CN107031985B

CN107031985B - Combined packaging system for medical instruments

Info

Publication number: CN107031985B
Application number: CN201710410209.9A
Authority: CN
Inventors: 王海涛; 朱莫恕
Original assignee: Individual
Current assignee: Wang Haitao
Priority date: 2017-06-03
Filing date: 2017-06-03
Publication date: 2020-02-18
Anticipated expiration: 2037-06-03
Also published as: CN107031985A; WO2018219316A1

Abstract

The invention relates to a combined packaging system for medical equipment, which comprises a handheld equipment, a main body bag, an extension pipe and a cover material, wherein the handheld equipment comprises a handle and an elongated rod connected with the handle; the body pocket includes a planar lip and a first connecting lip and a first shell extending therebetween; the lip inner edge defining an open package opening; the first connecting lip defines an open connecting aperture; the extension tube comprising a second connecting lip and a closed distal end and a second shell extending therebetween; the first connecting lip and the second connecting lip are welded to form a first sealing area; the first sealing area connects the main bag and the extension pipe into an integral seamless shell, and the seamless shell defines a seamless cavity with one open end; the cover material and the plane wall are welded to form a second sealing area, and the seamless shell and the cover material are connected into an integral closed cavity by the second sealing area.

Description

Combined packaging system for medical instruments

Technical Field

The invention relates to a surgical instrument, in particular to a packaging structure of a surgical instrument.

Background

Disposable surgical instruments include, but are not limited to, staplers, laparoscopic forceps, laparoscopic energy cutting instruments, laparoscopic suturing instruments, medical irrigation and aspiration tubes, extractors, retractors, and puncturers. Such surgical instruments typically include a relatively large-sized handle and an elongated shaft portion connected to the handle, and are hereinafter collectively referred to as hand-held instruments. The hand-held instrument is packaged in a terminally sterilized packaging, sterilized, and then sold and stored in an aseptic manner. The packaged product remains sterile during the sterilization expiration date and without damage to the terminally sterilized package. Sterilization is a wide variety of methods, and the most widely used include EO ethylene oxide sterilization and radiation sterilization. The sterilization means must generally be compatible with the final sterilized package.

The presently disclosed terminally sterilized packages for packaging hand-held instruments include primarily pouch and tray packages (or blister packages). The production of bag packs therein is highly automated and inexpensive, however, since hand-held instruments often contain bulky handles, elongated rods and sharp tips, which easily pierce their bag packing system resulting in sterility disruption. And the packaging reliability of the tray package (blister package) is better, so that the tray package is widely used.

The tray package (or blister package) generally comprises an upper cover plate (paper sheet) and a lower tray (lower blister), wherein the lower tray is generally made in a blister mode, namely, after a plastic hard sheet is heated and softened, a plurality of cavities or channels are formed in a vacuum adsorption mode, and the cavities or channels are used for containing and fixing packaged products. Fig. 1 depicts a typical pallet packaging system 30 of the prior art for hand held instruments. The tray packaging system 30 comprises a tyvek sheet 31 and a tray blister 32. The tray blister 32 includes a horizontal flange 33 and a plurality of recessed cavities 34 generally perpendicular thereto and channels 35 communicating the cavities. A hand-held instrument (10) includes a handle (11) and a sharp tip (15) with an elongate shaft (13) extending therebetween. The handle 11 is received in a locking recess 34, the elongated stem 13 is received in channel 35, and the paper sheet 31 and tray blister 32 are welded (heat sealed) along the horizontal flange 33 to form a complete sealed area 40 (not shown) to form a closed, terminally sterilized package.

The degree of stretch of the blister product is limited, and the depth/width ratio of the blister cavity is usually less than or equal to 1, and usually must not exceed 1.5 in the worst case. The wall thickness of the plastic suction molding cavity is usually less than or equal to 1mm, and the maximum stretching depth dimension of the cavity is usually not more than 100 mm. Tray packages (blister packages) for hand-held instruments which lie substantially within a tray or blister with the axis of their elongate shaft substantially parallel to the horizontal flange 33 (sealing region 40) have been disclosed so far, and are hereinafter referred to as horizontal blister packages (or tray blister packages). The horizontal blister package also has a plurality of defects, mainly including lower production efficiency of welding (heat sealing) and poor stability of the sealing area due to the longer whole sealing area; irregular cavity dimensions result in more wasted space when multiple terminally sterilized packages are stacked on top of each other, etc. For example, the hand-held instrument 10 depicted in fig. 1 is a 5 x 330 mm format curved separator clamp, and its tray packaging system 30 requires 570 x 200 mm plastic sheet material to make the tray blisters 32, and 570 x 200 mm tyvek sheets, resulting in not only a large overall material usage, but also a large processing footprint for blister processing and heat sealing of the final sterilized package, thereby reducing the production batch of blister production and package heat sealing, resulting in increased production costs. To address one or more of the foregoing problems, it is an object of the present invention to provide a modular packaging system for hand-held instrument packaging.

Disclosure of Invention

In one aspect of the invention, a modular packaging system for a medical device is provided, comprising a hand held device comprising a handle and an elongated shaft connected to the handle. The combination packaging system also includes a body bag, an extension tube, and a lidstock. The body pocket includes a planar lip and a first connecting lip and a first shell extending therebetween; the planar lip portion comprising a lip outer edge and a lip inner edge defining an open package opening and a planar wall extending therebetween; the first connection lip defines an open connection aperture. The extension tube includes a second connecting lip and a closed distal end and a second shell extending therebetween. The first connecting lip and the second connecting lip are welded to form a first sealing area; the first sealed region connects the body bag and the extension tube into an integral seamless housing defining a seamless cavity having an open end. The cover material and the plane wall are welded to form a second sealing area, and the seamless shell and the cover material are connected into an integral closed cavity by the second sealing area.

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

In another implementation, the closed distal end includes a third sealed region.

In a further embodiment, said first connecting lip is substantially parallel to said planar lip, adapted to said first sealing area being substantially parallel to said second sealing area.

In a further embodiment, said first connecting lip is substantially perpendicular to said planar lip, adapted to said first sealing area being substantially perpendicular to said second sealing area.

In yet another implementation, the body pocket includes a neck portion and a pocket portion, the neck portion being connected to the planar lip and having a dimension in a transverse direction parallel to the planar lip that is smaller than a dimension of the pocket portion.

In another aspect of the invention, a method of manufacturing a seamless shell for a modular packaging system is provided, the seamless shell comprising a body bag and an extension tube and a first sealing region integrally connecting the body bag and the extension tube. The manufacturing method comprises the following steps:

plastic uptake and trimming procedure: manufacturing a plurality of integrally connected main body bags by a plastic suction method, and trimming (blanking) to form single main body bags; extrusion molding and cutting working procedure: manufacturing the extension pipe by an extrusion molding method and cutting the extension pipe to a designed size;

a welding procedure: mainly comprises a closed welding for forming the closed far end of the extension tube and a connecting welding for connecting the main bag and the extension tube 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 together with the accompanying figures in which:

FIG. 1 is a schematic view of a tray blister packaging system typical of the prior art;

FIG. 2 is an assembled view of the unitized packaging system 100;

FIG. 3 is an exploded view of the modular packaging system 100;

fig. 4 is a schematic perspective view of the body bag 130;

FIG. 5 is a perspective view of the body pocket of FIG. 4 from the proximal end to the distal end;

FIG. 6 is a partial cross-sectional view of the unitized package system of FIG. 2;

FIG. 7 is an enlarged view of the closed distal end 157 of the packaging system shown in FIG. 6;

fig. 8 is an enlarged view of the first sealing area 140 of the combination packaging system of fig. 6;

fig. 9 is a schematic perspective view of another embodiment of a body bag 230;

FIG. 10 is a proximal to distal projection view of the body pocket 230 of FIG. 9;

FIG. 11 is a cross-sectional view 11-11 of the body pocket of FIG. 10;

FIG. 12 is a perspective view of the unitized packaging system 200;

FIG. 13 is a partial cross-sectional view of the packaging system of FIG. 12;

fig. 14 is a schematic perspective view of another embodiment of a body bag 330;

FIG. 15 is a proximal to distal projection view of the body pocket 330 of FIG. 14;

FIG. 16 is a side projection view of the main body pocket 330 shown in FIG. 15;

FIG. 17 is a schematic perspective view of another embodiment of an extension tube 350;

FIG. 18 is a schematic perspective view of a modular packaging system 300;

FIG. 19 is a partial cross-sectional view of combination packaging system 300;

fig. 20 is an enlarged view of the first sealed area 340 of the combination packaging system of fig. 19;

fig. 21 is a schematic perspective view of another embodiment of a body bag 430;

FIG. 22 is an opposite perspective view of the body pocket 430 shown in FIG. 21;

FIG. 23 is a proximal to distal projection view of the body pocket 430 of FIG. 21;

FIG. 24 is a cross-sectional view 24-24 of the body pocket 430 shown in FIG. 23;

FIG. 25 is a schematic perspective view of another embodiment of an extension tube 450;

FIG. 26 is a schematic perspective view of a modular packaging system 400;

FIG. 27 is a partial cross-sectional view of the unitized package system of FIG. 26;

fig. 28 is an enlarged partial view of the first sealed area 440 of the combination packaging system of fig. 27;

fig. 29 is an enlarged view of the closed distal end 457 of the unitized package system of fig. 27;

FIG. 30 is a schematic view of the blister manufacturing of the body pocket 130 of FIG. 4;

FIG. 31 is a schematic view of the body pocket 130 of FIG. 30 after being blister-fabricated;

like reference numerals refer to like parts or components throughout the several views.

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. Those skilled in the art will appreciate that disposable surgical instruments include, but are not limited to, staplers, laparoscopic surgical clamps, laparoscopic energy cutting instruments, laparoscopic stapling instruments, medical suction lines, extractors, retractors, and puncturers. Such surgical instruments typically include a relatively large-sized handle and an elongated shaft portion connected to the handle, and are hereinafter collectively referred to as hand-held instruments. In the present invention, the final sterilized packaging is described mainly by way of example of disposable curved dissecting forceps commonly used in laparoscopic surgery. For convenience, the next party to the operator is defined as the proximal end, and the party away from the operator is defined as the distal end.

Fig. 2-8 illustrate a unitized packaging system 100 of a first embodiment of the present invention. The modular packaging system 100 includes a hand held instrument 10, a body bag 130, an extension tube 150 and a lidstock 190. Hand-held instrument 10 includes a handle 11 and a sharp tip 15 with an elongate shaft 13 extending therebetween. The handle 11 includes a front handle 12 and a rear handle 14. Referring first to fig. 4-5, the body pocket 130 includes a planar lip 135 and a first connecting lip 137 and a first shell 136 extending therebetween. The planar lip 135 includes a lip outer edge 134 and a lip inner edge 132 and a planar wall 133 extending therebetween, the lip inner edge 132 defining an open package opening 131; the first coupling lip 137 defines an open coupling aperture 138. The shape of the package opening 131 may be a circle, an oval, a polygon, or other irregular closed loop shape. In the present invention, the package opening 131 is approximately rectangular in shape. Similarly, the connecting hole 138 may have a circular shape, an elliptical shape, a polygonal shape, or other irregular closed loop shapes. In this example, the connection hole 138 is circular. It will be appreciated by those skilled in the art that the shape of the first housing 136 generally conforms to the shape of the packaged product, generally based on the outer shape of the packaged product and simplifies formation.

Referring now to fig. 2-3, the extension tube 150 includes a second connecting lip 155 and a closed distal end 157 and a second shell 156 extending therebetween. In one embodiment, the extension tube 150 is first manufactured by extrusion as a tubular blank having a cylindrical open end 157a at one end and a second attachment lip 155 at the other end, and the cylindrical open end 157a is then heat and pressure welded to form the third sealed region 170. In this example, the third sealed region 170 constitutes a closed distal end 157.

Referring now to fig. 2 and 6-8, the first connecting lip 137 is welded to the second connecting lip 155 to form a first sealing area 140. The first sealed region 140 connects the body bag 130 and the extension tube 150 into an integral seamless shell 160, the seamless shell 160 defining a seamless cavity 161 that includes an open end. Referring now to fig. 2 and 6, the surgical device 10 is loaded into the modular packaging system 100, wherein the elongated rod 13 is loaded into the elongated tube 150, the handle 11 is loaded into the body pocket 130, the cover 190 and the planar wall 133 are welded to form a second sealing region 120, and the second sealing region 120 seals the opening of the seamless cavity 161 to form the fully enclosed modular packaging system 100. Referring now to fig. 5-6, the planar lip 135 further includes a protrusion 139, and the protrusion 139 is not welded to the lidstock 190 to facilitate tearing of the unitized package system 100 during use. With continued reference to fig. 6, in this example, the axis 151 of the elongated tube 150 is substantially perpendicular to the planar lip 135 (second sealing region 120).

Those skilled in the art will appreciate that the welding means can be of a wide variety, including but not limited to heat and pressure welding, ultrasonic welding, high frequency welding, radiation welding, pulse welding, and the like. For example, the first, second and third sealing regions of the present invention are formed by thermocompression bonding. The seamless housing 160 may be made from a variety of materials including, but not limited to, polyethylene (HDPE, LDPE), polypropylene (PP), polyvinyl chloride (PVC), thermoplastic elastomer (TPE), PET, PETG, and the like. The lidstock 190 may be made of a plastic film that is air impermeable or a porous, breathable material that is a biological barrier (e.g., Tyvek medical lidstock 4058B, 1059B, 1073B, Asuron). The Tyvek medical lidstock is widely applied to the field of terminal sterilization packaging of puncture outfits, but the Tyvek medical lidstock is expensive, and the seamless shell 160 is beneficial to reducing the using amount of the Tyvek medical lidstock. In addition, when the seamless shell 160 is made of transparent material, the seamless shell 160 of the present invention also facilitates displaying the packaged goods, which is convenient for selection.

Fig. 9-11 depict another embodiment of a body bag 230. The main body pocket 230 includes a planar lip 235 and a first attachment lip 237 and a first shell 236 extending therebetween. The planar lip 235 includes a lip outer edge 234 and a lip inner edge 232 and a planar wall 233 extending therebetween, the lip inner edge 232 defining an open package opening 231; the first attachment lip 237 defines an open attachment aperture 238. The shape of the first housing 236 generally conforms to the shape of the packaged product, generally based on the shape of the packaged product, and is easily formed. The first housing 236 further includes an inward protrusion 211, and the inward protrusion 211 is used to fix the front handle 12.

Fig. 12-13 depict a unitized packaging system 200 of a second embodiment of the present invention. The modular packaging system 200 includes the hand held instrument 10, a body bag 230, an extension tube 150 and a lidstock 190. The first attachment lip 237 is welded to the second attachment lip 155 to form a first sealing area 240. The first sealed region 240 connects the body bag 230 and the extension tube 150 into an integral seamless housing 260, the seamless housing 260 defining a seamless cavity 261 (not shown) including an open end. The surgical device 10 is loaded into the modular packaging system 100, wherein the elongated shaft 13 is loaded into the elongated tube 150, the handle 11 is loaded into the body pocket 230, the cover 190 and the planar wall 233 are welded to form a second sealing region 220, and the second sealing region 220 seals the opening of the seamless cavity 261 to form the fully enclosed modular packaging system 200. The inward protrusion 211 snaps into a grip ring of the front handle 12 to limit displacement of the front handle within the body pocket 230.

Fig. 14-16 depict another embodiment of a body bag 330. The main body pocket 330 includes a planar lip 335 and a first connecting lip 337 and a first shell 336 extending therebetween. The planar lip portion 335 includes a lip outer edge 334 and a lip inner edge 332 and a planar wall 333 extending therebetween. The lip inner edge 332 defines an open package opening 331; the first connecting lip 337 defines an open connecting aperture 338. The first housing 336 is generally shaped to conform to the shape of the packaged product, and is generally wrapped and formed in a simplified manner based on the outer shape of the packaged product. The main difference of the main body pocket 330 in comparison with the main body pockets 130 and 230 is the positional relationship between the planar lip portion and the first connecting lip portion, the planar lip portion 335 is substantially perpendicular to or extends at an acute angle to the first connecting lip portion 337, and the planar lip portion 135 is substantially parallel to the first connecting lip portion 137.

Fig. 17 depicts an extension tube 350 of another embodiment of the present invention. The extension tube 350 includes a second attachment lip 355 and a closed distal end 357 and a second housing 356 extending therebetween. The second attachment lip 355 includes a horizontal flange 355a and a transition flange 355 b. In one embodiment, the extension tube 150 is blow molded to form a raw extension tube comprising the extension tube 350 and then trimmed to remove excess material such as a blow nozzle to form the extension tube 350.

Fig. 18-20 depict a combination packaging system 300 of a third embodiment of the present invention. The modular packaging system 300 includes the hand held instrument 10, a body bag 330, an extension tube 350 and a lidstock 390. The first attachment lip 337 is welded to the horizontal flange 355a of the second attachment lip 355 to form a first closure region 340. The first sealed region 340 connects the body bag 330 and the extension tube 350 into an integral seamless housing 360, the seamless housing 360 defining a seamless cavity 361 that includes an open end. The surgical device 10 is loaded into the modular packaging system 300, wherein the elongated shaft 13 is loaded into the elongated tube 350, the handle 11 is loaded into the body bag 330, the cover 390 and the planar wall 333 are welded to form a second sealing region 320, and the second sealing region 320 seals the opening of the seamless chamber 361 to form the fully enclosed modular packaging system 300. With continued reference to fig. 19, in this example, the axis 351 of the elongated tube 350 is at an acute angle or parallel to the planar lip 335 (second sealing region 320).

Fig. 21-24 depict a further embodiment of a body bag 430. The body pocket 430 includes a planar lip 435 and a first connection lip 437 and a first shell 436 extending therebetween. The planar lip 435 includes an outer lip edge 434 and an inner lip edge 432 and a planar wall 433 extending therebetween. The labial inner edge 432 defining an open package opening 431; the first coupling lip 437 defines an open coupling aperture 438. The shape of the first housing 436 generally conforms to the shape of the packaged product, and is generally encapsulated and formed simply based on the shape of the packaged product. Referring now to fig. 22 and 24, in this example, the first shell 436 may be generally divided, from a proximal end to a distal end, into a narrowed neck portion 436a and a pocket portion 436B, wherein the narrowed neck portion 436a is connected to the lip inner edge 432 and has a first width dimension B1, and how many pocket portions 436B have a second width dimension B2, and the B1 < B2. The first connection lip 437 includes a first frustoconical wall and the first connection lip 437 is substantially perpendicular to the planar lip 435.

Fig. 25 depicts an extension tube 450 of yet another embodiment of the present invention. The extension tube 450 includes a second connecting lip 455 and a closed distal end 457 and a second shell 456 extending therebetween. In one embodiment, the extension tube 450 is first extruded to form a tubular blank having a cylindrical open end 457a at one end and a second attachment lip 455 at the other end, and the cylindrical open end 457a is then heat and pressure welded to form a third sealed region 470, the third sealed region 470 defining the closed distal end 457. In this example, the second connecting lip 455 includes a second frustoconical wall that conforms to the shape and size of the first connecting lip 437. In another embodiment, the extension tube 450 further comprises a bellows 480. The bellows 480 is formed of a plurality of pleats 482 arranged in an axial direction of the extension pipe 450, each of the pleats 482 including a laterally extending pleat peak 483 and pleat valley 485 and a pleat wall 484 extending between the pleat peak 483 and the pleat valley 485.

Fig. 26-29 depict a unitized packaging system 400 of a fourth embodiment of the present invention. The modular packaging system 400 includes the hand held instrument 10, a body bag 430, an extension tube 450 and a lidstock 490. The first connecting lip 437 is welded to the second connecting lip 455 to form a first sealing area 440. The first sealing region 440 connects the body bag 430 and the extension tube 450 into an integral seamless housing 460, the seamless housing 460 defining a seamless cavity 461 that includes an open end. The surgical device 10 is loaded into the modular packaging system 400, wherein the elongated shaft 13 is loaded into the elongated tube 450, the handle 11 is loaded into the body pocket 430, the cover 490 and the planar wall 433 are welded to form a second sealing region 420, and the second sealing region 420 seals the opening of the seamless chamber 461 to form the fully enclosed modular packaging system 400. With continued reference to fig. 19, in this example, the axis 451 of the elongated tube 450 is parallel to the planar lip 435 (second sealing region 420).

One of ordinary skill will appreciate that the seamless shell 160, the seamless shell 260, the non-seamless shell 360, and the seamless shell 460 add a welding process (welding to form the first sealing region 140, the first sealing region 240, the first sealing region 340, or the first sealing region 440) as compared to the tray blister 32 described above in the background, which may result in increased overall manufacturing costs for the seamless shell 160, the seamless shell 260, the seamless shell 360, and the seamless shell 460. However, the reasonable selection of the manufacturing method and the reasonable design of the manufacturing process can reduce the manufacturing cost.

In one aspect of the invention, a method of manufacturing the seamless housing 160 is provided. The seamless housing 160 comprises a body bag 130 and an extension tube 150 and a first sealing region 140 integrally connecting the same. The manufacturing method mainly comprises the steps of plastic suction and trimming, extrusion molding and trimming and welding.

Plastic uptake and trimming procedure: the blister is a plastic sheet (film) that is heated to soften, vacuum-sucked on the surface of a mold, cooled, and molded. So-called trimming, i.e. removing excess material. Fig. 30-31 depict a blister-making of the body pockets 130, and in one design, more than 30 of the body pockets 130 can be formed using 1m by 1m sheets. Fig. 31 depicts the process of trimming (blanking) to form individual body pockets 130. In one embodiment, the lip outer edge 134 and the first connecting lip 137 are formed by one-time blanking.

Extrusion molding and cutting working procedure: the extrusion molding is a processing method for manufacturing various cross-section products or semi-products by continuously passing through a machine head through the action between a material cylinder and a screw of an extruder, heating and plasticizing the plastic and pushing the plastic forwards by the screw. In a preferred embodiment, the extension tube 150 is manufactured by extrusion as a tubular blank having a cylindrical open end 157a at one end and a second attachment lip 155 at the other end. The shape and manufacturing process of the tubular blank is similar to straws which are widely used in the food industry. The plastic extruding of the suction pipe is one of the most mature processing technologies at present, the manufacturing cost of the processing equipment is low, the processing efficiency is high, and therefore the product cost is low.

A welding procedure: and basically includes a closure weld forming the second housing closed distal end 157 and a connection weld integrally joining the body pocket 130 and the second housing. The closed welding usually does not need an additional die, and the universal flat plate heating welding is adopted. As previously described, the closed distal end 157 is formed by close welding the cylindrical open end of the tubular blank, allowing for welding of a plurality of products at one time, and the tooling is inexpensive and efficient.

It was mentioned above that the quality control of the sealing of the final sterilized packages is very important and complicated, both because of the ease of unpacking the packages at the time of use and because of the assurance of sufficient sealing strength. It should be noted that the distinction is understood that the sealing control described herein refers primarily to the tearable sealing edge. For example, the second sealing region 120 described in this example is also referred to as a tear-off sealing edge. The sealing quality of such a tear-off edge is complicated by the fact that the seal strength of the tear-off edge is low to allow easy opening of the package during use, but at the same time sufficient seal strength is required to ensure package reliability. Until now, the relevant quality control of such peelable sealing edges has been standardized in different countries or regions, for example EN868-5 specifies that the strength of a peelable sealing edge formed by heat-sealing sterilized paper and plastic should be more than or equal to 1.5N/15MM, and that the peelable sealing edge should not be subjected to excessive heat-sealing to produce more than 10MM of shredded paper on the sealing edge when torn. However, the first sealing area 140 and the third sealing area 170 of the present invention do not belong to a tearable sealing edge, but only a common sealing edge for connection and sealing, and the main properties thereof include a certain sealing strength and sufficient air tightness.

In contrast to the method of manufacturing the tray blisters 32 by the blister process, only about 7 of the tray blisters can be formed at a time using 1m by 1m sheets, the tray packaging system 30 described above is required to consume 570 x 200 mm of tyvek, and the total length of the tear-off edges of the tray packaging system 30 is about 1600 mm. This results in a larger amount of packaging material and increased material costs, as well as a larger footprint for the countertop when the tray blister and lid are sealed and an increased manufacturing cost due to the long length of the tear-off sealing edge. Although the seamless shell 160 described in this example adds additional processes, the production efficiency of plastic suction and plastic extrusion is very high, so the plastic suction and trimming processes, the plastic extrusion and trimming processes, and the simultaneous processing number of each station of the welding process can be reasonably arranged, and the production efficiency can be greatly improved. At the same time, it is helpful to reduce waste, reduce the overall wall thickness of the product and obtain a more uniform wall thickness. Thus, the production cost can be reduced while maintaining excellent quality, mainly including reducing the length of the tearable sealing edge, reducing the packaging volume, preventing the sharp tip from puncturing the product package, being beautiful and convenient for display, etc.

In another aspect of the invention, a method of manufacturing the seamless shell 360 is provided. The seamless housing 360 comprises a main body bag 330 and an extension tube 350 and a first sealing region 340 integrally connecting them. The manufacturing method mainly comprises the steps of plastic suction and trimming, blow molding and trimming and welding.

Plastic uptake and trimming procedure: in one design, a plurality of integrally connected body pockets 330 may be formed by vacuum forming a sheet, and then trimmed (blanked) to form a single body pocket 330.

And (3) blowing and cutting processes: first, an original extension pipe including the extension pipe 350 is manufactured by a blow molding method; the primary elongated tube further includes a proximal scanning wall extending proximally from the second attachment lip 355 and defining a proximal lumen, and a mouthpiece penetrating the proximal scanning wall and communicating with the proximal lumen. The extension tube 350 is obtained by trimming the original extension tube along the second attachment lip 355.

A welding procedure: mainly comprising a connection welding for integrally connecting the main body bag 330 and the extension pipe 350.

In yet another aspect of the present invention, a method of manufacturing the seamless housing 460 is presented. The seamless housing 460 comprises a body bag 430 and an extension tube 450 with a first sealing region 440 integrally connecting them. The manufacturing method mainly comprises the steps of plastic suction and trimming, extrusion molding and trimming and welding.

Plastic uptake and trimming procedure: the method is characterized in that a flexible plastic sheet, for example, a PVC (polyvinyl chloride) sheet with the thickness of 0.2-0.5 mm is heated to be softened, then the PVC sheet is adsorbed on the surface of a mold in vacuum, and the PVC sheet is formed after cooling. In one design, more than 30 of the body pockets 430 can be formed integrally using a 1m by 1m PVC sheet of 0.5 mm thickness, and the individual body pockets 430 including the outer lip 134 and the first connecting lip 137 can be formed by one-time blanking.

Extrusion molding and cutting working procedure: in a preferred embodiment, the extension tube 450 is manufactured by extrusion into a tubular blank having a cylindrical open end 457a at one end (not shown) and a truncated-cone-shaped second connecting lip 455 at the other end.

A welding procedure: including essentially the closure weld that forms the closed distal end 457 of the second housing and the attachment weld that joins the body bag 430 and the second housing together as a unit. The closed welding usually does not need an additional die, and the universal flat plate heating welding is adopted. As described above, the cylindrical open end of the tubular blank is welded to form the closed distal end 457, so that a plurality of products can be welded at one time, and the processing equipment is low in cost and high in processing efficiency.

It will be appreciated by those skilled in the art that when rigid plastic or hard plastic is used to form the body pocket 430, the body pocket 430 cannot be demolded or is difficult to demold. The plastic materials can be roughly divided into four types according to the difference of hardness (Shore hardness), namely hard plastics (hardness is more than or equal to 86D), medium hard plastics (83D is more than or equal to 65D), semi-rigid plastics (98A is more than or equal to 90A), and soft plastics (86A is more than or equal to 10A). The hardness of the material can be measured according to the relevant specifications of ASTM D2240-97. In one design, the body bag 430 is made of a soft plastic or a semi-rigid plastic. The hardness of the material decreases and its strength and stiffness also respond to the decrease. The lower the hardness, the lower the material strength and stiffness. In a preferred embodiment, the sheet material from which the main body bag 430 is made has a material hardness HD, where 90A ≧ HD ≧ 70A. When the material hardness of the sheet material is more than or equal to 70A, the flexible part has enough rigidity and strength, and can effectively prevent the rupture in the packaging, storage and transportation processes; when the hardness of the material of the sheet is less than or equal to 90A, the sheet is soft enough to facilitate demoulding in the process of manufacturing the body belt 430 by vacuum forming.

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. For example, modifying the shape and size of the body pocket of the present invention to accommodate the packaged product, such as modifying the shape and size of the first attachment lip of the present invention, modifying the shape and size of the proximal lip of the present invention, and the like. 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. A modular packaging system for medical devices comprising a hand held device comprising a handle and an elongated shaft connected to the handle, wherein:

1) the combined packaging system also comprises a main bag, an extension tube and a cover material;

2) the body pocket includes a planar lip and a first connecting lip and a first shell extending therebetween; the planar lip portion comprising a lip outer edge and a lip inner edge defining an open package opening and a planar wall extending therebetween; the first connecting lip defines an open connecting aperture;

3) the extension tube comprises a second connecting lip and a closed distal end and a second shell extending therebetween;

4) the first connecting lip and the second connecting lip are welded to form a first sealing area; the first sealing area connects the main bag and the extension pipe into an integral seamless shell, and the seamless shell defines a seamless cavity with one open end;

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

2. The modular packaging system of claim 1, wherein said first attachment lip comprises a first frustoconical wall and said second attachment lip comprises a second frustoconical wall adapted in shape and size to said first attachment lip.

3. The combination packaging system of claim 1, wherein the closed distal end comprises a third sealed region.

4. The combination packaging system of claim 1, wherein said first attachment lip is substantially parallel to said planar lip, and wherein said first sealing area is substantially parallel to said second sealing area, in response thereto.

5. The combination packaging system of claim 1, wherein said first attachment lip is substantially perpendicular to said planar lip, and wherein said first sealing area is substantially perpendicular to said second sealing area, in response thereto.

6. A combination packaging system as in claim 5, wherein said body bag includes a neck portion and a pocket portion, said neck portion being connected to and parallel to said planar lip, said neck portion having a dimension less than a dimension of said pocket portion.

7. A method of manufacturing a seamless shell for a unitized package system of claim 3, said seamless shell comprising a main bag and an extension tube and a first seal area integrally connecting the two; it is characterized by comprising:

plastic uptake and trimming procedure: manufacturing a plurality of integrally connected main body bags by a plastic suction method, and trimming to form a single main body bag;

extrusion molding and cutting working procedure: manufacturing the extension pipe by an extrusion molding method and cutting the extension pipe to a designed size;

a welding procedure: including a seal weld forming a closed distal end of the extension tube and a connection weld joining the body bag and the extension tube together as a unit.