Sealed containers and methods of making and filling same

• US 7,726,352 B2
• Filed: 09/01/2006
• Issued: 06/01/2010
• Est. Priority Date: 02/11/2000
• Status: Expired due to Fees

• Current Assignee: Medical Instill Technologies Inc.
• Original Assignee: Medical Instill Technologies Inc.
• Inventors: Py, Daniel, Assion, Norbert M.
• Primary Examiner(s): MAUST, TIMOTHY LEWIS
• Application Number:
  US11/515,162
• Publication Number:
  US 20070000573A1
• Time in Patent Office: 1,369 Days
• Field of Search: 141/2, 141/11, 141/18, 141/69, 141/83, 141/85, 141/94.129, 141/130, 141/329, 141/330, 534/25, 534/26, 534/28, 534/40, 534/71, 534/78, 604/256, 604/414, 604/415, 604/537
• 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

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 method comprising the following steps:

forming a container body defining a chamber in a first mold in a clean room environment;

forming, in a second mold in the same clean room environment as the first mold, a thermoplastic stopper defining a needle penetration region that is pierceable with a needle to form a needle aperture therethrough and heat resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto; and

assembling the stopper and container body in the clean room environment to form a container defining a sealed empty chamber.

2. A method as defined in claim 1, wherein the first and second molds are located side-by-side within the clean room environment.

3. A method as defined in claim 1, further comprising:

after the assembling step, filling the chamber while the stopper and container body are assembled.

4. A method comprising the following steps:

forming a container body defining a chamber in a first mold in a clean room environment;

forming a stopper in a second mold in the same clean room environment as the first mold, 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;

assembling the stopper and container body in the clean room environment to form a sealed empty container;

penetrating the needle penetration region of the stopper with a filling needle such that the filling needle is in fluid communication with the chamber of the container;

introducing a substance through the needle and into the chamber of the container;

withdrawing the filling needle from the stopper; and

transmitting laser radiation at the predetermined wavelength and power onto an aperture formed in the needle penetration region of the stopper, and hermetically sealing the aperture.

5. A method as defined in claim 4, further comprising the step of sterilizing the sealed empty container between the assembling and penetrating steps.

6. A method comprising the following steps:

forming a body defining a chamber in a first mold in a clean room environment;

forming, in a second mold in the same clean room environment as the first mold, a penetrable and thermally resealable portion that is formed of thermoplastic and defines a penetration region that is pierceable with an injection member to form a penetration aperture therethrough and is heat resealable to hermetically seal the penetration aperture by applying laser radiation at a predetermined wavelength and power thereto; and

assembling the penetrable and thermally resealable portion and body in the clean room environment to form an assembly defining a sealed empty chamber.

7. A method as defined in claim 6, wherein the first and second molds are located side-by-side within the clean room environment.

13. A method as defined in claim 6, further comprising the step of fusing a tamper-resistant portion between the penetrable and thermally resealable portion and body.

14. A method as defined in claim 6, further comprising the step of over-molding a tamper-resistant portion to the penetrable and thermally resealable portion and body.

17. A method as defined in claim 6, further comprising:

after the assembling step, filling the chamber while the penetrable and thermally resealable portion and body are assembled.

8. A method comprising the following steps:

forming a body defining a chamber in a first mold in a clean room environment;

forming a penetrable and thermally resealable portion in a second mold in the same clean room environment as the first mold, wherein the penetrable and thermally resealable portion is formed of thermoplastic and defines a penetration region that is pierceable with an injection member to form a penetration aperture therethrough, and is heat resealable to hermetically seal the penetration aperture by applying laser radiation at a predetermined wavelength and power thereto;

assembling the penetrable and thermally resealable portion and body in the clean room environment to form a sealed empty assembly;

penetrating the penetration region of the penetrable and thermally resealable portion with an injection member such that the injection member is in fluid communication with the chamber of the assembly;

introducing a substance through the injection member and into the chamber of the assembly;

withdrawing the injection member from the penetrable and thermally resealable portion; and

transmitting laser radiation at the predetermined wavelength and power onto an aperture formed in the penetrable and thermally resealable portion, and hermetically sealing the aperture.

9. A method as defined in claim 8, further comprising the following steps:

forming a body 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

engaging the base of the body with a support during the step of withdrawing the injection member and substantially preventing axial movement of the body relative thereto.

10. A method as defined in claim 9, further comprising the step of engaging the support and the upper portion of the body during withdrawal of the injection member to further prevent axial movement of the body.

11. A method as defined in claim 9, further comprising the step of sterilizing the empty assembly prior to introducing the substance therein.

12. A method as defined in claim 11, wherein the step of sterilizing the empty assembly prior to introducing the substance includes at least one of applying gamma radiation, e-beam radiation and laser radiation thereto.

15. A method as defined in claim 8, further comprising the step of orienting at least one of an axis of the body and an axis of the injection member at an acute angle relative to the other defining an injection member penetration axis through the penetrable and thermally resealable portion oriented at an acute angle relative to the axis of the body.

16. A method as defined in claim 15, further comprising the step of introducing the substance through the 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.