical lap joint weld seam (Figure 21), when the sample equipped with a large amount of pathological tissuesBag 200 from the small otch of patient pull out when (Figure 17), lap joint is mainly by pulling force effect and due to the local strengthening of lap jointEffect, is difficult to produce fracture at the place of transitional region 242 (252) of the weld seam.Understood with reference to described previously, the He of specimen bag 200The intensity of specimen bag 100 determines by most weakness zone intensity, therefore, this brings up to the intensity of the specimen bag 200 described4~5 times of the intensity of specimen bag 100.
With reference to Fig. 4, Fig. 5 and Figure 17, when the specimen bag for being loaded with pathological tissues is received and extracted, usual sack does not have quiltIt is fully sealed.Thus a those skilled in the art are it is contemplated that when the specimen bag is received and extracted, its internal liquid for containingThe not compact power of body or the extruding force very little being subject to, the sack that otherwise liquid will not be fully sealed from specimen bag are spouting.Those skilled in the art is to be understood that when specimen bag is received and is extracted it contains tissue and applies for sample bagUneven extruding force.Finer, as shown in figure 17, when the specimen bag 200 is extracted, the bag 230 is relatively large in diameterRegion bear larger extruding force.And after the major part for working as the bag 230 is extracted by skin incision, it is describedThe bottom of bag 230, i.e., the extruding force that the close region of described edge-flange joint weld seam 235 bears is smaller, the edge-flange joint welderingThe probability of the fracture of seam 235 is relatively low.
Figure 22-25 illustrate in detail the structure and composition of second embodiment of the present invention specimen bag 300.The specimen bag300 include the sack 320 that can open and draw, and the closing from the extension of the sack 320 bag 330.The bagMouth 320 is included around the tunnel 322 of sack.In a kind of embodiment, the specimen bag 300 folds weldering by cylindrical thin-film 310Connect and form.With reference to Figure 22, the film 310 includes top margin 311 and the first base 313 and the second base 314 corresponding thereto.GinsengFigure 22-23 are examined, top margin 311 to form weld seam 325 along folding and welding, and the weld seam 325 limits tunnel 322.With reference to Figure 23-24, the length of the second base 314 is more than the first base 313, second base 314 is turned up so that first base313 and second base 314 it is overlapped.Welding is carried out along its overlapping region form lap joint weld seam 333 so as to by described inThe bottom lock of tubular film 310 is into an entirety.The bag 330 of the specimen bag 300 generally cannot disposable welding fabrication,Because lap joint welding may cause its weld seam 333 bag being fully sealed cannot be constituted together with soldered film,Therefore generally require to carry out second crimping welding weld.Such as Figure 24-25, along the two ends corner region of the weld seam 333Welding, forms edge-flange joint weld seam 334 and edge-flange joint weld seam 335, so as to by lap joint weld seam 333 and the film 310It is welded into an entirety for sealing.The tubular film 310, weld seam 334, weld seam 335 and weld seam 333 collectively form bag 330,And the tunnel 322 limits sack 320.The specimen bag 300 has the function and advantage similar to the specimen bag 200,And the specimen bag for being manufactured into Large Copacity preferably of specimen bag 300.
Figure 26-29 depicts the structure and composition of 3rd embodiment specimen bag 400.The specimen bag 400 includes sack420, and from the sack 420 extend closing bag 430.The sack 420 is included around the tunnel of sack422.The specimen bag 400 is folded by monolithic thin film 410 and is welded.With reference to Figure 26, the film 410 includes the He of top margin 411Base 413 corresponding thereto；The one end of first overlap edge 412 connects top margin 411 and its other end connects base 413；Second overlap jointThe one end of side 414 connects top margin 411 and its other end connects base 413.With reference to Figure 26-27, top margin 411 is along notional fold line423 fold and weld to form weld seam 425, and the weld seam 425 limits tunnel 422.With reference to Figure 27, along the He of notional fold line 416Notional fold line 418 turns up the film 410, so as to the film 410 is divided into three parts：First bag of face 415, second bagFace 417 and the 3rd bag of face 419.With reference to Figure 27-28, the overlap edge 414 of first overlap edge 412 and second is overlapped.AlongIts overlapping region carries out welding and forms lap joint weld seam 433 so as to first bag of face 415 and the 3rd bag of face 419 are connected into oneIt is overall.Such as Figure 29, welded along the outward flange on the base 413, form the first edge-flange joint weld seam 434 and the second edge-flange jointWeld seam 435, so as to first bag of face 415, second bag of face 417 and the 3rd bag of face 419 be linked into an integrated entity.First bag of face 415, secondBag face 417, the 3rd bag of face 419, the weld seam 433, the weld seam 434 and the weld seam 435 collectively form bag 430.And instituteState tunnel 422 and limit sack 420.
In a kind of embodiment, the first edge-flange joint weld seam 434 is excessive fusion weld, and second spinningHead weld seam 435 is the mixing weld seam comprising standard welding and deficient welding.The weld seam 435 helps to increase the intensity of weld seam, andThe excessive welding of the weld seam 434 is ensuring sealing integrity.Wherein owe that the surface that welding is welding region is melted, participate in moltenThe thinner thickness of the film of conjunction, failure mode when weld strength is tested is that the welding area of specimen bag is peeled off, and test resultLess than desired value.Standard welding be welding region surface be melted, participate in fusion film thickness it is moderate, weld strengthFailure mode during test is the welding area stripping of specimen bag, and test result reaches desired value.Excessive welding is weld zoneThe thickness of film that the surface in domain is melted, participating in fusion is too many, causes between specimen bag welding area and specimen bag base materialTransitional region thickness it is significantly thinning, weld strength test when failure mode be transitional region fracture, heat sealing strength surveyTest result is less than desired value.The lap joint weld seam 433 and the weld seam 435 are favorably improved specimen bag weld strength, fromAnd increased the intensity of the specimen bag 400.
Figure 30-33 illustrate in detail the structure and composition of fourth embodiment of the present invention specimen bag 500.The specimen bag500 include the sack 520 that can open and draw, and the closing from the extension of the sack 520 bag 530.The bagMouth 520 is included around the tunnel 522 of sack.The specimen bag 500 by monolithic thermoplastic's elastomer thin film 510 fold welding andInto.With reference to Figure 30, the film 510 includes top margin 511 and base 513a and base 513b corresponding thereto；First overlap edge512 one end connect top margin 511 and its other end connects base 513a；The one end of second overlap edge 514 connects top margin 511 and its is anotherEnd connection base 513b.With reference to Figure 30-31, top margin 511 folds along notional fold line 523 and welds to form weld seam 525, describedWeld seam 525 limits tunnel 522.With reference to Figure 31, along notional fold line 515, intend fold line 516 and notional fold line 517 by instituteState film 510 to turn up so that the overlap edge 514 of first overlap edge 512 and second is overlapped, at the same the base 513a andBase 513b is overlapped.Welding is carried out along overlapping region form lap joint weld seam 533 and lap joint weld seam 534.InstituteState the bag 530 of specimen bag 500 generally cannot disposable welding fabrication because lap joint welding may cause its weld seam534 cannot constitute the bag being fully sealed together with soldered film, therefore generally require to carry out second crimping to connectHead welding.Such as Figure 32-33, weld to form edge-flange joint weld seam 535 along the corner region of the weld seam 534.The film 510, takesJoint welding 533 is connect, lap joint weld seam 534 and edge-flange joint weld seam 535 collectively form bag 530.And the tunnel 522 is limitedMake sack 520.Disclosed in U.S. patent Nos US5480404, sample bag shape is designed to truncated cone body, and (i.e. base diameter is smallAnd the big specimen bag of mouth diameters), when when being conducive to using to loading tissue and being conducive to reduction to be pulled out in specimen bag bagExpansion for patient incision is acted on.The specimen bag 500 includes the shorter edge-flange joint weldering of 2 lap joint weld seams andSlit into the structure being gradually reduced to bag bottom diameter from sack, to loading group in 500 bags of specimen bag when being equally beneficial for usingKnit and be conducive to reduce expansion when being pulled out for patient incision to act on.And, what the lap joint weld seam 534 was formedLocal corner region is conducive to containing the watery blood or body fluid flowed out after pathological tissues are extruded.
Figure 34-37 illustrate in detail the structure and composition of fifth embodiment of the present invention specimen bag 600.The specimen bag600 include the sack 620 that can open and draw, and the closing from the extension of the sack 620 bag 630.The bagMouth 620 is included around the tunnel 622 of sack.The specimen bag 600 by monolithic thermoplastic's elastomer thin film 610 fold welding andInto.With reference to Figure 34, the film 610 includes top margin 611 and base 613a corresponding thereto, base 613b and base 613c；TheThe one end of one overlap edge 612 connects top margin 611 and its other end connects base 613a；The one end of second overlap edge 614 connects top margin 611And its other end connection base 613c.With reference to Figure 34-35, top margin 611 folds and welds to form weld seam along notional fold line 623625, the weld seam 625 limits tunnel 622.With reference to Figure 35, along notional fold line 615, intend fold line 616 and notional fold line617 turn up the film 610 so that the overlap edge 614 of first overlap edge 612 and second is overlapped, while the bottomSide 613b and base 613c are overlapped.Welding is carried out along overlapping region form lap joint weld seam 633 and lap joint welderingSeam 634.The bag 630 of the specimen bag 600 generally cannot disposable welding fabrication because lap joint welding may causeIts weld seam 634 cannot constitute the bag being fully sealed together with soldered film, therefore generally require to carry out second crimpingWelding point is welded.Weld to form edge-flange joint weld seam (not shown) along the corner region of the weld seam 634.The film 610, takesJoint welding 633 is connect, lap joint weld seam 634 and edge-flange joint weld seam collectively form bag 630.And the tunnel 622 is limitedGo out sack 620.
When foregoing specimen bag 200,300,400,500 swells to form revolving body, the lap joint most long of its bag is constitutedWeld seam is in approximately the same plane with the axis of rotation of formed revolving body, referred to as plane and straight line type weld seam.And it is describedWhen specimen bag 600 swells to form revolving body, the lap joint weld seam 633 is not at approximately the same plane with the axis of revolving bodyInterior, the weld seam 633 is distributed along the surface of revolving body in space curve, referred to as space curve type weld seam.The skill of this areaArt personnel are to be understood that relative to other weld seams the inclined weld seam 633 is conducive to during improvement specimen bag useWelded seam area problem of stress concentration.Because the plastic film material is notch sensitiveness material, when weld seam partial fractureAfterwards, breach can cause specimen bag to be quickly completely severed along the transitional region fast growth of aforesaid rectilinear type weld seam；And it is describedShaped form weld seam is conducive to preventing breach along the transitional region fast growth of weld seam, so as to reduce the quick and complete rupture of specimen bagRisk.The weld seam 633 of the specimen bag 600 is skew lines, but can also use full curve weld seam.The mark that Figure 37 is disclosedThis bag of 600a is substantially equivalent with the specimen bag 600, differs primarily in that the lap joint weld seam 633a of the specimen bag 600aIt is the weld seam of tracing pattern.
Figure 38-39 depicts the structure and composition of sixth embodiment of the present invention specimen bag 700.The specimen bag 700 is wrappedContaining the sack 720 that can be opened and draw in, and from the sack 720 extend closing bag 730.The sack 720Comprising around the tunnel 722 of sack.The specimen bag 700 is folded by monolithic thermoplastic's elastomer thin film 710 and is welded.It is describedBag 730 includes lap joint weld seam 733 and lap joint weld seam 734.
Figure 40-41 depicts the structure and composition of seventh embodiment of the present invention specimen bag 800.The specimen bag 800 is wrappedContaining the sack 820 that can be opened and draw in, and from the sack 820 extend closing bag 830.The sack 820Comprising around the tunnel 822 of sack.The specimen bag 800 is folded by monolithic thermoplastic's elastomer thin film 810 and is welded.It is describedSpecimen bag 800 is similar to the structure and shape of the specimen bag 200.For example make first overlap edge of the specimen bag 200212 and second overlap edge 214 staggeredly without overlapping, then be respectively welded along the overlap edge 214 of first overlap edge 212 and second,Form two overlapping the slot：Lap joint weld seam 833 and lap joint weld seam 834.It is described to connect joint welding 833 and overlap joint connectsInterstice coverage is left between head weld seam 834.Such then described specimen bag 200 is transformed into specimen bag 800.
Figure 42 depicts the structure and composition of eighth embodiment of the present invention specimen bag 900.The specimen bag 900 is included canOpen and draw in sack 920, and from the sack 920 extend closing bag 930.The sack 920 is includedAround the tunnel 922 of sack.The specimen bag 900 after the film 912 of the first film 911 and second mutually overlap joint by being welded.The bag 930 includes lap joint weld seam 933, lap joint weld seam 934 and lap joint weld seam 935.The technology of this areaPersonnel by the weld seam of more multi-disc film or more it is contemplated that can produce a variety of specimen bags, but increase in theoryDiaphragm number and weld seam quantity often significantly increase manufacturing cost and introduce new risk point.
Those skilled in the art is to be understood that the specimen bag of lap joint and the edge-flange joint sample of prior artThe manufacture method of bag is widely different, substantially comprising cross cutting thin film raw material, welds tunnel, overlap welding picking bag body, flange welding picking bag4, bottom (or crimping welding corner region) key step.The step of one of which manufacture method, is substantially as follows：
S1：Cross cutting thin film raw material, general shape such as sheet film 210 is die-cut to by thin film raw material (see Figure 12)；In order to protectCard quality, typically using cross cutting, those skilled in the art is contemplated that thin film raw material, it is also possible to using shearing or other sanctionsCut means and make sheet film 210.
S2：Welding tunnel, the edge for forming the film in the tunnel 222 of specimen bag is bent and is placed on the first weld moldLower mould on, weld to form tunnel 222 using the mold of the first weld mold (see Figure 13)；
S3：Lap joint method welds bag, turns up the film 210 along notional fold line 216 and notional fold line 218, makesObtain one bag region substantially closed of the overlapped formation of overlap edge of the both sides of the film 210；By the second weld moldLower mould intert into the bag region and be attached under the overlapping region of the overlap edge, use the second weld moldMold is welded into lap joint weld seam 233 (see Figure 16).
S4：Edge-flange joint method welding bag bottom, bag 230 is placed on the lower mould of the 3rd weld mold, using the 3rd welderingThe mold for connecing mould is welded along the outward flange on the base 213, forms the edge-flange joint weld seam 235 (see Figure 14).
Another optional manufacturing step is substantially as follows：
S1：Cross cutting raw material, the thin film raw material of tubular is die-cut to substantially such as the shape of tubular film 310 (see Figure 22)；
S2：Welding tunnel, the skirt materials bending that will form the tubular film in the tunnel 322 of specimen bag 300 is placed on theOn the lower mould of one weld mold, weld to form tunnel 322 using the mold of the first weld mold (see Figure 23)；
S3：Lap joint method welds bag, and the base 314 of the film 310 second is folded on the first base 313.So that instituteState first base 313 and the one bag region substantially closed of overlapped formation of the second base 314 of film 310；By secondThe lower mould of weld mold interts into the bag region and is attached under the overlapping region of the overlap edge, uses the second welderingThe mold for connecing mould is welded into lap joint weld seam 333 (see Figure 24).
S4:Edge-flange joint method welds corner region, and the bag 330 is placed on the lower mould of the 3rd weld mold, adoptsWelded along the two ends corner region of weld seam 333 with the mold bottom of the 3rd weld mold, form the edge-flange joint weld seam 335,So as to lap joint weld seam 333 and the film 310 are welded into an entirety for sealing (see Figure 25).
Another optional manufacturing step is substantially as follows：
S1：Cross cutting thin film raw material, general shape such as sheet film 410 is die-cut to by thin film raw material (see Figure 26)；
S2：Welding tunnel, the skirt materials for forming the film in the tunnel 442 of specimen bag are bent and are placed on the first weldingOn the lower mould of mould, weld to form tunnel 422 using the mold of the first weld mold (see Figure 27)；
S3：Lap joint method welds bag, turns up the film 410 along notional fold line 416 and notional fold line 418, willThe overlap edge 414 of first overlap edge 412 and second is overlapped, and the lower mould of the second weld mold is interspersed into the bagBody region is simultaneously attached under the overlapping region of the overlap edge, and being welded into lap joint using the mold of the second weld mold weldsSeam 433, so as to first bag of face 415 and the 3rd bag of face 419 are connected into an entirety (see Figure 28)；
S4:Edge-flange joint method welding bag bottom, bag 430 is placed on the lower mould of the 3rd weld mold, using the 3rd welderingThe mold for connecing mould is welded along the outward flange on base 413, forms the first edge-flange joint weld seam 434 and the second edge-flange joint welderingSeam 435, so as to first bag of face 415, second bag of face 417 and the 3rd bag of face 419 be linked into an integrated entity.(see Figure 29).
Another optional manufacturing step is substantially as follows：
S1：Cross cutting thin film raw material, general shape such as sheet film 510 is die-cut to by thin film raw material (see Figure 30)；
S2：Welding tunnel, the skirt materials for forming the tunnel 522 of specimen bag are bent and are placed on the lower mould of the first weld moldOn tool, weld to form tunnel 522 using the mold of the first weld mold (see Figure 31)；
S3：Lap joint method welds bag, along notional fold line 515, intends fold line 516 and notional fold line 517 will be described thinFilm 510 is turned up, and makes the first overlap edge 512 and the second overlap edge 514 overlapped, while base 513a and base 513b phase mutual respectsIt is folded, the lower mould of the second weld mold is interted into the bag region and is attached under the overlapping region of the overlap edge,Using the mold welding forming of the second weld mold into lap joint weld seam 533 and lap joint weld seam 534 (see Figure 32)；
S4:Edge-flange joint method welds corner region, and bag 530 is placed on the lower mould of the 3rd weld mold, using theThe mold of three weld molds welds to form edge-flange joint weld seam 535 along the corner region of weld seam 534 (see Figure 33).
What foregoing overlap joint welding was used is the oblique cut grafting of individual layer two, it should be appreciated by those skilled in the art that using 3 layers or manyLayer overlap joint can also equally reach similar overlap joint effect.Especially for the corner region of foregoing lap weld, using foldingForming multilayer overlap joint can avoid being welded using crimping.Therefore, those skilled in the art are also this public affairs using similar multilayer overlap jointThe protection domain opened.
Many different embodiments of the invention and example are had shown and described.One ordinary skill of this areaPersonnel, without departing from the scope of the invention, adaptive improvement can be made by suitably modified to methods described and apparatus.Simple adaptation for example is done using the specimen bag heat seal seam disclosed in other inventions, or uses different process, for example, adoptedWith pressure parameter, the various combination such as temperature parameter or dwell time.Several kinds of amendment schemes are referred, for this areaFor technical staff, other amendment schemes are also what is be contemplated that.Therefore the scope of the present invention should according to accessory claim,While being understood not to the structure for being shown and being recorded by specification and accompanying drawing, the particular content of material or behavior is limited.