Claims
- 1. A vial assembly for storing a substance, comprising:
a body defining an opening, a chamber in fluid communication with the opening for receiving therein the substance, 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 a stopper received within the opening and penetrable by a needle or like member for at least one of introducing the substance into, and withdrawing the substance from, the chamber.
- 2. A vial assembly as recited in claim 1, wherein each of the base, mid-portion and upper portion are approximately circular in cross section, and a maximum diameter of each of the base and upper portion is greater than a maximum diameter of the mid-portion.
- 3. A vial assembly as recited in claim 2, wherein the base, mid-portion and upper portion are substantially spool shaped.
- 4. A vial assembly as defined in claim 1, further comprising:
a tamper-resistant, substantially ring-shaped portion fixedly secured to the body and extending at least partially over the stopper for preventing unnoticeable removal of the stopper.
- 5. A vial assembly as defined in claim 4, wherein the tamper-resistant portion is thermally fused to the body.
- 6. A vial assembly as recited in claim 5, wherein the tamper-resistant portion is over-molded to the stopper and body.
- 7. A vial assembly as recited in claim 5, wherein the tamper-resistant portion is formed integral with the stopper, and the integral stopper and tamper-resistant portion is over-molded to the body.
- 8. A vial assembly as recited in claim 4, wherein the tamper-resistant portion defines a thermally-fused region forming a hermetic seal between the tamper-resistant portion and at least one of the body and stopper.
- 9. A vial assembly as recited in claim 1, further comprising a tamper-resistant portion fixedly secured to the vial body and completely overlying the stopper, wherein the stopper and tamper-resistant portion are penetrable by a needle for introducing a substance into the interior chamber of the vial, and the tamper-resistant portion is fusible in response to the application of thermal energy thereto for hermetically sealing any hole created in the tamper-resistant portion by the needle upon removal of the needle.
- 10. A vial assembly as recited in claim 4, wherein the stopper has an annular groove defined in an outer periphery thereof such that an annular recess is formed between the stopper and the body, and the tamper-resistant portion is at least partially formed in the annular recess.
- 11. A vial assembly as recited in claim 1, wherein the stopper includes a heat resealable portion overlying a substantially infusible portion.
- 12. A vial assembly as recited in claim 1, wherein the stopper is a thermoplastic stopper defining a needle penetration region that is pierceable with a needle to form a needle aperture therethrough, and is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, wherein the stopper comprises a thermoplastic body defining (i) a predetermined wall thickness in an axial direction thereof, (ii) a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof, and (iii) a predetermined color and opacity that causes the laser radiation at the predetermined wavelength and power to hermetically seal a needle aperture formed in the needle penetration region thereof in a predetermined time period of less than approximately 2 seconds and substantially without burning the needle penetration region.
- 13. A vial assembly as recited in claim 12, wherein the needle penetration region of the stopper is formed of a thermoplastic consisting essentially of a styrene block copolymer and an olefin.
- 14. A vial assembly as recited in claim 12, wherein the ratio of the styrene block copolymer to the olefin are within the range of about 50:50 by weight to about 90:5 by weight.
- 15. A vial assembly as recited in claim 12, wherein the predetermined wavelength is approximately 980 nm.
- 16. A vial assembly as recited in claim 12, wherein the predetermined power is less than approximately 30 Watts.
- 17. A vial assembly as recited in claim 16, wherein the predetermined power is less than or equal to about 10 Watts.
- 18. A vial assembly as recited in claim 12, wherein the predetermined color is gray.
- 19. A vial assembly as recited in claim 12, wherein the predetermined time period is less than about 1.5 seconds.
- 20. A vial assembly as recited in claim 12, wherein the predetermined wavelength is about 980 nm, the predetermined power is within the range of about 8 to 10 Watts, the predetermined color is gray, and the predetermined opacity is defined by a dark gray colorant additive within the range of about 0.3% to about 0.6% by weight.
- 21. A vial assembly as recited in claim 1, in combination with a vial support including a vial mounting surface engageable with the mid-portion of the vial, an upper surface located on one side of the mounting surface, and a lower surface located on another side of the mounting surface, wherein the upper portion of the vial is engageable with the upper surface of the vial support for substantially preventing axial movement of the vial relative thereto, and the base of the vial is engageable with the lower surface of the vial support for substantially prevent axial movement of the vial relative thereto.
- 22. An assembly as recited in claim 21, further comprising a filling module comprising a needle manifold including a plurality of needles spaced relative to each other and movable relative to the vial support for penetrating a plurality of vials mounted on the support within the module, filling the vials through the needles, and withdrawing the needles from the filled vials.
- 23. An assembly as recited in claim 22, wherein the module further comprises a plurality of laser optic assemblies, wherein each laser optic assembly is mounted adjacent to a respective needle, is connectable to a source of laser radiation, and is focused substantially on the penetration spot on a stopper of the respective needle for applying laser radiation thereto and resealing same.
- 24. An assembly as recited in claim 23, wherein the module further comprises a plurality of optical sensors, wherein each sensor is mounted adjacent to a respective laser optic and focused substantially on the laser resealed region of a stopper of the respective laser optic assembly, and generates signals indicative of the temperature of same.
- 25. An assembly as recited in claim 23, further comprising an e-beam port, a chamber receiving at least the portions of the needles that penetrate the stoppers and at least the surfaces of the stoppers that are penetrated by the needles, and an e-beam unit coupled to the e-beam port, wherein the e-beam unit transmits an e-beam into the chamber and onto surfaces of the needles and stoppers received within the chamber for sterilizing same.
- 26. A vial assembly as recited in claim 1, in combination with at least one filling needle movable relative to the vial assembly for penetrating the stopper, filling the chamber of the vial assembly through the needle, and withdrawing the needle from the filled vial assembly, and wherein at least one of the needle and an axis of the vial is oriented at an acute angle relative to the other.
- 27. A vial assembly as recited in claim 1, further comprising:
a tamper-resistant, substantially ring-shaped portion fixedly secured to the body, extending at least partially over the stopper for preventing unnoticeable removal of the stopper, and exposing a central portion of the stopper for penetrating same with a needle for removing substance from the chamber of the body; and a tamper-resistant cover overlying the ring-shaped portion and including a removable portion overlying an exposed central portion of the stopper, and a non-removable portion spaced laterally outwardly relative to the removable portion, wherein the removable portion is removable from the tamper-resistant cover to expose a portion of the stopper for penetrating same with a needle and removing substance from the chamber of the body therethrough, and the stopper defines a thermally resealed portion spaced laterally outwardly relative to the exposable portion of the stopper and underlying the non-removable portion of the tamper-resistant cover for substantially visually concealing same from a user.
- 28. A vial assembly for storing a substance, comprising:
a body defining an opening, a chamber in fluid communication with the opening for receiving therein the substance, 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 first means received within the opening for sealing the opening and being penetrable by a needle for at least one of introducing the substance into, and withdrawing the substance from, the chamber.
- 29. A vial assembly as defined in claim 28, further comprising:
second means fixedly secured to the first means and extending between the body and fist means for preventing unnoticeable removal of the first means.
- 30. A vial assembly as recited in claim 28, wherein the first means is defined by a stopper.
- 31. A vial assembly as recited in claim 30, wherein the stopper is heat-resealable.
- 32. A vial assembly as recited in claim 29, wherein the second means is thermally fused to at least one of the body and stopper.
- 33. A vial assembly as recited in claim 29, wherein the second means is a tamper-resistant ring.
- 34. A vial assembly as recited in claim 32, wherein the second means is over-molded to at least one of the first means and vial body.
- 35. A vial assembly as recited in claim 32, wherein the second means is formed integral with the first means and the integral first and second means is over-molded to the body.
- 36. A vial assembly as recited in claim 28,wherein each of the base, mid-portion and upper portion are approximately circular in cross section, and a maximum diameter of each of the base and upper portion is greater than a maximum diameter of the mid-portion.
- 37. A vial assembly as recited in claim 36, wherein the base, mid-portion and upper portion define an approximate diabolo shape.
- 38. A vial assembly as recited in claim 28, wherein the first means is a thermoplastic stopper defining a needle penetration region that is pierceable with a needle to form a needle aperture therethrough, and is heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, wherein the stopper comprises (i) a thermoplastic body defining a predetermined wall thickness in an axial direction thereof, (ii) third means for substantially absorbing the laser radiation at the predetermined wavelength and substantially preventing the passage of the radiation through the predetermined wall thickness thereof, and (ii) fourth means for causing the laser radiation at the predetermined wavelength and power to hermetically seal a needle aperture formed in the needle penetration region thereof in a predetermined time period of less than approximately 2 seconds and substantially without burning the needle penetration region.
- 39. A vial assembly as recited in claim 38, wherein the third means is defined by a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof.
- 40. A vial assembly as recited in claim 38, wherein the fourth means is defined by a predetermined color and opacity that causes the laser radiation at the predetermined wavelength and power to hermetically seal a needle aperture formed in the needle penetration region thereof in a predetermined time period of less than approximately 2 seconds and substantially without burning the needle penetration region.
- 41. A vial assembly as recited in claim 28, wherein the first means is defined by a stopper including a heat resealable portion overlying a substantially infusible portion.
- 42. A method comprising the following steps:
providing a vial including a body defining an opening, a chamber in fluid communication with the opening for receiving therein a predetermined substance, 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 a heat-resealable stopper fusible in response to the application of thermal energy thereto; prior to filling the vial with substance, assembling the stopper and vial and forming a substantially gas-tight seal between the stopper and vial; sterilizing the empty assembled stopper and vial; supporting the a vial with a vial support including mounting surface in engagement with the mid-portion of the vial, an upper surface located on one side of the mounting surface, and a lower surface located on another side of the mounting surface; penetrating the stopper with a needle coupled in fluid communication with a source of predetermined substance; introducing the predetermined substance through the needle and into the interior of the vial; withdrawing the needle from the stopper; and applying sufficient thermal energy to the penetrated region of the stopper to fuse the penetrated region and form a substantially gas-tight seal between the penetrated region and the interior of the vial.
- 43. A method as recited in claim 42, further comprising the steps of substantially preventing axial movement of the vial during needle penetration of the vial by engaging at least one of the upper surface of the vial support and the upper portion of the vial with the other.
- 44. A method as recited in claim 42, wherein the step of sterilizing the empty vial and stopper assembly includes at least one of applying gamma radiation, e-beam radiation or laser radiation thereto.
- 45. A method as recited in claim 42, wherein the step of assembling the stopper to the vial includes fusing a tamper-resistant portion between the stopper and vial.
- 46. A method as recited in claim 45, wherein the step of assembling the stopper to the vial includes over-molding the tamper-resistant portion to the stopper and vial.
- 47. A method as recited in claim 45, comprising the step of forming the tamper-resistant portion integral with the stopper and over-molding the integral stopper and tamper-resistant portion to the vial.
- 48. A method as recited in claim 42, comprising the steps of assembling the stopper and vial robotically and over-molding a tamper-resistant portion between the stopper and vial
- 49. A method as recited in claim 48, wherein the assembly of the vials and stoppers occurs prior to installing the vial/stopper assembly in the over-molding apparatus.
- 50. A method as recited in claim 48, wherein the vials and stoppers are assembled in an over-molding apparatus so that the step of over-molding the tamper-resistant portions can be achieved without further transportation of the vial/stopper assembly.
- 51. A method as recited in claim 42, further comprising the step of orienting at least one of an axis of the vial and an axis of the needle at an acute angle relative to the other defining a needle penetration axis through the stopper oriented at an acute angle relative to the axis of the vial.
- 52. A method as recited in claim 42, further comprising the step of introducing the substance through the needle at said acute angle and against a lateral wall of the body to facilitate substantially laminar flow of the substance into the vial.
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent application Ser. No. 10/393,966, filed Mar. 21, 2003, entitled “Medicament Vial Having A Heat-Sealable Cap, And Apparatus and Method For Filling The Vial”, which is a divisional of similarly titled U.S. patent application Ser. No. 09/781,846, filed Feb. 12, 2001, now U.S. Pat. No. 6,604,561, issued Aug. 12, 2003, which, in turn, claims the benefit of similarly titled U.S. Provisional Application Serial No. 60/182,139, filed on Feb. 11, 2000, and further, this application claims priority on U.S. Provisional Patent Application No. 60/408,068, filed Sep. 3, 2002, entitled “Sealed Containers And Methods Of Making And Filling Same”, each of which is hereby expressly incorporated by reference as part of the present disclosure.
Provisional Applications (2)
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Number |
Date |
Country |
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60182139 |
Feb 2000 |
US |
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60408068 |
Sep 2002 |
US |
Divisions (1)
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Number |
Date |
Country |
Parent |
09781846 |
Feb 2001 |
US |
Child |
10393966 |
Mar 2003 |
US |
Continuation in Parts (1)
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Number |
Date |
Country |
Parent |
10393966 |
Mar 2003 |
US |
Child |
10655455 |
Sep 2003 |
US |