Resealable containers and assemblies for filling and resealing same

• US 7,726,357 B2
• Filed: 10/31/2007
• 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:
  US11/933,272
• Publication Number:
  US 20080053565A1
• Time in Patent Office: 944 Days
• Field of Search: 141/11, 141/59, 141/69, 141/82, 141/285, 141/329, 215/247, 215/274, 215/280, 215/355, 534/40, 534/42, 534/71, 534/77, 534/78, 534/67, 604/256, 604/414, 604/415, 604/537
• US Class Current: 141/69
• 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. An assembly, comprising:

a device defining a chamber, and including a resealable portion for sealing a predetermined substance within the chamber, wherein the resealable portion includes;

a body defining a predetermined wall thickness, a penetrable region that is penetrable by a filling member and is heat resealable to hermetically seal an aperture therein by applying laser radiation from a laser source at a predetermined wavelength and power thereto to form a gas-tight seal between the resealable portion and the substance in the chamber, wherein the penetrable region defines a predetermined color and opacity that (i) substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof, and (ii) that causes the laser radiation at the predetermined wavelength and power to hermetically seal the aperture in the penetrable region thereof in a predetermined time period;

a filling assembly including a filling member for penetrating the resealable portion and introducing a substance through the resealable portion and into the chamber;

a substance source coupled in fluid communication to the filling assembly for introducing the substance through the filling member and into the chamber; and

a laser source connectable in thermal communication with the resealable portion for applying laser radiation at the predetermined wavelength and power thereto.

2. An assembly as defined in claim 1, wherein at least one of:

(i) the filling member is a needle, (ii) the substance is a medicament, and (iii) the resealable portion is a stopper.

3. An assembly as defined in claim 1, wherein the body further defines an underlying portion formed of a first material compatible with the predetermined substance within the chamber and defining a substance-exposed surface exposed to the predetermined substance contained within the chamber, the underlying portion being penetrable by the filling member for introducing the predetermined substance into the chamber, wherein the penetrable region of the underlying portion is substantially infusible in response to the application of thermal energy from the laser source.

4. An assembly as defined in claim 1, further comprising a radiation source for sterilizing the penetrable region of the resealable portion prior to penetration thereof by the filling member.

5. An assembly as defined in claim 4, wherein the radiation source is a laser source.

6. An assembly as defined in claim 1, further comprising a first fluid passageway extending through the filling member for introducing the substance from the substance source through the filling member and into the chamber, and a second fluid passageway for allowing fluid to flow out of the chamber upon introducing the substance from the first fluid passageway into the chamber.

7. An assembly as defined in claim 1, further comprising a scaled, empty device ready for filling in the filling assembly, wherein the sealed, empty device defines an opening and a resealable member covering the opening.

8. An assembly as defined in claim 1, wherein the body further defines an underlying portion formed of a first material compatible with the predetermined substance within the chamber and defining a substance-exposed surface exposed to the predetermined substance contained within the chamber, the underlying portion being penetrable by the filling member for introducing the predetermined substance into the chamber.

9. As assembly as defined in claim 8, wherein the underlying portion does not have said color and opacity.

10. A resealable member for sealing a predetermined substance within a device, wherein the device is usable in a filling assembly including a filling member for penetrating the resealable member and introducing a substance therethrough and into the device, a substance source coupled in fluid communication with the filling member for introducing the substance through the filling member and into the device, and a laser source connectable in thermal communication with the resealable member, wherein the resealable member comprises:

a body defining a predetermined wall thickness, a penetrable region that is penetrable by the filling member and is heat resealable to hermetically seal an aperture therein by applying laser radiation from the laser source at a predetermined wavelength and power thereto, wherein the penetrable region defines a predetermined color and opacity that (i) substantially absorbs the laser radiation at the predetermined wavelength and substantially prevents the passage of the radiation through the predetermined wall thickness thereof and (ii) that causes the laser radiation at the predetermined wavelength and power to hermetically seal the aperture formed in the penetrable region thereof in a predetermined time period to, in turn, seal the substance in the device from the ambient atmosphere.

11. A resealable member as defined in claim 10, wherein at least one of:

(i) the filling member is a needle, (ii) the substance is a medicament, and (iii) the resalable member is a stopper.

12. A resealable member as defined in claim 10, wherein the body further defines an underlying portion formed of a first material compatible with the predetermined substance within the device and defining a substance-exposed surface exposed to the predetermined substance contained within the device, and wherein a penetrable region of the underlying portion is substantially infusible in response to the application of thermal energy.

13. A resealable member as defined in claim 10, wherein the body further defines an underlying portion formed of a first material compatible with the predetermined substance within the device and defining a substance-exposed surface exposed to the predetermined substance contained within the device.

14. A resealable member as defined in claim 13, wherein the underlying portion does not have said color and opacity.

15. An assembly, comprising:

a device defining a chamber, and including a resealable portion for sealing a predetermined substance within the chamber, wherein the resealable portion includes;

(i) a body defining a predetermined wall thickness, wherein the body defines a penetrable region that is penetrable by a filling member and is heat resealable to hermetically seal an aperture therein by applying laser radiation from a laser source at a predetermined wavelength and power thereto, (ii) first means for substantially absorbing laser radiation at the predetermined wavelength and substantially preventing the passage of the radiation through the predetermined wall thickness thereof, and (ii) second means for causing laser radiation at the predetermined wavelength and power to hermetically seal the aperture formed in the penetrable region thereof in a predetermined time period;

a filling assembly including a filling member for penetrating the resealable member and introducing a substance through the resealable member and into the chamber;

a substance source coupled in fluid communication to the filling member for introducing substance through the filling member and into the chamber; and

a laser source connectable in thermal communication with the resealable member for applying laser radiation at the predetermined wavelength and power thereto.

16. An assembly as defined in claim 15, wherein at least one of:

(i) the filling member is a needle, (ii) the substance is a medicament, (iii) and the resealable portion is a stopper.

17. An assembly as defined in claim 15, further comprising a first fluid passageway extending through the filling member for introducing the substance from the substance source through the filling member and into the chamber, and a second fluid passageway for allowing fluid to flow out of the chamber upon introducing the substance from the first fluid passageway into the chamber.

18. A resealable member for sealing a predetermined substance within a device, wherein the device is usable in a filling assembly including a filling member for penetrating the resealable member and introducing a substance therethrough and into the device, a substance source coupled in fluid communication with the filling member for introducing the substance through the filling member and into the device, and a laser source connectable in thermal communication with the resealable member, wherein the resealable member comprises:

(i) a body defining a predetermined wall thickness, wherein the body defines a penetrable region that is penetrable by the filling member and is heat resealable to hermetically seal an aperture therein by applying laser radiation from the laser source at a predetermined wavelength and power thereto, (ii) first means for substantially absorbing laser radiation at the predetermined wavelength and substantially preventing the passage of radiation through the predetermined wall thickness thereof, and (ii) second means for causing laser radiation at the predetermined wavelength and power to hermetically seal the aperture in the penetrable region in a predetermined time period to, in turn, seal the substance in the device from the ambient atmosphere.

19. A resealable member as defined in claim 18, wherein the first means is defined by the penetrable region having a predetermined color and opacity that substantially absorbs laser radiation at the predetermined wavelength and substantially prevents the passage of said laser radiation through the predetermined wall thickness thereof.

20. A resealable member as defined in claim 18, wherein the second means is defined by the penetrable region having a predetermined color and opacity that causes laser radiation at the predetermined wavelength and power to hermetically seal the aperture formed in the penetrable region thereof in a predetermined time period.

21. A resealable member as defined in claim 18, further comprising means for insulating the substance in the device from the laser energy to thereby avoid thermal damage to the substance.

22. A resealable member as defined in claim 18, wherein at least one of(i) the device is a vial, (ii) the filling member is a needle, (iii) the substance is a medicament, and (iv) the resalable member is a stopper.