Sealed containers and methods of filling and resealing same

• US 8,960,242 B2
• Filed: 07/29/2011
• Issued: 02/24/2015
• Est. Priority Date: 02/11/2000
• Status: Expired due to Term

• Current Assignee: Medinstill Development, LLC
• Original Assignee: Medinstill Development, LLC
• Inventors: Py, Daniel, Assion, Norbert M.
• Primary Examiner(s): MAUST, TIMOTHY LEWIS
• Application Number:
  US13/193,662
• Publication Number:
  US 20110277873A1
• Time in Patent Office: 1,306 Days
• Field of Search: 141/11, 141/69, 141/82, 141/329, 215247-249, 220/363, 604411-415, 435/300.1, 435/301.1
• US Class Current: 141/11
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1412 Containers with closing means, e.g. caps
• CPC Class Codes: A61J 1/1425 Snap-fit type
• CPC Class Codes: A61J 1/1431 Permanent type, e.g. welded or glued
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61J 1/18 Arrangements for indicating condition of container contents, e.g. sterile condition
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: B65B 2039/009 Multiple outlets
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 3/027 Making containers from separate body and end-parts
• CPC Class Codes: B65B 51/10 Applying or generating heat or pressure or combinations thereof welding of plastics per se B29C65/02; closing plastic tube ends in general B29C57/10
• CPC Class Codes: B65B 55/08 by irradiation
• CPC Class Codes: B65B 7/161 Sealing filled ampoules
• CPC Class Codes: B65D 51/002 Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means

Abstract

A container and method for filling same. The container includes a penetrable and resealable portion that is resealable, and a container body having a sealed empty chamber in fluid communication with the penetrable and resealable portion for receiving therein a substance. The container also includes a base, a mid-portion, and an upper portion axially spaced from the base on an opposite side of the mid-portion relative to the base. Each of the base and upper portion define a laterally-extending dimension greater than a maximum laterally-extending dimension of the mid-portion. The method of filling the container includes penetrating the penetrable and resealable portion with an injection member and introducing a substance into the chamber, withdrawing the injection member while engaging the base of the body to substantially prevent upward movement of the body, and applying energy to the penetrable and resealable portion to form a gas-tight seal.

Claims

1. A method comprising the following steps:

filling a container including a container body and a penetrable and hermetically resealable portion, wherein the body defines an empty chamber sealed with respect to ambient atmosphere and in fluid communication with the penetrable and resealable portion for receiving therein a substance, and a generally diabolo shape defining a base, a mid-portion, and an upper portion axially spaced from the base on an opposite side of the mid-portion relative to the base, wherein each of the base and upper portion define a laterally-extending dimension greater than a maximum laterally-extending dimension of the mid-portion;

the filling step further comprising;

penetrating the penetrable and resealable portion with a filling or injection member coupled in fluid communication with a source of substance; and

introducing the substance through the filling or injection member and into the chamber of the container;

withdrawing the filling or injection member from the penetrable and resealable portion;

substantially preventing upward movement of the body with the filling or injection member during the step of withdrawing the filling or injection member; and

hermetically resealing the penetrable and resealable portion and forming a substantially gas-tight seal between the ambient atmosphere and the chamber.

2. A method as recited in claim 1, further comprising the step of sterilizing the empty chamber prior to introducing the substance therein.

3. A method as recited in claim 2, wherein the step of sterilizing the empty chamber includes applying at least one of gamma radiation, e-beam radiation or laser radiation thereto.

4. A method as recited in claim 1, further comprising the step of fusing a tamper-resistant portion between the penetrable and resealable portion and the container body.

5. A method as recited in claim 1, further comprising the step of over-molding a tamper-resistant portion to the penetrable and resealable portion and the container body.

6. A method as recited in claim 1, further comprising the step of forming a tamper-resistant portion integral with the penetrable and resealable portion and over-molding the integral penetrable and resealable portion and tamper-resistant portion to the container body.

7. A method as recited in claim 1, further comprising the steps of assembling the penetrable and resealable portion and container body robotically and over-molding a tamper-resistant portion to the penetrable and resealable portion and the container body.

8. A method as recited in claim 7, wherein the assembling step occurs prior to installing the container body/penetrable and resealable portion assembly in a molding apparatus.

9. A method as recited in claim 7, wherein the container body and the penetrable and resealable portion are assembled in an over-molding apparatus.

10. A method as defined in claim 1, wherein the step of substantially preventing upward movement of the body with the filling or injection member during the step of withdrawing the filling or injection member is performed using the generally diabolo shape of the container body.

11. A method as defined in claim 1, wherein the step of substantially preventing upward movement of the body with the filling or injection member during the step of withdrawing the filling or injection member comprises engaging at least one of the mid-portion and the base of the container body.

12. A method as recited in claim 11, further comprising the step of engaging the upper portion of the container body during withdrawal of the filling or injection member to further prevent upward movement of the body.

13. A method as defined in claim 11, wherein the engaging step comprises engaging the at least one of the mid-portion and the base of the container body with a container support.

14. A method as recited in claim 1, further comprising the step of orienting at least one of an axis of the container and an axis of the filling or injection member at an acute angle relative to the other defining a filling axis through the penetrable and resealable portion oriented at an acute angle relative to the axis of the container.

15. A method as recited in claim 14, further comprising the step of introducing the substance through the filling or injection member at said acute angle and against a lateral wall of the body to facilitate substantially laminar flow of the substance into the chamber.

16. A method as defined in claim 1, wherein the filling or injection member is a needle.

17. A method as defined in claim 1, further comprising the step of supporting the container with a container support in engagement with at least one of the mid-portion and the base of the container.

18. A method as defined in claim 1, further comprising the steps of providing the penetrable and resealable portion with a base portion comprising a first material compatible with the substance and defining a substance-exposed surface in fluid communication with the chamber, the base portion being penetrable by the filling or injection member for introducing the substance into the chamber;

and providing a resealing portion overlying the base portion comprising a second material that upon applying of energy or radiation, hermetically seals the aperture and the substance within the chamber.

19. A method as defined in claim 18, wherein the first material is substantially infusible by the energy or radiation.

20. A method as defined in claim 1, wherein the hermetically resealing step comprises applying radiation or energy to the penetrable and resealable portion.

21. A method as defined in claim 20, wherein the energy or radiation comprises laser radiation or laser energy.

22. A method as defined in claim 1, wherein the hermetically resealing step comprises covering the penetrable and resealable portion with a covering portion and thereby forming said substantially gas-tight seal.

23. A method comprising the following steps:

forming a sealed empty container within a mold, wherein the container includes a body defining a sealed empty chamber, and a penetrable portion in fluid communication with the chamber that is penetrable by a filling or injection member and is resealable;

penetrating the penetrable portion with a filling or injection member such that the filling or injection member is in fluid communication with the sealed empty chamber;

introducing a substance through the filling or injection member and into the chamber;

withdrawing the filling or injection member from the penetrable portion; and

transmitting energy or radiation to the penetrable portion, and hermetically sealing an aperture formed in the penetrable portion by the filling or injection member and the substance within the chamber.

24. A method as defined in claim 23, further comprising the step of over-molding the penetrable portion to the body.

25. A method as defined in claim 24, further comprising the step of over-molding a base to the body.

26. A method as defined in claim 23, wherein the step of transmitting energy or radiation comprises transmitting the energy or radiation at a predetermined wavelength and power.

27. A method as defined in claim 23, wherein the penetrable portion comprises an elastomeric portion.

28. A method as defined in claim 23, further comprising the steps of providing the penetrable portion with a base portion comprising a first material compatible with the substance and defining a substance-exposed surface in fluid communication with the chamber, the base portion being penetrable by the filling or injection member for introducing the substance into the chamber;

and providing a resealing portion overlying the base portion comprising a second material that upon said transmitting of the energy or radiation, hermetically seals the aperture and the substance within the chamber.

29. A method as defined in claim 28, wherein the first material is substantially infusible by the energy or radiation.

30. A method as defined in claim 23, wherein the energy or radiation comprises laser energy or radiation.

31. A container comprising a body and a penetrable and hermetically resealable portion, wherein the body defines an empty chamber sealed with respect to ambient atmosphere and in fluid communication with the penetrable and hermetically resealable portion for receiving therein a substance, wherein the penetrable and hermetically resealable portion is penetrable by a filling or injection member to form a penetration aperture therethrough for at least one of introducing a substance into and withdrawing a substance out of the chamber, and the body further defines a generally diabolo shape defining a base, a mid-portion, and an upper portion axially spaced from the base on an opposite side of the mid-portion relative to the base, wherein each of the base and upper portion define a laterally-extending dimension greater than a maximum laterally-extending dimension of the mid-portion, and the mid-portion defines an axial extent that is greater than an axial extent of the base.

32. A container as defined in claim 31, wherein the penetrable and hermetically resealable portion is hermetically resealable by transmitting energy or radiation to the penetrable and hermetically resealable portion and forming a substantially gas-tight seal between the ambient atmosphere and the chamber.

33. A container as defined in claim 31, wherein the penetration aperture of the penetrated penetrable and hermetically resealable portion is hermetically resealable by transmitting radiation or energy to the penetrable and hermetically resealable portion.

34. A container as defined in claim 33, wherein the radiation or energy comprises laser radiation or laser energy.

35. A container as defined in claim 31, wherein the sealed empty chamber is sterilized.

36. A container as defined in claim 31, wherein the penetrable and hermetically resealable portion is over-molded to the body.

37. A container as defined in claim 32, wherein the energy or radiation comprises laser radiation or laser energy.

38. A container comprising:

a body defining a generally diabolo shape defining a base, a mid-portion, and an upper portion axially spaced from the base on an opposite side of the mid-portion relative to the base, wherein each of the base and upper portion define a laterally-extending dimension greater than a maximum laterally-extending dimension of the mid-portion, and the mid-portion defines an axial extent that is greater than an axial extent of the base, and further defining a chamber for receiving therein a substance;

a substance within the chamber; and

a resealable portion having a penetration aperture formed therethrough by a filling or injection member, the resealable portion comprising a base portion comprising a first material compatible with the substance and defining a substance-exposed surface in fluid communication with the chamber and a resealing portion overlying the base portion comprising a second material that upon the transmitting of energy or radiation thereto at least one of (i) hermetically seals the aperture and the substance within the chamber, and (ii) forms a gas-tight seal between the ambient atmosphere and the chamber.

39. The container as defined in claim 38, wherein the first material is substantially infusible by the energy or radiation.

40. A container as defined in claim 38, wherein the radiation or energy comprises laser radiation or energy.

41. A container as defined in claim 38, wherein the resealable portion is over-molded to the body.