WO1999042049A1 - Element tenant lieu de monture pour implants chirurgicaux - Google Patents

Element tenant lieu de monture pour implants chirurgicaux Download PDF

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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
English (en)
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/fr

Links

Classifications

    • 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
    • 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
    • A61B50/20—Holders specially adapted for surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/865—Packages or dispensers for bone screws or threaded wires
    • 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
    • A61B2050/3008—Containers 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne des implants bio-absorbables fixés provisoirement dans des trous ou des fentes (18-20) sur la surface supérieure (15) d'un élément en trois dimensions qui tient lieu de monture (11). Les implants (21-23) sont soutenus et maintenus fermement par la monture (11) pendant le transport et le stockage avant l'utilisation en chirurgie. Durant l'intervention chirurgicale, les implants (21-23) placés sur la monture (11) sont accessibles par le chirurgien avec sûreté, facilité et rapidité. L'élément décrit en guise de monture comporte une surface supérieure perforée, droite, courbe ou pliée (15), pouvant accueillir provisoirement un ou plusieurs implants bio-absorbables (21-23) placés partiellement dans les perforations (18-20), de sorte que lesdits implants (21-23) fassent saillie par rapport à la surface (15). Ledit élément tenant lieu de monture a au moins une surface d'appui (64), ce qui permet de reposer au moins partiellement cette monture (11) sur ladite surface, soit dans un support spécial soit directement sur un plan de travail approprié.
PCT/US1999/003592 1998-02-19 1999-02-19 Element tenant lieu de monture pour implants chirurgicaux WO1999042049A1 (fr)

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 (fr) 1999-08-26

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ID=21829887

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/003592 WO1999042049A1 (fr) 1998-02-19 1999-02-19 Element tenant lieu de monture pour implants chirurgicaux

Country Status (2)

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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001049198A1 (fr) * 1999-12-30 2001-07-12 Biotech International (Sarl) Dispositif pour la manipulation et l"identification de petits 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 (fr) * 1999-12-30 2001-07-12 Biotech International (Sarl) Dispositif pour la manipulation et l"identification de petits implants

Also Published As

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

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