WO2018161768A1 - Specimen bag formed by fusion bonding of folding sections thereof and specimen removal instrument - Google Patents

Abstract

Provided are a specimen bag (200) formed by fusion bonding of folding sections thereof and a specimen removal instrument (10). The specimen bag (200) comprises an open end (220) capable of being opened and closed, and a bag body (230) extending from the open end (220). The open end (220) comprises a surrounding hem (222). The bag body (230) further comprises a bottom portion. The bag body (230) comprises a lamellar membrane (210). The membrane (210) has a top edge (211) connected to the hem (222) and a first folding edge section (212) and a second folding edge section (214) which are located at two ends of the top edge (211). After the membrane (210) has been folded along virtual folds (216, 218), the first folding edge section (212) and the second folding edge section (214) are overlapped with each other and then welded to form a folded weld joint (233). The specimen bag (200) formed by fusion bonding of folding sections thereof can effectively prevent the bag body (230) from breaking.

Description

Lap fusion specimen bag and retrieval device Technical field

The present invention relates to a minimally invasive surgical instrument, and more particularly to a specimen bag structure.

Background technique

In minimally invasive surgery (especially in hard laparoscopic surgery), internal tissue or diseased organs are usually removed via a small incision in the patient's skin or via a puncture catheter. How to safely and conveniently remove the intraluminal tissue or diseased organs has been a problem that plagues minimally invasive surgery. Since the first clinical application of self-hardening laparoscopic surgery, a variety of specimen bags for laparoscopic surgery have been developed at home and abroad. Although the structure and use of the specimen bags are different, they can be generally divided into two categories: the first category, a single specimen bag. U.S. Patent No. 5,037,379 discloses a singularly-opened line specimen bag which is used to hold the specimen bag and then enter the patient through a puncture catheter or a small incision. The second category consists of a specimen bag, a catheter and a retrieval device for the distraction mechanism. U.S. Patent No. 5, 546, 573, U.S. Patent No. 5, 480, 404, U.S. Patent No. 6, 383, 197, issued to U.S. Patent No. 6,383, 197, et al., the disclosure of which is incorporated herein by reference. 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). Those skilled in the art should understand that 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. In mass production, 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. However, 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".

One of ordinary skill in the art would appreciate that increasing the thickness of the film enhances the specimen bag. However, when the specimen bag is used in the aforementioned retrieval device, 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.

Summary of the invention

In one aspect of the invention, a lap splice type specimen bag is provided. The specimen bag 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.

In one embodiment, 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. In another embodiment, 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. In still another embodiment, 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.

In still another embodiment, 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. In still another embodiment, 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.

In still another embodiment, 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.

In yet another embodiment, the specimen bag can be inflated to form a hollow body of revolution while the lap joint weld becomes a space curved weld.

In another aspect of the invention, an retrieval device for minimally invasive surgery is presented. The retrieval device 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.

In yet another aspect of the invention, a method of making a specimen bag is presented, the steps of which are as follows:

S1: die-cutting a film raw material, and cutting the film raw material into a sheet-like film;

S2: welding the tunnel, bending the edge of the film forming the tunnel of 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 a tunnel;

S3: welding the bag body by the lap joint method, first folding the first overlapping edge and the second overlapping edge of the film along the virtual folding line and overlapping each other, and then folding the bottom edge of the film along the virtual folding line And overlapping each other, the lower mold of the second welding mold is inserted into the bag body region and attached under the overlapping region, and the upper die of the second welding die is welded into the lap joint weld to thereby form the sheet film. Connected into one whole;

S4: crimping the bottom of the bag, placing the bag on the lower die of the third welding die, and welding the upper die of the third welding die along the sharp corner region of the lap joint weld to form a bead Joint weld.

Another method of making a specimen bag is as follows:

S1: die-cutting a film raw material, and cutting a cylindrical film raw material into a tubular film;

S2: welding the mouth of the bag, forming an edge opening of the bag mouth of the specimen bag, bending the edge material on the lower die of the first welding die, and forming a tunnel by welding the upper die of the first welding die;

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;

S4: crimping the sharp corner region, placing the bag body 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 two ends of the weld seam to form the roll The edge joint welds weld the lap joint weld and the film into a sealed unitary body.

DRAWINGS

In order to more fully understand the essence of the present invention, a detailed description will be made with reference to the accompanying drawings, in which:

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;

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;

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.

Throughout the drawings, the same reference numerals are used to refer to the same or the like.

detailed description

Embodiments of the present invention are disclosed herein, but it should be understood that the disclosed embodiments are merely examples of the invention, which may be implemented in various ways. Therefore, the disclosure of the present invention is not to be construed as limiting, but as a basis

Embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. For convenience of description, one of the parties that is close to the operator is defined as the near end, and the party far from the operator is defined as the far end.

Figures 1-3 detail the structural composition of the retrieval device 10 of the first embodiment of the present invention. Briefly, 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. Referring to FIG. 2-3, 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 same tie loop 52. The elastomer 21 is inserted into the tunnel 222. After the dispensing device 10 is assembled (refer to FIG. 2), 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.

In the present embodiment, 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). It will be appreciated by those skilled in the art that 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. In this embodiment, a distraction mechanism 20, a catheter assembly 30, and a handle assembly 40 of a typical retrieval device 10 have been described. In addition, those skilled in the art will recognize that U.S. Patent No. 5,465,731, U.S. Patent No. 6,383,197, An alternative combination of the US8721658 and the like, the expansion mechanism 20 of the present embodiment, the catheter assembly 30 and the handle assembly 40 are also within the scope of the present invention.

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. In the fourth stage, the specimen is taken out of the stage. Referring to FIGS. 4-5, 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. During this procedure, 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. Although the structure and application of 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. In a prior implementation, 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.

Figure 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.

It should be understood by one of ordinary skill that 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). In the film heat sealing process, 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).

Generally, depending on the heat sealing strength and failure mode of the welded region and the transition region, 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. In the standard heat sealing, 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.

One of ordinary skill in the art will readily appreciate that the optimum heat sealing parameters required for standard heat sealing can be obtained experimentally. In the field of food packaging and medical packaging, especially in the field of blood product packaging, a large amount of research has been conducted on the heat sealing of plastic films. The disclosed prior art shows that the combination of heat sealing temperature, heat sealing pressure and heat sealing time generally determines the heat sealing quality of the plastic film, and the heat sealing temperature has the greatest influence on the heat sealing quality, and the heat sealing pressure and heat sealing time affect the heat sealing quality. Relatively small or negligible.

In the field of food packaging and medical packaging, the optimum heat sealing temperature is usually obtained experimentally. Usually, a acceptance standard of heat sealing strength (ie, target value) is preset, and the heat sealing strength of the test sample is tested according to the test method specified by the authoritative standard. When the test result satisfies the acceptance standard, the heat sealing temperature is determined to be a reasonable temperature or an optimum temperature. . For example, for peelable bags (packs 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. For blood bags, dialysis bags and other non-peelable bags (packages that do not need to be torn open by hand), usually according to the American Society for Testing and Materials, ASTM F2029, 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. When 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. However, as long as the test results meet the acceptance criteria, 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. 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.

Generally, when the optimal heat sealing temperature is obtained by the experimental method, 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. In actual production, 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. For products with long heat seal seams or poor heat sealing properties, the seal integrity and heat seal strength of the heat seal seams are conflicting. To ensure the seal integrity, excessive heat seal must be used, that is, the heat seal strength must be sacrificed. In the field of food packaging and medical packaging, the seal integrity of the package is the most critical indicator that must be met, and the heat seal strength is a secondary indicator. Food packaging and medical packaging are often the most critical indicators to meet seal integrity. Under this precondition, lower heat sealing temperature is selected to obtain better heat sealing strength. The optimum heat sealing temperature is usually higher than the theoretical optimum temperature. . When heat sealing is performed at this optimum heat sealing temperature, most of the area of the same heat sealing seam generally belongs to the standard heat sealing and the local area belongs to the excessive heat sealing.

So far, it has been disclosed that there is less research on the heat sealing of the laparoscopic-specific specimen bags according to the present invention. At present, 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. Inevitably, 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.

Referring to Figures 4-5, as described above, when the specimen bag and its contained diseased tissue or organ are removed through the puncture cannula or through the skin incision, the specimen bag is very affected due to the smaller diameter of the puncture cannula or the minimally invasive surgical incision. The large pressing force easily causes the bag to rupture. The significant decrease in strength caused by local overheating greatly increases the risk of rupture of the specimen bag. It will be readily apparent to one of ordinary skill in the art that increasing the thickness of the film increases the strength of the specimen bag. However, when the specimen bag is used in the aforementioned device, the increase in film thickness generally results in the specimen bag not being stored in the catheter due to the size limitation of the catheter or The specimen bag cannot be pushed out of the catheter. At the same time, since the specimen bag is usually used to hold diseased tissues or organs, 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.

Endo Catch ^TM和

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。 In view of the limited thickness of the film, and the specimen bag needs to bear a large pressing force in clinical application, there is no upper limit to the pursuit of the strength of the specimen bag, and the greater the strength, the better. Moreover, cases of rupture in clinical applications of specimen bags have occurred from time to time. Those skilled in the art may understand that the most representative product in the field is the trade name

Endo Catch ^TM and

There are also a certain degree of accidental rupture probability in mass production and sale of instruments. So far, the use of a Chinese standard bag rupture is almost inevitable, and rupture usually occurs at the transition zone at the weld; the disclosed control measures typically include the selection of better film materials and better weld control heat seal parameters. These measures can reduce the probability of weld cracking to a certain extent, but still need to continue to improve.

An ordinary technician should understand that when two metal plates are welded to each other, 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. Although the strength of different welded joints is different, the different welded joint forms are mainly adapted to the shape and structure of the product. For the welding of plastic film (sheet), 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. When the mutually overlapping films are horizontally pulled apart, 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). To date, the welded joints of the specimen bags and the already commercialized specimen bags disclosed in the prior art are almost all crimped joints. Moreover, 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. One of the main reasons is that 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.

Studies have shown that for specimen bags in the field, the strength of welding with lap joints is much greater than that of crimped joints. The lap joint, that is, only the seam edges of the two films to be welded overlap each other, and the substrate regions of the film do not overlap, refer to FIGS. 12-14 and 20-21. To understand this solution, sufficient elastic mechanics, elastoplastic mechanics and the knowledge background of plastic materials, especially thermoplastic elastomers, are needed. First, an experimental case is used to explain the beneficial effects of this scheme.

RxT85A聚氨酯材料并以压延法生产的0.1±0.02mm厚的薄膜，裁剪成200mm×200mm的样品进行热合焊接。焊接参数：焊接温度180±2℃，焊接压力0.2±0.01Mpa，焊接时间1±0.2s，焊缝宽度3±0.2mm。采用ASTM F2029-08规定的方法进行测试，测试结果如下表： 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:

Table 1 Welding strength comparison test table for crimped joints and lap joints

As can be seen from the test results in Table 1, for the purposes of this experiment, the tensile strength of the lap joint is much greater than the tensile strength of the crimp joint. The test conclusions for replacing different materials or using different welding parameters are basically the same, and the details are not described here. This test result does not seem to meet the judgment of daily experience, but it is in line with the material science and mechanics theory. Those skilled in the art of plastic materials and elastic mechanics should understand: First, plastic materials, especially thermoplastic elastomers, are usually anisotropic materials, while plastic films are typical anisotropic materials with material strength along the surface of the film. 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. For the tensile test of the welded sample in the form of a crimped joint, the adjacent area of the weld (ie, the transitional area) is mainly affected by the shearing force and the bending force, and the strength of the thickness direction of the film itself is relatively poor, so that the fracture is relatively easy to occur. . For the tensile test of the weld sample in the form of a lap joint, 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. In the region, 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. In summary, when the specimen bag is welded by the crimping joint method, increasing the strength of the film material does not significantly solve the aforementioned cracking problem. When the specimen bag is welded by the lap joint, 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.

Figures 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. In one aspect of the invention, the pocket 230 is formed by welding in a lap joint manner.

In one aspect, the specimen bag 200 is formed by folding and welding a single piece of polyurethane film 210. Referring to FIG. 12, 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. Referring to Figures 12-13, the top edge 211 is folded and welded along the virtual fold line 223 to form a weld 225 that defines the tunnel 222.

Referring to Figure 13, 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. Referring to Figures 13-14, 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. 14-15, welded along the outer edge of the bottom edge 213, 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. Referring to FIG. 6-8, when the crimping joint is welded, 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. Referring to 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). . Moreover, when the lap joint of the specimen bag 200 is welded, instead of placing the specimen bag on the lower mold, the lower mold is inserted inside the specimen bag and under the overlapping portion of the two films, and then the upper mold is moved down to the stroke. After the end point, the welding is started and the weld 233 is formed along the overlapping area. Figure 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).

It should be understood by those skilled in the art that 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. In addition, 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. Referring to Figures 18-19, when sufficient specimen or tissue is placed in the specimen pouch 100, the specimen pouch 100 becomes approximately conical, and the weld bead 105 exhibits a typical crimped joint weld (Fig. 19), when the specimen bag 100 containing a large amount of diseased tissue is pulled out from the small incision of the patient (Fig. 17), the transition region 132 (152) of the crimped weld is subject to large bending and shearing forces and is easily broken. . Referring to Figures 20-21, when sufficient specimen or tissue is placed in the specimen pouch 200, the specimen pouch 200 becomes approximately conical, and the weld bead 233 exhibits a typical lap joint weld (Fig. 21 When the specimen bag 200 containing a large amount of diseased tissue is pulled out from the small incision of the patient (Fig. 17), 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). As can be seen from the foregoing, 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.

Referring to Fig. 4, Fig. 5 and Fig. 17, when the specimen bag containing the diseased tissue is stored and pulled out, the bag mouth is usually not completely sealed. Therefore, an ordinary technician can think that when the specimen bag is stored and pulled out, the liquid contained in the specimen bag is not subjected to the pressing force or the pressing force is small, otherwise the liquid will not be completely sealed from the specimen bag. The mouth is sprayed out. It will be understood by those skilled in the art that when the specimen bag is stored and pulled out, its containing tissue exerts an uneven pressing force on the specimen bag body. More specifically, as shown in FIG. 17, when the specimen bag 200 is pulled out, the region of the bag body 230 having a large diameter is subjected to a large pressing force. And when the majority of the bag body 230 has been pulled out through the small skin incision, 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.

22-25 detail the structure and composition of the specimen bag 300 of the second embodiment of the present invention. 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. In one embodiment, the specimen bag 300 is folded and welded from a cylindrical film 310. Referring to FIG. 22, the film 310 includes a top edge 311 and a first bottom edge 313 and a second bottom edge 314 opposite thereto. Referring to Figures 22-23, the top edge 311 is folded and welded to form a weld 325 that defines a tunnel 322. Referring to Figures 23-24, 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. 24-25, welding along the sharp corners of both ends of the weld bead 333 to form a crimp joint weld 334 and a crimp joint weld 335, thereby welding the lap joint weld 333 and the film 310 into A sealed whole. 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.

26-29 depict the construction and composition of the specimen bag 400 of the third embodiment. 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. Referring to Figures 26-27, the top edge 411 is folded and welded along the virtual fold line 423 to form a weld 425 that defines the tunnel 422. Referring to Figure 27, 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. Referring to Figures 27-28, 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. 29, along the outer edge of the bottom edge 413, 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.

In one embodiment, 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.

Figures 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. 30, 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. Referring to Figures 30-31, 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. 31, along the virtual fold line 515, the fold line 516 and the virtual fold line 517 fold the film 510 such that the first lap 512 and the second lap 514 overlap each other while the bottom The side 513a and the bottom side 513b overlap each other. Welding along the overlap region forms a lap joint weld 533 and a lap joint weld 534. The bag 530 of the specimen bag 500 is generally not capable of being welded at one time because the lap joint welding method may cause the weld bead 534 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. 32-33, 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. Moreover, 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.

Figures 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. 34, 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. Referring to Figures 34-35, 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. 35, along the virtual fold line 615, the fold line 616 and the virtual fold line 617 fold the film 610 such that the first overlap edge 612 and the second overlap edge 614 overlap each other while the bottom The side 613b and the bottom side 613c overlap each other. Welding along the overlap region forms a lap joint weld 633 and a lap joint weld 634. The bag body 630 of the specimen bag 600 is generally not capable of being welded at one time because the lap joint welding method may cause the weld bead 634 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. 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.

When the aforementioned specimen bags 200, 300, 400, 500 are inflated to form a rotary body, 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. When the specimen bag 600 is inflated to form a rotary body, 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. Those skilled in the art will appreciate that the angled weld bead 633 facilitates improved stress concentration in the weld zone during use of the specimen bag relative to other welds. Since 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.

38-39 depict the construction and composition of a specimen pouch 700 of a sixth embodiment of the present invention. 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.

40-41 depict the construction and composition of a specimen pouch 800 of a seventh embodiment of the present invention. 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. For example, 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. Thus, 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.

It should be understood by those skilled in the art that 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. 13) 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. Under the region, the upper die of the second welding die is welded into the lap joint weld 433, thereby joining the first bag face 415 and the third bag face 419 into one piece (see FIG. 28); S4: crimping joint method The bag bottom 430 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 413 to form a first crimp joint weld 434 and a second Crimping joint weld 435, thereby first pocket surface 415, second pocket surface 4 17 and the third bag face 419 are joined together. (See Figure 29).

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. 31); 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. And affixed under the overlapping area of the lap joint, and welded to form the lap joint weld 533 and the lap joint weld 534 using the upper mold of the second welding mold (see FIG. 32); 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). .

The foregoing lap welding uses a single layer and two lap joints, and those skilled in the art should understand that a similar lap joint effect can also be achieved by using three or more layers of lap joints. In particular, for the sharp corner regions of the aforementioned lap weld, the use of folding to form a multi-layer overlap can avoid the use of seam welding. Therefore, it is also within the scope of the present disclosure to employ similar multilayer laps by those skilled in the art.

Many different embodiments and examples of the invention have been shown and described. One of ordinary skill in the art can make adaptations to the methods and apparatus by appropriate modifications without departing from the scope of the invention. For example, the specimen bag heat sealing seam disclosed in other inventions can be used for simple adaptive modification, or different processes, such as pressure parameters, temperature parameters or holding time, can be used. Therefore, the scope of the invention should be construed in the appended claims and the claims

Claims (10)

A lap fusion specimen bag comprising a bag opening that can be opened and closed, and a bag body extending from the bag mouth, the bag mouth comprising a surrounding tunnel, the bag body further comprising a bag bottom, wherein: 1) the bag body comprises a sheet-like film, the film comprising a top edge connected to the tunnel and a first overlapping edge and a second overlapping edge at both side edges thereof; 2) The first lap joint and the second lap joint are overlapped and welded to form a lap joint weld by folding the film along the virtual fold line. The specimen bag according to claim 1, wherein said film further comprises a bottom edge, said bottom edge being overlapped and welded to form another lap joint weld by folding said film along a virtual fold line. The specimen bag according to claim 1, wherein said film further comprises a third overlapping edge and a fourth overlapping edge, said third overlapping edge and said fourth overlapping edge passing through said film edge The virtual fold lines are folded to overlap each other and welded to form another lap joint weld. A specimen bag according to any of claims 1-3, further comprising a crimped joint weld welded from a sharp corner region of said lap joint weld, said crimp joint weld The bottom of the bag is closed. A specimen bag according to any of claims 1-3, wherein said specimen bag is expandable to form a hollow body of revolution, while said lap joint weld becomes a space-curved weld. The specimen bag according to claim 1 wherein said film further comprises a bottom edge welded along said bottom edge to form a seamed joint weld, said seamed joint weld sealing said bottom of said pocket. The specimen bag of claim 6 wherein said crimp 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. A lapped fused specimen bag, comprising: the specimen bag according to any one of claims 1-7, wherein the specimen bag further comprises a tying wire piercing the tunnel, the tying wire can be After receiving the tissue specimen, tighten the pocket of the specimen bag. An apparatus for minimally invasive surgery, comprising: the specimen bag of claim 8, further comprising a catheter assembly and a handle assembly therethrough, and an openable specimen coupled to the handle assembly a bag opening mechanism, the specimen bag and the distracting mechanism are disposed in the catheter assembly and movable relative to the axial direction; the specimen bag and the distracting mechanism are pushed forward and extended in the catheter assembly by the handle assembly operation The cannula assembly is distracted by the distracting mechanism; the distracting mechanism is withdrawn rearwardly from the catheter assembly and separated from the specimen bag, the pull wire extending through the catheter assembly. A method of manufacturing a specimen bag according to claim 3, wherein the steps are as follows: S1: die-cutting a film raw material, and cutting the film raw material into a sheet-like film; S2: welding the tunnel, bending the edge of the film forming the tunnel of 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 a tunnel; S3: welding the bag body by the lap joint method, first folding the first overlapping edge and the second overlapping edge of the film along the virtual folding line and overlapping each other, and then folding the bottom edge of the film along the virtual folding line And overlapping each other, the lower mold of the second welding mold is inserted into the bag body region and attached under the overlapping region, and the upper die of the second welding die is welded into the lap joint weld to thereby form the sheet film. Connected into one whole; S4: crimping the bottom of the bag, placing the bag on the lower die of the third welding die, and welding the upper die of the third welding die along the sharp corner region of the lap joint weld to form a bead Joint weld.

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