Device with needle penetrable and laser resealable portion

• US 7,810,529 B2
• Filed: 02/13/2009
• Issued: 10/12/2010
• 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
• Primary Examiner(s): Maust; Timothy L
• Application Number:
  US12/371,386
• Publication Number:
  US 20090145512A1
• Time in Patent Office: 606 Days
• Field of Search: 141/2, 141/18, 141/59, 141/82, 141/85, 141/94, 141/284, 141/285, 141/329, 534/03, 534/40, 534/42, 534/67, 534/71, 534/77, 534/78, 215/247, 215/274, 215/280, 604/256, 604/414, 604/415, 604/537
• 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 pierceable with an injection member to form an aperture therethrough, and is resealable to hermetically seal the aperture, wherein the thermoplastic portion includes (i) a first polymeric material in a first amount by weight including a styrene block copolymer and defining a first elongation;

(ii) a second polymeric material in a second amount by weight that is less then the first amount, including at least one of an ethylene alpha-olefin, a polyolefin, and an olefin, and defining a second elongation that is less than the first elongation; and

(iii) a lubricant in an amount that reduces friction forces at an interface of the injection member and thermoplastic portion during penetration thereof.

2. A device as defined in claim 1, wherein the thermoplastic portion is heat resealable.

3. A device as defined in claim 2, wherein the thermoplastic portion is heat resealable by applying laser radiation at a predetermined wavelength thereto.

4. A device as defined in claim 3, wherein the predetermined wavelength is approximately 980 nm.

5. A device as defined in claim 3, wherein the thermoplastic portion defines a predetermined wall thickness in an axial direction thereof, and further includes a pigment in an amount that allows the thermoplastic portion to substantially absorb laser radiation at the predetermined wavelength and substantially prevent the passage of radiation through the predetermined wall thickness thereof, and hermetically seal an aperture formed in the penetrable region thereof.

6. A device as defined in claim 5, wherein the amount of pigment is within the range of about 0.3% to about 0.6% by weight.

7. A device as defined in claim 1, wherein the first material defines a higher melting temperature than the second material.

8. A device as defined in claim 1, wherein the first amount is within the range of about 80% to about 97% by weight and the second amount is within the range of about 3% to about 20% by weight.

9. A device as defined in claim 1, wherein the first material defines a first elongation of at least about 75% at about 10 lbs force.

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

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

12. A device as defined in claim 1, in combination with an injection member in the form of a needle for penetrating the thermoplastic portion, wherein the needle includes a non-coring, conically-pointed tip defining an included angle within the range of about 15 degrees to about 25 degrees.

13. A device and needle as defined in claim 12, wherein the needle includes a low-friction exterior surface that reduces friction forces between the needle and thermoplastic portion during penetration thereof.

14. A device and needle as defined in claim 13, wherein the low-friction surface is selected from the group including a tungsten carbide surface, an electro-polished stainless steel surface, and a titanium surface.