CA2105105A1 - Sterile package for surgical instruments - Google Patents
Sterile package for surgical instrumentsInfo
- Publication number
- CA2105105A1 CA2105105A1 CA002105105A CA2105105A CA2105105A1 CA 2105105 A1 CA2105105 A1 CA 2105105A1 CA 002105105 A CA002105105 A CA 002105105A CA 2105105 A CA2105105 A CA 2105105A CA 2105105 A1 CA2105105 A1 CA 2105105A1
- Authority
- CA
- Canada
- Prior art keywords
- tray
- layers
- tray member
- thermal formed
- thermal
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
Classifications
-
- 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
- B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
- B65D25/02—Internal fittings
- B65D25/10—Devices to locate articles in containers
-
- 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
- A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
- A61B50/33—Trays
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00362—Packages or dispensers for MIS 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
- A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
- A61B2050/0065—Peelable cover
Abstract
An improved sterile package for surgical instruments. The package is a thermo-formed tray with an outwardly extending flange. The tray is disposed between two layers and heat sealed together about the periphery of the tray. END-18
Description
2 1 ~ 0 ~
13T~R~ PACR;~ FOAR 13U~ 8~TRt]NENT8 ~ield o~ Inventio~ -This invention relates to an iroproved package for the ~terile packaging o~ surgical instruments.
Backqround o~ ~he Inv~ention In recent years, mechanical instruments for surgica~l use; e.g., joining tissue, closing vessels, manipulating tissue, cutting tissue, etc. have been developed. Many of these instruments are of substantial size or bulk and have some weight.
A typical package f or packaging surgical products or devic~s in a steril~ manner are heat sealed packages.
These are peelable packages co~prising two layer~; of paper, film, nonwoven fabxic or combinations thereof which are generally sealed about their periphery to join them together s~ith the surgical product disposed between the layers. U~ually, the heat seal will not extend to the outer ed~e o~ the layer~ along one side thereof ~;o that the lay~r may be readily grasped and the la~fers p~eled apart. Such packages have gain~d wide acceptanc:e becau~e o~ their ease of sterilizability, their low cost and their ~ase of use and opening.
With the advent of the bulk or heavier instrument~, it has become difficult to packag2 such instrument~ in these inexpensive he~ t sealable paclcages. The instrument will tend t~ move around within the package during shipping and handling of the package and may well disrupt the heat -eeal and compromise th~ ~;terility o~ the .
.
:
.
' : ' ' .
21~10~
instrument. A nu~ber of techniques have been developed to oYerco~e these problems such a~ puttlng ~ome type o~
~tiffened insert in the heat sealed package or pro~iding a thermal formed tray in which the lnstrument fit~ to stabilize the instrument within the package. However, æuch techniqu2s cause other problems in that the package insert is usually a thin sti~f member, which on movement may disrupt the heat seal. Al~o, the thermal ~ormed member usually has a thin flange extending from either its upper or lower surface which if the thermal formed member moves within the heat ~ealed package during handling and transportation, can disrupt the heat seal and compromise the sterility of the package.
It i~ an object of the present invention to provide a package wherein the in~trument is ~tabilized within the package during handling or shipping. It is another object o~ the present invention to provide a package which reduces the possibility of the heat seal being disrupted and the sterility of the instrument compromised during handling or shipping of the packi~ge.
$ummary Q~ th~ P~esent Invention What we have discovered is an i~proved sterile package for surgical instru~ents. The package comprises an upper layer of film, paper, or the like and a low~r layer of film, paper, or the like. The layers are substantially co extensive and at lea-~t one oP tAe layers includes a heat ealabl¢ material. The layer ~ay b~
overall coated with haat sealable material or the ~aterial ~ay b~ disposed about the outer circumference o~ the layer as desired. The layers are heat sealed together about their entire periphery. The package includes a thermal : ' ' , ........................................... .. .
. . .. . : . ,: ~ , .
, . ' ' . ' ' : ' : :
2 1 0 ~
for~ed tray member. The tray member ha~ at lea~t one ther~al formed cavity for holding a surgical instrument~
The ther~al form~d tray member has an outwardly extending ~lange abo~t ~ubstantially its entir~ periphery. The flange is disposed substantially mid-way between the top plane and the bottom plane of the thermal ~ormed tray member to reduce the possibility o~ separation of the heat sealed upper and lower layers of the package.
In certain embodiments of the present invPntion, the thermal formed tray member includes a tab extending outwardly ~rom the ~lange. The tab is foldably attached to the ~langa. The tab may be folded back over the tray to contain an instrument positioned in the cavity. ~he thermal formed member also includes a slot or a pair of slots positioned on the side of the thermal formed member opposite the tab. The 510ts accept the foldable tab to assist in holding an instrument within the cavity.
Brief_Pescri~ion o~ the D~awin~
Figure 1 is a perspective view of a thermo formed tray o~
thQ ~terile package of the present invention;
Figure 2 i~ a partial cut-away perspective view showing a foldable tab used to lock an instrument in the thermo formed tray of the present invention;
Figure 3 i~ an enlarged cross-~ectional view showing the slots u~ed tv contain tha ~oldable flap;
Figure 4 i8 a plan view of the thermo formed tray of the present invention;
- , .
. , : "
..
2 ~ 0 '~
Figure 5 i8 a cro~s-sectional view of the thermo formed tray of the present invention; and Figure 6 is a perspective view of a sterile package aocording to the present invention.
D~taila~ De~ariptio~ o~ the ~ra~i~
Referring to the drawings, in Figure 6, there i~
shown a sterile package 10 of the present invention. The package comprises a bottom or first layer 11 of film paper or the like and a second or upper layer 12 o~ film, paper or the like. Disposed between the layers is a thermally formed tray 13 having desired cavities di~posed therein ~or holding one or more surgical in~truments. The in truments are lo~ked in position by the foldable hinge portion 1~. The upper and lower layer~ are heat ~ealed 15 together about the periphery of the thermal ~ormed tray.
One end of the layers is left open to provide means for peeling apart the two layers to have ready ~ccess to the tray and the instruments in the tray.
Referring to Figures l, 4 and 5, there i5 shown a thermal formed tray 20 used in the sterile pack~ge of the present invention. The tray is substantially rectangular in shape and has one or more caviti~ 21 disposed therein for holding surgical instr~ments. The tray has a bottom ~loor 22 and a continuous wall 23 extending upwardly from the bottom floor. The wall is disposed inwardly from the outer periphery of the tray. Disposed outwardly fro~ the tnp of the wall is an outwardly extending upper ~urface - 25O A econd wall 26 extends downwardly ~rom the outwardly extending upper surface and ter~inates in an outwardly extending ~lange 27. The botto~ floor for~s the . : . : ................... '. ' ....... - .' .
21 0 ~ .1 O ~
bottom plane of the tray and tha outwardly extending upper sur~ace forms the top plane o~ the tray. About substantially the entire periphery of ths tray i~ th~
~lange portion. As shown in Figure 5, the flange portion 27 is disposed approximately midway ~etween the upper surface 25 and the bottom floor 22 of the tray. By disposing the flange portion in ~uch a manner, not only i~
excellent stabilization and strength obtained in the tray, but when the tray i~ packaged between two layer~ of papers or film or the like and heat sealed therein, the possibility for the heat sealed area to become di~rupted i5 substantially reduced. Extending from one longitudinal edge of the f lange portion of the thermal ~ormed tray is a foldable tab 28. Said ~oldable tab is Polclable at hinge 15 line 29 and may be folded back over the top of the thermal tray as sh~wn in Figure 1.
As more clearly shown in Figures 2 and 3, the ~oldable tab 30 folds over the top of the thermal ~or~ed tray. The free end portion 31 of the tab i~ urged into the pair of slots 32 and 33 disposed in the formed tray.
This allows instruments to be placed in the cavi~ie~ and locked in place by folding the foldabla tab over the top of the in~truments and locking it into the slots. The hinge 34 attaching the foldable tab tc the tray i ~ade by perforating the edge o~ the tray so that the tab 30 may be readily folded over the top o~ the tray. The hinge line o~ the tab portion may b~ obtained by a die cutting process.
The thermal ~ormed trays used in the package of the present invention may be formed using conventional ther~al ~orming equipm~nt and processes. The thermal forming process typically consists of an initial stage where a ~ND-18 . . . . . . .
.
, - , . ..
: .
~, ' . ' :.:.. ', . :
~:
. . .
210al~
sheet of plastic is heated to a temperature where it 1 ef~ectively moldable. The heated plastic is placed ov~r a mold havin~ cavities ~orming the structure of tha trAy.
A vacuum i5 drawn through perforations in the mold to 5 force the plastic into a conPiguration which conform~ to the contour of the mold. The mold and the plastic sheet is cooled and the molded sheet removed from the mold. The plastic foldable hinge section may be die cut on it8 scored line using conventional apparatus.
The plastics which may be used to manufacture thermal formed trays include conventional plastic sheeting material~ such as polyethylene terephthalate, polyvinylchloride, polypropylene, and the like. The thickness of the sheet material is typically as thin as possible but ~ufficiently thick to provide de~ired mechanical strength. The thickness may be between .010 inch to .0606 inch.
The out~r packaging layer~3 may ba made ~rom any of the well known fil~, paper, nonwoven fabric or combination~ of the same. Bleached kraft board may hs used or a polyethylene film may be used or combination~
thereo~. The heat sealable resin us~d are well known in .-the art. Examples of suitable heat sealQd resins ar~
the polyethylenes, polyvinylchloride and the llke.
While the present invention has been described in connection with specific embodiments thereof, it will be understood that modifications and variations will be readily apparent to those of ordinary skill in the art.
This disclosure and the ~ollowing claims are intended to cover such modi~ications and variations.
- . ~ . ... . . . . .
. . ' ' . :
. , :
13T~R~ PACR;~ FOAR 13U~ 8~TRt]NENT8 ~ield o~ Inventio~ -This invention relates to an iroproved package for the ~terile packaging o~ surgical instruments.
Backqround o~ ~he Inv~ention In recent years, mechanical instruments for surgica~l use; e.g., joining tissue, closing vessels, manipulating tissue, cutting tissue, etc. have been developed. Many of these instruments are of substantial size or bulk and have some weight.
A typical package f or packaging surgical products or devic~s in a steril~ manner are heat sealed packages.
These are peelable packages co~prising two layer~; of paper, film, nonwoven fabxic or combinations thereof which are generally sealed about their periphery to join them together s~ith the surgical product disposed between the layers. U~ually, the heat seal will not extend to the outer ed~e o~ the layer~ along one side thereof ~;o that the lay~r may be readily grasped and the la~fers p~eled apart. Such packages have gain~d wide acceptanc:e becau~e o~ their ease of sterilizability, their low cost and their ~ase of use and opening.
With the advent of the bulk or heavier instrument~, it has become difficult to packag2 such instrument~ in these inexpensive he~ t sealable paclcages. The instrument will tend t~ move around within the package during shipping and handling of the package and may well disrupt the heat -eeal and compromise th~ ~;terility o~ the .
.
:
.
' : ' ' .
21~10~
instrument. A nu~ber of techniques have been developed to oYerco~e these problems such a~ puttlng ~ome type o~
~tiffened insert in the heat sealed package or pro~iding a thermal formed tray in which the lnstrument fit~ to stabilize the instrument within the package. However, æuch techniqu2s cause other problems in that the package insert is usually a thin sti~f member, which on movement may disrupt the heat seal. Al~o, the thermal ~ormed member usually has a thin flange extending from either its upper or lower surface which if the thermal formed member moves within the heat ~ealed package during handling and transportation, can disrupt the heat seal and compromise the sterility of the package.
It i~ an object of the present invention to provide a package wherein the in~trument is ~tabilized within the package during handling or shipping. It is another object o~ the present invention to provide a package which reduces the possibility of the heat seal being disrupted and the sterility of the instrument compromised during handling or shipping of the packi~ge.
$ummary Q~ th~ P~esent Invention What we have discovered is an i~proved sterile package for surgical instru~ents. The package comprises an upper layer of film, paper, or the like and a low~r layer of film, paper, or the like. The layers are substantially co extensive and at lea-~t one oP tAe layers includes a heat ealabl¢ material. The layer ~ay b~
overall coated with haat sealable material or the ~aterial ~ay b~ disposed about the outer circumference o~ the layer as desired. The layers are heat sealed together about their entire periphery. The package includes a thermal : ' ' , ........................................... .. .
. . .. . : . ,: ~ , .
, . ' ' . ' ' : ' : :
2 1 0 ~
for~ed tray member. The tray member ha~ at lea~t one ther~al formed cavity for holding a surgical instrument~
The ther~al form~d tray member has an outwardly extending ~lange abo~t ~ubstantially its entir~ periphery. The flange is disposed substantially mid-way between the top plane and the bottom plane of the thermal ~ormed tray member to reduce the possibility o~ separation of the heat sealed upper and lower layers of the package.
In certain embodiments of the present invPntion, the thermal formed tray member includes a tab extending outwardly ~rom the ~lange. The tab is foldably attached to the ~langa. The tab may be folded back over the tray to contain an instrument positioned in the cavity. ~he thermal formed member also includes a slot or a pair of slots positioned on the side of the thermal formed member opposite the tab. The 510ts accept the foldable tab to assist in holding an instrument within the cavity.
Brief_Pescri~ion o~ the D~awin~
Figure 1 is a perspective view of a thermo formed tray o~
thQ ~terile package of the present invention;
Figure 2 i~ a partial cut-away perspective view showing a foldable tab used to lock an instrument in the thermo formed tray of the present invention;
Figure 3 i~ an enlarged cross-~ectional view showing the slots u~ed tv contain tha ~oldable flap;
Figure 4 i8 a plan view of the thermo formed tray of the present invention;
- , .
. , : "
..
2 ~ 0 '~
Figure 5 i8 a cro~s-sectional view of the thermo formed tray of the present invention; and Figure 6 is a perspective view of a sterile package aocording to the present invention.
D~taila~ De~ariptio~ o~ the ~ra~i~
Referring to the drawings, in Figure 6, there i~
shown a sterile package 10 of the present invention. The package comprises a bottom or first layer 11 of film paper or the like and a second or upper layer 12 o~ film, paper or the like. Disposed between the layers is a thermally formed tray 13 having desired cavities di~posed therein ~or holding one or more surgical in~truments. The in truments are lo~ked in position by the foldable hinge portion 1~. The upper and lower layer~ are heat ~ealed 15 together about the periphery of the thermal ~ormed tray.
One end of the layers is left open to provide means for peeling apart the two layers to have ready ~ccess to the tray and the instruments in the tray.
Referring to Figures l, 4 and 5, there i5 shown a thermal formed tray 20 used in the sterile pack~ge of the present invention. The tray is substantially rectangular in shape and has one or more caviti~ 21 disposed therein for holding surgical instr~ments. The tray has a bottom ~loor 22 and a continuous wall 23 extending upwardly from the bottom floor. The wall is disposed inwardly from the outer periphery of the tray. Disposed outwardly fro~ the tnp of the wall is an outwardly extending upper ~urface - 25O A econd wall 26 extends downwardly ~rom the outwardly extending upper surface and ter~inates in an outwardly extending ~lange 27. The botto~ floor for~s the . : . : ................... '. ' ....... - .' .
21 0 ~ .1 O ~
bottom plane of the tray and tha outwardly extending upper sur~ace forms the top plane o~ the tray. About substantially the entire periphery of ths tray i~ th~
~lange portion. As shown in Figure 5, the flange portion 27 is disposed approximately midway ~etween the upper surface 25 and the bottom floor 22 of the tray. By disposing the flange portion in ~uch a manner, not only i~
excellent stabilization and strength obtained in the tray, but when the tray i~ packaged between two layer~ of papers or film or the like and heat sealed therein, the possibility for the heat sealed area to become di~rupted i5 substantially reduced. Extending from one longitudinal edge of the f lange portion of the thermal ~ormed tray is a foldable tab 28. Said ~oldable tab is Polclable at hinge 15 line 29 and may be folded back over the top of the thermal tray as sh~wn in Figure 1.
As more clearly shown in Figures 2 and 3, the ~oldable tab 30 folds over the top of the thermal ~or~ed tray. The free end portion 31 of the tab i~ urged into the pair of slots 32 and 33 disposed in the formed tray.
This allows instruments to be placed in the cavi~ie~ and locked in place by folding the foldabla tab over the top of the in~truments and locking it into the slots. The hinge 34 attaching the foldable tab tc the tray i ~ade by perforating the edge o~ the tray so that the tab 30 may be readily folded over the top o~ the tray. The hinge line o~ the tab portion may b~ obtained by a die cutting process.
The thermal ~ormed trays used in the package of the present invention may be formed using conventional ther~al ~orming equipm~nt and processes. The thermal forming process typically consists of an initial stage where a ~ND-18 . . . . . . .
.
, - , . ..
: .
~, ' . ' :.:.. ', . :
~:
. . .
210al~
sheet of plastic is heated to a temperature where it 1 ef~ectively moldable. The heated plastic is placed ov~r a mold havin~ cavities ~orming the structure of tha trAy.
A vacuum i5 drawn through perforations in the mold to 5 force the plastic into a conPiguration which conform~ to the contour of the mold. The mold and the plastic sheet is cooled and the molded sheet removed from the mold. The plastic foldable hinge section may be die cut on it8 scored line using conventional apparatus.
The plastics which may be used to manufacture thermal formed trays include conventional plastic sheeting material~ such as polyethylene terephthalate, polyvinylchloride, polypropylene, and the like. The thickness of the sheet material is typically as thin as possible but ~ufficiently thick to provide de~ired mechanical strength. The thickness may be between .010 inch to .0606 inch.
The out~r packaging layer~3 may ba made ~rom any of the well known fil~, paper, nonwoven fabric or combination~ of the same. Bleached kraft board may hs used or a polyethylene film may be used or combination~
thereo~. The heat sealable resin us~d are well known in .-the art. Examples of suitable heat sealQd resins ar~
the polyethylenes, polyvinylchloride and the llke.
While the present invention has been described in connection with specific embodiments thereof, it will be understood that modifications and variations will be readily apparent to those of ordinary skill in the art.
This disclosure and the ~ollowing claims are intended to cover such modi~ications and variations.
- . ~ . ... . . . . .
. . ' ' . :
. , :
Claims (4)
1. A sterile package for sterile instruments comprising an upper layer of paper, film, and the like and a lower layer of paper, film and the like, said layers being substantially co-extensive and being heat sealed together about the entire periphery of said layers and a thermal formed tray member disposed between said layers, said tray member having at least one thermal formed cavity for holding a surgical instrument, said tray member having an outwardly extending flange about its periphery said flange being disposed substantially mid-way between the top plane and the bottom plane of said thermal formed member to reduce premature separation of the heat sealed upper and lower layers.
2. A sterile package according to Claim 1 wherein the upper layer and the lower layer are heat sealed together around the periphery of the thermal formed tray member and said upper layer and lower layer extend beyond said heat sealed portion on at least one side of said thermal formed tray member to provide an area that facilitates the peeling apart of said upper and lower layers.
3. A sterile package according to Claim 1 wherein the thermal formed tray member includes a tab portion foldably attached to said outwardly extending flange and foldable back on said thermal formed member to enclose a surgical instrument disposed in said cavity.
4. A sterile package according to Claim 3 wherein the tab portion is die cut.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US937,932 | 1992-08-31 | ||
US07/937,932 US5284244A (en) | 1992-08-31 | 1992-08-31 | Sterile package for surgical instruments |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2105105A1 true CA2105105A1 (en) | 1994-03-01 |
Family
ID=25470592
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002105105A Abandoned CA2105105A1 (en) | 1992-08-31 | 1993-08-30 | Sterile package for surgical instruments |
Country Status (8)
Country | Link |
---|---|
US (1) | US5284244A (en) |
EP (1) | EP0586209B1 (en) |
JP (1) | JP3390848B2 (en) |
AT (1) | ATE149815T1 (en) |
CA (1) | CA2105105A1 (en) |
DE (1) | DE69308695T2 (en) |
ES (1) | ES2098671T3 (en) |
IL (1) | IL106560A0 (en) |
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US9265578B2 (en) * | 2013-11-04 | 2016-02-23 | Ethicon, Llc | Multi-component packages for medical devices |
US10220995B2 (en) * | 2015-01-07 | 2019-03-05 | Westrock Mwv, Llc | Blister card with flange strap |
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US9757222B2 (en) | 2015-09-28 | 2017-09-12 | Howmedica Osteonics Corp. | Snapback card implant package |
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-
1992
- 1992-08-31 US US07/937,932 patent/US5284244A/en not_active Expired - Lifetime
-
1993
- 1993-08-02 IL IL106560A patent/IL106560A0/en unknown
- 1993-08-26 JP JP23222993A patent/JP3390848B2/en not_active Expired - Lifetime
- 1993-08-27 AT AT93306838T patent/ATE149815T1/en not_active IP Right Cessation
- 1993-08-27 ES ES93306838T patent/ES2098671T3/en not_active Expired - Lifetime
- 1993-08-27 DE DE69308695T patent/DE69308695T2/en not_active Expired - Fee Related
- 1993-08-27 EP EP93306838A patent/EP0586209B1/en not_active Expired - Lifetime
- 1993-08-30 CA CA002105105A patent/CA2105105A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
JPH06191559A (en) | 1994-07-12 |
ATE149815T1 (en) | 1997-03-15 |
EP0586209A3 (en) | 1994-05-25 |
IL106560A0 (en) | 1993-12-08 |
ES2098671T3 (en) | 1997-05-01 |
EP0586209B1 (en) | 1997-03-12 |
DE69308695T2 (en) | 1997-07-03 |
DE69308695D1 (en) | 1997-04-17 |
JP3390848B2 (en) | 2003-03-31 |
EP0586209A2 (en) | 1994-03-09 |
US5284244A (en) | 1994-02-08 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
FZDE | Discontinued |