Device with Needle Penetrable and Laser Resealable Portion and Related Method

• US 20080072996A1
• Filed: 12/03/2007
• Published: 03/27/2008
• Est. Priority Date: 02/11/2000
• Status: Active Grant

• Current Assignee: Daniel Py
• Original Assignee: Daniel Py
• Inventors: Py, Daniel
• Granted Patent: US 7,490,639 B2
• Time in Patent Office: Days
• US Class Current: 141/329
• 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 defining a chamber for receiving a substance and a thermoplastic portion in fluid communication with the chamber is provided along with a method of filling and sealing the substance within the chamber. 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. The thermoplastic portion comprises a thermoplastic body defining a predetermined wall thickness and includes a styrene block copolymer, an olefin and a predetermined amount of pigment allowing the body to absorb laser radiation at the predetermined wavelength, substantially prevent the passage of radiation through the predetermined wall thickness, and hermetically seal the aperture in the penetrable region in a predetermined time period. The body includes a predetermined amount of lubricant that reduces friction forces at an interface of the filling member and body during penetration thereof.

Claims

1. A device defining a chamber for receiving a substance and a thermoplastic portion in fluid communication with the chamber, the thermoplastic portion defining 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, wherein the thermoplastic portion comprises a thermoplastic body defining a predetermined wall thickness and including (i) a styrene block copolymer;

(ii) an olefin;

(iii) a predetermined amount of pigment that allows the body to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness, and hermetically seal the aperture in the penetrable region in a predetermined time period; and

(iv) a predetermined amount of lubricant that reduces friction forces at an interface of the filling member and body during penetration thereof.

2. A device as defined in claim 1, wherein the predetermined time period is less than approximately 2 seconds.

3. A device as defined in claim 1, wherein the styrene block copolymer is within the range of about 80% to about 97% by weight.

4. A device as defined in claim 1, wherein the olefin is within the range of about 3% to about 20% by weight.

5. A device as defined in claim 1, wherein the ratio of the styrene block copolymer to the olefin is within the range of about 50:

50 by weight to about 90;

5 by weight.

6. A device as defined in claim 1, wherein the predetermined wavelength is approximately 980 nm and the predetermined power is less than approximately 30 Watts.

7. A device as defined in claim 1, wherein the amount of pigment is within the range of about 0.3% to about 0.6% by weight.

8. A device as defined in claim 1, wherein at least one of (i) the thermoplastic portion is a stopper, (ii) the filling member is a needle, (iii) the device is a vial;

and (iv) the device is a syringe.

9. A device as defined in claim 1, wherein the lubricant is selected from the group including silicone, mineral oil, and silicone oil.

10. A device as defined in claim 1, wherein the amount of lubricant is within the range of about 0.4% to about 0.6% by weight.

11. A device as defined in claim 1, in combination with a filling member for penetrating the thermoplastic portion, wherein the filling member includes a non-coring, conically-pointed tip.

12. A device and filling member as defined in claim 11, wherein the filling member includes a low-friction coating for reducing friction forces between the filling member and the thermoplastic portion during penetration thereof.

13. A device and filling member as defined in claim 11, wherein the low-friction coating is at least one of tungsten carbide and titanium.

14. A device and filling member as defined in claim 11, wherein the filling member is a needle.

15. A method comprising the following steps:

providing a device including a body defining a chamber for receiving a substance and a thermoplastic portion in fluid communication with the chamber, wherein the thermoplastic portion includes a styrene block copolymer and an olefin, and 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;

providing the thermoplastic portion with a predetermined amount of pigment that allows the penetrable region to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof,

providing a filling member defining a non-coring, conically-pointed tip and at least one flow aperture located adjacent to the tip and connectable in fluid communication with a source of substance;

penetrating the penetrable region of the thermoplastic portion with the conically-pointed tip of the filling member such that the flow aperture of the filling member is in fluid communication with the chamber of the device;

providing a lubricant at the interface of the filling member and thermoplastic portion to reduce friction forces therebetween;

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.

16. A method as defined in claim 15, wherein the step of providing a lubricant includes providing a lubricant within the thermoplastic portion that reduces friction forces at the interface of the filling member and thermoplastic portion.

17. A method as defined in claim 15, further comprising the steps of molding the thermoplastic portion and body from plastic under a substantially laminar flow;

and 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 sterile chamber sealed with respect to ambient atmosphere.

18. A method as defined in claim 15, further comprising the step of transmitting e-beam radiation onto the surface of the filling member prior to penetrating the thermoplastic portion therewith.

19. A method as defined in claim 15, further comprising the step of transmitting e-beam radiation onto the thermoplastic portion during laser sealing thereof.

20. A method as defined in claim 15, wherein the step of introducing includes introducing at least one of a medicament, cosmetic and a food product.

21. A method as defined in claim 21, further comprising the step of sterilizing the sealed empty device prior to introducing the substance.

22-26. -26. (canceled)