Sealed containers and methods of filling and resealing same

• US 7,992,597 B2
• Filed: 06/01/2010
• Issued: 08/09/2011
• Est. Priority Date: 02/11/2000
• Status: Expired due to Fees

• Current Assignee: Medical Instill Technologies Inc.
• Original Assignee: Medical Instill Technologies Inc.
• Inventors: Assion, Norbert M., Py, Daniel
• Primary Examiner(s): Maust; Timothy L
• Application Number:
  US12/791,629
• Publication Number:
  US 20100236193A1
• Time in Patent Office: 434 Days
• Field of Search: 141/2, 141/11, 141/18, 141/69, 141/83, 141/94, 141/129, 141/130, 141/329, 141/330, 531/11.R, 531/27, 534/25, 534/26, 534/28, 534/40, 604/414, 604/415, 604/256, 604/537
• US Class Current: 141/2
• 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 container and method for filling same. The container includes a thermally resealable portion that is fusible in response to thermal energy, and a container body having a sealed empty chamber in fluid communication with the 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 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 axial movement of the body, and applying thermal energy to the resealable portion to thermally fuse the penetrated region thereof.

Claims

1. A method comprising the following steps:

providing a container including a container body, a resealable portion sealable in response to the application of energy thereto, wherein the body defines an empty chamber sealed with respect to ambient atmosphere, and in fluid communication with the resealable portion 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;

penetrating the resealable portion with an injection member coupled in fluid communication with a source of predetermined substance;

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

withdrawing the injection member from the resealable portion;

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; and

applying sufficient energy to the resealable portion to seal the penetrated region and form a substantially gas-tight seal between the penetrated region and the chamber.

2. A method as recited in claim 1, further comprising the step of engaging the support and the upper portion of the container during withdrawal of the injection member to further prevent axial movement of the body.

3. A method as defined in claim 1, wherein the container support further includes an upper surface located on one side of the mounting surface, and a lower surface located on another side of the mounting surface.

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

5. A method as recited in claim 4, wherein the step of sterilizing the empty chamber prior to introducing the predetermined substance includes at least one of applying gamma radiation, e-beam radiation or laser radiation thereto.

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

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

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

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

10. A method as recited in claim 9, wherein the assembly of the container body and resealable portion occurs prior to installing the container body/ resealable portion assembly in a molding apparatus.

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

12. 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 injection member at an acute angle relative to the other defining an injection member penetration axis through the resealable portion oriented at an acute angle relative to the axis of the container.

13. A method as recited in claim 12, 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.

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

15. A method as defined in claim 1, further comprising the step of supporting the container with a container support including a support surface in engagement with the mid-portion of the container.

16. A method as defined in claim 1, wherein the resealable portion is thermally resealable in response to laser radiation.

17. 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 thermoplastic portion in fluid communication with the body and defining a penetrable region that is penetrable by a filling member and is resealable to hermetically seal an aperture therein by applying energy at a predetermined wavelength and power thereto;

penetrating the penetrable region of the thermoplastic portion with a filling member such that the filling member is in fluid communication with the sealed empty chamber;

introducing the substance through the filling member and into the chamber;

withdrawing the filling member from the thermoplastic portion; and

transmitting energy at the predetermined wavelength and power onto an aperture formed in the penetrable region of the thermoplastic portion, and hermetically sealing the aperture and the substance within the chamber.

18. A method as defined in claim 17, further comprising the step of over-molding the thermoplastic portion to the container body.

19. A method as defined in claim 18, further comprising the step of over-molding a base to the body.