CN107416351B

CN107416351B - Combined packaging system for puncture outfit

Info

Publication number: CN107416351B
Application number: CN201710410210.1A
Authority: CN
Inventors: 朱莫恕
Original assignee: 5r Med Technology Chengdu Co ltd
Current assignee: 5r Med Technology Chengdu Co ltd
Priority date: 2017-06-03
Filing date: 2017-06-03
Publication date: 2023-08-29
Anticipated expiration: 2037-06-03
Also published as: CN107416351A; WO2018219315A1

Abstract

The invention relates to a combined packaging system for a puncture outfit, which comprises a first shell, a second shell and a cover material; the first housing includes a planar lip and a first connecting lip and a first shell extending therebetween; the planar lip including an outer lip edge and an inner lip edge and a planar wall extending therebetween, the inner lip edge defining an open package opening; the first connecting lip defines an open connecting aperture; the second housing including a second connecting lip and a closed distal end, and a second housing extending therebetween; the first connecting lip and the second connecting lip are welded to form a first sealing edge; the first sealing edge connects the first housing and the second housing into a unitary seamless housing, the seamless housing defining a seamless cavity comprising an open-ended end; the cover material and the plane wall are welded to form a second sealing edge, and the seamless shell and the cover material are connected into an integral closed cavity by the second sealing edge.

Description

Combined packaging system for puncture outfit

Technical Field

The invention relates to minimally invasive surgical instruments, in particular to a puncture outfit packaging structure.

Background

A puncture device is a surgical instrument used in minimally invasive surgery (especially hard endoscopic surgery) to create an artificial channel into a body cavity. The penetrator typically comprises a cannula assembly and a needle. At present, the disposable puncture outfit is widely applied to various clinical operations. The puncture outfit is packaged in a final sterilized package, sold and stored in a sterile manner after sterilization, and the packaged product maintains a sterile state within a sterilization validity period without damage to the final sterilized package. Sterilization is carried out in a wide variety of ways, including EO ethylene oxide sterilization and radiation sterilization. The sterilization regimen must generally be compatible with the final sterilized package.

The presently disclosed terminal sterilization wrap for packaging piercers primarily includes bag wrap and tray wrap (or blister wrap). Wherein the bag packs are produced with a high degree of automation and low cost, however, because the piercer (spike or cannula assembly) typically comprises a large handle or cartridge, an elongated tube and a sharp tip which easily pierces its bag packaging system resulting in a sterility failure, whereas the mutual squeezing of the bag packs provided with the piercer easily results in a bag pack rupture due to the large dimensional differences of the profiles. In US patent 7677392 a tip protector is disclosed for preventing the tip of the piercer from piercing the packaging system, however the tip protector adds to the overall packaging cost and does not address the problem of bag package crushing against each other. Tray packaging (blister packaging) is widely used due to its relatively high cost performance.

The tray package (or blister package) is generally composed of an upper cover plate (paper sheet) and a lower tray (lower blister), which is generally made by a plastic sucking mode, namely, after the plastic hard sheet is heated and softened, a plurality of cavities or channels are formed by adopting a vacuum adsorption mode, and the cavities or channels are used for containing and fixing the packaged products. Figures 1-2 depict a typical tray packaging system 30 of the prior art for piercer packaging. The tray packaging system 30 includes a sheet of te-rSite paper 31 and a tray blister 32. The tray bulb 32 includes a horizontal flange 33, a plurality of concave cavities 34 generally perpendicular thereto, and channels 35, 36 communicating the cavities. In one version, the channels 35 and 36 further include laterally protruding release tabs 37. A cannula assembly 10 includes a relatively massive cannula housing 11 and a relatively sharp cannula tip 15 with an elongate tube 13 extending therebetween, and a valve assembly 17 projecting beyond the cannula housing 11. A needle 20 includes a relatively massive handle portion 21 and a needle tip 25 with an elongate shaft 23 extending therebetween. With continued reference to fig. 1-2, the sleeve assembly 10 is loaded into the tray bulb 32 with the elongated tube 13 generally parallel to the horizontal flange 33 and the elongated tube 13 mated with the channel 35 and secured by the release button 37. The spike 20 is loaded into the tray blister 32 with the elongate stem 23 generally parallel to the horizontal flange 33 and the elongate stem 23 mated with the channel 36 and secured by the release button 37. The sheet 31 and tray bulb 32 are welded (heat sealed) along the horizontal flange 33 to form a complete sealed area 40, forming a closed, terminally sterilized package.

The mold manufacturing and molding process for producing the tray blisters 32 is relatively low cost and high productivity, but suffers from a number of drawbacks. The degree of stretching of the blister molded article is limited, and the depth/width ratio of the blister cavity is usually less than or equal to 1, and in worst case is usually not more than 1.5. And the wall thickness of the plastic sucking molding cavity is generally less than or equal to 1mm, and the maximum stretching depth of the cavity is generally not more than 100mm. However, the sleeve assembly or needle is typically greater than 100mm in its axial dimension and its axial dimension/transverse dimension ratio is much greater than 1.5. Thus, a tray package (blister package) of piercers has been disclosed so far, the sleeve assembly or piercing needle lying in a tray or blister with its axis substantially parallel to the sealing region 40, hereinafter referred to as a horizontal blister package (or a tray blister package). The horizontal blister package has a plurality of defects, mainly comprising lower production efficiency of welding (heat sealing) and poor stability of a sealing area due to long whole sealing area; the different sizes of the cavities cause more space waste when a plurality of terminal sterilization packages are mutually stacked; the top end of the sleeve assembly or the valve assembly is easy to puncture the packaging system, and the top end of the puncture needle is easy to puncture the packaging system; poor packaging system compatibility, and the like. To solve one or more of the problems described above, it is an object of the present invention to propose a combined packaging system for puncture outfit packaging.

Disclosure of Invention

In one aspect of the present invention, a combination packaging system for puncture outfit packaging is presented. In one embodiment, a combination packaging system includes a first housing, a second housing, and a lidstock. The first housing includes a planar lip and a first connecting lip and a first shell extending therebetween. The planar lip including an outer lip edge and an inner lip edge and a planar wall extending therebetween, the inner lip edge defining an open package opening; the first connecting lip defines an open connecting aperture. The second housing includes a second connecting lip and a closed distal end and a second housing extending therebetween. The first connecting lip and the second connecting lip are welded to form a first sealing edge; the first sealing edge connects the first and second shells into a unitary seamless housing defining a seamless cavity containing an opening at one end. The cover material and the plane wall are welded to form a second sealing edge, and the seamless shell and the cover material are connected into an integral closed cavity by the second sealing edge.

In one implementation, the first connection lip comprises a first frustoconical wall and the second connection lip comprises a second frustoconical wall conforming to the shape and size of the first connection lip.

In another implementation, the first connection lip comprises a first planar wall and the second connection lip comprises a second planar wall conforming to the shape and size of the first connection lip.

In yet another embodiment, the closed distal end of the combination packaging system includes a third sealing edge.

In another aspect of the present invention, a spike assembly is provided comprising the combination packaging system, further comprising a spike and/or cannula assembly. The puncture outfit component is provided for users after being sterilized.

In yet another aspect of the invention, a method of manufacturing a seamless housing for the combination package is provided. In one implementation, the seamless housing of the packaging system includes a first sealed edge that integrally connects the first housing and the second housing. The manufacturing method comprises the following steps: and (3) plastic sucking and trimming: a plurality of integrated first housings are manufactured by a plastic suction method, and are trimmed (punched) to form a single first housing. Extrusion and cutting: the second housing is manufactured by extrusion and cut to design dimensions. Welding procedure: essentially comprising a closed weld forming a closed distal end of the second housing, and a connecting weld connecting the first housing and the second housing as one piece. In another embodiment, the manufacturing method includes: and (3) plastic sucking and trimming: a plurality of integrated first housings are manufactured by a plastic suction method, and are trimmed (punched) to form a single first housing. Blow molding and cutting: blow molding an original housing comprising the second housing; the original housing further includes a proximal scan wall extending proximally from the second connecting lip and a proximal cavity defined thereby, and a mouthpiece penetrating the proximal scan wall and communicating with the proximal cavity; trimming the second housing from the original housing along the second connecting lip. Welding procedure: mainly comprises a connecting welding for connecting the first housing and the second housing into a whole.

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 schematic illustration of a typical prior art spike pack;

FIG. 2 is a cross-sectional view of the package of FIG. 1 taken perpendicular to its sealed edges;

FIG. 3 is a perspective view of a first embodiment of a lancet assembly 200 of the present invention;

FIG. 4 is an exploded view of the lancet assembly shown in FIG. 3;

FIG. 5 is an axial cross-sectional view of the stand-up container 100 of the assembly of FIG. 4;

FIG. 6 is a perspective view of the stand-up container of FIG. 5 from the proximal end to the distal end in an axial direction;

FIG. 7 is an axial cross-sectional view of the lancet assembly of FIG. 3;

FIG. 8 is a view of the needle assembly of FIG. 7 from the proximal end to the distal end;

FIG. 9 is a 9-9 cross-sectional view of the needle assembly of FIG. 7;

FIG. 10 is a cross-sectional view 10-10 of the lancet assembly of FIG. 7;

fig. 11 is a perspective view of the original container 100 a;

FIG. 12 is an axial cross-sectional view of the original container shown in FIG. 11;

FIG. 13 is a schematic view of the primary container secondary trim-on container 100 of FIG. 11;

fig. 14 is a perspective view of a multi-well plate for packaging the assembly 200;

FIG. 15 is a schematic view of a package for the assembly 200;

fig. 16 is a perspective view of a second embodiment sleeve assembly product package 400 of the present invention;

FIG. 17 is an exploded view of the assembly of FIG. 16;

fig. 18 is an axial sectional view of the vertical type container 300 shown in fig. 17;

FIG. 19 is an axial cross-sectional view of the vertical container 300 of FIG. 17 in another direction;

FIG. 20 is a perspective view of the stand-up container of FIG. 18 from the proximal end to the distal end in an axial direction;

FIG. 21 is a cross-sectional view, 21-21, of the stand container of FIG. 19;

FIG. 22 is an exploded view of the combination packaging system 500;

FIG. 23 is a side elevational view of the combination packaging system of FIG. 22 assembled;

FIG. 24 is an axial cross-sectional view of the combination packaging system of FIG. 23;

FIG. 25 is an exploded view of the combination packaging system 600;

FIG. 26 is a side elevational view of the combination packaging system of FIG. 25 assembled;

FIG. 27 is an axial cross-sectional view of the combination packaging system of FIG. 26;

FIG. 28 is an enlarged partial view of the first sealing edge region of FIG. 24;

FIG. 29 is an enlarged partial view of the first sealing edge region of FIG. 27;

fig. 30 is a schematic drawing of the plastic uptake manufacturing of the first housing 630;

FIG. 31 is a schematic view of the first housing 630 of FIG. 30 after plastic molding;

FIG. 32 is an enlarged view of a portion of the bellows depicted in FIG. 27;

fig. 33 is a schematic view of welding the first housing 630 and the second housing 650;

FIG. 34 is an enlarged partial view of the first sealing edge of FIG. 33;

fig. 35 is a schematic perspective view of a spike assembly 800;

fig. 36 is an exploded view of the combination packaging system 700;

fig. 37 is a perspective view of a seamless housing 760;

FIG. 38 is an enlarged partial view of the first sealing edge 740;

FIG. 39 is an axial cross-sectional view of the seamless housing 760 of FIG. 37;

FIG. 40 is a proximal-to-distal projection of the seamless housing of FIG. 37;

FIG. 41 is a sectional view 41-41 of the seamless housing of FIG. 39;

FIG. 42 is a cross-sectional view 42-42 of the seamless housing of FIG. 39;

FIG. 43 is a cross-sectional view 43-43 of the seamless housing of FIG. 39;

throughout the drawings, like reference numerals designate identical 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 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. As will be appreciated by those skilled in the art, a puncture device in minimally invasive surgery, and in particular in hard endoscopic surgery, typically comprises a cannula assembly and/or a puncture needle, hereinafter "puncture device" being referred to as a puncture needle or cannula assembly, or a combination of a puncture needle and a cannula assembly. Puncture devices can be generally classified into a reusable puncture device and a disposable puncture device. In the present invention, unless specifically described, the puncture outfit of the present invention is a disposable puncture outfit. For convenience of description, the party closer to the operator is defined as the proximal end, and the party farther from the operator is defined as the distal end.

Fig. 3-4 depict a spike assembly, and more specifically, the structure and composition of spike assembly 200. Referring to fig. 3-4, the lancet assembly 200 comprises a lancet 20, a stand-up container 100, and a cover 190. The needle 20 includes a relatively massive handle portion 21 and a needle tip 25 with an elongate shaft 23 extending therebetween.

Fig. 5-6 depict the structure and composition of the stand-up container 100. The stand-up container 100 includes an axis 110 and a planar lip 141 generally perpendicular to the axis 110, the planar lip 141 including an outer lip edge 146 and an inner lip edge 144 and a wall portion extending therebetween. The lip inner edge 144 defines the container opening 140. The stand-up container 100 further includes a distally extending first housing 151 coupled to the lip inner edge 144, the first housing 151 defining a first cavity 150. The stand-up container 100 further includes a second housing 171 connected to the first housing 151 and extending distally, the second housing 171 defining a second cavity 170. The transition housing 161 extends proximally to intersect the first housing 151 at a proximal transition edge 162 and extends distally to intersect the second housing 171 at a distal transition edge 164. The transition housing 161 defines a transition cavity 160 that communicates with the first cavity 150 and the second cavity 170. The stand-up container 100 further includes a closed apex 184 and a distal housing 181 extending between the second housing 171 and the closed apex 184, the distal housing 181 defining a distal cavity 180. The first housing 151, the transition housing 161, the second housing 171, and the distal housing 181 are sequentially connected to form an integral seamless third housing 121. The container opening 140, the first cavity 150, the transition cavity 160, the second cavity 170, and the distal cavity 180 are sequentially formed through to form a closed container 120 comprising the container opening. With continued reference to fig. 6, in one design, the minimum width distance Wmin between the outer lip edge 146 and the inner lip edge 144 is 6 millimeters or greater. In another design, the lip outer edge 146 includes a radiused region 147. In another design, the radiused region 147 includes a local bulge 148 from the distal end to the proximal end. Referring now to fig. 7-10, the spike 20 is loaded into the stand-up container 100 wherein the first cavity 150 is substantially matched in shape and size to the handle portion 21, primarily accommodating the handle portion 21; the second cavity 170 generally matches the shape and size of the elongated rod 23, primarily accommodating the elongated rod 23. The lidstock 190 is welded with the planar lip 141 of the stand-up container 100 to form a closed, terminally sterilized package. Referring now to fig. 8, in one design, the lidstock 190 is welded to the planar lip 141 to form an annular sealing edge 195 having a width of 6mm or greater, while one of the corners 198 of the lidstock 190 is not welded to the planar lip 141, the protrusion 148 separating the corner 198 from the planar lip 141 to facilitate handling and tearing during disassembly of the terminally sterilized package.

As mentioned in the background, in the final sterilization wrap of puncture outfits disclosed and commercially used, a blister process is typically used to produce a tray blister in which the sleeve assembly or puncture needle is laid with its axis substantially parallel to the sealing area, i.e., a horizontal blister wrap. Those skilled in the art will appreciate that the cost of manufacturing the tray blisters is low and the productivity is high, but there are many drawbacks: the degree of stretching of the blister molded article is limited, and the depth/width ratio of the blister cavity is usually less than or equal to 1, and in worst case is usually not more than 1.5. And the wall thickness of the plastic sucking molding cavity is generally less than or equal to 1mm, and the maximum stretching depth of the cavity is generally not more than 100mm. Those skilled in the art will appreciate that the shape and configuration of the stand-up container 100 described in this example has significant distinguishing features relative to prior art tray blisters. In the prior art, the spike and or cannula assembly is substantially horizontal within the tray blister and, more particularly, the elongate shaft of the spike is substantially parallel to the sealing edge of its sealed package or the elongate tube of the cannula assembly is substantially parallel to the sealing edge of its sealed package. While the final packaging system of this example contains a stand-up container 100, the elongate shaft 23 of the spike is substantially perpendicular to the sealing edge 195 of the final packaging system.

Fig. 9 depicts a 9-9 cross-sectional view of the needle assembly 200 of fig. 7, the first lumen 150 in this example having a cross-section with a diameter D ₁ Is approximately circular in shape; FIG. 10 depicts a cross-sectional view 10-10 of the lancet assembly 200 of FIG. 7, the second cavity 170 in this example having a cross-section with a diameter D ₂ Is approximately circular in shape; wherein D is ₁ ＞D ₂ . 7-10, for ease of quantification, the axial depth of the second cavity 170 is defined as HA1, in this example HA 1. Gtoreq.5D ₂ I.e., the axial depth of the second cavity 170 is greater than or equal to 5 times the minimum width of the cross section of the second cavity 170. The vertical container 100 cannot be manufactured or is extremely difficult (costly) to manufacture using the plastic suction method.

Fig. 11-13 depict a method of manufacturing a primary container 100a using a blow molding process, and then trimming the primary container 100a to form the vertical container 100 (hereinafter referred to as a blow molding secondary process). The original container 100a contains the upright container 100, further comprising a proximal scanning wall 131 extending proximally from a planar lip 141 and a proximal cavity 130 defined thereby, and a mouthpiece 132 penetrating the proximal scanning wall 131 and communicating with the proximal cavity 130. Referring now to fig. 13, a closed, approximately annular cut is made around the inner lip edge 144 to divide the original container 100a into two parts, a holding container 100 and a waste part 100b, wherein the cut cuts the planar lip 141 to form an outer lip edge 146, and the minimum width distance between the outer lip edge 146 and the inner lip edge 144 is 6mm or more.

It will be appreciated by those skilled in the art that the blow molding secondary process is more costly than the manufacturing process of a blister tray blister as described in the background, and that the cost of manufacturing a single package housing is higher than the cost of manufacturing a single tray blister. However, the overall cost of the vertical container 100a made by the blow molding secondary process of the present invention is much lower than that of the tray blister packaging process. A typical 12mm gauge needle 20 has been commercialized with a handle portion 21 having a cylindrical shape with a diameter of 40mm and a length of 30mm and an elongate shaft 23 having a cylindrical shape with a diameter of 13mm and a length of 160 mm. The width of the package sealing edge is set to be 6mm. When the horizontal type blister packaging method is adopted, the shortest length of the sealing edge is larger than 460mm, and the sealing edge occupies 52mm multiplied by 202mm of the working table surface of a sealing machine during sealing. When the vertical container 100 of the present invention is used, the shortest length of the sealing edge is about 126mm, and the sealing edge occupies 52mm×52mm of the working surface of the sealing machine. It will be appreciated by those skilled in the art that the quality control of the closure of the terminally sterilized package is important and complex, since it is convenient to unpack the package at the time of use while ensuring sufficient closure strength. The shorter the length of the sealing line, the smaller the size of the working table surface of the sealing machine is occupied during sealing, the better the controllability of the sealing process is, the better the stability of the formed sealing edge is, and the more products can be sealed at one time. It can be seen that the sealing quality and sealing efficiency can be improved to a greater extent by adopting the vertical container 100.

Fig. 14-15 depict one method of shipping the lancet assembly 200. Perforated plate 220 comprises a planar sheet 221 and a plurality of cavities 150 formed in the shape of said first cavityThe perforated plate 220 includes 50 substantially uniformly distributed through holes 222. Referring to fig. 15, the lancet assembly 200 is snapped into the perforated plate 220 with the first housing 151 mated with the through hole 222 and the planar lip 141 mated with the planar sheet 221. A single of the porous plates 220 may be loaded 50 with the lancet assembly 200; the porous plates of the two full-loaded puncture needle assemblies 200 are mutually buckled and put into a packing box with the size of 55cm multiplied by 28cm multiplied by 22cm, namely 100 puncture needle assemblies 200 occupy the packing space of 33880cm ³ . If the blister tray blister is used to package the same spike 20, 100 product packs occupy a package space of approximately 51376 cm ³ . It can be seen that with the vertical container 100, a greater degree of product packaging space is saved. It will be appreciated by those skilled in the art that sterilization, storage, and shipping of the lancet assembly 200 is priced by volume, and that greater packaging space savings may result in greater sterilization, storage, and shipping costs.

The stand-up container 100 may be made from a variety of materials including, but not limited to, polyethylene (HDPE, LDPE), polypropylene (PP), polyvinylchloride (PVC), thermoplastic elastomer (TPE), PET, PETG, and the like. The lidstock 190 can be made of a gas impermeable plastic film, or a porous gas permeable material with bio-barrier properties (e.g., tyvek medical lidstock 4058B, 1059B, 1073B, asuron). The Tyvek medical cover material is widely applied in the field of final sterilization packaging of puncture outfits, but the cost is high, and the vertical container 100 is beneficial to reducing the dosage of the Tyvek medical cover material. In addition, when the vertical container 100 is made of transparent materials, the vertical container 100 of the present invention is also helpful for displaying the packaged articles, and is beneficial for selection.

Fig. 16-21 depict another penetrator assembly, more specifically, the structure and composition of a cannula assembly product package 400. Referring to fig. 16-17, the sleeve assembly product package 400 includes the sleeve assembly 10, the vertical container 300, and the lidstock 290. The cannula assembly 10 includes a relatively massive cannula housing 11 and a relatively sharp cannula tip 15 with an elongate tube 13 extending therebetween, and a valve assembly 17 projecting beyond the cannula housing 11.

Fig. 18-21 depict the structure and composition of the stand-up container 300. The stand-up container 300 includes an axis 310 and a planar lip 341 generally perpendicular to the axis 310, the planar lip 341 including an outer lip edge 346 and an inner lip edge 344 and a wall portion extending therebetween. The lip inner edge 344 defines a container opening 240. The stand-up container 300 further includes a distally extending first housing 351 connected to the lip inner edge 344, the first housing 351 defining a first cavity 350. The stand-up container 300 further includes a second housing 371 connected to the first housing 351 and extending distally, the second housing 371 defining a second cavity 370. The transition housing 361 extends proximally to intersect the first housing 351 at a proximal transition edge 362 and extends distally to intersect the second housing 371 at a distal transition edge 364. The transition housing 361 defines a transition cavity 360 that communicates with the first cavity 350 and the second cavity 370. The vertical container 300 further includes a closed vertex 384 and a distal housing 381 extending between the second housing 371 and the closed vertex 384, the distal housing 381 defining a distal cavity 380. The first casing 351, the transition casing 361, the second casing 371 and the distal casing 381 are sequentially connected to form an integral seamless third casing 321; the container opening 240, the first cavity 350, the transition cavity 360, the second cavity 370, and the distal cavity 380 are sequentially formed therethrough to form a closed container 320 comprising the container opening.

Referring now to fig. 16-17, the cannula assembly 10 is loaded into a vertical container 300 wherein a first cavity 350 substantially matches the shape and size of the cartridge body 11, primarily housing the cannula cartridge body 11; the second cavity 170 substantially matches the shape and size of the elongated tube 13, primarily accommodating the elongated tube 13; the lidstock 290 is welded to the planar lip 341 of the stand-up container 300 to form a closed, terminally sterilized package. In one design, the cover 290 is welded to the planar lip 341 to form an annular seal with a width of 6mm or more. The vertical container 300 may be manufactured using a similar method to the vertical container 100 described above, i.e., the original jacket is produced by blow molding and then trimmed to form the vertical container 300. The cannula assembly product package 400 has similar advantages as the needle assembly 200.

Referring to fig. 9, 10 and 21, the first housing 151 forming the vertical type container 100 is a regular cylindrical wall, and the first housing 151 forming the vertical type container 300 is an irregular closed loop wall formed by sweeping along a certain track. The stereoscopic container 300 has an irregular shape, and the manufacturing complexity is higher than that of the vertical container 100, however, the secondary processing method of blow molding according to the present invention can conveniently manufacture the stereoscopic container 300 without greatly increasing the manufacturing cost. More complex shapes and structures are also possible. Those skilled in the art having knowledge of the blow molding process will appreciate that the blow molding process can be broadly divided into: injection blow molding, extrusion blow molding, injection stretch blow molding and extrusion stretch blow molding. Blow molding generally employs a two-step process, a first step of molding a parison and a second step of blow molding; different blow molding processes refer to different ways of forming the parison and blow molding. The various blow molding processes have advantages and disadvantages, and suitable processes and control methods are generally selected in the processing batch according to the product shape. For example, in the three-dimensional container 300 of the present invention, the difference between the lateral and axial dimensions of the first and second cavities 350 and 370 is large, while the shape and wall thickness of the parison are well controlled, and the three-dimensional container 300 having a uniform wall thickness can be obtained. For example, for ease of manufacture (demolding), the planar lip 141 and planar wall 341 are generally not strictly planar, typically having a draft angle of 1 ° to 5 °. Because of the space limitations, those skilled in the art will readily appreciate that the disclosed embodiments may be adapted to conform to a specific design or configuration as described herein with reference to related manufacturing process documents or process experiences or as a result of a limited number of tests.

As described above, the irregular shape of the three-dimensional container 300 generally requires extruding or pre-blowing a relatively complex parison, then blow molding, and then trimming to form the three-dimensional container 300. The complex parison extrusion or preblowing molds and equipment are often expensive and are disadvantageous for small and medium volume production. Fig. 22-24 illustrate an improved combination packaging system 500. The combination packaging system 500 includes an axis 501. The combination packaging system includes a lidstock 510, a first housing 530, and a second housing 550. The first housing 530 includes a planar lip 535 and a first connecting lip 537 and a first shell 536 extending therebetween. The planar lip 535 comprises an outer lip edge 534 and an inner lip edge 532 and a planar wall 533 extending therebetween, the inner lip edge 532 defining an open package opening 531; the first connection lip 537 defines an open connection aperture 538. The shape of the package opening 531 may be a circle shape, an oval ring shape, a polygonal ring shape, or other irregular closed ring shape. In the present invention, the shape of the package opening 531 is approximately elliptical. Similarly, the connection holes 538 may be in the shape of circles, ellipses, polygonal rings, or other irregular closed rings. In this example, the connection hole 538 is in the shape of a circle. The first housing 536 in this example comprises three parts, namely a cylindrical housing 536a, a rectangular housing 536b and a frustoconical housing 536c, the cylindrical housing 536a, rectangular housing 536b and frustoconical housing 536c being interconnected and transitioning smoothly to form a seamless first housing 536. It will be appreciated by those skilled in the art that the shape of the first housing 536 generally conforms to the shape of the packaged product, generally based on the exterior shape of the packaged product and simplifying formation.

With continued reference to fig. 22-24 and 28, the second housing 550 includes a second attachment lip 555 and a closed distal end 557 with a second shell 556 extending therebetween. The first connection lip 537 is welded to the second connection lip 555 to form a first sealing edge 540. The first sealing edge 540 connects the first housing 530 and the second housing 550 together into a unitary seamless shell 560, the seamless shell 560 defining a seamless cavity 561 that includes an opening at one end. In one embodiment, the second housing 550 is first manufactured by extrusion as a tubular blank with two open ends, and then one of the ends of the tubular blank is heat and pressure welded to form a third sealing edge 570, in this example, the third sealing edge 570 forming the closed distal end 557. While the other end of the tubular blank is reserved as a second connecting lip 555. With continued reference to fig. 22-24, the lidstock 510 and the planar wall 533 are welded to form a second sealed edge 520, the second sealed edge 520 connecting the seamless shell 560 to the lidstock 510 as an integral, closed package cavity. Those skilled in the art will appreciate that there are a wide variety of welding means including, but not limited to, hot press welding, ultrasonic welding, high frequency welding, radiation welding, pulse welding, and the like. For example, the first, second and third sealing edges of the present invention are formed by thermocompression bonding.

Figures 25-27 illustrate another improved combination packaging system 600. The combination packaging system 600 includes an axis 601. The composite packaging system 600 includes a lidstock 610, a first housing 630, and a second housing 650. The first housing 630 includes a planar lip 635 and a first connecting lip 637 and a first shell 636 extending therebetween. The planar lip 635 includes an outer lip edge 634 and an inner lip edge 632 and a planar wall 633 extending therebetween, the inner lip edge 632 defining an open package opening 631; the first connection lip 637 defines an open connection hole 638. Referring to fig. 25-27 and 29, the second housing 650 includes a second connection lip 655 and a closed distal end 657, and a second shell 656 extending therebetween. The first connection lip 637 is welded to the second connection lip 655 to form a first sealed edge 640. In this example, the first connection lip 637 comprises a first truncated conical wall and the second connection lip 655 comprises a second truncated conical wall and is shaped and sized to match the first connection lip 637, the mating of the approximately truncated conical walls facilitating welding. The first sealing edge 640 connects the first housing 630 and the second housing 650 into a unitary seamless shell 660, the seamless shell 660 defining a seamless cavity 661 that includes an opening at one end. In a preferred embodiment, the second housing 650 is manufactured by extrusion to form a tubular blank having a cylindrical open end at one end and a frustoconical second attachment lip 655 at the other end, and then heat and pressure welding the cylindrical open end to form the third sealing edge 670. In this example, the third sealing edge 670 forms a closed distal end 657. With continued reference to fig. 25-27, the cover 610 and the planar wall 633 are welded to form a second sealing edge 620, the second sealing edge 620 connecting the seamless housing 660 to the cover 610 as an integral, closed package cavity.

Referring to fig. 26, 27 and 32, the second housing 650 further comprises a bellows 680, the bellows 680 being comprised of a plurality of axially disposed corrugations 682, each of the corrugations 682 comprising transversely extending corrugation peaks 683 and corrugation valleys 685 and corrugation walls 684 extending between the corrugation peaks 683 and corrugation valleys 685. As will be appreciated by those skilled in the art, minimally invasive surgery (hard endoscopic surgery) is typically performed on lean, normal and obese patients with correspondingly matched shortened, normal and lengthened penetrators, respectively. The nominal length specification of the shortened puncture outfit is usually 65-75 mm, the length specification of the common puncture outfit is usually 90-110 mm, and the length specification of the lengthened puncture outfit is usually 145-155 mm. In one design, if the size, angle and number of folds of the bellows 680 are set reasonably, the same combined packaging system 600 can be compatible with packaging shortened piercers, normal piercers and lengthened piercers. Thereby saving the manufacturing mould cost to a great extent, reducing the inventory and saving the management cost.

One of ordinary skill will appreciate that the seamless shell 560, 660 may add a welding process (welding to form the first sealing edge 540 or the first sealing edge 640) as compared to the three-dimensional container 300, which may result in an increase in the overall manufacturing cost of the seamless shell 560, 660. However, reasonable selection of manufacturing methods and reasonable design manufacturing processes may instead reduce manufacturing costs.

In one aspect of the invention, a method of manufacturing the seamless housing 660 is presented. The seamless housing 660 includes a first sealing edge 640 that integrally joins the first housing 630 and the second housing 650. The manufacturing method mainly comprises the steps of plastic sucking and trimming, extrusion molding and trimming and welding.

And (3) plastic sucking and trimming: the plastic molding is a process in which a plastic sheet (film) is heated and softened, then vacuum-sucked onto a mold surface, cooled and molded. So-called trimming, i.e. removing excess material. Fig. 30 depicts a schematic drawing of a plastic suction process for the first housing 630. In one design, more than 100 first housings 630 may be plastic suction using a1 meter by 1 meter sheet. Fig. 31 depicts a process of trimming (blanking) to form a single first housing 630. In one design, the lip outer edge 634 and the first connecting lip 637 are formed by one-shot blanking. One preferred first connection lip 637 is frustoconical.

Extrusion and cutting: the extrusion molding refers to a processing method that plastics are heated and plasticized under the action of an extruder charging barrel and a screw rod, and are pushed forward by the screw rod while continuously passing through a machine head to prepare various section products or semi-products. In a preferred embodiment, the second housing 650 is a tubular blank having a cylindrical open end at one end and a frustoconical second attachment lip 655 at the other end, by extrusion. The shape and manufacturing process of the tubular blank resembles a straw that is widely used in the food industry. Straw extrusion molding is one of the most mature processing technologies at present, and the processing equipment has low manufacturing cost and high processing efficiency, so the product cost is low.

Welding procedure: essentially comprising a closed weld forming a closed distal end 657 of the second housing, and a joining weld joining the first housing 630 and the second housing as a single unit. The closed welding generally does not need an additional die, and the general flat plate heating welding is adopted. As described above, the cylindrical open end of the tubular blank is sealed and welded to form the sealed distal end 657, so that a plurality of products can be welded at one time, and the manufacturing equipment is low in cost and high in processing efficiency. As shown in fig. 33-34, the welding tool required for welding the first connecting lip 637 and the second connecting lip 655 together to form the first sealing edge 640 mainly includes a lower welding die 691 and a welding head 693, which has a simple structure and can conveniently realize one-time welding of a plurality of products. And the first and second connection lips 637 and 655 comprise mating frustoconical shapes to facilitate control of the welding process.

The sealing quality control of the terminally sterilized packages is very important and complicated, as it is mentioned before that it is convenient to unpack the package at the time of use while at the same time sufficient sealing strength is ensured. It should be noted that the distinction is understood that the closure control described herein primarily refers to a tearable closure edge. The second sealing edge 620, such as described in this example, is also referred to as a tearable sealing edge. The heat seal strength of the peelable seal should be low to allow easy unpacking of the package for use, but at the same time have sufficient heat seal strength to ensure package reliability, so that the quality control of the seal of such peelable seal is complicated. So far, the relevant quality control of such tearable sealing edges has been standardized in different countries or regions, for example EN868-5 prescribes that the tearable sealing edges formed by heat sealing of sterilized paper and plastic should have a sealing edge strength of not less than 1.5N/15MM and that the tearable sealing edges should not be subjected to excessive heat sealing resulting in the creation of paper shreds of more than 10MM on said sealing edges. However, the first sealing edge 640, the third sealing edge 670 of the present invention is not a tearable sealing edge, but is simply a conventional sealing edge that performs the functions of connection and sealing, and its main properties include a certain sealing strength and sufficient air tightness, and those skilled in the art will appreciate that the quality control of such conventional sealing edges is relatively easy, without greatly increasing the quality control cost.

Although the seamless case 660 described in this example adds a process step to the method of manufacturing a combined packaging system for puncture outfit packaging with respect to the method of manufacturing a secondary blow molding process, since the production efficiency of the suction molding and the extrusion molding is much higher than that of the blow molding, the suction molding and the trimming process, the extrusion molding and the trimming process are reasonably arranged, and the number of simultaneous processes per station of the welding process can be greatly increased instead. While helping to reduce scrap, reduce the overall wall thickness of the product and achieve a more uniform wall thickness. Thus, it is possible to maintain excellent quality while reducing production costs. Whereas the tray blister method described above, such as with the tray for manufacturing the sleeve assembly 10 of the present invention, the individual blisters occupy approximately 120mm by 220mm of the blister sheet area, and the individual first housing 630 occupies approximately 90mm by 70mm of the blister sheet area. A standard 1 meter by 1 meter sheet may be able to blister over 100 of the first shells 630, but only about 32 120mm by 220mm tray blisters. In addition, other advantages of the seamless housing 660 over the tray blister are similar to those described above for the upright container 100, including reduced tear seam length, reduced packaging volume, reduced use of a tyvek to prevent the sharp tip from puncturing the product packaging, aesthetics and ease of display, etc.

Fig. 35-43 depict a spike package assembly 800 comprising a cannula assembly 10, a spike 20, and a combination packaging system 700. The composite packaging system 700 includes a cover 710, a first housing 730, and a second housing 750. The first housing 730 includes a planar lip 735 and a first connecting lip 737 and a first shell 736 extending therebetween. The planar lip 735 includes an outer lip edge 734 and an inner lip edge 732 and a planar wall 733 extending therebetween, the inner lip edge 732 defining an open package opening 731; the first connection lip 737 defines an open connection aperture 738. 36-39, the second housing 750 includes a second connecting lip 755 and a closed distal end 757 with a second housing 756 extending therebetween. The first connection lip 737 and the second connection lip 755 are welded to form a first sealing edge 740. In this example, the first connection lip 737 comprises a first planar wall and the second connection lip 755 comprises a second planar wall, the cooperation of the first and second planar walls facilitating welding. The first sealing edge 740 connects the first housing 730 and the second housing 750 together into a unitary seamless housing 760, the seamless housing 760 defining a seamless cavity 761 having an open end. Referring now to fig. 35, the lidstock 710 and the planar wall 733 are welded to form a second sealed edge 720, the second sealed edge 720 connecting the seamless housing 760 to the lidstock 710 as an integral, closed package cavity. Fig. 41-42 depict a cross-section of the first housing 730 and fig. 43 depicts a cross-section of the second housing 750. The cross section is irregularly closed and approximately elliptical, and the cross section is reduced in size from the proximal end to the distal end.

In one aspect of the invention, a method of manufacturing the seamless housing 760 is provided. The seamless housing 760 includes a first sealing edge 740 that integrally connects the first housing 730 and the second housing 750. The manufacturing method mainly comprises the steps of plastic sucking and trimming, blowing and trimming and welding.

And (3) plastic sucking and trimming: in one design, a plurality of integral first housings 730 may be formed from sheet material by suction molding and then trimming (blanking) to form individual first housings 730.

Blow molding and cutting: first, a blow molding method is used to manufacture an original housing containing the second housing 750; the original housing further includes a proximal scan wall extending proximally from the second connecting lip 755 and a proximal cavity defined thereby, and a mouthpiece penetrating the proximal scan wall and communicating with the proximal cavity. The second outer shell 750 is trimmed from the original outer shell along the second attachment lip 755.

Welding procedure: mainly comprises a connection welding for connecting the first housing 730 and the second housing 750 into a whole.

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. For example, the first shell, the transition shell and the second sweeping wall are adaptively modified, so that the appearance is more attractive and smooth; or by increasing or decreasing the number of cannula assemblies or piercing needles. 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 combination packaging system for a puncture outfit, comprising:

the combined packaging system comprises a first shell, a second shell and a cover material;

the first housing includes a planar lip and a first connecting lip, and a first shell extending between the planar lip and the first connecting lip; the planar lip includes a lip outer edge and a lip inner edge and a planar wall extending between the lip outer edge and the lip inner edge, the lip inner edge defining an open package opening; the first connecting lip defines an open connecting aperture;

the second housing including a second connecting lip and a closed distal end, a second housing extending between the second connecting lip and the closed distal end;

the first connecting lip and the second connecting lip are welded to form a first sealing edge; the first sealing edge connects the first housing and the second housing into a unitary seamless housing, the seamless housing defining a seamless cavity comprising an open-ended end;

the cover material and the plane wall are welded to form a second sealing edge, and the seamless shell and the cover material are connected into an integral closed cavity by the second sealing edge.

2. The combination packaging system of claim 1, wherein the first connection lip comprises a first frustoconical wall and the second connection lip comprises a second frustoconical wall conforming to the shape and size of the first connection lip.

3. The combination packaging system of claim 1, wherein the first connection lip comprises a first planar wall and the second connection lip comprises a second planar wall conforming to the shape and size of the first connection lip.

4. The combination packaging system of claim 1, wherein the closed distal end comprises a third sealing edge.

5. A puncture outfit assembly comprising the combination packaging system of any one of claims 1-4, further comprising a puncture needle and/or cannula assembly.

6. A method of manufacturing a seamless housing for a combination packaging system as recited in claim 2, comprising the steps of:

and (3) plastic sucking and trimming: manufacturing a plurality of first shells connected into a whole by a plastic suction method, and trimming or blanking to form a single first shell;

extrusion and cutting: manufacturing the second housing by an extrusion molding method and cutting the second housing to a design size;

welding procedure: including a closed weld forming a closed distal end of the second housing, and a connection weld connecting the first housing and the second housing as a single unit.

7. A method of manufacturing a seamless shell for a combination packaging system as recited in claim 3, wherein the main steps include:

blow molding and cutting: blow molding an original housing comprising the second housing; the original housing further includes a proximal scan wall extending proximally from the second connecting lip and a proximal cavity defined thereby, and a mouthpiece penetrating the proximal scan wall and communicating with the proximal cavity; trimming the second housing along the second connecting lip from the original housing;

welding procedure: comprising a connection weld connecting the first housing and the second housing as a single unit.