Sealed containers and methods of filling and resealing same

• US 9,637,251 B2
• Filed: 01/30/2015
• Issued: 05/02/2017
• Est. Priority Date: 02/11/2000
• Status: Expired due to Fees

• Current Assignee: Medinstill Development, LLC
• Original Assignee: Medinstill Development, LLC
• Inventors: Py, Daniel, Assion, Norbert M.
• Primary Examiner(s): Maust, Timothy L
• Application Number:
  US14/610,016
• Publication Number:
  US 20150225094A1
• Time in Patent Office: 823 Days
• Field of Search: 141 11, 141 69, 141 82, 141329, 215247-249, 220363, 604411-415, 4353001-3011
• 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

A container and method for filling same. The container includes a penetrable and resealable portion that is resealable, and a container body having a sealed empty chamber in fluid communication with the penetrable and 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 penetrable and 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 upward movement of the body, and applying energy to the penetrable and resealable portion to form a gas-tight seal.

Claims

1. A method comprising the following steps:

filling a sealed, empty device defining a chamber sealed with respect to ambient atmosphere and a penetrable portion in fluid communication with the chamber, wherein the filling step comprises;

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

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 one or more of (a) at the penetration aperture;

(b) contiguous to the penetration aperture;

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

(ii) hermetically sealing the substance within the chamber;

or (iii) forming a gas-tight seal between the ambient atmosphere and the chamber.

2. A method 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 or injection member to thereby maintain the device in a sealed condition between the withdrawing and covering steps.

3. A method as defined in claim 1, 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.

4. A method as defined in claim 1, wherein the filling or injection member comprises a needle.

5. A method as defined in claim 1, wherein the device is a vial and the penetrable portion is defined by a resealable stopper.

6. A method as defined in claim 1, wherein the substance comprises one or more of a liquid or a medicament.

7. A method as defined in claim 1, wherein the covering portion comprises one or more of (i) a cover;

or (ii) a cover layer.

8. A method as defined in claim 1, wherein the penetrable portion is resealable by applying radiation or energy thereto, and further comprising the step of applying radiation or energy thereto.

9. A method as defined in claim 8, wherein the step of applying radiation or energy comprises applying laser radiation or energy.

10. A method 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 the step of providing a resealing portion overlying the base portion comprising a second material that upon the transmitting of radiation or energy thereto one or more of (i) hermetically seals the penetrated portion from the ambient atmosphere;

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

11. A method as defined in claim 10, wherein the first material is substantially infusible by the radiation or energy.

12. A method as defined in claim 10, further comprising the step of transmitting radiation or energy to the resealing portion.

13. A method as defined in claim 10, wherein the step of transmitting radiation or energy comprises transmitting laser radiation or energy.

14. A method as defined in claim 1, wherein the covering step further comprises one or more of (i) compressing the penetrable portion or (ii) forming an interference fit with the penetrable portion.

15. A method as defined in claim 14, 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.

16. A method as defined in claim 8, 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.

17. A method as defined in claim 16, 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.