WO2018161767A1 - 一种多重熔合标本袋及制造方法 - Google Patents

一种多重熔合标本袋及制造方法 Download PDF

Info

Publication number
WO2018161767A1
WO2018161767A1 PCT/CN2018/075802 CN2018075802W WO2018161767A1 WO 2018161767 A1 WO2018161767 A1 WO 2018161767A1 CN 2018075802 W CN2018075802 W CN 2018075802W WO 2018161767 A1 WO2018161767 A1 WO 2018161767A1
Authority
WO
WIPO (PCT)
Prior art keywords
weld
welding
bag
specimen
specimen bag
Prior art date
Application number
PCT/CN2018/075802
Other languages
English (en)
French (fr)
Inventor
朱莫恕
Original Assignee
成都五义医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201710129503.2A external-priority patent/CN107041764B/zh
Priority claimed from CN201710129327.2A external-priority patent/CN106725654B/zh
Application filed by 成都五义医疗科技有限公司 filed Critical 成都五义医疗科技有限公司
Publication of WO2018161767A1 publication Critical patent/WO2018161767A1/zh

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets

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 multiple fusion specimen bag includes a bag opening that can be opened and closed and a bag body extending from the mouth of the bag, the bag opening comprising a surrounding tunnel, the bag body comprising a film and a weld a weld that welds the film into a bag-like closed body;
  • the weld includes an outer weld portion and an inner weld portion;
  • the outer weld portion includes an over-welded weld or a standard weld and excess A welded weld that is welded;
  • the inner weld portion includes a weld weld of under-weld and standard weld.
  • a multiple fusion specimen bag in another aspect of the invention, includes a bag opening that can be opened and closed and a bag body extending from the mouth of the bag, the bag opening comprising a surrounding tunnel, characterized in that: the bag The body comprises a film and a first weld seam, the first weld seam welding the film into a closed bag-like body; the bag body further comprising a second weld bead disposed inside the first weld bead; the first weld An empty side is included between the seam and the second weld.
  • the first weld includes an over-welded weld or a standard weld and an over-welded hybrid weld; an alternative, the second weld comprising a weld weld of under-weld and standard weld. In still another alternative, the second weld comprises a discontinuous weld or a continuous weld.
  • an apparatus for dispensing in another aspect of the invention, includes a tie line through which the specimen bag is placed, and the tie line can tighten the bag mouth of the sample bag after receiving the tissue sample.
  • an apparatus for dispensing further includes a catheter assembly and a handle assembly therethrough, and a distraction mechanism for extending the specimen bag connected to the handle assembly, the specimen bag and the distracting mechanism being disposed in the catheter assembly Moving axially relative thereto; operating the handle bag and the distraction mechanism forwardly within the catheter assembly and extending out of the cannula assembly by the handle assembly and being distracted by the distraction mechanism; the distraction mechanism is as described
  • the catheter assembly is withdrawn rearwardly from the specimen bag, the pull wire extending through the catheter assembly.
  • Another method for manufacturing the specimen bag has the following steps:
  • 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 side elevational view of the specimen bag 200 of the first embodiment
  • Figure 13 is a cross-sectional view taken along line 13-13 of Figure 12;
  • Figure 14 is a cross-sectional view taken along line 14-14 of Figure 12;
  • Figure 15 is a schematic view of a welding die that can output two temperatures
  • Figure 16 is a side elevational view of the specimen bag 300 of the second embodiment
  • Figure 17 is a cross-sectional view taken along line 17-17 of Figure 16;
  • Figure 18 is a development view of a film of the specimen bag 400 of the third embodiment
  • Figure 19 is a schematic view showing the folding of the film of the specimen bag 400 of the third embodiment.
  • Figure 20 is a schematic view showing the first welding of the specimen bag 400 of the third embodiment
  • Figure 21 is a sectional view taken along line 21-21 of Figure 20;
  • Figure 22 is a schematic view showing the second welding of the specimen bag shown in Figure 20;
  • Figure 23 is a cross-sectional view taken along line 23-23 of Figure 22 .
  • Figure 24 is a schematic view showing still another first welding of the specimen bag 400 of the third embodiment.
  • Figure 25 is a 25-25 cross-sectional view of Figure 24.
  • 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 201 that can be opened and closed, and a closed pouch 202 that extends from the pouch opening 201.
  • the pocket 201 includes a tunnel 211 surrounding 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 elastic body 21 is inserted into the tunnel 211.
  • 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 folding and welding a single piece of film (sheet), or by welding two sheets of film (sheet).
  • Materials for the film (sheet) include, but are not limited to, polyethylene, polyvinyl chloride, polypropylene, nylon, Teflon, thermosetting elastomers (such as silica gel), and thermoplastic elastomers (such as polyurethane).
  • the film (sheet) welding process includes, but is not limited to, heat welding, ultrasonic welding, high frequency welding, radiation welding, pulse welding, and the like.
  • the specimen bag 100 of the present example is formed by superheating and welding two sheets of polyethylene film.
  • 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 103 and the film 104 are overlapped and placed on the lower heat sealing mold 65, and finally started.
  • the heat sealing machine completes the 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 highest heat sealing strength test value is the best heat sealing joint.
  • 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.
  • Figures 12-14 detail the structure and composition of the specimen pouch 200 of the first embodiment of the present invention.
  • the heat sealing methods for achieving seal integrity and optimum heat seal strength are conflicting, that is, it is difficult to control the heat sealing quality of the specimen bag 200 by the optimum heat sealing parameter method, so that the weld seam has both seal integrity. At the same time, it ensures that the welds are all in the standard heat sealing state to obtain the best heat sealing strength.
  • a multi-weld method is employed to resolve the aforementioned conflicts. More specifically, the specimen bag 200 contains at least two welds, wherein the outermost weld achieves seal integrity and the inner weld primarily achieves good heat seal strength.
  • the specimen pouch 200 includes a pouch 201 that can be opened and closed, and a pouch 202 that extends from the pouch 201.
  • the pocket 201 includes a tunnel 211 surrounding the pocket for receiving the expansion mechanism 20 and the cable 50.
  • the bag body 202 includes a first film 203 and a second film 205.
  • first film 203 and second film 205 having substantially the same size and shape are overlapped with each other, and then the entire outer portion of the overlapping portion
  • the edge is subjected to heat welding (referred to as heat sealing) to form a first heat sealing seam 204 (hereinafter simply referred to as a first weld seam 204), thereby thermally combining the first film 203 and the second film 205 into a bag-like whole having an opening.
  • the shape of the heat sealing seam formed by the first weld bead 204 along the edge of the bag body is approximately U-shaped.
  • the bag body 202 further includes a second heat sealing seam 208 (hereinafter referred to as a second weld seam 208), and the second weld seam 208 is disposed inside the first weld seam 204.
  • the second weld bead 208 is substantially parallel to the first weld bead 204 in the present example, and a vacant section 206 is disposed between the first weld bead 204 and the second weld bead 208.
  • the first weld 204 and the second weld 208 may also be non-parallel.
  • the first film 203 and the second film 205 are welded together by heat welding in this example, ultrasonic welding, high frequency welding, radiation welding, pulse welding, or the like may be employed.
  • Materials for the film 203 and film 205 include, but are not limited to, polyethylene, polyvinyl chloride, polypropylene, nylon, Teflon, thermoset elastomers (e.g., silica gel), and thermoplastic elastomers (e.g., polyurethane).
  • the first film 203 and the second film 205 are both made of polyurethane.
  • the main difference is that the welding energy sources are different, and the welding is essentially the same.
  • the specimen bag is manufactured by other welding methods, and the mutually welded film is also in a molten state, and the polymer segments on the surface of the heat-sealed region of the film are mutually diffused, infiltrated and intertwined, so that the two-piece (or multiple) film is welded at together.
  • Specimen bags can also be more carefully divided into film substrates, transition areas and weld areas.
  • the film in the molten state of the heat sealing region is calendered and extruded under the action of heat sealing pressure to form the transition region.
  • the film thickness of the transition region is less than the thickness of the film substrate.
  • the welded joints can also be roughly divided into under-welded (equivalent to under-heat sealing), standard welded (equivalent to standard fusion) and over-welded (equivalent to excessive heat sealing).
  • under-welded Equivalent to under-heat sealing
  • standard welded Equivalent to standard fusion
  • over-welded equivalent to excessive heat sealing
  • An ordinary technician can understand that under different welding methods, the parameters affecting the welding quality are different. Different welding parameters are used to determine whether the welded joint is under-welded, standard welded or over-welded.
  • other well-known welding methods can also be obtained by experimental methods of maximum weld strength, optimum weld seams and theoretical optimum weld parameters.
  • Under-welding that is, the surface of the welded area is melted, and the thickness of the film to be fused 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.
  • 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.
  • the thickness of the film that is melted and involved in fusion of the surface of the welded area is too large, resulting in a significant thinning of the thickness of the transition region between the welded portion of the specimen bag and the substrate of the specimen bag, and the failure mode during the welding strength test.
  • the heat seal strength test result is lower than the target value.
  • Under-weld weld The weld strength test is performed as an under-welded weld.
  • Standard welded seam The weld strength test is expressed as a standard welded weld.
  • Over-weld weld The weld strength test is characterized by an over-welded weld.
  • Optimum weld The failure mode during the weld strength test is the weld where the weld zone of the specimen bag is peeled off and the test result reaches the maximum.
  • Theoretically optimal welding parameters the welding parameters for the best weld.
  • the sample to be tested is prepared in advance as a strip test specimen having a width of 25 mm, 20 mm or 15 mm.
  • the test results may include under-weld, standard weld and over-weld, and such long welds are defined herein as hybrid welds.
  • Under-weld and standard weld hybrid welds The same weld contains both the under-welded part and the standard welded part.
  • Standard and over-welded hybrid welds The same weld contains both standard and over-welded parts.
  • Figure 13 depicts a partial cross-sectional view of the bag body 202 at the 13-13 position.
  • the first film 203 is approximately inwardly divided from the outer edge into a first weld zone 231, a first transition zone 233, a second weld zone 235, a second transition zone 237 and a specimen bag substrate 239.
  • the second film 205 can be approximately divided into a first fusion zone 251, a first transition zone 253, a second weld zone 255, a second transition zone 257 and a specimen bag substrate 259 from the outer edge.
  • Figure 14 depicts a partial cross-sectional view of the second weld 208 of the bag 202 at a 14-14 position.
  • the weld 208 in this example includes a micro slit 262 and a micro slit 266 on the 14-14 weld section.
  • the materials and thicknesses of the first film 203 and the second film 205 are the same, one of the film films may be selected.
  • the materials or thicknesses of the first film 203 and the second film 205 are not the same, one of the thintest films may be selected for research.
  • the first film 203 selected in the present example is the main research object.
  • the first weld 204 is an over-welded weld or a standard weld and an over-welded hybrid weld; and the second weld 208 is an under-weld and standard weld hybrid weld.
  • the specimen bag 200 is manufactured by a method of heat welding (heat sealing). First, the theoretical optimum temperature for the heat sealing of the first film 203 and the second film 205 is obtained by an experimental method.
  • the temperature at any position of the heat sealing mold for ensuring heat output is greater than or equal to the theoretical optimum temperature, ensuring that there is no under-welding on the entire weld seam of the first weld bead 204, that is, Ensure its seal integrity. That is, the first weld bead 204 is all over-welded, or a combination of standard welding and partial over-welding. Referring to FIG. 13, as described above, in an implementation, the over-welding manner causes the thickness of the first transition region 233 to be reduced by 15% to 30%; when the thickness of the first transition region 233 is reduced by 30% in an extreme case.
  • the first weld 204 is rendered as a standard welded and over-welded hybrid weld by reducing the heat sealing temperature, i.e., using a lower heat seal while ensuring the seal integrity of the first weld 204.
  • the temperature enhances the weld strength of the first weld 204 by reducing the degree of thickness reduction of the first transition region 233.
  • the temperature at any position of the heat sealing mold for ensuring heat output is less than or equal to the theoretical optimum temperature, and the entire weld of the second weld bead 208 is ensured to be not excessively welded.
  • the second weld 208 is allowed to contain under-weld And standard welding. Referring to FIG.
  • the thickness reduction of the second transition region 237 is controlled to be 0 to 15%.
  • the failure mode during the weld strength test is that the weld zone 208 of the specimen bag is peeled off rather than the second transition zone 237 being broken.
  • a higher heat sealing temperature is used to enhance the weld strength of the second weld 208 while ensuring that there is no over-welding of the entire weld of the second weld 208. Since the second weld 208 is not allowed to contain over-welded welds, under-weld welds are inevitably present in the entire second weld 208 due to various error factors, particularly for long welds.
  • the weld 208 includes micro slits 262 and micro slits 266 on the 14-14 weld segments. Since the second weld 208 does not need to ensure seal integrity, local micro-slits (under-welding) are acceptable.
  • the principle, use method and advantages of the specimen bag 200 as described above, in the field of food packaging and medical packaging, such as blood packaging bags, the uniform pressure (pressure) of the weld of the packaging bag when the rupture fails. Therefore, for blood bags or similar products, it is almost meaningless to use multiple welds. However, the clinical application and failure mode of the specimen bag is completely different from the aforementioned blood packaging.
  • the seal integrity of the specimen bag weld is to ensure that blood or body fluids in the cut diseased tissue or organ do not penetrate and leak into the patient's body cavity.
  • the packaging organization applies uneven pressing force to the specimen bag body, and then the internal force of the specimen bag body is transferred to the second weld seam. 208. Since the diseased tissue is not a fluid, it is not possible to pass through the micro-slits on the second weld 208 and transfer the force to the first weld 204. Those skilled in the art will appreciate that partial under-welding does not significantly reduce weld strength.
  • the plastic film is a typical slit-sensitive material, and the undercut phenomenon caused by local over-melting is likely to cause the weld to be torn and rapidly grow by a large internal force, thereby significantly reducing the strength of the specimen bag.
  • the outermost weld seam achieves sealing integrity
  • the inner weld seam mainly achieves heat sealing strength, which satisfies the clinical application requirements of the specimen bag, and better solves the sealing integrity and the best heat seal. Intensity conflict.
  • the first weld bead 204 and the second weld bead 208 are formed by heat sealing twice; first, heat sealing of the first weld bead 204 is completed to complete heat sealing of the second weld bead 208; or first completed into a second The heat sealing of the weld bead 208 completes the heat sealing of the first weld bead 204.
  • the first weld bead 204 and the second weld bead 208 are formed by a single heat seal. Referring to Figure 15, the heat sealing apparatus partially localizes two independently heated heat sealing tools to achieve a single thermal synthesis of two different welds.
  • the first weld bead 204 and the second weld bead 208 are formed by two welding processes by other known welding methods, and the two welding methods may be the same or different.
  • the specimen bag 300 is substantially identical in structure to the specimen bag 200 except for the second weld bead.
  • the specimen bag 300 includes a bag mouth 201 and a closed bag body 302.
  • the pocket 201 includes a tunnel 211 that surrounds the pocket.
  • the bag body 302 includes a first film 203 and a second film 205.
  • the first film 203 and the second film 205 are overlapped with each other and then welded along the outer edge to form a first weld 204, thereby the first film 203 and The second film 205 is thermally combined into a bag-like unit having an opening.
  • the bag body 302 also includes a second weld bead 308 disposed on the inside of the first weld bead 204.
  • the second weld bead 308 is substantially parallel to the first weld bead 204 in the present example, and a vacant section 206 is disposed between the first weld bead 204 and the second weld bead 308.
  • a joint weld 305 and a joint weld 307 join the first weld 204 and the second weld 308.
  • the entire weld of the second weld 308 is discontinuous and includes a plurality of void segments 362.
  • the first weld bead 204 is an over-welded weld, or is a standard welded and over-welded hybrid weld; and the second weld 208 is an under-welded and standard welded hybrid weld.
  • the specimen bag 300 and the specimen bag 200 have similar functions and performance.
  • the heat sealing methods for achieving seal integrity and optimum heat seal strength are conflicting, that is, it is difficult to control the heat seal quality of the specimen bag 400 by the optimum heat sealing parameter method, so that the weld seam has both seal integrity. At the same time, it ensures that the welds are all in the standard heat sealing state to obtain the best heat sealing strength.
  • a single weld multiple welding method is employed to resolve the aforementioned conflicts. More specifically, the specimen bag 400 includes a single outer edge weld 409 formed by multiple welds, and the outer edge weld 409 is divided into a typical inner weld portion and an outer weld portion.
  • the specimen pouch 400 includes a pouch 401 and a pouch 402 that can receive a tissue specimen, the pouch 401 including a tunnel 411 that surrounds the pouch.
  • the bag body 402 includes a centerline 404 and a first pocket surface 403 and a second pocket surface 405 that are folded up along the centerline 404.
  • the first pocket surface 403 and the second pocket surface 405 are substantially the same size and shape and overlap each other, and the entire outer edge of the overlapping portion is welded to form an outer edge weld 409, thereby the first pocket surface 403 and the second pocket.
  • the face 405 is welded into a bag-like unit having an opening.
  • the outer edge weld 409 includes a first weld bead 407 disposed on the outer side and a second weld bead 408 disposed on the inner side, the first weld bead 407 and the second weld bead 408 being substantially parallel and fused to each other. There are no obvious blanks or vacant segments.
  • Figure 23 depicts a partial cross-sectional view of the pocket 402 at positions 23-23.
  • the first pocket surface 403 is approximately inwardly divided from the outer edge into a first weld zone 431, a second weld zone 433, a second transition zone 435, and a specimen bag substrate 437.
  • the second pocket surface 405 can be approximately divided into a first weld zone 451, a second weld zone 453, a second transition zone 455 and a specimen bag substrate 457 from the outer edge. It will be understood by those skilled in the art that when the material and thickness of the first bag surface 403 and the second bag surface 405 are the same, one of the bag faces may be studied.
  • the first pocket surface 403 is selected in this example as the main research object.
  • the first weld 407 is an over-welded weld or a standard weld and an over-welded hybrid weld; and the second weld 408 is an under-weld and standard weld hybrid weld.
  • the specimen bag 400 is manufactured by heat welding (heat sealing).
  • heat sealing heat sealing
  • the theoretical optimum temperature for heat sealing welding is obtained by experimental method.
  • the temperature at any position of the heat sealing mold for ensuring heat output is greater than or equal to the theoretical optimum temperature, ensuring that there is no under-welding on the entire weld seam of the first weld bead 407, that is, Ensure its seal integrity.
  • the first weld bead 407 is all over-welded, or combined with standard fusion and partial over-fusion.
  • the first weld 407 is rendered as a standard welded and over-welded hybrid weld by reducing the heat sealing temperature, i.e., using a lower heat seal while ensuring the seal integrity of the first weld 407.
  • the temperature enhances the weld strength of the first weld 407 by reducing the degree of thickness reduction of the first transition region 233.
  • the temperature at any position of the heat sealing mold for ensuring heat output is less than or equal to the theoretical optimum temperature, and the entire weld bead of the second weld bead 408 is not excessively welded.
  • the second weld 408 is allowed to contain under-weld And standard welding.
  • the thickness reduction of the second transition region 435 is controlled from 0 to 15% when fabricated in a standard fusion process.
  • the failure mode during the weld strength test is that the weld zone 408 of the specimen bag is peeled off rather than the second transition zone 435 being broken.
  • a higher heat sealing temperature is used to enhance the weld strength of the second weld 408 while ensuring that there is no over-welding of the entire weld of the second weld 408. Since the second weld bead 408 is not allowed to contain over-weld welds, due to various error factors, especially for long welds, under-weld welds or even micro-slits are inevitable in the entire second weld bead 408. . Since the second weld 408 does not need to ensure seal integrity, local micro-slits (under-welding) are acceptable.
  • the specimen bag 400 has similar functions and performance relative to the specimen bag 200. There is no obvious gap between the first weld 407 and the second weld 408 of the specimen bag 400, and a single outer edge weld 409 is formed, which can reduce the wrinkles or curls in the manufacturing process of the bag surface (film) of the specimen bag, and also Can save space.
  • the specimen bag 400 is folded by a single piece of film, which is advantageous for reducing the length of the weld, reducing the welding difficulty and improving the stability of the production.
  • the specimen bag 400 has various manufacturing methods, and a preferred manufacturing step is generally as follows:
  • S2 a bag surface 403 and a bag surface 405 formed by folding the bag body 402 along the center line 404 (as shown in FIG. 19);
  • Another optional manufacturing step is as follows:
  • S2 a bag surface 403 and a bag surface 405 formed by folding the bag body 402 along the center line 404 (as shown in FIG. 19);
  • S4 performing a second welding along the outer edge of the second weld 408 to form a hybrid weld including standard weld and over-welding, or forming a single over-welded weld, referred to as a first weld 407.
  • the first weld 407 and the second weld 408 are collectively referred to as the outer weld 409, and there is no significant blank or vacant section between the first weld and the second weld.
  • Yet another optional manufacturing step is as follows:
  • S2 a bag surface 403 and a bag surface 405 formed by folding the bag body 402 along the center line 404 (as shown in FIG. 19);
  • S4 performing a second welding along the outer edge of the second weld bead 408 to form a weld comprising an under-weld and a standard weld, referred to as a second weld 408.
  • the first weld 407 and the second weld 408 are collectively referred to as the outer weld 409, and there is no significant blank or vacant section between the first weld and the second weld.

Abstract

一种多重熔合标本袋（200）及制造方法，包含可打开和收拢的袋口（201）以及从袋口（201）延伸而成的袋体（202），袋口（201）包含环绕的隧道（211），袋体（202）包含薄膜（203，205）和第一焊缝（204），第一焊缝（204）将薄膜（203，205）焊接成一个封闭的袋状整体；袋体（202）还包含设置在第一焊缝（204）内侧的第二焊缝（208）；第一焊缝（204）和第二焊缝（208）之间包含空置边（206）。第一焊缝（204）包含过度熔接焊缝或标准熔接和过度熔接的混合焊缝；第二焊缝（208）包含欠熔接和标准熔接的混合焊缝。标本袋（200）可以有效防止袋体（202）破裂。

Description

一种多重熔合标本袋及制造方法 技术领域
本发明涉及微创手术器械，尤其涉及一种标本袋结构。
背景技术
在微创手术中(尤其是硬管腔镜手术)，通常需经由患者皮肤小切口或经由穿刺导管取出内部组织或病变器官。如何安全的便捷的取出腔内组织或病变器官，一直是困扰微创手术的难题。自硬管腔镜手术首次临床应用以来，国内外研制了多种腔镜手术专用标本袋。虽然所述标本袋的结构和使用方式各有差异，但总体可分为两类：第一类，单一标本袋。美国发明专利US5037379中披露了一种单边开口的带线标本袋，使用时需使用抓钳夹持标本袋体再经过穿刺导管或小切口进入患者体内。第二类，包含标本袋，导管和撑开机构的取物器械。US5465731，US5480404，US6383197等美国发明专利中披露了多种取物器械，其标本袋被卷起并收纳于导管之内，使用时所述取物器械经过穿刺套管进入患者体内，再推动其撑开机构将所述卷起的标本袋推出到导管之外，并由撑开机构将标本袋撑开，方便装入手术中切割的组织或病变器官。
所述标本袋通常由0.05mm～0.1mm的塑料薄膜或塑料片材制成。到目前为止，难以采用整体成型的方式制造标本袋，通常采用两片薄膜重叠热合(焊接)，或者采用单片薄膜对折重叠热合(焊接)。本领域技术人员应该可以理解，标本袋的热合(焊接)接缝较长，由于热合(焊接)工夹具误差，热合(焊接)压力误差，热合(焊接)温度不均匀等因素，极易出现局部空隙或接缝局部不牢固等缺陷，且难以通过检验手段遴选含此类缺陷的产品。大批量生产时，通常采用提高热合(焊接)温度和增加热合(焊接)时间的方法实现过度熔接，确保接缝牢固和无残留空隙。然而过度熔接通常造成标本袋薄膜基材与接缝过渡的局部区域厚度显著变薄，从而导致所述接缝临近区域的材料强度显著降低，极易出现破损，这种现象通常称之为“根切”。
一个普通的技术人员可想到，增加薄膜厚度可增强标本袋，然而标本袋用于前述取物器械中时，由于导管的尺寸限制，增加薄膜厚度通常导致标本袋无法收纳于导管内或无法从导管中推出。现有技术之标本袋的薄膜最大厚度通常≤0.1mm，而过度熔接通常造成前述局部区域厚度降低30％～50％，显著的降低了标本袋的强度。到目前为止，标本袋在临床使用中破裂的事故的发生概率仍然较大。提供更安全更便捷的取出患者内部组织或病变器官的器械或方法，有助于提高微创手术的安全性，并将推动微创手术更大的发展。
发明内容
在本发明的一个方面，一种多重熔合标本袋，包含可打开和收拢的袋口以及从袋口延伸而成的袋体，所述袋口包含环绕的隧道，所述袋体包含薄膜和焊缝，所述焊缝将所述薄膜焊接成一个袋状封闭的整体；所述焊缝包含外侧焊缝部分和内侧焊缝部分；所述外侧焊缝部分包含过度熔接焊缝或标准熔接和过度熔接的混合焊缝；所述内侧焊缝部分包含欠熔接和标准熔接的混合焊缝。
在本发明的另一个方面，一种多重熔合标本袋，包含可打开和收拢的袋口以及从袋口延伸而成的袋体，所述袋口包含环绕的隧道，其特征在于：所述袋体包含薄膜和第一焊缝，所述第一焊缝将所述薄膜焊接成一个封闭的袋状整体；所述袋体还包含设置在第一焊缝内侧的第二焊缝；第一焊缝和第二焊缝之间包含空置边。所述第一焊缝包含过度熔接焊缝或标准熔接和过度熔接的混合焊缝；一种可选的方案，所述第二焊缝包含欠熔接和标准熔接的混合焊缝。又一种可选的方案，所述第二焊缝包含间断焊缝或连续焊缝。
在本发明的另一个方面，提出一种取物器械。所述取物器械包含标本袋穿设在所述隧道内的扎线，所述扎线可在接收组织标本后，收紧标本袋的袋口。
在本发明的另一个方面，提出一种取物器械。所述取物器械还包含导管组件和贯穿其的手柄组件，以及与所述手柄组件连接的可撑开标本袋的撑开机构，所述标本袋和撑开机构设于所述导管组件内并可相对其轴向运动；通过手柄组件操作使所述标本袋和撑开机构在导管组件内向前推动并伸出套管组件并被所述撑开机构撑开；所述撑开机构随所述导管组件向后抽出与所述标本袋分离，所述拉线贯穿于所述导管组件。
在本发明的又一个方面，提出一种所述标本袋的制造方法，其步骤如下：
S1:焊接隧道，将形成标本袋的隧道的所述薄膜的边缘弯折并焊接；
S2:将所述袋体沿中心线对折形成的两个形状相同的薄膜；
S3:沿对折后重叠区的边缘的内侧进行第一次焊接,形成包含欠熔接和标准熔接混合焊缝，称为内侧焊缝部分；
S4:沿所述欠熔接和标准熔接混合焊缝的外边缘进行第二次焊接，形成包含标准熔接和过度熔接的混合焊缝，称为外侧焊缝部分。
另一种所述标本袋的制造方法，其步骤如下：
S1:焊接隧道，将形成标本袋的隧道的所述薄膜的边缘弯折并焊接；
S2:将所述袋体沿中心线对折形成的两个形状相同的薄膜；
S3:沿薄膜对折后重叠区的边缘进行第一次焊接,形成包含标准熔接和过度熔接的混合 焊缝，称为外侧焊缝部分；
S4:沿所述标准熔接和过度熔接混合焊缝的内边缘进行第二次焊接，形成包含欠熔接和标准熔接混合焊缝，称为内侧焊缝部分。
又一种所述的标本袋的制造方法，其步骤如下：
S1:焊接隧道，将形成标本袋的隧道的所述薄膜的边缘弯折并焊接；
S2:将所述袋体沿中心线对折形成的两个形状相同的薄膜；
S3:沿薄膜对折后重叠区的边缘进行第一次焊接,形成包含欠熔接和标准熔接的混合焊缝，称为初始焊缝；
S4:对齐所述初始焊缝的外边缘，且焊接宽度小于初始焊缝进行第二次焊接，形成包含标准熔接和过渡熔接的混合焊缝，称为外侧焊缝部分；初始焊缝除去外侧焊缝部分后剩余的焊缝称之为内侧焊缝部分。
附图说明
为了更充分的了解本发明的实质，下面将结合附图进行详细的描述，其中：
图1是本发明第一实施例取物器械处于缩回状态的立体图；
图2是图1所示取物器械处于展开状态的立体图；
图3是图2所示取物器械的爆炸图；
图4是图2所示取物器械使用时袋口封闭的模拟图；
图5是图4所述取物器械移除导管与撑开机构后的模拟图；
图6是现有技术热合机热合过程的示意图；
图7是现有技术的标本袋100的立体示意图；
图8是图7所示标本袋的8-8剖视图；
图9是焊接接头失效模式为焊接边剥离的示意图；
图10是焊接接头失效模式为过渡区域断裂的示意图；
图11是图7所示标本袋的11-11剖视图；
图12是第一实施例标本袋200的侧面投影视图；
图13是图12的13-13剖视图；
图14是图12的14-14剖视图；
图15是可输出两种温度的焊接模具的示意图；
图16是是第二实施例标本袋300的侧面投影视图；
图17是图16的17-17剖视图；
图18是第三实施例标本袋400的薄膜展开图；
图19是第三实施例标本袋400的薄膜折叠示意图；
图20是第三实施例标本袋400的第一次焊接的示意图；
图21是图20的21-21剖视图；
图22是图20所示标本袋第二次焊接的示意图；
图23是图22的23-23剖视图。
图24是第三实施例标本袋400又一种第一次焊接的示意图；
图25图24的25-25剖视图。
在所有的视图中，相同的标号表示等同或类似的零件或部件。
具体实施方式
这里公开了本发明的实施方案，但是，应该理解所公开的实施方案仅是本发明的示例，本发明可以通过不同的方式实现。因此，这里公开的内容不是被解释为限制性的，而是仅作为权利要求的基础，以及作为教导本领域技术人员如何使用本发明的基础。
现将参照附图详细描述本公开的实施例，为方便表述，后续凡接近操作者的一方定义为近端，而远离操作者的一方定义为远端。
图1-3详细描绘了本发明的第一个实施例取物器械10的结构组成。简单地说，取物器械10从远端到近端依次包含标本袋200，撑开机构20，导管组件30，手柄组件40和扎线50。导管组件30包括中空导管33和与之固定结合在一起的导管手柄部31和导管手柄部32。不同临床应用情形下，所述中空导管33的外径不同，常见直径大致分为5mm，8mm，10mm，12mm和15mm。手柄组件40包括从近端到远端依次连接的指环42和中空驱动杆41，所述驱动杆41定位在中空导管33中，并可相对于所述中空导管33轴向移动，以在缩回状态(图1)和展开状态(图2)之间移动撑开机构20和标本袋200。
撑开机构20包含弹性体21以及与弹性体21近端连接的连接轴22，所述弹性体21包括两个大体上柔性或弹性的弹性带23和弹性带24，所述弹性带23和弹性带24形状大致相同并沿连接轴22对称设置。所述弹性带23和弹性带24包含位于近端的直线段23b和直线段24b以及远端的弹性段23a和弹性段24a，所述弹性段23a和弹性段24a具有柔性和形状记忆功能，受外力可变形收纳而移除外力可自动撑开。所述直线段23b近端设置安装孔23c，所述直线段24b近端设置安装孔24c，所述连接轴22与安装孔24c和安装孔23c对应位置设置有轴孔22a并通过铆钉25将弹性带23和弹性带24铆接在连接轴22上。所述连接轴22的近端插入驱动杆41的远端，并通过胶水粘接，螺纹连接或焊接等方式连 接固定。本领域的技术人员可以想到，所述弹性体21和连接轴22连接方式也可以是焊接，销钉连接或将所述弹性体21直接与驱动杆41远端进行连接固定。
所述标本袋200包含可打开和收拢的袋口201，以及从所述袋口201延伸而成的封闭的袋体202。所述袋口201包含环绕袋口的隧道211，所述隧道211用以容纳撑开机构20和扎线50。参考图2-3，所述扎线50的远端包含滑动节51，所述扎线50的远端穿过隧道211而其近端53穿过所述滑动节51，形成与袋口尺寸大致相同的扎线环52。所述弹性体21插入所述隧道211中。所述取物器械10完成组装后(参考图2)，通常将标本袋200缠绕在弹性体21上并收纳于中空导管33之内(参考图1)。美国发明专利US8986321中披露了取物器械的多种缠绕和收纳方式，其他取物器械专利用也披露了多种缠绕和收纳方式，一个普通的技术人员对其稍作适应性修改，即可应用于本发明。
本实施方案中，所述弹性体21具有形状记忆功能，在所述取物器械10的缠绕和收纳方式可方便的自动展开。操作者推动驱动杆41将处于缩回状态(图1)的标本袋200和撑开机构20推出到中空导管33之外，弹性体21具有形状记忆功能而自动复原，从而将标本袋200自动打开(图2)。本领域的技术人员可以想到，也可将弹性体21的弹性带23和弹性带24设置成连杆机构来实现撑开作用。本实施中中已经描述了一种典型取物器械10的撑开机构20，导管组件30以及手柄组件40，除此之外，本领域的技术人员可以想到，通过将美国发明专利US5465731，US6383197，US8721658等和本实施中的撑开机构20，导管组件30和手柄组件40进行替换组合，也是本发明的保护范围。
所述取物器械10临床应用的相关操作大体可以分为以下几个阶段：
第一个阶段：预备阶段。处于回缩状态的取物器械经由穿刺套管插入患者体内并延伸至目标区域。第二阶段：取物器械展开阶段。操作手柄组件40控制驱动杆41由近端向远端相对于中空导管33轴向移动，直至所述撑开机构20和标本袋200完全露出在所述中空导管33之外，弹性体21具有形状记忆功能而自动复原，从而将标本袋200自动打开(图2)。第三阶段：剪除标本阶段。将展开状态的取物器械10在内窥镜等配合下，定位到病变组织或器官位置下方，通过手术剪将病变组织或器官剪除并落入到标本袋200中。第四阶段，标本取出阶段。参考图4-5，先操作手柄组件40将撑开机构20经由穿刺套管取出，同时拉动扎线50的近端53，使得滑动节51滑动并缩小扎线环52，从而将标本袋200的袋口201收拢。然后拉动扎线50将标本袋200及其盛装的标本经由穿刺套管或经由皮肤切口取出。此过程中，由于穿刺套管内径或微创手术切口较小，在切除较大组织或器官时，标本袋200受到很大的挤压力。虽然各种取物器械的结构和应用方式各有不同，但其功能 和主要使用步骤大体相同。本发明之取物器械10的临床应用方法，也可参考US5465731中的相关描述理解，以更好的了解本发明的用途。
图7描绘了现有技术的一种典型的标本袋100。所述标本袋100通常由单片薄膜(片材)折叠焊接而成，或两片薄膜(片材)重叠焊接而成。薄膜(片材)的材料包括但不限于聚乙烯，聚氯乙烯，聚丙烯，尼龙，特氟龙，热固性弹性体(例如硅胶)和热塑性弹性体(例如聚氨酯)。薄膜(片材)焊接的工艺包括但不限于加热焊接，超声波焊接，高频焊接，辐射焊接，脉冲焊接等。本实例之标本袋100使用两片聚乙烯薄膜重叠加热焊接而成。
图6描述标本袋现有制造技术的一种典型加热焊接(简称为热合)过程。热合机60包含与地面安装固定的基座66和与其连接的机身67，以及与机身67连接并可沿竖直方向移动的上热合动模64和与机身67连接固定的下热合定模65。所述标本袋100的热合过程可简单表述为，先调整好热合参数(主要包括热合温度，热合时间和热合压力)，再将薄膜103和薄膜104重叠并放在下热合定模65上，最后启动热合机完成标本袋100的热合焊接。
一个普通的技术人员应该可以理解，所述薄膜热合(焊接)，即在熔融状态下，薄膜的被热合区域表面的高分子链段相互扩散、渗透，相互缠绕，使得双片(或多片)薄膜熔接在一起。参考图7，袋面103和袋面104相互熔接形成包含热合接缝105的标本袋100。图8描绘了热合接缝105任意位置的局部断面图，即所述标本袋100可更细致的划分为薄膜基材131(薄膜基材151)，过渡区域132(过渡区域152)和熔接区域133(熔接区域153)。薄膜热合过程中，在热合压力的作用下,使热合区域的处于熔融状态的薄膜被压延挤出，从而形成所述过渡区域132(过渡区域152)。所述过渡区域132(152)的薄膜厚度小于所述薄膜基材131(151)的厚度。
通常，根据熔接区域和过渡区域的热合强度和失效模式不同，可将所述热合接缝分成欠热合，标准热合和过度热合三个类别。所述欠热合，即热合区域的表面被熔化的、参与热合的薄膜的厚度较薄，热合强度测试时的失效模式为熔接区域剥离，且测试结果低于目标值。所述标准热合，即热合区域的表面被熔化的、参与热合的薄膜的厚度适中，失效模式为熔接区域剥离，且热合强度测试结果达到目标值。所述过度热合，即热合区域的表面被熔化的、参与热合的薄膜的厚度太多，导致所述过渡区域的厚度显著的变薄，使得过渡区域的结构强度显著的低于所述熔接区域的剥离强度，这种现象通常简称为“根切”，而失效模式为过渡区域断裂，热合强度测试结果低于目标值。另外标准热合中，称热合强 度测试值最大的热合接缝为最佳热合接缝。一个普通的技术人员可以理解，使用不同的热合参数，决定了所述热合接缝105是欠热合，标准热合还是过度热合。
一个普通技术人员容易想到，可通过实验取得标准热合所需的最佳热合参数。食品包装和医疗包装领域中，特别是血液制品包装袋制造领域中，对塑料薄膜热合进行了大量研究。已披露的现有技术表明，通常热合温度，热合压力和热合时间的综合作用决定了塑料薄膜的热合质量，而且热合温度对于热合质量的影响最大，热合压力和热合时间对所述热合质量的影响相对较小或可忽略不计。
在食品包装和医疗包装领域中，通常以实验法获取最佳热合温度。通常预先设定一个热合强度的接受标准(即目标值)，再依据权威标准规定的测试方法对试验样品的热合强度进行测试，测试结果满足接受标准则认定该热合温度为合理温度或最佳温度。例如对于可剥离包装袋(方便使用时徒手撕开的包装袋)，通常依据美国材料与试验协会的《ASTM F88挠性阻隔材料密封强度试验方法》进行测试，样品测试时的主要失效模式为热合区域剥离(图9)，其测试结果基本等同于被测样品的真实热合强度。而对于血液袋，透析袋等不可剥离包装袋(使用时无需徒手撕开的包装袋)，通常依据美国材料与试验协会的《ASTM F2029通过测量密封强度测定挠性材料热密封能力用热焊接实施规程》进行测试，样品测试时的主要失效模式为热合区域剥离(图9)或过渡区域断裂(图10)。所述过渡区域断裂现象，主要因为局部的过度热合导致相应过渡区域的厚度显著变薄，从而导致局部的强度显著降低。当样品测试时的失效模式为过渡区域断裂时，其测试结果小于被测样品的真实热合强度。但是，只要测试结果符合接受标准，仍然认定该热合温度为合理温度或最佳温度。应当特别指出的，所述最佳温度的确立主要取决于其测试方法和接受标准，因此最佳热合温度并不表明其热合接缝的热合强度为最佳。当热合强度测试的失效模式为热合区域剥离而非过渡区域断裂时，且热合区域剥离力最大时，称为最佳热合，而称其样品的热合温度为最佳热合温度，更准确的，通常称此最佳温度参数为理论最佳温度或理想最佳温度。
通常以实验法获取最佳热合温度时，并未将工夹具误差，被热合薄膜误差和环境误差等因素引入综合评价。而实际生产制造时，由于薄膜厚度误差，薄膜不平整，热合工夹具误差，受热不均等因素的综合影响，特别对于热合接缝较长和可热合性较差的材料(例如热塑性弹性体)，采用理论最佳温度进行热合(焊接)容易出现局部残留空隙，即热合接缝的密封完整性不达标。对于热合接缝较长或热合性能较差的产品，热合接缝的密封完整性和热合强度是相互冲突的，为确保密封完整性通常必须采用过度热封，即必须牺牲热 合强度。在食品包装和医疗包装领域，其包装的密封完整性是必须满足的最关键指标，而热合强度为次要指标。食品包装和医疗包装领域通常以满足密封完整性为最关键指标，在此前提条件下选择较低的热合温度以获得较好的热合强度，其采用的最佳热合温度通常高于理论最佳温度。以此最佳热合温度进行热合时，通常同一热合接缝的大部分区域属于所述标准热合而其局部区域属于所述过度热合。
到目前为止，已披露的，对于本发明所述的腹腔镜专用标本袋的热合研究较少，目前所述标本袋批量热合制造时通常沿用食品包装和医疗包装领域的经验，即采用高于理论最佳温度进行热合以同时获得密封完整性和较好的热合强度，不可避免的，所述形成的同一热合接缝的大部分区域属于所述标准热合而其局部区域属于所述过度热合。参考图7，图8和图11，例如所述标本袋100在最佳热合温度条件下热合时，所述热合接缝105的大部分区域属于标准热合(其热合接缝图参见图8)，而热合接缝105的局部区域属于过度热合(其热合接缝图参见图11)。参考图11，如前文所述，所述局部过度热合导致所述过渡区域132局部显著变薄，从而导致局部的强度显著降低。
参考图4-5，如前文所述，将标本袋及其盛装的病变组织或器官经由穿刺套管或经由皮肤切口取出时，由于穿刺套管内径或微创手术切口较小，标本袋受到很大的挤压力，容易导致取物袋破裂。而局部过度热合导致的强度显著降低就大大的增加了标本袋的破裂风险。一个普通的技术人员容易想到，增加薄膜厚度可增加标本袋的强度，然而当标本袋用于前述取物器械中时，由于导管的尺寸限制，增加薄膜厚度通常导致标本袋无法收纳于导管内或标本袋无法从导管中推出。同时，由于标本袋通常用于盛装病变组织或器官，其密封完整性也是同等重要的，任何泄露都可能增加患者意外感染的风险或增加后续清洁处理的工作量。获得密封完整性的热合方法和获得最佳热合强度的热合方法是相互冲突的，到目前为止还没有很好的方法来解决这一冲突。
鉴于薄膜厚度尺寸受限制，而标本袋临床应用时又需承受很大的挤压力，因此对于标本袋强度的追求是没有上限的，强度越大越好。而且到目前为止标本袋临床应用中破裂的案例仍然时有发生。本领域的技术人员可能会了解，在本领域处于领先地位的最有代表性的产品，即以商品名
Figure PCTCN2018075802-appb-000001
Endo Catch TM和
Figure PCTCN2018075802-appb-000002
大量生产销售和使用的取物器械，也存在一定程度的意外破裂概率。到目前为止，使用中标本袋破裂几乎无法避免，而且破裂通常发生在焊缝处的所述过渡区域；已披露的控制措施通常包括选择更好的薄膜材料和更好的焊接控制热封参数，这些措施可一定程度的降低焊缝破裂概率，然而仍需继续改进。
图12-14详细描绘了本发明的第一实施例标本袋200的结构和组成。如前文所述，获得密封完整性和最佳热合强度的热合方法是相互冲突的，即难以通过最佳热合参数法来控制所述标本袋200的热合质量，使其焊缝既具备密封完整性的同时又确保其焊缝全部处于标准热合状态，以获得最佳热合强度。在本发明的一个方面，采用多焊缝法来解决前述冲突。更细致的，所述标本袋200至少包含2条焊缝，其中最外侧焊缝实现密封完整性，而内侧的焊缝主要实现良好热合强度。
参考图12，所述标本袋200包含可打开和收拢的袋口201，以及从所述袋口201延伸而成的袋体202。所述袋口201包含环绕袋口的隧道211，用以容纳撑开机构20和扎线50。所述袋体202包含第一薄膜203和第二薄膜205，一种实施方案中，将两片尺寸和外形大致相同的第一薄膜203和第二薄膜205相互重叠，然后对重叠部分的整个外边缘进行加热焊接(简称热合)形成第一热合接缝204(后文简称为第一焊缝204)，从而将第一薄膜203和第二薄膜205热合成一个具有开口的袋状整体。所述第一焊缝204沿袋体的边缘形成的热合接缝形状为近似U型。所述袋体202还包含第二热合接缝208(后文简称为第二焊缝208)，所述第二焊缝208设置在第一焊缝204的内侧。本实例中所述第二焊缝208与所述第一焊缝204大致平行，且所述第一焊缝204和第二焊缝208之间设置有空置段206。然而所述第一焊缝204和第二焊缝208也可以不平行。虽然本实例中采用加热焊接的方式将所述第一薄膜203和第二薄膜205焊接在一起，然而也可以采用超声波焊接，高频焊接，辐射焊接，脉冲焊接等方式。所述薄膜203和薄膜205的材料包括但不限于聚乙烯，聚氯乙烯，聚丙烯，尼龙，特氟龙，热固性弹性体(例如硅胶)和热塑性弹性体(例如聚氨酯)。本实例中，所述第一薄膜203和第二薄膜205均采用聚氨酯。
为了更好的理解本方案，在此首先回顾前文所述采用加热焊接(热合)法制造标本袋时的欠热合，标准热合和过度热合情形，以及采用试验法获得最大热合强度，最佳热合接缝和理论最佳温度的方法。一个普通的技术人员可以想到，不同的材料，或同类料不同的厚度，或同类材料相同厚度但不同的硬度，采用实验法获得的最大热合强度，最佳热合接缝和理论最佳温度的差异非常大，因此本发明中不针对某一具体材料的某一具体案例进行研究。
采用其他焊接方式时，主要区别在于焊接能量的来源不同，其焊接的本质相同。采用其他焊接方式制造标本袋，所述相互焊接的薄膜也是在熔融状态下，薄膜的被热合区域表面的高分子链段相互扩散、渗透，相互缠绕，使得双片(或多片)薄膜熔接在一起。标本袋也可更细致的划分为薄膜基材，过渡区域和熔接区域。薄膜热合过程中，在热合压力 的作用下,使热合区域的处于熔融状态的薄膜被压延挤出，从而形成所述过渡区域。所述过渡区域的薄膜厚度小于所述薄膜基材的厚度。其焊接接缝也可近似的分成欠熔接(等同于欠热合)，标准熔接(等同于标准熔合)和过度熔接(等同于过度热合)。一个普通的技术人员可以理解，不同的焊接方式下，其影响焊接质量的参数不同，使用不同的焊接参数，决定了焊接接缝属于欠熔接，标准熔接还是过度熔接。同样，其他公知的焊接方式，也可以通过实验法获得的最大焊接强度，最佳焊接接缝和理论最佳焊接参数。
本领域的技术人员应该可以理解，虽然标本袋在不同的材料，不同的结构，或不同的焊接方式等条件下，影响其焊接接缝质量的因素差异很大，但可采用相同的测试方法和接受标准来控制其接缝质量，同时也能采用实验法获得相关控制参数。为清晰的阐述本发明的思想，在此对标本袋焊接接缝质量相关的术语进行如下定义：
欠熔接：即焊接区域的表面被熔化的、参与熔合的薄膜的厚度较薄，焊接强度测试时的失效模式为标本袋的熔接区域剥离，且测试结果低于目标值。
标准熔接：即焊接区域的表面被熔化的、参与熔合的薄膜的厚度适中，焊接强度测试时的失效模式为标本袋的熔接区域剥离，且测试结果达到目标值。
过度熔接：即焊接区域的表面被熔化的、参与熔合的薄膜的厚度太多，导致标本袋熔接区域与标本袋基材之间的过渡区域的厚度显著的变薄，焊接强度测试时的失效模式为过渡区域断裂，热合强度测试结果低于目标值。
欠熔接焊缝：焊接强度测试表现为欠熔接的焊缝。
标准熔接焊缝：焊接强度测试表现为标准熔接的焊缝。
过度熔接焊缝：焊接强度测试表现为过度熔接的焊缝。
最佳焊缝：焊接强度测试时的失效模式为标本袋的熔接区域剥离，且测试结果达到最大值的焊缝。理论最佳焊接参数：取得最佳焊缝时的焊接参数。
本领域的技术人员容易理解，依据ASTM F2029或ASTM F88进行薄膜焊接强度测试时，需预先将被测样品制备成宽度为25mm，20mm或15mm的带状测试标本。具有长焊缝的被测样品被制备成多个带状测试标本后，其测试结果可能包含欠熔接，标准熔接和过度熔接，在此定义此类长焊缝为混合焊缝。
欠熔接和标准熔接混合焊缝：同一焊缝中同时包含欠熔接部分和标准熔接部分。
标准熔接和过度熔接混合焊缝：同一焊缝中同时包含标准熔接部分和过度熔接部分。
基于前述理论和相关定义更细致的剖析本实例，以方便教导本领域技术人员更好的理解本方案的核心技术。图13描绘了袋体202的13-13位置的局部断面图。第一薄膜 203从外边缘向内可近似划分为第一熔接区231，第一过渡区233，第二熔接区235，第二过渡区237和标本袋基材239。同理，第二薄膜205从外边缘向内可近似划分为第一熔接区251，第一过渡区253，第二熔接区255，第二过渡区257和标本袋基材259。图14描绘了袋体202的第二焊缝208的14-14位置的局部断面图。所述第二焊缝208的局部区域可能存在一个或多个微缝隙。本实例中所述焊缝208在14-14焊缝段上包含了微缝隙262和微缝隙266。本领域技术人员可以理解，当所述第一薄膜203和第二薄膜205的材料和厚度相同时，任选其中一个片薄膜研究即可。当所述第一薄膜203和第二薄膜205的材料或厚度不相同时，选择其中最薄弱的一片薄膜研究即可。本实例中选定第一薄膜203为主要研究对象。
一种实施方案中，所述第一焊缝204属于过度熔接焊缝，或者属于标准熔接和过度熔接混合焊缝；而第二焊缝208属于欠熔接和标准熔接混合焊缝。一种制造方法中，所述标本袋200以加热焊接(热合)的方法制造。首先采用实验法获得所述第一薄膜203和第二薄膜205热合焊接的理论最佳温度。第一焊缝204的热合制造过程中，确保输出热量的热合模具的任意位置的温度大于等于所述理论最佳温度，确保所述第一焊缝204的整条焊缝上无欠熔接，即确保其密封完整性。即所述第一焊缝204全部过度熔接，或标准熔接和局部过度熔接相结合。参考图13，如前文所述，一种实现方案中，所述过度熔接方式造成前述第一过渡区域233的厚度降低15％～30％；当极端情况下第一过渡区域233的厚度降低30％时，其焊缝强度测试时表现出典型的“根切”现象，但是由于所述第一焊缝204主要实现密封完整性，仍然可以接受。一种优选的实现方案中，通过降低热合温度使第一焊缝204表现为标准熔接和过度熔接的混合焊缝，即在确保第一焊缝204的密封完整性的前提下使用较低的热合温度以减小第一过渡区域233的厚度降低程度，增强第一焊缝204的焊缝强度。而第二焊缝208的热合制造过程中，确保输出热量的热合模具的任意位置的温度小于等于所述理论最佳温度，并确保所述第二焊缝208的整条焊缝上无过度熔接，以增加第二焊缝208的焊缝强度。如前文所述，由于各种误差因素的影响，特别对于长焊缝，难以确保整条焊缝都处于标准熔接状态(或者实现成本很高)，因此所述第二焊缝208允许包含欠熔接和标准熔接。参考图13，如前文所述，一种实现方案中，以标准熔接方式制造时，所述第二过渡区域237的厚度降低控制在0～15％。其焊接强度测试时的失效模式为标本袋的熔接区域208剥离而非所述第二过渡区域237断裂。一种优选的方案中，在确保第二焊缝208的整条焊缝上无过度熔接的前提下使用较高的热合温度以增强第二焊缝208的焊缝强度。由于所述第二焊缝208不允许包含过度熔接焊缝，由于各种误 差因素的影响，特别对于长焊缝，则整条第二焊缝208中难免出现欠熔接焊缝。参考图14所示，所述焊缝208在14-14焊缝段上包含了微缝隙262和微缝隙266。由于所述第二焊缝208不需要保证密封完整性，因此局部微缝隙(欠熔接)是可以接受的。
所述标本袋200的原理，使用方法和优势：如前文所述，食品包装和医疗包装领域，例如血液包装袋，使用破裂失效时其包装袋的焊缝受到液体传递的均匀的压强(压力)，因此对于血液包装袋或类似产品，采用多重焊缝法几乎没有意义。然而标本袋的临床应用和失效模式与前述血液包装完全不一样。标本袋焊缝的密封完整性用以确保切割下来的病变组织或器官中的血水或体液不会渗透并泄露到患者体腔内。参考图4-5可见，盛装有病变组织的标本袋收纳并拔出时，通常袋口并没有被完全密封；由此一个普通的技术人员可以理解，所述标本袋收纳并拔出时，其内部盛装的液体不受挤压力或受到的挤压力很小，否则液体将从标本袋没有完全密封的袋口喷射而出。因此标本袋内盛装的液体穿过第二焊缝208后传递给第一焊缝204的压强(压力)很小。另外，本领域的技术人员应该可以理解，当标本袋收纳并拔出时，其盛装组织对于标本袋体施加不均匀的挤压力，进而转变成标本袋袋体的内力传递至第二焊缝208。由于所述病变组织不是流体，不能穿过第二焊缝208上的微缝隙并将力传递至第一焊缝204。本领域的技术人员应该可以理解，局部欠熔接并不会显著的降低焊缝强度。塑料薄膜是典型的切口敏感性材料，局部过度熔接导致的根切现象容易导致焊缝受较大内力是撕裂并快速长大，从而显著的降低了标本袋的强度。同时，即使局部欠热合较大的影响了焊缝强度，第二焊缝的局部欠热合处的焊缝裂开，但是薄膜并未破裂，而且还剩余第一焊缝作为下一道防线。因此，仍然能显著的降低标本袋破碎的概率。综上所述，所述最外侧焊缝实现密封完整性，而内侧的焊缝主要实现热合强度的方案很好的满足标本袋临床应用需求，较好的解决了密封完整性和最佳热封强度的冲突。
一种制造方案中，所述第一焊缝204和第二焊缝208分两次热合形成；先完成第一焊缝204的热合再完成第二焊缝208的热合；或者先完成成第二焊缝208的热合再完成第一焊缝204的热合。又一种制造方案中，所述第一焊缝204和第二焊缝208单次热合形成。参考图15，所述热合设备局部两个独立加温的热合工具，从而实现两条不同焊缝的单次热合成型。又一种制造方案中，所述第一焊缝204和第二焊缝208分采用其他公知的焊接方式分两次焊接形成，两次焊接的方法可以相同也可以不同。
图16-17详细描绘了本发明的第二实施例标本袋300的结构组成。所述标本袋300与所述标本袋200的结构大致相同，其区别仅在于第二焊缝。所述标本袋300包含袋口 201和封闭的袋体302。所述袋口201包含环绕袋口的隧道211。所述袋体302包含第一薄膜203和第二薄膜205，所述第一薄膜203和第二薄膜205相互重叠后沿外边缘进行焊接，形成第一焊缝204，从而将第一薄膜203和第二薄膜205热合成一个具有开口的袋状整体。所述袋体302还包含第二焊缝308，所述第二焊缝308设置在第一焊缝204的内侧。本实例中所述第二焊缝308与所述第一焊缝204大致平行，且所述第一焊缝204和第二焊缝308之间设置有空置段206。在所述袋口201的临近区域，连接焊缝305和连接焊缝307将所述第一焊缝204和第二焊缝308连接起来。所述第二焊缝308的整个焊缝是间断，包含多个空隙段362。所述第一焊缝204属于过度熔接焊缝，或者属于标准熔接和过度熔接混合焊缝；而第二焊缝208属于欠熔接和标准熔接混合焊缝。所述标本袋300和标本袋200具有近似的功能和性能。
图18-23详细描绘了本发明的第三实施例标本袋400的结构和组成。如前文所述，获得密封完整性和最佳热合强度的热合方法是相互冲突的，即难以通过最佳热合参数法来控制所述标本袋400的热合质量，使其焊缝既具备密封完整性的同时又确保其焊缝全部处于标准热合状态，以获得最佳热合强度。在本发明的另一个方面，采用单一焊缝多重焊接的方法来解决前述冲突。更细致的，所述标本袋400包含多次焊接形成的单一的外缘焊缝409，且所述外缘焊缝409分成典型的内侧焊缝部分和外侧焊缝部分。
参考图18-20，所述标本袋400包含可接收组织标本的袋口401和袋体402，所述袋口401包含环绕袋口的隧道411。所述袋体402包含中心线404，以及沿中心线404对折形成的第一袋面403和第二袋面405。所述第一袋面403和第二袋面405的尺寸和外形大致相同并相互重叠，对重叠部分的整个外边缘进行焊接形成外缘焊缝409，从而将第一袋面403和第二袋面405熔接成一个具有开口的袋状整体。
参考图22，所述外缘焊缝409包括设置在外侧的第一焊缝407和设置在内侧的第二焊缝408，所述第一焊缝407和第二焊缝408大致平行并相互融合而没有明显的空白或空置段。图23描绘了袋体402的23-23位置的局部断面图。第一袋面403从外边缘向内可近似划分为第一熔接区431，第二熔接区433，第二过渡区435和标本袋基材437。同理，第二袋面405从外边缘向内可近似划分为第一熔接区451，第二熔接区453，第二过渡区455和标本袋基材457。本领域技术人员可以理解，所述第一袋面403和第二袋面405的材料和厚度相同时，任选其中一个袋面研究即可。本实例中选定第一袋面403为主要研究对象。
一种可选的实施方案中，所述第一焊缝407属于过度熔接焊缝，或者属于标准熔 接和过度熔接混合焊缝；而第二焊缝408属于欠熔接和标准熔接混合焊缝。一种具体的实施方案中，所述标本袋400以加热焊接(热合)的方法制造。首先采用实验法获得热合焊接的理论最佳温度。第一焊缝407的热合制造过程中，确保输出热量的热合模具的任意位置的温度大于等于所述理论最佳温度，确保所述第一焊缝407的整条焊缝上无欠熔接，即确保其密封完整性。即所述第一焊缝407全部过度熔接，或标准熔接和局部过度熔接相结合。一种优选的实现方案中，通过降低热合温度使第一焊缝407表现为标准熔接和过度熔接的混合焊缝，即在确保第一焊缝407的密封完整性的前提下使用较低的热合温度以减小第一过渡区域233的厚度降低程度，增强第一焊缝407的焊缝强度。而第二焊缝408的热合制造过程中，确保输出热量的热合模具的任意位置的温度小于等于所述理论最佳温度，并确保所述第二焊缝408的整条焊缝上无过度熔接，以增加第二焊缝408的焊缝强度。如前文所述，由于各种误差因素的影响，特别对于长焊缝，难以确保整条焊缝都处于标准熔接状态(或者实现成本很高)，因此所述第二焊缝408允许包含欠熔接和标准熔接。参考图23，如前文所述，一种实现方案中，以标准熔接方式制造时，所述第二过渡区域435的厚度降低控制在0～15％。其焊接强度测试时的失效模式为标本袋的熔接区域408剥离而非所述第二过渡区域435断裂。一种优选的方案中，在确保第二焊缝408的整条焊缝上无过度熔接的前提下使用较高的热合温度以增强第二焊缝408的焊缝强度。由于所述第二焊缝408不允许包含过度熔接焊缝，由于各种误差因素的影响，特别对于长焊缝，则整条第二焊缝408中难免出现欠熔接焊缝，甚至出现微缝隙。由于所述第二焊缝408不需要保证密封完整性，因此局部微缝隙(欠熔接)是可以接受的。
所述标本袋400相对于标本袋200具有近似的功能和性能。所述标本袋400的第一焊缝407和第二焊缝408之间没有明显间隙，组成单一外缘焊缝409，能减少标本袋的袋面(薄膜)制造过程中褶皱或卷曲，同时也能节约空间。另外，标本袋400采用单片薄膜对折焊接，有利于减小焊缝的长度，降低焊接难度，提高制成稳定性。
所述标本袋400有多种制造方法，一种优选的制造步骤大体如下：
S1:首先将标本袋400的袋口401弯折并通过焊接形成隧道411(如图18所示)；
S2:将袋体402沿中心线404对折形成的袋面403和袋面405(如图19所示)；
S3:沿袋面403和袋面405对折后重叠区的边缘进行第一次焊接,形成包含欠熔接和标准熔接混合焊缝，称为初始焊缝406(如图20-21所示)；
S4:沿所述初始焊缝406的外边缘进行第二次焊接，形成包含标准熔接和过度熔接的混合焊缝，或者形成单一过度熔接焊缝，称之为第一焊缝407。初始焊缝406中除开外侧 的第一焊缝407之后，剩余的内侧部分称之为第二焊缝408,。第一焊缝407和第二焊缝408合称外缘焊缝409(如图22-23所示)。
另一种可选的制造步骤大体如下：
S1:首先将标本袋400的袋口401弯折并通过焊接形成隧道411(如图18所示)；
S2:将袋体402沿中心线404对折形成的袋面403和袋面405(如图19所示)；
S3:沿袋面403和袋面405对折后重叠区的边缘的内侧进行第一次焊接,形成包含欠熔接和标准熔接混合焊缝，称为第二焊缝408(如图24-25所示)；
S4:沿所述第二焊缝408外边缘进行第二次焊接，形成包含标准熔接和过度熔接的混合焊缝，或者形成单一过度熔接焊缝，称之为第一焊缝407。第一焊缝407和第二焊缝408合称外缘焊缝409，第一焊缝和第二焊缝之间没有明显的空白或空置段。
又一种可选的制造步骤大体如下：
S1:首先将标本袋400的袋口401弯折并通过焊接形成隧道411(如图18所示)；
S2:将袋体402沿中心线404对折形成的袋面403和袋面405(如图19所示)；
S3:沿袋面403和袋面405对折后重叠区的边缘的外侧进行第一次焊接,形成包含标准熔接和过度熔接的混合焊缝，或者形成单一过度熔接焊缝，称之为第一焊缝407。
S4:沿所述第二焊缝408外边缘进行第二次焊接，形成包含欠熔接和标准熔接混合焊缝，称为第二焊缝408。第一焊缝407和第二焊缝408合称外缘焊缝409，第一焊缝和第二焊缝之间没有明显的空白或空置段。
已经展示和描述了本发明的很多不同的实施方案和实例。本领域的一个普通技术人员，在不脱离本发明范围的前提下，通过适当修改能对所述方法和器械做出适应性改进。例如利用其他发明中披露的标本袋热合接缝做简单适应性修改，或采用不同工艺，例如采用压力参数，温度参数或保压时间等不同组合。好几种修正方案已经被提到，对于本领域的技术人员来说，其他修正方案也是可以想到的。因此本发明的范围应该依照附加权利要求，同时不应被理解为由说明书及附图显示和记载的结构，材料或行为的具体内容所限定。

Claims (8)

  1. 一种多重熔合标本袋，包含可打开和收拢的袋口以及从袋口延伸而成的袋体，所述袋口包含环绕的隧道，其特征在于：所述袋体包含薄膜和第一焊缝，所述第一焊缝将所述薄膜焊接成一个封闭的袋状整体；所述袋体还包含设置在第一焊缝内侧的第二焊缝；第一焊缝和第二焊缝之间包含空置边。
  2. 如权利要求1所述的标本袋，其特征在于：所述第一焊缝包含过度熔接焊缝或标准熔接和过度熔接的混合焊缝；所述第二焊缝包含欠熔接和标准熔接的混合焊缝。
  3. 如权利要求2所述的标本袋，其特征在于：所述第二焊缝包含间断焊缝或连续焊缝。
  4. 如权利要求1所述的标本袋，其特征在于：所述标本袋还包括穿设在所述隧道内的扎线，所述扎线可在接收组织标本后，收紧标本袋的袋口。
  5. 一种用于微创手术的取物器械，其特征在于：包括如权利要求1-4所述的任一标本袋，还包含导管组件和贯穿其的手柄组件，以及与所述手柄组件连接的可撑开标本袋的撑开机构，所述标本袋和撑开机构设于所述导管组件内并可相对其轴向运动；通过手柄组件操作使所述标本袋和撑开机构在导管组件内向前推动并伸出套管组件并被所述撑开机构撑开；所述撑开机构随所述导管组件向后抽出与所述标本袋分离，所述拉线贯穿于所述导管组件。
  6. 一种用于制造如权利要求1所述的标本袋的制造方法，其特征在于，制造步骤如下：
    S1:焊接隧道，将形成标本袋的隧道的所述薄膜的边缘弯折并焊接；
    S2:将所述袋体沿中心线对折形成的两个形状相同的薄膜；
    S3:沿对折后重叠区的边缘的内侧进行第一次焊接,形成包含欠熔接和标准熔接混合焊缝；
    S4:沿所述欠熔接和标准熔接混合焊缝的外边缘进行第二次焊接，形成包含标准熔接和过度熔接的混合焊缝。
  7. 一种用于制造如权利要求1所述的标本袋的制造方法，其特征在于，制造步骤如下：
    S1:焊接隧道，将形成标本袋的隧道的所述薄膜的边缘弯折并焊接；
    S2:将所述袋体沿中心线对折形成的两个形状相同的薄膜；
    S3:沿薄膜对折后重叠区的边缘进行第一次焊接,形成包含标准熔接和过度熔接的混合焊缝；
    S4:沿所述标准熔接和过度熔接混合焊缝的内边缘进行第二次焊接，形成包含欠熔接 和标准熔接混合焊缝。
  8. 一种用于制造如权利要求1所述的标本袋的制造方法，其特征在于，制造步骤如下：
    S1:焊接隧道，将形成标本袋的隧道的所述薄膜的边缘弯折并焊接；
    S2:将所述袋体沿中心线对折形成的两个形状相同的薄膜；
    S3:沿薄膜对折后重叠区的边缘进行第一次焊接,形成包含欠熔接和标准熔接的混合焊缝，称为初始焊缝；
    S4:对齐所述初始焊缝的外边缘，且焊接宽度小于初始焊缝进行第二次焊接，形成包含标准熔接和过渡熔接的混合焊缝，称为外侧焊缝部分；初始焊缝除去外侧焊缝部分后剩余的焊缝称之为内侧焊缝部分。
PCT/CN2018/075802 2017-03-06 2018-02-08 一种多重熔合标本袋及制造方法 WO2018161767A1 (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201710129503.2A CN107041764B (zh) 2017-03-06 2017-03-06 一种多重熔合标本袋及制造方法
CN201710129327.2A CN106725654B (zh) 2017-03-06 2017-03-06 一种多重熔合标本袋及取物器械
CN201710129503.2 2017-03-06
CN201710129327.2 2017-03-06

Publications (1)

Publication Number Publication Date
WO2018161767A1 true WO2018161767A1 (zh) 2018-09-13

Family

ID=63447915

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2018/075802 WO2018161767A1 (zh) 2017-03-06 2018-02-08 一种多重熔合标本袋及制造方法

Country Status (1)

Country Link
WO (1) WO2018161767A1 (zh)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1470786A (en) * 1975-01-09 1977-04-21 Boyd S Bag and bag making machine
US5465731A (en) * 1992-06-30 1995-11-14 United States Surgical Corporation Specimen retrieval pouch and method for use
CN1394552A (zh) * 2001-06-29 2003-02-05 伊西康内外科公司 改进的样品回收袋
CN1528244A (zh) * 2003-10-17 2004-09-15 李艳芳 易回收的生物标本袋
CN201905926U (zh) * 2010-12-28 2011-07-27 广州金域医学检验中心有限公司 标本与申请单分离的双层标本袋
CN106725654A (zh) * 2017-03-06 2017-05-31 成都五义医疗科技有限公司 一种多重熔合标本袋及取物器械
CN107041764A (zh) * 2017-03-06 2017-08-15 成都五义医疗科技有限公司 一种多重熔合标本袋及制造方法

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1470786A (en) * 1975-01-09 1977-04-21 Boyd S Bag and bag making machine
US5465731A (en) * 1992-06-30 1995-11-14 United States Surgical Corporation Specimen retrieval pouch and method for use
CN1394552A (zh) * 2001-06-29 2003-02-05 伊西康内外科公司 改进的样品回收袋
CN1528244A (zh) * 2003-10-17 2004-09-15 李艳芳 易回收的生物标本袋
CN201905926U (zh) * 2010-12-28 2011-07-27 广州金域医学检验中心有限公司 标本与申请单分离的双层标本袋
CN106725654A (zh) * 2017-03-06 2017-05-31 成都五义医疗科技有限公司 一种多重熔合标本袋及取物器械
CN107041764A (zh) * 2017-03-06 2017-08-15 成都五义医疗科技有限公司 一种多重熔合标本袋及制造方法

Similar Documents

Publication Publication Date Title
WO2018161768A1 (zh) 一种搭接熔合标本袋及取物器械
CN106859704A (zh) 一种搭接熔合筒状标本袋及取物器械
US9949748B2 (en) Laparoscopic tissue retrieval system
CN109464165B (zh) 一种多重熔合标本袋及制造方法
WO2018161769A1 (zh) 一种组合取物器及其使用方法
CN109745080B (zh) 一种多重熔合标本袋及取物器械
CN107303198A (zh) 内镜取物袋
WO2018161767A1 (zh) 一种多重熔合标本袋及制造方法
CN113229867B (zh) 一种适用于定制生产的医用取物袋
CN106725637B (zh) 一种筒型标本袋及取物器械
CN106725638B (zh) 一种微创手术减压防破标本袋
CN207561929U (zh) 一种筒状标本袋及取物器械
CN207561930U (zh) 一种整体吹塑成型标本袋及取物器械
WO2005074817A1 (en) Instruments for sutureless surgical technique
CN207236809U (zh) 一种微创手术减压防破标本袋及装置
CN207561931U (zh) 一种用于微创手术的褶皱减压取物袋
CN111685813B (zh) 一种新型定制医用标本袋
CN111685810B (zh) 一种定制一次性医用标本袋
CN111685811B (zh) 一次性使用的取物袋产品包
CN107041765A (zh) 一种用于微创手术的褶皱减压取物袋
CN106691517A (zh) 一种整体吹塑成型标本袋及取物器械
JP6010244B1 (ja) 自動縫合器誘導用チューブ

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18763912

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 18763912

Country of ref document: EP

Kind code of ref document: A1