WO1999042049A1 - Packaging component for surgical implants - Google Patents

Packaging component for surgical implants Download PDF

Info

Publication number
WO1999042049A1
WO1999042049A1 PCT/US1999/003592 US9903592W WO9942049A1 WO 1999042049 A1 WO1999042049 A1 WO 1999042049A1 US 9903592 W US9903592 W US 9903592W WO 9942049 A1 WO9942049 A1 WO 9942049A1
Authority
WO
WIPO (PCT)
Prior art keywords
mounting
implants
rack
holes
container
Prior art date
Application number
PCT/US1999/003592
Other languages
French (fr)
Inventor
Pertti Tormala
Michael J. Simpson
Harri Happonen
Hilkka Kuisma
Auvo Kaikkonen
Original Assignee
Bionx Implants Oy
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.)
Filing date
Publication date
Application filed by Bionx Implants Oy filed Critical Bionx Implants Oy
Priority to AU27745/99A priority Critical patent/AU2774599A/en
Publication of WO1999042049A1 publication Critical patent/WO1999042049A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/20Holders specially adapted for surgical or diagnostic appliances or instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/865Packages or dispensers for bone screws or threaded wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B2050/3008Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments having multiple compartments

Definitions

  • Bioabsorbable (biodegradable or bioresorbable) materials, devices (implants) or their components are used generally in surgery in the treatment of damaged tissues. Typical applications for such elements can be found in joining, supporting, protecting or separating damaged tissues, such as bone, ligaments, cartilage or different connective tissues.
  • Bioabsorbable surgical devices are described e.g. in the following publications: Vainionpaa. S.. Rokkanen. P.. Tormala. P. Surgical Applications of Biodegradable Polymers in Human Tissues.
  • structures comprising e.g. a heat sealable thermoplastic layer forming at least a portion of the
  • the package must maintain the sterility of the surgical implant and the non-sterile outer surface of the container must not contaminate the sterile implant when the package is opened.
  • a package which comprises two containers, one within the other, so that only the outer surface of the outer container is non-sterile.
  • the inner surface of the outer container and both the inner and outer surfaces of the inner container are sterile.
  • the inner container is substantially impervious to water vapor.
  • the bioabsorbable medical devices are held temporarily on or within a mounting or frame, which keeps the implants in position, protects them inside of the container, and helps the surgeon or nurse remove the implants from the container (strippable containers are most popular).
  • the mountings which typically are made of paper, cardboard or plastics, are flat and may contain holes and/or slots into which the implant can be pushed to fix it temporarily to the mounting.
  • Figure 1 shows some typical paper mountings with a bioabsorbable pin (FIG. 1 A- 1 C). and screw (FIG. 1D-E).
  • the prior art mountings are easily removed from the stripped container and the implants are easily removed from the mountings, either with fingers or a special tool.
  • a surgeon or a nurse must hold the prior art mountings with their fingers during implant removal because of the mounting ' s flat structure. This is inconvenient and requires an extra person to hold the mounting.
  • the assistant may be required to hold the mounting for a substantial period of time (such as half an hour or even longer). This increases the costs of the operation.
  • the alternative, temporarily laying the mounting down. creates a risk that the medical devices may contact instruments, surgical fabrics or cottons etc.
  • bioabsorbable implants may be fixed temporarily within holes or slots on the upper surface of a three-dimensional mounting.
  • the implants are carried and held firmly by the mounting during transportation and storage before surgical use. During the surgical procedure, the implants within the mounting may be safely, easily, and rapidly accessed by the operating surgeon.
  • the mounting of this invention comprises a straight, curved or folded perforated upper surface into which one or several bioabsorbable implants can be fixed temporarily by placing the implants partially into the perforations, such that the implants protrude from the upper surface; and at least one supporting surface (member) on which the mounting can rest at least partially, either in a special rack or directly on a proper working surface.
  • the mounting may further comprise a basal surface on which the mounting can rest at least partially, either in a special rack or directly on a proper working surface.
  • the size of the perforations is such that during normal transportation or storage the implants do not fall out of the mountings, yet may be easily removed from the perforations by fingers or by means of a proper surgical installation instrument during surgery.
  • the mounting including the bioabsorbable implants, may be closed into a package that comprises an air tight sealed container fabricated from a material that is substantially impervious to water vapor.
  • the gaseous contents of the container are, prior to sealing the container, either evacuated to yield vacuum packaged implants or replaced with a gas that is non-reactive with the implants and substantially free from water.
  • a particularly suitable container material is aluminum foil laminate.
  • the container, including the mounting with the implants can be sterilized with prior art sterilization methods (e.g. ethylene oxide gas sterilization or gamma radiation) either before or after sealing the container.
  • the mounting of the present invention may be fabricated from various materials, such as paper or cardboard, by folding and/or gluing the paper or cardboard into the desired form. It is also possible to form the mounting of the present invention from a three-dimensional solid or porous block of paper or pulp mass. In yet another embodiment of the present invention, the mounting may be fabricated from a plastic foil or sheet by folding and/or glueing.
  • the perforations for holding implants can be fabricated in paper, cardboard or plastic mountings with prior art mechanical processing methods, such as drilling, punching and/or cutting. If plastic mountings (solid, porous, or foamed) are used, they may be fabricated through injection molding, using a proper mold corresponding to the form of the mounting.
  • the mounting may also be fabricated from an inert metal, such as stainless steel or titanium foil or sheet, by folding and/or by other mechanical processing. It is also possible to combine different materials, such as paper. plastic and/or metal components to fabricate the mounting. Regardless of the particular material used for the mounting, it must be inert in relation to the implants, it must be stable enough to withstand storage in dry conditions inside of a container for several years, and it must survive the sterilization process without suffering harmful changes in its properties.
  • an inert metal such as stainless steel or titanium foil or sheet
  • FIG. 1 shows typical prior art paper mountings with a bioabsorbable pin (FIGS. 1 A- 1 C) and a screw (FIGS. ID and IE).
  • FIGS. 2A and 2B are perspective figures of a preferred embodiment of the invention portraying a box-like mounting with three cross-like slots on its upper surface (FIG. 2A) and with three small implants (screws) pushed partially into those slots (FIG. 2B).
  • FIG. 3 shows in perspective figures some non-limiting, typical mountings of the present invention, fabricated by folding sheet-like material (such as paper, cardboard, plastic or metal) and perforating their upper surfaces for implant insertion.
  • FIGS. 4A-4F show in cross-sectional figures some non-limiting, typical mountings of the present invention located at least partially within a slot in a supporting rack.
  • FIG. 5 shows a schematic perspective figure of an instrument box combined with a rack having a longitudinal groove into which the mounting of the present invention may be at least partially located.
  • FIG. 6 shows a schematic perspective figure of a rack with a tongue below which a part of a mounting may be slipped to keep it firmly bound to the rack.
  • FIG. 7 shows a schematic perspective figure of a rack with spikes on its upper surface upon which a mounting is placed.
  • FIGS. 8A and 8B show schematic perspective figures of a rack with an optionally hinged
  • FIGS. 9A-9E show different geometries of perforation on the upper surface of the
  • FIGS. 10A-10D show a box-like cardboard mounting for bioabsorbable screws and a plastic rack for supporting the mounting.
  • FIG. 1A shows a typical flat prior an mounting 1 in its open (unfolded) form with a bioabsorbable pin 2 fixed into slots 3, 4 in the wall of the mounting, which typically is made of cardboard.
  • the mounting has a folding plane 5 and FIG. IB shows the mounting 1 in its folded form so that the tip of the pin 2 is visible.
  • This folded mounting may be located inside of a storage container, such as an aluminum foil laminate pouch, which may be closed, e.g. with heat sealing, after drying (and optional sterilization).
  • FIG. 1 C shows the mounting 1 inside of an aluminum foil laminate container 6 which had been closed with heat sealing to store the mounting with the pin. Thereafter, the container has been torn partially open so that the tip of the pin 2 is visible and may be gripped by fingers (or by a special gripping tool) and drawn out of the mounting to be used in the operation.
  • FIG. ID shows an open prior art mounting 7 with a bioabsorbable screw 8 fixed into slots 9, 10.
  • FIG. IE shows the mounting 7 folded so that the head of the screw 8 is visible.
  • FIG. 2A shows a typical mounting 11 of the present invention, comprising a perforated upper surface 12. and supporting surfaces (members) 13, 14, 15, 16. and a lower basal surface 17.
  • FIG. 2B shows the mounting of figure 2A, with three bioabsorbable implants (small screws) 21, 22 and 23 temporarily fixed in the slots 18, 19 and 20. The screws
  • the mounting of Figure 2B (equipped with small bioabsorbable screws) can be placed in a suitable container, such as an aluminum foil laminated container. Thereafter, the whole system can be sterilized, dried, and the container can be closed with heat sealing. If desired, another container can be closed over the first one and the outer surface of the inner container can be sterilized either before or after closing the outer container. In an operation theater, a nurse would open the outer container and drop the sterile inner container on a sterile area (like an operation table).
  • the sterile inner container would be opened and the sterile mounting with the screws taken out and located as such on a proper working surface or (at least partially) in a special rack which supports the mounting and keeps it in the desired position.
  • the operating surgeon could take screws 21 , 22 and 23 one at a time, for example, by pushing the cross-like tip of a surgical screwdriver into the cross-like slot in the head of the screw and by drawing the screw out of the mounting with the screwdriver. In this fashion, all of the screws may be removed easily from the mounting to be applied in the operation.
  • FIGS. 2A and 2B may be manufactured, e.g., of paper or cardboard, by cutting a proper blank with appropriate holes for the implants from a paper or cardboard sheet and by folding the blank so that the box-like mounting is formed. If necessary or desired, some
  • the mounting of the present invention can be folded (and optionally glued) from different types of medical grade paper, cardboard or plastic foil or sheet, that are known in the art.
  • FIGS. 3A-3J shows schematically as perspective figures some typical mountings of the present invention, which can be made, e.g., by folding paper, cardboard, plastic or metal sheets or foils.
  • FIG.3A shows a box-like mounting (similar to the mounting of FIG. 2) that, in addition to the structures described in FIG. 2, includes on its upper part a special visor 24, which can be folded or bent over the perforated upper surface of the mounting and at the same time over the heads of the implants protruding from the perforated upper surface.
  • the visor 24 provides additional protection for the heads of the implants and helps prevent the implants from slipping out of the mounting.
  • the visor 24 can be placed over the heads of the implants and the rim 25 of the visor 24 can be bent and attached to the side of the mounting, e.g. with a sticker or with glue, at supporting surface (member) 26, or it can be slipped into a slot made in the perforated upper surface or supporting surface (member) of the mounting.
  • FIG. 3B shows a simple mounting with the straight perforated surface 27 with holes 28 (for temporarily holding implants) in it and one supporting surface (member) 29.
  • FIGS. 3C and 3D show prism-shaped mountings.
  • FIG. 3E shows an anvil-shaped mounting that has been folded from a single sheet of paper, cardboard, plastic or metal, showing the straight perforated surface 30 with holes 31 and 32, supporting surface (member) 33 and basal surface 34.
  • FIG. 3F shows an upside down U-shaped mounting with perforated upper surface 35 and two supporting surfaces (members) 36 and 37.
  • the mounting of FIG. 3G has a bent perforated upper surface 38 and two supporting surfaces (members) 39 and 40.
  • the mounting of FIG. 3H has the oblique
  • FIG. 31 shows a mounting with a curved perforated upper surface 47. supporting surfaces (members) 48 and 49 and basal surface 50.
  • FIG. 3J shows an arch-shaped mounting, where the perforated surface 51 is curved and connects seamlessly with supporting surfaces (members) 52A and 53B.
  • the mountings shown in 3A and 3E-3J can stand independently when located on a proper working surface (like the operation table) and the mountings 3B-3D should be placed in a special supporting rack or frame after they have been removed from the packaging container. If desired, the mountings 3A, 3E-3J, can also be placed in a supporting rack or frame to provide extra stability.
  • a typical supporting rack or frame is a three-dimensional hollow or solid object, manufactured of paper, cardboard, plastic or other organic material or of metal.
  • Such a rack or frame comprises a body which includes a supporting element to keep the mounting in the desired position.
  • the supporting element can be, e.g., a longitudinal groove in the body of the rack or frame into which at least part of the supporting surface(s) (member(s)) and/or basal surfaces of the mounting are placed. In such cases the mounting maintains its position in the groove by means of frictional forces and/or by means of gravity.
  • FIGS. 4A-4F show as cross-sectional figures some typical racks of the present invention having a longitudinal groove into which at least the lower parts of the supporting and/or basal surface(s) of a mounting can be placed.
  • FIG. 4A shows a rack 53 with a groove 54 with a rectangular cross-section, into which a box-like mounting 55, like that of FIG. 3A. has been placed so that the basal surface 56 of the mounting rests on the bottom of the groove 54 and the
  • FIG. 4B shows a rack 64 with a longitudinal groove 65 which has walls that form acute angles with the bottom of the groove.
  • Mounting 66 can be slid into such a groove by compressing the middle part of the supporting surfaces (members) 67 and 68 with a thumb and a forefinger and pushing the mounting 66 into the groove 65.
  • FIG. 4B also shows one implant 69 in a hole on the perforated upper surface 70 of the mounting 66.
  • FIG. 4C shows a rack 71 with a groove 72 having a V-shaped cross-section.
  • FIGS. 4D-4F show additional typical cross-sections of grooved racks and mountings (with implants therein).
  • the rack of the present invention is combined with an instrument tray (which holds the instruments needed in an operation).
  • FIG. 5 shows a perspective figure of such a combined instrument tray and rack 76, comprising a section 77 for instruments and a rack 78 with a longitudinal groove 79 into which one or several mountings of the present invention containing implants, can be placed.
  • structures other than a groove can be used to keep the mounting in its desired position within the supporting rack.
  • the rack can include on its surface or on its side a tongue below which a part of a mounting can be slipped to hold it within the rack.
  • FIG. 6A shows, as an example, a rack 80 with a tongue 81 , below which the basal surface of a mounting can be slipped.
  • the rack's surface has sharp spikes onto which a mounting of the present invention can be placed by pushing the basal surface of the mounting
  • FIG. 7 shows a perspective figure of a rack 82. with three spikes 83-85 on its upper surface.
  • the spikes can have also barbs to more securely hold the mounting.
  • the rack 82 can have on its upper surface blunt pins or mushroom-like protuberances upon which to fix the basal surface of the mounting by pushing the basal surface against the upper surface of the frame so that the pins or protuberances penetrate the basal surface. The penetration can be facilitated if the basal surface of the mounting is equipped with small holes or slots which guide the penetration of the pins or protuberances through the basal surface.
  • the rack comprises two parts: a framework upon which the mounting rests and a cover containing a hole through which the perforated upper surface of the mounting, including the implants, emerges. When closed, the cover keeps the mounting in its position.
  • FIGS. 8A-8B show an example of such an embodiment.
  • the rack comprises a framework 86, with an upper surface 87 on which the mounting 88, having two implants 89 and 90 fixed temporarily into holes on the perforated upper surface 91, is located.
  • the mounting has two flaps 92 and 93.
  • the rack also has a cover 94 which may be connected to the framework 86 with hinges 95 and 96.
  • the cover has an opening 97, whose shape corresponds to the horizontal cross-section of the mounting 88.
  • the flaps 92 and 93 remain between the surface 87 and the cover 94, locking the mounting 88 in place, while the perforated upper surface of the mounting with the implants 89 and 90 protrudes upwards through the opening 97 so that the implants 89 and 90 are easily within the reach of a surgeon.
  • FIGS. 9A-9E show upper views of some advantageous embodiments of the perforation geometries within cardboard mountings.
  • FIG. 9A shows three rounded holes 98-100 in the perforated upper surface 101 of a mounting. The diameters of the holes must be slightly smaller than the maximum diameter of the stems of the implants so that a good frictional grip is achieved when the implant stem is pushed into the hole.
  • FIG. 9B shows three longitudinal slots 102-104 in the perforated upper surface 105.
  • FIGS. 9C-9D show star-like slots 106-108 and 109- 1 1 1 in the perforated upper surfaces 112 and 113, respectively.
  • the friction between the tip of the surgical installation instrument and the socket at the head of the implant is, after insertion of the instrument tip into the socket, greater than the friction between the implant stem and the perforation in the upper surface of the mounting. Therefore, the implant can be drawn from the perforation with the surgical instrument. It is also possible to use an instrument which grips the outside of the head and/or the stem of the implant.
  • the instrument is first pushed into the socket in the head of the implant and thereafter the implant.
  • the implant such as a screw
  • the implant is pushed downwards so that the bulky head of the implant and/or the bulky tip of the instrument widens the perforation of the upper surface of the mounting. Thereafter, it is easy to remove the implant from the widened perforation.
  • the blank was folded into the form of a three-dimensional mounting 119 described in
  • FIG. 10B is a diagrammatic representation of FIG. 10B.
  • the maximum length (ML) of the blank was 134 mm and maximum width, MW, 61 mm.
  • the mounting had the following dimensions: breadth (B) 44 mm, height (H) 29 mm, thickness (T) 1 1 mm.
  • the total height (TH) of the visor 120 was 35 mm.
  • the diameter of the holes 122-126 on the fixing surface 121 was optimized in the following way.
  • a proper diameter for the holes in the fixing surface of the mounting was optimized, so that the implants retain their positions in the holes, but can be drawn out of the holes with a proper operation instrument (such as a screwdriver).
  • a mounting was developed with proper holes for endo brow lifting screws, having a total length of 6 mm, a threaded stem length of 4 mm, a maximum thread diameter of 2.15 mm and a head diameter of 8 mm.
  • Table 1 gives the results of the screw lifting and dropping tests.
  • the visor 120 may be bent over the implants and the rim 130 of the visor 120 may be
  • the mounting may be placed in a sealable container, which can be dried, sterilized and sealed to store the sterile mounting and implants.
  • the container will be opened and the sterile mounting with the sterile implants may be removed and located on a proper working surface with the perforated upper surface (with the implants) facing upwards.
  • the visor will be opened, so that the surgeon can take the implants, one after another, from the perforated upper surface.
  • Another alternative is that after opening the visor, the nurse or surgeon places the mounting 133 into a longitudinal groove 134 in a sterile rack 135 as shown in FIG. 10D.
  • the rack 135 can stand on a proper working surface, such as the operating table, and the surgeon can grip the implants 136-138 easily with fingers or with an instrument, like a screwdriver.
  • the surgeon can push the tip of the screwdriver into the socket in the head of the screw and draw the screw out of the hole with the screwdriver, without having to grip the mounting.

Abstract

The present invention relates to bio-absorbable implants that are fixed temporarily within holes or slots (18-20) on the upper surface (15) of a three-dimensional mounting (11). The implants (21-23) are carried and held firmly by the mounting (11) during transportation, and storage before surgical use. During the surgical procedure, the implants (21-23) within the mounting (11) may be safely, easily, and rapidly accessed by the operating surgeon. The mounting of this invention comprises a straight, curved or folded perforated upper surface (15) into which one or several bio-absorbable implants (21-23) can be fixed temporarily by placing the implants partially into the perforations (18-20), such that the implants (21-23) protrude from the upper surface (15); and at least one supporting surface (64) on which the mounting (11) can rest at least partially, either in a special rack or directly on a proper working surface.

Description

PACKAGING COMPONENT FOR SURGICAL IMPLANTS
BACKGROUND OF THE INVENTION Bioabsorbable (biodegradable or bioresorbable) materials, devices (implants) or their components ("'elements*') are used generally in surgery in the treatment of damaged tissues. Typical applications for such elements can be found in joining, supporting, protecting or separating damaged tissues, such as bone, ligaments, cartilage or different connective tissues. Bioabsorbable surgical devices are described e.g. in the following publications: Vainionpaa. S.. Rokkanen. P.. Tormala. P. Surgical Applications of Biodegradable Polymers in Human Tissues.
Prog. Polym. Sci., Vol. 14. 1989. 679-716. US Pat. No. 4.743.257. US Pat. No. 5.084.051. US Pat. No. 4.968.317. EPO Pat. No. 0423155. EPO Pat. No. 044291 1. US Pat. No. 5.562,704, and FI Pat. Appl. No. 9651 1 1. the entire disclosures of each of which are incorporated herein by way of this reference. Typical bioabsorbable medical devices mentioned in the above publications are pins, screws, tacks, nails, bolts, arrows and plates, which are used in various bone-to-bone, soft tissue-to-bone and soft tissue-to-soft tissue fixation operations.
Because atmospheric moisture and any residual moisture in the bioabsorbable material
damage bioabsorbable implants during their storage, they must be dried thoroughly before packaging and they must be packaged in air-tight sealed containers which are fabricated from
a material that is substantially impervious to water vapor. Typical containers have laminated
structures comprising e.g. a heat sealable thermoplastic layer forming at least a portion of the
inner surface of the container, an aluminum foil layer, an adhesive layer and a printable paper
outer layer glued on the adhesive layer. Inside of the heat-sealed container, the dried medical
device sufficiently retains its structure and properties for several years, typically 3-5 years. Such
containers, which are described above, and other containers substantially imperv ious to water vapor are described in many publications, such as US Pat.No. 3,728.839 and US Pat. No. 4,135,622, the entire disclosures of which are incorporated herein by way of this reference, and in references therein.
The package must maintain the sterility of the surgical implant and the non-sterile outer surface of the container must not contaminate the sterile implant when the package is opened.
To achieve these goals it is typical to use a package which comprises two containers, one within the other, so that only the outer surface of the outer container is non-sterile. The inner surface of the outer container and both the inner and outer surfaces of the inner container are sterile. Generally, the inner container is substantially impervious to water vapor. Usually the bioabsorbable medical devices are held temporarily on or within a mounting or frame, which keeps the implants in position, protects them inside of the container, and helps the surgeon or nurse remove the implants from the container (strippable containers are most popular). The mountings, which typically are made of paper, cardboard or plastics, are flat and may contain holes and/or slots into which the implant can be pushed to fix it temporarily to the mounting. Figure 1 shows some typical paper mountings with a bioabsorbable pin (FIG. 1 A- 1 C). and screw (FIG. 1D-E).
BRIEF DESCRIPTION OF THE PRIOR ART
The prior art mountings are easily removed from the stripped container and the implants are easily removed from the mountings, either with fingers or a special tool. However, a surgeon or a nurse must hold the prior art mountings with their fingers during implant removal because of the mounting's flat structure. This is inconvenient and requires an extra person to hold the mounting. Especially in the case of very small devices, like small bioabsorbable maxillofacial screws, when several devices can be fixed to the same mounting, the assistant may be required to hold the mounting for a substantial period of time (such as half an hour or even longer). This increases the costs of the operation. The alternative, temporarily laying the mounting down. creates a risk that the medical devices may contact instruments, surgical fabrics or cottons etc. which may lead to the undesired contamination of, or damage to, the medical devices. It is thus an object of the present invention to provide a mounting for bioabsorbable medical devices that eliminates the aforementioned limitations and risks of the prior art mountings. It is further an object of this invention to describe a mounting that is easy and safe to use in surgical practice. It is further an object of this invention to describe a mounting which reduces the need for additional staff in the operating room to hold the mounting during an operation. It is further an object of this invention to describe a mounting which shortens the surgical procedure by allowing a large number of implants to be delivered rapidly and easily to the operating surgeon.
BRIEF DESCRIPTION OF THE P VENTION The present invention is predicated upon the surprising and unexpected discovery that bioabsorbable implants may be fixed temporarily within holes or slots on the upper surface of a three-dimensional mounting. The implants are carried and held firmly by the mounting during transportation and storage before surgical use. During the surgical procedure, the implants within the mounting may be safely, easily, and rapidly accessed by the operating surgeon. The mounting of this invention comprises a straight, curved or folded perforated upper surface into which one or several bioabsorbable implants can be fixed temporarily by placing the implants partially into the perforations, such that the implants protrude from the upper surface; and at least one supporting surface (member) on which the mounting can rest at least partially, either in a special rack or directly on a proper working surface. The mounting may further comprise a basal surface on which the mounting can rest at least partially, either in a special rack or directly on a proper working surface. In relation to the size of the implants, the size of the perforations is such that during normal transportation or storage the implants do not fall out of the mountings, yet may be easily removed from the perforations by fingers or by means of a proper surgical installation instrument during surgery.
The mounting, including the bioabsorbable implants, may be closed into a package that comprises an air tight sealed container fabricated from a material that is substantially impervious to water vapor. The gaseous contents of the container are, prior to sealing the container, either evacuated to yield vacuum packaged implants or replaced with a gas that is non-reactive with the implants and substantially free from water. A particularly suitable container material is aluminum foil laminate. The container, including the mounting with the implants, can be sterilized with prior art sterilization methods (e.g. ethylene oxide gas sterilization or gamma radiation) either before or after sealing the container.
The mounting of the present invention may be fabricated from various materials, such as paper or cardboard, by folding and/or gluing the paper or cardboard into the desired form. It is also possible to form the mounting of the present invention from a three-dimensional solid or porous block of paper or pulp mass. In yet another embodiment of the present invention, the mounting may be fabricated from a plastic foil or sheet by folding and/or glueing. The perforations for holding implants can be fabricated in paper, cardboard or plastic mountings with prior art mechanical processing methods, such as drilling, punching and/or cutting. If plastic mountings (solid, porous, or foamed) are used, they may be fabricated through injection molding, using a proper mold corresponding to the form of the mounting. The mounting may also be fabricated from an inert metal, such as stainless steel or titanium foil or sheet, by folding and/or by other mechanical processing. It is also possible to combine different materials, such as paper. plastic and/or metal components to fabricate the mounting. Regardless of the particular material used for the mounting, it must be inert in relation to the implants, it must be stable enough to withstand storage in dry conditions inside of a container for several years, and it must survive the sterilization process without suffering harmful changes in its properties.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows typical prior art paper mountings with a bioabsorbable pin (FIGS. 1 A- 1 C) and a screw (FIGS. ID and IE).
FIGS. 2A and 2B are perspective figures of a preferred embodiment of the invention portraying a box-like mounting with three cross-like slots on its upper surface (FIG. 2A) and with three small implants (screws) pushed partially into those slots (FIG. 2B).
FIG. 3 shows in perspective figures some non-limiting, typical mountings of the present invention, fabricated by folding sheet-like material (such as paper, cardboard, plastic or metal) and perforating their upper surfaces for implant insertion. FIGS. 4A-4F show in cross-sectional figures some non-limiting, typical mountings of the present invention located at least partially within a slot in a supporting rack.
FIG. 5 shows a schematic perspective figure of an instrument box combined with a rack having a longitudinal groove into which the mounting of the present invention may be at least partially located. FIG. 6 shows a schematic perspective figure of a rack with a tongue below which a part of a mounting may be slipped to keep it firmly bound to the rack.
FIG. 7 shows a schematic perspective figure of a rack with spikes on its upper surface upon which a mounting is placed. FIGS. 8A and 8B show schematic perspective figures of a rack with an optionally hinged
cover for fixing the mounting on the surface of the rack.
FIGS. 9A-9E show different geometries of perforation on the upper surface of the
mounting. FIGS. 10A-10D show a box-like cardboard mounting for bioabsorbable screws and a plastic rack for supporting the mounting.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
FIG. 1A shows a typical flat prior an mounting 1 in its open (unfolded) form with a bioabsorbable pin 2 fixed into slots 3, 4 in the wall of the mounting, which typically is made of cardboard. The mounting has a folding plane 5 and FIG. IB shows the mounting 1 in its folded form so that the tip of the pin 2 is visible. This folded mounting may be located inside of a storage container, such as an aluminum foil laminate pouch, which may be closed, e.g. with heat sealing, after drying (and optional sterilization). FIG. 1 C shows the mounting 1 inside of an aluminum foil laminate container 6 which had been closed with heat sealing to store the mounting with the pin. Thereafter, the container has been torn partially open so that the tip of the pin 2 is visible and may be gripped by fingers (or by a special gripping tool) and drawn out of the mounting to be used in the operation.
FIG. ID shows an open prior art mounting 7 with a bioabsorbable screw 8 fixed into slots 9, 10.
FIG. IE shows the mounting 7 folded so that the head of the screw 8 is visible.
Flat prior art mountings, like those described in FIGS. 1 A- IE, cannot stand on a table or other working surface because of their flat form. FIG. 2A shows a typical mounting 11 of the present invention, comprising a perforated upper surface 12. and supporting surfaces (members) 13, 14, 15, 16. and a lower basal surface 17. On the upper surface 12 are three cross-like slots 18, 19, and 20 for temporarily holding bioabsorbable implants. Figure 2B shows the mounting of figure 2A, with three bioabsorbable implants (small screws) 21, 22 and 23 temporarily fixed in the slots 18, 19 and 20. The screws
21 , 22 and 23 are easily pressed into the slots so that only their heads are above the perforated upper surface 12. The stems of the screws are inside of the mounting, in free space if the mounting is hollow, or inside proper channels if the mounting has a solid internal structure. The mounting of Figure 2B (equipped with small bioabsorbable screws) can be placed in a suitable container, such as an aluminum foil laminated container. Thereafter, the whole system can be sterilized, dried, and the container can be closed with heat sealing. If desired, another container can be closed over the first one and the outer surface of the inner container can be sterilized either before or after closing the outer container. In an operation theater, a nurse would open the outer container and drop the sterile inner container on a sterile area (like an operation table). Thereafter, the sterile inner container would be opened and the sterile mounting with the screws taken out and located as such on a proper working surface or (at least partially) in a special rack which supports the mounting and keeps it in the desired position. Thereafter, the operating surgeon could take screws 21 , 22 and 23 one at a time, for example, by pushing the cross-like tip of a surgical screwdriver into the cross-like slot in the head of the screw and by drawing the screw out of the mounting with the screwdriver. In this fashion, all of the screws may be removed easily from the mounting to be applied in the operation.
The mounting of FIGS. 2A and 2B may be manufactured, e.g., of paper or cardboard, by cutting a proper blank with appropriate holes for the implants from a paper or cardboard sheet and by folding the blank so that the box-like mounting is formed. If necessary or desired, some
7 of the folded surfaces may be glued together. The mounting of the present invention can be folded (and optionally glued) from different types of medical grade paper, cardboard or plastic foil or sheet, that are known in the art.
FIGS. 3A-3J shows schematically as perspective figures some typical mountings of the present invention, which can be made, e.g., by folding paper, cardboard, plastic or metal sheets or foils.
FIG.3A shows a box-like mounting (similar to the mounting of FIG. 2) that, in addition to the structures described in FIG. 2, includes on its upper part a special visor 24, which can be folded or bent over the perforated upper surface of the mounting and at the same time over the heads of the implants protruding from the perforated upper surface. The visor 24 provides additional protection for the heads of the implants and helps prevent the implants from slipping out of the mounting. After the implants have been placed in the holes/slots on the perforated upper surface of the mounting, the visor 24 can be placed over the heads of the implants and the rim 25 of the visor 24 can be bent and attached to the side of the mounting, e.g. with a sticker or with glue, at supporting surface (member) 26, or it can be slipped into a slot made in the perforated upper surface or supporting surface (member) of the mounting.
FIG. 3B shows a simple mounting with the straight perforated surface 27 with holes 28 (for temporarily holding implants) in it and one supporting surface (member) 29. FIGS. 3C and 3D show prism-shaped mountings. FIG. 3E shows an anvil-shaped mounting that has been folded from a single sheet of paper, cardboard, plastic or metal, showing the straight perforated surface 30 with holes 31 and 32, supporting surface (member) 33 and basal surface 34. FIG. 3F shows an upside down U-shaped mounting with perforated upper surface 35 and two supporting surfaces (members) 36 and 37. The mounting of FIG. 3G has a bent perforated upper surface 38 and two supporting surfaces (members) 39 and 40. The mounting of FIG. 3H has the oblique
8 perforated upper surface 41, four supporting surfaces (members) 42-45 and basal surface 46. FIG. 31 shows a mounting with a curved perforated upper surface 47. supporting surfaces (members) 48 and 49 and basal surface 50. FIG. 3J shows an arch-shaped mounting, where the perforated surface 51 is curved and connects seamlessly with supporting surfaces (members) 52A and 53B.
The mountings shown in 3A and 3E-3J can stand independently when located on a proper working surface (like the operation table) and the mountings 3B-3D should be placed in a special supporting rack or frame after they have been removed from the packaging container. If desired, the mountings 3A, 3E-3J, can also be placed in a supporting rack or frame to provide extra stability. A typical supporting rack or frame is a three-dimensional hollow or solid object, manufactured of paper, cardboard, plastic or other organic material or of metal. Such a rack or frame comprises a body which includes a supporting element to keep the mounting in the desired position. The supporting element can be, e.g., a longitudinal groove in the body of the rack or frame into which at least part of the supporting surface(s) (member(s)) and/or basal surfaces of the mounting are placed. In such cases the mounting maintains its position in the groove by means of frictional forces and/or by means of gravity.
FIGS. 4A-4F show as cross-sectional figures some typical racks of the present invention having a longitudinal groove into which at least the lower parts of the supporting and/or basal surface(s) of a mounting can be placed. FIG. 4A shows a rack 53 with a groove 54 with a rectangular cross-section, into which a box-like mounting 55, like that of FIG. 3A. has been placed so that the basal surface 56 of the mounting rests on the bottom of the groove 54 and the
supporting surfaces (members) 57 and 58 are in close contact with the walls of the groove 54. One implant 59 can be seen located temporarily within a hole in the perforated upper surface 60. The visor 61 covers the implant 59 and the folded rim 62 of the visor 61 has been temporarily fixed on the supporting surface (member) 57 with a two-sided sticker 63. FIG. 4B shows a rack 64 with a longitudinal groove 65 which has walls that form acute angles with the bottom of the groove. Mounting 66, like that of FIG. 3A, can be slid into such a groove by compressing the middle part of the supporting surfaces (members) 67 and 68 with a thumb and a forefinger and pushing the mounting 66 into the groove 65. The partially compressed mounting is firmly held within the groove because of the frictional contact between the walls of the groove and the supporting surfaces (members) of the mounting. FIG. 4B also shows one implant 69 in a hole on the perforated upper surface 70 of the mounting 66. FIG. 4C shows a rack 71 with a groove 72 having a V-shaped cross-section. A mounting 73 with a triangular cross-section and one implant 74 in a hole in the perforated upper surface 75 of the mounting, is located within the groove 72. FIGS. 4D-4F show additional typical cross-sections of grooved racks and mountings (with implants therein).
According to an advantageous embodiment, the rack of the present invention is combined with an instrument tray (which holds the instruments needed in an operation). FIG. 5 shows a perspective figure of such a combined instrument tray and rack 76, comprising a section 77 for instruments and a rack 78 with a longitudinal groove 79 into which one or several mountings of the present invention containing implants, can be placed.
In other embodiments of the present invention, structures other than a groove can be used to keep the mounting in its desired position within the supporting rack. For instance, the rack can include on its surface or on its side a tongue below which a part of a mounting can be slipped to hold it within the rack. FIG. 6A shows, as an example, a rack 80 with a tongue 81 , below which the basal surface of a mounting can be slipped.
According to another embodiment, the rack's surface has sharp spikes onto which a mounting of the present invention can be placed by pushing the basal surface of the mounting
10 against the spikes so that they penetrate it and hold the mounting on the upper surface of the rack. FIG. 7 shows a perspective figure of a rack 82. with three spikes 83-85 on its upper surface. The spikes can have also barbs to more securely hold the mounting. To avoid the risks connected with sharp spikes, the rack 82 can have on its upper surface blunt pins or mushroom-like protuberances upon which to fix the basal surface of the mounting by pushing the basal surface against the upper surface of the frame so that the pins or protuberances penetrate the basal surface. The penetration can be facilitated if the basal surface of the mounting is equipped with small holes or slots which guide the penetration of the pins or protuberances through the basal surface. According to another advantageous embodiment of the present invention, the rack comprises two parts: a framework upon which the mounting rests and a cover containing a hole through which the perforated upper surface of the mounting, including the implants, emerges. When closed, the cover keeps the mounting in its position. FIGS. 8A-8B show an example of such an embodiment. According to FIG. 8A, the rack comprises a framework 86, with an upper surface 87 on which the mounting 88, having two implants 89 and 90 fixed temporarily into holes on the perforated upper surface 91, is located. The mounting has two flaps 92 and 93. The rack also has a cover 94 which may be connected to the framework 86 with hinges 95 and 96. The cover has an opening 97, whose shape corresponds to the horizontal cross-section of the mounting 88. According to FIG. 8B, when the cover 94 is closed on the surface of the framework 86, the flaps 92 and 93 remain between the surface 87 and the cover 94, locking the mounting 88 in place, while the perforated upper surface of the mounting with the implants 89 and 90 protrudes upwards through the opening 97 so that the implants 89 and 90 are easily within the reach of a surgeon.
11 The perforations for temporarily holding the implants within the mounting may take various forms. FIGS. 9A-9E show upper views of some advantageous embodiments of the perforation geometries within cardboard mountings. FIG. 9A shows three rounded holes 98-100 in the perforated upper surface 101 of a mounting. The diameters of the holes must be slightly smaller than the maximum diameter of the stems of the implants so that a good frictional grip is achieved when the implant stem is pushed into the hole. FIG. 9B shows three longitudinal slots 102-104 in the perforated upper surface 105. FIGS. 9C-9D show star-like slots 106-108 and 109- 1 1 1 in the perforated upper surfaces 112 and 113, respectively. FIG. 9E shows combined hole and slot structures 1 14-1 16 on the perforated upper surface 1 17. According to another advantageous embodiment of the present invention, the friction between the tip of the surgical installation instrument and the socket at the head of the implant is, after insertion of the instrument tip into the socket, greater than the friction between the implant stem and the perforation in the upper surface of the mounting. Therefore, the implant can be drawn from the perforation with the surgical instrument. It is also possible to use an instrument which grips the outside of the head and/or the stem of the implant.
According to yet another advantageous embodiment of the present invention, the instrument is first pushed into the socket in the head of the implant and thereafter the implant. such as a screw, is pushed downwards so that the bulky head of the implant and/or the bulky tip of the instrument widens the perforation of the upper surface of the mounting. Thereafter, it is easy to remove the implant from the widened perforation.
It is natural that constructions other than those described here, for the supporting rack or the mounting, can be formulated on the basis of the present invention without departing from the spirit and scope thereof.
12 The following non-limiting example illustrates the function of the invention.
EXAMPLE 1
A cardboard mounting for bioabsorbable screws was manufactured by die cutting a mounting blank 1 18 of FIG. 10A from cardboard (Galerie Super, 255 g/πr, pH = 7.0, manufactured by Metsa-Serla Corporation Tako Board Mill, Tampere, Finland).
The blank was folded into the form of a three-dimensional mounting 119 described in
FIG. 10B.
The maximum length (ML) of the blank was 134 mm and maximum width, MW, 61 mm. The mounting had the following dimensions: breadth (B) 44 mm, height (H) 29 mm, thickness (T) 1 1 mm. The total height (TH) of the visor 120 was 35 mm.
Optimization of the diameter of holes on the fixing surface
The diameter of the holes 122-126 on the fixing surface 121 was optimized in the following way.
A proper diameter for the holes in the fixing surface of the mounting was optimized, so that the implants retain their positions in the holes, but can be drawn out of the holes with a proper operation instrument (such as a screwdriver).
A mounting was developed with proper holes for endo brow lifting screws, having a total length of 6 mm, a threaded stem length of 4 mm, a maximum thread diameter of 2.15 mm and a head diameter of 8 mm.
Mountings with three holes for screws on the upper surface were manufactured as described above. Hole diameters of 2.0, 2.1, 2.2, and 2.3 mm were studied. According to FIG. 10C three endo brow lifting screws (diameter of 2.15 mm ) were pushed into three holes on the
13 perforated upper surface of the mounting 1 19. The heads of the screws 127-129 contained crosslike sockets, as seen protruding from the fixing surface 121. The visors were left open.
The ease with which the screws could be lifted from the holes with a screwdriver was
studied.
Additionally, the security with which the screws are held within the holes of the mounting was studied with a dropping test. Each mounting was dropped to a smooth laboratory table surface from the height of 30 cm. The position of screws was registered after dropping.
Table 1 gives the results of the screw lifting and dropping tests.
TABLE 1.
Hole diameter Lifting of the screw Security of screw mm from hole with fixation in the holes a screwdriver in dropping test
2.0 Difficult, only by turning Secure fixation 2.1 Difficult by pulling Secure fixation Easy by turning
2.2 Easy by pulling with a Secure fixation slight rotation
2.3 Easy by pulling Unsafe fixation (loosening of the screw from the hole)
The study showed that a hole diameter of 2.2 mm is optimal for holding the studied endo brow screws within the mounting of this example.
After insertion of the implants into holes or slots on the perforated upper surface of the mount, the visor 120 may be bent over the implants and the rim 130 of the visor 120 may be
14 pushed into the slot 131 in the supporting surface (member) 132 of the mounting 1 19. Thereafter, the mounting may be placed in a sealable container, which can be dried, sterilized and sealed to store the sterile mounting and implants.
In the operating room, the container will be opened and the sterile mounting with the sterile implants may be removed and located on a proper working surface with the perforated upper surface (with the implants) facing upwards. The visor will be opened, so that the surgeon can take the implants, one after another, from the perforated upper surface. Another alternative is that after opening the visor, the nurse or surgeon places the mounting 133 into a longitudinal groove 134 in a sterile rack 135 as shown in FIG. 10D. The rack 135 can stand on a proper working surface, such as the operating table, and the surgeon can grip the implants 136-138 easily with fingers or with an instrument, like a screwdriver.
Because of the optimal hole diameter on the perforated upper surface of the mounting, the surgeon can push the tip of the screwdriver into the socket in the head of the screw and draw the screw out of the hole with the screwdriver, without having to grip the mounting.
15

Claims

We claim:
1. A mounting for temporarily holding surgical implants, comprising: an upper surface having a first side and at least one perforation capable of removably receiving a surgical implant; and a supporting member having a second side; wherein said first side and said second side are connected and intersect at an angle of greater than 0 degrees.
2. The mounting of claim 1 further comprising a basal surface on which said mounting at least partially rests.
3. The mounting of claim 1 , wherein said perforations are holes having a diameter and said implants each have a head and a shaft having a diameter.
4. The mounting of claim 3 in which said diameter of said holes are about the same as said diameter of said shaft.
5. The mounting of claim 1 further comprising a visor connected to said mounting for temporarily covering said upper surface and said implants.
6. The mounting of claim 1, further comprising a rack for supporting said mounting, on which said supporting member of said mounting at least partially rests.
7. The mounting of claim 6 wherein said rack is connected to a surgical instrument tray.
16
8. The mounting of claim 6 wherein said mounting further comprises a basal surface which rests at least partially on said rack.
9. A method for manufacturing a mounting for temporarily holding bioabsorbable surgical implants comprising the steps of: forming a blank from a flat sheet of material; forming at least one perforation in the blank; folding the blank into the form of a three dimensional mounting having an upper surface, so that said perforation is located on the upper surface of said mounting.
17
PCT/US1999/003592 1998-02-19 1999-02-19 Packaging component for surgical implants WO1999042049A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU27745/99A AU2774599A (en) 1998-02-19 1999-02-19 Packaging component for surgical implants

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US2609898A 1998-02-19 1998-02-19
US09/026,098 1998-02-19

Publications (1)

Publication Number Publication Date
WO1999042049A1 true WO1999042049A1 (en) 1999-08-26

Family

ID=21829887

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/003592 WO1999042049A1 (en) 1998-02-19 1999-02-19 Packaging component for surgical implants

Country Status (2)

Country Link
AU (1) AU2774599A (en)
WO (1) WO1999042049A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001049198A1 (en) * 1999-12-30 2001-07-12 Biotech International (Sarl) Device for handling and identifying small implants

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5007535A (en) * 1988-09-26 1991-04-16 Hammerlit Gmbh Syringe tray
US5833056A (en) * 1997-03-19 1998-11-10 Goldman; Jay R Non-spill steady cup holder

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5007535A (en) * 1988-09-26 1991-04-16 Hammerlit Gmbh Syringe tray
US5833056A (en) * 1997-03-19 1998-11-10 Goldman; Jay R Non-spill steady cup holder

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001049198A1 (en) * 1999-12-30 2001-07-12 Biotech International (Sarl) Device for handling and identifying small implants

Also Published As

Publication number Publication date
AU2774599A (en) 1999-09-06

Similar Documents

Publication Publication Date Title
EP0602965B1 (en) Sterile package for surgical devices
CA2131052C (en) Foldable package for endoscopic components and the like
US8585712B2 (en) Surgical retrieval apparatus
CA1203204A (en) Three panel needled suture holder
US5358624A (en) Package for endoscopic suture loop and cannula
US5655657A (en) Package for specimen retrieval bag
US5199561A (en) Package for endoscopic needle and suture and cannula assembly
US5219077A (en) Package for mesh onlay and attached mesh plug technical field
US4412613A (en) Microsurgical foam needle control package
US20200246052A1 (en) Sterile Packaging of K-Wire and Cap
US20050082188A1 (en) Surgical or medical instrument holder
AU2011302324B2 (en) Packages for medical devices and methods therefor
CN106420105A (en) Package
KR20070061875A (en) A medical package, a medical container, a medical package system and methods for removal of a medical component from a container
US7128208B2 (en) Package for sterile reamer
JPH06321268A (en) Container for medical instrument
EP0591858A2 (en) Suture display rack and procedure kit
EP0055823B1 (en) Package for surgical sutures
WO1999042049A1 (en) Packaging component for surgical implants
US11850136B2 (en) Packaging for medical device
US6409016B1 (en) Holder and dispenser for spools, tube-shaped devices, and cylindrical devices with recessed ends

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AL AM AT AU AZ BA BB BG BR BY CA CH CN CU CZ DE DK EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MD MG MK MN MW MX NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT UA UG US UZ VN YU ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW SD SZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
NENP Non-entry into the national phase

Ref country code: KR

REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

122 Ep: pct application non-entry in european phase