CN109745080B

CN109745080B - Multiple fusion specimen bag and fetching machinery

Info

Publication number: CN109745080B
Application number: CN201910112885.7A
Authority: CN
Inventors: 朱莫恕
Original assignee: 5r Med Technology Chengdu Co ltd
Current assignee: 5r Med Technology Chengdu Co ltd
Priority date: 2017-03-06
Filing date: 2017-03-06
Publication date: 2023-06-27
Anticipated expiration: 2037-03-06
Also published as: CN109745080A; CN106725654B; CN106725654A

Abstract

The invention relates to a multiple fusion specimen bag, which comprises a bag opening capable of being opened and folded and a bag body formed by extending from the bag opening, wherein the bag opening comprises a surrounding tunnel, the bag body comprises a film and a first welding line, and the film is welded into a closed bag-shaped whole by the first welding line; the bag body further comprises a second welding line arranged on the inner side of the first welding line; an empty edge is included between the first weld and the second weld. The first weld comprises an overseld weld or a hybrid weld of standard fusion and overseld; the second weld comprises a hybrid weld of under-welded and standard welded. The specimen bag can effectively prevent the bag body from being broken.

Description

Multiple fusion specimen bag and fetching machinery

The application is named as: a multiple fusion specimen bag and a fetching device, the application date is: 03 and 06 days 2017, the application number is: division of the invention patent application of 2017101293272.

Technical Field

The invention relates to a minimally invasive surgical instrument, in particular to a specimen bag structure.

Background

In minimally invasive surgery (especially hard endoscopic surgery), it is often necessary to remove internal tissue or diseased organs through a small incision in the patient's skin or through a puncture catheter. How to safely and conveniently take out tissues or lesion organs in a cavity is always a difficult problem which puzzles the minimally invasive surgery. Since the first clinical application of hard tube endoscopic surgery, various special specimen bags for endoscopic surgery are developed at home and abroad. Although the specimen bags differ in structure and manner of use, they can be generally divided into two categories: first, a single specimen bag. In US5037379, a single-side-opening strip specimen bag is disclosed, and in use, the specimen bag body is held by a grasper and then passed through a puncture catheter or small incision into a patient. The second type comprises a specimen bag, a catheter and a fetching device of a spreading mechanism. In US patent inventions of US5465731, US5480404 and US6383197, various sampling devices are disclosed, wherein a specimen bag is rolled up and stored in a catheter, and when in use, the sampling device enters a patient through a puncture cannula, and then pushes a spreading mechanism to push out the rolled specimen bag from the catheter, and the spreading mechanism spreads the specimen bag, so that the sampling device can be conveniently placed into tissues or lesion organs cut in an operation.

The specimen bag is typically made of a plastic film or sheet of 0.05mm to 0.1 mm. Heretofore, it has been difficult to manufacture specimen bags by integral molding, and two films are commonly used for overlapping and heat sealing (welding), or a single film is used for overlapping and heat sealing (welding). It should be understood by those skilled in the art that the heat sealing (welding) seam of the specimen bag is long, and due to factors such as errors of a heat sealing (welding) fixture, errors of heat sealing (welding) pressure, uneven heat sealing (welding) temperature, etc., defects such as local gaps or local insecurity of the seam are extremely easy to occur, and products containing such defects are difficult to select through inspection means. In mass production, the method of raising the heat sealing (welding) temperature and increasing the heat sealing (welding) time is generally adopted to realize excessive welding, so that the joint is firm and no residual gap exists. However, excessive welding generally results in a significant reduction in the thickness of the specimen bag film substrate in the localized areas where it meets the seam, resulting in a significant reduction in the material strength in the areas adjacent to the seam, and is highly susceptible to breakage, a phenomenon commonly referred to as "undercut".

One of ordinary skill will appreciate that increasing the film thickness may enhance the specimen bag, however, when the specimen bag is used in the aforementioned retrieval device, the increased film thickness often results in the specimen bag being either not received within or not ejected from the catheter due to the size limitations of the catheter. The maximum thickness of the film of the specimen bag in the prior art is usually less than or equal to 0.1mm, and the thickness of the local area is reduced by 30-50% due to excessive welding, so that the strength of the specimen bag is obviously reduced. So far, the occurrence probability of accidents of rupture of specimen bags in clinical use is still large. The instrument or the method for taking out the tissue or the lesion organ in the patient is safer and more convenient, which is beneficial to improving the safety of the minimally invasive surgery and pushing the minimally invasive surgery to develop more.

Disclosure of Invention

In one aspect of the present invention, a multiple-fused specimen bag is presented comprising an openable and collapsible pouch and a pouch body extending from the pouch, the pouch comprising a surrounding tunnel. In one embodiment, the pouch comprises a film and a first weld that welds the film into a closed pouch-like whole, and a second weld that is disposed inside the first weld. In a preferred embodiment, the first weld comprises an overstock weld or a hybrid of standard and overstock welds, and the second weld comprises a hybrid of understock and standard welds. In an alternative, the first weld and the second weld include a free edge therebetween. In yet another alternative, the second weld comprises a discontinuous weld or a continuous weld.

In yet another embodiment, the pouch comprises a film and a weld that welds the film into a pouch-like whole. The weld includes an outboard weld segment and an inboard weld segment. The outboard weld portion comprises an overstocked weld or a hybrid weld of standard welding and overstocked. The inboard weld portion comprises a hybrid weld of under-welded and standard welded.

In another aspect of the present invention, an extraction instrument is presented. The fetching instrument comprises a tying wire which is formed by penetrating the specimen bag into the tunnel, and the tying wire can tighten the bag mouth of the specimen bag after receiving the tissue specimen. The object taking instrument further comprises a catheter assembly, a handle assembly penetrating through the catheter assembly, and a spreading mechanism which is connected with the handle assembly and can spread a specimen bag, wherein the specimen bag and the spreading mechanism are arranged in the catheter assembly and can axially move relative to the catheter assembly; the specimen bag and the opening mechanism are pushed forward in the catheter assembly through the operation of the handle assembly, extend out of the sleeve assembly and are opened by the opening mechanism; the opening mechanism is pulled out backwards along with the catheter assembly and separated from the specimen bag, and the pull wire penetrates through the catheter assembly.

In still another aspect of the present invention, there is provided a method for manufacturing the specimen bag, comprising the steps of:

s1, welding a tunnel, namely bending and welding the edges of the films forming the tunnel of the specimen bag;

s2, folding the bag body along the central line to form two films with the same shape;

s3, performing primary welding along the inner side of the edge of the folded overlapping area to form a mixed welding seam comprising underwelding and standard welding, which is called an inner welding seam part;

And S4, performing secondary welding along the outer edge of the underwelded and standard welded mixed welding seam to form a mixed welding seam comprising standard welding and excessive welding, which is called an outer welding seam part.

Another method for manufacturing the specimen bag comprises the following steps:

s3, performing first welding along the edge of the overlapping area after the film is folded in half to form a mixed welding seam comprising standard welding and excessive welding, which is called an outer welding seam part;

and S4, performing secondary welding along the inner edge of the standard welding and overspray welding mixed welding seam to form a welding seam comprising the underspray welding and the standard welding mixed welding seam, which is called an inner welding seam part.

The manufacturing method of the specimen bag comprises the following steps:

s3, performing first welding along the edge of the overlapping area after the film is folded in half to form a mixed welding seam comprising underwelding and standard welding, which is called an initial welding seam;

S4, aligning the outer edge of the initial welding line, and performing secondary welding with a welding width smaller than that of the initial welding line to form a mixed welding line comprising standard welding and transitional welding, namely an outer welding line part; the weld remaining after the initial weld removes the outboard weld portion is referred to as the inboard weld portion.

Drawings

For a fuller understanding of the nature of the present invention, reference should be made to the following detailed description taken in conjunction with the accompanying drawings in which:

FIG. 1 is a perspective view of a first embodiment of the retrieval mechanism of the present invention in a retracted state;

FIG. 2 is a perspective view of the retrieval mechanism of FIG. 1 in an expanded state;

FIG. 3 is an exploded view of the extraction mechanism of FIG. 2;

FIG. 4 is a simulated view of the bag closure of the article removal apparatus of FIG. 2 in use;

FIG. 5 is a simulated view of the retrieval mechanism of FIG. 4 after removal of the catheter and the distracting mechanism;

FIG. 6 is a schematic illustration of a prior art heat sealing process;

FIG. 7 is a schematic perspective view of a prior art specimen bag 100;

FIG. 8 is a cross-sectional view 8-8 of the specimen bag of FIG. 7;

FIG. 9 is a schematic illustration of weld joint failure mode as weld edge peel;

FIG. 10 is a schematic illustration of a weld joint failure mode as a transition zone break;

FIG. 11 is a cross-sectional view of the specimen bag 11-11 of FIG. 7;

FIG. 12 is a side projection view of the specimen bag 200 of the first embodiment;

FIG. 13 is a sectional view taken along line 13-13 of FIG. 12;

FIG. 14 is a sectional view taken along line 14-14 of FIG. 12;

FIG. 15 is a schematic diagram of a welding die that can output two temperatures;

FIG. 16 is a side projection view of a second embodiment specimen bag 300;

FIG. 17 is a cross-sectional view of FIG. 16 taken along line 17-17;

FIG. 18 is a film development of a third embodiment specimen bag 400;

FIG. 19 is a film folding schematic view of a third embodiment specimen bag 400;

FIG. 20 is a schematic view of a first weld of a third embodiment specimen bag 400;

FIG. 21 is a cross-sectional view taken along line 21-21 of FIG. 20;

FIG. 22 is a schematic illustration of a second weld of the specimen bag of FIG. 20;

FIG. 23 is a sectional view of FIG. 22 taken along line 23-23;

FIG. 24 is a schematic view of yet another first weld of a third embodiment specimen bag 400;

FIG. 25 is a sectional view taken along line 25-25 of FIG. 24;

the same reference numbers will be used throughout the drawings to refer to identical or similar parts or components.

Detailed Description

Embodiments of the present invention are disclosed herein, however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, the disclosure herein is not to be interpreted as limiting, but merely as a basis for the claims and as a basis for teaching one skilled in the art how to employ the invention.

Embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings, with the following side closer to the operator being defined as the proximal side and the side farther from the operator being defined as the distal side for convenience of description.

Fig. 1-3 depict in detail the structural composition of a first embodiment of an extraction instrument 10 of the present invention. Briefly, the retrieval device 10 includes, in order from the distal end to the proximal end, a specimen bag 200, a spreader mechanism 20, a catheter assembly 30, a handle assembly 40, and a ligature 50. The catheter assembly 30 includes a hollow catheter 33 and catheter handle portion 31 and catheter handle portion 32 fixedly joined thereto. The outer diameter of the hollow catheter 33 varies according to the clinical application, and the common diameters are roughly divided into 5mm,8mm,10mm,12mm and 15mm. The handle assembly 40 includes a finger ring 42 and a hollow drive rod 41 connected in sequence from a proximal end to a distal end, the drive rod 41 being positioned within the hollow catheter 33 and axially movable relative to the hollow catheter 33 to move the spreader mechanism 20 and the specimen bag 200 between a retracted state (fig. 1) and an extended state (fig. 2). The opening mechanism 20 comprises an elastic body 21 and a connecting shaft 22 connected with the proximal end of the elastic body 21, wherein the elastic body 21 comprises two

elastic bands

23 and 24 which are flexible or elastic in general, and the

elastic bands

23 and 24 are approximately the same in shape and are symmetrically arranged along the connecting shaft 22. The elastic band 23 and the elastic band 24 comprise a linear section 23b and a linear section 24b at the proximal end and an elastic section 23a and an elastic section 24a at the distal end, wherein the elastic section 23a and the elastic section 24a have the functions of flexibility and shape memory, can be deformed and stored by external force, and can be automatically opened by removing the external force. The proximal end of the straight line segment 23b is provided with a mounting hole 23c, the proximal end of the straight line segment 24b is provided with a mounting hole 24c, the connecting shaft 22 is provided with a shaft hole 22a corresponding to the mounting hole 24c and the mounting hole 23c, and the elastic band 23 and the elastic band 24 are riveted on the connecting shaft 22 through rivets 25. 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, screw connection, welding, or the like. It will be appreciated by those skilled in the art that the elastomer 21 and the connecting shaft 22 may be welded, pinned or otherwise attached directly to the distal end of the drive rod 41.

The specimen bag 200 includes an openable and collapsible pouch mouth 201, and a closed pouch body 202 extending from the pouch mouth 201. The pocket 201 includes a tunnel 211 surrounding the pocket, the tunnel 211 being configured to receive the spreader mechanism 20 and the tie 50. Referring to fig. 2-3, the distal end of the tie 50 includes a sliding knot 51, and the distal end of the tie 50 passes through the tunnel 211 and the proximal end 53 thereof passes through the sliding knot 51 to form a tie loop 52 having approximately the same size as the mouth of the bag. The elastic body 21 is inserted into the tunnel 211. After the extractor 10 is assembled (see fig. 2), the specimen bag 200 is typically wound around the elastic body 21 and received in the hollow catheter 33 (see fig. 1). Various ways of winding and receiving the retrieval device are disclosed in U.S. patent 8986321, and other retrieval devices are also disclosed in specific use, with minor adaptations of the same by one of ordinary skill in the art as applicable to the present invention.

In this embodiment, the elastic body 21 has a shape memory function, and can be automatically and conveniently unfolded in a winding and receiving manner of the fetching device 10. The operator pushes the driving lever 41 to push the specimen bag 200 and the expanding mechanism 20 in the retracted state (fig. 1) out of the hollow catheter 33, and the elastic body 21 has a shape memory function to automatically restore, thereby automatically opening the specimen bag 200 (fig. 2). It will be appreciated by those skilled in the art that the

elastic bands

23 and 24 of the elastic body 21 may also be configured as a linkage mechanism to achieve the distraction. In addition to the description of the distractor mechanism 20, catheter assembly 30, and handle assembly 40 of the exemplary retrieval device 10 described in this embodiment, it will be appreciated by those skilled in the art that alternative combinations of catheter assembly 30 and handle assembly 40 are contemplated as being within the scope of the present invention, such as by the use of U.S. patent nos. 5465731, 6383197, 8721658, etc. and the distractor mechanism 20 of this embodiment.

The relevant operation of the clinical application of the retrieval mechanism 10 may be generally divided into the following stages:

the first stage: and (5) a preparation stage. The retrieval device in the retracted state is inserted into the patient via the penetrating cannula and extends to the target area. And a second stage: and a picking mechanism unfolding stage. The operation handle assembly 40 controls the driving rod 41 to axially move relative to the hollow catheter 33 from the proximal end to the distal end until the opening mechanism 20 and the specimen bag 200 are completely exposed out of the hollow catheter 33, and the elastic body 21 has a shape memory function to automatically restore, thereby automatically opening the specimen bag 200 (fig. 2). And a third stage: and cutting off the specimen. The deployed object-taking device 10 is positioned under the lesion tissue or organ position under the cooperation of an endoscope or the like, and the lesion tissue or organ is sheared off by surgical scissors and dropped into the specimen bag 200. And a fourth stage, a specimen taking-out stage. Referring to fig. 4-5, the handle assembly 40 is first operated to withdraw the spreader mechanism 20 through the puncture cannula while pulling on the proximal end 53 of the wire 50, causing the sliding joint 51 to slide and contract the wire loop 52, thereby collapsing the mouth 201 of the specimen bag 200. The tie wire 50 is then pulled to withdraw the specimen bag 200 and its contained specimen through the puncture cannula or through the percutaneous incision. In this procedure, the specimen bag 200 is subjected to a large compressive force during the removal of large tissues or organs due to the small inside diameter of the puncture cannula or the small incision in minimally invasive surgery. Although the various extraction devices are different in structure and application, their functions and main steps are substantially the same. The method of clinical application of the retrieval device 10 of the present invention may also be understood with reference to the relevant description in US5465731 to better understand the use of the present invention.

Fig. 7 depicts a typical specimen bag 100 of the prior art. The specimen bag 100 is typically formed by folding and welding a single sheet of film (sheet material), or by overlapping and welding two sheets of film (sheet material). Materials for the film (sheet) include, but are not limited to, polyethylene, polyvinyl chloride, polypropylene, nylon, teflon, thermoset elastomers (e.g., silicone), and thermoplastic elastomers (e.g., polyurethane). The process of welding the film (sheet) 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 this example is formed by overlapping and heat-welding two polyethylene films.

Fig. 6 depicts a typical heat welding (abbreviated as heat sealing) process of the prior art for manufacturing specimen bags. The heat sealer 60 includes a base 66 fixed to the ground, a body 67 connected thereto, an upper heat sealing movable die 64 connected to the body 67 and movable in the vertical direction, and a lower heat sealing die 65 connected to the body 67. The heat sealing process of the specimen bag 100 can be simply expressed as that the heat sealing parameters (mainly including the heat sealing temperature, the heat sealing time and the heat sealing pressure) are adjusted, then the film 103 and the film 104 are overlapped and placed on the lower heat sealing mold 65, and finally the heat sealing machine is started to finish the heat sealing welding of the specimen bag 100.

One of ordinary skill will appreciate that the films are heat sealed (welded), i.e., the polymer segments on the surface of the heat sealed area of the film in the molten state diffuse and penetrate and intertwine, such that the two (or more) films are welded together. Referring to fig. 7, the pouch face 103 and the pouch face 104 are welded to each other to form the specimen pouch 100 including the heat seal seam 105. Fig. 8 depicts a partial cross-sectional view of the heat seal seam 105 at any location, i.e., the specimen bag 100 may be more finely divided into a film substrate 131 (film substrate 151), a transition region 132 (transition region 152), and a weld region 133 (weld region 153). During the film heat-sealing process, the film in the molten state of the heat-sealing region is calendered and extruded under the effect of the heat-sealing pressure, thereby forming the transition region 132 (transition region 152). The transition region 132 (152) has a film thickness that is less than the film substrate 131 (151).

Generally, the heat-sealed seams can be classified into three categories, under-heat-sealed, standard heat-sealed and over-heat-sealed, depending on the heat-seal strength and failure mode of the fusion zone and transition zone. The under-heat seal is that the thickness of the film which is melted on the surface of the heat seal area and participates in the heat seal is thinner, the failure mode in the heat seal strength test is that the heat seal area is peeled off, and the test result is lower than the target value. The standard heat seal, namely the thickness of the film which is melted on the surface of the heat seal area and participates in the heat seal is moderate, the failure mode is that the heat seal area is peeled off, and the heat seal strength test result reaches the target value. The excessive heat sealing, i.e. the film that is melted on the surface of the heat sealing area and participates in heat sealing, has too much thickness, which results in a significant thinning of the thickness of the transition area, so that the structural strength of the transition area is significantly lower than the peel strength of the welding area, this phenomenon is usually simply called "undercut", and the failure mode is that the transition area breaks, and the heat sealing strength test result is lower than the target value. In addition, in the standard heat sealing, the heat sealing joint with the largest heat sealing strength test value is called the optimal heat sealing joint. One of ordinary skill will appreciate that the use of different heat sealing parameters determines whether the heat sealed joint 105 is under-sealed, standard heat sealed or over-sealed.

One of ordinary skill will readily recognize that the optimal heat sealing parameters required for standard heat sealing can be achieved experimentally. In the fields of food packaging and medical packaging, particularly in the field of blood product packaging bag manufacturing, a great deal of research has been conducted on heat sealing of plastic films. The prior art disclosed shows that the combined effect of the heat sealing temperature, heat sealing pressure and heat sealing time generally determines the heat sealing quality of the plastic film, and that the heat sealing temperature has the greatest effect on the heat sealing quality, and that the heat sealing pressure and heat sealing time have relatively little or negligible effect on the heat sealing quality.

In the field of food packaging and medical packaging, the optimal heat sealing temperature is usually obtained experimentally. An acceptance standard (i.e. target value) of the heat seal strength is preset in general, then the heat seal strength of the test sample is tested according to a test method specified by an authoritative standard, and the heat seal temperature is determined to be a reasonable temperature or an optimal temperature if the test result meets the acceptance standard. For example, for peelable packages (packages that are intended to be torn by hand when used conveniently), the test is typically conducted in accordance with ASTM F88 flexible barrier seal strength test method, by the american society for testing and materials, and the primary failure mode for testing samples is heat seal area peeling (fig. 9), with test results substantially equivalent to the true heat seal strength of the sample being tested. In the case of non-peelable bags (bags that do not need to be torn by hand during use), such as blood bags, dialysis bags, and the like, the test is usually performed by measuring the heat sealing ability of a flexible material by measuring the seal strength according to ASTM F2029, american society for testing and materials, and the application of heat welding protocol, and the main failure mode in the test of a sample is peeling of the heat sealing area (fig. 9) or fracture of the transition area (fig. 10). The fracture phenomenon of the transition region is mainly caused by the fact that the thickness of the corresponding transition region is obviously thinned due to local excessive heat sealing, so that the local strength is obviously reduced. When the failure mode of the sample during testing is that the transition area breaks, the testing result is smaller than the real heat seal strength of the tested sample. However, as long as the test results meet the acceptance criteria, the heat sealing temperature is still considered to be a reasonable or optimal temperature. It should be particularly pointed out that the establishment of the optimum temperature is mainly dependent on its test method and acceptance criteria, so that the optimum heat sealing temperature does not indicate that the heat sealing strength of its heat sealing seam is optimum. When the failure mode of the heat seal strength test is that the heat seal area is peeled off, not the transition area is broken, and the peeling force of the heat seal area is maximum, the heat seal is called as the optimal heat seal temperature, and more accurately, the optimal temperature parameter is usually called as the theoretical optimal temperature or the ideal optimal temperature.

When the optimal heat sealing temperature is obtained by an experimental method, the fixture error is not introduced into comprehensive evaluation by factors such as heat sealing film error, environmental error and the like. In actual production and manufacture, due to the comprehensive influences of factors such as film thickness errors, film unevenness, heat sealing fixture errors, heat non-uniformity and the like, particularly for materials with longer heat sealing joints and poorer heat sealing performance (such as thermoplastic elastomer), the heat sealing (welding) is carried out at the theoretical optimal temperature, so that local residual gaps are easy to appear, namely the sealing integrity of the heat sealing joints is not up to standard. For products with longer or poorer heat seal seams, the seal integrity and heat seal strength of the heat seal seams are conflicting and often an excessive heat seal must be employed to ensure seal integrity, i.e., the heat seal strength must be sacrificed. In the field of food packaging and medical packaging, the seal integrity of the packaging is the most critical indicator that must be met, while the heat seal strength is a secondary indicator. The field of food packaging and medical packaging is generally based on the fact that the seal integrity is the most critical indicator, and the lower heat sealing temperature is chosen under the precondition that a better heat sealing strength is obtained, and the optimal heat sealing temperature is usually higher than the theoretical optimal temperature. When heat-sealing is performed at this optimum heat-sealing temperature, usually most of the area of the same heat-sealing seam belongs to the standard heat-sealing and its local area belongs to the oversheat-sealing.

To date, there has been little research on the heat sealing of the laparoscopic dedicated specimen bag according to the present invention, and at present, the mass heat sealing of the specimen bags is generally performed using experience in the fields of food packaging and medical packaging, i.e., heat sealing is performed at a temperature higher than the theoretical optimum temperature to obtain both seal integrity and good heat sealing strength, and it is inevitable that most of the area of the same heat sealing seam formed belongs to the standard heat sealing and the local area thereof belongs to the oversealing. Referring to fig. 7, 8 and 11, for example, when the specimen bag 100 is heat sealed under the optimal heat sealing temperature condition, most of the area of the heat sealing seam 105 belongs to standard heat sealing (the heat sealing seam view thereof is shown in fig. 8), and the local area of the heat sealing seam 105 belongs to excessive heat sealing (the heat sealing seam view thereof is shown in fig. 11). As previously described with reference to fig. 11, the localized overseal results in localized substantial thinning of the transition region 132, resulting in localized substantial reduction in strength.

Referring to fig. 4-5, as previously described, when the specimen bag and the diseased tissue or organ contained therein are removed through the puncture cannula or through the percutaneous incision, the specimen bag is subjected to a large compressive force due to the small inside diameter of the puncture cannula or the small incision for minimally invasive surgery, which can easily cause the retrieval bag to rupture. The significant decrease in strength caused by localized overseal increases the risk of rupture of the specimen bag significantly. One of ordinary skill will readily appreciate that increasing the film thickness increases the strength of the specimen bag, however, when the specimen bag is used in the aforementioned retrieval device, the increased film thickness often results in the specimen bag being either not received within the catheter or not being pushed out of the catheter due to the size limitations of the catheter. Also, since specimen bags are commonly used to contain diseased tissue or organs, their sealed integrity is equally important, and any leakage can increase the risk of accidental infection to the patient or increase the effort for subsequent cleaning processes. The heat sealing method to achieve seal integrity and the heat sealing method to achieve optimal heat seal strength are conflicting and so far there is no good method to resolve this conflict.

In view of the limited thickness and size of the film, the specimen bag needs to bear large extrusion force in clinical application, so the pursuit of the strength of the specimen bag is not limited, and the larger the strength is, the better the strength is. And so far the case of rupture in the clinical application of specimen bags still occurs. Those skilled in the art will likely appreciate that the most representative products in the art that are leading, i.e., under the trade name

Endo Catch ^TM And->

There is also a degree of probability of accidental breakage for mass production, marketing and use of the retrieval machinery. Up to now, rupture of the specimen bag in use has almost been unavoidable and the rupture usually occurs in said transition region at the weld; the disclosed control measures generally include selection of better film materials and better weld control heat sealing parameters, which can reduce the weld cracking probability to some extent, yet continue to improve.

Fig. 12-14 depict in detail the structure and composition of a specimen bag 200 according to a first embodiment of the present invention. As described above, the heat sealing methods for obtaining the seal integrity and the optimal heat sealing strength are conflicting, that is, it is difficult to control the heat sealing quality of the specimen bag 200 by the optimal heat sealing parameter method, so that the weld joint has the seal integrity and the weld joint is ensured to be in the standard heat sealing state, so as to obtain the optimal heat sealing strength. In one aspect of the invention, a multiple weld process is employed to resolve the aforementioned conflict. More precisely, the specimen bag 200 contains at least 2 welds, with the outermost weld achieving seal integrity and the inner weld achieving primarily good heat seal strength.

Referring to fig. 12, the specimen bag 200 includes a openable and closable pouch opening 201, and a bag body 202 extending from the pouch opening 201. The mouth 201 includes a tunnel 211 around the mouth for receiving the spreader mechanism 20 and the tie 50. The pouch 202 comprises a first film 203 and a second film 205, and in one embodiment, the two

first films

203 and 205 having substantially the same size and shape are overlapped with each other, and then the whole outer edge of the overlapped portion is heat-welded (simply referred to as heat-sealed) to form a first heat-sealed seam 204 (hereinafter simply referred to as a first weld 204), thereby heat-sealing the first film 203 and the second film 205 into a pouch-like whole having an opening. The first weld 204 forms a heat seal seam along the edges of the bag body that is approximately U-shaped in shape. The pouch 202 further includes a second heat seal seam 208 (hereinafter referred to simply as a second weld seam 208), the second weld seam 208 being disposed inboard of the first weld seam 204. The second weld 208 in this example is substantially parallel to the first weld 204, and a free section 206 is disposed between the first weld 204 and the second weld 208. However, the first weld 204 and the second weld 208 may not be parallel. Although 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 used. Materials for the

films

203 and 205 include, but are not limited to, polyethylene, polyvinyl chloride, polypropylene, nylon, teflon, thermoset elastomers (e.g., silicone), and thermoplastic elastomers (e.g., polyurethane). In this example, the first film 203 and the second film 205 are both made of polyurethane.

For a better understanding of the present solution, the methods described above for under-heat sealing, standard heat sealing and over-heat sealing conditions when manufacturing specimen bags using heat welding (heat sealing) methods, and for obtaining maximum heat seal strength, optimal heat seal seams and theoretical optimal temperatures using experimental methods, are first reviewed herein. One of ordinary skill will recognize that the maximum heat seal strength obtained by experimental methods, the difference between the optimal heat seal joint and the theoretical optimal temperature, and the thickness of different materials, or the thickness of the same material, or the hardness of the same material, are very large, so that the invention is not studied for a specific case of a specific material.

When other welding modes are adopted, the main difference is that the sources of welding energy are different, and the welding nature is the same. And manufacturing the specimen bag by adopting other welding modes, wherein the mutually welded films are also in a molten state, and polymer chain segments on the surface of a heat-sealed area of the films are mutually diffused and permeated and mutually intertwined, so that the two (or more) films are welded together. The specimen bag may also be more finely divided into a film substrate, a transition region and a fusion region. In the film heat sealing process, under the action of heat sealing pressure, the film in a molten state in the heat sealing area is rolled and extruded, so that the transition area is formed. The transition region has a film thickness less than the film substrate thickness. The welded joints can be classified into under-welding (equivalent to under-heat-sealing), standard welding (equivalent to standard welding), and over-welding (equivalent to over-heat-sealing). One of ordinary skill will appreciate that under different welding modes, parameters affecting welding quality are different, and different welding parameters are used to determine whether a welded joint belongs to under welding, standard welding or over welding. Similarly, other known welding methods can also be used to obtain the maximum welding strength, the optimal welding joint and the theoretical optimal welding parameters through an experimental method.

It should be understood by those skilled in the art that although the factors influencing the quality of the welded seam of the specimen bag vary greatly under the conditions of different materials, different structures, or different welding modes, the same test method and acceptance criteria can be used to control the quality of the welded seam, and experimental methods can be used to obtain relevant control parameters. For clarity of explanation of the concepts of the present invention, terms relating to the quality of the welded seams of specimen bags are defined herein as follows:

under-welding: that is, the thickness of the film that is fused on the surface of the welded area and participates in fusion is thin, the failure mode in the welding strength test is that the welded area of the specimen bag is peeled off, and the test result is lower than the target value.

Standard welding: that is, the thickness of the film which is fused on the surface of the welding area and participates in fusion is moderate, the failure mode in the welding strength test is that the welding area of the specimen bag is peeled off, and the test result reaches the target value.

And (3) excessive welding: that is, the surface of the welded region is melted, and the thickness of the film involved in the fusion is too much, so that the thickness of the transition region between the specimen bag welded region and the specimen bag base material is significantly thinned, the failure mode in the welding strength test is that the transition region breaks, and the heat seal strength test result is lower than the target value.

Under-welded weld: the weld strength test is manifested as an underwelded weld.

Standard fusion welds: the weld strength test is presented as a standard welded weld.

And (3) excessively welding: the weld strength test is manifested as an overly welded weld.

Optimal weld: the failure mode in the welding strength test is the peeling of the welding area of the specimen bag, and the test result reaches the maximum welding line. Theoretical optimal welding parameters: and obtaining welding parameters of the optimal welding seam.

As will be readily appreciated by those skilled in the art, when testing film weld strength according to ASTM F2029 or ASTM F88, the sample to be tested is prepared in advance as a strip test specimen having a width of 25mm,20mm or 15 mm. After a test specimen having a long weld is prepared into a plurality of strip-shaped test specimens, the test results may include under-fusion, standard fusion and over-fusion, and such long weld is defined herein as a hybrid weld.

Under-fusion and standard fusion hybrid welds: the same weld joint contains both an under-welded portion and a standard welded portion.

Standard fusion and overstock hybrid welds: the same weld joint contains both standard welded portions and overstocked portions.

The present example is parsed more closely based on the foregoing theory and related definitions to facilitate teaching of a person of skill in the art to better understand the core technology of the present solution. Fig. 13 depicts a partial cross-sectional view of the 13-13 position of the pouch 202. The first film 203 may be divided approximately inward 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. Similarly, the second film 205 may be divided approximately inward from the outer edge into a first weld zone 251, a first transition zone 253, a second weld zone 255, a second transition zone 257, and a specimen bag substrate 259. FIG. 14 depicts a partial cross-sectional view of the second weld 208 of the pouch 202 at the 14-14 location. One or more micro-gaps may be present in a localized area of the second weld 208. The weld 208 in this example includes micro-slots 262 and 266 on the 14-14 weld segment. One skilled in the art will appreciate that when the materials and thicknesses of the first film 203 and the second film 205 are the same, one of the films may be selected. When the materials or thicknesses of the first film 203 and the second film 205 are different, the weakest film may be selected for study. The first film 203 is selected as the primary subject in this example.

In one embodiment, the first weld 204 is an overspray weld, or is a hybrid standard fusion and overspray weld; while the second weld 208 is a hybrid weld of under-fusion and standard fusion. In a manufacturing method, the specimen bag 200 is manufactured by a heat welding (heat sealing) method. First, the theoretical optimal temperature for the heat seal welding of the first film 203 and the second film 205 is obtained by an experimental method. In the process of heat sealing manufacturing the first welding seam 204, the temperature of any position of the heat sealing die outputting heat is ensured to be more than or equal to the theoretical optimal temperature, and the whole welding seam of the first welding seam 204 is ensured to be free from lack of welding, namely the sealing integrity of the welding seam is ensured. I.e., the first weld 204 is entirely overstocked, or a combination of standard welding and localized overstock. Referring to fig. 13, as previously described, in one implementation, the over-welding results in a 15% to 30% reduction in thickness of the aforementioned first transition region 233; when the thickness of the first transition region 233 is reduced by 30% in the extreme case, it exhibits a typical "undercut" phenomenon when tested for weld strength, but is still acceptable because the first weld 204 primarily achieves seal integrity. In a preferred implementation, the weld strength of the first weld 204 is enhanced by reducing the heat sealing temperature such that the first weld 204 appears as a hybrid of standard fusion and oversfusion, i.e., using a lower heat sealing temperature to reduce the degree of thickness reduction of the first transition region 233 while ensuring the sealing integrity of the first weld 204. In the process of heat sealing the second weld 208, the temperature of any position of the heat sealing mold outputting heat is ensured to be less than or equal to the theoretical optimal temperature, and no excessive welding is ensured on the whole weld of the second weld 208, so as to increase the weld strength of the second weld 208. As previously described, the second weld 208 allows for the inclusion of both under-and standard welds, because of the effects of various error factors, particularly for long welds, it is difficult to ensure that the entire weld is in a standard weld condition (or is costly to implement). Referring to fig. 13, in one implementation, the thickness reduction of the second transition region 237 is controlled to be 0-15% when manufactured in a standard fusion manner, as previously described. The failure mode at the time of the weld strength test is that the welded region 208 of the specimen bag is peeled off instead of the second transition region 237 being broken. In a preferred arrangement, a higher heat sealing temperature is used to enhance the weld strength of the second weld 208, while ensuring that no excessive welds are made across the entire weld of the second weld 208. Since the second weld 208 is not allowed to include an overly welded weld, the occurrence of an underwelded weld in the entire second weld 208 is unavoidable due to various error factors, particularly for long welds. Referring to FIG. 14, the weld 208 includes

micro-slots

262 and 266 on the 14-14 weld segments. Since the second weld 208 is not required to ensure seal integrity, localized micro-gaps (under-fusion) are acceptable.

Principle, method of use and advantages of the specimen bag 200: as described above, in the fields of food packaging and medical packaging, such as blood packaging bags, the weld of the packaging bag is subjected to uniform pressure (pressure) of liquid transmission when the packaging bag is broken and failed, and therefore, it is hardly meaningful to employ a multiple weld method for blood packaging bags or the like. However, the clinical application and failure mode of the specimen bag is quite different from the aforementioned blood packaging. The sealed integrity of the specimen bag weld is used to ensure that blood or body fluids in the severed diseased tissue or organ do not penetrate and leak into the patient's body cavity. Referring to fig. 4-5, it can be seen that when a specimen bag containing diseased tissue is received and pulled out, the mouth of the bag is not normally completely sealed; it will be appreciated by one of ordinary skill in the art that when the specimen bag is received and withdrawn, the liquid contained therein is not or only little compressed, or else the liquid will be ejected from the mouth of the bag which is not completely sealed. The pressure (force) transmitted to the first weld 204 by the fluid contained in the specimen bag after passing through the second weld 208 is small. In addition, as will be appreciated by those skilled in the art, when the specimen bag is received and withdrawn, the contained tissue thereof applies an uneven compressive force to the specimen bag body, which in turn translates into an internal force of the specimen bag body being transferred to the second weld 208. Since the diseased tissue is not fluid, it cannot pass through the micro-gaps on the second weld 208 and transfer force to the first weld 204. It will be appreciated by those skilled in the art that localized underwelding does not significantly reduce the weld strength. Plastic films are typical incision sensitive materials, and the undercut phenomenon caused by local overstock easily causes the weld to tear and grow rapidly under large internal forces, thereby significantly reducing the strength of the specimen bag. Meanwhile, even if the local under-heat sealing greatly influences the strength of the welding line, the welding line at the local under-heat sealing position of the second welding line is cracked, but the film is not cracked, and the first welding line is remained as the next defending line. Therefore, the probability of breaking the specimen bag can be remarkably reduced. In summary, the outermost weld realizes the sealing integrity, and the scheme of the inner weld mainly realizing the heat seal strength well meets the clinical application requirements of the specimen bag, and the conflict between the sealing integrity and the optimal heat seal strength is well solved.

In one fabrication scheme, the first weld 204 and the second weld 208 are formed in two heat seals; the heat sealing of the first weld 204 is completed before the heat sealing of the second weld 208 is completed; or the heat sealing of the second weld 208 is completed before the heat sealing of the first weld 204 is completed. In yet another alternative, the first weld 204 and the second weld 208 are formed in a single heat seal. Referring to fig. 15, the heat sealing device locally comprises two heat sealing tools which are heated independently, so that single heat sealing forming of two different welding seams is realized. In yet another manufacturing scheme, the first weld 204 and the second weld 208 are formed by welding two times in other well-known welding manners, and the two welding methods may be the same or different.

Fig. 16-17 depict in detail the structural composition of a second embodiment specimen bag 300 of the present invention. The specimen bag 300 is substantially identical in structure to the specimen bag 200, except for a second weld. The specimen bag 300 includes a mouth 201 and a closed pouch body 302. The pocket 201 includes a tunnel 211 surrounding the pocket. The bag 302 includes a first film 203 and a second film 205, where the first film 203 and the second film 205 are overlapped with each other and welded along an outer edge to form a first weld 204, so that the first film 203 and the second film 205 are thermally formed into a bag-shaped whole having an opening. The pouch 302 further includes a second weld 308, the second weld 308 being disposed inboard of the first weld 204. The second weld 308 in this example is substantially parallel to the first weld 204, and a free section 206 is disposed between the first weld 204 and the second weld 308. In the vicinity of the pocket 201, a joining weld 305 and a joining weld 307 join the first weld 204 and the second weld 308. The entire weld of the second weld 308 is intermittent, comprising a plurality of void segments 362. The first weld 204 is an overstock weld or a hybrid standard weld and overstock weld; while the second weld 208 is a hybrid weld of under-fusion and standard fusion. The specimen bag 300 and the specimen bag 200 have similar functions and properties.

Fig. 18-23 depict in detail the structure and composition of a third embodiment specimen bag 400 of the present invention. As described above, the heat sealing methods for obtaining the seal integrity and the optimal heat sealing strength are conflicting, that is, it is difficult to control the heat sealing quality of the specimen bag 400 by the optimal heat sealing parameter method, so that the weld joint has the seal integrity and the weld joint is ensured to be in the standard heat sealing state, so as to obtain the optimal heat sealing strength. In another aspect of the invention, a single bead multiple welding method is employed to resolve the aforementioned conflict. More specifically, the specimen bag 400 contains a single peripheral weld 409 formed by a plurality of welds, and the peripheral weld 409 is divided into typical inboard and outboard weld portions.

Referring to fig. 18-20, the specimen bag 400 includes a bag mouth 401 for receiving a tissue specimen and a bag body 402, the bag mouth 401 including a tunnel 411 surrounding the bag mouth. The bag 402 includes a center line 404, and a first bag face 403 and a second bag face 405 formed by folding in half along the center line 404. The first and

second faces

403, 405 are substantially identical in size and shape and overlap each other, and the entire outer edges of the overlapping portions are welded to form an outer edge weld 409, thereby welding the first and

second faces

403, 405 together into a bag-like whole having an opening.

Referring to fig. 22, the outer edge weld 409 includes a first weld 407 disposed on the outside and a second weld 408 disposed on the inside, the first weld 407 and the second weld 408 being substantially parallel and fused to each other without significant empty or space. Fig. 23 depicts a partial cross-sectional view of the pocket 402 at positions 23-23. The first pouch face 403 may be divided approximately inward from the outer edge into a first welding zone 431, a second welding zone 433, a second transition zone 435, and a specimen pouch substrate 437. Similarly, the second pouch face 405 may be divided approximately inward from the outer edge into a first welding zone 451, a second welding zone 453, a second transition zone 455, and a specimen pouch substrate 457. One skilled in the art will appreciate that when the materials and thicknesses of the first and

second faces

403, 405 are the same, one of the faces may be selected. The first pocket 403 is selected as the primary subject in this example.

In an alternative embodiment, the first weld 407 is an overspray weld, or is a hybrid standard fusion and overspray weld; while the second weld 408 is a hybrid of under-welded and standard welded welds. In a specific embodiment, the specimen bag 400 is manufactured by a heat welding (heat sealing) method. Firstly, obtaining the theoretical optimal temperature of heat seal welding by adopting an experimental method. In the process of heat sealing the first weld 407, the temperature of any position of the heat sealing mold outputting heat is ensured to be greater than or equal to the theoretical optimal temperature, and the whole weld of the first weld 407 is ensured to be free from lack of welding, namely the sealing integrity of the first weld is ensured. I.e. the first weld 407 is wholly overstocked or a combination of standard welding and localized overstocked. In a preferred implementation, the weld strength of the first weld 407 is enhanced by reducing the heat sealing temperature such that the first weld 407 appears as a hybrid of standard fusion and oversfusion, i.e., using a lower heat sealing temperature to reduce the degree of thickness reduction of the first transition region 233 while ensuring the sealing integrity of the first weld 407. In the process of heat sealing the second weld 408, the temperature of any position of the heat sealing mold outputting heat is ensured to be less than or equal to the theoretical optimal temperature, and no excessive welding is ensured on the whole weld of the second weld 408, so as to increase the weld strength of the second weld 408. As previously mentioned, the second weld 408 allows for inclusion of both under-and standard welds, because of the effects of various error factors, particularly for long welds, it is difficult to ensure that the entire weld is in a standard weld condition (or is costly to implement). Referring to fig. 23, in one implementation, the thickness reduction of the second transition region 435 is controlled to be 0-15% when manufactured in a standard fusion manner, as previously described. The failure mode at the time of its weld strength test is that the welded region 408 of the specimen bag is peeled off rather than the second transition region 435 being broken. In a preferred arrangement, a higher heat sealing temperature is used to enhance the weld strength of the second weld 408, while ensuring that no excessive welds are made across the entire weld of the second weld 408. Since the second weld 408 is not allowed to include an excessive weld, the occurrence of an under-weld or even a micro-gap in the entire second weld 408 is unavoidable due to various error factors, particularly for long welds. Since the second weld 408 is not required to ensure seal integrity, localized micro-gaps (under-fusion) are acceptable.

The specimen bag 400 has similar functions and capabilities with respect to the specimen bag 200. No obvious gap exists between the first welding seam 407 and the second welding seam 408 of the specimen bag 400, and a single outer edge welding seam 409 is formed, so that folds or curls in the manufacturing process of a bag surface (film) of the specimen bag can be reduced, and meanwhile, the space can be saved. In addition, the specimen bag 400 is formed by folding and welding a single film, so that the length of a welding line is reduced, the welding difficulty is reduced, and the manufacturing stability is improved.

The specimen bag 400 is manufactured by a variety of methods, one preferred manufacturing procedure being generally as follows:

s1, firstly, bending a bag opening 401 of a specimen bag 400 and forming a tunnel 411 by welding (shown in FIG. 18);

s2, folding the bag body 402 in half along the central line 404 to form a bag surface 403 and a bag surface 405 (shown in FIG. 19);

s3, performing first welding along the edge of the overlapping area after the bag face 403 and the bag face 405 are folded in half to form a hybrid welding seam comprising underwelding and standard welding, namely an initial welding seam 406 (shown in figures 20-21);

and S4, performing secondary welding along the outer edge of the initial welding seam 406 to form a mixed welding seam comprising standard welding and excessive welding, or forming a single excessive welding seam, namely a first welding seam 407. After the first weld 407 of the initial weld 406 is removed, the remaining inner portion is referred to as the second weld 408. The first weld 407 and the second weld 408 are collectively referred to as an outer edge weld 409 (as shown in fig. 22-23).

Another alternative manufacturing step is generally as follows:

s3, performing first welding along the inner side of the edge of the overlapping area after the bag face 403 and the bag face 405 are folded in half to form a mixed welding line comprising underwelding and standard welding, namely a second welding line 408 (shown in figures 24-25);

and S4, performing secondary welding along the outer edge of the second welding seam 408 to form a mixed welding seam comprising standard welding and excessive welding, or forming a single excessive welding seam, namely a first welding seam 407, wherein the first welding seam 407 and the second welding seam 408 are combined to form an outer edge welding seam 409, and no obvious blank or empty section exists between the first welding seam and the second welding seam.

Yet another alternative manufacturing step is generally as follows:

s3, performing first welding along the outer side of the edge of the overlapping area after the bag face 403 and the bag face 405 are folded in half to form a mixed welding line comprising standard welding and excessive welding, or forming a single excessive welding line, namely a first welding line 407;

And S4, performing secondary welding along the outer edge of the second welding seam 408 to form a mixed welding seam comprising underwelding and standard welding, namely a second welding seam 408, wherein the first welding seam 407 and the second welding seam 408 are jointly called an outer edge welding seam 409, and no obvious blank or empty section exists between the first welding seam and the second welding seam.

Many different embodiments and examples of the invention have been shown and described. One of ordinary skill in the art will be able to make adaptations to the method and apparatus by appropriate modifications without departing from the scope of the invention. Such as simple adaptations of the thermal sealing seams of the specimen bag disclosed in other inventions, or different processes, such as different combinations of pressure parameters, temperature parameters, or dwell times. Several modifications have been mentioned, and other modifications are conceivable to the person skilled in the art. The scope of the present invention should therefore be determined with reference to the appended claims, rather than with reference to the structures, materials, or acts illustrated and described in the specification and drawings.

Claims

1. A multiple fusion specimen bag comprising a openable and collapsible pouch and a pouch extending from the pouch, the pouch comprising a surrounding tunnel, characterized in that: the bag body comprises a film and a first welding line, and the film is welded into a closed bag-shaped whole by the first welding line;

The film material comprises polyethylene, polyvinyl chloride, polypropylene, nylon, teflon, a thermosetting elastomer or a thermoplastic elastomer;

the bag body further comprises a second welding line arranged on the inner side of the first welding line; an empty edge is arranged between the first welding line and the second welding line;

the first weld comprises an overseld weld or a hybrid weld of standard fusion and overseld; the second weld comprises a hybrid weld of under-welded and standard welded;

the first weld joint ensures the sealing integrity of the specimen bag, and the second weld joint releases the extrusion force in a stripping mode to realize the increase of the integral strength of the weld joint.

2. The specimen bag of claim 1, wherein: the second weld comprises a discontinuous weld or a continuous weld.

3. The specimen bag of claim 1, wherein: the specimen bag further comprises a binding wire penetrating through the tunnel, and the binding wire can tighten the bag mouth of the specimen bag after receiving the tissue specimen.

4. An article taking instrument for minimally invasive surgery, which is characterized in that: a specimen bag comprising any one of claims 1-3, further comprising a catheter assembly and a handle assembly extending therethrough, and a spreader mechanism coupled to the handle assembly for spreading the specimen bag, the specimen bag and spreader mechanism being disposed within the catheter assembly and being axially movable relative thereto; the specimen bag and the opening mechanism are pushed forward in the catheter assembly through the operation of the handle assembly, extend out of the sleeve assembly and are opened by the opening mechanism; the opening mechanism is pulled out backwards along with the catheter assembly and separated from the specimen bag.