CA2044122A1 - Storage device with positive displacement dispenser by means of egress through a pierced septum - Google Patents

Storage device with positive displacement dispenser by means of egress through a pierced septum

Info

Publication number
CA2044122A1
CA2044122A1 CA002044122A CA2044122A CA2044122A1 CA 2044122 A1 CA2044122 A1 CA 2044122A1 CA 002044122 A CA002044122 A CA 002044122A CA 2044122 A CA2044122 A CA 2044122A CA 2044122 A1 CA2044122 A1 CA 2044122A1
Authority
CA
Canada
Prior art keywords
vessel
fluid
wall
needle
storage system
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
Application number
CA002044122A
Other languages
French (fr)
Inventor
Mark Steven Schlosser
Lionel Solomon Goldring
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Spacelabs Medical Inc
Original Assignee
Spacelabs Medical Inc
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 Spacelabs Medical Inc filed Critical Spacelabs Medical Inc
Publication of CA2044122A1 publication Critical patent/CA2044122A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2422Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/2429Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by telescoping of ampoules or carpules with the syringe body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06Ampoules or carpules
    • A61J1/062Carpules

Abstract

STORAGE DEVICE WITH POSITIVE DISPLACEMENT DISPENSER
BY MEANS OF EGRESS THROUGH A PIERCED SEPTUM
Abstract of the Disclosure A positive displacement ampule for storing a fluid therein and dispensing the fluid therefrom. The ampule includes an elongate vessel for storing the fluid having a large diameter base portion at one end thereof joined to a small diameter stemportion at the other end thereof, a piston disposed in the vessel at the base end thereof for forcing the fluid from the vessel, a fracture probe for fracturing the base end of the vessel and needle for inserting into the fractured base end of the vessel and for piercing the piston such that one end of the needle protrudes outwardly from the vessel and the other end of the needle communicates with the fluid in the vessel. In this manner, the fluid is pumped from the vessel through the needle by pushing the piston in the direction of the fluid. The positive displacement ampule is manufactured by providing the elongate vessel with the stem end of the vessel being open and the base end of the vessel being closed, injecting a monomer liquid into the vessel through the open stem end thereof, polymerizing the liquid so as to convert the liquid to a solid designed to function as a piston, injecting the fluid into the vessel through the open stem end thereof in such a manner as to maintain the fluid between the piston and the stem end sealing the stem end of the vessel.

Description

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Descrip~ion STOE~AGE DEVICE WlTH POSITIVE DISPL~CE~vfENT DTSPENSER
BY ~IEANS OF EGRESS ~ROUGH ~ PIERCED SEPrU~vf S
Technical Field This invention relates to a storage device, and more parucularly, to a storage device having a positive displacement dispenser for dispensing ~uid therefrom.
Back~round of the Invention There are three ~pes of arnpules that are presently known: a pressurized ampule, an evacuated ampule and a non-pressurized ampule. The pressu~zed arnpule contains tluid or powder which is at a pressure 8reater than 15 atmospheric pressure such that the fluid or powder is propelled from the ampule by breaking the tip of the ampule. This type of ampule is manufactured by i~troducing the fluid or powder into the opened tip end of the ampule in a pressur~zed atmosphere and thereafter sealing the ampule.
The eYacuated ~npule is prirnarily designed for conducting chemical analyses of water. The evacuated ampule contains a fluid at a pressure that is less than a~mospheric pressure. The a~alysis is conducted by breaking the tip of the ampule while immersed in the water being analvzed. Due tO the low pressure in the ampule relative to the environment, the water is forced into theampule and mLYes with the analyzing fluid or powder. The water is analyzed by observing the change in color o~ the mixed fluid.
The non-pressuized ampule includes stern portions at opposite ends and is filled with a ~uid, such as a medici~e, at atmosphenc pressure. To dispe.lse the ~uid, both stems are broken and the fluid is drained from the ampule.
There are no known ampules having positive disp}acement capabilities which per~nit the user to pump the fluid contained in the ampule therefrom. Further, there are no Icnown positive displacement devices which s~ore fluids with gases trapped in predictable volume regions.

3S Su~maryof the~nvs~Qn The present invention r~osides in a positive displal ement ampule which allows the user to pump the fluid therefrom. The positive displacement ;
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arnpule comprises an elongate vessel for storing a ~uid therein having a large diameter base portion at one end thereof joined to a small diameter stem portionat the other end thereof, a piston disposed in the vessel at the base end thereof for forcing the fluid from the vessel~ a fracture probe for fracturing the base end of S the vessel and a needle for inserting into the fractured base end of the vessel and for piercing the piston such that one end of the needle protrudes outwardly fromthe vessel and the other end of the needle communicates with the fluid. In this marmer the fluid is pumped from the vessel through the needle by pushing the piston in the direction of the fluid. The base of the vessel has a weakened area10 which permits the fracturing thereof by conventional mearls.
The positive displacement arnpule is manufactured by manufacturing the elongate vessel ~,vith the stem end of the vessel being open and the base end of the vessel being closed, injecting a monomer liquid into the vessel through the open stem end thereof, polymerizing the liquid so as to convert the 15 liquid to a solid, the solid being designed to function as a piston, injecting the fluid into the vessel through the open stem end thereof in such a manner as to maintain the fluid betwee~ the piston and the stem and sealing the stem end of the vessel.

Brief Description of the Drawings Figure 1 is an elevational view of the positive displacement ampule according to the present in~ention;
Figures 2 through 4 are elevational views showing the method by which the fluid in the ampule is withdrawn therefrom; and ~igures S through 11 are elevational views showing the method of manuf;3cturing the ampule according to the present invention.

Detailed Des~iptinn of the Invention Referring to Figure 1, the positive displacement ampule 10 is an elongate vessel 12 having a small diarneter stem 14 at one end thereof joined to a 30 relatively large diameter portion 16 at the other end thereo~. A cylindrical piston 18 is disposed at the base 20 of the large diameter portion with fluid 21 being contained bet~,veen the piston 18 and the bottom æ of the stem 14.
The base 20 has a weakened area 24 at the central portion thereof such that the user can fracture that poltion of the base with a probe 26 illustrated 35 in Figure 2. The weakened area 24 can be fonned by, for instance, reducing the thic~ness of the base of the vessel, scoring a circle in the base or providing acerami~ piece in the base. According to the preferred embodiment of the ..

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invention, tbe vessel 12 is made of glass and the base 20 has a plastic coating adhered to the exterior thereof. In this manner, when the base 20 is fractured the glass shards shards are retained by the coating. As illustrated in Figure 2, theprobe 26 has a pointed end 28 for fractur~ng the base 20 and has a bore 30 S e~ending axially therethrough for slidably receiving a needle 32.
Figures 2 through 4 illustrate the manner in which the fluid 21 is withdrawn from the vessel 12. Referring to Figure ~, as noted above, the base ~0of the vessel 12 is fractured by pushing the ~robe 26 in the direction of arrow A
against the base with the necess~y force. Since the base is coated with plastic, the 10 glass shards resulting from the fracturing of the base are retained by the base.
After the base 20 has been ractured, the needle 32 is pushed in the direction f arrow B illustrated in Figure 3 to thereby pierce the piston 18 such that the needle extends into the interior of the vessel so as to communicate with the fluid ~1.
Thereafter, as shown in Figure 4, both the probe 26 and the needle 32 are moved 15 in the direction Oe arrow C causing the fluid to pumped through the needle and ejected from the vessel as illustrated by arrow D. The glass shards are forced into the area 34 disposed between the base 20 of the vessel 12 and the piston 18 suchthat they do not contaminate the ejected ~uid.
Accordingly, as can be seen from the ~oregoing, the ~uid in the 20 vessel can be withdrawn without the necessity of ~actur~ng the vessel in two places as in the conventional ampule discussed above. Rather, only one end of the vessel need be fractured.
Figures 5 through 11 illustrate the method by which the ampule 10 is manufactured. Referring to Figure S, initially, the vessel 12 is open at the top of 25 the stem 14 ~d closed at the base 20 of ti~e large diameter portion 16. A needle 36 is inserted into the opening and a coating agerlt 38 applied to the in~erior of the base 20. The coating agent is designed to insure that the piston liquid that is subsequerltly injected and polymerized does not stick to the in~erior of the vessel 12. After coating the base, ancther needle 40 is inserted through the opening and 30 a monomer 42 containing a polymerizing agent in the forrn of a liquid is injected into the vessel as shown in Figure 6. An important characteristic of the polymenzeable monomer is that, once polymerized, it expands when exposed to an aqueous solution (i.e., it is water-swellable). The specific monomer u~ilized is in the HE~ family and has the chernical name POLY-35 HYDROXYE7~YLMETHACRYLAIE. An example of a polymerizing agent isBENZOYL PEROXIDE (which is polymerized by heat) or 2,2,DIETHOXY
ACETOPHEI~ONE (which is polymerized by ultra~iole~ light).

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As illustrated in Figure 7, the monomer liquid 42 is polymerized by exposing the liquid to ultraviolet light or, alternatively, to heat. By polyrnerizing the liquid, the cylindrical piston 18 is ~ormed which is utili2ed to force the fluid in the vessel therefrorn~ as described above.
If it is important to ma~ntain the gas concentration of the lluid in the vessel after the fluid has been polyrne~ized, the vessel 12 may be filled with atonometered gas rnixture 44 and, thereafter, a tonometered calibraut fluid 46, as illustrated iIl Figures 8 and 9, respec~ively. The calibrant fluid 46 contains aknown amouut of carbon dioxide, oxygen and nitrogen in terms of partial pressure.
10 This is important because when analyzing the oxygen and carbon dioxide content of blood a flow cell must be calibrated by passing a calibrant fluid having a known arnount of carbon dioxide and o~ygen into the ilow cell. In order to prevent thecalibrant fluid ~om releasing any of its gases and to thereby maintain the proper ratio of gases in the calibrant fluid when injecting the fluid into the vessel, it is recornmended that the vessel be filled w~th a gas mixture having the same percentage of gases as the calibrant fluid. Accordingly, as noted above, a gas mixture 44 having a known percentage of gases, which are correspondingly presentin the calibrant ~uid 46, îs injected into the vessel 12 prior to the iQjection of the calibrant fluid 46.
Subsequent thereto, as noted above, the calibrant fluid 46 is injected utilizing a needle, as illustrated in ~igure 9, such that the fluid extends up to the bottom 22 of the stem 14. At this time, the piston 18 swells sufficiently to press firmly against the interior wall of the vessel to thereby provide an adequate piston seal, as shown in Figure 10. Speci~lcally, the piston seals the fluid 21 in the vessel 12 such that when the weakened central area 24 of the base 20 is fractured the fluid ~1 does not leak past the piston 18 and from the vessel 12. After the fluid has been injected into the vessel, the top of the stern 14 is sealed, as shown in Figure 1 1.
While the above description describes the manner in which a 30 monomer liquid is injected into the vessel and thereafter polymerized to form the pistor~ it is of course understood that the invention is not intended to be limited to this embodiment. Rather, any liquid (i.e., any viscous substance) that c~n be converted to a solid may be used to form the piston. For instance, ~n epoxy liquid could be injected into the vessel and thereafter converted to a solid by curing it.
35 Moreover, while the above embodiment is directed towards filling the s~essel with a calibrant fluid, it should be understood that any appropriate fluid could be ..

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stored in the vessel, such as a wash fluid. Thus, the step of injecting a tonometered gas mixture is not always required.
The vessel is capable of being filled to greater than 90% of its volume. Moreover, the stem design insures that all of the gases in the vessel are 5 trapped in the stem 14 of the vessel~ and therefore, do not mix w~th the fluid. In particular, the inner diameter of the stem is designed to be less than lmm such that the stems act as a capi}lary tube. In this manner, the surface ter~ion of the fluid acts to prevent the fluid from mLxing with the gases. Thus, according to the invention, the fluid can be pumped from the ampule with the ampule disposed in 10 ar~y orientation without effecting the position of the gases in the vessel, as discussed above. Moreover, the pump arran~ement allows the fluid to be pumped from the arnpule at a spec~c rate. Of course9 it is understood that the vessel 12 need not include the stem 14 if it is not important to prevent the mixing of thefluid and the gases.
Wllen the fluid is withdrawn from the vessel in the marmer described above, an air bubble forms at the leading edge of the flow to thereby form a negative fluid meniscus. The leading edge of the negative fluid meniscus serves t~ scrape previous fluids from the walls of the path, such as in a flow cell, so as to prevent the previous fluids from mi7~ing with the present fluid thereby 20 preventing what is commonly referred to as "carIy-over."
The vessel can be made out of a gas ~mpermeable material such as glass so as to insure that the gases in the fluid do not perrneate the vessel.
Alternatively, ~he vessel can be made out of gas permeable material such as plastic if maintaining the gas concentration in the fluid is not important.

.

Claims (21)

1. A fluid storage system, comprising:
a vessel for storing a fluid therein;
sealing means disposed in said vessel;
a fluid contained in said vessel, said fluid being separated by said sealing means from at least a portion of the wall of said vessel;
access means for passing through a portion of the wall of said vessel where said sealing means separates said fluid from the wall of said vessel, said access means when passing through said sealing means such that one end of said access means communicates with said fluid and the other end of said access means extends outwardly from said vessel; and means for causing said fluid to flow from said vessel through said access means.
2. The fluid storage system of claim 1 wherein said access means comprise:
probe means for passing through a portion of the wall of said vessel where said sealing means separates said fluid from the wall of said vessel; and penetration means insertable through the portion of the wall of said vessel through which said probe means has passed, said penetration means then passing through said sealing means such that one end of said penetration means communicates with said fluid and the other end of said penetration means extends outwardly from said vessel.
3. The fluid storage system of claim 2 wherein said penetration means is a needle having a hollow bore.
4. The fluid storage system of claim 3 wherein said sealing means is a piston slideably mounted in said vessel through which said needle extends when said needle has pierced said sealing means.
5. The fluid storage system of claim 4 wherein said means for causing said fluid to flow from said vessel includes an actuator for forcingsaid piston into said vessel thereby displacing fluid from said vessel through said needle.
6. The fluid storage system of claim 3 wherein said probe means is a rod having a needle receiving bore disposed wherein, and wherein said needle is slideably disposed in said bore so that said rod may be used to penetrate a wall of said vessel, whereby allowing said needle to puncture said sealing means through the area of said wall that has been penetrated by said rod.
7. The fluid storage system of claim 1 wherein said vessel is an elongated container having a sidewall and at least one end wall, and wherein the portion of the wall of said vessel through which said access means passes isin said end wall of said container.
8. The fluid storage system of claim 7 wherein said vessel is fabricated from glass, and wherein said end wall of said vessel is made relatively weak in the portion of the wall of said vessel through which said access means passes thereby better allowing said access means to pass through the wall of said vessel.
9. The fluid storage system of claim 1 wherein said -fluid is a liquid.
10. An fluid storage system, comprising:
a vessel for storing a fluid therein;
a seal disposed in said vessel;
a fluid contained in said vessel, said fluid being separated by said seal from at least a portion of the wall of said vessel;
an access device adapted to pass through a portion of the wall of said vessel where said seal separates said fluid from the wall of said vessel;
said access device being adapted to then passing through said seal such that oneend of said access device communicates with said fluid and the other end of said access extends outwardly from said vessel; and a fluid conveyor for causing said fluid to flow from said vessel through said penetrator.
11. The fluid storage system of claim 10 wherein said access device comprises:
a probe adapted to pass through a portion of the wall of said vessel where said seal separates said fluid from the wall of said vessel; and a penetrator insertable through a portion of the wall of said vessel through which said probe is adapted to pass after said probe has passed through the wall of said vessel, said penetrator adapted to then pass through said seal such that one end of said penetrator communicates with said fluid and the other end of said penetrator extends outwardly from said vessel;
12. The fluid storage system of claim 11 wherein said penetrator is a needle having a hollow bore.
13. The fluid storage system of claim 12 wherein said seal is a piston slideably mounted in said vessel through which said needle extends when said needle has pierced said seal.
14. The fluid storage system of claim 13 wherein said fluid conveyor includes an actuator for forcing said piston into said vessel, thereby displacing fluid from said vessel through said needle.
15. The fluid storage system of claim 12 wherein said probe is a rod having a needle receiving bore disposed therein, and wherein said needle is slideably disposed in said bore so that said rod may be used to penetrate a wall of said vessel, thereby allowing said needle to puncture said seal through the area of said wall that has been penetrated by said rod.
16. The fluid storage system of claim 10 wherein said vessel is an elongated container having a sidewall and at least one end wall, and wherein the portion of the wall of said vessel through which said access device passes is in said end wall of said container.
17. The fluid storage system of claim 16 wherein said vessel is fabricated from glass, and wherein said end wall of said vessel is made relatively weak in the portion of the wall of said vessel through which said access device passes thereby better allowing said access device to pass through the wall of said vessel.
18. The fluid storage system of claim 10 wherein said fluid is a liquid.
19. A method of removing a fluid from a vessel having a seal disposed in said vessel, a fluid contained in said vessel, and a seal separatingsaid fluid from a portion of the wall of said vessel; said method comprising:
penetrating a portion of a wall of said vessel in an area where said seal separates said fluid from the wall of said vessel;
penetrating said seal after entering said vessel in an area of said wall has been penetrated; and withdrawing said fluid from said vessel through the penetrated areas of said seal and said wall.
20. The method of claim 19 wherein said seal is a piston slideably disposed in said vessel, wherein said step of penetrating said seal isaccomplished by penetrating said piston with a needle, and wherein said step of withdrawing said fluid from said vessel is accomplished by forcing said piston into said vessel, thereby displacing said fluid from said vessel through said needle.
21. The method of claim 20 wherein said seal is a piston slideably disposed in said vessel, and wherein both of said penetrating steps are accomplished by:
providing a probe having an axial bore, and a needle slideably mounted in said bore;
advancing said probe through an area of said wall of said vessel thereby penetrating said wall;
advancing said needle relative to said probe thereby causing said needle to pierce said piston; and further advancing said probe and needle into said vessel so that said probe forces said piston into said vessel, thereby displacing said fluid from said vessel.
CA002044122A 1990-06-11 1991-06-07 Storage device with positive displacement dispenser by means of egress through a pierced septum Abandoned CA2044122A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/535,903 US5207654A (en) 1990-06-11 1990-06-11 Storage device with positive displacement dispenser by means of egress through a pierced septum
US07/535,903 1990-06-11

Publications (1)

Publication Number Publication Date
CA2044122A1 true CA2044122A1 (en) 1991-12-12

Family

ID=24136278

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002044122A Abandoned CA2044122A1 (en) 1990-06-11 1991-06-07 Storage device with positive displacement dispenser by means of egress through a pierced septum

Country Status (5)

Country Link
US (2) US5207654A (en)
EP (1) EP0461585B1 (en)
JP (1) JPH05124614A (en)
CA (1) CA2044122A1 (en)
DE (1) DE69108612T2 (en)

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Publication number Priority date Publication date Assignee Title
US7331912B2 (en) * 2003-06-27 2008-02-19 Keiser Corporation Adjustable bench
DE102004046536A1 (en) * 2004-09-21 2006-03-30 Bernd Hansen container
ES1064346Y (en) * 2006-11-29 2007-06-01 Agell Jose Luis Flores CONTAINER
EP2266881A1 (en) * 2009-06-24 2010-12-29 José Luis Flores Agell Hollow glass container

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Publication number Priority date Publication date Assignee Title
US1770632A (en) * 1928-07-02 1930-07-15 Arthur E Smith Ampul syringe
US1770631A (en) * 1928-07-02 1930-07-15 Arthur E Smith Syringe
US2175365A (en) * 1934-11-20 1939-10-10 Multipule Corp Hypodermic syringe and cartridge and method of making cartridge
FR1241230A (en) * 1959-08-04 1960-09-16 Prolabo Sa Ampoule for reagent conditioning
US3534735A (en) * 1969-02-07 1970-10-20 Lincoln Lab Inc Disposable injector and holder therefor
BE759374A (en) * 1970-06-08 1971-04-30 Ims Ltd MEDICINE PACKAGING
SE381577B (en) * 1974-06-24 1975-12-15 Mediplast Ab DEVICE FOR TRANSFERRING A LIQUID, AS BLOOD FROM A CYLINDRICAL CONTAINER TO A PIPETTE
US4020831A (en) * 1975-12-04 1977-05-03 Technicon Instruments Corporation Blood collecting syringe
US4191225A (en) * 1976-10-20 1980-03-04 Ims Limited Pharmaceutical cocktail package
US4390016A (en) * 1981-10-23 1983-06-28 Temp-Trak Inc. Prefillable hypodermic syringe and method of assembling the syringe
US4684366A (en) * 1985-03-15 1987-08-04 Denny Christopher G Syringe for the remote injection of animals and fish
SE451942B (en) * 1986-02-26 1987-11-09 Broden Bengt Inge DEVICE FOR HANDLING ORGANIC BODY WELDINGS
US4648532A (en) * 1986-05-09 1987-03-10 Green Russell D Mixing and discharge capsule
US4828540A (en) * 1987-07-28 1989-05-09 Fordyce Glenn B Folding apparatus with adjustable swing chute
US4976966A (en) * 1988-12-29 1990-12-11 Alza Corporation Delayed release osmotically driven fluid dispenser

Also Published As

Publication number Publication date
EP0461585A1 (en) 1991-12-18
DE69108612T2 (en) 1995-08-17
US5350366A (en) 1994-09-27
DE69108612D1 (en) 1995-05-11
JPH05124614A (en) 1993-05-21
EP0461585B1 (en) 1995-04-05
US5207654A (en) 1993-05-04

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Legal Events

Date Code Title Description
EEER Examination request
FZDE Discontinued