Device with needle penetrable and laser resealable portion and related method

• US 7,967,034 B2
• Filed: 03/10/2009
• Issued: 06/28/2011
• 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:
  US12/401,567
• Publication Number:
  US 20090229702A1
• Time in Patent Office: 840 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, 220/200, 220/254.1
• 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 resealable member for sealing a substance within a chamber of a device, wherein the device is fillable in a filling assembly including a filling member for penetrating the resealable member and introducing a substance through the resealable member and into the chamber, a substance source coupled in fluid communication with the filling member for introducing the substance through the filling member and into the chamber, and an energy source connectable in communication with the resealable member, wherein the resealable member comprises:

a base portion formed of a first material compatible with the substance and defining a substance-exposed surface in fluid communication with the chamber, the base portion being penetrable by the filling member for introducing the substance into the chamber; and

a resealing portion overlying the base portion and formed of a second material that, upon the application of energy from the energy source thereto after removing the filling member from the chamber, forms a gas-tight seal between the ambient atmosphere and the substance in the chamber.

2. A resealable member as defined in claim 1, wherein the resealing portion is formed of at least one of a thermoplastic and elastomeric material.

3. A resealable member as defined in claim 1, wherein penetrable region of the base portion is substantially infusible in response to the application of energy thereto.

4. A resealable member as defined in claim 3, wherein the base portion is formed of vulcanized rubber.

5. An apparatus comprising:

a resealable member as defined in claim 1; and

a device wherein the resealable member is mounted on the device in fluid communication with the chamber and forming a fluid tight seal between the chamber and the ambient atmosphere.

6. An apparatus as defined in claim 5, further comprising:

a filling assembly, including;

a filling member for penetrating the resealable member and introducing the substance through the resealable member and into the chamber;

a substance source coupled in fluid communication with the filling member for introducing the substance through the filling member and into the chamber; and

at least one energy source coupled in communication with the resealable member for applying energy to the region of the resealing portion penetrable by the filling member and sealing the penetrable region to form a gas-tight seal between the resealing portion and the substance in the chamber.

7. An apparatus as defined in claim 6, wherein the filling member defines a first fluid passageway coupled in fluid communication with the substance source for introducing the substance therethrough and into the chamber, and a second fluid passageway extending adjacent to the first fluid passageway for allowing the passage of gas out of the chamber upon introducing the substance therein.

8. An apparatus as defined in claim 6, wherein the at least one energy source includes a laser directed onto the penetrable region of the resealing portion for transmitting radiation thereon and sealing the penetrable region to form a gas-tight seal.

9. A resealable member for sealing a substance within a chamber of a device, wherein the device is fillable in a filling assembly including a filling member for penetrating the resealable member and introducing a substance through the resealable member and into the chamber, a substance source coupled in fluid communication with the filling member for introducing the substance through the filling member and into the chamber, and a laser source connectable in communication with the resealable member, wherein the resealable member comprises:

a body defining a predetermined wall thickness in an axial direction thereof, a base portion formed of a first material compatible with the substance and defining a substance-exposed surface in fluid communication with the chamber, a resealing portion overlying the base portion and defining a penetrable region that is penetrable with the filling member to form an aperture therethrough, and is resealable to hermetically seal the aperture by applying laser radiation from the laser source at a predetermined wavelength and power thereto, wherein the penetrable region defines a predetermined color and opacity that substantially absorbs the laser radiation at the predetermined wavelength and causes the laser radiation at the predetermined wavelength and power to hermetically seal the aperture formed in the penetrable region thereof, and the predetermined wall thickness substantially prevents the passage of the radiation therethrough.

10. An apparatus comprising:

a resealable member as defined in claim 9; and

a device wherein the resealable member is mounted on the device in fluid communication with the chamber and forming a fluid tight seal between the chamber and the ambient atmosphere.

11. An apparatus as defined in claim 10, further comprising:

a filling assembly including a filling member for penetrating the penetrable region of the resealable member and introducing a substance through the resealable member and into the device;

a substance source coupled in fluid communication with the filling member for introducing the substance through the filling member and into the device; and

a laser source connectable in communication with the resealable member for applying laser radiation at the predetermined wavelength and power thereto.

12. An apparatus as defined in claim 11, further comprising a radiation source for sterilizing the penetrable region of the resealable member prior to penetration thereof by the filling member.

13. An apparatus as defined in claim 12, wherein the radiation source is a laser source.

14. An apparatus as defined in claim 13, wherein the radiation source sterilizes the penetrable region of the resealable member within a cycle time of approximately ½

second.

15. An apparatus as defined in claim 11, further comprising a first fluid passageway extending through the filling member for introducing the substance from the substance source through the filling member and into the chamber, and a second fluid passageway for allowing fluid to flow out of the chamber.

16. An apparatus as defined in claim 15, wherein the second fluid passageway is defined by the filling member.

17. An apparatus as defined in claim 11, wherein the substance source contains a preservative-free medicament, and the filling member is adapted to introduce the preservative-free medicament through the resealable member and into the chamber.

18. An apparatus as defined in claim 11, wherein the filling member is axially alignable with the penetrable region of the resealable member for penetrating the resealable member and introducing the substance into the chamber.

19. An apparatus as defined in claim 11, further comprising a sealed, empty device ready for filling in the filling assembly, wherein the sealed, empty device defines an opening, a resealable member covering the opening, and a member securing the resealable member to the device.

20. An apparatus as defined in claim 19, wherein the sealed, empty device is sterilized by the application of radiation thereto.

21. An apparatus as defined in claim 20, further comprising a radiation source for sterilizing the sealed, empty device prior to filling with the substance.

22. An apparatus as defined in claim 21, wherein the radiation source is a laser source for transmitting radiation at a predetermined wavelength and power onto the penetrable region of the resealable member of a sealed, empty device for a predetermined cycle time to sterilize a surface of the penetrable region of the resealable member prior to introducing the filling member therethrough.

23. An apparatus as defined in claim 22, wherein the predetermined cycle time is approximately ½

second.

24. An apparatus as defined in claim 11, further comprising a device filled with the substance, wherein the filled device was previously a sealed, empty, sterilized device that was filled by penetrating the resealable member with the filling member and introducing the substance through the filling member and into the chamber.

25. An apparatus as defined in claim 24, wherein the filled device defines a resealed penetrable region that was resealed by the application of laser radiation from the laser source thereto.

26. An apparatus as defined in claim 25, wherein the filled device contains a preservative-free medicament.

27. An apparatus as defined in claim 10, wherein the device is a vial.

28. A resealable member for sealing a substance within a chamber of a device, wherein the device is fillable in a filling assembly including a filling member for penetrating the resealable member and introducing a substance through the resealable member and into the chamber, a substance source coupled in fluid communication with the filling member for introducing the substance through the filling member and into the chamber, and an energy source connectable in communication with the resealable member, wherein the resealable member comprises:

a base portion formed of a first material compatible with the substance and defining a substance-exposed surface in fluid communication with the chamber, the base portion being penetrable by the filling member for introducing the substance into the chamber; and

a resealing portion overlying the base portion and formed of a second material that, upon the application of energy from the energy source thereto after removing the filling member from the chamber, seals the region penetrated in the base portion by the filling member.