Device with needle penetrable and laser resealable portion and related method

• US 7,500,498 B2
• Filed: 10/31/2007
• Issued: 03/10/2009
• 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
• Primary Examiner(s): MAUST, TIMOTHY LEWIS
• Application Number:
  US11/933,300
• Publication Number:
  US 20080053561A1
• Time in Patent Office: 496 Days
• Field of Search: 141/1, 141/2, 141/11, 141/69, 141/85, 141/91, 141/92, 141/285, 141/329, 534/25, 534/26
• US Class Current: 141/11
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• 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 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: B29C 65/00 Joining or sealing of preformed parts , e.g. welding of plastics materials; Apparatus therefor general aspects of processes or apparatus for joining preformed parts B29C66/00; using porous material formed by internal pressure generated therein for joining preformed parts B29C44/1228, B29C44/326
• CPC Class Codes: B29C 65/16 Laser beams
• CPC Class Codes: B29C 65/1616 Near infrared radiation [NIR], e.g. by YAG lasers
• CPC Class Codes: B29C 65/1619 Mid infrared radiation [MIR], e.g. by CO or CO2 lasers
• CPC Class Codes: B29C 65/1654 scanning at least one of the parts to be joined
• CPC Class Codes: B29C 65/1677 making use of an absorber or impact modifier
• CPC Class Codes: B29C 65/18 using heated tools
• CPC Class Codes: B29C 66/001 Joining in special atmospheres
• CPC Class Codes: B29C 66/1222 comprising at least a lapped joint-segment
• CPC Class Codes: B29C 66/1224 comprising at least a butt joint-segment
• CPC Class Codes: B29C 66/12461 being rounded, i.e. U-shaped or C-shaped
• CPC Class Codes: B29C 66/1312 Single flange to flange joints, the parts to be joined being rigid the parts to be joined being flexible B29C66/133
• CPC Class Codes: B29C 66/342 Preventing air-inclusions
• CPC Class Codes: B29C 66/534 Joining single elements to open ends of tubular or hollow articles or to the ends of bars
• CPC Class Codes: B29C 66/5344 said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends B29C66/5346 takes precedence
• CPC Class Codes: B29C 66/542 : joining hollow covers or hollow bottoms to open ends of container bodies
• CPC Class Codes: B29C 66/612 : Making circumferential joints
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/73755 : the to-be-joined area of at least one of the parts to be joined being fully cured, i.e. fully cross-linked, fully vulcanized
• CPC Class Codes: B29C 66/7392 : characterised by the material of at least one of the parts being a thermoplastic
• CPC Class Codes: B29C 66/73921 : characterised by the materials of both parts being thermoplastics
• CPC Class Codes: B29C 66/7394 : characterised by the material of at least one of the parts being a thermoset
• CPC Class Codes: B29C 66/8322 : Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29C 67/004 : Closing perforations or small holes, e.g. using additional moulding material
• CPC Class Codes: B29K 2023/00 : Use of polyalkenes or derivatives thereof as moulding material
• CPC Class Codes: B29K 2025/08 : Copolymers of styrene, e.g. AS or SAN, i.e. acrylonitrile styrene B29K2055/02 takes precedence
• CPC Class Codes: B29L 2031/7158 : Bottles
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B65B 3/003 : Filling medical containers such as ampoules, vials, syringes or the like
• 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 device and method are provided for needle penetrating and filling a chamber with a predetermined substance, and laser resealing a resulting needle hole in the device. A needle penetrable and laser resealable portion of the device is pierceable with a needle to form a needle aperture therethrough to fill the chamber through the needle, and is laser resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto. The needle penetrable and laser resealable portion defines a predetermined wall thickness in an axial direction thereof, and includes a thermoplastic that substantially prevents the formation of particles released into the chamber from the needle penetrable and laser resealable portion during penetration by and withdrawal of the needle. The thermoplastic includes a predetermined amount of pigment that allows the thermoplastic to substantially absorb laser radiation at the predetermined wavelength, substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal a needle aperture formed in the needle penetration region thereof in a predetermined time period.

Claims

1. A method comprising the following steps:

providing a laser source that transmits laser radiation at a predetermined wavelength and power;

providing a sealed, empty device defining a sterile chamber sealed with respect to ambient atmosphere and a resealable portion in fluid communication with the sterile chamber, wherein the resealable portion includes a body defining a predetermined wall thickness that substantially absorbs the laser radiation at the predetermined wavelength and power and substantially prevents the passage of the radiation therethrough, and a penetrable region that is penetrable with a filling member and that defines a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and power to hermetically seal an aperture therein;

penetrating the penetrable region of the body with a filling member coupled in fluid communication with a source of a substance;

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

withdrawing the filling member from the penetrable region of the body;

applying laser radiation from the laser source at the predetermined wavelength and power to an aperture formed in the penetrable region of the body;

substantially absorbing within the penetrable region of the body the laser radiation at the predetermined wavelength and power and substantially preventing the passage of radiation through the predetermined wall thickness of the body; and

hermetically sealing the aperture in the penetrable region of the body with the laser radiation within a predetermined time period and, in turn, hermetically sealing the substance within the chamber of the device.

2. A method as defined in claim 1, further comprising the step of:

sterilizing the sealed empty device prior to penetrating the penetrable region of the body with the filling member.

3. A method as defined in claim 2, wherein the sterilizing step includes transmitting radiation onto the penetrable region of the body.

4. A method as defined in claim 1, further comprising the step of using the body to thermally insulate the substance in the chamber from the laser energy applied by the laser source to avoid thermal damage to the substance in the chamber.

5. A method as defined in claim 1, wherein the step of providing a resealable portion includes providing a body defining an underlying portion formed of a first material compatible with the predetermined substance and defining a substance-exposed surface exposed to the predetermined substance within the device;

and a resealable portion overlying the underlying portion, the resealable portion and underlying portion being penetrable by the filling member for introducing the predetermined substance through the resealable portion and into the chamber of the device, wherein the penetrable region of the underlying portion is substantially infusible in response to the application of thermal energy from the laser source, and the penetrable region of the resealable portion is fusible in response to the application of thermal energy from the laser source.

6. A method as defined in claim 2, wherein the sterilizing step includes achieving an approximately 6 log reduction in bio-burden on the penetrable region of the resealable portion.

7. A method as defined in claim 6, further comprising the step of sterilizing the penetrable region within a cycle time of approximately 0.5 seconds.

8. A method as defined in claim 1, further comprising the step of introducing substance through a first fluid passageway of the filling 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.

9. A method as defined in claim 1, wherein the filling member is a needle.

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

11. A method as defined in claim 1 wherein the substance is at least one of a liquid and a medicament.