Dispensing package for unit dosage

• US 5,292,307 A
• Filed: 09/16/1992
• Issued: 03/08/1994
• Est. Priority Date: 09/16/1992
• Status: Expired due to Fees

• Current Assignee: Baskin, Steven I., Theodore W. Dolzine
• Original Assignee: Baskin, Steven I., Theodore W. Dolzine
• Inventors: Dolzine, Theodore W., Baskin, Steven I.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): WILKENS, FRANK
• Application Number:
  US07/945,671
• Time in Patent Office: 538 Days
• Field of Search: 604/54, 604/57, 604/59-63, 604/111, 222/78, 222/322, 222/325, 222/343, 222/510, 221/79, 221/87, 221/88, 221/209, 221/197, 221/270, 221/268
• US Class Current: 604/514
• CPC Class Codes: A61J 7/0053 Syringes, pipettes or oral dispensers
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

A unit dosage, packaged for direct administration into a body cavity, is encapsulated in a packet between a pair of leaves of foil. The leaves are sealed to each other about their peripheries. The packet is packaged with a tubular injector having a longitudinal bore extending from the head end of the injector to the tail end. The packet is positioned in the bore adjacent the head end by a annular support member having a central opening in registry with the bore. A plunger is mounted in the bore and has a head adapted to slide in the bore and a tail projecting out of the tail end of the tubular injector, and the tail end of the plunger is used to displace the head of the plunger through the packet, through the opening in the annular support, and beyond the head end of the tubular injector. The head of the plunger is provided with a beveled surface along one side.

Claims

1. A method of administering a unit dosage into a body cavity, comprising the steps of

encapsulating the unit dosage in the center of a packet comprising a pair of confronting leaves of frangible material,

positioning the dosage between the leaves at the center part of the packet and sealing the leaves around the periphery of the packet, to form a sealed packet which seals the unit dosage from exposure to conditions which might cause degradation of the dosage,

providing an elongated tubular injector having a head end and a tail end with a longitudinal bore extending from end to end with a cross section larger than said dosage, and a plunger mounted for longitudinal displacement within said bore,

said plunger having a nose portion having a cross section corresponding to the cross section of the bore, and with a beveled edge at one side of the plunger with a contour along the periphery of said nose cross section, and operable to slide within said bore,

said plunger having a tail portion projecting out of said bore at the tail end of the injector,

mounting said packet in said injector adjacent the head end remote from said tail end, and registering the dosage in the packet in alignment with said bore, and supporting said packet in said injector with an annular ring having a central opening corresponding in size with the cross section of said nose, said central opening having a contour conforming to the contour of said beveled edge,

positioning the head end of the injector in the body cavity receiving the dosage, and

dispensing said unit dosage by using the tail to displace the nose of the plunger through said packet and through the opening of said annular ring, whereby said beveled edge at one side of the plunger first penetrates the frangible material at said one side to provide a dispensing opening in the packet for the unit dosage and then the nose expresses the unit dosage out from between the leaves of the packet and through the opening of said ring and then through the head end of the injector into the body cavity receiving the dosage.

2. A method according to claim 1 wherein the dosage is to be administered by placement of the dosage under the tongue in the oral cavity of the body,

said positioning step comprising placing the head end of the injector under the tongue.

3. A method according to claim 1 including the step of anchoring the leaves of said packet within the injector while expressing the dosage from therebetween.

4. A method according to claim 1 wherein said displacement of the nose of the plunger is of an extent to cause the nose of the plunger to project beyond the head end of the injector to thereby guide the dosage into a selected administration site within the body cavity.

5. A method according to claim 1 wherein said packet is supported by anchoring said leaves to said annular ring so that when said plunger penetrates the leaves to provide the dispensing opening, the penetrated leaves are retained in said injector by their being anchored to said ring.

6. A method of packaging a unit dosage for administration into a body cavity, comprising the steps of

encapsulating the unit dosage in the center of a packet comprising a pair of confronting leaves of frangible material,

positioning the dosage between the leaves at the center part of the packet and sealing the leaves around the periphery of the packet, to form a sealed packet which seals the unit dosage from exposure to conditions which might cause degradation of the dosage, and anchoring said packet on an annular ring having a central opening larger in size than the cross section of said dosage, with the dosage in registry with the opening,

providing an elongated tubular injector having a head end and a tail end with a longitudinal bore extending between said ends with a cross section not substantially larger than as said central opening, and a plunger mounted for longitudinal displacement within said bore,

said plunger having a nose portion having a cross section corresponding to the cross section of the bore, and with a beveled edge at one side of the plunger, and operable to slide within said bore and said opening,

said plunger having an operator projecting out of said bore, and

mounting said packet in said injector adjacent the head end remote from said tail end, and registering the dosage in the packet and said central opening in alignment with said bore,

whereby upon positioning the head end of the injector in the body cavity receiving the dosage, the unit dosage may be dispensed by using the operator to displace the nose of the plunger through said packet and through the opening of said annular ring, and whereby further said beveled edge at one side of the plunger first penetrates the frangible material at said one side to provide a dispensing opening in the packet for the unit dosage and then the nose expresses the unit dosage out from between the leaves of the packet and through the opening of said ring and then through the head end of the injector into the body cavity receiving the dosage.

7. A method of packaging according to claim 6 including the step of providing a cover element for the operator which prevents use of the operator to displace the nose of the plunger, and providing a tamper-proof seal as the connection of said cover element to the injector, whereby breaking said seal is required to displace the cover element to afford use of the operator.

8. A package according to claim 6 including the step of enclosing the head end of the injector with a sterile sheath which may be removed prior to positioning the end in the body cavity.

9. A unit dosage adapted to be administered by placement into a body cavity, comprising

a packet comprising a pair of confronting leaves of frangible material, a unit dosage positioned between the leaves at the center part of the packet and means sealing the leaves together around the periphery of the packet, to form a packet which seals the unit dosage from exposure to conditions which might cause degradation of the dosage,

an elongated tubular injector having a head end and a tail end with a longitudinal bore extending between said ends,

a plunger mounted for longitudinal displacement within said bore, said plunger having a nose portion with a beveled edge at one side of the plunger and having across section operable to slide within said bore, and a tail portion projecting out of said bore, said beveled edge having a contour extending along the periphery of the nose cross section, and

an annular ring mounting said packet in said injector adjacent the head end with the dosage in alignment with said bore and supporting said packet in said injector, said annular ring having a central opening corresponding in size with the cross section of said nose and having a contour conforming to the contour of said beveled edge,

the bore at the head end of the injector being open to permit communication of the bore of the injector with the cavity receiving the dosage,

whereby upon displacing the nose of the plunger through said packet and through the opening of said annular ring, said beveled edge at one side of the plunger first penetrates the frangible material at said one side to provide a dispensing opening in the packet for the unit dosage and the nose then expresses the unit dosage out from between the leaves of the packet and through the opening of said ring and then through the head end of the injector into the body cavity receiving the dosage.

10. A unit dosage according to claim 9 wherein said bore extends from end to end, and said tail portion of the plunger projects from the tail end of the tubular bore of the injector a distance greater than the distance between the head end of the injector and the packet, and

a cover element mounted on said tubular member to capture said tail portion and guard against inadvertent actuation of said plunger.

11. A unit dosage according to claim 10 including a tamper-proof seal securing said cover element to said tubular member,

said tamper-proof seal serving as a connection between said elements which must be broken to free the tail portion for actuation of the plunger.

12. A unit dosage according to claim 10 wherein said cover element comprises an end cap having a pocket clip for anchoring the unit dosage in a pocket.

13. A unit dosage according to claim 9 including a removable sheath covering the head end of the tubular element to provide a sterile environment upon removal of the sheath prior to insertion of the head end into the body cavity.