Sealed containers and methods of making and filling same

• US 7,100,646 B2
• Filed: 09/03/2003
• Issued: 09/05/2006
• Est. Priority Date: 02/11/2000
• Status: Expired due to Term

• Current Assignee: Medinstill Development, LLC
• Original Assignee: Medical Instill Technologies Inc.
• Inventors: Py, Daniel, Assion, Norbert M.
• Primary Examiner(s): Maust, Timothy L.
• Application Number:
  US10/655,455
• Publication Number:
  US 20040141886A1
• Time in Patent Office: 1,098 Days
• Field of Search: 141/82, 141/164, 141/165, 141/234, 141/237, 141/238, 141/329, 141/330, 604411-415, 215/247, 215/227, 215/364, 206/204, 435/300.1, 435/301.1, 220/363
• US Class Current: 141/329
• 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. 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 the mid-portion defines an axial extent that is greater than an axial extent of the base and of the upper portion;

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 and a cover overlying the stopper.

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, wherein the cover defines:

a tamper-resistant portion extending 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, wherein the cover defines a tamper-resistant portion fixedly secured to the vial body and overlying the stopper.

11. A vial assembly as recited in claim 1, wherein the stopper includes a heat resealable portion overlying a substantially infusible portion.

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 preventing axial movement of the vial relative thereto.

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.

10. 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 the mid-portion defines an axial extent that is greater than an axial extent of the base;

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; and

a tamper-resistant portion extending over the stopper for preventing unnoticeable removal of the stopper;

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 received in the annular recess.

12. 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 the mid-portion defines an axial extent that is greater than an axial extent of the base; 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;

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 is 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.

22. An assembly comprising:

a vial including 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, end the mid-portion defines an axial extent that is greater than an axial extent of the base; and

a stopper received within the opening and penetrable by a needle or like member for at least one of introducing a substance into, and withdrawing the substance from, the chamber;

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 preventing axial movement of the vial relative thereto; and

a filling assembly 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 filling assembly, filling the vials through the needles, and withdrawing the needles from the filled vials.

23. An assembly as recited in claim 22, wherein the filling assembly 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 filling assembly further comprises a plurality of optical sensors, wherein each sensor is mounted adjacent to a respective laser optic assembly 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 tat 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.

27. 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 the mid-portion defines an axial extent that is greater than a an axial extent of the base and of the upper portion;

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 and a second means for covering the first means.

28. A vial assembly as recited in claim 27, wherein the first means is defined by a stopper.

29. A vial assembly as recited in claim 28, wherein the stopper is heat-resealable.

30. A vial assembly as recited in claim 27, 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.

31. A vial assembly claim 30, wherein the base, mid-portion and upper portion define an approximate diabolo shape.

32. A vial assembly as recited in claim 27, wherein the first means is defined by a stopper including a heat resealable portion overlying a substantially infusible portion.

33. A vial assembly as recited in claim 27, in combination with at least one filling needle movable relative to the vial assembly for penetrating the first means 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.

34. A vial assembly comprising:

a body a vial including 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 the mid-portion defines an axial extent that is greater than a an axial extent of the base; 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,

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) second 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 (iii) third 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.

35. A vial assembly as recited in claim 34, wherein the second 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.

36. A vial assembly as recited in claim 34, wherein the third 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 farmed 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.

37. A vial assembly as recited in claim 34, wherein the needle penetration region of the stopper is formed of a thermoplastic consisting essentially of a styrene block copolymer and an olefin.

38. A vial assembly as recited in claim 34, wherein the ratio of the styrene block copolymer to the olefin is within the range of about 50:

50 by weight to about 90;

5 by weight.

39. A vial assembly comprising:

a body a vial including 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 the mid-portion defines an axial extent that is greater than a an axial extent of the base;

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, end withdrawing the substance from, the chamber and;

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 preventing axial movement of the vial relative thereto.

40. An assembly as recited in claim 39, further comprising a filling assembly 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 filling assembly, filling the vials through the needles, and withdrawing the needles from the filled vials.

41. An assembly as recited in claim 40, wherein the filling assembly 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.

42. An assembly as recited in claim 41, 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.