Device with needle penetrable and laser resealable portion and related method

• US 7,243,689 B2
• Filed: 04/21/2006
• Issued: 07/17/2007
• 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:
  US11/408,704
• Publication Number:
  US 20060191594A1
• Time in Patent Office: 452 Days
• Field of Search: 141 1- 7, 141/59, 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: 141/2
• 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

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 of providing and filling a device with a predetermined substance, comprising the following steps:

providing a needle penetrable and laser resealable portion including a thermoplastic that is pierceable with a needle to form a needle aperture therethrough, and is laser resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, wherein the needle penetrable and laser resealable portion defines a predetermined wall thickness in an axial direction thereof;

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

connecting the needle penetrable and laser resealable portion to a device defining a chamber;

providing a needle 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 the predetermined substance;

configuring at least one of the needle penetrable and laser resealable portion and needle to substantially prevent the formation of particles released into the chamber from the thermoplastic upon penetrating same with the needle and withdrawing the needle therefrom;

penetrating the needle penetrable and laser resealable portion with the conically-pointed tip of the needle such that the flow aperture of the needle is in fluid communication with the chamber of the device, and substantially preventing the formation of particles released into chamber from the thermoplastic during penetration by the needle;

introducing the predetermined substance through the needle and into the chamber of the device, withdrawing the needle from the needle penetrable and laser resealable portion, and substantially preventing the formation of particles released into the chamber from the thermoplastic during withdrawal of the needle; and

transmitting laser radiation at the predetermined wavelength and power onto the needle penetrated region of the needle penetrable and laser resealable portion, and hermetically sealing the needle aperture formed in the needle penetrable and laser resealable portion and the predetermined substance within the chamber.

2. A method as defined in claim 1, wherein the step of configuring at least one of the needle penetrable and laser resealable portion and needle to substantially prevent the formation of particles released into the chamber includes providing a thermoplastic including a styrene block copolymer and an olefin, and providing a lubricant at an interface of the needle and needle penetrable and laser resealable portion.

3. A method as defined in claim 2, wherein the step of providing a lubricant includes providing within the thermoplastic a predetermined amount of lubricant that reduces friction forces at the interface of the needle and thermoplastic.

4. A method as defined in claim 3, wherein the step of providing a lubricant includes providing a lubricant selected from the group including silicone, mineral oil and silicone oil.

5. A method as defined in claim 1, wherein the step of configuring at least one of the needle penetrable and laser resealable portion and needle to substantially prevent the formation of particles released into the chamber includes providing a low-friction coating on the needle.

6. A method as defined in claim 5, wherein the low-friction coating is selected from the group including tungsten carbide and titanium.

7. A method as defined in claim 2, further comprising providing a thermoplastic including an olefin within the range of about 3% to about 20% by weight, and a styrene block copolymer within the range of about 80% to about 97% by weight.

8. A method as defined in claim 1, wherein the step of configuring at least one of the needle penetrable and laser resealable portion and needle to substantially prevent the formation of particles released into the chamber includes providing a thermoplastic including (i) a first polymeric material in an amount within the range of about 80% to about 97% by weight and defining a first elongation, (ii) a second polymeric material in an amount within the range of about 3% to about 20% by weight and defining a second elongation that is less than the first elongation of the first material, and (iii) a lubricant in an amount that reduces friction forces at an interface of the needle and needle penetrable and laser resealable portion.

9. A method as defined in claim 1, further comprising the steps of molding the needle penetrable and laser resealable portion and device;

and prior to allowing the needle penetrable and laser resealable portion and device to cool to an ambient temperature, assembling the needle penetrable and laser resealable portion and device and forming a sealed, sterile chamber therebetween.

10. A method as defined in claim 1, further comprising the step of sterilizing the sealed, empty needle penetrable and laser resealable portion and device assembly prior to the step of needle penetrating the needle penetrable and laser resealable portion.

11. A method as defined in claim 10, wherein the sterilizing step is selected from the group including (i) applying gamma radiation, (ii) applying e-beam radiation, and (iii) applying laser radiation, to the sealed, empty needle penetrable and laser resealable portion and device assembly.

12. A method as defined in claim 1, wherein the step of providing a needle penetrable and laser resealable portion includes providing a needle penetrable and laser resealable portion 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 needle for introducing the predetermined substance through the needle penetrable and laser resealable portion and into the chamber.

13. A method as defined in claim 12, wherein the step of providing a needle penetrable and laser resealable portion further includes providing a penetrable region of the underlying portion that is substantially infusible in response to the application of thermal energy from the laser source, and providing a penetrable region of the resealable portion that is fusible in response to the application of thermal energy from the laser source to form a gas-tight seal between the resealable portion and the predetermined substance in the device upon removing the needle therefrom.

14. A method as defined in claim 1, wherein the step of introducing the predetermined substance through the needle and into the chamber of the device includes introducing the predetermined substance through a first fluid passageway of the needle, and allowing fluid to flow out of the chamber through a second fluid passageway upon introducing predetermined substance from the first fluid passageway into the chamber.

15. A device including a needle penetrable and laser resealable portion that is pierceable with a needle defining a non-coring, conically-pointed tip, to form a needle aperture therethrough to fill a chamber of the device with a predetermined substance through the needle, and is laser resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, wherein the needle penetrable and laser resealable portion defines a predetermined wall thickness in an axial direction thereof, and includes a thermoplastic, the thermoplastic and the needle substantially prevent the formation of particles released into the chamber from the needle penetrable and laser resealable portion during penetration by and withdrawal of the needle, and 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.

16. A device as defined in claim 15, wherein the thermoplastic includes an olefin within the range of about 3% to about 20% by weight, a styrene block copolymer within the range of about 80% to about 97% by weight, and a lubricant.

17. A device as defined in claim 15, wherein the thermoplastic includes (i) a first polymeric material in an amount within the range of about 80% to about 97% by weight and defining a first elongation, (ii) a second polymeric material in an amount within the range of about 3% to about 20% by weight and defining a second elongation that is less than the first elongation of the first material, and (iii) a lubricant in an amount that reduces friction forces at an interface of the needle and body.

18. A device as defined in claim 17, wherein the first material is a styrene block copolymer and the second material is an olefin.

19. A device as defined in claim 15, wherein the needle penetrable and laser resealable portion includes an underlying portion formed of a first material compatible with a predetermined substance and defining a substance-exposed surface exposed to the predetermined substance within the device;

and a resealable portion overlying the underlying portion, wherein the resealable portion is penetrable by the needle for introducing the predetermined substance through the stopper and into the device.

20. A device as defined in claim 19, wherein the penetrable region of the underlying portion is substantially infusible in response to the application of radiation from the laser source, and the penetrable region of the resealable portion is fusible in response to the application of radiation from the laser source to form a gas-tight seal between the resealable portion and the predetermined substance in the device after removing the needle therefrom.

21. A device as defined in claim 15, in combination with the needle for penetrating the needle penetrable and laser resealable portion, wherein the non-coring, conically-pointed tip defines an included angle within the range of about 15 degrees to about 25 degrees.

22. A device as defined in claim 15, wherein the predetermined amount of pigment is within the range of about 0.3% to about 0.6% by weight.

23. A device as defined in claim 15, wherein the device is selected from the group including (i) a vial and (ii) a syringe.

24. A device as defined in claim 15, wherein the predetermined time period is less than approximately 2 seconds.

25. A device as defined in claim 15, in combination with a filling apparatus including the needle defining a non-coring, conically-pointed tip.

26. A device including a needle penetrable and laser resealable portion that is pierceable with a needle to form a needle aperture therethrough to fill a chamber of the device with a predetermined substance through the needle, and is laser resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, wherein the needle penetrable and laser resealable portion includes a thermoplastic and defines a predetermined wall thickness in an axial direction thereof, and further includes first means for substantially preventing the formation of particles released into the chamber from the stopper upon penetrating the stopper with the needle and withdrawing the needle from the stopper, and second means for allowing the thermoplastic 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 a needle aperture formed in the needle penetration region thereof in a predetermined time period.

27. A device as defined in claim 26, wherein the first means is defined by the thermoplastic including a styrene block copolymer, an olefin, and a lubricant.

28. A device as defined in claim 27, wherein the thermoplastic includes an olefin within the range of about 3% to about 20% by weight and a styrene block copolymer within the range of about 80% to about 97% by weight.

29. A device as defined in claim 27, wherein the first means is defined by the thermoplastic including (i) a first polymeric material in an amount within the rang of about 80% to about 97% by weight and defining a first elongation, (ii) a second polymeric material in an amount within the range of about 3% to about 20% by weight and defining a second elongation that is less than the first elongation of the first material, and (iii) a lubricant in an amount that reduces friction forces at an interface of the needle and body.

30. A device as defined in claim 26, wherein the predetermined time period is less than approximately 2 seconds.

31. A device as defined in claim 26, in combination with a filling apparatus including a needle defining a non-coring, conically-pointed tip.