Resealable containers and methods of making, filling and resealing same

• US 9,051,064 B2
• Filed: 05/28/2010
• Issued: 06/09/2015
• 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:
  US12/789,565
• Publication Number:
  US 20100236659A1
• Time in Patent Office: 1,838 Days
• Field of Search: 141/11, 141/59, 141/69, 141/82, 141/285, 141/329, 215/247, 215/274, 215/280, 215/355, 534/40, 534/42, 534/71, 534/77, 534/78, 534/67, 604/256, 604/414, 604/415, 604/537
• US Class Current: 1/1
• 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

Disclosed is a uniquely configured medicament vial assembly which includes a storage vial, a stopper member and a securing ring. The vial assembly is configured to improve healthcare worker safety by providing a shielded gripping location to aid in the reduction of accidental needle sticks. The storage vial has a body portion which defines an interior chamber for storing a predetermined medicament and a neck portion through which medicament is received into and withdrawn from the interior chamber. The stopper member is inserted into the mouth of the vial and establishes a first seal. The securing ring is engaged with the mouth of the vial and adapted and configured for retaining the stopper member within the vial mouth and effectuating a second seal. The securing ring is formed from a thermoplastic and/or elastic material. Preferably, the securing ring is formed by molding the thermoplastic and/or elastic material over a portion of the storage vial and stopper member when engaged within the vial mouth.

Claims

1. An assembly, comprising:

a device defining a chamber containing a substance therein and sealable with respect to ambient atmosphere and a penetrable portion in fluid communication with the chamber, the penetrable portion having a penetrated portion containing a penetration aperture formed therein by a filling or injection member penetrating through the penetrable portion for introducing the substance into the chamber; and

a covering portion attached to the device and having a configuration such that it is covering the penetrated portion and engaging the penetrable portion at least one of (a) at the penetration aperture;

(b) contiguous to the penetration aperture; and

(c) directly adjacent to the penetration aperture around an entirety of the penetration aperture, and thereby at least one of (i) hermetically sealing the penetrated portion from the ambient atmosphere;

(ii) hermetically sealing the substance within the chamber, and (iii) forming a gas-tight seal between the ambient atmosphere and the chamber.

2. An assembly as defined in claim 1, wherein the penetrable portion is defined by an elastomeric portion sufficiently resilient to close upon itself after withdrawal of the filling member to thereby maintain the device in a sealed condition prior to covering the penetrated portion with the covering portion.

3. An assembly as defined in claim 1, wherein the covering portion includes a frangible portion that is removable prior to use of the device to remove the substance from the chamber.

4. An assembly as defined in claim 1, wherein the covering portion forms a MVT barrier between the chamber and ambient atmosphere.

5. An assembly as defined in claim 1, wherein the chamber is sterile.

6. An assembly as defined in claim 1, wherein the penetrable portion is configured and adapted to be resealable to hermetically seal the aperture therein by applying radiation or energy thereto.

7. An assembly as defined in claim 1, further comprising:

a filling assembly including a filling or injection member for penetrating the penetrable portion and introducing a substance through the penetrable portion and into the chamber; and

a substance source coupled in fluid communication with the filling assembly for introducing the substance through the filling or injection member and into the chamber.

8. An assembly as defined in claim 1, wherein the penetrable portion comprises a base portion comprising a first material compatible with the substance and defining a substance-exposed surface in fluid communication with the chamber, and further comprising a resealing portion overlying the base portion comprising a second material that upon the transmitting of radiation or energy thereto at least one of (i) hermetically seals the penetrated portion from the ambient atmosphere;

(ii) hermetically seals the substance within the chamber, and (iii) forms a gas-tight seal between the ambient atmosphere and the chamber.

9. An assembly as defined in claim 1, wherein the filling or injection member comprises a needle.

10. An assembly as defined in claim 1, wherein the substance comprises at least one of a liquid and a medicament.

11. An assembly as defined in claim 1 wherein the covering portion at least one of (i) compresses the penetrable portion and (ii) forms an interference fit with the penetrable portion.

12. An assembly as defined in claim 11, wherein the penetrable portion is defined by an elastomeric portion sufficiently resilient to close upon itself after withdrawal of the filling member to thereby maintain the device in a sealed condition prior to covering the penetrated portion with the covering portion.

13. An assembly as defined in claim 11, wherein the covering portion forms a MVT barrier between the chamber and ambient atmosphere.

14. An assembly as defined in claim 11, wherein the chamber is sterile.

15. An assembly as defined in claim 11, further comprising:

a filling assembly including a filling or injection member for penetrating the penetrable portion and introducing a substance through the penetrable portion and into the chamber; and

a substance source coupled in fluid communication with the filling assembly for introducing the substance through the filling or injection member and into the chamber.

16. An assembly as defined in claim 1, wherein the penetrable portion defines a substantially planar external surface.

17. An assembly as defined in claim 1, wherein the penetrable portion defines a generally curved or domed shape.

18. An assembly as defined in claim 11, wherein the covering portion compresses the penetrable portion.

19. An assembly as defined in claim 1, wherein the covering portion is engaging the penetrable portion at the penetration aperture.

20. An assembly as defined in claim 1, wherein the covering portion is engaging the penetrable portion contiguous to the penetration aperture.

21. An assembly as defined in claim 6, wherein the penetrable portion includes a body defining a predetermined wall thickness, a penetrable region that is penetrable by the filling or injection member and is heat resealable to hermetically seal the aperture therein by applying the radiation or energy from a radiation or energy source at a predetermined wavelength and power thereto to form a gas-tight seal between the ambient atmosphere and the substance in the chamber, wherein the penetrable region defines a predetermined color and opacity that (i) substantially absorbs the radiation or energy at the predetermined wavelength and substantially prevents the passage of the radiation or energy through the predetermined wall thickness thereof, and (ii) that causes the radiation or energy at the predetermined wavelength and power to hermetically seal the aperture in the penetrable region thereof in a predetermined time period.

22. An assembly as defined in claim 21, wherein the assembly further comprises a radiation or energy source connectable in thermal communication with the resealable portion for applying radiation or energy at the predetermined wavelength and power thereto.

23. An assembly as defined in claim 21, wherein the radiation or energy comprises laser radiation or energy.

24. An assembly as defined in claim 6, wherein the radiation or energy comprises laser radiation or laser energy.

25. An assembly as defined in claim 6, wherein at least a portion of the aperture is resealed.

26. An assembly as defined in claim 25, wherein the at least a portion of the aperture is laser resealed.

27. The container as defined in claim 8, wherein the first material is substantially infusible by the energy or radiation.

28. A method comprising the following steps:

sterilizing a sealed, empty device defining a chamber sealed with respect to ambient atmosphere and a penetrable portion in fluid communication with the sterile chamber;

penetrating the penetrable portion with a filling or injection member coupled in fluid communication with a source of a substance and forming a penetrated portion of the penetrable portion containing a penetration aperture formed therein;

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

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

covering the penetrated portion with a covering portion such that the covering portion is attached to the device and engaging the covering portion against the penetrable portion at least one of (a) at the penetration aperture;

(b) contiguous to the penetration aperture; and

(c) directly adjacent the penetration aperture around an entirety of the penetration aperture, and thereby at least one of (i) hermetically sealing the penetrated portion from the ambient atmosphere;

(ii) hermetically sealing the substance within the chamber, and (iii) forming a gas-tight seal between the ambient atmosphere and the chamber.

29. A method as defined in claim 28, wherein the penetrable portion is defined by an elastomeric portion sufficiently resilient to close upon itself after withdrawal of the filling or injection member to thereby maintain the device in a sealed condition between the withdrawing and covering steps.

30. A method as defined in claim 28, wherein the sterilizing step includes transmitting radiation onto the penetrable portion.

31. A method as defined in claim 28, wherein the sterilizing step includes achieving an approximately 6 log reduction in bio-burden on the elastomeric penetrable portion.

32. A method as defined in claim 28, further comprising performing the sterilizing step within a cycle time of approximately 0.5 second.

33. A method as defined in claim 28, further comprising the step of introducing substance through a first fluid passageway of the filling or injection member, and allowing fluid to flow out of the chamber of the device through a second fluid passageway upon introducing substance from the first fluid passageway into the chamber.

34. A method as defined in claim 28, wherein the filling or injection member comprises a needle.

35. A method as defined in claim 28, wherein the device is a vial and the penetrable portion is defined by a resealable stopper.

36. A method as defined in claim 28, wherein the substance comprises at least one of a liquid and a medicament.

37. A method as defined in claim 28, wherein the covering portion comprises at least one of (i) a cover;

and (ii) a cover layer.

38. A method as defined in claim 28, wherein the penetrable portion is resealable by applying radiation or energy thereto, and further comprising the step of applying radiation or energy thereto.

39. A method as defined in claim 38, wherein the step of applying radiation or energy comprises applying laser radiation or energy.

40. A method as defined in claim 28, wherein the penetrable portion comprises a base portion comprising a first material compatible with the substance and defining a substance-exposed surface in fluid communication with the chamber, and further comprising the step of providing a resealing portion overlying the base portion comprising a second material that upon the transmitting of radiation or energy thereto at least one of (i) hermetically seals the penetrated portion from the ambient atmosphere;

(ii) hermetically seals the substance within the chamber, and (iii) forms a gas-tight seal between the ambient atmosphere and the chamber.

41. A method as defined in claim 40, wherein the first material is substantially infusible by the radiation or energy.

42. A method as defined in claim 40, further comprising the step of transmitting radiation or energy to the resealing portion.

43. A method as defined in claim 42, wherein the step of transmitting radiation or energy comprises transmitting laser radiation or energy.

44. A method as defined in claim 28, wherein the covering step further comprises at least one of (i) compressing the penetrable portion and (ii) forming an interference fit with the penetrable portion.

45. A method as defined in claim 44, wherein the penetrable portion is defined by an elastomeric portion sufficiently resilient to close upon itself after withdrawal of the filling member to thereby maintain the device in a sealed condition prior to covering the penetrated portion with the covering portion.

46. A method as defined in claim 38, wherein the penetrable portion includes a body defining a predetermined wall thickness that substantially absorbs laser radiation or energy at a predetermined wavelength and power and substantially prevents the passage of the radiation or energy therethrough, and a penetrable region that is penetrable with the filling or injection member and that defines a predetermined color and opacity that substantially absorbs the laser radiation or energy at the predetermined wavelength and power to hermetically seal an aperture therein formed by the filling or injection member, and the method further comprises the following steps:

applying laser radiation or energy from a laser source at the predetermined wavelength and power to the penetrable region of the body;

substantially absorbing within the penetrable region of the body the laser radiation or energy at the predetermined wavelength and power and substantially preventing the passage of the radiation or energy through the predetermined wall thickness of the body; and

hermetically sealing the aperture in the penetrable region of the body with the laser radiation or energy within a predetermined time period.

47. A method as defined in claim 46, further comprising the step of using the body to insulate the substance in the chamber from the laser radiation or energy applied by the laser source to avoid damage to the substance in the chamber.

48. A method of making an assembly that comprises a device defining a chamber containing a substance therein and sealable with respect to ambient atmosphere and a penetrable portion in fluid communication with the chamber, the penetrable portion having a penetrated portion containing a penetration aperture formed therein by a filling or injection member penetrating through the penetrable portion for introducing the substance into the chamber, and a covering portion attached to the device and having a configuration such that it is covering the penetrated portion and engaging the penetrable portion at least one of (a) at the penetration aperture;

(b) contiguous to the penetration aperture; and

(c) directly adjacent to the penetration aperture around an entirety of the penetration aperture, and thereby at least one of (i) hermetically sealing the penetrated portion from the ambient atmosphere;

(ii) hermetically sealing the substance within the chamber, and (iii) forming a gas-tight seal between the ambient atmosphere and the chamber, the method comprising the following steps;

sterilizing a sealed, empty device defining a chamber sealed with respect to ambient atmosphere and a penetrable portion in fluid communication with the sterile chamber;

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

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

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

covering the penetrated portion with a covering portion and engaging the covering portion against the penetrable portion at least one of (a) at the penetrated portion;

(b) contiguous to the penetration aperture; and

(c) directly adjacent to the penetrated portion and thereby at least one of (i) hermetically sealing the penetrated portion from the ambient atmosphere;

(ii) hermetically sealing the substance within the chamber, and (iii) forming a gas-tight seal between the ambient atmosphere and the chamber.

49. A method as defined in claim 48, wherein the penetrable portion is defined by an elastomeric portion sufficiently resilient to close upon itself after withdrawal of the filling or injection member to thereby maintain the device in a sufficiently sealed condition between the withdrawing and covering steps.

50. A method as defined in claim 48, wherein the sterilizing step includes transmitting radiation onto the penetrable portion.

51. A method as defined in claim 48, wherein the sterilizing step includes achieving an approximately 6 log reduction in bio-burden on the elastomeric penetrable portion.

52. A method as defined in claim 48, further comprising performing the sterilizing step within a cycle time of approximately 0.5 second.

53. A method as defined in claim 48, further comprising the step of introducing substance through a first fluid passageway of the filling or injection member, and allowing fluid to flow out of the chamber of the device through a second fluid passageway upon introducing substance from the first fluid passageway into the chamber.

54. A method as defined in claim 48, wherein the filling or injection member comprises a needle.

55. A method as defined in claim 48, wherein the device is a vial and the penetrable portion is defined by a resealable stopper.

56. A method as defined in claim 48, wherein the substance comprises at least one of a liquid and a medicament.

57. A method as defined in claim 48, wherein the covering portion comprises at least one of (i) a cover;

and (ii) a cover layer.

58. A method as defined in claim 48, wherein the penetrable portion is resealable by applying radiation or energy thereto, and further comprising the step of applying radiation or energy thereto.

59. A method as defined in claim 58, wherein the penetrable portion includes a body defining a predetermined wall thickness that substantially absorbs laser radiation or energy at a predetermined wavelength and power and substantially prevents the passage of the radiation or energy therethrough, and a penetrable region that is penetrable with the filling or injection member and that defines a predetermined color and opacity that substantially absorbs the laser radiation or energy at the predetermined wavelength and power to hermetically seal an aperture therein formed by the filling or injection member, and the method further comprises the following steps:

applying laser radiation or energy from a laser source at the predetermined wavelength and power to the penetrable region of the body;

substantially absorbing within the penetrable region of the body the laser radiation or energy at the predetermined wavelength and power and substantially preventing the passage of the radiation or energy through the predetermined wall thickness of the body; and

hermetically sealing the aperture in the penetrable region of the body with the laser radiation or energy within a predetermined time period.

60. A method as defined in claim 59, further comprising the step of using the body to insulate the substance in the chamber from the laser radiation or energy applied by the laser source to avoid damage to the substance in the chamber.

61. A method as defined in claim 58, wherein the step of applying radiation or energy comprises applying laser radiation or energy.

62. A method as defined in claim 48, wherein the penetrable portion comprises a base portion comprising a first material compatible with the substance and defining a substance-exposed surface in fluid communication with the chamber, and further comprising the step of providing a resealing portion overlying the base portion comprising a second material that upon the transmitting of radiation or energy thereto at least one of (i) hermetically seals the penetrated portion from the ambient atmosphere;

(ii) hermetically seals the substance within the chamber, and (iii) forms a gas-tight seal between the ambient atmosphere and the chamber.

63. A method as defined in claim 62, wherein the first material is substantially infusible by the radiation or energy.

64. A method as defined in claim 62, further comprising the step of transmitting radiation or energy to the resealing portion.

65. A method as defined in claim 64, wherein the step of transmitting radiation or energy comprises transmitting laser radiation or energy.

66. A method as defined in claim 48, wherein the engaging step includes engaging the covering portion at the penetration aperture.

67. A method as defined in claim 48, wherein the engaging step includes engaging the covering portion contiguous to the penetration aperture.