WO2018219316A1

WO2018219316A1 - Combined packaging system for medical instrument

Info

Publication number: WO2018219316A1
Application number: PCT/CN2018/089185
Authority: WO
Inventors: 朱莫恕
Original assignee: 成都五义医疗科技有限公司
Priority date: 2017-06-03
Filing date: 2018-05-31
Publication date: 2018-12-06
Also published as: CN107031985A; CN107031985B

Abstract

Disclosed is a combined packaging system for a medical instrument. The combined packaging system comprises a handheld instrument (10) comprising a handle (11) and a slender rod (13) connected to the handle, the combined packaging system further comprising a main body bag (130), an extension pipe (150) and a cover (190). The main body bag comprises a planar lip (135), a first connecting lip (137) and a first shell (136) extending therebetween. An open packaging opening is defined by an inner lip edge (132). An open connecting hole (138) is defined by the first connecting lip. The extension pip comprises a second connecting lip (155), a sealed distal end (157) and a second shell (156) extending therebetween. The first connecting lip and the second connecting lip are welded to form a first sealed area (140); the main body bag and the extension pip are connected by the first sealed area to form an integral seamless housing (160); and a seamless cavity (161) comprising an end opening is defined by the seamless housing. The cover and a planar wall (133) are welded to form a second sealed area (120), and the seamless housing and the cover are connected by the second sealed area to form an integral sealed cavity. The combined packaging system can reduce the production cost, the length of the tearable sealed edge and the packaging volume of same.

Description

Combined packaging system for medical instruments

Technical field

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

Background technique

Disposable surgical instruments, including but not limited to staplers, laparoscopic surgical forceps, laparoscopic energy cutting instruments, laparoscopic suture instruments, medical suction straws, extractors, tractors, and trocars. Typically such surgical instruments include a larger sized handle and an elongated shank that is coupled to the handle, which will be collectively referred to hereinafter as a hand held instrument. The hand held device is packaged in a terminally sterilized package and sterilized for sale and storage in a sterile manner. The packaged product remains sterile during the sterilization period and the final sterilization package is not damaged. There are many sterilization methods, the most widely used including EO ethylene oxide sterilization and radiation sterilization. The sterilization method must generally be compatible with the final sterilization package.

The terminally sterilized packages currently disclosed for packaging hand-held devices mainly include bag packaging and tray packaging (or blister packaging). Among them, the production of bag packaging is highly automated and inexpensive, however, since hand-held instruments typically include a large handle, an elongated rod and a sharp tip, the elongated rod and sharp tip easily pierce its bag packaging system resulting in sterility damage. The packaging of tray packaging (bubble packaging) is more reliable and widely used.

A tray package (or blister pack) usually consists of an upper cover (paper sheet) and a lower tray (lower bulb), which is usually made by blistering, that is, after the plastic hard sheet is heated and softened, A plurality of cavities or channels are created by vacuum adsorption, which are used to hold and secure the packaged product. Figure 1 depicts a typical tray packaging system 30 of the existing packaging technology for hand held instruments. The tray packaging system 30 includes a Tyvek paper 31 and a tray blister 32. The tray blister 32 includes a horizontal flange 33 and a plurality of concave cavities 34 that are generally perpendicular thereto and a channel 35 that communicates the cavities. A hand-held instrument 10 includes a handle 11 and a sharp tip 15 and an elongated rod 13 extending therebetween. The locking recess 34 accommodates the handle 11, the channel 35 accommodates the elongated rod 13, and the sheet 31 and the tray blister 32 are welded (heat sealed) along the horizontal flange 33 to form a complete The closure area 40 (not shown) forms a closed terminal sterilization package.

The stretchability of the molded articles is limited, and the depth/width ratio of the molded cavity is usually less than or equal to 1, and in the worst case, it is usually not more than 1.5. Moreover, the wall thickness of the plastic forming cavity is usually less than or equal to 1 mm, and the maximum stretching depth of the cavity is usually not more than 100 mm. A tray package (bubble package) of a hand-held device has been disclosed so far, the hand-held device being lie on a tray or blister substantially in such a manner that the axis of its elongated rod is substantially parallel to the horizontal flange 33 (sealing region 40) Inside, it is referred to as horizontal blister packaging (or tray blister packaging). The horizontal blister package also has many defects, mainly including the long sealing area as a whole leads to low production efficiency of welding (heat sealing) and poor stability of the sealing area; irregular cavity size leads to multiple terminal sterilization The packaging wastes more space when stacked on each other. For example, the hand-held instrument 10 depicted in Figure 1 is a 5 x 330 mm gauge splitting pliers, the tray packaging system 30 requires a 570 x 200 mm plastic sheet to make the tray blister 32, and 570 x 200 mm Tyvek paper not only leads to a large amount of material, but also causes a large processing area occupied by the heat sealing of the shell processing and the final sterilization package, thereby reducing the production volume of the bulb production and packaging heat sealing, resulting in Production costs increase. In order to address one or more of the foregoing problems, it is an object of the present invention to provide a combined packaging system for a hand held device package.

Summary of the invention

In one aspect of the invention, a combination packaging system for a medical device, a combination packaging system for a medical device, comprising a hand held instrument comprising a handle and an elongated rod coupled to the handle is provided. The combination packaging system also includes a body bag, an extension tube and a cover material. The body bag includes a planar lip and a first connecting lip and a first housing extending therebetween; the planar lip includes an outer lip and an inner lip and a planar wall extending therebetween, the inner lip An open packaging opening is defined; the first connecting lip defines an open connecting aperture. The extension tube includes a second attachment lip and a closed distal end and a second housing extending therebetween. The first connecting lip is welded to the second connecting lip to form a first sealing region; the first sealing region connects the main body bag and the extension tube into a unitary seamless casing, the The slot housing defines a seamless cavity that includes an opening at one end. The cover material and the planar wall are welded to form a second sealing region, and the second sealing region connects the seamless casing and the cover material into an integral closed cavity.

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 sealing region.

In still another implementation, the first attachment lip is substantially parallel to the planar lip, and the first closure region is substantially parallel to the second closure region.

In still another implementation, the first connecting lip is substantially perpendicular to the planar lip, and the first sealing region is substantially perpendicular to the second sealing region.

In still another implementation, the main body bag includes a thin neck portion and a bag body portion, the thin neck portion being coupled to the planar lip, and in a lateral direction parallel to the planar lip, the thin The size of the neck portion is smaller than the size of the body portion.

In another aspect of the invention, a method of making a seamless casing of a combination packaging system is disclosed, the seamless casing comprising a main bag body and an extension tube and a first closure region that is integrally joined thereto. Its manufacturing method has:

Blistering and trimming process: blistering process to manufacture a plurality of integrated main bag bodies, and trimming (punching) to form a single main bag body;

Extrusion and cutting process: the extension tube is manufactured by extrusion and cut to the design size;

Welding process: mainly includes forming a closed weld of the extended end of the extension pipe, and connecting the main bag body and the extension pipe into a unitary joint welding.

DRAWINGS

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

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

Figure 2 is a combined view of the combined packaging system 100;

Figure 3 is an exploded view of the combined packaging system 100;

4 is a perspective view of the main bag body 130;

Figure 5 is a plan view of the main bag body shown in Figure 4 from the proximal end to the distal end;

Figure 6 is a partial cross-sectional view of the combination packaging system of Figure 2;

Figure 7 is an enlarged plan view of the closed distal end 157 of the packaging system of Figure 6;

Figure 8 is an enlarged plan view of the first closure region 140 of the combination packaging system of Figure 6;

Figure 9 is a perspective view of a main bag body 230 of another embodiment;

Figure 10 is a plan view of the main bag body 230 of Figure 9 from the proximal end to the distal end;

Figure 11 is a cross-sectional view taken along line 11-11 of the main bag body shown in Figure 10;

Figure 12 is a perspective view of the combined packaging system 200;

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

Figure 14 is a perspective view of a main body bag 330 of another embodiment;

Figure 15 is a plan view of the main body bag 330 of Figure 14 from the proximal end to the distal end;

Figure 16 is a side elevational view of the main body bag 330 of Figure 15;

Figure 17 is a perspective view of an extension tube 350 of another embodiment;

Figure 18 is a perspective view of the combined packaging system 300;

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

Figure 20 is an enlarged plan view of the first closure region 340 of the combination packaging system of Figure 19;

21 is a perspective view of a main body bag 430 according to another embodiment;

Figure 22 is a perspective view showing the opposite direction of the main body bag 430 shown in Figure 21;

Figure 23 is a plan view of the main body bag 430 of Figure 21 from the proximal end to the distal end;

Figure 24 is a cross-sectional view taken along line 24-24 of the main body bag 430 of Figure 23;

Figure 25 is a perspective view of an extension tube 450 of another embodiment;

Figure 26 is a perspective view of the combined packaging system 400;

Figure 27 is a partial cross-sectional view of the combination packaging system of Figure 26;

Figure 28 is a partial enlarged view of the first sealing region 440 of the combined packaging system of Figure 27;

Figure 29 is an enlarged plan view of the closed distal end 457 of the combination packaging system of Figure 27;

Figure 30 is a schematic view showing the plastic manufacturing of the main body bag 130 shown in Figure 4;

Figure 31 is a schematic view showing the trimming of the main body bag 130 of Figure 30 after being manufactured by blister;

In all the views, the same reference numerals indicate equivalent parts or parts.

detailed description

Embodiments of the present invention are disclosed herein, but it should be understood that the disclosed embodiments are merely examples of the invention, which may be implemented in various ways. Therefore, the disclosure of the present invention is not to be construed as limiting, but as a basis Those skilled in the art will appreciate that disposable surgical instruments include, but are not limited to, staplers, laparoscopic surgical forceps, laparoscopic energy cutting instruments, laparoscopic suture instruments, medical irrigation straws, retractors, tractors, punctures. Device. Typically such surgical instruments include a larger sized handle and an elongated shank that is coupled to the handle, which will be collectively referred to hereinafter as a hand held instrument. In the present invention, the terminal sterilization package is mainly described by taking a disposable bending separation forceps commonly used in laparoscopic surgery as an example. For convenience of presentation, one of the parties that is close to the operator is defined as the near end, and the party that is far from the operator is defined as the far end.

2-8 illustrate a combined packaging system 100 of a first embodiment of the present invention. The combination packaging system 100 includes a hand-held instrument 10, a body bag 130, an extension tube 150, and a cover material 190. The handpiece 10 includes a handle 11 and a sharp tip 15 and an elongated rod 13 extending therebetween. The handle 11 includes a front handle 12 and a rear handle 14. Referring first to Figures 4-5, the body pocket 130 includes a planar lip 135 and a first attachment lip 137 and a first housing 136 extending therebetween. The planar lip 135 includes an outer lip 134 and an inner lip 132 and a planar wall 133 extending therebetween, the inner lip 132 defining an open package opening 131; the first attachment lip 137 defining an open Connection hole 138. The shape of the package opening 131 may be a circle shape, an elliptical circle shape, a polygonal ring shape or other irregular closed ring shape. In the present invention, the shape of the package opening 131 is approximately rectangular. Similarly, the connecting hole 138 may also be a circle shape, an elliptical ring shape, a polygonal ring shape or other irregular closed ring shape. In the present example, the connecting hole 138 has a circular shape. It will be understood by those skilled in the art that the shape of the first housing 136 is generally adapted to the shape of the packaged product, typically based on the contour of the packaged product and simplified formation.

Referring now to Figures 2-3, the extension tube 150 includes a second attachment lip 155 and a closed distal end 157 and a second housing 156 extending therebetween. In one embodiment, the extension tube 150 is first manufactured by extrusion into a tubular blank having a cylindrical open end 157a at one end and a second connecting lip 155 at the other end, and then hot-welded the cylindrical open end 157a to form a third. Sealing edge 170. In the present example, the third sealing edge 170 constitutes a closed distal end 157.

Referring now to Figures 2 and 6-8, the first attachment lip 137 is welded to the second attachment lip 155 to form a first closure region 140. The first closure region 140 joins the body pocket 130 and the extension tube 150 into a unitary seamless housing 160 that defines a seamless cavity 161 that includes an open end. Referring now to Figures 2 and 6, the surgical instrument 10 is loaded into the interior of the combination packaging system 100, wherein the elongate shaft 13 fits inside the extension tube 150, and the handle 11 fits into the main bag body Inside the 130, the cover material 190 and the planar wall 133 are welded to form a second sealing region 120, which closes the opening of the seamless cavity 161 to form a completely closed combined packaging system 100. . Referring now to Figures 5-6, the planar lip 135 further includes a projection 139 that is not welded to the cover member 190 to facilitate tearing of the combination packaging system 100 during use. With continued reference to FIG. 6, in the present example, the axis 151 of the extension tube 150 is generally perpendicular to the planar lip 135 (second sealing region 120).

Those skilled in the art will appreciate that there are many types of welding methods including, but not limited to, thermocompression bonding, 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 can 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, etc. Wait. The cover material 190 may be made of a gas impermeable plastic film or a porous gas permeable material having bio-barrier properties (for example, Tyvek medical cover material 4058B, 1059B, 1073B, Asuron). Tyvek medical cover materials are widely used in the field of final sterilization packaging of trocars, but they are expensive, and the seamless housing 160 of the present invention facilitates reducing the amount of Tyvek medical cover material. In addition, when the seamless casing 160 is fabricated from a transparent material, the seamless casing 160 of the present invention also facilitates the display of its packaged articles for ease of use.

9-11 depict a body bag 230 of another embodiment. The body pocket 230 includes a planar lip 235 and a first attachment lip 237 and a first housing 236 extending therebetween. The planar lip 235 includes an outer lip 234 and an inner lip 232 and a planar wall 233 extending therebetween, the inner lip 232 defining an open package opening 231; the first attachment lip 237 defining an open Connection hole 238. The shape of the first housing 236 is generally adapted to the shape of the packaged product, typically based on the contour of the packaged product and simplified formation. The first housing 236 further includes an inward protrusion 211 for fixing the front handle 12.

Figures 12-13 depict a combined packaging system 200 of a second embodiment of the present invention. The combination packaging system 200 includes a hand-held instrument 10, a body bag 230, an extension tube 150, and a cover material 190. The first connecting lip 237 is welded to the second connecting lip 155 to form a first sealing region 240. The first sealing region 240 connects the main body bag 230 and the extension tube 150 into a unitary seamless housing 260, the seamless housing 260 defining a seamless cavity 261 including an opening at one end (not shown) Mark). The surgical instrument 10 is loaded into the interior of the combination packaging system 100, wherein the elongated rod 13 fits inside the extension tube 150, and the handle 11 is loaded into the interior of the main bag body 230, the cover material 190 Welding with the planar wall 233 forms a second closure region 220 that closes the opening of the seamless cavity 261 to form a fully enclosed modular packaging system 200. The inward protrusion 211 is snapped into the handle ring of the front handle 12 to limit displacement of the front handle within the body pocket 230.

14-16 depict a body bag 330 of another embodiment. The body pocket 330 includes a planar lip 335 and a first attachment lip 337 and a first housing 336 extending therebetween. The planar lip 335 includes an outer lip 334 and an inner lip 332 and a planar wall 333 extending therebetween. The lip inner edge 332 defines an open package opening 331; the first attachment lip 337 defines an open attachment aperture 338. The shape of the first housing 336 is generally adapted to the shape of the packaged product, typically based on the contour of the packaged product and simplified formation. The main difference between the main body bag 330 and the main body bag 130 and the main body bag 230 is the positional relationship between the planar lip and the first connecting lip, the planar lip 335 and the first connecting lip. The portions 337 intersect substantially perpendicularly or at an acute angle, and the planar lip 135 is substantially parallel to the first connecting lip 137.

Figure 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 355b. In one embodiment, the extension tube 150 is first made of a blow-molten original extension tube containing the extension tube 350, and then trimmed to remove excess material such as a mouthpiece to obtain the extension tube 350.

18-20 depict a combined packaging system 300 of a third embodiment of the present invention. The combination packaging system 300 includes a hand-held instrument 10, a body bag 330, an extension tube 350, and a cover material 390. The first connecting lip 337 is welded to the horizontal flange 355a of the second connecting lip 355 to form a first sealing region 340. The first closure region 340 joins the body pocket 330 and the extension tube 350 into a unitary seamless housing 360 that defines a seamless cavity 361 that includes an opening at one end. The surgical instrument 10 is loaded into the interior of the combination packaging system 300, wherein the elongated rod 13 fits inside the extension tube 350, and the handle 11 is loaded into the interior of the main bag body 330, the cover member 390 The planar wall 333 is welded to form a second sealing region 320 that closes the opening of the seamless cavity 361 to form a fully enclosed modular packaging system 300. With continued reference to FIG. 19, in the present example, the planar lip 335 (second sealing region 320) of the axis 351 of the extension tube 350 is at an acute angle or parallel thereto.

21-24 depict a body bag 430 of yet another embodiment. The body pocket 430 includes a planar lip 435 and a first attachment lip 437 and a first housing 436 extending therebetween. The planar lip 435 includes an outer lip 434 and an inner lip 432 and a planar wall 433 extending therebetween. The lip inner edge 432 defines an open package opening 431; the first attachment lip 437 defines an open attachment aperture 438. The shape of the first housing 436 is generally adapted to the shape of the packaged product, typically based on the contour of the packaged product and simplified formation. Referring now to Figures 22 and 24, the first housing 436 in this example can be generally divided into a thin neck portion 436a and a pocket portion 436b from a proximal end to a distal end, wherein the thin neck portion 436a and the lip Inner edges 432 are joined, having a first width dimension B1, how many pocket portions 436b have a second width dimension B2, and said B1 < B2. The first attachment lip 437 includes a first frustoconical wall and the first attachment lip 437 is substantially perpendicular to the planar lip 435.

Figure 25 depicts an extension tube 450 of yet another embodiment of the present invention. The extension tube 450 includes a second attachment lip 455 and a closed distal end 457 and a second housing 456 extending therebetween. In one embodiment, the extension tube 450 is first extruded into a tubular blank having a cylindrical open end 457a at one end and a second connecting lip 455 at the other end, and then hot-welded the cylindrical open end 457a to form a third Sealing edge 470, which forms a closed distal end 457. In the present example, the second connecting lip 455 includes a second frustoconical wall that is compliant with the shape and size of the first connecting lip 437. In another design, the extension tube 450 further includes a bellows 480. The bellows 480 is comprised of a plurality of pleats 482 disposed along the axial direction of the extension tube 450, each of the pleats 482 including laterally extending pleat peaks 483 and pleat valleys 485 and at the pleat peaks 483 and pleat valleys 485 A pleated wall 484 extends between.

26-29 depict a combined packaging system 400 of a fourth embodiment of the present invention. The combination packaging system 400 includes a hand-held instrument 10, a body bag 430, an extension tube 450, and a cover material 490. The first connecting lip 437 is welded to the second connecting lip 455 to form a first sealing region 440. The first closure region 440 joins the body pocket 430 and the extension tube 450 into a unitary seamless housing 460 that defines a seamless cavity 461 that includes an opening at one end. The surgical instrument 10 is loaded into the interior of the combination packaging system 400, wherein the elongated rod 13 is loaded into the interior of the extension tube 450, and the handle 11 is loaded into the interior of the main bag body 430, the cover material 490 The planar wall 433 is welded to form a second sealing region 420 that closes the opening of the seamless cavity 461 to form a fully enclosed modular packaging system 400. With continued reference to FIG. 19, in the present example, the planar lip 435 (second sealing region 420) of the axis 451 of the extension tube 450 is parallel.

It will be appreciated by one of ordinary skill that the seamless housing 160, the seamless housing 260, the incomplete housing 360 and the seamless housing 460 have increased soldering procedures (welding) compared to the tray blister 32 described above. Forming a first sealing area 140, a first sealing area 240, a first sealing area 340 or a first sealing area 440), which may result in a seamless housing 160, a seamless housing 260, a seamless housing 360 The overall manufacturing cost of the seamless housing 460 is increased. However, a reasonable choice of manufacturing methods and a reasonable design and manufacturing process can reduce manufacturing costs.

In one aspect of the invention, a method of manufacturing the seamless housing 160 is presented. The seamless housing 160 includes a main body pocket 130 and an extension tube 150 and a first sealing region 140 that is integrally connected thereto. The manufacturing method mainly includes a blistering and trimming process, an extrusion and trimming process, and a welding process.

Blistering and trimming process: so-called blistering, that is, using a plastic sheet (film) to heat and soften, vacuum adsorption on the surface of the mold, cooling and forming. The so-called trimming, that is, removing excess material. 30-31 depict a schematic view of the blister manufacturing of the body bag 130. In one design, more than 30 of the body pockets 130 can be blipped using a sheet of 1 meter by 1 meter. Figure 31 depicts the process of trimming (punching) a single body pocket 130. In one design, the outer edge 134 and the first connecting lip 137 are formed by one-time blanking.

Extrusion and cutting process: the extrusion means that the plastic passes through the action between the barrel of the extruder and the screw, and is plasticized while being pushed forward by the screw, continuously passing through the head to make various cross-section products or A processing method for semi-finished products. In a preferred embodiment, the extension tube 150 is manufactured by extrusion to a tubular blank having a cylindrical open end 157a at one end and a second connecting lip 155 at the other end. The shape and manufacturing process of the tubular blank is similar to straws that are widely used in the food industry. Pipette extrusion is one of the most mature processing methods at present. Its processing equipment is low in cost and high in processing efficiency, so its product cost is very low.

The welding process: mainly includes forming a closed weld of the second outer casing closing distal end 157, and joining the main body bag 130 and the second outer casing into a unitary joint. The closed weld usually does not require an additional mold and can be welded using a universal flat plate. As described above, the cylindrical open end of the tubular blank is closed and welded to form a closed distal end 157, and a plurality of products can be welded at one time, and the processing equipment is low in cost and high in processing efficiency.

As mentioned above, the sealing quality control of the final sterilization package is very important and complicated because it is convenient to disassemble the package at the same time and to ensure sufficient sealing strength. It should be noted that the understanding of the difference is that the sealing control described herein mainly refers to the tearable sealing edge. For example, the second sealing region 120 described in this example is also referred to as a tearable sealing edge. The heat seal strength of the tearable sealing edge should be small so that the package can be easily disassembled when used, but at the same time, sufficient heat sealing strength is required to ensure the reliability of the package, so the sealing quality control of the tearable sealing edge is controlled. More complicated. So far, the relevant quality control for such tearable sealing edges has been standardized in different countries or regions. For example, EN868-5 stipulates the tearable sealing edge formed by the heat sealing of sterilized paper and plastic, and the strength of the sealing edge should be ≥ 1.5N/15MM, and the tear-sealing edge cannot be excessively heat-sealed, resulting in a scrap paper of 10 mm or more on the sealing edge when tearing. However, the first sealing area 140 of the present invention, the third sealing area 170 does not belong to the tearable sealing edge, and is only a common sealing edge for connecting and sealing, and its main properties include a certain sealing strength and sufficient. The hermeticity, it will be understood by those skilled in the art that the quality control of such conventional sealing edges is relatively easy and does not increase the quality control cost to a large extent.

With respect to the method of manufacturing the tray blister 32 by the blistering process, only about 7 of the tray blister can be blipped at one time using a sheet of 1 m x 1 m. The tray packaging system 30 described in the background It is necessary to consume 570 x 200 mm Tyvek paper, and the total length of the tearable sealing edge of the tray packaging system 30 is about 1600 mm. This results in a larger amount of the packaging material and an increase in the material cost. At the same time, when the tray blister and the cover material are sealed, the size of the work surface is large and the length of the tearable sealing edge is too long, which increases the processing cost. Although the seamless casing 160 described in the present example has an increased process, since the production efficiency of the blistering and extrusion is high, the blistering and trimming processes, the extrusion and trimming processes, and the welding process each station are rationally arranged. At the same time, the number of processing can greatly improve production efficiency. It also helps to reduce waste, reduce the overall wall thickness of the product and achieve a more uniform wall thickness. Therefore, it is possible to maintain excellent quality while reducing production cost, mainly including reducing the length of the tearable sealing edge, reducing the packaging volume, preventing the sharp tip from piercing the product package, and being beautiful and convenient for display.

In another aspect of the invention, a method of making the seamless housing 360 is presented. The seamless housing 360 includes a body pocket 330 and an extension tube 350 and a first closure region 340 that is integrally joined thereto. The manufacturing method mainly includes a blistering and trimming process, a blow molding and trimming process, and a welding process.

Blistering and Trimming Process: In one design, a plurality of integrally formed body pockets 330 can be formed by blistering and then trimmed (punched) to form a single body pocket 330.

Blow molding and cutting process: firstly, the original extension tube including the extension tube 350 is manufactured by blow molding; the original extension tube further includes a proximal scanning wall extending proximally from the second connecting lip 355 and its definition The proximal lumen further includes a mouthpiece that penetrates the proximal scanning wall and communicates with the proximal lumen. The extension tube 350 is obtained by trimming the original extension tube along the second connection lip 355.

The welding process mainly includes connecting the main body bag 330 and the extension pipe 350 into a single joint welding.

In yet another aspect of the invention, a method of making the seamless housing 460 is presented. The seamless housing 460 includes a main body pocket 430 and an extension tube 450 and a first sealing region 440 that is integrally joined thereto. The manufacturing method mainly includes a blistering and trimming process, an extrusion and trimming process, and a welding process.

Blistering and trimming process: a flexible plastic sheet is used. For example, a PVC (polyvinyl chloride) sheet having a thickness of 0.2 to 0.5 mm is heated and softened, and then vacuum-adsorbed on the surface of the mold to be cooled and formed. In one design, more than 30 integral body pockets 430 can be molded using a 1 meter by 1 meter 0.5 mm thick PVC sheet, and then blanked to form a lip-containing outer edge 134 and first. A single body pocket 430 that connects the lips 137.

Extrusion and cutting process: In a preferred embodiment, the extension tube 450 is manufactured by an extrusion method to have a second connecting lip 455 having a cylindrical open end 457a (not shown) at one end and a truncated cone at the other end. Tubular blank.

The welding process: mainly includes forming a closed weld of the second outer casing closing distal end 457, and joining the main body bag 430 and the second outer casing into a unitary joint weld. The closed weld usually does not require an additional mold and can be welded using a universal flat plate. As described above, the cylindrical open end of the tubular blank is closed and welded to form a closed distal end 457, and 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 understood by those skilled in the art that when the main bag body 430 is manufactured by rigid plastic or hard plastic blister, the main bag body 430 cannot be demolded or difficult to release. Plastic materials can be roughly divided into four categories according to their hardness (hardness hardness), hard plastic (hardness≥86D), medium hard plastic (83D≥hardness≥65D), semi-rigid plastic (98A≥hardness≥90A), soft Plastic (86A≥hardness≥10A). The hardness of the material can be measured in accordance with the relevant regulations of ASTM D2240-97. In one design, the main bag body 430 is made of soft plastic or semi-rigid plastic. The hardness of the material is reduced, and its strength and stiffness are also reduced in response. If the hardness is too low, the material strength and rigidity are lower. In a preferred implementation, the sheet material from which the main bag body 430 is fabricated has a material hardness of HD, wherein 90A ≥ HD ≥ 70A. When the material hardness of the sheet is greater than or equal to 70A, the flexible portion has sufficient rigidity and strength to effectively prevent cracking during packaging and storage; when the material hardness of the sheet is less than or equal to 90A, the sheet is sufficient Soft to facilitate blistering to demold the body strip 430.

Many different embodiments and examples of the invention have been shown and described. One of ordinary skill in the art can make adaptations to the methods and apparatus by appropriate modifications without departing from the scope of the invention. For example, modifying the shape and size of the main bag body of the present invention to suit the packaged product, for example, modifying the shape and size of the first connecting lip of the present invention, modifying the proximal lip of the present invention Shape and size, etc. Several corrections have been mentioned, and other modifications are also conceivable to those skilled in the art. Therefore, the scope of the invention should be construed in the appended claims and the claims

Claims

A combination packaging system for a medical device, comprising a hand-held instrument comprising a handle and an elongated rod coupled to the handle, wherein:

1) The combined packaging system further comprises a main body bag, an extension tube and a cover material;

2) the body bag comprises a planar lip and a first connecting lip and a first housing extending therebetween; the planar lip comprising an outer lip and an inner lip and a planar wall extending therebetween, the lip The inner edge defines an open packaging opening; the first connecting lip defines an open connecting aperture;

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

4) the first connecting lip is welded to the second connecting lip to form a first sealing region; the first sealing region connects the main body bag and the extension tube into a unitary seamless casing, The seamless housing defines a seamless cavity including an opening at one end;

5) The cover material and the planar wall are welded to form a second sealing region, and the second sealing region connects the seamless casing and the cover material into an integral closed cavity.
The combination packaging system of claim 1 wherein said first attachment lip comprises a first frustoconical wall, said second attachment lip comprising a shape and size adapted to said first attachment lip The second truncated conical wall.
The combination packaging system of claim 1 wherein said closed distal end comprises a third closure region.
The combination packaging system of claim 1 wherein said first attachment lip is substantially parallel to said planar lip, and wherein said first closure region is substantially parallel to said first Two sealed areas.
The combination packaging system of claim 1 wherein said first attachment lip is substantially perpendicular to said planar lip, and wherein said first closure region is substantially perpendicular to said first Two sealed areas.
The combination packaging system according to claim 5, wherein said body bag comprises a neck portion and a bag portion, said neck portion being coupled to said planar lip and parallel to said planar lip The size of the neck portion is smaller than the size of the bag portion.
The method of manufacturing a seamless casing of a combination packaging system according to claim 3, wherein the seamless casing comprises a main body bag and an extension tube, and a first sealing region that is integrally connected thereto;

Blistering and trimming process: blistering process to manufacture a plurality of integrated body bags, and trimming (punching) to form a single body bag; extrusion and cutting process: extrusion process to manufacture the extension tube and cutting to design size ;

Welding process: mainly includes forming a closed welding of the extended end of the extension tube, and connecting the main body bag and the extension tube into a single joint welding