EP0001452A1 - Ampulle für das langfristige Aufbewahren polymerisierbarer Substanzen - Google Patents

Ampulle für das langfristige Aufbewahren polymerisierbarer Substanzen Download PDF

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Publication number
EP0001452A1
EP0001452A1 EP78101106A EP78101106A EP0001452A1 EP 0001452 A1 EP0001452 A1 EP 0001452A1 EP 78101106 A EP78101106 A EP 78101106A EP 78101106 A EP78101106 A EP 78101106A EP 0001452 A1 EP0001452 A1 EP 0001452A1
Authority
EP
European Patent Office
Prior art keywords
ampule
piston
sealing
opening
chamber
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.)
Withdrawn
Application number
EP78101106A
Other languages
English (en)
French (fr)
Inventor
Harold Corey
Lee R. Bolduc
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.)
Population Research Inc
Bionexus Inc
Original Assignee
Population Research Inc
Bionexus 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 Population Research Inc, Bionexus Inc filed Critical Population Research Inc
Publication of EP0001452A1 publication Critical patent/EP0001452A1/de
Withdrawn legal-status Critical Current

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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
    • B65D83/00—Containers or packages with special means for dispensing contents
    • B65D83/0005—Containers or packages provided with a piston or with a movable bottom or partition having approximately the same section as the container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/062—Carpules

Definitions

  • the present invention is directed to an improved ampule construction for long-term storage and for ready ultimate use of polymerizable substances such as a monomer of methyl cyanoacrylate (MCA).
  • MCA Methyl cyanocrylate
  • MCA has found application in the field of permanent sterilization of human females. Sterilization in the female is accomplished by introduction of small quantities of MCA into the fallopian tubes.
  • MCA is the preferred polymerizable substance insofar as this invention is concerned, the following description will refer to MCA in particular.
  • the invention is not limited to MCA as the only polymerizable substance to be stored in ampules constructed according to this invention. Rather, the invention is concerned with the construction of ampules as set forth herein.
  • Related polymerizable substances are described in U.S. Patents 2,763,677; 3,483,870; 3,527,841; 3,564,078; 3,699,076; 3,759,264 and British Patent 1,159,548. An article appearing in the Society of Plastics Engineers Journal 15 (No.
  • polymerizable substances is intended to be inclusive of all such equivalent substances or compositions, which are readily catalyzed by moisture, heat, light, radiation, and the active sites provided by various organic materials and caused to polymerize.
  • MCA polymerizes under a variety of conditions including exposure to even trace amounts of moisture, heat, high energy radiation, and virtually any active site organic, as do the other polymerizable substances referred to hereinabove. It is also difficult to store MCA for any period of time due to its tendency to autocatalyze itself into a solid cured polymer in storage.
  • the prior art ampule comprises a tube made, for example, of a material such as polyethylene, which is generally sealed at one end with a stopped or diaphragm of rubber or the like, and, at the other end, a movable piston of rubber or the like is provided for sealing the ampule while moving toward the stopper as the polymerizable substance is withdrawn from the ampule, such as by the needle of a hypodermic syringe passed through the stopper in a fashion similar to that normally used in removing drug solutions from ampules.
  • the problem which occurs is that the rubber, and similar materials used in the stopper and piston, usually contains active sites which cause catalyzation of the polymerizable substances stored in the ampule, such as MCA.
  • a protective coating such as a conventional polyteleofluorelbylene (PTFE or TEFLON) material.
  • PTFE polyteleofluorelbylene
  • One such process utlizes a thin PTFE coating to be bonded to the rubber surface at the same time the rubber is being vulcanized. This is a relatively costly process and utilizes relatively expensive materials.
  • any of the polymerizable substance which escapes past the PTFE coated portion of the piston contacts the rubber portion of the piston and polymerizes. This causes the "set up" of the balance of the polymerizable substance in the ampule.
  • polymerizable sub- - stances such as bacterially purified MCA monomer
  • the present invention permits the use of a low level of inhibitor content in the polymerizable substance, which is desirable in the finished product to prevent autocatalyzation during storage.
  • the ampule of the present invention may be made of relatively inexpensive materials and allows relatively long-term storage of polymerizable substances such as MCA with reduced risk that polymerization may occur even though the ampule experiences elevated temperature conditions such as those found in tropical areas. Desirably, the ampule of the present invention and its contents will be maintained at low temperatures where possible to further reduce the possibilities of unintended polymerization.
  • both the piston and stopper may be made of inexpensive materials and are of such construction that the polymerizable substance is not permitted to contact those portions of the piston and stopper which in prior art ampules have come into contact with the substance. Therefore, the piston and stopper construction of the present invention are such that catalyzation of the substance is prevented.
  • the construction of the ampule of the present invention also allows the ampule and its contents to be frozen thus preserving the contents over a longer period of time.
  • This invention provides an ampule for long-term storage of a polymerizable substance such as a monomer of an aliphatic cyanoacrylate and comprises an ampule body for holding a quantity of such a substance, first sealing means for sealing one portion of the ampule body and constructed and arranged to permit access to the inside thereof by a needle to permit draining of the substance and second sealing means including piston means situated within the ampule for sealing another portion thereof and for inhibiting catalyzation of substances stored in the ampule.
  • a polymerizable substance such as a monomer of an aliphatic cyanoacrylate
  • the first sealing means includes a stopper or diaphragm member which has an inexpensive protective coating on the portion of the member which contacts the monomer inside the ampule body. This coating prevents the stored substance from contacting the first seal means even when a needle is passed through the seal member into the ampule body for draining the monomer.
  • the second sealing means includes a piston of a material similar to that of the ampule body in that it does not foster polymerization of the stored substance upon contact.
  • the piston has an "O" ring sealing member which acts as a secondary seal and a flared interior end section which provides a seal.
  • the flared end section of the piston fits within the container means and bears against the inside wall of the container to sealingly engage it so as to prevent the leakage of the polymerizable substance from the container.
  • the "O" ring acts as a secondary seal such that in the event any stored substance does pass the primary seal provided by the flared end section, it will be trapped in the space between the flared end section, the "O” ring, and the inner wall of the ampule body and held separate from the remaining polymerizable substance within the ampule. This trapping action inhibits the "O” ring from causing the polymerizable substance stored inside the ampule from being catalyzed by contact with the "O" ring.
  • Figs. 1 and 2 show an ampule 10 of the present invention which includes a tubular body or member 12 having a beveled end portion 14 at one end 15 thereof and having a cylindrical opening 16 of slightly decreasing diameter forming an apertured passage therethrough from beveled end portion 14 to opposite end portion 18 thereby defining a chamber.
  • member 12 is a cylindrical tube but it could have other configurations, with appropriate modifications in the other components of ampule 10.
  • the opening 16 at end 18 is smaller in cross-sectional diameter than is the cross-sectional diameter of member 12 at the beveled end portion 14.
  • the end 18 of member 12 has a neck portion 20 affixed thereto. Neck portion 20 has an opening 22 passing completely through the neck portion 20. Opening 22 communicates both with opening 16 and the space outside member 12.
  • Member 12 and neck portion 20 are preferrably made of a water tight, noncatalyzing plastic material such as polyethylene or polypropylene. Opening 16 of member 12 has a very smooth inner wall 24 so that the polymerizable substance contained within ampule 10 will have less tendency to leave a layer on the inner surface or wall 24. Located on the end of neck portion 20 opposite end 18 of member 12 is a lip or raised portion 26. Neck 20 and lip 26 are made of the same material as member 12 and may be integrally molded together as a single unit. As noted, opening 16 is provided with a slightly decreasing cross-sectional diameter, and ampule 10 may be readily molded as a single piece.
  • a coating such as a sprayed-on PTFE coating 36 is provided over the inner surface of member 28 so as to render it inert to the contents thereof.
  • Member 28 is preferably made of a high modulus rubber material such as butyl, natural, buna, neoprene, or any other appropriate high modulus rubber.
  • Such high modulus rubbers have the appropriate characteristics for allowing a device such as that disclosed in U.S. Patents 3,822,702 and 3,948,259 such as that shown in phantom at 40 having a needle 42 to puncture member 28 and be used for draining from the ampule chamber defined by opening 16.
  • the high modulus rubber materials allow needle 42 to puncture member 28 without coring the member and also allowing the member to reseal once needle 42 is withdrawn from the ampule.
  • Coating 36 is provided because it is inert to the polymerizable substance contained within ampule 10 and is not a catalyst for polymerization. By providing coating 36, any reactive sites are shielded from the ampule contents since coating 36 prevents contact between the contents and the inner surface of member 28 prior to needle 42 being passed therethrough to drain contents out of the chamber.
  • Cylindrical member 12 is also provided with a generally cylindrical piston 50, shown in perspective view in Fig. 3.
  • Piston 50 is introduced into opening 16 via the beveled end portion 14 of member 12 and is seated within the apertured passage formed by opening 16 at end 15.
  • Piston 50 is of a material inert to the ampule contents and is preferably of a material similar to member 12, i.e., a polyethylene or polypropylene or any other suitable material to which the polymerizable substances to be contained in the ampule will have a relatively low tendency to adhere and which does not catalyze the polymerization of the ampule contents.
  • Piston 50 has a cylindrical portion 52 located at one end thereof and a frusto-conical or flared section 54 formed integrally with and adjacent cylindrical portion 52. Piston 50 is provided with a hole 56 extending partially therethrough and tapering in cross-sectional diameter with its largest dimension being at end 58 of piston 50. Tapered hole 56 is provided to allow piston 50 to be integrally molded of a plastic material of the type described above as a single member. Located around the outer surface of cylindrical portion 52 of piston 50 is an annular peripheral seal or groove 60 which carries snugly therein an "O" ring 62 which is preferably made of the same materials as member 28.
  • a frusto-conical or flared section 54 which flares outwardly beginning at the point of connection 66 with cylindrical portion 52. Flared portion 54 together with end 70 of cylindrical portion 52 defines an annular groove on the flare of end 70 as a space 72, the purpose of which is explained below.
  • the outer diameter of "O" ring 62 and the maximum diameter of outwardly flared frusto-conical section 54 at point 68 are such that when piston 50 is introduced into opening 16 of member 12 at the beveled end portion 14, both the "O" ring 62 and end point 68 of flared portion 54 will be compressed by the inner wall 24 of opening 16 resulting in two areas of sealing engagement, i.e., first and second seal means on the piston.
  • flared portion 54 may be readily compressed as piston 50 moves in the direction of arrow 74 toward member 28 as the contents of the ampule are being withdrawn by means of needle 42. Since flared portion 54 and "0" ring 62 bear snugly against inner wall 24 of opening 16, as piston 50 moves, a seal is provided both at end point 68 of flared portion 54 where it contacts inner wall 24 and also at the area of contact between the "O" ring 62 and inner wall 24. These seals, shown at points 76 and - 78 for the position of piston 50 as shown in Fig. 2, and the body of piston 50 define or provide a trapping space 80 all the way around piston 50 between "0" ring 62 and end 68 of flared portion 54.
  • Ampule 10 operates as follows. For filling the chamber provided by opening 16 in ampule 10 with the polymerizable substance to be stored, a standard type automatic filling machine may be used (not shown). Piston 50 is positioned within opening 16 so as to eliminate any space not occupied by the polymerizable substance which is introduced through opening 22 in neck portion 20. Once the space between piston 50 and end 18 of member 12 is completely filled with the substance, member 28 is seated in opening 22 and cap 30 is automatically affixed in position leaving a small portion of end 32 of stopper 28 exposed for access by needle 42.
  • Ampule 10 is thus sealed at both ends, and with coating 36 over the inner surface of member 28 and with the construction of piston 50, the contents of ampule 10 can be stored for long periods without "0" ring 62 or member 28 providing any catalyzation which would cause polymerization thereof.
  • opening 16 filled with a desired amount of polymerizable substance
  • coating 36 on member 28 prevents contact between the contents and inner surface of member 28.
  • end 68 of flared portion 54 on piston 50 provides a primary seal to prevent leakage of the contents out of end 15 of member 12. Since piston 50 is made of materials which do not affect the polymerizable substances, the bulk of the contents of the chamber provided by opening 16 is prevented from reaching "O" ring 62. Therefore, no reaction can occur between the active sites of "O" ring 62 and the polymerizable substance contained within opening - 16.
  • needle 42 is passed through member 28 and through coating 36. Material may then be drained from opening 16 through needle 42.
  • piston 50 moves toward end 18 of member 12 eliminating any space not occupied by stored contents as it is being withdrawn from member 12.
  • the inner wall 24 of member 12 continues to further compress portion 68 of flared portion 64, as well as further compressing the outer surface of "O" ring 62.
  • ampules of the present invention is such that once filled with stored substance, ampule 10 may be frozen so as to preserve the contents thereof over a long period of time.
  • ampule construction of the present invention may be utilized with various forms of polymerizable substances. That is, the invention is not limited to the storage of monomeric methyl cyanoacrylate but can be utilized in the storage of all polymerizable substances as defined hereinabove but particularly in the storage of the monomeric esters of aliphatic cyanoacrylates described in U.S. Patent Nos. 2,763,677 and 3,659,264.
  • MCA is utilized as an example only.
  • monomeric polymer as used herein is intended to include the monomer and mixtures therewith of dimers or trimers where these mixtures are substantially monomers and are liquid substances at room temperatures.

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  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP78101106A 1977-10-11 1978-10-09 Ampulle für das langfristige Aufbewahren polymerisierbarer Substanzen Withdrawn EP0001452A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US84090377A 1977-10-11 1977-10-11
US840903 1977-10-11

Publications (1)

Publication Number Publication Date
EP0001452A1 true EP0001452A1 (de) 1979-04-18

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP78101106A Withdrawn EP0001452A1 (de) 1977-10-11 1978-10-09 Ampulle für das langfristige Aufbewahren polymerisierbarer Substanzen

Country Status (3)

Country Link
EP (1) EP0001452A1 (de)
JP (1) JPS5463989A (de)
AU (1) AU3950678A (de)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1984000893A1 (en) * 1982-09-01 1984-03-15 Labsystems Oy Procedure for pumping medical substance and medicine container for applying the procedure
FR2605701A1 (fr) * 1986-10-22 1988-04-29 Cables De Lyon Geoffroy Delore Joint annulaire d'etancheite pour plateau suiveur d'une pompe d'extraction de produits visqueux conditionnes en futs
DE8717881U1 (de) * 1986-02-26 1991-01-03 Hoechst Ag, 6230 Frankfurt, De
FR2705951A1 (fr) * 1993-06-04 1994-12-09 Oreal Ensemble de distribution comprenant un récipient cylindrique comportant un piston.
DE102006045959B3 (de) * 2006-09-27 2008-01-10 Lts Lohmann Therapie-Systeme Ag Zylinderkolbeneinheit mit mindestens drei Dichtelementen
EP2281542A1 (de) * 2009-07-29 2011-02-09 F. Hoffmann-La Roche AG Arzneimittelkartusche

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0783749B2 (ja) * 1986-11-06 1995-09-13 オリンパス光学工業株式会社 内視鏡用処置具

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1074325A (fr) * 1953-04-03 1954-10-05 Chimie Atomistique Ampoule en matière plastique pour l'introduction de produits fluides dans les cavités naturelles de l'homme ou des animaux
US2695735A (en) * 1951-10-23 1954-11-30 Johanna Margaretha Maria Van D Dispensing device
GB811398A (en) * 1956-11-21 1959-04-02 S & R J Everett & Co Ltd Improvements relating to hypodermic syringes
CH366126A (fr) * 1959-03-17 1962-12-15 S E D A T Garniture en matière plastique pour piston de seringue, et procédé pour sa fabrication
FR1333235A (fr) * 1962-06-16 1963-07-26 Piston jointif d'une seule pièce moulé en matière plastique pour seringue à utiliser une seule fois
US3151617A (en) * 1962-05-29 1964-10-06 Baum Leo Syringe
FR1412340A (fr) * 1964-10-23 1965-09-24 Amalgamated Dental Co Ltd Cartouche pour appareil pour injections sous-cutanées
US3540444A (en) * 1968-01-15 1970-11-17 Scherer Corp R P Plastic ampoule for use with hypodermic injector
GB1346982A (en) * 1971-02-24 1974-02-13 Saint Gobain Stoppered bottle and a stopper therefor
FR2264562A2 (en) * 1974-03-22 1975-10-17 Radiologie Cie Gle Injection syringe - serving as sterile storage vessel ready for use

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2695735A (en) * 1951-10-23 1954-11-30 Johanna Margaretha Maria Van D Dispensing device
FR1074325A (fr) * 1953-04-03 1954-10-05 Chimie Atomistique Ampoule en matière plastique pour l'introduction de produits fluides dans les cavités naturelles de l'homme ou des animaux
GB811398A (en) * 1956-11-21 1959-04-02 S & R J Everett & Co Ltd Improvements relating to hypodermic syringes
CH366126A (fr) * 1959-03-17 1962-12-15 S E D A T Garniture en matière plastique pour piston de seringue, et procédé pour sa fabrication
US3151617A (en) * 1962-05-29 1964-10-06 Baum Leo Syringe
FR1333235A (fr) * 1962-06-16 1963-07-26 Piston jointif d'une seule pièce moulé en matière plastique pour seringue à utiliser une seule fois
FR1412340A (fr) * 1964-10-23 1965-09-24 Amalgamated Dental Co Ltd Cartouche pour appareil pour injections sous-cutanées
US3540444A (en) * 1968-01-15 1970-11-17 Scherer Corp R P Plastic ampoule for use with hypodermic injector
GB1346982A (en) * 1971-02-24 1974-02-13 Saint Gobain Stoppered bottle and a stopper therefor
FR2264562A2 (en) * 1974-03-22 1975-10-17 Radiologie Cie Gle Injection syringe - serving as sterile storage vessel ready for use

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1984000893A1 (en) * 1982-09-01 1984-03-15 Labsystems Oy Procedure for pumping medical substance and medicine container for applying the procedure
DE8717881U1 (de) * 1986-02-26 1991-01-03 Hoechst Ag, 6230 Frankfurt, De
FR2605701A1 (fr) * 1986-10-22 1988-04-29 Cables De Lyon Geoffroy Delore Joint annulaire d'etancheite pour plateau suiveur d'une pompe d'extraction de produits visqueux conditionnes en futs
FR2705951A1 (fr) * 1993-06-04 1994-12-09 Oreal Ensemble de distribution comprenant un récipient cylindrique comportant un piston.
WO1994029190A1 (fr) * 1993-06-04 1994-12-22 L'oreal Ensemble de distribution comprenant un recipient cylindrique comportant un piston
US5577641A (en) * 1993-06-04 1996-11-26 L'oreal Dispensing assembly comprising a cylindrical container including a piston
DE102006045959B3 (de) * 2006-09-27 2008-01-10 Lts Lohmann Therapie-Systeme Ag Zylinderkolbeneinheit mit mindestens drei Dichtelementen
US8167850B2 (en) 2006-09-27 2012-05-01 Lts Lohmann Therapie-Systeme Ag Cylinder/piston unit with at least three sealing elements
EP2281542A1 (de) * 2009-07-29 2011-02-09 F. Hoffmann-La Roche AG Arzneimittelkartusche

Also Published As

Publication number Publication date
AU3950678A (en) 1980-03-13
JPS5463989A (en) 1979-05-23

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Inventor name: COREY, HAROLD

Inventor name: BOLDUC, LEE R.