WO2018219317A1 - 一种用于穿刺器包装的阶梯外套及其制造方法 - Google Patents

一种用于穿刺器包装的阶梯外套及其制造方法 Download PDF

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Publication number
WO2018219317A1
WO2018219317A1 PCT/CN2018/089194 CN2018089194W WO2018219317A1 WO 2018219317 A1 WO2018219317 A1 WO 2018219317A1 CN 2018089194 W CN2018089194 W CN 2018089194W WO 2018219317 A1 WO2018219317 A1 WO 2018219317A1
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WO
WIPO (PCT)
Prior art keywords
wall
cavity
stepped
scanning
outer casing
Prior art date
Application number
PCT/CN2018/089194
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English (en)
French (fr)
Inventor
朱莫恕
Original Assignee
成都五义医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from CN201710410205.0A external-priority patent/CN107117389A/zh
Priority claimed from CN201710410215.4A external-priority patent/CN107054876A/zh
Application filed by 成都五义医疗科技有限公司 filed Critical 成都五义医疗科技有限公司
Publication of WO2018219317A1 publication Critical patent/WO2018219317A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D85/00—Containers, packaging elements or packages, specially adapted for particular articles or materials
    • B65D85/20—Containers, packaging elements or packages, specially adapted for particular articles or materials for incompressible or rigid rod-shaped or tubular articles
    • B65D85/24—Containers, packaging elements or packages, specially adapted for particular articles or materials for incompressible or rigid rod-shaped or tubular articles for needles, nails or like elongate small articles

Definitions

  • the present invention relates to a minimally invasive surgical instrument, and more particularly to a trocar packaging structure.
  • 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.
  • 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.
  • 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 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.
  • the channel 35 and channel 36 also include a laterally projecting release button 37.
  • a cannula assembly 10 includes a relatively large cartridge body 11 and a relatively sharp cannula tip 15 and an elongated tube 13 extending therebetween, and a valve assembly 17 projecting beyond the cartridge body 11.
  • a puncture needle 20 includes a relatively large handle portion 21 and a puncture needle tip 25 and an elongated rod 23 extending therebetween.
  • 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.
  • 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.
  • 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.
  • 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
  • a stepped jacket for a trocar pack is presented.
  • the stepped outer casing includes a proximal opening defined by a horizontal wall, the stepped outer casing further comprising a closed distal end and a seamless casing extending between the horizontal wall and the closed distal end,
  • the seamless housing defines a seamless cavity that includes an opening at one end.
  • the seamless housing may be divided into a first scanning wall, a transition scanning wall and a second scanning wall from a proximal end to a distal end; the first scanning wall defines a body cavity, and the transition scanning wall defines a transition cavity
  • the second scanning wall defines an elongated cavity; the body cavity, the transition cavity and the elongated cavity intersect each other to form a major portion of the seamless cavity.
  • the direction substantially perpendicular to the horizontal wall is referred to as the axial direction, and the direction substantially parallel to the horizontal wall is referred to as the lateral direction; the lateral cross-sectional dimension of the body cavity is greater than the transverse cross-sectional dimension of the elongated cavity.
  • the axial depth of the elongated cavity is HA, and the transverse section has a minimum width of Bmin, HA ⁇ 5Bmin.
  • the horizontal wall of the stepped jacket has a minimum width Wmin, Wmin ⁇ 6 mm.
  • the stepped jacket is integrally blow molded from a plastic material.
  • a trocar product package comprising the stepped outer casing, further comprising a cover material, a puncture needle and/or a cannula assembly, the puncture needle and/or cannula assembly being housed in the stepped outer casing, A welded seal is formed between the cover material and the horizontal wall to form a complete sealing edge, and the sealing edge has a minimum width of 6 mm or more.
  • the trocar product package is characterized in that the distance between the tip of the puncture needle and/or the tip of the cannula and the closed tip is M, M ⁇ 2 mm.
  • a transport packaging system puncturing product package further comprising a first fixing plate, a second fixing plate, a partition plate and a packaging box; the plurality of first and second fixing plates comprising a plurality of shapes and the second scanning wall a fixed through hole having a transverse dimension; the package includes a bottom surface of the box and a top surface of the box; and a plurality of second scanning walls of the puncturing product package are inserted into the fixed through holes of the first fixing plate to form a first layer a packaging assembly; the first layer packaging component is loaded into the packaging box, wherein a cover material of the puncturing product package is adjacent to a bottom surface of the box; and a second scanning wall of the plurality of puncturing product packages is inserted into the second Forming a second layer packaging component in the fixed through hole of the fixing plate; the second layer packaging component is loaded into the packaging box, wherein the cover material of the puncturing product package is adjacent to the top surface of the box; the first layer packaging The assembly and
  • a manufacturing method of a stepped jacket is provided.
  • a manufacturing method of a stepped jacket, the main manufacturing steps are as follows:
  • blow molding manufacturing comprising an original outer jacket, the original outer casing comprising the stepped outer casing, further comprising a proximal scanning wall extending proximally from the horizontal wall and a proximal end cavity thereof, and further comprising penetrating the proximal end a mouthpiece that scans the wall and communicates with the proximal cavity;
  • a multi-functional stepped jacket for a trocar pack wherein: the stepped outer casing includes a proximal opening defined by a horizontal wall, the stepped outer casing further comprising a closed distal end and a seamless housing extending between the horizontal wall and the closed distal end, the seamless housing defining a seamless cavity including an opening at one end; the seamless housing including the first scanning wall from the proximal end to the distal end a transition scan wall and a second scan wall; the first scan wall defining a body cavity, the transition scan wall defining a transition cavity, the second scan wall defining an elongated cavity; the body cavity, the transition cavity and The extension chambers are interpenetrated to form the seamless cavity; the direction perpendicular to the horizontal wall is referred to as the axial direction, and the direction substantially parallel to the horizontal wall is referred to as the lateral direction; the lateral cross-sectional dimension of the body cavity is larger than the extended cavity The transverse cross-sectional dimension of the
  • FIG. 1
  • 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 product package 200 of the first embodiment of the present invention.
  • Figure 4 is an exploded view of the puncture needle product package of Figure 3;
  • Figure 5 is an axial cross-sectional view of the stepped outer casing 100 of the product package of Figure 4;
  • Figure 6 is a plan view of the stepped casing 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 product package of Figure 3.
  • Figure 8 is a plan view of the puncture needle product package 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 product package of Figure 7;
  • Figure 10 is a cross-sectional view taken along line 10-10 of the puncture needle product package of Figure 7;
  • Figure 11 is a perspective view of the original outer casing 100a
  • Figure 12 is an axial cross-sectional view of the original outer casing of Figure 11;
  • Figure 13 is a schematic view showing the original casing of the original casing shown in Figure 11 trimmed into a stepped jacket 100;
  • Figure 14 is a perspective view of a perforated plate for packaging the product package 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 product package shown in Figure 16;
  • Figure 18 is an axial cross-sectional view of the stepped casing 300 of Figure 17;
  • Figure 19 is an axial cross-sectional view of the stepped outer casing 300 of Figure 17 in another direction;
  • Figure 20 is a plan view of the stepped casing of Figure 18 taken from the proximal end to the distal end in the axial direction;
  • Figure 21 is a cross-sectional view taken along line 21-21 of the stepped casing shown in Figure 19;
  • Figure 22 is a perspective view of a puncture product package 600 of a third embodiment of the present invention.
  • Figure 23 is an exploded view of the puncture product package of Figure 22;
  • Figure 24 is an axial cross-sectional view of the stepped outer casing 500 of Figure 23;
  • Figure 25 is a plan view of the stepped casing of Figure 24 taken from the proximal end to the distal end in the axial direction;
  • Figure 26 is a cross-sectional view taken along line 26-26 of the stepped casing of Figure 24;
  • Figure 27 is a cross-sectional view taken along line 27-27 of the stepped casing of Figure 24;
  • Figure 28 is a cross-sectional view taken along line 28-28 of the stepped casing of Figure 24;
  • FIG. 29 is a perspective view of another embodiment trocar product package 500a
  • Figure 30 is a perspective view of another embodiment stepped jacket 500a
  • Figure 31 is a perspective cross-sectional view of the stepped outer casing 500a of Figure 30;
  • Figure 32 is a perspective view of a puncture product package 800 of a fourth embodiment of the present invention.
  • Figure 33 is a perspective view of the stepped jacket 700 of Figure 32;
  • Figure 34 is another perspective view of the stepped outer casing 700 of Figure 32;
  • Figure 35 is a perspective view of the first fixing plate 920a
  • Figure 36 is a perspective cross-sectional view of the transport package 900 of the present invention.
  • Figure 37 is a perspective view of the stepped jacket 301
  • Figure 38 is an axial cross-sectional view of the stepped outer casing of Figure 37;
  • Figure 39 is a partial enlarged view of the pleat shown in Figure 38;
  • Figure 40 is a schematic view showing the stepped casing 301 of Figure 37 in a compressed state
  • Figure 41 is a schematic view showing the stepped casing 301 shown in Figure 37 in a stretched state
  • Figure 42 is a perspective view of the stepped jacket 301a
  • Figure 43 is an axial cross-sectional view of the stepped casing shown in Figure 42;
  • Figure 44 is a perspective view of the stepped jacket 301b
  • Figure 45 is an axial cross-sectional view of the stepped casing shown in Figure 44;
  • Figure 46 is a perspective view of the puncture needle product package 200a
  • Figure 47 is a schematic illustration of the removal of the product pack 200a in the clinic.
  • a trocar in a minimally invasive 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 puncture product package and, more specifically, the structure and composition of the puncture needle product package 200.
  • the puncture needle product package 200 includes a puncture needle 20, a stepped outer casing 100 and a cover plate 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.
  • FIGS. 5-6 depict the structure and composition of the stepped jacket 100.
  • the stepped outer casing 100 includes a proximal end opening 140 defined by a horizontal wall 141 that further includes a closed apex 184 and a seamless casing 121 extending between the horizontal wall 141 and the closed apex 184, the The slit housing 121 defines a seamless cavity 120 that includes an opening at one end.
  • the stepped outer casing 100 further includes an axis 110 extending axially from the proximal end to the distal end and may be mainly divided into a first scanning wall 151, a transition scanning wall 161 and a second scanning wall 171.
  • the first scanning wall 151 defines a body cavity 150 that defines a transition cavity 160 that defines an elongated cavity 170, the body cavity 150, a transition cavity 160, and an elongated cavity 170 interpenetratingly forms a major component of the seamless cavity 120.
  • the planar wall 141 extends laterally inwardly to intersect the first scanning wall 151 to form a planar inner wall edge 144 that extends laterally outwardly to form a planar outer wall edge 146.
  • the transition scan wall 161 extends proximally to the first scan wall 151 at a proximal transition edge 162 and distally to the second scan wall 171 at a distal transition edge 164.
  • the stepped outer casing 100 further includes a distal cavity 180 formed by the distal scanning wall 181, the distal scanning wall 181 extending proximally and intersecting the second scanning wall 171 to form a transition edge 182, the scanning wall 181 Extending toward the distal end and self-intersecting form a vertex 184.
  • the planar wall outer edge 146 includes a rounded region 147.
  • the fillet region 147 includes a partial projection 148 from the distal end to the proximal end.
  • the puncture needle 20 is loaded into the stepped outer casing 100, wherein the body cavity 150 substantially matches the shape and size of the handle portion 21, the elongated cavity 170 and the elongated The shape and size of the rod 23 are substantially matched; the cover plate 190 is welded to the planar wall 141 of the stepped outer casing 100 to form a closed, terminally sterilized package.
  • the cover plate 190 is welded to the planar wall 141 to form an annular sealing edge 195 having a width ⁇ 6 mm, and one of the corners 198 of the cover plate 190 is not
  • the planar walls 141 are welded together, and the projections 148 separate the corners 198 from the planar wall 141 to facilitate gripping and tearing of the final sterilization package.
  • the needle tip 25 is not in contact with the distal scanning wall 181 and the closed apex 184, which can effectively prevent the piercing needle from piercing the sharp tip during storage and transportation.
  • the seamless outer casing 121 causes the aseptic package to fail.
  • 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.
  • 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.
  • the shape and configuration of the stepped outer casing 100 of the present example has significant distinguishing features relative to prior art tray blister. While prior art tray blister may also include a cavity recessed by its main cavity, the ratio of the depth of the lower cavity to the minimum width of its cavity may not be greater than 1.5. The ratio of the extended cavity depth to the extended cavity minimum width of this example is much greater than 1.5. 9-9 FIG. 9 depicts a cross-sectional view of the puncture needle package 200 shown in FIG. 7, the present example the body cavity cross section 150 is approximately circular diameter of D 1; FIG. 10 depicts FIG.
  • FIGS. 7-10 cross-sectional view of the puncture needle product package 200, the cross-section of the elongated cavity 170 in this example is an approximately circular shape having a diameter D 2 ; where D 1 > D 2 .
  • the axial depth of the extended cavity 170 is defined as HA1 for ease of quantification, and HA1 ⁇ 5D2 in the present example, that is, the axial depth value of the extended cavity 170 is greater than or equal to the horizontal length of the extended cavity 170. 5 times the minimum width of the section. Therefore, the stepped jacket 100 cannot be manufactured or extremely difficult to manufacture (costly) by the blister method.
  • the original outer casing 100a includes an axis 110 and a proximal nozzle 132 disposed in a proximal direction from the proximal end to the distal end in the axial direction, a proximal lumen 130 defined by the proximal scanning wall 131, and a planar wall 141
  • the first scanning wall 151 defines a body cavity 150
  • the second scanning wall 171 defines an elongated cavity 170
  • a distal scanning cavity 181 defines a distal cavity 180.
  • the proximal mouthpiece 132 communicates with the proximal cavity through the proximal scanning wall; the planar wall 141 and the proximal scanning wall 131 extend to form a planar wall proximal edge 142; The wall 141 intersects the first scanning wall 151 to form a planar wall inner edge 144 and defines a proximal opening 140 that communicates with the body cavity 150.
  • the outer casing 100 further includes a transitional scanning wall 161 that extends proximally to intersect the first scanning wall 151 at the proximal transition edge 162 and distally to the distal end of the second scanning wall 171. End transition edge 164.
  • the transition scan wall 151 defines a transition cavity 160 that communicates with the body cavity 150 and the elongated cavity 170.
  • the distal scan wall 181 extends proximally and intersects the second scan wall 171 to form a transition edge 182 that extends distally and self-intersects to form a closed apex 184.
  • a closed, approximately annular cutting opening is formed around the inner edge 144 of the planar wall (the approximate annular shape may be a polygonal ring, a running ring or any other shape of closed ring),
  • the original outer casing 100a is divided into two parts, a stepped outer casing 100 and a waste portion 100b, wherein the cutting opening cuts the planar wall 141 to form a planar outer wall edge 146, and the planar outer wall edge 146 and the planar inner wall edge 144 The minimum width distance between them is W min ⁇ 6 mm.
  • the protrusion 148 may be integrally formed by blow molding with the original outer casing 100a, or may be formed by a post-processing process.
  • the protrusions 148 depicted in this example are formed by post processing.
  • 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 stepped outer casing 100a manufactured by the blow molding secondary processing method of the present invention has a lower overall cost than 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.
  • 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.
  • the shortest length of the sealing edge is about 126 mm, and the sealing machine work 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 sealable
  • the number of products can be increased. It can be seen that when the stepped jacket 100 is used, the sealing quality can be improved to a large extent, and the sealing efficiency is improved to a large extent.
  • the blistering method cannot manufacture or is extremely difficult to manufacture (costly) the stepped jacket 100, but it can also be manufactured by high-speed injection molding, such as the stepped jacket 100 used in the 12mm package, the lateral dimension of which is described above.
  • high-speed injection molding such as the stepped jacket 100 used in the 12mm package, the lateral dimension of which is described above.
  • Approximately 52 mm x 52 mm allows for a plurality of mold cavities to be placed in the same mold. For example, a small and medium-sized mold cavity can achieve a ten, and each molding cycle time of high-speed injection molding is less than that of the plastic manufacturing method. Therefore, the production efficiency when using high-speed injection molding is higher than that of the tray suction process (52 mm ⁇ 202 mm). .
  • the high-speed injection molding step jacket 100 is still superior to the background. Blister tray packaging.
  • the perforated plate 220 includes a planar plate 221 and a plurality of through holes 222 adapted to the shape and size of the body cavity 170.
  • the perforated plate 220 includes 50 substantially uniform through holes 222.
  • the product package 200 is stuck in the perforated plate 220, wherein the first scanning wall 151 is matched with the through hole 222, and the planar wall 141 is matched with the planar plate 221.
  • a single perforated plate 220 can be loaded with 50 of the product packages 200; the two perforated plates of the fully loaded product package 200 are fastened to each other and placed in a package having a size of about 55 cm x 28 cm x 22 cm, that is, 100 of the products.
  • the package 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, by using the stepped jacket 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 product package 200 are all calculated by volume, and a large degree of space saving can greatly save the sterilization, storage and transportation costs.
  • an existing tray blister package typically employs a release button 37 to secure the elongate shaft 23 of the puncture needle 20, preventing its sharp tip 25 from puncturing the packaging tray blister or cap.
  • the plate however, the shock vibration during transport tends to easily disengage the elongate shaft 23 from the release buckle 37, thereby increasing the risk of the tip 25 piercing the tray blister pack.
  • the minimum axial depth of the outer casing 100 can be designed to be greater than the axial depth of the puncture needle 20, i.e., in the puncture needle product package 200, the puncture needle tip 25
  • the contact with the distal scanning wall 181 and the apex 184 can effectively prevent the piercing needle from piercing the seamless casing 121 during storage and transportation, causing the aseptic packaging to fail, and the handle portion 21 is elongated.
  • the non-sharp position of the rod 23 or the like contacts the stepped outer casing 100 or the cover plate 190 without causing damage or integrity damage to the package under normal transportation conditions.
  • the minimum distance between the puncture needle tip 25 and the closed apex 184 is greater than or equal to 2 mm, thereby preventing the puncture needle tip 25 from being deformed after the vertical container is deformed.
  • the closed vertex 184 is in contact.
  • the stepped outer casing 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 plate 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 stepped outer casing 100 of the present invention is advantageous for reducing the amount of Tyvek medical cover material.
  • the stepped outer casing 100 of the present invention also helps to display the articles to be packaged, which is advantageous for use.
  • Figures 16-21 depict another piercing product package and, more specifically, the structure and composition of the cannula assembly product package 400.
  • the cannula assembly product package 400 includes a cannula assembly 10, a stepped outer casing 300, and a cover plate 290.
  • the cannula assembly 10 includes a relatively large cartridge body 11 and a relatively sharp cannula tip 15 and an elongated tube 13 extending therebetween, and a valve assembly 17 projecting beyond the cartridge body 11.
  • the stepped jacket 300 includes a proximal opening 340 defined by a horizontal wall 341 that further includes a closed apex 384 and a seamless housing 321 extending between the horizontal wall 341 and the closed apex 384, the absence
  • the slit housing 321 defines a seamless cavity 320 that includes an opening at one end.
  • the stepped outer casing 300 further includes an axis 310 extending axially from the proximal end to the distal end and may be mainly divided into a first scanning wall 351, a transition scanning wall 361 and a second scanning wall 371.
  • the first scanning wall 351 defines a body lumen 350 that defines a transition lumen 360 that defines an elongated lumen 370, the body lumen 350, a transition lumen 360, and an elongated lumen
  • the 370 interpenetrates to form a major component of the seamless cavity 320.
  • the planar wall 341 extends laterally inwardly to intersect the first scanning wall 351 to form a planar inner wall edge 344 that extends laterally outwardly to form a planar outer wall edge 346.
  • the transition scan wall 361 extends proximally to the first scan wall 351 at a proximal transition edge 362 and distally to the second scan wall 371 at a distal transition edge 364.
  • the stepped outer casing 300 further includes a distal lumen 380 formed by the distal scanning wall 381 that extends proximally and intersects the second scanning wall 371 to form a transition edge 382, the scanning wall 381 Extending toward the distal end and self-intersecting form a apex 384.
  • the cannula assembly 10 is incorporated into the stepped outer casing 300, wherein the body cavity 350 substantially matches the shape and size of the cartridge body 11, the elongated cavity 170 and the thinner
  • the long tubes 13 are substantially matched in shape and size;
  • the cover plate 290 is welded to the planar wall 341 of the stepped outer casing 300 to form a closed terminally sterilized package.
  • the cover plate 290 is welded to the planar wall 341 to form an annular sealing edge 315 (not shown) having a width ⁇ 6 mm.
  • the stepped outer casing 300 may adopt a manufacturing method similar to that of the stepped outer casing 100 described above, that is, the original outer casing is first produced by blow molding, and then the stepped outer casing 300 is trimmed.
  • the cannula assembly product package 400 has similar advantages to the puncture needle product package 200, including shortening the length of the sealing edge to facilitate sealing process control and increasing sealing productivity, and reducing the volume of the shipping package to save sterilization and For freight storage, it also includes preventing the top of the casing or the valve assembly from piercing the package.
  • 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 formed by sweeping along a certain path. 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.
  • 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.
  • blow molding process 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 methods of blow molding and inflating are different.
  • Different blow molding processes have their own advantages and disadvantages.
  • the processing batch selects the appropriate process and control method.
  • 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.
  • blow molding process 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.
  • the trocar product package 600 includes a cannula assembly 10, a puncture needle 20, a stepped outer casing 500, and a cover plate 590.
  • 24-25 depict the structure and composition of the stepped jacket 500.
  • the stepped outer casing 500 includes a proximal end opening 540 defined by a horizontal wall 541 that further includes a closed bottom surface 584 and a seamless housing 521 extending between the horizontal wall 541 and the closed bottom surface 584, the The slit housing 521 defines a seamless cavity 520 that includes an opening at one end.
  • the stepped outer casing 500 further includes an axis 510 extending axially from the proximal end to the distal end and may be mainly divided into a first scanning wall 551, a transition scanning wall 561 and a second scanning wall 571.
  • the first scanning wall 551 defines a body cavity 550 that defines a transition cavity 560 that defines an elongated cavity 570, the body cavity 550, a transition cavity 560, and an elongated cavity
  • the 570 interconnects form a major component of the seamless cavity 520.
  • the planar wall 541 extends laterally inwardly to intersect the first scanning wall 551 to form a planar inner wall edge 544 that extends laterally outwardly to form a planar outer wall edge 546.
  • the transition scan wall 561 extends proximally to the first scan wall 551 at a proximal transition edge 562 and extends distally to the second scan wall 571 at a distal transition edge 564.
  • the stepped outer casing 500 further includes a distal end cavity 580 formed by a distal scanning wall 581 that extends proximally and intersects the second scanning wall 571 to form a transition edge 582, the scanning wall 581 Extending toward the distal end and self-intersecting forms a closed bottom surface 584.
  • the cannula assembly 10 and the puncture needle 20 are loaded into the stepped outer casing 500, wherein the cartridge body 11 is substantially aligned with the planar wall 541, the body cavity
  • the shape and dimensions of the 350 are designed to receive the handle portion 21, the cartridge body 11 and the valve assembly 17, which are shaped and sized to receive the elongated tube 13 and the elongated shaft 23.
  • the cover plate 590 is welded to the planar wall 541 of the stepped outer casing 500 to form a closed, terminally sterilized package. In one design, the cover plate 590 is welded to the planar wall 541 to form an annular sealing edge 515 (not shown) having a width ⁇ 6 mm.
  • the stepped outer casing 500 may adopt a manufacturing method similar to that of the stepped outer casing 100 described above, that is, the original outer casing is first produced by a blow molding method, and then the stepped outer casing 500 is trimmed.
  • the trocar product package 600 has similar advantages to the puncturing needle product package 200, including shortening the length of the sealing edge to facilitate sealing process control and increasing sealing productivity, and reducing the volume of the shipping package to save sterilization and storage. For shipping purposes, it also includes preventing the top of the casing or the valve assembly from puncturing the package.
  • Figure 26 depicts a cross section of the body cavity 550
  • Figure 27 depicts a cross section of the transition cavity 560
  • Figure 28 depicts a cross section of the extension cavity 570.
  • 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.
  • Defining the extended cross-sectional length dimension of the cavity 570 is L 3, the width dimension B 3, defining the cavity 570 extended axial depth dimension HA 2, wherein HA 2 ⁇ 5B 3.
  • Figures 29-31 depict an optimized stepped jacket 500a of the stepped jacket 500.
  • the stepped outer casing 500a is substantially identical in structure and composition to the stepped outer casing 500.
  • the stepped outer casing 500a includes a proximal opening 540 defined by a horizontal wall 541, the stepped outer casing 500a further comprising a closed bottom surface 584 and a seamless casing 521a extending between the horizontal wall 541 and the closed bottom surface 584, the
  • the slit housing 521a defines a seamless cavity 520a that includes an opening at one end.
  • the stepped casing 500a further includes an axis 510 extending axially from the proximal end to the distal end and may be mainly divided into a first scanning wall 551a, a transition scanning wall 561a and a second scanning wall 571.
  • the first scanning wall 551a defines a body cavity 550a that defines a transition cavity 560a that defines an elongated cavity 570.
  • the body cavity 550a, the transition cavity 560a and the extension cavity 570 are interconnected to form a major component of the seamless cavity 520a. Referring to FIG.
  • the cannula assembly 10 and the puncture needle 20 are loaded into the stepped outer casing 500a, wherein the proximal end of the handle portion 21 is substantially aligned with the planar wall 541, The distal end of the handle portion 21 is substantially aligned with the proximal end of the cartridge body 11, the body cavity 350a being shaped and dimensioned to receive the handle portion 21, the cartridge body 11 and the valve assembly 17; the elongated chamber 170
  • the shape and dimensions are designed to be sufficient to receive the elongated tube 13 and the elongated rod 23.
  • the transition of the stepped outer casing 500a relative to the stepped outer casing 500, the first scanning wall 551a and the transitional scanning wall 561a is smoother, and the formed body cavity 550a and the transition cavity 560a are smaller in size, and the appearance is more beautiful.
  • the streamlined shape is conducive to packaging storage and display.
  • the trocar product package 800 includes a cannula assembly 10, a puncture needle 20, a stepped outer sleeve 700, and a cover plate 790.
  • Figures 33-34 depict the structure and composition of the stepped jacket 700.
  • the stepped outer casing 700 includes a proximal end opening 540 defined by a horizontal wall 541 that further includes a closed distal end portion 780 and a seamless housing 721 extending between the horizontal wall 541 and the distal end portion 780
  • the seamless housing 721 defines a seamless cavity 720 that includes an opening at one end.
  • the stepped outer casing 700 further includes an axis 710 extending axially from the proximal end to the distal end and may be mainly divided into a first scanning wall 751, a transitional scanning wall 761 and a second scanning wall 771.
  • the first scanning wall 751 mainly includes a first scanning wall 751a, a first scanning wall 751b and a first scanning wall 751c
  • the body cavity 750 corresponding thereto mainly comprises a main body cavity 750a, a main body cavity 750b and a main body Cavity 750c.
  • the transition scanning wall 761 mainly comprises three parts: a transition scanning wall 761a, a transition scanning wall 761b and a transition scanning wall 761c.
  • the distal portion 780 includes a first distal lumen 780a formed by a first distal scanning wall 781a and a first bottom surface 784a, and a second distal lumen 780b formed by a second distal scanning wall 781b and a second bottom surface 784b.
  • the cannula assembly 10 and the puncture needle 20 are loaded into the stepped outer casing 700.
  • the cartridge body 11 is substantially aligned with the planar wall 541
  • the body cavity 751a is mainly for receiving the cartridge body 11
  • the body cavity 751b is mainly for receiving the handle ratio 21
  • the body cavity 751c is mainly for receiving the valve assembly 17.
  • the first distal lumen 780a is primarily for receiving the cannula tip 15, and the second distal lumen 780b is primarily for receiving the needle tip 25.
  • the cover plate 790 is welded to the planar wall 741 of the stepped outer casing 700 to form a closed, terminally sterilized package.
  • the trocar product package 800 has similar advantages as the trocar product package 600.
  • the stepped outer casing 700 is more complex and closer to the shape of the packaged product than the stepped outer casing 700.
  • the manufacturing difficulty and the manufacturing cost are relatively high, but the packaging of the stepped outer casing 700 is stable. Good sex. Commercially disclosed production can be selected according to different priorities, and can be modified to reduce costs.
  • the stepped outer casing 100, the stepped outer casing 300, the stepped outer casing 500, and the stepped outer casing 700 have various manufacturing methods, and generally, a blow molding secondary trimming method or a rotational molding secondary trimming method can be employed.
  • a preferred blow molding secondary trimming method the main steps of which are generally as follows:
  • the original outer casing 100a is manufactured by a blow molding method.
  • the original outer casing 100a sequentially has a proximal end nozzle 132 disposed in the axial direction, and the proximal scanning wall 131 defines a proximal cavity 130, a planar wall 141, and a first scan.
  • the proximal mouthpiece 132 communicates with the proximal cavity through the proximal scanning wall; the planar wall 141 and the proximal scanning wall 131 extend to form a planar wall proximal edge 142; The wall 141 intersects the first scanning wall 151 to form a planar wall inner edge 144 and defines an opening portion 140 that communicates with the body cavity 150. (as shown in Figure 11-12);
  • a shipping package 900 for use in the present invention is presented.
  • 35-36 depict the structure and composition of the transport packaging system 900.
  • the transport packaging system 900 includes a package 910, a first fixed plate 920a, a second fixed plate 920b, and a partition 930.
  • the structure and size of the first fixing plate 920a and the second fixing plate 920b are substantially the same.
  • the first fixing plate 920a (the second fixing plate 920b) includes a flat plate 921 and a plurality of through-average through holes 922.
  • the fixing plate 920 includes 30 through holes 922, and the shape and size of the through holes 922 match the shape and size of the first housing 571.
  • the puncturing device assemblies 600 are snapped into the first fixing plate 920a, wherein the through holes 922 are matched with the first housing wall 571 to form a first layer fixing assembly; 30 The trocar assembly 600 is snapped into the second fixed plate 920b, wherein the through hole 922 mates with the first housing wall 571 to form a second layer of fixing assembly.
  • the package 910 includes a bottom surface 911 and a top surface 919.
  • the first layer fixing component is loaded into the package box 910, wherein the cover material 590 of the puncturing device assembly 600 is adjacent to the box bottom surface 911; the second layer fixing component is loaded into the packaging box 910, The cover material 590 of the trocar assembly 600 is adjacent to the top surface 919 of the box; the puncturing unit 600 of the first layer fixing assembly and the second layer fixing assembly are interlaced with each other and placed at the first position by at least two partitions 930 Between the fixed plate 920a and the second fixed plate 920b.
  • the bottom surface 911 of the box, the transition housing 561 of the trocar assembly, the partition 930 and the top surface 919 together limit the up and down movement of the first fixed plate 920a, the second fixed plate 920b and the puncturing unit 600.
  • the transport package 900 can package 60 of the trocar assemblies 600, although more or less adaptive tamper assembly 600 can be packaged.
  • the transport package 900 and stepped jacket 500 of the present example can save about 50% of the volume relative to prior art tray blister packs and shipping packages.
  • the stepped outer casing 301 includes a proximal opening 140 defined by a horizontal wall 141 that further includes a closed apex 184 and a non-extension between the horizontal wall 141 and the closed apex 184.
  • the housing 121 is defined, and the seamless housing 121 defines a seamless cavity 120 that includes an opening at one end.
  • the stepped outer casing 100 further includes an axis 110 extending axially from the proximal end to the distal end and may be mainly divided into a first scanning wall 151, a transition scanning wall 161 and a second scanning wall 171.
  • the first scanning wall 151 defines a body cavity 150 that defines a transition cavity 160 that defines an elongated cavity 170, the body cavity 150, a transition cavity 160, and an elongated cavity 170 interpenetratingly forms a major component of the seamless cavity 120.
  • the planar wall 141 extends laterally inwardly to intersect the first scanning wall 151 to form a planar inner wall edge 144 that extends laterally outwardly to form a planar outer wall edge 146.
  • the transition scan wall 161 extends proximally to the first scan wall 151 at a proximal transition edge 162 and distally to the second scan wall 171 at a distal transition edge 164.
  • the stepped outer casing 100 further includes a distal cavity 180 formed by the distal scanning wall 181, the distal scanning wall 181 extending proximally and intersecting the second scanning wall 171 to form a transition edge 182, the scanning wall 181 Extending toward the distal end and self-intersecting form a vertex 184.
  • the second scanning wall 171 further includes a bellows 271 and its defined bellows lumen 270.
  • the bellows 271 is composed of a plurality of axially disposed pleats 272, each of which includes a laterally extending pleat peak 273 and a pleat valley 275 and pleats extending between the pleat peak 273 and the pleat valley 275 Wall 274.
  • the second scanning wall 171 defines a cavity having a lateral dimension D2
  • the pleat valley 275 defining a cavity having a lateral dimension DV
  • the pleat peak 273 defining a lateral dimension of the cavity Is DP, where DP>DV, DP>D2.
  • DV can be greater than or equal to D2 or less than or equal to D2.
  • the bellows 271 has an axial length PO, the bellows 271 can be compressed in the axial direction to a compression length PS, and the bellows 271 can be stretched in the axial direction. Long to the stretch length PL. 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
  • the elongated puncturing device has a length specification of usually 145 to 155 mm.
  • the specific size specifications of the puncturing device of different manufacturers are slightly different, but generally the difference between the length of the ordinary puncturing device and the shortening puncturing device is greater than or equal to 25 mm, and the difference between the length of the elongated puncturing device and the ordinary puncturing device is greater than Equal to 40 mm.
  • the wrinkle size, the wrinkle angle and the number of wrinkles of the bellows 271 are reasonably set such that P L -P O ⁇ 40 mm and P O - P S ⁇ 25 mm, the same step jacket 301 can be Compatible packaging shortens the puncture device, common puncture device and extended puncture device. Thereby, the manufacturing mold cost is saved to a large extent, the inventory is reduced, and the management cost is saved.
  • the stepped outer casing 301a being substantially identical in structure to the stepped outer casing 301, the main difference being that the first scanning wall 151 of the stepped outer casing 301a further comprises a bellows 251 .
  • the bellows 251 is comprised of a plurality of axially disposed pleats, each pleat comprising laterally extending pleat peaks and pleat valleys and pleat walls extending between the pleat peaks and the pleat valleys.
  • the stepped outer casing 301b being substantially identical in construction to the stepped outer casing 301, the main difference being that the distal end scanning wall 181 of the stepped outer casing 301b comprises a stepped axial cavity portion .
  • the first stepped wall 283, the second stepped wall 285 and the third stepped wall 287 are sequentially joined and extend distally to form a seamless distal scan wall 181.
  • the first stepped wall 283 defines a first shaft hole 282 having a diameter D3;
  • the second stepped wall 285 defines a second shaft hole 284 having a diameter D4;
  • the third stepped wall 287 defines a distal end cavity 286.
  • the puncturing device is divided into its diameter specifications and can be divided into 3 mm (mm), 5 mm, 8 mm, 10 mm, 11 mm, 12 mm, 15 mm and the like.
  • the stepped shaft cavity of the distal scanning wall 181 facilitates compatibility with different diameter series of trocars.
  • the bellows 271 causes the axial dimension of the stepped jacket 301b to be correspondingly elongated or shortened to accommodate the length dimension of the packaged trocar, which is compatible with packages of 10 mm, 11 mm and 12 mm.
  • a diameter gauge puncture device is Those skilled in the art will appreciate that the size and shape of the aforementioned stepped shaft cavity can be slightly modified to be compatible with more different diameter gauge puncturing devices.
  • a typical surgical team typically includes at least one unpacking nurse dedicated to disassembling a disposable package and a device nurse or doctor who delivers the device in a sterile manner, including, of course, a surgeon and an assistant.
  • the unpacking nurse does not touch the disposable device, and it is more convenient to transfer the disposable device from the unpacking nurse to the device nurse.
  • a method of disassembling and delivering a device for a disposable puncture package is presented.
  • the puncture needle product package 200a includes a puncture needle 20, a stepped outer casing 301 and a cover material 190 heat sealed therewith.
  • the unpacking nurse tears the cover corner 198 to disassemble the final sterilization package, and then holds the proximal end of the second scanning wall 171 with one hand and the distal end of the second scanning wall 171 with the other hand as shown in FIG.
  • the bellows 271 is axially compressed to push the handle portion 11 of the puncture needle out of the body lumen 150 for convenient delivery to the instrument nurse in a sterile manner.
  • the second scanning wall 171 constituting the stepped outer casing 100 is a regular cylindrical wall, and the second scanning wall 171 forming the stepped outer casing 301 further includes a bellows 271. .
  • the stepped outer casing 301 is more complicated to manufacture than the stepped outer casing 100.
  • the stepped outer casing 301 can be conveniently manufactured by the blow molding secondary processing method of the present invention without greatly increasing the manufacturing cost. More complex shapes and structures can also be made.
  • blow molding process can be broadly divided into: injection blow molding, extrusion blow molding, and injection stretch blow molding box 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.
  • the processing batch selects the appropriate process and control method.
  • the shape and wall thickness of the parison are preferably controlled, and the stepped jacket 301 having a uniform wall thickness can still be obtained.
  • the planar wall 141 is generally not a strictly planar surface and typically has a draft angle of 1 to 5 degrees.
  • blow molding process 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.
  • the second scanning wall is adaptively modified to make the shape more beautiful and smoother; or different types of products are derived by increasing or decreasing the number of the sleeve assembly or the needle. package.

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Abstract

一种用于穿刺器包装的阶梯外套及其制造方法，所述阶梯外套（100）包含水平壁（141）限定的近端开口（140），所述阶梯外套还包含封闭远端以及在所述水平壁和封闭远端之间延伸的无缝壳体（121），所述无缝壳体限定出包含一端开口的无缝腔体（120）；所述无缝壳体由近端向远端可主要划分为第一扫描壁（151），过渡扫描壁（161）和第二扫描壁（171）；所述第一扫描壁限定出主体腔（150），所述过渡扫描壁限定出过渡腔（160），所述第二扫描壁限定出延长腔（170）；所述主体腔、过渡腔和延长腔相互贯通构成所述无缝腔体的主要部分；基本垂直所述水平壁的方向称为轴向，基本平行所述水平壁的方向称为横向；所述主体腔的横向截面尺寸大于所述延长腔体的横向截面尺寸。

Description

一种用于穿刺器包装的阶梯外套及其制造方法 技术领域
本发明涉及微创手术器械，尤其涉及一种穿刺器包装结构。
背景技术
穿刺器是一种微创手术中(尤其是硬管腔镜手术)，用于建立进入体腔的人工通道的手术器械。穿刺器通常包含套管组件和穿刺针两部分。目前一次性使用的穿刺器已经大量应用于各类临床手术中。穿刺器被包装在最终灭菌包装中，经灭菌后以无菌的方式销售和储运，在灭菌有效期内且所述最终灭菌包装不被损坏的情况下，被包装的产品保持无菌状态。灭菌方式很多，应用最广的包括EO环氧乙烷灭菌和射线灭菌。所述灭菌方式通常必须与最终灭菌包装相适应。
目前已披露的用于包装穿刺器的最终灭菌包装主要包括袋子包装和托盘包装(或称泡壳包装)。其中袋子包装的生产自动化程度高，成本低廉，然而由于穿刺器(穿刺针或套管组件)通常包含粗大手柄或仓体，细长管和锋利顶端，所述锋利顶端容易刺穿其袋子包装系统导致无菌状态破坏，而由于外形的尺寸差异较大，装有穿刺器的袋子包装相互挤压容易导致袋子包装破裂。美国发明专利US7677392中披露了一种顶端保护器可用以防止穿刺器的顶端刺穿包装系统，然而所述顶端保护器增加了整体的包装成本，而且并不能解决袋子包装相互挤压破裂的问题。托盘包装(泡壳包装)由于性价比相对更高而广泛应用。
托盘包装(或称泡壳包装)通常由上盖板(纸片)和下托盘(下泡壳)组成，所述下托盘通常由吸塑方式制成，即将塑料硬片材加热变软后，采用真空吸附的方式生成多个型腔或渠道，所述型腔或渠道用于盛装和固定被包装的产品。图1-2描绘了穿刺器现有包装技术的一种典型托盘包装系统30。所述托盘包装系统30包含特卫强纸片31和托盘泡壳32。所述托盘泡壳32包含水平凸缘33以及大致与之垂直的多个下凹型腔34和将各型腔联通的渠道35，渠道36。一种方案中，所述渠道35和渠道36还包括侧向凸出的释放扣37。一种套管组件10包含相对粗大的仓体11和相对锋利的套管顶端15及在其间延伸的细长管13，还包括凸出在所述仓体11之外的阀组件17。一种穿刺针20包含相对粗大的手柄部分21和穿刺针顶端25及在其间延伸的细长杆23。继续参考图1-2，所述套管组件10装入到所述托盘泡壳32之中，其中所述细长管13大致与所述水平凸缘33平行，且所述细长管13与渠道35匹配并被释放扣37所固定。所述穿刺针20装入到所述托盘泡 壳32之中，其中所述细长杆23大致与所述水平凸缘33平行，且所述细长杆23与渠道36匹配并被释放扣37所固定。所述纸片31和托盘泡壳32之间沿着所述水平凸缘33焊接(热合)形成完整的封合区域40，形成封闭的最终灭菌包装。
吸塑法生产所述托盘泡壳32的模具制造及成型过程的成本较低，而生产率较高，但也存在许多缺陷。吸塑成型制品的拉伸度受到一定限制，吸塑成型型腔的深度/宽度比值通常小于等于1，最恶劣情形下通常不得超过1.5。而且吸塑成型型腔的壁厚通常小于等于1mm，型腔最大拉伸深度尺寸通常不得大于100mm。然而所述套管组件或穿刺针沿其轴向的尺寸通常大于100mm，且其轴向尺寸/横向尺寸之比远大于1.5。因此，到目前为止已披露穿刺器的托盘包装(泡壳包装)，所述套管组件或穿刺针以其轴线基本平行于封合区域40的方式横卧在托盘或泡壳内，后文称之为卧式泡壳包装(或称为托盘泡壳包装)。所述卧式泡壳包装还存在很多缺陷，主要包括封合区域整体较长导致焊接(热合)的生产效率较低且封合区域稳定性不好；型腔尺寸不一导致多个最终灭菌包装相互堆叠时浪费空间较多；套管组件的顶端或阀组件容易刺破包装系统，穿刺针顶端容易刺破包装系统；包装系统兼容性不好等等。为解决前述一个或多个问题，本发明的一个目的是提出一种用于穿刺器包装的阶梯外套。
发明内容
在本发明的一个方面，提出一种用于穿刺器包装的阶梯外套。一种实现方案中所述所述阶梯外套包含水平壁限定的近端开口，所述阶梯外套还包含封闭远端以及在所述水平壁和封闭远端之间延伸的无缝壳体，所述无缝壳体限定出包含一端开口的无缝腔体。所述无缝壳体由近端向远端可主要划分为第一扫描壁，过渡扫描壁和第二扫描壁；所述第一扫描壁限定出主体腔，所述过渡扫描壁限定出过渡腔，所述第二扫描壁限定出延长腔；所述主体腔，过渡腔和延长腔相互贯通构成所述无缝腔体的主要部分。基本垂直所述水平壁的方向称为轴向，基本平行所述水平壁的方向称为横向；所述主体腔的横向截面尺寸大于所述延长腔体的横向截面尺寸。所述延长腔的轴向深度为HA，所述延长腔的横向截面最小宽度为Bmin，HA≥5Bmin。另一种实现方案中，所述阶梯外套的水平壁最小宽度Wmin，Wmin≥6毫米。又一种实现方案中，所述阶梯外套由塑胶材料整体吹塑成型。
在本发明的又一个目的，提出一种穿刺器产品包。一种穿刺器产品包，包含所述阶梯外套，其特征在于还包含盖材，穿刺针和/或套管组件，所述穿刺针和/或套管组件盛装在所述阶梯外套中，所述盖材与所述水平壁之间焊接封合形成完整的封合边，所述封合 边的最小宽度大于等于6毫米。
在本发明的又一个方面，所述的穿刺器产品包，其特征在于，所述穿刺针顶端和/或套管顶端与所述封闭顶端之间的距离M，M≥2毫米。
在本发明的又一个目的，提出一种运输包装系统。一种运输包装系统穿刺器产品包，还包括第一固定板，第二固定板，隔板和包装箱；所述多第一、第二固定板包含多个与所述第二扫描壁外形和横向尺寸相匹配的固定通孔；所述包装箱包含箱底面和箱顶面；多个所述穿刺器产品包的第二扫描壁插入所述第一固定板的固定通孔中形成第一层包装组件；所述第一层包装组件装入所述包装箱中，其中所述穿刺器产品包的盖材贴近箱底面；多个所述穿刺器产品包的第二扫描壁插入所述第二固定板的固定通孔中形成第二层包装组件；所述第二层包装组件装入所述包装箱中，其中所述穿刺器产品包的盖材贴近箱顶面；所述第一层包装组件和第二层包装组件相互交错，所述隔板将所述第一固定半和第二固定板分隔开。
在本发明的又一个目的，提出一种阶梯外套的制造方法。一种阶梯外套的制造方法，主要制造步骤如下：
S1：吹塑法制造包含原始外套，所述原始外套包含所述阶梯外套，还包括由水平壁向近端延伸的近端扫描壁及其限定的近端腔，还包括穿透所述近端扫描壁并与所述近端腔联通的吹嘴；
S2:由所述原始外套，沿所述水平壁修剪活动所述阶梯外套。
在本发明的又一个方面，提出一种用于穿刺器包装的多功能的阶梯外套，其中：所述阶梯外套包含水平壁限定的近端开口，所述阶梯外套还包含封闭远端以及在所述水平壁和封闭远端之间延伸的无缝壳体，所述无缝壳体限定出包含一端开口的无缝腔体；所述无缝壳体由近端向远端包括第一扫描壁，过渡扫描壁和第二扫描壁；所述第一扫描壁限定出主体腔，所述过渡扫描壁限定出过渡腔，所述第二扫描壁限定出延长腔；所述主体腔，过渡腔和延长腔相互贯通构成所述无缝腔体；基本垂直所述水平壁的方向称为轴向，基本平行所述水平壁的方向称为横向；所述主体腔的横向截面尺寸大于所述延长腔体的横向截面尺寸；所述第二扫描壁还包含多个沿轴向设置的褶皱，每个褶皱包含横向延伸的褶皱峰和褶皱谷以及在所述褶皱峰和褶皱谷之间延伸的褶皱壁。
附图说明
为了更充分的了解本发明的实质，下面将结合附图进行详细的描述，其中： 图1是一种现有技术典型的穿刺器包装示意图；
图2是图1所述包装垂直其封合边的截面图；
图3是本发明第一个实施例穿刺针产品包200的立体图；
图4是图3所示穿刺针产品包的爆炸图；
图5是图4所示产品包的阶梯外套100的轴向剖视图；
图6是图5所示阶梯外套沿轴向由近端向远端的投影视图；
图7是图3所示穿刺针产品包的轴向剖视图；
图8是图7所示穿刺针产品包由近端向远端的投影视图；
图9是图7所示穿刺针产品包的9-9剖视图；
图10是图7所示穿刺针产品包的10-10剖视图；
图11是原始外套100a的立体图；
图12是图11所示原始外套的轴向剖视图；
图13是图11所示原始外套二次加工修剪成阶梯外套100的示意图；
图14是一种用于包装所述产品包200的多孔板的立体图；
图15是一种用于包装所述产品包200的示意图；
图16是本发明第二个实施例套管组件产品包400的立体图；
图17是图16所示产品包的爆炸图；
图18是图17所示阶梯外套300的轴向剖视图；
图19是图17所述阶梯外套300的另一方向的轴向剖视图；
图20是图18所示阶梯外套沿轴向由近端向远端的投影视图；
图21是图19所示阶梯外套的21-21剖视图；
图22是本发明第三个实施例穿刺器产品包600的立体图；
图23是图22所示穿刺器产品包的爆炸图；
图24是图23所示阶梯外套500的轴向剖视图；
图25是图24所示阶梯外套沿轴向由近端向远端的投影视图；
图26是图24所示阶梯外套的26-26剖视图；
图27是图24所示阶梯外套的27-27剖视图；
图28是图24所示阶梯外套的28-28剖视图；
图29是另一实施方案穿刺器产品包500a的立体图；
图30是另一实施方案阶梯外套500a的立体图；
图31是图30所示阶梯外套500a立体剖视图；
图32是本发明第四个实施例穿刺器产品包800的立体图；
图33是图32所示阶梯外套700的立体图；
图34是图32所示阶梯外套700的又一视角立体图；
图35是第一固定板920a的立体图；
图36是本发明的运输包装900的立体剖视图；
图37是阶梯外套301的立体图；
图38是图37所示阶梯外套的轴向剖视图；
图39是图38所示褶皱的局部放大视图；
图40是图37所示阶梯外套301处于压缩状态的示意图；
图41是图37所示的阶梯外套301处于拉伸状态的示意图；
图42是阶梯外套301a的立体图；
图43是图42所示阶梯外套的轴向剖视图；
图44是阶梯外套301b的立体图；
图45是图44所示阶梯外套的轴向剖视图；
图46是穿刺针产品包200a的立体示意图；
图47是临床中拆卸所述产品包200a的示意图。
在所有的视图中，相同的标号表示等同的零件或部件。
具体实施方式
这里公开了本发明的实施方案，但是，应该理解所公开的实施方案仅是本发明的示例，本发明可以通过不同的方式实现。因此，这里公开的内容不是被解释为限制性的，而是仅作为权利要求的基础，以及作为教导本领域技术人员如何使用本发明的基础。本领域的技术人员可以理解，微创手术特别是硬管腔镜手术中的穿刺器通常包括套管组件和或穿刺针，后文中用“穿刺器”代表穿刺针或套管组件，或者穿刺针和套管组件的组合。穿刺器通常可分为重复使用穿刺器和一次性使用穿刺器。在本发明中，若无特定描述，本发明所述的穿刺器即为一次性穿刺器。为方便表述，后续凡接近操作者的一方定义为近端，而远离操作者的一方定义为远端。
图3-4描绘了一种穿刺器产品包，更确切的，描绘了穿刺针产品包200的结构和组成。参考图3-4，所述穿刺针产品包200包含穿刺针20，阶梯外套100和盖板190。所述穿刺针20包含相对粗大的手柄部分21和穿刺针顶端25及在其间延伸的细长杆23。
图5-6描绘了阶梯外套100的结构和组成。所述阶梯外套100包含水平壁141限定的近端开口140，所述阶梯外套100还包含封闭顶点184以及在所述水平壁141和封闭顶点184之间延伸的无缝壳体121，所述无缝壳体121限定出包含一端开口的无缝腔体120。所述阶梯外套100还包含轴线110，所述无缝壳体121沿轴向由近端向远端延伸，并可主要划分为第一扫描壁151，过渡扫描壁161和第二扫描壁171。所述第一扫描壁151限定出主体腔150，所述过渡扫描壁161限定出过渡腔160，所述第二扫描壁171限定出延长腔170，所述主体腔150，过渡腔160和延长腔170相互贯通构成所述无缝腔体120的主要组成部分。
所述平面壁141横向向内延伸与所述第一扫描壁151相交形成平面壁内边缘144，所述平面壁141横向向外延伸形成平面壁外边缘146。所述过渡扫描壁161向近端延伸与第一扫描壁151相交于近端过渡边162，向远端延伸与所述第二扫描壁171相交于远端过渡边164。所述阶梯外套100还包括远端扫描壁181形成的远端腔180，所述远端扫描壁181朝向近端延伸并与所述第二扫描壁171相交形成过渡边182，所述扫描壁181朝向远端延伸并自我相交形成顶点184。继续参考图6，一种设计方案中，所述平面壁外边缘146与所述平面壁内边缘144之间的最小宽度距离Wmin≥6毫米。另一种设计方案中，所述平面壁外边缘146包含圆角区域147。另一种设计方案中，所述圆角区域147包含由远端向近端的局部凸起148。
现参考图7-10，所述穿刺针20装入所述阶梯外套100之中，其中所述主体腔150与所述手柄部分21形状和尺寸大致匹配，所述延长腔170与所述细长杆23的形状和尺寸大致匹配；所述盖板190与所述阶梯外套100的平面壁141焊接在一起形成封闭的最终灭菌包装。现参考图8，一种设计方案中，所述盖板190与所述平面壁141焊接形成宽度≥6毫米的环形封合边195，而所述盖板190的其中一个角198不与所述平面壁141焊接在一起，所述凸起148将所述角198与所述平面壁141分隔开，方便拆开最终灭菌包装时的握持和撕扯。现参考图7，一种可选的设计方案中，所述穿刺针顶端25与所述远端扫描壁181和封闭顶点184不接触，可有效防止储运过程中穿刺针较锋利的顶端刺穿所述无缝外壳121导致无菌包装失效。
如背景所述，已披露和已商业化应用的穿刺器最终灭菌包装中，通常采用吸塑法生产托盘泡壳，所述套管组件或穿刺针以其轴线基本平行于封合区域的方式横卧在所述托盘泡壳中，即为卧式泡壳包装。本领域的技术人员应该可以理解，吸塑法制造托盘泡壳的成本较低，且生产率较高，但也存在许多缺陷：吸塑成型制品的拉伸度受到一定限制，吸 塑成型型腔的深度/宽度比值通常小于等于1，最恶劣情形下通常不得超过1.5。而且吸塑成型型腔的壁厚通常小于等于1mm，且其型腔最大拉伸深度尺寸通常不得大于100mm。本领域的技术人员可以理解，本实例所述之阶梯外套100的形状和结构相对于现有技术的托盘泡壳，具有显著的区别特征。虽然现有技术的托盘泡壳也可以包括由其主腔体下凹的腔体，但其下凹腔体的深度和其腔体最小宽度的比值不得大于1.5。而本实例的延长腔深度与其延长腔最小宽度之比远大于1.5。图9描绘了图7所示穿刺针产品包200的9-9横截面图，本实例中所述主体腔150的横截面为直径为D 1的近似圆形；图10描绘了图7所示穿刺针产品包200的10-10横截面图，本实例中所述延长腔170的横截面为直径为D 2的近似圆形；其中D 1＞D 2。继续参考图7-10，为便于量化，定义所述延长腔170的轴向深度为HA1，本实例中HA1≥5D2，即所述延长腔170的轴向深度数值大于等于所述延长腔170横截面最小宽度的5倍。因此采用吸塑法不能制造或极难制造(成本高昂)所述阶梯外套100。
图11-13描绘了采用吹塑法生产原始外套100a，再对所述原始外套100a修剪形成所述阶梯外套100的制造方法(下文简称吹塑二次加工法)。首先参考图11-12，所述原始外套100a包含轴线110以及沿轴线方向由近端向远端依次设置的近端吹嘴132，近端扫描壁131限定的近端腔体130，平面壁141，第一扫描壁151限定的主体腔150，第二扫描壁171限定的延长腔170和远端扫描壁181限定的远端腔180。所述近端吹嘴132穿透所述近端扫描壁与所述近端腔体联通；所述平面壁141与所述近端扫描壁131延伸相交形成平面壁近端边缘142；所述平面壁141与所述第一扫描壁151延伸相交形成平面壁内边缘144并限定出与所述主体腔150联通的近端开口140。所述外套100还包含过渡扫描壁161，所述过渡扫描壁161向近端延伸与第一扫描壁151相交于近端过渡边162，向远端延伸与所述第二扫描壁171相交于远端过渡边164。所述过渡扫描壁151限定出联通所述主体腔150和延长腔170的过渡腔160。所述远端扫描壁181朝向近端延伸并与所述第二扫描壁171相交形成过渡边182，所述扫描壁181朝向远端延伸并自我相交形成封闭顶点184。现参考图13，围绕所述平面壁内边缘144作一个封闭的近似环状的切断口(所述近似环状可以为多边形圈、跑到形圈或者其他任意形状的封闭圈)，将所述原始外套100a分割成阶梯外套100和废料部分100b两部分，其中所述切断口切割所述平面壁141形成平面壁外边缘146，且所述平面壁外边缘146与所述平面壁内边缘144之间的最小宽度距离W min≥6毫米。所述凸起148可与所述原始外套100a一体吹塑成型，或者后加工处理形成。本实例中描绘的凸起148由后加工形成。
本领域的技术人员应该可以理解，所述吹塑二次加工法与背景所述的吸塑托盘泡壳的制造方法相比，所述吹塑二次加工法制造单件包装外壳的成本高于吸塑法制造单件托盘泡壳的成本。然而本发明所述吹塑二次加工法制造的阶梯外套100a，其综合成本却远低托盘泡壳包装法。已商业化的一种典型12mm规格穿刺针20，其手柄部分21的尺寸约为直径为40mm长30mm的圆柱形，其细长杆23的尺寸约为直径为13mm长160mm的圆柱形。设定其包装封合边宽度为6mm。当采用背景所述卧式泡壳包装法时，其封合边的最短长度大于460mm，封合时占用封合机器工作台面尺寸52mm×202mm。而当采用本发明所述的阶梯外套100时，其封合边最短长度约为126mm，封合时占用封合机器工作台面尺寸52mm×52mm。本领域的技术人员应该可以理解，因为既要使用时拆开包装方便同时又要确保足够的封合强度，最终灭菌包装的封合质量控制非常重要且复杂。封合线长度越短，封合时占用封合机器工作台面尺寸越小，则封合过程的可控性也更好，且形成的封合边的稳定性越好，而单次可封合的产品数量则可越多。可见，采用所述阶梯外套100时，可以较大程度的提高封合质量，并较大程度的提高封合效率。
如前文所述，吸塑法不能制造或极难制造(成本高昂)所述阶梯外套100，然而也可以采用高速注塑法制造，例如前文所述，12mm规格包装所用的阶梯外套100，其横向尺寸约52mm×52mm使得同一模具中可以设置很多个模腔。例如中小型的模腔即可实现一出十，而且高速注塑的每一个成型周期时间也少于吸塑制造法，因此采用高速注塑时的生产效率反而高于托盘吸塑工艺(52mm×202mm)。当然为了减小注塑缺陷，可能需要增加壁厚从而浪费材料，然而结合前文所述的封合质量，包装，储运，灭菌等综合成本考虑，高速注塑阶梯外套100仍然优于背景所述的吸塑托盘包装。
图14-15描绘了穿刺针产品包200的一种运输包装法。多孔板220包含平面板材221和多个与所述主体腔170形状和尺寸相适应的通孔222，本实施中，所述多孔板220包含50个大致均布的通孔222。参考图15，所述产品包200卡所述多孔板220中，其中所述第一扫描壁151与所述通孔222匹配，所述平面壁141与所述平面板材221匹配。单个所述多孔板220可以装载50个所述产品包200；两个满载产品包200的多孔板相互扣装，放入一个尺寸约为55cm×28cm×22cm包装箱中，即100个所述产品包200占用包装空间约为33880cm 3。若采用背景所述的吸塑托盘泡壳包装同样的穿刺针20，100个产品包占用包装空间大约为51376cm 3。可见，采用所述阶梯外套100，可以较大程度的节约产品包装空间。本领域的技术人员应该可以理解，所述产品包200的灭菌，储存，运输都是按体积计算价格的，较大程度的节约包装空间可以较大程度的节约灭菌，储存和运输 成本。
现参考图1，图2，图7和图15，现有托盘泡壳包装通常采用释放扣37固定穿刺针20的细长杆23，防止其锋利的顶端25刺破包装托盘泡壳或上盖板，然而运输过程中的冲击振动往往容易所述细长杆23与所述释放扣37脱离，从而增加了顶端25刺破托盘泡壳包装的风险。而且通常不能采用增加释放扣37的固定力的方式来防止脱离，增加固定力则可能导致拆卸包装时所述穿刺针20不容易被取下，从而影响使用体验。而采用本发明所述的阶梯外套100，所述外套100的最小轴向深度可以设计成大于所述穿刺针20的轴向深度，即所述穿刺针产品包200中，所述穿刺针顶端25与所述远端扫描壁181和顶点184不接触，可有效防止储运过程中穿刺针较锋利的顶端刺穿所述无缝外壳121导致无菌包装失效，而所述手柄部分21，细长杆23等非锋利位置接触所述阶梯外套100或盖板190正常运输条件下不会造成包装破损或完整性破坏。更详细的，一种设计方案中，所述穿刺针顶端25与所述封闭顶点184之间的最小距离大于等于2毫米，从而防止所述立式容器变形后，所述穿刺针顶端25与所述封闭顶点184接触。
所述阶梯外套100可由多种材料制成，包括但不限于聚乙烯(HDPE,LDPE)，聚丙烯(PP)，聚氯乙烯(PVC)，热塑性弹性体(TPE)，PET，PETG等等。所述盖板190可由不透气的塑料薄膜制成，或者由具有生物阻隔性的多孔透气材料制成(例如Tyvek医用盖材4058B、1059B、1073B、Asuron)。Tyvek医用盖材在穿刺器的最终灭菌包装领域广泛应用，但其价格昂贵，本发明所述的阶梯外套100有利于减少Tyvek医用盖材的用量。另外，当采用透明材料制造所述阶梯外套100时，本发明所述的阶梯外套100还有助于展示其被包装的物品，利于选用。
图16-21描绘了另一种穿刺器产品包，更确切的，描绘了套管组件产品包400的结构和组成。参考图16-17，所述套管组件产品包400包含套管组件10，阶梯外套300和盖板290。所述套管组件10包含相对粗大的仓体11和相对锋利的套管顶端15及在其间延伸的细长管13，还包括凸出在所述仓体11之外的阀组件17。
图18-21描绘了阶梯外套300的结构和组成。所述阶梯外套300包含水平壁341限定的近端开口340，所述阶梯外套300还包含封闭顶点384以及在所述水平壁341和封闭顶点384之间延伸的无缝壳体321，所述无缝壳体321限定出包含一端开口的无缝腔体320。所述阶梯外套300还包含轴线310，所述无缝壳体321沿轴向由近端向远端延伸，并可主要划分为第一扫描壁351，过渡扫描壁361和第二扫描壁371。所述第一扫描壁351限定出主体腔350，所述过渡扫描壁361限定出过渡腔360，所述第二扫描壁371限定出 延长腔370，所述主体腔350，过渡腔360和延长腔370相互贯通构成所述无缝腔体320的主要组成部分。
所述平面壁341横向向内延伸与所述第一扫描壁351相交形成平面壁内边缘344，所述平面壁341横向向外延伸形成平面壁外边缘346。所述过渡扫描壁361向近端延伸与第一扫描壁351相交于近端过渡边362，向远端延伸与所述第二扫描壁371相交于远端过渡边364。所述阶梯外套300还包括远端扫描壁381形成的远端腔380，所述远端扫描壁381朝向近端延伸并与所述第二扫描壁371相交形成过渡边382，所述扫描壁381朝向远端延伸并自我相交形成顶点384。
现参考图16-17，所述套管组件10装入所述阶梯外套300之中，其中所述主体腔350与所述仓体11形状和尺寸大致匹配，所述延长腔170与所述细长管13的形状和尺寸大致匹配；所述盖板290与所述阶梯外套300的平面壁341焊接在一起形成封闭的最终灭菌包装。一种设计方案中，所述盖板290与所述平面壁341焊接形成宽度≥6毫米的环形封合边315(图中未示出)。所述阶梯外套300可采用与前述阶梯外套100近似的制造方法，即先采用吹塑法生产原始外套，再经修剪制成所述阶梯外套300。所述套管组件产品包400具有与所述穿刺针产品包200类似的优点，包括缩短封合边的长度利于封合过程控制和提高封合生产率，以及缩小运输包装的体积以节省灭菌和储运费用，还包括防止套管顶端或阀组件刺破包装等作用。
参考图9，图10和图21，形成所述阶梯外套100的第一扫描壁151为规则的圆柱形壁，而形成所述阶梯外套300的第一扫描壁351为沿一定轨迹扫略形成的不规则的封闭环壁。所述阶梯外套300的形状不规则，其制造复杂程度高于所述阶梯外套100，然而采用本发明所述的吹塑二次加工法可以方便的制造所述阶梯外套300而不至于大幅度的增加制造成本。更为复杂的形状和结构也是可以制造的。对于吹塑工艺有所了解的技术人员应该可以理解，吹塑工艺大致可分为：注射吹塑，挤出吹塑，注射拉伸吹塑和挤出拉伸吹塑。吹塑通常采用两步法，第一步制造型坯，第二步吹胀成型；不同吹塑方法的制造型坯和吹胀成型的方式不同。不同吹塑工艺各有优点和劣势，通常根据产品形状，加工批量选择合适的工艺及控制方法。例如本发明所述的阶梯外套300，所述主体腔350和延长腔370的横向尺寸和轴向尺寸差异较大，而较好的控制型坯的形状和壁厚，仍然可以获得壁厚均匀的所述阶梯外套300。例如为方便制造(脱模)，所述平面壁141和平面壁341通常不是严格意义的平面，通常具有1°到5°的脱模斜度。由于篇幅限制，本发明中不讨论吹塑工艺相关的细节问题，本领域的技术人员容易想到，通过参考相关制造工艺文献或工艺 经验，或者经过有限次数的试验，可以对本发明所披露的实施例进行适应性修改，使其结构更利于生产制造。
图22-28描绘了又一种穿刺器产品包600的结构和组成。参考图22-23，所述穿刺器产品包600包含套管组件10，穿刺针20，阶梯外套500和盖板590。图24-25描绘了阶梯外套500的结构和组成。所述阶梯外套500包含水平壁541限定的近端开口540，所述阶梯外套500还包含封闭底面584以及在所述水平壁541和封闭底面584之间延伸的无缝壳体521，所述无缝壳体521限定出包含一端开口的无缝腔体520。所述阶梯外套500还包含轴线510，所述无缝壳体521沿轴向由近端向远端延伸，并可主要划分为第一扫描壁551，过渡扫描壁561和第二扫描壁571。所述第一扫描壁551限定出主体腔550，所述过渡扫描壁561限定出过渡腔560，所述第二扫描壁571限定出延长腔570，所述主体腔550，过渡腔560和延长腔570相互贯通构成所述无缝腔体520的主要组成部分。所述平面壁541横向向内延伸与所述第一扫描壁551相交形成平面壁内边缘544，所述平面壁541横向向外延伸形成平面壁外边缘546。所述过渡扫描壁561向近端延伸与第一扫描壁551相交于近端过渡边562，向远端延伸与所述第二扫描壁571相交于远端过渡边564。所述阶梯外套500还包括远端扫描壁581形成的远端腔580，所述远端扫描壁581朝向近端延伸并与所述第二扫描壁571相交形成过渡边582，所述扫描壁581朝向远端延伸并自我相交形成封闭底面584。
现参考图22，所述套管组件10和穿刺针20装入所述阶梯外套500之中，其中所述仓体11，所述手柄部分21与所述平面壁541基本对齐，所述主体腔350的形状和尺寸设计成刚好接纳所述手柄部分21，仓体11以及阀组件17，所述延长腔570形状和尺寸设计成足以接纳所述所述细长管13和细长杆23。所述盖板590与所述阶梯外套500的平面壁541焊接在一起形成封闭的最终灭菌包装。一种设计方案中，所述盖板590与所述平面壁541焊接形成宽度≥6毫米的环形封合边515(图中未示出)。所述阶梯外套500可采用与前述阶梯外套100近似的制造方法，即先采用吹塑法生产原始外套，再经修剪制成所述阶梯外套500。所述穿刺器产品包600具有与所述穿刺针产品包200类似的优点，包括缩短封合边的长度利于封合过程控制和提高封合生产率，以及缩小运输包装的体积以节省灭菌和储运费用，还包括防止套管顶端或阀组件刺破包装等作用。
参考图24-28，图26描绘了所述主体腔550横截面，图27描绘了所述过渡腔560的横截面，图28描绘了所述延长腔570的横截面。其横截面的形状为不规则的封闭的近似椭圆形，由近端向远端，横截面的尺寸减小。定义所述延长腔570的横截面长度尺寸为 L 3，宽度尺寸为B 3，定义所述延长腔570的轴向深度尺寸为HA 2，其中HA 2≥5B 3。
图29-31描绘了所述阶梯外套500的一种优化的阶梯外套500a。所述阶梯外套500a与所述阶梯外套500的结构和组成基本等同。所述阶梯外套500a包含水平壁541限定的近端开口540，所述阶梯外套500a还包含封闭底面584以及在所述水平壁541和封闭底面584之间延伸的无缝壳体521a，所述无缝壳体521a限定出包含一端开口的无缝腔体520a。所述阶梯外套500a还包含轴线510，所述无缝壳体521a沿轴向由近端向远端延伸，并可主要划分为第一扫描壁551a，过渡扫描壁561a和第二扫描壁571。所述第一扫描壁551a限定出主体腔550a，所述过渡扫描壁561a限定出过渡腔560a，所述第二扫描壁571限定出延长腔570。所述主体腔550a，过渡腔560a和延长腔570相互贯通构成所述无缝腔体520a的主要组成部分。参考图29，一种实现方案中，所述套管组件10和穿刺针20装入所述阶梯外套500a之中，其中所述手柄部分21的近端与所述平面壁541基本对齐，所述手柄部分21的远端与所述仓体11的近端基本对齐，所述主体腔350a的形状和尺寸设计成刚好接纳所述手柄部分21，仓体11以及阀组件17；所述延长腔170形状和尺寸设计成足以接纳所述所述细长管13和细长杆23。所述阶梯外套500a相对于所述阶梯外套500，所述第一扫描壁551a和过渡扫描壁561a的过渡更加顺滑，形成的主体腔550a和过渡腔560a的尺寸更小，而且外观具有更加美观的流线造型，利于包装储运和展示。
图32-34描绘了又一种穿刺器产品包800的结构和组成。参考图32，所述穿刺器产品包800包含套管组件10，穿刺针20，阶梯外套700和盖板790。图33-34描绘了阶梯外套700的结构和组成。所述阶梯外套700包含水平壁541限定的近端开口540，所述阶梯外套700还包含封闭的远端部分780以及在所述水平壁541和远端部分780之间延伸的无缝壳体721，所述无缝壳体721限定出包含一端开口的无缝腔体720。所述阶梯外套700还包含轴线710，所述无缝壳体721沿轴向由近端向远端延伸，并可主要划分为第一扫描壁751，过渡扫描壁761和第二扫描壁771。所述第一扫描壁751主要包含第一扫描壁751a，第一扫描壁751b和第一扫描壁751c三部分,与之相对应的所述主体腔750主要包含主体腔750a，主体腔750b和主体腔750c。所述过渡扫描壁761主要包含过渡扫描壁761a，过渡扫描壁761b和过渡扫描壁761c三部分。所述远端部分780包含第一远端扫描壁781a和第一底面784a形成的第一远端腔780a；以及第二远端扫描壁781b和第二底面784b形成的第二远端腔780b。
现参考图32，所述套管组件10和穿刺针20装入所述阶梯外套700之中。其中所述仓体11，所述手柄部分21与所述平面壁541基本对齐，所述主体腔751a主要用以接纳 所述仓体11，所述主体腔751b主要用以接纳所述手柄比方21，所述主体腔751c主要用以接纳所述阀组件17。所述第一远端腔780a主要用以接纳所述套管顶端15，所述第二远端腔780b主要用以接纳所述穿刺针顶端25。所述盖板790与所述阶梯外套700的平面壁741焊接在一起形成封闭的最终灭菌包装。所述穿刺器产品包800具有与所述穿刺器产品包600具有类似的优点。而所述阶梯外套700与所述阶梯外套500相比，所述阶梯外套700的形状更复杂更贴近被包装产品的形状，制造难度和制造成本相比较高，但所述阶梯外套700的包装稳固性较好。商业化披露生产时，可根据不同侧重点选用，并可加以适应性修改降低成本。
所述阶梯外套100，阶梯外套300，阶梯外套500，阶梯外套700有多种制造方法，通常可采用吹塑二次修剪法或者滚塑二次修剪法。一种优选的吹塑二次修剪法，其主要步骤大体如下：
S1:吹塑，首先采用吹塑法制造原始外套100a，所述原始外套100a沿轴线方向依次设置近端吹嘴132，近端扫描壁131限定近端腔体130，平面壁141，第一扫描壁151限定的主体腔150，第二扫描壁171限定的延长腔170和远端扫描壁181形成的远端腔180。所述近端吹嘴132穿透所述近端扫描壁与所述近端腔体联通；所述平面壁141与所述近端扫描壁131延伸相交形成平面壁近端边缘142；所述平面壁141与所述第一扫描壁151延伸相交形成平面壁内边缘144并限定出与所述主体腔150联通的开口部分140。(如图11-12所示)；
S2:修剪，围绕所述平面壁内边缘144作一个封闭的近似环状的切断口，将所述原始外套100a分割成阶梯外套100和废料部分100b两部分，其中所述切断口切割所述平面壁141形成平面壁外边缘146，且所述平面壁外边缘146与所述平面壁内边缘144之间的最小宽度距离Bmin≥6毫米。(如图13所示)。
在本发明的又一个方面，提出一种用于本发明的运输包装900。图35-36描绘了所述运输包装系统900的结构和组成。所述运输包装系统900包含包装箱910，第一固定板920a，第二固定板920b和隔板930。所述第一固定板920a和所述第二固定板920b的结构和尺寸基本等同。所述所述第一固定板920a(第二固定板920b)包含平面板材921和多个贯穿的近似均布的通孔922。本实例中，所述固定板920包含30个通孔922，且通孔922的形状和尺寸与所述第一壳体571的形状和尺寸相匹配。本实例中，30个所述穿刺器组件600被卡入所述第一固定板920a中，其中所述通孔922与所述第一壳体壁571匹配，形成第一层固定组件；30个所述穿刺器组件600被卡入所述第二固定板920b中，其中所 述通孔922与所述第一壳体壁571匹配，形成第二层固定组件。如图36所示，所述包装箱910包含箱底面911和箱顶面919。所述第一层固定组件装入所述包装箱910中，其中所述穿刺器组件600的盖材590贴近所述箱底面911；所述第二层固定组件装入所述包装箱910中，所述穿刺器组件600的盖材590贴近所述箱顶面919；所述第一层固定组件和第二层固定组件的穿刺器组件600相互交错，并用至少两块隔板930放置在第一固定板920a和第二固定板920b之间。所述箱底面911，穿刺器组件的过渡壳体561，隔板930和箱顶面919，一起限制所述第一固定板920a，第二固定板920b和穿刺器组件600的上下运动。而所述包装箱910的侧面限制所述第一、第二固定板的外周，而所述通孔922限制所述第一壳体571，从而限制所述组件600的侧向移动。本实例中，所述运输包装900可以包装60个所述穿刺器组件600，然而稍做适应性修改可以包装更多或较少的所述穿刺器组件600。本实例所述的运输包装900和阶梯外套500，相对于现有技术的托盘泡壳包装及其运输包装，可以节省约50％的体积。
图37-41描绘了另一实施例阶梯外套301，所述阶梯外套301与所述阶梯外套100的结构大体等同，主要区别在于所述阶梯外套301还包含波纹管结构。首先参考图16-18，所述阶梯外套301包含包含水平壁141限定的近端开口140，所述阶梯外套100还包含封闭顶点184以及在所述水平壁141和封闭顶点184之间延伸的无缝壳体121，所述无缝壳体121限定出包含一端开口的无缝腔体120。所述阶梯外套100还包含轴线110，所述无缝壳体121沿轴向由近端向远端延伸，并可主要划分为第一扫描壁151，过渡扫描壁161和第二扫描壁171。所述第一扫描壁151限定出主体腔150，所述过渡扫描壁161限定出过渡腔160，所述第二扫描壁171限定出延长腔170，所述主体腔150，过渡腔160和延长腔170相互贯通构成所述无缝腔体120的主要组成部分。所述平面壁141横向向内延伸与所述第一扫描壁151相交形成平面壁内边缘144，所述平面壁141横向向外延伸形成平面壁外边缘146。所述过渡扫描壁161向近端延伸与第一扫描壁151相交于近端过渡边162，向远端延伸与所述第二扫描壁171相交于远端过渡边164。所述阶梯外套100还包括远端扫描壁181形成的远端腔180，所述远端扫描壁181朝向近端延伸并与所述第二扫描壁171相交形成过渡边182，所述扫描壁181朝向远端延伸并自我相交形成顶点184。
继续参考图37-39，所述第二扫描壁171还包含波纹管271及其限定的波纹管腔270。所述波纹管271由多个沿轴向设置的褶皱272组成，每个所述褶皱272包含横向延伸的褶皱峰273和褶皱谷275以及在所述褶皱峰273和褶皱谷275之间延伸的褶皱壁274。现主要参考图18，所述第二扫描壁171限定的腔体的横向尺寸为D2，所述褶皱谷275限 定的腔体的横向尺寸为DV，所述褶皱峰273限定的腔体的横向尺寸为DP，其中DP＞DV，DP＞D2。而DV既可大于等于D2也可小于等于D2。
现参考图37，图40和图41，所述波纹管271具有轴向长度PO，所述波纹管271可沿轴向压缩缩短至压缩长度PS，所述波纹管271可沿轴向拉伸伸长至拉伸长度PL。本领域的技术人员可以理解，微创手术(硬管腔镜手术)针对瘦弱患者，普通患者和肥胖患者，通常分别采用与之相匹配的缩短穿刺器，普通穿刺器和加长穿刺器。所述缩短穿刺器的标称长度规格通常为65～75毫米，所述普通穿刺器的长度规格通常为90～110毫米，所述加长穿刺器的长度规格通常为145～155毫米。不同厂家的穿刺器的具体尺寸规格略有不同，但通常所述普通穿刺器与缩短穿刺器的长度之差大于等于25毫米，而所述加长穿刺器与所述普通穿刺器的长度之差大于等于40毫米。一种设计方案中，合理的设置波纹管271的褶皱尺寸，褶皱角度和褶皱数量，使得P L-P O≥40毫米，P O-P S≥25毫米，则同一个所述阶梯外套301可以兼容的包装缩短穿刺器，普通穿刺器和加长穿刺器。从而较大程度的节约制造模具成本，减少库存和节约管理成本。
图42-43描绘了另一实施方案的阶梯外套301a，所述阶梯外套301a与所述阶梯外套301的结构基本等同，主要区别在于所述阶梯外套301a的第一扫描壁151还包含波纹管251。相似的，所述波纹管251由多个沿轴向设置的褶皱组成，每个褶皱包含横向延伸的褶皱峰和褶皱谷以及在所述褶皱峰和褶皱谷之间延伸的褶皱壁。
图44-45描绘了又一实施方案的阶梯外套301b，所述阶梯外套301b与所述阶梯外套301的结构基本等同，主要区别在于所述阶梯外套301b的远端扫描壁181包含阶梯轴腔部分。一种实施方案中，第一阶梯壁283，第二阶梯壁285和第三阶梯壁287依次连接并朝向远端延伸构成无缝隙的远端扫描壁181。所述第一阶梯壁283限定出直径为D3的第一轴孔282；所述第二阶梯壁285限定出直径为D4的第二轴孔284；所述第三阶梯壁287限定出远端腔286。本领域的技术人员可以理解，所述穿刺器按其直径规格划分，可分为3mm(毫米)，5mm，8mm，10mm，11mm，12mm，15mm等规格。所述远端扫描壁181的阶梯轴腔有利于兼容不同直径系列的穿刺器。一种具体的实现方案中，所述延长腔170的直径D2＝12mm，D3＝11mm，D4＝10mm。如前文所述，所述波纹管271使得所述阶梯外套301b的轴向尺寸相应的伸长或缩短以适应被包装穿刺器的长度尺寸，所述阶梯外套301b可兼容包装10mm，11mm和12mm三种直径规格的穿刺器。本领域技术人员可以想到，对前述阶梯轴腔的尺寸和形状稍作适应性修改，可兼容更多不同直径规格的穿刺器。
本领域的技术人员应该可以理解，在外科手术中，通常严格按标准程序准备和拆卸一次性包装，以避免污染手术器械。典型的手术团队中通常包含至少一名专门负责拆卸一次性包装的拆包护士和一名以无菌方式传递器械的器械护士或医生，当然还包括手术医生和助手。通常拆包护士并不接触一次性器械，而更方便的将一次性器械由拆包护士传递给器械护士是值得研究的问题。在本发明的另一个方面，提出一种一次性穿刺器包装的拆卸和传递器械的方法。参考图25，穿刺针产品包200a包含穿刺针20，阶梯外套301和与之热封在一起的盖材190。首先拆包护士撕扯盖材角198拆开最终灭菌包装，然后如图26所示一手握持所述第二扫描壁171的近端，另一手握持所述第二扫描壁171的远端，轴向压缩所述波纹管271，从而将所述穿刺针的手柄部分11推挤出所述主体腔150，从而方便的以无菌的方式传递给器械护士。
参考图10，图12，图38和图39，构成所述阶梯外套100的第二扫描壁171为规则的圆柱形壁，而形成所述阶梯外套301的第二扫描壁171还包含波纹管271。所述阶梯外套301的制造复杂程度高于所述阶梯外套100，然而采用本发明所述的吹塑二次加工法可以方便的制造所述阶梯外套301而不至于大幅度的增加制造成本。更为复杂的形状和结构也是可以制造的。对于吹塑工艺有所了解的技术人员应该可以理解，吹塑工艺大致可分为：注射吹塑，挤出吹塑，注射拉伸吹塑盒挤出拉伸吹塑。吹塑通常采用两步法，第一步制造型坯，第二步吹胀成型；不同吹塑方法指制造型坯和吹胀成型的方式不同。不同吹塑工艺各有优点和劣势，通常根据产品形状，加工批量选择合适的工艺及控制方法。例如较好的控制型坯的形状和壁厚，仍然可以获得壁厚均匀的所述阶梯外套301。例如为方便制造(脱模)，所述平面壁141通常不是严格意义的平面，通常具有1°到5°的脱模斜度。由于篇幅限制，本发明中不讨论吹塑工艺相关的细节问题，本领域的技术人员容易想到，通过参考相关制造工艺文献或工艺经验，或者经过有限次数的试验，可以对本发明所披露的实施例进行适应性修改，使其结构更利于生产制造。
在不脱离本发明范围的前提下，通过适当修改能对所述方法和器械做出适应性改进。例如利用对本发明所述的第一扫描壁，过渡扫描壁，第二扫描壁进行适应性修改，使造型更美观更顺滑；或者通过增减套管组件或穿刺针的数量衍生不同种类的产品包。好几种修正方案已经被提到，对于本领域的技术人员来说，其他修正方案也是可以想到的。因此本发明的范围应该依照附加权利要求，同时不应被理解为由说明书及附图显示和记载的结构，材料或行为的具体内容所限定。

Claims (12)

  1. 一种用于穿刺器包装的阶梯外套，其特征在于：
    所述阶梯外套包含水平壁限定的近端开口，所述阶梯外套还包含封闭远端以及在所述水平壁和封闭远端之间延伸的无缝壳体，所述无缝壳体限定出包含一端开口的无缝腔体；
    所述无缝壳体由近端向远端可主要划分为第一扫描壁，过渡扫描壁和第二扫描壁；所述第一扫描壁限定出主体腔，所述过渡扫描壁限定出过渡腔，所述第二扫描壁限定出延长腔；所述主体腔，过渡腔和延长腔相互贯通构成所述无缝腔体的主要部分；
    基本垂直所述水平壁的方向称为轴向，基本平行所述水平壁的方向称为横向；所述主体腔的横向截面尺寸大于所述延长腔体的横向截面尺寸；
    所述延长腔的轴向深度为HA，所述延长腔的横向截面最小宽度为B min，HA≥5B min。
  2. 如权利要求1所述的阶梯外套，其特征在于，所述水平壁最小宽度W min，W min≥6毫米。
  3. 如权利要求1所述的阶梯外套，其特征在于，所述阶梯外套由塑胶材料整体吹塑成型或整体注塑成型。
  4. 一种穿刺器产品包，包含如权利要求1-3任一所述的阶梯外套，其特征在于还包含盖材，穿刺针和/或套管组件，所述穿刺针和/或套管组件盛装在所述阶梯外套中，所述盖材与所述水平壁之间焊接封合形成完整的封合边，所述封合边的最小宽度大于等于6毫米。
  5. 如权利要求4所述的穿刺器产品包，其特征在于，所述穿刺针顶端和/或套管顶端与所述封闭顶端之间的距离M，M≥2毫米。
  6. 一种运输包装系统，包含如权利要求4所述的穿刺器产品包，其特征在于，还包括第一固定板，第二固定板，隔板和包装箱；所述多第一、第二固定板包含多个与所述第二扫描壁外形和横向尺寸相匹配的固定通孔；所述包装箱包含箱底面和箱顶面；多个所述穿刺器产品包的第二扫描壁插入所述第一固定板的固定通孔中形成第一层包装组件；所述第一层包装组件装入所述包装箱中，其中所述穿刺器产品包的盖材贴近箱底面；多个所述穿刺器产品包的第二扫描壁插入所述第二固定板的固定通孔中形成第二层包装组件；所述第二层包装组件装入所述包装箱中，其中所述穿刺器产品包的盖材贴近箱顶面；所述第一层包装组件和第二层包装组件相互交错，所述隔板将所述第一固定板和第二固定板分隔开。
  7. 一种用于如权利要求3所述的阶梯外套的制造方法，其特征在于，主要制造步骤如下：
    S1：吹塑法制造包含原始外套，所述原始外套包含所述阶梯外套，还包括由水平壁向近 端延伸的近端扫描壁及其限定的近端腔，还包括穿透所述近端扫描壁并与所述近端腔联通的吹嘴；
    S2:由所述原始外套，沿所述水平壁修剪活动所述阶梯外套。
  8. 一种用于穿刺器包装的多功能的阶梯外套，其特征在于：
    1)所述阶梯外套包含水平壁限定的近端开口，所述阶梯外套还包含封闭远端以及在所述水平壁和封闭远端之间延伸的无缝壳体，所述无缝壳体限定出包含一端开口的无缝腔体；
    2)所述无缝壳体由近端向远端包括第一扫描壁，过渡扫描壁和第二扫描壁；所述第一扫描壁限定出主体腔，所述过渡扫描壁限定出过渡腔，所述第二扫描壁限定出延长腔；所述主体腔，过渡腔和延长腔相互贯通构成所述无缝腔体；
    3)基本垂直所述水平壁的方向称为轴向，基本平行所述水平壁的方向称为横向；所述主体腔的横向截面尺寸大于所述延长腔体的横向截面尺寸；
    4)所述第二扫描壁还包含多个沿轴向设置的褶皱，每个褶皱包含横向延伸的褶皱峰和褶皱谷以及在所述褶皱峰和褶皱谷之间延伸的褶皱壁。
  9. 如权利要求8所述的阶梯外套，其特征在于，所述多个褶皱构成波纹管，所述波纹管可沿着所述轴向伸长或压缩；所述波纹管具有初始长度P O，压缩长度P S和拉伸长度P L，其中：P L-P O≥40毫米，P O-P S≥25毫米。
  10. 如权利要求8所述的阶梯外套，其特征在于，所述延长腔的轴向深度为HA，所述延长腔的横向截面最小宽度为B min，HA≥5B min。
  11. 一种穿刺器产品包，包含如权利要求8-10任一所述的阶梯外套，其特征在于还包含盖材，穿刺针和/或套管组件，所述穿刺针和/或套管组件盛装在所述阶梯外套中，所述盖材与所述水平壁之间焊接封合形成完整的封合边，所述封合边的最小宽度大于等于6毫米。
  12. 如权利要求11所述的穿刺器产品包，其特征在于，所述穿刺针顶端和/或套管顶端与所述封闭顶端之间的距离M，M≥2毫米。
PCT/CN2018/089194 2017-06-03 2018-05-31 一种用于穿刺器包装的阶梯外套及其制造方法 WO2018219317A1 (zh)

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CN107054876A (zh) * 2017-06-03 2017-08-18 成都五义医疗科技有限公司 一种用于穿刺器包装的多功能的阶梯外套
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US2651407A (en) * 1952-03-19 1953-09-08 Seymour N Blackman Container for hypodermic needles
US7677392B2 (en) * 2003-09-30 2010-03-16 Ethicon Endo-Surgery, Inc. Trocar assembly tip protector
CN104648835A (zh) * 2013-11-22 2015-05-27 深圳市金洲精工科技股份有限公司 一种包装盒及其顶料器
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