WO2018219315A1

WO2018219315A1 - Combined packaging system for puncture outfit

Info

Publication number: WO2018219315A1
Application number: PCT/CN2018/089180
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: CN107416351A; CN107416351B

Abstract

Disclosed is a combined packaging system for a puncture outfit, the combined packaging system comprising a first housing (530), a second housing (550) and a cover (510), wherein the first housing (530) comprises a planar lip (535), a first connecting lip (537) and a first shell (536) extending therebetween; the planar lip (535) includes an outer lip edge (534), an inner lip edge (532) and a planar wall (533) extending therebetween, and an open packaging opening (531) is defined by the inner lip edge (532); an open connecting hole (538) is defined by the first connecting lip (537); the second housing (550) includes a second connecting lip (555), a sealed distal end (557) and a second shell (556) extending therebetween; the first connecting lip (537) and the second connecting lip (555) are welded to form a first sealed side; the first housing (530) and the second housing (550) are connected by the first sealed side to form an integral seamless housing, and a seamless cavity comprising an end opening is defined by the seamless housing; and the cover (510) and the planar wall (533) are welded to form a second sealed side, and the seamless housing and the cover (510) are connected by the second sealed side to form an integral sealed cavity.

Description

Combined packaging system for puncturing device

Technical field

The present invention relates to a minimally invasive surgical instrument, and more particularly to a trocar packaging structure.

Background technique

A trocar is a surgical instrument used to create an artificial passage into a body cavity during minimally invasive surgery (especially for hard laparoscopic surgery). The trocar usually consists of a cannula assembly and a puncture needle. Currently, single-use puncture devices have been widely used in various clinical operations. The puncturing device is packaged in a terminally sterilized package, sterilized and sold and stored in a sterile manner, and the packaged product remains intact during the sterilization period and the final sterilized package is not damaged. Bacterial status. 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 terminal sterilization packages currently disclosed for packaging punctures mainly include bag packaging and tray packaging (or blister packaging). The bag packaging is highly automated and inexpensive to produce, however, since the piercer (puncture needle or cannula assembly) typically contains a large handle or cartridge body, a slender tube and a sharp tip, the sharp tip easily pierces its bag packaging system. As a result of the destruction of the aseptic state, and due to the large difference in the size of the shape, the bag packaging with the puncturing device is mutually squeezed, which easily causes the bag package to be broken. U.S. Patent No. 7,767,392 discloses a tip protector that can be used to prevent the tip of the piercer from piercing the packaging system. However, the tip protector increases the overall packaging cost and does not solve the problem of the bag packages being crushed against each other. Tray packaging (bubble packaging) is widely used due to its relatively high cost performance.

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. Figures 1-2 depict a typical tray packaging system 30 of the prior art packaging techniques of the trocar. 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 generally perpendicular thereto and a channel 35, a channel 36, for communicating the cavities. In one version, the channel 35 and channel 36 also include a laterally projecting release button 37. A cannula assembly 10 includes a relatively large cannula cartridge body 11 and a relatively sharp cannula tip 15 and an elongated tube 13 extending therebetween, and a valve assembly projecting beyond the cannula cartridge body 11 17. A puncture needle 20 includes a relatively large handle portion 21 and a puncture needle tip 25 and an elongated rod 23 extending therebetween. With continued reference to Figures 1-2, the cannula assembly 10 is loaded into the tray blister 32, wherein the elongated tube 13 is generally parallel to the horizontal flange 33, and the elongated tube 13 is The channel 35 is matched and fixed by the release button 37. The puncture needle 20 is loaded into the tray blister 32, wherein the elongate shaft 23 is substantially parallel to the horizontal flange 33, and the elongate rod 23 mates with the channel 36 and is released by the buckle 37 Fixed. The paper sheet 31 and the tray blister 32 are welded (heat sealed) along the horizontal flange 33 to form a complete sealing area 40 to form a closed terminal sterilization package.

The mold manufacturing and molding process for producing the tray blister 32 by the blister method is low in cost and high in productivity, but there are also many drawbacks. 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. However, the sleeve assembly or puncture needle is typically larger than 100 mm in its axial direction, and its axial dimension/transverse dimension ratio is much greater than 1.5. Thus, the tray package (bubble package) of the trocar has been disclosed so far, the sleeve assembly or the lancet being lying in the tray or blister with its axis substantially parallel to the sealing area 40, hereinafter referred to as It is a horizontal blister pack (or tray blister pack). The horizontal blister package also has many defects, mainly including a long overall sealing area, resulting in low welding (heat sealing) production efficiency and poor sealing area stability; different cavity sizes result in multiple final sterilization The packaging wastes more space when stacked on each other; the top end of the casing assembly or the valve assembly is easy to pierce the packaging system, the tip of the puncture needle is easy to pierce the packaging system; the packaging system is not compatible. In order to solve one or more of the foregoing problems, it is an object of the present invention to provide a stepped jacket for a trocar package.

Summary of the invention

In one aspect of the invention, a combination packaging system for a trocar package is presented. In one embodiment, a combination packaging system includes a first outer casing, a second outer casing, and a cover material. The first outer casing 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 defining an open package opening; the first attachment lip defining an open attachment aperture. The second outer casing includes a second connecting 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 edge; the first sealing edge connects the first outer casing and the second outer casing into a unitary seamless casing, The seamless 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 edge, and the second sealing edge 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 first connecting lip comprises a first planar wall, and the second connecting lip comprises a second planar wall adapted to the shape and size of the first connecting lip.

In still another implementation, the closed distal end of the combined packaging system includes a third sealing edge.

In another aspect of the invention, a trocar assembly is provided, comprising the combination packaging system, further comprising a puncture needle and/or a cannula assembly. The trocar assembly is sterilized and provided to the user for use.

In still another aspect of the invention, a method of making a seamless casing of the combined package is presented. In one implementation, the seamless housing of the packaging system includes a first closure edge that the first outer casing and the second outer casing are joined together. The manufacturing method has the following steps: a blistering and trimming process: a plurality of first outer casings are integrally formed by blistering, and trimmed (punched) to form a single first outer casing. Extrusion and cutting process: The second outer casing is manufactured by extrusion and cut to the design size. The welding process: mainly includes forming a closed weld of the second outer casing to close the distal end, and connecting the first outer casing and the second outer casing into a unitary joint welding. In another implementation, the manufacturing method has: a blistering and trimming process: a plurality of integrally formed first outer casings are fabricated by blistering, and trimmed (punched) to form a single first outer casing. Blow molding and cutting process: blow molding to manufacture a raw outer casing comprising the second outer casing; the original outer casing further comprising a proximal scanning wall extending proximally from the second connecting lip and a proximal end cavity defined thereby Also included is a mouthpiece that penetrates the proximal scanning wall and communicates with the proximal lumen; the second outer casing is obtained by trimming the original outer casing along the second connecting lip. Welding process: mainly comprising connecting the first outer casing and the second outer casing into a single 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 conventional prior art puncturing device;

Figure 2 is a cross-sectional view of the package of Figure 1 perpendicular to its sealing edge;

Figure 3 is a perspective view of a puncture needle assembly 200 in accordance with a first embodiment of the present invention;

Figure 4 is an exploded view of the puncture needle assembly of Figure 3;

Figure 5 is an axial cross-sectional view of the vertical vessel 100 of the assembly of Figure 4;

Figure 6 is a plan view of the vertical container of Figure 5 from the proximal end to the distal end in the axial direction;

Figure 7 is an axial cross-sectional view of the puncture needle assembly of Figure 3;

Figure 8 is a plan view of the puncture needle assembly of Figure 7 from the proximal end to the distal end;

Figure 9 is a cross-sectional view taken along line 9-9 of the puncture needle assembly of Figure 7;

Figure 10 is a cross-sectional view taken along line 10-10 of the puncture needle assembly of Figure 7;

Figure 11 is a perspective view of the original container 100a;

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

Figure 13 is a schematic view of the original container secondary processing trimming type container 100 shown in Figure 11;

Figure 14 is a perspective view of a perforated plate for packaging the assembly 200;

Figure 15 is a schematic illustration of a package 200 for packaging;

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

Figure 17 is an exploded view of the assembly of Figure 16;

Figure 18 is an axial cross-sectional view of the vertical container 300 of Figure 17;

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

Figure 20 is a plan view of the vertical container of Figure 18 from the proximal end to the distal end in the axial direction;

Figure 21 is a sectional view taken along line 21-21 of the vertical container shown in Figure 19;

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

Figure 23 is a side elevational view of the assembled packaging system of Figure 22 assembled;

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

Figure 25 is an exploded view of the combined packaging system 600;

Figure 26 is a side elevational view of the assembled packaging system of Figure 25 assembled;

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

Figure 28 is a partial enlarged view of the first sealing edge region of Figure 24;

Figure 29 is a partial enlarged view of the first sealing edge region of Figure 27;

Figure 30 is a schematic view showing the blister manufacturing of the first outer casing 630;

Figure 31 is a schematic view showing the trimming of the first outer casing 630 of Figure 30 after being blister-molded;

Figure 32 is a partial enlarged view of the bellows of Figure 27;

Figure 33 is a schematic view showing the welding of the first outer casing 630 and the second outer casing 650;

Figure 34 is a partial enlarged view of the first sealing edge of Figure 33;

Figure 35 is a perspective view of the trocar assembly 800;

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

Figure 37 is a perspective view of the seamless housing 760;

Figure 38 is a partial enlarged view of the first sealing edge 740;

Figure 39 is an axial cross-sectional view of the seamless casing 760 of Figure 37;

Figure 40 is a plan view of the seamless housing of Figure 37 from the proximal end to the distal end;

Figure 41 is a cross-sectional view taken along the line 41-41 of the seamless casing shown in Figure 39;

Figure 42 is a cross-sectional view taken along line 42-42 of the seamless casing of Figure 39;

Figure 43 is a sectional view taken along line 43-43 of the seamless casing shown in Figure 39;

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 It will be understood by those skilled in the art that a trocar in a minimally invasive procedure, particularly in a rigid endoscopic procedure, typically includes a cannula assembly and or a puncture needle, hereinafter referred to as a "puncture device" for a puncture needle or cannula assembly, or a puncture needle. Combination with sleeve assembly. Puncture devices are generally classified into reusable puncture devices and disposable puncture devices. In the present invention, the puncturing device of the present invention is a disposable puncturing device unless otherwise specified. 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.

Figures 3-4 depict a trocar assembly, and more specifically, the structure and composition of the lancet assembly 200. Referring to Figures 3-4, the puncture needle assembly 200 includes a puncture needle 20, a vertical container 100, and a cover material 190. The puncture needle 20 includes a relatively large handle portion 21 and a puncture needle tip 25 and an elongated rod 23 extending therebetween.

Figures 5-6 depict the structure and composition of the vertical vessel 100. The vertical container 100 includes an axis 110 and a planar lip 141 that is generally perpendicular to the axis 110, the planar lip 141 including an outer lip 146 and an inner lip 144 and a wall portion extending therebetween. The lip inner edge 144 defines a container opening 140. The vertical container 100 further includes a first housing 151 extending distally that is coupled to the inner lip 144, the first housing 151 defining a first cavity 150. The vertical container 100 further includes a second housing 171 coupled to the first housing 151 and extending distally, the second housing 171 defining a second cavity 170. The transition housing 161 extends proximally to the first housing 151 at a proximal transition edge 162 and distally to 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 vertical container 100 also 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 third housing 121 without gaps. The container opening 140, the first cavity 150, the transition cavity body 160, the second cavity 170 and the distal cavity 180 sequentially pass through to form a closed container 120 containing the container opening. With continued reference to FIG. 6, in one design, the minimum width distance between the outer lip edge 146 and the inner lip edge 144 is greater than or equal to 6 millimeters. In another design, the lip outer edge 146 includes a rounded region 147. In another design, the fillet region 147 includes a partial projection 148 from the distal end to the proximal end. Referring now to Figures 7-10, the puncture needle 20 is loaded into the vertical container 100, wherein the first cavity 150 substantially matches the shape and size of the handle portion 21, primarily accommodating the handle portion 21 The second cavity 170 substantially matches the shape and size of the elongate shaft 23, primarily accommodating the elongate shaft 23. The cover material 190 is welded to the planar lip 141 of the vertical container 100 to form a closed terminal sterilization package. Referring now to Figure 8, in one design, the cover member 190 is welded to the flat lip 141 to form an annular sealing edge 195 having a width of 6 mm or more, and one of the corners 198 of the cover member 190 is not The planar lips 141 are welded together, the projections 148 separating the corners 198 from the planar lip 141 to facilitate gripping and tearing of the final sterilization package.

As described in the background, in a final sterilization package of a puncturing device that has been disclosed and commercialized, a tray blister is typically produced by a blistering method in which the sleeve assembly or puncture needle is substantially parallel to the sealing region. Lying in the tray blister, it is a horizontal blister pack. It should be understood by those skilled in the art that the method of manufacturing the tray blister by the blister method is low in cost and high in productivity, but there are also many defects: the stretchability of the blister molded product is limited, and the shape of the blister forming cavity The depth/width ratio is usually less than or equal to 1, and in the worst case it is usually no 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. Those skilled in the art will appreciate that the shape and configuration of the vertical container 100 of the present example has significant distinguishing features relative to prior art tray blister. In the prior art, the puncture needle and or cannula assembly is substantially lying in the tray blister, and more particularly, the elongate shaft of the puncture needle is substantially parallel to the sealing edge of its closure package, or The elongated tube of the cannula assembly is substantially parallel to the sealing edge of its closure package. While the final packaging system of the vertical container 100 of the present example is described, the elongated rod 23 of the puncture needle is substantially perpendicular to the sealing edge 195 of the final packaging system.

9-9 FIG. 9 depicts a cross-sectional view of the lancet assembly 200 shown in FIG. 7, the first example of the cross section of cavity 150 is approximately circular diameter of D _1; FIG. 10 depicts 7 A cross-sectional view of the 10-10 of the puncture needle assembly 200 is shown. The cross section of the second cavity 170 in this example is an approximately circular shape having a diameter D ₂ ; wherein D ₁ > D ₂ . With continued reference to FIGS. 7-10, the axial depth of the second cavity 170 is defined as HA1 for ease of quantification, and HA1 ≥ 5D _{2 in the} present example, that is, the axial depth of the second cavity 170 is greater than or equal to The second cavity 170 is 5 times the minimum width of the cross section. Therefore, the vertical container 100 cannot be manufactured or extremely difficult to manufacture (high cost) by the blister method.

11 to 13 illustrate a manufacturing method (hereinafter referred to as a blow molding secondary processing method) in which the original container 100a is produced by a blow molding method, and the original container 100a is trimmed to form the vertical container 100. The original outer casing 100a includes the stepped outer casing 100, and further includes a proximal scanning wall 131 extending proximally from the planar lip 141 and a proximal end cavity 130 thereof, further comprising penetrating the proximal scanning wall 131 and The proximal cavity 130 communicates with the mouthpiece 132. Referring now to Figure 13, a closed, approximately annular cut-out opening is formed around the lip inner edge 144 to divide the original container 100a into two portions, the setup container 100 and the waste portion 100b, wherein the cut-out port cuts the plane The lip 141 forms a lip outer edge 146 and a minimum width distance between the lip outer edge 146 and the lip inner edge 144 is greater than or equal to 6 millimeters.

It will be understood by those skilled in the art that the blow molding secondary processing method has a higher cost of manufacturing a one-piece packaging outer casing than the manufacturing method of the blister tray blister described in the background. The cost of making a one-piece pallet blister by blistering. However, the vertical container 100a manufactured by the blow molding secondary processing method of the present invention has a comprehensive cost far lower than that of the tray blister packaging method. A typical 12 mm gauge puncture needle 20, which has been commercialized, has a handle portion 21 having a cylindrical shape of about 40 mm in length and 30 mm in length, and the elongated rod 23 has a cylindrical shape of about 13 mm in length and 160 mm in length. Set the width of the package sealing edge to 6mm. When the horizontal blister packaging method of the background is adopted, the shortest length of the sealing edge is greater than 460 mm, and the sealing machine working surface size is 52 mm×202 mm when sealing. When the vertical container 100 of the present invention is used, the shortest length of the sealing edge is about 126 mm, and the sealing machine working surface size of the sealing machine is 52 mm x 52 mm. It will be understood by those skilled in the art that the sealing quality control of the final sterilization package is very important and complicated because it is convenient to disassemble the package while ensuring sufficient sealing strength. The shorter the length of the sealing line, the smaller the size of the working surface of the sealing machine during sealing, the better the controllability of the sealing process, and the better the stability of the sealing edge formed, and the single sealing The number of products that can be combined can be increased. It can be seen that when the vertical container 100 is used, the sealing quality can be improved to a large extent, and the sealing efficiency is improved to a large extent.

14-15 depict a shipping package method for the needle assembly 200. The perforated plate 220 includes a planar plate 221 and a plurality of through holes 222 adapted to the shape and size of the first cavity 170. In the present embodiment, the perforated plate 220 includes 50 substantially uniform through holes 222. Referring to FIG. 15, the puncture needle assembly 200 is captured in the perforated plate 220, wherein the first sweeping wall 171 is mated with the through hole 222, and the planar lip 141 is mated with the planar plate 221 . A single perforated plate 220 can be loaded with 50 the puncture needle assembly 200; the perforated plates of the two fully loaded puncture needle assemblies 200 are fastened to each other and placed in a package having a size of about 55 cm x 28 cm x 22 cm, i.e., 100 The puncture needle assembly 200 occupies a packaging space of approximately 33880 cm ³ . If the same puncture needle 20 is packaged with the blister tray blister described in the background, 100 product packages occupy a packaging space of approximately 51376 cm ³ . It can be seen that with the vertical container 100, the product packaging space can be saved to a large extent. It should be understood by those skilled in the art that the sterilization, storage and transportation of the puncture needle assembly 200 are all calculated according to the volume, and a large degree of space saving can greatly save the sterilization, storage and transportation costs. .

The vertical vessel 100 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, and the like. . 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 vertical container 100 of the present invention is advantageous for reducing the amount of Tyvek medical cover material. In addition, when the vertical container 100 is manufactured using a transparent material, the vertical container 100 of the present invention also contributes to the display of the packaged article, which is advantageous for use.

Figures 16-21 depict another piercer assembly and, more specifically, the structure and composition of the cannula assembly package 400. Referring to Figures 16-17, the cannula assembly product package 400 includes a cannula assembly 10, a vertical container 300 and a cover material 290. The cannula assembly 10 includes a relatively large cannula cartridge body 11 and a relatively sharp cannula tip 15 and an elongated tube 13 extending therebetween, and a valve assembly projecting beyond the cannula cartridge body 11 17.

18-21 depict the structure and composition of the vertical vessel 300. The vertical container 300 includes an axis 310 and a planar lip 341 that is generally perpendicular to the axis 310, the planar lip 341 including an outer lip 346 and an inner lip 344 and a wall portion extending therebetween. The lip inner edge 344 defines a container opening 340. The vertical container 300 also includes a first housing 351 that extends distally coupled to the lip inner edge 344, the first housing 351 defining a first cavity 350. The vertical container 300 further includes a second housing 371 coupled to the first housing 351 and extending distally, the second housing 371 defining a second cavity 370. The transition housing 361 extends proximally to the first housing 351 at a proximal transition edge 362 and distally to 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, the second cavity 370. The vertical container 300 also includes a closed apex 384 and a distal housing 381 extending between the second housing 371 and the closed apex 384, the distal housing 381 defining a distal cavity 380. The first housing 351, the transition housing 361, the second housing 371 and the distal housing 381 are sequentially connected to form a unitary seamless third housing 321; the container opening 340, the first cavity 350, The transition cavity body 360, the second cavity 370 and the distal cavity 380 are sequentially passed through to form a closed container 320 containing the container opening.

Referring now to Figures 16-17, the cannula assembly 10 is loaded into the vertical container 300, wherein the first cavity 350 substantially matches the shape and size of the cartridge body 11 to accommodate the cannula cartridge body 11; The second cavity 170 substantially matches the shape and size of the elongated tube 13 to primarily accommodate the elongated tube 13; the cover member 290 is welded to the planar lip 341 of the vertical container 300 to form Closed terminal sterilization package. In one design, the cover material 290 is welded to the planar lip 341 to form an annular sealing edge 315 (not shown) having a width ≥ 6 mm. The vertical container 300 may adopt a manufacturing method similar to that of the above-described vertical container 100, that is, the original outer casing is first produced by a blow molding method, and then the vertical container 300 is trimmed. The cannula assembly product package 400 has similar advantages as the puncture needle assembly 200.

Referring to FIG. 9, FIG. 10 and FIG. 21, the first scanning wall 151 forming the stepped outer casing 100 is a regular cylindrical wall, and the first scanning wall 351 forming the stepped outer casing 300 is scanned along a certain path. A slightly formed irregular closed ring wall. The shape of the stepped outer casing 300 is irregular, and the manufacturing complexity is higher than that of the stepped outer casing 100. However, the stepped outer casing 300 can be conveniently manufactured by the blow molding secondary processing method of the present invention without a large scale. Increase manufacturing costs. More complex shapes and structures can also be made. Those skilled in the art of blow molding should understand that blow molding processes can be broadly classified into injection blow molding, extrusion blow molding, injection stretch blow molding, and extrusion stretch blow molding. Blow molding usually uses a two-step process, the first step of making the parison, the second step of inflation molding; the different blow molding methods refer to the different ways of making the parison and the inflation molding. Different blow molding processes have their own advantages and disadvantages. Usually, according to the shape of the product, the processing batch selects the appropriate process and control method. For example, in the stepped jacket 300 of the present invention, the lateral dimension and the axial dimension of the main body cavity 350 and the elongated cavity 370 are different, and the shape and wall thickness of the parison are preferably controlled to obtain a uniform wall thickness. The stepped jacket 300. For example, for ease of manufacture (release), the planar wall 141 and the planar wall 341 are generally not strictly planar, and typically have a draft angle of 1 to 5 degrees. Due to space limitations, the details of the blow molding process are not discussed in the present invention, and those skilled in the art will readily appreciate that the disclosed embodiments of the present invention may be made by reference to the relevant manufacturing process literature or process experience, or after a limited number of tests. Adaptation is made to make the structure more conducive to manufacturing.

[0000] As described above, the shape of the stepped jacket 300 is irregular, and it is usually necessary to first extrude or pre-blow a relatively complicated parison, then blow molding, and then trimming the stepped jacket 300. The complex parison extrusion or pre-blowing molds and equipment are generally expensive and are not conducive to small to medium batch production. Figures 22-24 illustrate an improved combination packaging system 500. The combined packaging system 500 includes an axis 501. The combined packaging system includes a cover material 510, a first outer casing 530 and a second outer casing 550. The first housing 530 includes a planar lip 535 and a first connecting lip 537 and a first housing 536 extending therebetween. The planar lip 535 includes an outer lip 534 and an inner lip 532 and a planar wall 533 extending therebetween, the inner lip 532 defining an open package opening 531; the first attachment lip 537 defining an open Connection hole 538. The shape of the package opening 531 may be a circle shape, an elliptical 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 connecting hole 538 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 538 has a circular shape. The first housing 536 in the present example comprises a cylindrical housing 536a, a rectangular housing 536b and a truncated cone housing 536c. The cylindrical housing 536a, the rectangular housing 536b and the truncated cone housing 536c are connected to each other. The slip transition constitutes a first housing 536 that is seamless. It will be understood by those skilled in the art that the shape of the first housing 536 is generally adapted to the shape of the packaged product, and is generally coated and simplified based on the shape of the packaged product.

With continued reference to FIGS. 22-24 and 28, the second outer casing 550 includes a second attachment lip 555 and a closed distal end 557 and a second housing 556 extending therebetween. The first connecting lip 537 is welded to the second connecting lip 555 to form a first sealing edge 540. The first sealing edge 540 joins the first outer casing 530 and the second outer casing 550 into a unitary seamless casing 560 that defines a seamless cavity 561 that includes an open end. In one embodiment, the second outer casing 550 is first extruded into a tubular blank having open ends, and one end of the tubular blank is thermowelded to form a third sealing edge 570, in the present example, The third sealing edge 570 constitutes a closed distal end 557. The other end of the tubular blank is reserved as a second connecting lip 555. With continued reference to FIGS. 22-24, the cover member 510 and the planar wall 533 are welded to form a second sealing edge 520, and the second sealing edge 520 connects the seamless housing 560 and the cover member 510 to form an integral closure. Packaging cavity. 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 edges of the present invention are formed by thermocompression bonding.

[0000] Figures 25-27 illustrate another improved combination packaging system 600. The combined packaging system 600 includes an axis 601. The combination packaging system 600 includes a cover material 610, a first outer casing 630 and a second outer casing 650. The first outer casing 630 includes a planar lip 635 and a first connecting lip 637 and a first housing 636 extending therebetween. The planar lip 635 includes an outer lip 634 and an inner lip 632 and a planar wall 633 extending therebetween, the inner lip 632 defining an open package opening 631; the first connecting lip 637 defining an open Connection hole 638. Referring to Figures 25-27 and 29, the second housing 650 includes a second attachment lip 655 and a closed distal end 657 and a second housing 656 extending therebetween. The first connecting lip 637 is welded to the second connecting lip 655 to form a first sealing edge 640. In the present example, the first connecting lip 637 includes a first frustoconical wall, and the second connecting lip 655 includes a second frustoconical wall that matches the shape and size of the first connecting lip 637. The fit of the approximately frustoconical wall facilitates welding. The first sealing edge 640 joins the first outer casing 630 and the second outer casing 650 into a unitary seamless casing 660 that defines a seamless cavity 661 that includes an open end. In a preferred embodiment, the second outer casing 650 is first manufactured by extrusion into a tubular blank having a cylindrical open end 657a (not shown) at one end and a second connecting lip 655 having a truncated cone at the other end. The cylindrical open end 657a (not shown) is thermowel welded to form a third sealing edge 670. In the present example, the third sealing edge 670 constitutes a closed distal end 657. With continued reference to FIGS. 25-27, the cover material 610 and the planar wall 633 are welded to form a second sealing edge 620, and the second sealing edge 620 connects the seamless housing 660 and the cover material 610 to form an integral closure. Packaging cavity.

Referring to Figures 26, 27 and 32, the second outer casing 650 further includes a bellows 680 comprised of a plurality of axially disposed pleats 682, each of the pleats 682 including laterally extending pleats Peaks 683 and pleat valleys 685 and pleat walls 684 extending between the pleat peaks 683 and the pleat valleys 685. It will be understood by those skilled in the art that minimally invasive surgery (hard laparoscopic surgery) is generally used for thin patients, ordinary patients and obese patients, respectively, with a shortening puncture device, a common puncture device and an elongated puncture device. The shortening puncturing device has a nominal length specification of usually 65 to 75 mm, the conventional puncturing device has a length specification of usually 90 to 110 mm, and the elongated puncturing device has a length specification of usually 145 to 155 mm. In one design, the wrinkle size, the wrinkle angle and the number of wrinkles of the bellows 680 are reasonably set, and the same combination packaging system 600 can be compatible with the package shortening puncture device, ordinary puncture device and lengthening puncture device. Thereby, the manufacturing mold cost is saved to a large extent, the inventory is reduced, and the management cost is saved.

One of ordinary skill in the art would appreciate that the seamless housing 560, the seamless housing 660, adds a welding process (welding to form the first sealing edge 540 or the first sealing edge 640 as compared to the stepped jacket 300). This may result in an increase in the overall manufacturing cost of the seamless housing 560, the seamless housing 660. 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 660 is presented. The seamless housing 660 includes a first sealing edge 640 that the first outer casing 630 and the second outer casing 650 are joined together. 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. Figure 30 depicts a schematic view of the blister manufacturing of the first outer casing 630. In one design, more than 100 of the first outer casings 630 can be blipped using a sheet of 1 meter by 1 meter. FIG. 31 depicts a process of trimming (punching) a single first outer casing 630. In one design, the disposable outer edge 634 and the first connecting lip 637 are formed by one-time blanking. A preferred first connecting lip 637 is frustoconical.

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 second outer casing 650 is manufactured by an extrusion process to form a second connecting lip 655 tubular blank having a cylindrical open end 657a (not shown) at one end and a frustoconical shape 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 657, and joining the first outer casing 630 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 657, which can weld a large number of products at one time, and the processing equipment is low in cost and high in processing efficiency. As shown in FIGS. 33-34, the welding tools required to weld the first connecting lip 637 and the second welding 655 together to form the first sealing edge 640 mainly include a welding lower die 691 and a welding head 693, which are simple in structure. It is convenient to realize multiple products at one time. Moreover, the first connecting lip 637 and the second weld 655 comprise mutually matching truncated cone shapes to facilitate control of the welding process.

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. Attention should be paid to the understanding of the difference, and the sealing control described herein mainly refers to the tearable sealing edge. For example, the second sealing edge 620 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, it has to have sufficient heat sealing strength to ensure the reliability of the package, so the sealing quality of the tearable sealing edge Control is 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 edge 640 of the present invention, the third sealing edge 670 does not belong to the tearable sealing edge, and is only a common sealing edge for connection 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.

[0000] A method of manufacturing the stepped jacket 300a relative to a blow molding secondary processing method, although the seamless housing 660 of the present example adds a process, the production efficiency due to blistering and extrusion is much greater than that of blow molding. Processing efficiency, so the reasonable arrangement of the plastic and trimming process, extrusion and trimming process, the number of simultaneous processing of each station in the welding process, can greatly improve the 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 costs. With respect to the tray blister method described in the background, for example, by using a tray for manufacturing a package assembly 10 according to the present invention, a single blister occupies a plastic sheet area of about 120 mm x 220 mm, and a single said first The outer casing 630 occupies a plastic sheet area of about 90 mm x 70 mm. A standard 1 meter by 1 meter sheet can dispense more than 100 of the first outer casings 630, and can only absorb about 32 120 mm x 220 mm tray bulbs. In addition, the other advantages of the seamless housing 660 relative to the tray blister are similar to those of the aforementioned step outer casing 100, mainly including reducing the length of the tearable sealing edge, reducing the packaging volume, and reducing the use of the special reinforced paper. Come, prevent the sharp top from piercing the product packaging, beautiful and convenient display.

35-43 depict a trocar pack assembly 800 that includes a cannula assembly 10, a puncture needle 20, and a combination packaging system 700. The combination packaging system 700 includes a cover material 710, a first outer casing 730 and a second outer casing 750. The first outer casing 730 includes a planar lip 735 and a first connecting lip 737 and a first housing 736 extending therebetween. The planar lip 735 includes an outer lip 734 and an inner lip 732 and a planar wall 733 extending therebetween, the inner lip 732 defining an open package opening 731; the first connecting lip 737 defining an open Connection hole 738. Referring to Figures 36-39, the second housing 750 includes a second attachment lip 755 and a closed distal end 757 and a second housing 756 extending therebetween. The first connecting lip 737 is welded to the second connecting lip 755 to form a first sealing edge 740. In the present example, the first connecting lip 737 includes a first planar wall, and the second connecting lip 755 includes a second planar wall, the mutual cooperation of the first planar wall and the second planar wall facilitating welding. The first sealing edge 740 joins the first outer casing 730 and the second outer casing 750 into a unitary seamless casing 760 that defines a seamless cavity 761 that includes an open end. Referring now to Figure 35, the cover member 710 and the planar wall 733 are welded to form a second sealing edge 720, and the second sealing edge 720 connects the seamless housing 760 and the cover member 710 into a unitary closed package. Cavity. 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-sectional shape is an irregular closed, approximately elliptical shape with a reduced cross-sectional dimension from the proximal end to the distal end.

In one aspect of the invention, a method of manufacturing the seamless housing 760 is presented. The seamless housing 760 includes a first sealing edge 740 that the first outer casing 730 and the second outer casing 750 are joined together. 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, the sheet may be blister-formed to form a plurality of integrally joined first outer casings 730, which are then trimmed (punched) to form a single first outer casing 730.

Blow molding and cutting process: firstly, the original outer casing including the second outer casing 750 is manufactured by blow molding; the original outer casing further includes a proximal scanning wall extending proximally from the second connecting lip 755 and a defined portion thereof The proximal lumen further includes a mouthpiece that penetrates the proximal scanning wall and communicates with the proximal lumen. The second outer casing 750 is obtained by trimming the original outer casing along the second connecting lip 755.

The welding process mainly includes connecting the first outer casing 730 and the second outer casing 750 into a single joint welding.

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, by using the first casing, the transition shell, and the second sweeping wall of the present invention, the second sweeping wall is adaptively modified to make the shape more beautiful and smoother; or different types are derived by increasing or decreasing the number of the bushing assembly or the puncture needle. Product package. 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 combined packaging system for a trocar, characterized in that:

The combined packaging system includes a first outer casing, a second outer casing and a cover material;

The first outer casing 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 lip The edge defines an open packaging opening; the first connecting lip defines an open connecting aperture;

The second outer casing includes a second connecting 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 edge; the first sealing edge connects the first outer casing and the second outer casing into a unitary seamless casing, The seamless housing defines a seamless cavity including an opening at one end;

The cover material and the planar wall are welded to form a second sealing edge, and the second sealing edge 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 first attachment lip comprises a first planar wall, said second attachment lip comprising a shape and size adapted to said first attachment lip Second plane wall.
The combination packaging system of claim 1 wherein said closed distal end comprises a third sealing edge.
A trocar assembly comprising the combination packaging system of any of claims 1-4, further comprising a puncture needle and/or cannula assembly.
A method of manufacturing a seamless casing of a combination packaging system according to claim 2, comprising the steps of:

Blistering and trimming process: a plurality of first outer casings are manufactured by blistering, and trimmed (punched) to form a single first outer casing;

Extrusion and cutting process: extrusion molding the second outer casing and cutting to a design size;

The welding process: mainly includes forming a closed weld of the second outer casing to close the distal end, and connecting the first outer casing and the second outer casing into a unitary joint welding.
A method of manufacturing a seamless casing of a combination packaging system according to claim 3, wherein the main steps comprise:

Blistering and trimming process: a plurality of first outer casings are manufactured by blistering, and trimmed (punched) to form a single first outer casing;

Blow molding and cutting process: blow molding to manufacture a raw outer casing comprising the second outer casing; the original outer casing further comprising a proximal scanning wall extending proximally from the second connecting lip and a proximal end cavity defined thereby And a mouthpiece penetrating the proximal scanning wall and communicating with the proximal cavity; the second outer casing is obtained by trimming the original outer casing along the second connecting lip; welding process: mainly including The first outer casing and the second outer casing are joined together to form an integral joint weld.