Device with needle penetrable and laser resealable portion and related method

• US 7,445,033 B2
• Filed: 07/16/2007
• Issued: 11/04/2008
• 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:
  US11/879,485
• Publication Number:
  US 20080066824A1
• Time in Patent Office: 477 Days
• Field of Search: 141/2, 141/11, 141/59, 141/82, 141/85, 141/285, 141/290, 141/329, 534/26, 534/73, 534/77, 534/89, 264/239, 264/250
• US Class Current: 141/2
• 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

Device and method 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 is pierceable with a needle to form a needle aperture therethrough to fill the chamber, and is laser resealable to hermetically seal the needle aperture by applying laser radiation. 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 during penetration by and withdrawal of the needle. The thermoplastic includes a predetermined amount of pigment that allows it 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:

molding a body defining a chamber under a flow of sterile filtered air;

molding a thermoplastic portion under a flow of sterile filtered air and in close proximity to the molding of the body, wherein the thermoplastic portion 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 at a predetermined wavelength and power thereto;

prior to allowing the thermoplastic portion and body to cool to an ambient temperature, assembling the thermoplastic portion and body and, in turn, forming a device defining a sterile chamber sealed with respect to ambient atmosphere;

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

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

withdrawing the filling member from the thermoplastic portion; and

transmitting laser radiation at the predetermined wavelength and power onto an aperture formed in the penetrable region of the thermoplastic portion, and hermetically sealing the aperture within a time period of less than about 2 seconds.

2. A method as defined in claim 1, wherein the flow of sterile filtered air defines a substantially laminar flow.

3. A method as defined in claim 1, wherein the assembly step includes assembling the body and thermoplastic portion at a bactericidal temperature.

4. A method as defined in claim 1, wherein the assembly step includes using an assembly fixture to bring a plurality of thermoplastic portions into engagement with a plurality of bodies, or a plurality of bodies into engagement with a plurality of thermoplastic portions.

5. A method as defined in claim 1, wherein the substance is at least one of a food product, a cosmetic product, and a medicament.