CN113229866A

CN113229866A - Medical specimen bag adopting bonding and welding combination

Info

Publication number: CN113229866A
Application number: CN202110500276.6A
Authority: CN
Inventors: 刘贵容
Original assignee: Chongqing Chengyi Technology Co ltd
Current assignee: Chongqing Chengyi Technology Co ltd
Priority date: 2020-07-03
Filing date: 2020-07-03
Publication date: 2021-08-10
Also published as: CN111685813B; CN111685813A

Abstract

The invention relates to a medical specimen bag combined by bonding and welding, which comprises a bag opening capable of being opened and closed and a bag body formed by extending from the bag opening, wherein the bag opening comprises a surrounding tunnel; the pair of folds, the inlet weld, the body weld and the tail weld connect the films into a semi-closed bag-shaped whole body containing a bag opening.

Description

Medical specimen bag adopting bonding and welding combination

The application is named as: a medical specimen bag adopting bonding and welding combination has the following application date: year 2020, month 07, 03, application number: 202010635778.5 patent application for inventions.

Technical Field

The invention relates to a minimally invasive surgical instrument, in particular to a medical specimen bag combining bonding and welding.

Background

In minimally invasive surgery (especially in hard-barreled surgery), it is often necessary to remove internal tissues or diseased organs through a small incision in the patient's skin or through a puncture catheter. How to safely and conveniently take out the tissue or the diseased organ in the cavity is always a difficult problem which troubles the minimally invasive surgery. Since the first clinical application of the self-hardening lumen endoscopic surgery, various specimen bags special for endoscopic surgery are developed at home and abroad. Although the specimen bags are different in structure and use mode, the general types can be divided into two types: first, single specimen bags. US5037379 discloses a single-side opening threaded specimen bag which is used by grasping the specimen bag body with a grasper and passing the grasped specimen bag body through a puncture catheter or a small incision into a patient. And the second type is an extraction instrument comprising a specimen bag, a catheter and a stretching mechanism. US patent inventions US5465731, US patent 5480404, US patent 6383197 and the like disclose various fetching instruments, wherein a specimen bag is rolled up and contained in a catheter, when in use, the fetching instrument enters the body of a patient through a puncture cannula, then a stretching mechanism is pushed to push the rolled specimen bag out of the catheter, and the stretching mechanism stretches the specimen bag, so that the specimen bag is conveniently loaded into tissues or diseased organs cut in an operation.

The specimen bag is typically made of 0.05mm to 0.1mm plastic film or sheet. It has been difficult to manufacture specimen bags by integral molding, and it has been common to heat seal (weld) two films one on top of the other or to heat seal (weld) a single film folded in half. It should be understood by those skilled in the art that the heat seal (welding) seam of the specimen bag is long, and due to factors such as errors of a fixture of the heat seal (welding) tool, errors of pressure of the heat seal (welding), non-uniform temperature of the heat seal (welding) tool, and the like, defects such as local gaps or local weak seams are easy to occur, and products containing such defects are difficult to select through an inspection means. In mass production, excessive welding is usually achieved by raising the heat-sealing (welding) temperature and increasing the heat-sealing (welding) time, so as to ensure that the joint is firm and has no residual gap. However, excessive welding often results in a significant thinning of the film substrate of the specimen bag in the local area where the seam is located, which results in a significant reduction in material strength in the vicinity of 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 used in the aforementioned retrieval devices, increasing the film thickness often results in the specimen bag not being received within or pushed out of 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 excessive welding usually causes the thickness of the local area to be reduced by 30-50%, thus obviously reducing the strength of the specimen bag. Up to now, the probability of the occurrence of an accident that a specimen bag is broken in clinical use is still large.

On the other hand, with the deep development of minimally invasive surgery (especially hard-tube endoscopic surgery), the types of surgery are increasing, and the surgery is more and more complicated. The problem of the minimally invasive surgery is solved by taking out the pathological tissue. Generally, the surgeon wants to precisely select a specimen bag (extractor) with a proper size according to the size of the lesion tissue, the extraction site, and the like, so as to cause minimum damage to the wound of the patient during the extraction process. However, as mentioned above, the heat sealing process of the specimen bags belongs to a special process, and the factors such as errors of a fixture of a heat sealing (welding) tool, errors of pressure of the heat sealing (welding), non-uniform temperature of the heat sealing (welding) tool and the like are strictly controlled, which causes high cost of small-batch customization of specimen bags with different specifications and sizes, and no person or organization proposes or provides a feasible customized product or scheme for the specimen bags.

Disclosure of Invention

In one aspect of the invention, a medical specimen bag for custom production is provided, comprising a bag opening that can be opened and closed, the bag opening comprising a surrounding tunnel, and a bag body extending from the bag opening. The bag body comprises a film bag face, a folded edge, an inlet welding line, a main body welding line and a tail welding line. The bag body also comprises a film bag surface, a folded edge, a first double-sided adhesive bonding seam, a second double-sided adhesive bonding seam, an inlet welding seam approximately parallel to the first double-sided adhesive bonding seam, a main body welding seam approximately parallel to the second double-sided adhesive bonding seam, and a tail welding seam; the pair of folded edges, the inlet welding line, the main body welding line and the tail welding line connect the films into a semi-closed bag-shaped whole body containing a bag opening; the inlet welding seam, the main body welding seam and the tail welding seam can be manufactured by a same welding die and a same welding parameter through multiple welding processes.

In one scheme, the bag mouth welding seam, the inlet welding seam, the main body welding seam and the tail welding seam can be manufactured by a same welding mould through multiple times of welding processing. In yet another aspect, the inlet weld comprises an inboard inlet weld edge and an outboard inlet weld edge, and the body weld comprises an inboard body weld edge and an outboard body weld edge; the main body weld joint and the inlet weld joint form a cross joint which does not intersect with the inner side main body weld edge, and the outer side main body weld edge and the inner side inlet weld edge form an intersection point. In another scheme, the body welding seam extends from the intersection point position to the bag opening direction continuously to form a cantilever welding seam with the length X2. In a specific embodiment, X2 is greater than or equal to 1 mm.

In yet another aspect of the present invention, a medical specimen bag suitable for custom manufacture is provided, comprising a bag opening that can be opened and closed, the bag opening comprising a surrounding tunnel, and a bag body extending from the bag opening. The bag body comprises a film bag surface, a folded edge, an inlet welding line, a main body welding line and a tail welding line; the pair of folds, the inlet weld, the body weld and the tail weld connect the membranes into a semi-enclosed bag-like whole containing a bag opening. The tunnel contains a bag mouth weld. The bag opening welding seam, the inlet welding seam, the main body welding seam and the tail welding seam are all linear welding seams. In one scheme, the widths of the bag mouth weld joint, the inlet weld joint, the main body weld joint and the tail weld joint are the same. In another scheme, the bag mouth welding seam, the inlet welding seam, the main body welding seam and the tail welding seam can be manufactured by multiple times of welding processing of the same welding die and the same processing parameters. In yet another aspect, the inlet weld comprises an inboard inlet weld edge and an outboard inlet weld edge, and the body weld comprises an inboard body weld edge and an outboard body weld edge; the main body weld joint and the inlet weld joint form a cross joint which does not intersect with the inner side main body weld edge, and the outer side main body weld edge and the inner side inlet weld edge form an intersection point. In another scheme, the body welding seam extends from the intersection point position to the bag opening direction continuously to form a cantilever welding seam with the length X2. In a specific embodiment, X2 is greater than or equal to 1 mm.

In yet another aspect of the present invention, a medical specimen bag suitable for custom manufacture is provided, comprising a bag opening that can be opened and closed, the bag opening comprising a surrounding tunnel, and a bag body extending from the bag opening, the bag body comprising a film bag face, a facing edge, an entrance weld, a body weld, and a tail weld; the pair of folds, the inlet weld, the body weld and the tail weld connect the membranes into a semi-enclosed bag-like whole containing a bag opening. The tunnel contains the sack welding seam, the entry welding seam, main part welding seam and afterbody welding seam all are linear type welding seams. In one scheme, the bag mouth welding seam, the inlet welding seam, the main body welding seam and the tail welding seam can be welded and processed for multiple times by the same welding mould. In another embodiment: the folded edge and the inlet welding line define an inlet bag and an outlet bag, the folded edge and the main body welding line define a main body bag, and the folded edge and the tail welding line define a tail bag; the size setting of the specimen bag satisfies the following relational expression:

2*(B1-B2)≥H1≥0.5*(B1-B2)；

2.5*H1≥H2≥1.5*H1；

wherein:

b1 is the width of the bag opening 201;

b2 is the width of the mouth of the body bag 202B;

the depth dimension of H1 inlet bag 202a along the opposing flaps;

h2 body bag is along the depth dimension of the opposing flaps.

In yet another aspect, the inlet weld comprises an inboard inlet weld edge and an outboard inlet weld edge, and the body weld comprises an inboard body weld edge and an outboard body weld edge; the main body weld joint and the inlet weld joint form a cross joint which does not intersect with the inner side inlet weld edge, and the outer side inlet weld edge and the inner side main body weld edge form an intersection point. In yet another aspect, the inlet weld extends from the intersection location further into the bag to form a cantilever weld having a length X1. In one embodiment, X1 is greater than or equal to 1 mm.

In yet another aspect of the present invention, a medical specimen bag for minimally invasive surgery is provided, comprising a bag opening that can be opened and closed, and a bag body that extends from the bag opening, the bag opening comprising a surrounding tunnel, the bag body comprising a film bag face, a facing edge, an entrance weld, a body weld, and a tail weld; the pair of folded edges, the inlet welding line, the main body welding line and the tail welding line connect the films into a semi-closed bag-shaped whole body containing a bag opening; the tunnel comprises a bag opening welding seam; the bag opening welding seam, the inlet welding seam, the main body welding seam and the tail welding seam are all linear welding seams. In one approach, the width of the pocket weld is greater than the width of the inlet weld and/or the body weld. In another scheme, the bag mouth welding seam, the inlet welding seam, the main body welding seam and the tail welding seam can be manufactured by a same welding die and a same welding parameter through multiple welding processes. In another scheme, the folded edge and the inlet welding line define an access pocket, the folded edge and the main body welding line define a main body pocket, and the folded edge and the tail welding line define a tail pocket; the size setting of the specimen bag satisfies the following relational expression:

2*(B1-B2)≥H1≥0.5*(B1-B2)；

2.5*H1≥H2≥1.5*H1；

wherein:

b1 is the width of the bag opening 201;

b2 is the width of the mouth of the body bag 202B;

the depth dimension of H1 inlet bag 202a along the opposing flaps;

h2 body bag is along the depth dimension of the opposing flaps.

In yet another aspect, the inlet weld comprises an inboard inlet weld edge and an outboard inlet weld edge, and the body weld comprises an inboard body weld edge and an outboard body weld edge; the main body weld joint and the inlet weld joint form a cross joint which does not intersect with the inner side inlet weld edge, and the outer side inlet weld edge and the inner side main body weld edge form an intersection point. And the inlet welding seam extends from the intersection point position to the inside of the bag body to form a cantilever welding seam with the length of X1. In a specific embodiment, X1 is greater than or equal to 1 mm.

In another aspect of the invention, an extractor for minimally invasive surgery is provided, which comprises any one of the specimen bags, a catheter assembly, a handle assembly penetrating through the catheter assembly, and an expanding mechanism connected with the handle assembly and capable of expanding the specimen bag, wherein the specimen bag and the expanding mechanism are arranged in the catheter assembly and can axially move relative to the catheter assembly; the specimen bag and the spreading mechanism are pushed forwards in the catheter component by the operation of the handle component, and extend out of the sleeve component and are spread by the spreading mechanism; the opening mechanism is drawn out backwards along with the duct assembly and separated from the specimen bag, and the pull wire penetrates through the duct assembly.

In yet another aspect of the present invention, a disposable specimen bag product package is provided, which comprises any one of the specimen bags, a sterilization packaging bag and a label; the specimen bag is sealed in the sterilized packaging bag and is sterilized by ethylene oxide or irradiation to reach the sterile level; the label comprises necessary regulation information, a structural schematic diagram of the specimen bag and records the width B1 of the opening of the bag and the width B2 of the opening of the main bag; the depth dimension of the inlet bag along the opposing flaps H1; the body pocket is along the depth dimension H2 of the opposing flaps.

In another aspect of the present invention, a method for manufacturing any one of the specimen bags is provided, the method comprising the steps of:

s1, cutting the film bag face raw material to form a film bag face with a proper size, folding one side of the film bag face and putting the film bag face into welding equipment (a die) to start welding to form a bag mouth welding line and a tunnel;

s2, folding the welded film bag surface along the center line to form a folded edge;

s3, putting the folded film bag surface into a welding mould to start welding to form a main body welding line;

s4, putting the folded film bag surface into a welding mould to start welding to form an inlet welding line;

s5, putting the folded film bag surface into a welding mould to start welding to form a tail welding line;

and S6, cutting along the welding seam, and removing the redundant leftover materials outside the bag body to form the specimen bag.

s1, cutting the raw material of the film bag surface to form a film bag surface with a proper size, folding one side of the film bag surface and putting the folded film bag surface into a welding mould, and starting welding to form a bag opening welding line and a tunnel;

s3, putting the folded film bag surface 203 into a welding mould to start welding to form an inlet welding seam;

s4, putting the folded film bag surface into a welding mould to start welding to form a main body welding line;

and S6, cutting along the edge of the welding seam, and removing the redundant leftover materials outside the bag body to form the specimen bag.

In yet another aspect of the present invention, a method for manufacturing a specimen bag is provided, wherein the manufacturing steps are as follows:

s3, one end of the welding mould is aligned with the top end of the cantilever to form the cantilever welding seam as a starting point, the other end extends out of the bag body, the welding seam which is connected with the cantilever welding seam into a whole is firstly completed, then the other welding seam which is intersected with the welding seam is completed, and finally the welding of the tail welding seam is completed;

and S4, cutting along the welding seam or along the outer edge of the welding seam, and removing the redundant leftover materials outside the bag body to form the specimen bag.

Drawings

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

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

FIG. 2 is a perspective view of the extractor instrument of FIG. 1 in a deployed state;

FIG. 3 is an exploded view of the extractor instrument of FIG. 2;

FIG. 4 is a simulated view of the pouch opening closure of the extraction instrument of FIG. 2 in use;

FIG. 5 is a simulated view of the extraction instrument of FIG. 4 with the catheter and distraction mechanism removed;

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

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 shown in FIG. 7;

FIG. 9 is a schematic view of a weld joint failure mode being weld edge peel;

FIG. 10 is a schematic view of a weld joint failure mode being a fracture of the transition zone;

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

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

FIG. 13 is a schematic view of a welding die and welding apparatus;

FIG. 14 is a schematic view of a tunnel weld;

FIG. 15 is a schematic illustration of a welding manufacturing process of the specimen bag 200;

fig. 16 is a schematic view of a welding manufacturing process of the specimen bag 300;

FIG. 17 is an enlarged view 17-17 of the interface joint 260 of FIG. 15;

FIG. 18 is an enlarged view of a modified interface joint 260 a;

FIG. 19 is an enlarged view of a modified interface joint 260 b; (ii) a

Fig. 20 is a schematic diagram of a first specimen bag product package 800.

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

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 can 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 present invention.

Embodiments of the present disclosure will now be described in detail with reference to the drawings, where for convenience, the party proximal to the operator is defined as the proximal end and the party distal from the operator is defined as the distal end.

Fig. 1-3 depict in detail the structural components of the extractor instrument 10. Briefly, the retrieval instrument 10 includes, in order from the distal end to the proximal end, a specimen bag 100, a distraction mechanism 20, a catheter assembly 30, a handle assembly 40, and a cable 50. The catheter assembly 30 includes a hollow catheter 33 and a

catheter handle portion

31 and 32 fixedly coupled thereto. The hollow catheter 33 has different outer diameters for different clinical applications, and the common diameters are roughly divided into 5mm, 8mm, 10mm, 12mm and 15 mm. The handle assembly 40 includes a finger ring 42 and a hollow drive rod 41 connected in series 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 deployment mechanism 20 and the specimen bag 100 between a retracted state (fig. 1) and an expanded state (fig. 2).

The distracting mechanism 20 comprises an elastic body 21 and a connecting shaft 22 connected to a proximal end of the elastic body 21, the elastic body 21 comprising two substantially flexible or

elastic bands

23 and 24, the

elastic bands

23 and 24 being substantially identical in shape and symmetrically disposed along the connecting shaft 22. The

elastic bands

23 and 24 comprise proximal straight segments 23b and 24b and distal

elastic segments

23a and 24a, and the

elastic segments

23a and 24a have flexibility and shape memory functions and can be deformed and stored under external force and automatically opened when external force is removed. The proximal end of the straight line section 23b is provided with an installation hole 23c, the proximal end of the straight line section 24b is provided with an installation hole 24c, the connecting shaft 22 is provided with a shaft hole 22a corresponding to the installation hole 24c and the installation hole 23c, and the elastic band 23 and the elastic band 24 are riveted on the connecting shaft 22 through a rivet 25. The proximal end of the connecting shaft 22 is inserted into the distal end of the driving rod 41 and is fixed by gluing, screwing or welding. It will be appreciated by those skilled in the art that the connection between the elastic body 21 and the connection shaft 22 may be welding, pinning or directly connecting and fixing the elastic body 21 to the distal end of the driving rod 41.

The specimen bag 100 includes a bag opening 101 that can be opened and closed, and a closed bag body 102 that extends from the bag opening 101. The bag mouth 101 includes a tunnel 111 surrounding the bag mouth, the tunnel 111 being configured to receive the opening mechanism 20 and the cable 50. Referring to fig. 2-3, the distal end of the cable 50 includes a sliding knot 51, the distal end of the cable 50 passing through the tunnel 211 and the proximal end 53 passing through the sliding knot 51 forming a cable loop 52 of approximately the same size as the mouth of the bag. The elastic body 21 is inserted into the tunnel 111. After the extraction instrument 10 is assembled (see fig. 2), the specimen bag 100 is typically wrapped around the elastomer 21 and received within the hollow conduit 33 (see fig. 1). The invention of US patent 8986321 discloses various winding and storage modes of the fetching device, and other fetching devices are specifically disclosed, and one of ordinary skill can apply the invention with slight modifications.

In this embodiment, the elastic body 21 has a shape memory function, and the winding and storage manner of the fetching device 10 can be conveniently and automatically unfolded. The operator pushes the driving rod 41 to push the specimen bag 100 and the opening mechanism 20 in the retracted state (fig. 1) out of the hollow guide tube 33, and the elastic body 21 has a shape memory function to automatically recover, thereby automatically opening the specimen bag 100 (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 be provided as a linkage mechanism to achieve the spreading action. While the present embodiment has described the distraction mechanism 20, catheter assembly 30 and handle assembly 40 of a typical extraction instrument 10, it is within the scope of the present invention to substitute the combination of the distraction mechanism 20, catheter assembly 30 and handle assembly 40 of the present embodiment with the invention of U.S. patent nos. 5465731, 6383197, 8721658, etc.

The operation of the extractor device 10 in clinical application can be generally divided into the following stages:

in the first stage: a preliminary stage. The retrieval device in a retracted state is inserted into the patient via the puncture cannula and extends to the target area. And a second stage: and (3) a fetching instrument unfolding stage. The actuating handle assembly 40 controls the actuating rod 41 to move axially relative to the hollow catheter 33 from the proximal end to the distal end until the opening mechanism 20 and the specimen bag 100 are completely exposed out of the hollow catheter 33, and the elastic body 21 has a shape memory function to automatically recover, thereby automatically opening the specimen bag 100 (fig. 2). And a third stage: and (5) cutting off the specimen. The fetching device 10 in the unfolded state is positioned below the position of the lesion tissue or organ by an endoscope or the like, and the lesion tissue or organ is cut off by the surgical scissors and falls into the specimen bag 100. The fourth stage, specimen taking-out stage. Referring to fig. 4-5, handle assembly 40 is first operated to withdraw spreader mechanism 20 through the puncture cannula while pulling on proximal end 53 of cable 50, causing sliding knob 51 to slide and contract cable loop 52, thereby gathering the mouth 101 of specimen bag 100. The cable 50 is then pulled to withdraw the specimen bag 100 and the specimen contained therein via the puncture cannula or via a skin incision. In this process, since the inner diameter of the puncture cannula or the incision of the minimally invasive surgery is small, the specimen bag 100 is subjected to a large pressing force when a large tissue or organ is excised. Although the various extraction instruments vary in structure and application, their function and primary procedure of use are generally the same. The clinical application of the extractor device 10 according to the invention can also be understood with reference to the description in US5465731, in order to better understand the use of the invention.

Fig. 7 depicts the structure and composition of the specimen bag 100 in more detail. The specimen bag 100 is generally formed by folding and welding a single film (sheet) or by overlapping and welding two films (sheets). 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). Processes for thin film (sheet) welding include, but are 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 two polyethylene films and heat-welding them.

Figure 6 depicts a typical heat welding (heat sealing for short) process of the prior art specimen bag manufacturing process. The heat sealing machine 60 comprises a base 66 fixedly installed on the ground, a machine body 67 connected with the base, an upper heat sealing movable die 64 connected with the machine body 67 and capable of moving in the vertical direction, and a lower heat sealing fixed die 65 fixedly connected with the machine body 67. The heat sealing process of the specimen bag 100 can be simply expressed as adjusting the heat sealing parameters (mainly including the heat sealing temperature, the heat sealing time and the heat sealing pressure), overlapping the film 103 and the film 104 and placing the film on the lower heat sealing fixed die 65, and finally starting the heat sealing machine to complete the heat sealing welding of the specimen bag 100.

It will be appreciated by one of ordinary skill that the films are heat sealed (welded), i.e., in a molten state, the polymer segments on the surfaces of the sealed regions of the films interdiffuse, penetrate, and entangle, causing the two (or more) films to fuse together. Referring to fig. 7, the bag face 103 and the bag face 104 are welded to each other to form a specimen bag 100 including a heat-sealed seam 105. Fig. 8 depicts a partial cross-sectional view of any location of the heat-sealed seam 105, 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 welded region 133 (welded region 153). In the film sealing process, the film in the molten state in the sealing region is calendered and extruded under the sealing pressure, thereby forming the transition region 132 (transition region 152). The film thickness of the transition region 132(152) is smaller than that of the film substrate 131 (151).

Referring to FIGS. 8-11, generally, the heat-sealed seams can be classified into an under-heat seal, a standard heat seal and an over-heat seal, depending on the heat-seal strength and failure mode of the weld region and the transition region. The undersealing, i.e. the thickness of the film which is fused on the surface of the heat-sealing area and participates in heat sealing, is thin, the failure mode in the heat-sealing strength test is that the welding area is stripped, and the test result is lower than the target value. The standard heat sealing is that the thickness of the film which is fused on the surface of the heat sealing area and participates in heat sealing is moderate, the failure mode is that the welding area is stripped, and the heat sealing strength test result reaches a target value. The over-sealing, i.e. the surface of the sealing area is melted and the thickness of the film involved in the sealing is too much, 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 welded area, a phenomenon commonly referred to as "undercut" for short, whereas the failure mode is the breakage of the transition area, the sealing strength test results being lower than the target value. In addition, in the standard heat seal, the heat seal seam with the largest heat seal strength test value is called the optimal heat seal seam. One of ordinary skill will appreciate that different sealing parameters are used to determine whether the sealed seam 105 is under-sealed, standard sealed or over-sealed.

One of ordinary skill will readily appreciate that the optimum sealing parameters required for a standard seal can be obtained experimentally. In the field of food packaging and medical packaging, particularly in the field of blood product packaging bag manufacture, there has been much research on heat sealing of plastic films. The prior art disclosed shows that, in general, the combined effect of sealing temperature, sealing pressure and sealing time determines the sealing quality of the plastic film, and that the sealing temperature has the greatest effect on the sealing quality, and that the effect of sealing pressure and sealing time on said sealing quality is relatively small or negligible.

When the specimen bags are actually manufactured, the heat sealing process of the specimen bags is monitored and managed as a special process, and before production, special process confirmation (including IQ, OQ and PQ) is required, and the production process is strictly managed according to parameters confirmed by the special process.

IQ installation confirmation: for example, the installation of the heat sealing machine 60 is confirmed, and then the installation of the heat sealing movable die 64 and the heat sealing fixed die 65 is confirmed. The main work for installing the heat-sealing movable mold 64 and the heat-sealing fixed mold 65 is the leveling work of the movable mold and the fixed mold, and the process is quite complex and consumes a great deal of labor and time cost. Particularly under the condition of long and narrow and complex welding lines, the relative parallelism of a movable mold and a fixed mold is difficult to ensure due to errors of a working table of a heat sealing machine and processing errors of a mold, and the relative parallelism needs to be ensured by means of repeated debugging and trial welding of workers. IQ installation can be confirmed by OQ operation verification, i.e. the best heat-seal temperature is found by welding a certain batch of specimen bags. And after the optimal heat sealing temperature is determined, performing a PQ performance test, namely performing batch test production of more than three batches at the optimal heat sealing temperature, and when the heat sealing strength test value proves that all production samples are in standard heat sealing, completing PQ verification. So that the product can be produced. If the mold is replaced, IQ confirmation, mainly leveling verification of the mold, must be performed again. The above-mentioned OQ and PQ are based on the verification under a specific mold and mounting conditions, and the OQ and PQ should be re-verified due to a change in the mold and its mounting conditions. This results in high costs for small batches of custom specimen bags of different gauge sizes, and no individual or organization has so far proposed or provided a viable custom specimen bag product or solution.

Fig. 12 depicts in detail the structure and composition of a first embodiment specimen bag 200 of the present invention. The specimen bag 200 comprises a bag opening 201 capable of being opened and closed and a bag body 202 formed by extending from the bag opening, wherein the bag opening 201 comprises a surrounding tunnel 211 and a bag opening welding seam 212. The bag body 202 includes a film bag face 203, a hem 220, an inlet weld 230, a body weld 240, and a tail weld 250. The flaps 220, inlet welds 230, body welds 240 and tail welds 250 connect the film bag face 203 into a semi-enclosed bag-like whole containing the bag mouth 201. Wherein the opposing flap 220 and the entrance weld 230 generally define the access pocket 202a, the opposing flap 220 and the body weld 240 generally define the body pocket 202b, and the opposing flap 220 and the tail weld 250 generally define the tail pocket 202 c.

In one embodiment, the pocket weld 212, the inlet weld 230, the body weld 240, and the tail weld 250 are all straight welds. In a specific embodiment, the pocket weld 212, the inlet weld 230, the body weld 240, and the tail weld 250 have the same weld width. In a detailed embodiment, the pocket weld 212, the inlet weld 230, the body weld 240, and the tail weld 250 are made by multiple welding processes with the same welding tool.

In one design, when the specimen bag 200 is in the flat, folded-in-half position shown in fig. 12, the length of the mouth weld 212 is B0, the width of the mouth 201 is B1, and the width of the mouth of the body bag 202B is B2. The inlet weld 230 has a length L1, the inlet weld 230 forming an angle ANG1 with the opposing edge 220; the length of the body weld 240, L2, the body weld 240 forming an included angle ANG2 with the opposing edge 220; the tail weld 250 forms an angle ANG3 with the opposing edge. Pocket 202a is along a depth dimension H1 of the opposing flap and the body pocket is along a depth dimension H2 of the opposing flap.

The specimen bag 200 may be manufactured in a variety of ways, and as shown in FIGS. 13-15, a specimen bag 200 may be manufactured generally as follows:

s1, cutting the film bag face raw material to form a film bag face 203 with a proper size, folding one side of the film bag face 203, putting the folded film bag face into welding equipment (a mold), and starting welding to form a bag mouth welding seam 212 and a tunnel 211 (as shown in FIG. 14);

s2, folding the welded film bag surface 203 along the center line to form a folded edge 220;

s3, putting the folded film bag surface 203 into a welding device (mold) to start welding to form an inlet welding line 230;

s4, putting the folded film bag surface 203 into welding equipment (a mold) to start welding to form a main body welding seam 240;

s5, putting the folded film bag surface 203 into welding equipment (a mold) to start welding to form a tail welding seam 250;

and S6, cutting along the edge of the welding seam, and removing the excess leftover materials outside the bag body 202 to form the specimen bag 200.

As can be appreciated from fig. 13 and the foregoing, the pocket weld 212, the inlet weld 230, the body weld 240, and the tail weld 250 may all be made using the same welding equipment, the same welding die, and the same welding parameters. It will be appreciated by those skilled in the art that by translating and rotating the inlet weld 230, the body weld 240, and the tail weld 250, various size specification specimen bags may be formed. The specimen bags with different shapes and sizes can be customized by using the same welding equipment, the same welding mould and the same welding parameters.

Studies have shown that in clinical applications of specimen bags, the width B1 of the mouth of the specimen bag, the width B2 of the mouth of the body bag, and the volumes of the inlet bag and the body bag are the most significant parameters for clinical applications of specimen bags. The width B1 of the specimen bag opening determines whether the excised tissue can easily fall into the specimen bag during clinical use, while ensuring that the excised site has sufficient space to accommodate the opening width of the specimen bag. The pocket width B2 of the body pocket determines whether the excised tissue can be successfully introduced into the specimen pocket, while the trauma to the patient wound when the specimen pocket is pulled out of the patient wound is related to the pocket width B2 of the body pocket. In one particular embodiment, the specimen bags are dimensioned with reference to B1, B2, H1 and H2, and in a preferred embodiment, the specimen bags are dimensioned to satisfy the following relationship:

2*(B1-B2)≥H1≥0.5*(B1-B2)；

2.5*H1≥H2≥1.5*H1；

wherein

B1 is the width of the bag opening 201;

b2 is the width of the mouth of the body bag 202B;

the depth dimension of H1 inlet bag 202a along the opposing flaps;

h2 body bag is along the depth dimension of the opposing flaps.

The above limitations ensure that the specimen bag meets the requirements of clinical applications while reducing unnecessary specifications. In a specific embodiment, it is generally defined that 250. gtoreq.B 1. gtoreq.50 mm, 300. gtoreq.H 1+ H2. gtoreq.150 mm. And a selection table with B1, B2, H1, H2 as parameters is given, and the increment of each parameter is set to an integer ten (e.g., 20 mm).

The structure and composition of yet another modified specimen bag 300 is substantially the same as the specimen bag 200, except for the width dimension of the weld. Briefly, the specimen bag 300 includes a bag opening 201 that can be opened and closed, and a bag body 202 extending from the bag opening, the bag opening 201 including a surrounding tunnel 211 and a bag opening weld 212. The bag body 202 includes a film bag face 203, a hem 220, an inlet weld 230, a body weld 240, and a tail weld 250. The flaps 220, inlet welds 230, body welds 240 and tail welds 250 connect the film bag face 203 into a semi-enclosed bag-like whole containing the bag mouth 201. The pocket weld 212, the inlet weld 330, the body weld 340, and the tail weld 350 are all linear welds. In a specific embodiment, the pocket weld 212, the inlet weld 330, the body weld 340, and the tail weld 350 are formed by multiple welding operations using the same welding tool. While the width of the pocket weld 212 is greater than the weld width of the inlet weld 330 (body weld 340, tail weld 350). (Note that the geometric structures are numbered the same, meaning that the structures with the same numbers are substantially identical).

The steps for manufacturing a specimen bag 300 are generally as follows (see fig. 16):

s1, cutting the film bag face raw material to form a film bag face 203 with a proper size, folding one side of the film bag face 203, putting the folded film bag face into welding equipment (a die), and starting welding to form a bag mouth welding seam 212 and a tunnel 211;

s3, putting the folded film bag surface 203 into welding equipment (a mold) to start welding to form a main body welding seam 240;

s4, putting the folded film bag surface 203 into a welding device (mold) to start welding to form an inlet welding line 230;

and S6, cutting along the welding seam to remove the excess leftover materials outside the bag body 202, thereby forming the specimen bag 300.

The specimen bag 300 is mainly characterized by a different weld width than the specimen bag 200. The width of the mouth weld 212 of the specimen bag 300 is greater than the weld width of the inlet weld 330 (body weld 340, tail weld 350); and the widths of the mouth weld 212, the inlet weld 230, the body weld 240, and the tail weld 250 of the specimen bag 200 are the same. This difference is mainly due to the different ways of cutting. The specimen bag 300 is cut along the welding seam, and is cut along the welding seam edge relative to the specimen bag 200, so that a smooth cut edge is formed more easily, local weakness caused by small irregular cuts is prevented, and the cutting efficiency is higher.

It should be readily understood by one skilled in the art that the inlet weld 230, the body weld 240, and the tail weld 350 are not significantly distinguished in the order in which they are welded, as the manufacturing steps for the

specimen bags

200 and 300 are combined. Before the customized specimen bag is manufactured, the intersection point of the inlet weld 230 and the main body weld 240 is found according to the drawing (or positioning fixture) of the specimen bag, so as to align the intersection point at one end of the welding mold, and the other end extends out of the bag body 202, so that different weld joints can be welded by using the same equipment, the same welding mold and the same welding parameters, please refer to fig. 15-16. Similarly, the intersection of the main body weld 240 and the tail weld 250 is found to weld the aligned intersection of one end of the mold, and the other end extends out of the bag 202, thereby completing the welding of the tail weld 250.

An improved manufacturing process for specimen bags generally comprises the steps of:

s3, finding the intersection point of the inlet weld 230 and the main body weld 240 to weld the aligned intersection point at one end of the mould, and extending the other end of the mould to the outside of the bag body 202 to respectively complete the welding of the inlet weld 230 and the main body weld 240; finding the intersection point of the main body welding line 240 and the tail welding line 250 to weld the aligned intersection point at one end of the mold, and extending the other end of the mold out of the bag body 202 to complete the welding of the tail welding line 250;

and S4, cutting along the welding seam or along the outer edge of the welding seam, and removing the excess leftover materials outside the bag body 202 to form the specimen bag.

As described above, the inlet weld 230 and the body weld 240 inevitably form an interface joint if the bag 202 is formed by multiple welding processes with the same parameters using the same equipment and the same mold; the same also applies to the body weld 240 and tail weld 250 which necessarily form an interface joint.

In one version, the inlet weld 230 and the body weld 240 form an interface joint 260 as shown in FIG. 17. Entry weld 230 includes an inner entry weld edge 231, a starting entry weld edge 233, and an outer entry weld edge 235; body weld 240 includes an inner body weld edge 241, a starting body weld edge 243, and an outer body weld edge 245. Where the inner inlet bead 231, the start inlet bead 233, the inner body bead 241 and the start body bead 243 intersect at an intersection point 261. The intersection point 261, the area of overlap defined by the origin entry weld edge 233 and the origin body weld edge 243, is the interface joint 260. The inlet weld 230 and the body weld 240 shown in fig. 17 form a smooth transition joint 260 with a clean connection. However, such an interface joint presents a weak link.

Please see the clinical application of the specimen bags in connection with the above description. In clinical applications, after the tissue is excised and dropped into the access bag, the ligature is pulled to remove the specimen bag and the tissue contained therein via the puncture cannula or via a skin incision. In the process, because the inner diameter of the puncture cannula or the incision of the minimally invasive surgery is small, the specimen bag is subjected to large extrusion force when large tissues or organs are excised. Typically the maximum compression force is concentrated primarily in the area where the inlet bag meets the main body bag. The intersection point 261 of the cross-over joint 260 shown in fig. 17 may be excessively heat-sealed and locally weakened due to 2 welding heats during the butt joint forming process. While the intersection 260 shown in fig. 17 is susceptible to damage during the process of squeezing the tissue contained therein from the inlet bag into the body bag as the specimen bag is tightened, the intersection 260 of weakness breaks causing susceptibility to cuts and resulting in rupture of the entire specimen bag.

In an optimized design, the inlet weld 230 and the body weld 240 form a "in-line" interface joint 260a as shown in FIG. 18. Entry weld 230 includes an inner entry weld edge 231, a starting entry weld edge 233, and an outer entry weld edge 235; body weld 240 includes an inner body weld edge 241, a starting body weld edge 243, and an outer body weld edge 245. Wherein the start body weld edge 243 intersects the entry weld 230 and does not intersect the inboard entry weld edge 231; inner body weld edge 241 intersects inlet weld 230 and does not intersect inner inlet weld edge 231; the inner body weld 241 intersects the outer inlet weld 235 to form an intersection 261 a. The intersection 261a may form a weak point. The origin inlet weld 233 does not intersect the body weld 240, and the inlet weld 230 extends into the bag body beyond the intersection point 261a to form a cantilever weld 230 a. The length X1 of cantilever weld 230a is obtained by measuring the longest distance from the origin entry weld edge 233 to the intersection point 261 a. The length of the cantilever weld 230a is of a value long enough (large) to hide the intersection point 261a "behind the body". In a specific design, X1 is greater than or equal to 1mm, so that the intersection point 261a is hidden behind. The optimized cross-over joint 260a, although the intersection point 261a may still be heated by 2 times of welding, and may form excessive heat seal, resulting in local weakness; however, due to the local enhanced protection of the cantilever weld 230a, the stress at the intersection point 261a is less and does not cause a rupture accident.

In yet another preferred embodiment, the inlet weld 230 and the body weld 240 form a "chevron" interface joint 260b as shown in FIG. 19. Entry weld 230 includes an inner entry weld edge 231, a starting entry weld edge 233, and an outer entry weld edge 235; body weld 240 includes an inner body weld edge 241, a starting body weld edge 243, and an outer body weld edge 245. Wherein inlet bead 231 intersects body bead 240 and does not intersect inner body bead 241, and start inlet bead 233 intersects body bead 240 and does not intersect inner body bead 241. The inboard inlet weld edge 231 intersects the outboard body weld edge 245 to form an intersection point 261 b. The intersection 261b may form a weak point. Beginning body weld edge 243 does not intersect inlet weld 230, and body weld 240 extends beyond intersection point 261b in the pocket direction to form cantilever weld 240 b. The length X2 of cantilever weld 240b is measured by the longest distance from the origin body weld edge 243 to the intersection point 261 b. The length of the cantilever weld 240b is of a value long enough (large) to hide the intersection point 261b "behind the body". In a specific design, X2 is greater than or equal to 1mm, so that the intersection point 261b is hidden behind. The optimized cross-over joint 260b, although the intersection point 261b may still be heated by 2 welding, may form an excessive heat seal, resulting in a local weakness; however, due to the local enhanced protection of the cantilever weld 240b, the stress at the intersection point 261b is less, and no cracking accident is caused.

Based on the optimized butt joint scheme, an improved specimen bag manufacturing method is provided, and the method comprises the following steps:

s3, one end of the welding mould is aligned with the top end of the cantilever to form the cantilever welding seam as a starting point, the other end extends out of the bag body 202, the welding seam which is connected with the cantilever welding seam into a whole is firstly completed, then the other welding seam which is intersected with the welding seam is completed, and finally the welding of the tail welding seam 250 is completed;

In yet another embodiment, as shown in fig. 20, a disposable specimen bag product package 800 comprises the

specimen bag

200 or 300, a sterilization package 810 and a label 820. The specimen bag 200(300) is sealed in the sterilization packaging bag 810 and sterilized by ethylene oxide sterilization or irradiation sterilization to a sterile level. The label 820 contains necessary regulatory information, also contains a structural schematic diagram of the specimen bag and records the width B1 of the bag opening 201 and the width B2 of the bag opening of the main body bag; the depth dimension of the inlet bag along the opposing flaps H1; the body pocket is along the depth dimension H2 of the opposing flaps. Thus, the surgeon can clearly judge whether the specimen bag product package 800 meets the requirements of clinical use without disassembling the sterile package.

It should be noted that the clinical application value of selecting a proper specimen bag according to the actual requirements of the operation is very high. When the selected specimen bag is too large, the operation space is generally occupied when the pathological tissue is cut off, and the field of view of the operation is not sufficiently exposed; meanwhile, when the specimen bag is too large (inappropriate), the lesion tissues are formed into balls (lumps) in the specimen bag and are difficult to take out when the specimen bag is pulled out through the small hole of the abdominal wall, so that the abdominal wall wound of the patient is greatly damaged. Optimally, the surgeon should select the smallest possible specimen bag based on the size of the tissue being removed during the procedure. However, the size of the excised tissue can be estimated accurately only at the ending stage of the operation, and the existing specimen bags have too few specifications, and the package does not show the structure, namely the size characteristics, and cannot meet the requirements. The specimen bag product package 800 can be used for customizing specimen bags of various specifications in small batches, detailed structure and dimension characteristics are marked on product packages, the specimen bag product packages of various specifications are firstly applied and taken in the operation preparation process, then proper specimen bags are selected according to the real size of excised tissues for disassembly, and the specimen bag product packages which are not used can be withdrawn.

. In conclusion, the specimen bag and the specimen bag product package of the invention well solve the problem that doctors are difficult to obtain a proper specimen bag in a minimally invasive surgery.

Many different embodiments and examples of the invention have been shown and described. One of ordinary skill in the art can adapt the methods and apparatus described herein by making appropriate modifications without departing from the scope of the invention. Several modifications have been mentioned, and other modifications will occur to those skilled in the art. The scope of the invention should, therefore, be determined with reference to the appended claims, and not be construed as limited to the details of structure, materials, or acts shown and described in the specification and drawings.

Claims

1. The utility model provides an adopt medical sample bag that bonds and welding combine, contains the sack that can open and draw in and extends the bag body that forms from the sack, the sack contains the tunnel that encircles, its characterized in that:

1) the bag body also comprises a film bag surface, a folded edge, a first double-sided adhesive bonding seam, a second double-sided adhesive bonding seam, an inlet welding seam approximately parallel to the first double-sided adhesive bonding seam, a main body welding seam approximately parallel to the second double-sided adhesive bonding seam, and a tail welding seam;

2) the pair of folded edges, the inlet welding line, the main body welding line and the tail welding line connect the films into a semi-closed bag-shaped whole body containing a bag opening;

3) the inlet weld comprises an inner inlet weld edge and an outer inlet weld edge, and the main body weld comprises an inner main body weld edge and an outer main body weld edge; the main body weld joint and the inlet weld joint form a cross joint which does not intersect with the inner side main body weld edge, and the outer side main body weld edge and the inner side inlet weld edge form an intersection point.

2. The specimen bag of claim 2, wherein the body weld extends from the intersection location further toward the bag mouth to form a cantilever weld having a length X2, the first and second double-sided adhesive seams not intersecting in the vicinity of the cantilever weld to form a void area sufficient to accommodate the cantilever weld.

3. The specimen bag of claim 3, wherein X2 is ≧ 1 mm.

4. The specimen bag of claim 1, wherein the opposing flaps and the inlet weld define an access pocket, the opposing flaps and the body weld define a body bag, and the opposing flaps and the tail weld define a tail bag; the size setting of the specimen bag satisfies the following relational expression:

2*(B1-B2)≥H1≥0.5*(B1-B2)；

2.5*H1≥H2≥1.5*H1；

wherein:

b1 is the width of the bag opening 201;

b2 is the width of the mouth of the body bag 202B;

the depth dimension of H1 inlet bag 202a along the opposing flaps;

h2 body bag is along the depth dimension of the opposing flaps.

5. The specimen bag of claim 1, wherein the inlet weld, the body weld, and the tail weld are formed by multiple welding processes using the same welding die and the same welding parameters.