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WO2018161768A1 - Sac à échantillon formé par liaison par fusion de sections de pliage de celui-ci et instrument de retrait d'échantillon - Google Patents

Sac à échantillon formé par liaison par fusion de sections de pliage de celui-ci et instrument de retrait d'échantillon Download PDF

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Publication number
WO2018161768A1
WO2018161768A1 PCT/CN2018/075805 CN2018075805W WO2018161768A1 WO 2018161768 A1 WO2018161768 A1 WO 2018161768A1 CN 2018075805 W CN2018075805 W CN 2018075805W WO 2018161768 A1 WO2018161768 A1 WO 2018161768A1
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Prior art keywords
weld
bag
film
specimen
welding
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PCT/CN2018/075805
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English (en)
Chinese (zh)
Inventor
朱莫恕
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5r Med Technology (chengdu) Co Ltd
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5r Med Technology (chengdu) Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/50—Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing

Definitions

  • the present invention relates to a minimally invasive surgical instrument, and more particularly to a specimen bag structure.
  • the second category consists of a specimen bag, a catheter and a retrieval device for the distraction mechanism.
  • the opening mechanism pushes the rolled specimen bag out of the catheter, and the specimen bag is opened by the opening mechanism to facilitate the insertion of the cut tissue or the diseased organ during the operation.
  • the specimen bag is usually made of a plastic film or a plastic sheet of 0.05 mm to 0.1 mm. So far, it has been difficult to manufacture specimen bags by integral molding, usually by two sheets of film overlap heat sealing (welding), or by using a single film to fold overlap heat sealing (welding).
  • the heat sealing (welding) seam of the specimen bag is long, and it is easy to appear locally due to heat sealing (welding) fixture error, heat sealing (welding) pressure error, heat sealing (welding) temperature unevenness and the like. Defects such as voids or seams are not strong, and it is difficult to select products containing such defects by inspection.
  • over-welding is usually achieved by increasing the heat sealing (welding) temperature and increasing the heat sealing (welding) time to ensure a firm seam and no residual voids.
  • excessive fusion usually causes the thickness of the local area of the specimen film substrate and the joint transition to be significantly thinner, resulting in a significant decrease in the material strength of the adjacent region of the seam, which is prone to breakage, which is commonly referred to as "root.” cut".
  • the increase in film thickness generally results in the specimen bag being unable to be stored in the catheter or being unable to be removed from the catheter due to the size limitation of the catheter. Launched in the middle.
  • the maximum thickness of the film of the prior art specimen bag is usually ⁇ 0.1 mm, and excessive fusion generally causes the thickness of the aforementioned partial region to be reduced by 30% to 50%, which significantly reduces the strength of the specimen bag. So far, the probability of an accident in which the specimen bag is broken during clinical use is still large. Providing a safer and more convenient device or method for removing internal tissue or diseased organs of the patient helps to improve the safety of minimally invasive surgery and will promote greater development of minimally invasive surgery.
  • a lap splice type specimen bag in one aspect of the invention, includes a bag opening that can be opened and closed, and a closed bag body extending from the mouth of the bag, the bag mouth including a surrounding tunnel, the bag body including a lap joint weld.
  • the bag body comprises a sheet-like film comprising a top edge joined to the tunnel and a first lap edge and a second lap edge on both side edges thereof.
  • the first overlapping edge and the second overlapping edge are overlapped and welded to each other by folding the film along the virtual folding line to form a lap joint weld.
  • the film further comprises a bottom edge that overlaps and welds to form another lap joint weld by folding the film along the virtual fold line.
  • the film further includes a third overlapping edge and a fourth overlapping edge, the third overlapping edge and the fourth overlapping edge being mutually folded by folding the film along the virtual folding line Overlap and weld to form another lap joint weld.
  • the film further includes a bottom edge along which the bead joint weld is formed to form a bead joint weld that closes the bottom of the bag.
  • the crimped joint weld comprises a first crimp joint weld and a second crimp joint weld.
  • the first crimp joint weld comprises an over weld weld or an over weld and a standard weld weld, the second crimp joint weld comprising a standard weld or a standard weld and an under weld weld.
  • the specimen bag further includes a bag bottom and a crimped joint weld welded by a sharp corner region of the lap joint weld, the crimp joint weld seaming the bottom of the bag Closed.
  • the specimen bag can be inflated to form a hollow body of revolution while the lap joint weld becomes a space curved weld.
  • an retrieval device for minimally invasive surgery includes a specimen bag and a cable that is disposed in the tunnel, and the cable can tighten the bag mouth of the specimen bag after receiving the tissue specimen. Also included is a catheter assembly and a handle assembly therethrough, and a distraction mechanism for the openable specimen bag coupled to the handle assembly.
  • the specimen bag and the distraction mechanism are disposed within the catheter assembly and moveable relative thereto; the specimen assembly and the distraction mechanism are urged forwardly within the catheter assembly and extend out of the cannula assembly by the handle assembly operation
  • the distracting mechanism is distracted; the distracting mechanism is separated from the specimen bag with the catheter assembly being rearwardly separated, and the pull wire is inserted through the catheter assembly.
  • Another method of making a specimen bag is as follows:
  • S3 lap welding the bag body, folding the second bottom edge of the film to the first bottom edge, so that the first bottom edge and the second bottom edge of the film overlap each other to form a substantially closed bag body region; a lower mold of the second welding mold is inserted into the bag body region and is attached under the overlapping region of the overlapping edge, and is welded into the lap joint weld using the upper die of the second welding die;
  • Figure 1 is a perspective view showing the first embodiment of the present invention in a retracted state
  • Figure 2 is a perspective view of the pickup device of Figure 1 in an unfolded state
  • Figure 3 is an exploded view of the pickup device shown in Figure 2;
  • Figure 4 is a simulation diagram of the closure of the bag when the device of Figure 2 is used;
  • Figure 5 is a schematic view of the apparatus of Figure 4 after removing the catheter and the distraction mechanism
  • FIG. 6 is a schematic view of a heat sealing process of a prior art heat sealing machine
  • Figure 7 is a perspective view of a prior art specimen bag 100
  • Figure 8 is a cross-sectional view taken along line 8-8 of the specimen bag shown in Figure 7;
  • Figure 9 is a schematic view showing the failure mode of the welded joint as the peeling of the welded joint
  • Figure 10 is a schematic view showing the failure mode of the welded joint as a transition region fracture
  • Figure 11 is a cross-sectional view taken along line 11-11 of the specimen bag shown in Figure 7;
  • Figure 12 is a development view of the film of the specimen bag 200 of the first embodiment
  • Figure 13 is a schematic view of the film of Figure 12 after completion of tunnel welding
  • Figure 14 is a plan view of the specimen bag 200 of the first embodiment along the weld side;
  • Figure 15 is a partial enlarged view of the bottom of the specimen bag shown in Figure 14;
  • Figure 16 is a schematic view showing the welding of the lap joint of the specimen bag shown in Figure 14;
  • Figure 17 is a simulated view of a specimen bag filled with tissue drawn from a small incision in the patient's skin;
  • FIG. 18 is a perspective view of a prior art specimen bag 100
  • Figure 19 is a cross-sectional view taken along line 19-19 of the specimen bag shown in Figure 18;
  • Figure 20 is a perspective view of the specimen bag 200 of the first embodiment
  • Figure 21 is a cross-sectional view taken along line 21-21 of the specimen bag shown in Figure 20;
  • Figure 22 is a development view of the film of the specimen bag 300 of the second embodiment
  • Figure 23 is a schematic view of the film of Figure 22 after completion of tunnel welding
  • Figure 24 is a plan view of the specimen bag 300 of the second embodiment along the weld side;
  • Figure 25 is a partial enlarged view of the bottom of the specimen bag shown in Figure 24;
  • Figure 26 is a development view of a film of the specimen bag 400 of the third embodiment.
  • Figure 27 is a schematic view of the film of Figure 26 after completion of tunnel welding
  • Figure 28 is a plan view of the specimen bag 400 of the third embodiment along the weld side;
  • Figure 29 is a schematic view showing the welding seam of the double crimping joint of the bottom of the specimen bag shown in Figure 28;
  • Figure 30 is a development view of a film of the specimen bag 500 of the fourth embodiment
  • Figure 31 is a schematic view of the film of Figure 30 after completion of tunnel welding
  • Figure 32 is a plan view of the specimen bag 500 along the weld side of the fourth embodiment
  • Figure 33 is a partial enlarged view of the bottom of the specimen bag shown in Figure 32;
  • Figure 34 is a development view of a film of the specimen bag 600 of the fifth embodiment
  • Figure 35 is a schematic view of the film of Figure 34 after completion of tunnel welding
  • Figure 36 is a plan view of the specimen bag 600 of the fifth embodiment along the weld side;
  • Figure 37 is a plan view of the specimen bag 600a of the other embodiment of the specimen bag of Figure 6 along the weld side;
  • Figure 38 is a development view of a film of the specimen bag 700 of the sixth embodiment.
  • Figure 39 is a plan view of the specimen bag 700 of the sixth embodiment along the weld side;
  • Figure 40 is a perspective view of the specimen bag 800 of the seventh embodiment
  • Figure 41 is a cross-sectional view taken along the line 41-41 of the specimen bag shown in Figure 40;
  • Figure 42 is a perspective view of the specimen bag 900 of the eighth embodiment.
  • Figures 1-3 detail the structural composition of the retrieval device 10 of the first embodiment of the present invention.
  • the retrieval device 10 includes a specimen bag 200, a distraction mechanism 20, a catheter assembly 30, a handle assembly 40 and a cable 50 from the distal end to the proximal end.
  • the catheter assembly 30 includes a hollow catheter 33 and a catheter handle portion 31 and a catheter handle portion 32 that are fixedly coupled thereto.
  • the outer diameter of the hollow conduit 33 is different for different clinical applications, and the common diameters are roughly divided into 5 mm, 8 mm, 10 mm, 12 mm, and 15 mm.
  • the handle assembly 40 includes a finger ring 42 and a hollow drive rod 41 that are sequentially connected from a proximal end to a distal end, the drive rod 41 being positioned in the hollow catheter 33 and axially movable relative to the hollow catheter 33 for retraction
  • the distraction mechanism 20 and the specimen bag 200 are moved between the state (Fig. 1) and the unfolded state (Fig. 2).
  • the distraction mechanism 20 comprises an elastic body 21 and a connecting shaft 22 connected to the proximal end of the elastic body 21, the elastic body 21 comprising two substantially flexible or elastic elastic bands 23 and elastic bands 24, said elastic band 23 and elastic
  • the belts 24 are substantially identical in shape and are symmetrically disposed along the connecting shaft 22.
  • the elastic band 23 and the elastic band 24 comprise a straight section 23b and a straight section 24b at the proximal end and an elastic section 23a and an elastic section 24a at the distal end, the elastic section 23a and the elastic section 24a having a flexible and shape memory function,
  • the external force can be deformed and stored, and the external force can be automatically opened.
  • a mounting hole 23c is disposed at a proximal end of the straight line segment 23b, and a mounting hole 24c is disposed at a proximal end of the straight line segment 24b.
  • the connecting shaft 22 is provided with a shaft hole 22a at a position corresponding to the mounting hole 24c and the mounting hole 23c and is elasticized by the rivet 25.
  • the belt 23 and the elastic band 24 are riveted to the connecting shaft 22.
  • the proximal end of the connecting shaft 22 is inserted into the distal end of the driving rod 41, and is fixedly connected by glue bonding, screwing or welding. It is conceivable to those skilled in the art that the elastic body 21 and the connecting shaft 22 can also be connected by welding, pin connecting or directly connecting the elastic body 21 to the distal end of the driving rod 41.
  • the specimen pouch 200 includes a pouch 220 that can be opened and closed, and a closed pouch 230 that extends from the pouch opening 220.
  • the pocket 220 includes a tunnel 222 that surrounds the pocket for receiving the expansion mechanism 20 and the cable 50.
  • the distal end of the cable 50 includes a sliding joint 51.
  • the distal end of the cable 50 passes through the tunnel 211 and the proximal end 53 passes through the sliding joint 51 to form a size corresponding to the pocket.
  • the elastomer 21 is inserted into the tunnel 222.
  • the specimen bag 200 is usually wound around the elastic body 21 and housed inside the hollow catheter 33 (refer to FIG. 1).
  • U.S. Patent No. 8,986,321 discloses various winding and accommodating methods of the pick-up device, and other patents for the taking device also disclose various winding and accommodating methods, which can be applied by an ordinary technician. In the present invention.
  • the elastic body 21 has a shape memory function, and the winding and storing manner of the taking device 10 can be automatically and automatically deployed.
  • the operator pushes the drive lever 41 to push the specimen bag 200 and the distracting mechanism 20 in the retracted state (FIG. 1) out of the hollow catheter 33, and the elastic body 21 has a shape memory function and is automatically restored, thereby automatically opening the specimen bag 200. (figure 2).
  • the elastic band 23 of the elastic body 21 and the elastic band 24 can also be provided as a link mechanism to achieve the distracting action.
  • a distraction mechanism 20, a catheter assembly 30, and a handle assembly 40 of a typical retrieval device 10 have been described.
  • the related operations of the clinical application of the retrieval device 10 can be roughly divided into the following stages:
  • the first stage the preparatory stage.
  • the retrieval device in the retracted state is inserted into the patient via the puncture cannula and extends to the target area.
  • the second stage the stage of the instrument retrieval.
  • the operating handle assembly 40 controls the drive rod 41 to move axially from the proximal end to the distal end relative to the hollow conduit 33 until the expansion mechanism 20 and the specimen bag 200 are completely exposed outside the hollow conduit 33, and the elastomer 21 has a shape
  • the memory function is automatically restored to automatically open the specimen bag 200 (Fig. 2).
  • the third stage the stage of cutting off the specimen.
  • the unloading device 10 is positioned under the endoscope or the like, positioned under the lesion tissue or organ position, and the diseased tissue or organ is cut off by the surgical scissors and dropped into the specimen bag 200.
  • the specimen is taken out of the stage.
  • the handle assembly 40 is first operated to remove the distraction mechanism 20 via the puncture cannula while pulling the proximal end 53 of the cable 50 so that the sliding segment 51 slides and reduces the cable loop 52, thereby placing the specimen bag 200
  • the pockets 201 are gathered.
  • the tie 50 is then pulled and the specimen bag 200 and its contained specimen are removed via a puncture cannula or via a skin incision.
  • the specimen bag 200 is subjected to a large compressive force when the larger tissue or organ is removed due to the smaller diameter of the puncture cannula or the minimally invasive surgical incision.
  • various instruments are different, their functions and main steps are basically the same.
  • the clinical application method of the device 10 of the present invention can also be understood by referring to the related description in US5465731 for better understanding of the use of the present invention.
  • Figure 7 depicts a typical specimen bag 100 of the prior art.
  • the specimen bag 100 is usually formed by laminating a single piece of film (sheet), or by welding two sheets of film (sheet).
  • Materials for the film include, but are not limited to, polyethylene, polyvinyl chloride, polypropylene, nylon, Teflon, thermoset elastomers, and thermoplastic elastomers such as polyurethane.
  • Film bonding processes include, but are not limited to, heat welding, ultrasonic welding, high frequency welding, radiation welding, pulse welding, and the like.
  • the specimen bag 100 is formed by folding and laminating a single piece of polyurethane film 101. One end of the film 101 is crimped and welded to form a tunnel 111.
  • the film 101 is folded in two opposite directions along a geometrically symmetrical axis 102 that is substantially perpendicular to the direction of the tunnel 111 to form pocket faces 103 and pocket faces 104 that substantially coincide with one another.
  • the heat sealing weld 105 is formed by heat welding (referred to as heat sealing) along the outer edge shape in which the bag surface 103 and the bag surface 104 overlap.
  • the pocket surface 103, the pocket surface 103 and the weld bead 105 define a pocket opening 110 and a closed pocket 120 extending from the pocket opening 110.
  • the tunnel 111 is approximately circumferentially distributed along the pocket 110.
  • FIG. 6 depicts a typical heat welding (referred to as heat sealing) process of the prior art manufacturing techniques of the specimen bag.
  • the heat sealing machine 60 includes a base 66 fixed to the ground and a body 67 connected thereto, and an upper heat-synchronizing die 64 connected to the body 67 and movable in the vertical direction and a lower heat-bonding fixed to the body 67. Mode 65.
  • the heat sealing process of the specimen bag 100 can be simply expressed as: firstly, the heat sealing parameters (mainly including heat sealing temperature, heat sealing time and heat sealing pressure) are adjusted, and then the film 101 is overlapped and placed on the lower heat sealing mold 65, and finally the heat sealing machine is started. Heat sealing welding of the specimen bag 100.
  • the film is heat-sealed (welded), that is, in a molten state, the polymer segments on the surface of the heat-sealed region of the film are mutually diffused, infiltrated, and intertwined, so that two sheets (or multiple sheets) are intertwined.
  • the films are welded together. Referring to Figure 7, the pocket surface 103 and the pocket surface 104 are welded to each other to form a specimen pouch 100 comprising a heat sealing seam 105.
  • Figure 8 depicts a partial cross-sectional view of the heat sealing seam 105 at any position, i.e., the specimen bag 100 can be more finely divided into a film substrate 131 (film substrate 151), a transition region 132 (transition region 152) and a fusion region 133. (welding area 153).
  • the film in the molten state of the heat sealing region is calendered and extruded under the action of the heat sealing pressure, thereby forming the transition region 132 (transition region 152).
  • the film thickness of the transition region 132 (152) is less than the thickness of the film substrate 131 (151).
  • the heat sealing seam can be classified into three categories: underheating, standard heat sealing and excessive heat sealing.
  • the underheating that is, the surface of the heat sealing region is melted, and the thickness of the film participating in the heat sealing is thin, and the failure mode in the heat sealing strength test is the peeling of the welded region, and the test result is lower than the target value.
  • the standard heat sealing that is, the surface of the heat sealing region is melted, and the thickness of the film participating in the heat sealing is moderate, the failure mode is the peeling of the welded region, and the heat sealing strength test result reaches the target value.
  • the excessive heat sealing that is, the thickness of the film which is melted and the heat sealing film is too thick, causes the thickness of the transition region to be significantly thinned, so that the structural strength of the transition region is remarkably lower than that of the welded region. Peel strength, which is often referred to as "root cut", and the failure mode is the transition zone fracture, and the heat seal strength test result is lower than the target value.
  • peel strength which is often referred to as "root cut”
  • the failure mode is the transition zone fracture
  • the heat seal strength test result is lower than the target value.
  • the heat sealing joint with the largest heat sealing strength test value is the best heat sealing seam.
  • One of ordinary skill will appreciate that the use of different heat sealing parameters determines whether the heat seal seam 105 is underheated, standard heat seal or excessive heat seal.
  • the optimum heat sealing temperature is usually obtained experimentally.
  • a acceptance standard of heat sealing strength ie, target value
  • the heat sealing strength of the test sample is tested according to the test method specified by the authoritative standard.
  • the test result satisfies the acceptance standard
  • the heat sealing temperature is determined to be a reasonable temperature or an optimum temperature.
  • peelable bags packages that are torn open by hand when used
  • they are usually tested according to the American Society for Testing and Materials' ASTM F88 Flexible Barrier Material Sealing Strength Test Method.
  • the main failure mode during sample testing is heat sealing.
  • the area is stripped ( Figure 9) and the test results are essentially equivalent to the true heat seal strength of the sample being tested.
  • the thermal sealing ability of flexible materials is measured by measuring the sealing strength.
  • the procedure is tested.
  • the main failure modes during sample testing are heat-sealing area peeling (Fig. 9) or transition area fracture (Fig. 10).
  • the transition region fracture phenomenon is mainly caused by the local excessive heat sealing, which causes the thickness of the corresponding transition region to be significantly thinned, resulting in a significant decrease in local strength.
  • the failure mode of the sample test is the transition region fracture, the test result is smaller than the true heat bond strength of the sample to be tested.
  • the heat sealing temperature is still considered to be a reasonable temperature or an optimum temperature. It should be particularly pointed out that the establishment of the optimum temperature depends mainly on its test method and acceptance criteria, so that the optimum heat sealing temperature does not indicate that the heat sealing strength of the heat sealing joint is optimal.
  • the optimal heat sealing When the failure mode of the heat sealing strength test is the heat sealing zone peeling instead of the transition zone fracture, and the heat sealing zone peeling force is the largest, it is called the optimal heat sealing, and the heat sealing temperature of the sample is called the optimal heat sealing temperature, more accurate, usually This optimum temperature parameter is referred to as the theoretical optimum temperature or the ideal optimum temperature.
  • the fixture error is not introduced, and the factors such as the heat sealing film error and the environmental error are introduced into the comprehensive evaluation.
  • the factors such as the heat sealing film error and the environmental error are introduced into the comprehensive evaluation.
  • film thickness error due to film thickness error, film irregularity, heat fixture jig error, heat unevenness and other factors, especially for heat-sealed joints and materials with poor heat sealability (such as thermoplastic elastomers)
  • the use of the theoretical optimum temperature for heat sealing (welding) is prone to local residual voids, that is, the sealing integrity of the heat sealing joint is not up to standard.
  • the seal integrity and heat seal strength of the heat seal seams are conflicting.
  • the batch-sealing heat-sealing manufacturing of the specimen bags generally follows the experience in the field of food packaging and medical packaging, that is, higher than theory.
  • the optimum temperature is heat sealed to achieve both seal integrity and better heat seal strength.
  • most of the area of the same heat seal seam that is formed belongs to the standard heat seal and its local area belongs to the excessive heat seal. Referring to FIG. 7, FIG. 8 and FIG. 11, for example, when the specimen bag 100 is heat-sealed under an optimum heat sealing temperature, most of the area of the heat sealing seam 105 belongs to standard heat sealing (see FIG. 8 for the heat sealing seam pattern).
  • the partial area of the heat-sealed seam 105 is excessively heat-sealed (see Figure 11 for the heat-sealed seam pattern). Referring to Fig. 11, as described above, the local excessive heat sealing causes the transition region 132 to be locally significantly thinned, resulting in a significant decrease in local strength.
  • the sealing integrity is equally important, and any leakage may increase the risk of accidental infection of the patient or increase the workload of subsequent cleaning treatment.
  • the heat sealing method for achieving seal integrity and the heat sealing method for obtaining the best heat sealing strength are conflicting, and so far there is no good way to solve this conflict.
  • the welded joints are numerous in form, and can be roughly divided into butt joints, terminating joints, corner joints, T-joints, cross joints, lap joints and Types such as crimping joints.
  • the strength of different welded joints is different, the different welded joint forms are mainly adapted to the shape and structure of the product.
  • various welding methods and welded joint forms can also be used in theory. Since the thickness is very thin and the overall softness can be freely deformed, the complicated welding joint form is usually not considered in the field of film welding. At present, it is widely used that the two films to be welded overlap each other and then welded along the overlapping edges thereof.
  • the shape of the welded joint is similar to that of a metal welded crimped joint, and a film of this type is defined herein.
  • the welded joint is a crimped joint (see Figures 18-19).
  • the welded joints of the specimen bags and the already commercialized specimen bags disclosed in the prior art are almost all crimped joints.
  • research on film welding which has been disclosed in food packaging, medical packaging and other fields, is usually only studied for crimped joints; the research and application of other forms of welded joints are rare.
  • the crimping joint is the simplest and easy to automate the production.
  • the second is based on the overall softness and random deformability of the film. There is no reason or need to apply other forms of welded joints.
  • Experimental Case 1 In order to compare the difference in tensile strength between the crimped joint and the lap joint, the same materials, processing equipment, processing parameters, test equipment and test methods were selected to eliminate other interference factors. More detailed, choose RxT85A polyurethane material and 0.1 ⁇ 0.02 mm thick film produced by calendering, cut into 200 mm ⁇ 200 mm samples for heat sealing welding. Welding parameters: welding temperature 180 ⁇ 2°C, welding pressure 0.2 ⁇ 0.01Mpa, welding time 1 ⁇ 0.2s, weld width 3 ⁇ 0.2mm. The test is carried out according to the method specified in ASTM F2029-08. The test results are as follows:
  • the strength is much larger than the thickness direction; secondly, during the tensile fracture process of the film, it first elastically stretches and becomes thinner in the thickness direction, and then plastically deforms to exceed the material limit fracture, and the elongation deformation and thinning occur most seriously.
  • the place is the weakest link in the material.
  • the adjacent area of the weld ie, the transitional area
  • the strength of the thickness direction of the film itself is relatively poor, so that the fracture is relatively easy to occur. .
  • the weld of the lap joint has self-reinforcing effect, so that the elongation deformation of the weld and its transition zone is small, and the position of the fixed sample of the test fixture is closer.
  • the film is elongated and thinned due to stress concentration, and becomes a weak region and undergoes plastic deformation to exceed the material limit fracture.
  • increasing the strength of the film material does not significantly solve the aforementioned cracking problem.
  • the weld seam and its adjacent area are not weak points, and the true strength of the specimen bag is close to the strength of the film material, and increasing the strength of the film material can significantly increase the strength of the specimen bag.
  • FIGS 12-15 detail the structure and composition of the specimen pouch 200 of the first embodiment of the present invention.
  • the specimen pouch 200 includes a pouch 220 that can be opened and closed, and a closed pouch 230 that extends from the pouch opening 220.
  • the pocket 220 includes a tunnel 222 that surrounds the pocket for receiving the expansion mechanism 20 and the cable 50.
  • the pocket 230 is formed by welding in a lap joint manner.
  • the specimen bag 200 is formed by folding and welding a single piece of polyurethane film 210.
  • the film 210 includes a top edge 211 and a bottom edge 213 opposite thereto; the first lap edge 212 is connected to the top edge 211 at one end and the bottom edge 213 at the other end; the top edge of the second lap edge 214 is connected to the top edge. The other end is connected to the bottom edge 213.
  • the top edge 211 is folded and welded along the virtual fold line 223 to form a weld 225 that defines the tunnel 222.
  • the film 210 is folded along the virtual fold line 216 and the virtual fold line 218 to divide the film 210 into three portions: a first pocket 215, a second pocket 217, and a third pocket 219.
  • the first lap edge 212 and the second lap edge 214 overlap each other, typically the overlap region width B ranges: 1 mm ⁇ B ⁇ 5 mm.
  • Welding along its overlap region forms a lap joint weld 233 to join the first pocket surface 215 and the third pocket surface 219 together.
  • a crimp joint weld 235 is formed to join the first pocket surface 215, the second pocket surface 217 and the third pocket surface 219 in one piece.
  • the first pocket surface 215, the second pocket surface 217, the third pocket surface 219, the lap joint weld 233 and the crimp joint weld 235 together form the pocket 230.
  • the tunnel 222 defines a pocket 220.
  • the lap joint welding and the crimp joint welding method are completely different.
  • the two films (sheets) constituting the welded joint are overlapped with each other and placed on the lower welding mold, and then the upper welding mold is moved down to the end of the stroke to start welding.
  • Welds 105 are formed by welding along the outer edges of the two overlapping stencils.
  • FIG. 14, FIG. 16, FIG. 20 and FIG. 21 when the lap joint is welded, the two films constituting the welded joint only have their welded edges overlapping each other, and the substrates of the two films do not overlap (in the opposite direction). .
  • FIG 21 depicts a partial cross-sectional view of the weld bead 233 at any position, i.e., the specimen bag 200 can be more finely divided into a film substrate 241 (film substrate 251), a transition region 242 (transition region 252) and a weld region. 243 (welding area 253). Similar to the crimp joint, the lap joint weld transition region 242 (252) has a film thickness that is less than the thickness of the film substrate 241 (251).
  • the bag body 120 of the specimen bag 100 can be welded at one time, and the bag body 230 of the specimen bag 200 is generally not capable of being welded at one time because the lap joint welding method may cause it to be
  • the weld 233 cannot form a completely sealed bag with the film being welded, so a second crimped joint weld is usually required.
  • the virtual fold line 216 and the virtual fold line 218 are only present in the welding process of the lap joint, and there is no obvious virtual fold line in the finished product of the specimen bag 200.
  • the specimen bag 200 has a significantly improved strength in clinical application relative to the specimen bag 100.
  • the specimen pouch 100 becomes approximately conical, and the weld bead 105 exhibits a typical crimped joint weld (Fig. 19)
  • the transition region 132 (152) of the crimped weld is subject to large bending and shearing forces and is easily broken. .
  • the specimen pouch 200 becomes approximately conical, and the weld bead 233 exhibits a typical lap joint weld (Fig. 21
  • the lap joint is mainly subjected to the tensile force and is difficult to be in the transition region of the weld due to the local reinforcement of the lap joint.
  • a fracture occurred at 242 (252).
  • the strength of the specimen pouch 200 and the specimen pouch 100 is determined by the strength of the weakest region, and therefore, the strength of the specimen pouch 200 is increased to 4 to 5 times the strength of the specimen pouch 100.
  • the bottom of the bag body 230 that is, the adjacent region of the crimping joint weld 235, is subjected to a small pressing force, the roll
  • the edge joint weld 235 has a lower probability of breaking.
  • the specimen bag 300 includes a pocket 320 that can be opened and closed, and a closed pocket 330 that extends from the pocket 320.
  • the pocket 320 includes a tunnel 322 that surrounds the pocket.
  • the specimen bag 300 is folded and welded from a cylindrical film 310.
  • the film 310 includes a top edge 311 and a first bottom edge 313 and a second bottom edge 314 opposite thereto.
  • the top edge 311 is folded and welded to form a weld 325 that defines a tunnel 322.
  • the second bottom edge 314 is longer than the first bottom edge 313, and the second bottom edge 314 is folded such that the first bottom edge 313 and the second bottom edge 314 overlap each other.
  • Welding along its overlap region forms a lap joint weld 333 to close the bottom of the tubular film 310 as a unit.
  • the bag 330 of the specimen bag 300 is generally not capable of being welded at one time because the lap joint welding method may cause the weld bead 333 to fail to form a completely sealed bag together with the film to be welded, so a second roll is often required. Welded joints are welded.
  • the tubular film 310, the weld bead 334, the weld bead 335 and the weld bead 333 together form a pocket 330, and the tunnel 322 defines a pocket 320.
  • the specimen bag 300 has similar functions and advantages as the specimen bag 200, and the specimen bag 300 is more suitably manufactured into a large-capacity specimen bag.
  • the specimen bag 400 includes a pocket 420 and a closed pocket 430 extending from the pocket 420.
  • the pocket 420 includes a tunnel 422 that surrounds the pocket.
  • the specimen bag 400 is formed by folding and welding a single piece of film 410. Referring to FIG. 26, the film 410 includes a top edge 411 and a bottom edge 413 opposite thereto; the first overlapping edge 412 has one end connected to the top edge 411 and the other end of which is connected to the bottom edge 413; the second overlapping edge 414 has one end connected to the top edge 411 and the other end is connected to the bottom edge 413.
  • the top edge 411 is folded and welded along the virtual fold line 423 to form a weld 425 that defines the tunnel 422.
  • the film 410 is folded along the virtual fold line 416 and the virtual fold line 418 to divide the film 410 into three portions: a first pocket 415, a second pocket 417 and a third pocket 419.
  • the first lap 412 and the second lap 414 overlap each other. Welding along its overlap region forms a lap joint weld 433 to join the first pocket surface 415 and the third pocket surface 419 together. As shown in Fig.
  • a first crimp joint weld 434 and a second crimp joint weld 435 are formed, thereby forming the first pocket surface 415, the second pocket surface 417 and the first The three pocket faces 419 are joined together.
  • the first pocket surface 415, the second pocket surface 417, the third pocket surface 419, the weld bead 433, the weld bead 434 and the weld bead 435 together form a pocket 430.
  • the tunnel 422 defines a pocket 420.
  • the first crimp joint weld 434 is an over weld weld and the second seam weld weld 435 is a hybrid weld including a standard weld and an under weld.
  • the weld 435 helps to increase the strength of the weld, and the weld 434 is over-welded to ensure seal integrity.
  • the under-welding that is, the surface of the welded region is melted, and the thickness of the film participating in the fusion is thin.
  • the failure mode during the welding strength test is that the welded portion of the specimen bag is peeled off, and the test result is lower than the target value.
  • the standard welding that is, the surface of the welded portion is melted, and the thickness of the film to be fused is moderate.
  • the failure mode during the welding strength test is that the welded portion of the specimen bag is peeled off, and the test result reaches the target value.
  • Excessive welding that is, the surface of the welded portion is melted, and the thickness of the film involved in fusion is too large, resulting in a significant thinning of the thickness of the transition region between the specimen bag welding region and the specimen bag substrate, and the failure mode in the welding strength test is The transition zone is broken and the heat sealing strength test result is lower than the target value.
  • the lap joint weld 433 and the weld bead 435 help to increase the specimen bag weld strength, thereby increasing the strength of the specimen bag 400.
  • FIG. 30-33 detail the construction and composition of the specimen pouch 500 of the fourth embodiment of the present invention.
  • the specimen pouch 500 includes a pouch 520 that can be opened and closed, and a closed pouch 530 that extends from the pouch 520.
  • the pocket 520 includes a tunnel 522 that surrounds the pocket.
  • the specimen bag 500 is formed by folding and welding a single piece of thermoplastic elastomer film 510. Referring to FIG.
  • the film 510 includes a top edge 511 and a bottom edge 513a and a bottom edge 513b opposite thereto; the first overlapping edge 512 has a top end 511 connected to one end and a bottom edge 513a connected to the other end; a second overlapping edge 514 One end is connected to the top edge 511 and the other end is connected to the bottom edge 513b.
  • the top edge 511 is folded and welded along the virtual fold line 523 to form a weld 525 that defines the tunnel 522. Referring to FIG.
  • a crimp joint weld 535 is formed along the sharp corner region of the weld bead 534.
  • the film 510, the lap joint weld 533, the lap joint weld 534 and the crimp joint weld 535 together form a pocket 530.
  • the tunnel 522 defines a pocket 520.
  • US Patent No. 5,480,404 discloses that the shape of the specimen bag is designed as a truncated cone (i.e., a specimen bag having a small diameter at the bottom and a large diameter of the mouth), which facilitates loading the tissue into the specimen bag and facilitating the removal of the specimen bag during use. The expansion of the patient's incision.
  • the specimen bag 500 comprises two lap joint welds and a short crimp joint weld formed by a structure in which the diameter of the bag is gradually reduced from the bag mouth to the bottom of the bag, which is also advantageous for loading into the bag 500 of the specimen bag during use.
  • the tissue is beneficial to reduce the expansion of the patient's incision when it is pulled out.
  • the local sharp corner region formed by the lap joint weld 534 is advantageous for containing blood water or body fluid that flows out after the diseased tissue is squeezed.
  • FIG. 34-37 detail the construction and composition of the specimen bag 600 of the fifth embodiment of the present invention.
  • the specimen bag 600 includes a pocket 620 that can be opened and closed, and a closed pocket 630 that extends from the pocket 620.
  • the pocket 620 includes a tunnel 622 that surrounds the pocket.
  • the specimen bag 600 is formed by folding and welding a single piece of thermoplastic elastomer film 610. Referring to FIG.
  • the film 610 includes a top edge 611 and a bottom edge 613a opposite thereto, a bottom edge 613b and a bottom edge 613c; the first overlapping edge 612 has one end connected to the top edge 611 and the other end of which is connected to the bottom edge 613a; One end of the lap 614 is connected to the top edge 611 and the other end is connected to the bottom edge 613c.
  • the top edge 611 is folded and welded along the virtual fold line 623 to form a weld 625 that defines the tunnel 622. Referring to FIG.
  • a bead joint weld (not shown) is formed along the sharp corner region of the weld 634.
  • the film 610, the lap joint weld 633, the lap joint weld 634 and the crimp joint weld together form the bag 630.
  • the tunnel 622 defines a pocket 620.
  • the longest lap joint welds constituting the bag body are in the same plane as the rotation axis of the formed rotary body, which is called a planar straight weld.
  • the lap joint weld 633 is not in the same plane as the axis of the rotary body, and the weld bead 633 is distributed along the surface of the rotary body in a spatial curve. It is a space curve weld.
  • the angled weld bead 633 facilitates improved stress concentration in the weld zone during use of the specimen bag relative to other welds.
  • the plastic film material is a slit-sensitive material, when the weld is partially broken, the crack rapidly grows along the transition region of the straight weld, causing the specimen bag to be completely and completely broken; and the curved weld has It helps to prevent the crack from growing rapidly along the transition zone of the weld, thereby reducing the risk of rapid and complete rupture of the specimen bag.
  • the weld bead 633 of the specimen bag 600 is a straight line, however a full curve weld can also be used.
  • the specimen bag 600a disclosed in Fig. 37 is substantially identical to the specimen bag 600, the main difference being that the lap joint weld 633a of the specimen bag 600a is a weld in a curved form.
  • the specimen pouch 700 includes a pouch 720 that can be opened and closed, and a closed pouch 730 that extends from the pouch 720.
  • the pocket 720 includes a tunnel 722 that surrounds the pocket.
  • the specimen bag 700 is formed by folding and welding a single piece of thermoplastic elastomer film 710.
  • the bag body 730 includes a lap joint weld 733 and a lap joint weld 734.
  • the specimen bag 800 includes a pocket 820 that can be opened and closed, and a closed pocket 830 that extends from the pocket 820.
  • the pocket 820 includes a tunnel 822 that surrounds the pocket.
  • the specimen bag 800 is formed by folding and welding a single piece of thermoplastic elastomer film 810.
  • the specimen bag 800 is similar in structure and shape to the specimen bag 200.
  • the first overlapping edge 212 and the second overlapping edge 214 of the specimen bag 200 are staggered without overlapping, and then welded along the first overlapping edge 212 and the second overlapping edge 214 respectively to form two Strip lap joints: lap joint welds 833 and lap joint welds 834.
  • a void region is left between the lap joint weld 833 and the lap joint weld 834.
  • the specimen bag 200 is converted into a specimen bag 800.
  • Figure 42 depicts the structure and composition of a specimen pouch 900 of an eighth embodiment of the present invention.
  • the specimen bag 900 includes a pocket 920 that can be opened and closed, and a closed pocket 930 that extends from the pocket 920.
  • the pocket 920 includes a tunnel 922 that surrounds the pocket.
  • the specimen bag 900 is formed by welding the first film 911 and the second film 912 to each other.
  • the bag body 930 includes a lap joint weld 933, a lap joint weld 934 and a lap joint weld 935.
  • Those skilled in the art will appreciate that in theory, a variety of different specimen bags can be made from more sheets or more welds. However, increasing the number of sheets and the number of welds often increases the manufacturing cost and introduces new ones. risk point.
  • the specimen bag of the lap joint is different from the manufacturing method of the prior art crimp joint specimen bag, and roughly comprises a die-cut film raw material, a welded tunnel, a lap welded bag body, and a crimping There are 4 main steps in the bottom of the welded bag (or crimped corner area).
  • the steps of one of the manufacturing methods are generally as follows:
  • S1 die-cutting the raw material of the film, and cutting the raw material of the film into a general shape such as a sheet-like film 210 (see FIG. 12); in order to ensure the quality, the film raw material is generally die-cut, and those skilled in the art may also consider cutting. Or other cutting means to form the sheet film 210.
  • S2 welding the tunnel, bending the edge of the film of the tunnel 222 forming the specimen bag and placing it on the lower mold of the first welding mold, and welding the upper mold of the first welding mold to form the tunnel 222 (see FIG.
  • S3 lap joint welding the bag body, folding the film 210 along the virtual folding line 216 and the virtual folding line 218, so that the overlapping sides of the film 210 overlap each other to form a substantially closed bag body a region; a lower mold of the second welding mold is inserted into the bag body region and attached under the overlapping region of the overlapping edge, and is welded to the lap joint weld 233 using the upper die of the second welding die (see FIG. 16).
  • S4 the crimping joint method welds the bottom of the bag, and the bag body 230 is placed on the lower die of the third welding die, and the upper die of the third welding die is welded along the outer edge of the bottom edge 213 to form the bead Joint weld 235 (see Figure 14).
  • Another optional manufacturing step is as follows:
  • S1 die-cutting the raw material, and cutting the cylindrical film raw material into a shape substantially like a cylindrical film 310 (see FIG. 22);
  • S2 welding a tunnel, which will form the edge material of the tubular film of the tunnel 322 of the specimen bag 300 The bending is placed on the lower mold of the first welding mold, and the upper mold is welded by the first welding mold to form a tunnel 322 (see FIG. 23);
  • S3 the lap joint method is used to weld the bag body, and the film 310 is bottomed. The edge 314 is folded over the first bottom edge 313.
  • the first bottom edge 313 and the second bottom edge 314 of the film 310 are overlapped with each other to form a substantially closed bag body region; a lower die of the second soldering die is inserted into the bag body region and attached to the overlap Below the overlap area of the sides, the upper die of the second welding die is welded into a lap joint weld 333 (see Figure 24).
  • S4 crimping the joint method to weld the sharp corner region, placing the bag body 330 on the lower mold of the third welding mold, and welding the upper mold bottom of the third welding mold along the sharp corner regions of the welded joint 333,
  • the crimp joint weld 335 is formed to weld the lap joint weld 333 and the film 310 into a sealed unitary body (see Figure 25).
  • Yet another optional manufacturing step is as follows:
  • S1 die-cutting the film raw material, and cutting the film raw material into a general shape such as a sheet-like film 410 (see FIG. 26);
  • S2 welding a tunnel, bending and placing the edge material of the film forming the tunnel 442 of the specimen bag Above the lower mold of the first welding mold, the upper mold is welded using the first welding mold to form a tunnel 422 (see Fig. 27);
  • S3 the lap joint method welds the bag body along the virtual folding line 416 and the virtual folding line 418
  • the film 410 is folded up, and the first overlapping edge 412 and the second overlapping edge 414 are overlapped with each other, and the lower die of the second welding die is inserted into the bag body region and adhered to the overlap of the overlapping edges.
  • Yet another optional manufacturing step is as follows:
  • S1 die-cutting a film raw material, and cutting the film raw material into a general shape such as a sheet-like film 510 (see FIG. 30);
  • S2 welding a tunnel, bending an edge material of the tunnel 522 forming the specimen bag and placing it in the first welding die Above the lower mold, the upper mold is welded using the first welding mold to form a tunnel 522 (see FIG.
  • S3 the lap joint method welds the bag body along the virtual fold line 515, the pseudo fold line 516 and the virtual fold line 517 will
  • the film 510 is folded up such that the first overlapping edge 512 and the second overlapping edge 514 overlap each other, while the bottom edge 513a and the bottom edge 513b overlap each other, and the lower die of the second welding die is inserted into the bag body region.
  • S4 crimp joint method The sharp corner region is welded, the bag body 530 is placed on the lower mold of the third welding mold, and the upper mold of the third welding mold is welded along the sharp corner region of the weld bead 534 to form the crimp joint weld 535 (see Fig. 33). .

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  • Health & Medical Sciences (AREA)
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  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

L'invention concerne un sac à échantillon (200) formé par liaison par fusion de sections de pliage de celui-ci et un instrument de retrait d'échantillon (10). Le sac à échantillon (200) comprend une extrémité ouverte (220) pouvant être ouverte et fermée, et un corps de sac (230) s'étendant à partir de l'extrémité ouverte (220). L'extrémité ouverte (220) comprend un ourlet périphérique (222). Le corps de sac (230) comprend en outre une partie inférieure. Le corps de sac (230) comprend une membrane lamellaire (210). La membrane (210) a un bord supérieur (211) relié à l'ourlet (222) et une première section de bord de pliage (212) et une seconde section de bord de pliage (214) qui sont situées à deux extrémités du bord supérieur (211). Après que la membrane (210) a été pliée le long de plis virtuels (216, 218), la première section de bord de pliage (212) et la seconde section de bord de pliage (214) se chevauchent et sont ensuite soudées pour former un joint de soudure plié (233). Le sac d'échantillon (200) formé par liaison par fusion de sections de pliage de celui-ci peut empêcher efficacement le corps de sac (230) de se casser.
PCT/CN2018/075805 2017-03-06 2018-02-08 Sac à échantillon formé par liaison par fusion de sections de pliage de celui-ci et instrument de retrait d'échantillon Ceased WO2018161768A1 (fr)

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CN201710129505.1A CN106859705A (zh) 2017-03-06 2017-03-06 一种搭接熔合标本袋及取物器械

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CN106859705A (zh) * 2017-03-06 2017-06-20 成都五义医疗科技有限公司 一种搭接熔合标本袋及取物器械
CN113229867B (zh) * 2020-07-03 2022-09-20 重庆橙壹科技有限公司 一种适用于定制生产的医用取物袋
CN113229866A (zh) * 2020-07-03 2021-08-10 重庆橙壹科技有限公司 一种采用粘接和焊接结合的医用标本袋
CN113520490A (zh) * 2020-07-03 2021-10-22 重庆橙壹科技有限公司 一种一次性医用标本袋产品包
CN113331884A (zh) * 2020-07-03 2021-09-03 重庆橙壹科技有限公司 一种适用于腔镜手术的定制生产的医用取物袋
CN111685820A (zh) * 2020-07-09 2020-09-22 重庆橙壹科技有限公司 一种带收缩中空管的医用取物器
CN112248551B (zh) * 2020-11-09 2024-05-03 兰州交通大学 一种自动化铝粉袋接缝热压夹持装置

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