Device with penetrable and resealable portion and related method

• US 8,347,923 B2
• Filed: 06/28/2011
• Issued: 01/08/2013
• 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:
  US13/170,613
• Publication Number:
  US 20110253253A1
• Time in Patent Office: 560 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
• 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

Device and method for needle penetrating and filling a chamber with a predetermined substance, and hermetically resealing a resulting needle hole in the device by applying radiation thereto. The needle penetrable and resealable portion defines a predetermined wall thickness in an axial direction thereof, and may include a thermoplastic that substantially prevents the formation of particles released into the chamber from the needle penetrable and resealable portion during penetration by and withdrawal of the needle. Such thermoplastic may include a predetermined amount of pigment that allows the thermoplastic to substantially absorb laser radiation at a 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:

resealing a resealable member for sealing a substance within a chamber of a device, wherein the resealable member comprises (i) a base portion formed of a first material compatible with the substance and defining a substance-exposed surface for fluid communication with the chamber, wherein the base portion further (a) is penetrable by an injection or filling member for introducing substance therethrough into the chamber and (b) has a hole therein resulting from penetration of an injection or filling member therein; and

(ii) a resealing portion overlying the base portion and formed of a second material that, upon application of radiation or energy from a radiation or energy source thereto after removing the injection or filling member from the base portion, forms a gas-tight seal between the ambient atmosphere and the substance in the chamber, and wherein the device is fillable in a filling assembly including (i) an injection or filling member for penetrating the base portion and introducing a substance therethrough and into the chamber, (ii) a substance source coupled in fluid communication with the injection or filling member for introducing the substance therethrough and into the chamber, and (iii) a radiation or energy source for applying radiation or energy to the resealing portion;

wherein the resealing step further comprises applying radiation or energy from the radiation or energy source to the resealing portion.

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

3. A method as defined in claim 1, wherein the base portion is substantially infusible in response to the application of the radiation or energy thereto.

4. A method as defined in claim 3, wherein the base portion comprises vulcanized rubber.

5. A method as defined in claim 1, further comprising the step of providing the resealable member.

6. A method as defined in claim 1, further comprising mounting the resealable member on the device, wherein the substance-exposed surface is in fluid communication with the chamber, and forming a fluid tight seal between the chamber and the ambient atmosphere.

7. A method as defined in claim 6, further comprising:

penetrating the base portion with an injection or filling member coupled in fluid communication a substance source;

introducing the substance through the base portion and into the chamber;

withdrawing the injection or filing member from the base portion; and

applying the radiation or energy after withdrawing the injection or filing member.

8. A method as defined in claim 7, wherein the injection or 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.

9. A method as defined in claim 7, wherein the step of applying radiation or energy comprises directing a laser onto the resealing portion for sealing the resealable member and forming the gas-tight seal.

10. A method as defined in claim 1, wherein the step of applying radiation or energy comprises applying the radiation or energy at least one of (i) at a predetermined power;

(ii) for a predetermined time; and

(iii) at a predetermined wavelength to form the seal.

11. A method comprising:

resealing a resealable member for sealing a substance within a chamber of a device, 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 for fluid communication with the chamber, a resealing portion overlying the base portion, and defining a penetrable region that is penetrable with an injection or filling member to form an aperture therethrough and has an aperture therein resulting from penetration of an injection or filling member therein, and is resealable to hermetically seal the aperture by applying laser radiation from a 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, and wherein the device is fillable in a filling assembly including an injection or 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 injection or filling member for introducing the substance therethrough and into the chamber, and a laser source for applying laser radiation to the resealable member;

wherein the resealing step further comprises applying laser radiation to the resealable member at the predetermined wavelength and power.

12. A method as defined in claim 11, further comprising the step of providing the resealable member.

13. A method as defined in claim 11, further comprising mounting the resealable member on the device, wherein the substance-exposed surface is in fluid communication with the chamber, and forming a fluid tight seal between the chamber and the ambient atmosphere.

14. A method as defined in claim 13, further comprising:

penetrating the penetrable region of the resealable member with an injection or filling member coupled in fluid communication a substance source;

introducing the substance through the resealable member and into the device;

withdrawing the injection or filing member from the penetrable region; and

applying laser radiation at the predetermined wavelength and power thereto after withdrawing the injection or filing member.

15. A method as defined in claim 14, further comprising sterilizing the penetrable region of the resealable member with radiation from a radiation source prior to penetrating the resealable member with the injection or filling member.

16. A method as defined in claim 15, wherein the radiation source is a laser source.

17. A method as defined in claim 16, wherein the radiation source sterilizes the penetrable region of the resealable member within a cycle time of approximately ½

second.

18. A method as defined in claim 14, wherein the introducing step comprises introducing the substance into the chamber through a first fluid passageway extending through the injection or filling member, and further comprises allowing fluid to flow out of the chamber through a second fluid passageway.

19. A method as defined in claim 18, wherein the second fluid passageway is defined by the injection or filling member.

20. A method as defined in claim 14, wherein the substance source contains a preservative-free medicament, and the injection or filling member is adapted to introduce the preservative-free medicament through the resealable member and into the chamber.

21. A method as defined in claim 14, wherein the injection or 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.

22. A method as defined in claim 14, further comprising providing a sealed, empty device ready for filling in the filling assembly, wherein the sealed, empty device defines an opening, the resealable member covering the opening, and a member securing the resealable member to the device.

23. A method as defined in claim 22, further comprising sterilizing the sealed, empty device by applying radiation thereto.

24. A method as defined in claim 23, wherein the step of applying radiation comprises applying radiation from a radiation source.

25. A method as defined in claim 24, 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 the sealed, empty device for a predetermined cycle time to sterilize a surface of the penetrable region of the resealable member prior to introducing the injection or filling member therethrough.

26. A method as defined in claim 25, wherein the predetermined cycle time is approximately ½

second.

27. A method as defined in claim 14, wherein the substance comprises a preservative-free medicament.

28. A method as defined in claim 11, wherein the device is a vial.

29. A method comprising:

resealing a resealable member for sealing a substance within a chamber of a device, wherein the resealable member comprises (i) a base portion formed of a first material compatible with the substance and defining a substance-exposed surface for fluid communication with the chamber, wherein the base portion further (a) is penetrable by an injection or filling member for introducing substance therethrough into the chamber and (b) has a hole therein resulting from penetration of an injection or filling member therein; and

(ii) a resealing portion overlying the base portion and formed of a second material that, upon application of radiation or energy from a radiation or energy source thereto after removing the injection or filling member from the base portion, forms a gas-tight seal between the ambient atmosphere and the substance in the chamber, and wherein the device is fillable in a filling assembly including (i) an injection or filling member for penetrating the base portion and introducing a substance therethrough and into the chamber, (ii) a substance source coupled in fluid communication with the injection or filling member for introducing the substance therethrough and into the chamber, and (iii) a radiation or energy source for applying radiation or energy to the resealing portion;

wherein the resealing step further comprises applying radiation or energy from the radiation or energy source to the resealing portion to seal the penetration in the base portion.

30. A method as defined in claim 29, wherein the step of applying radiation or energy comprises applying the radiation or energy at least one of (i) at a predetermined power;

(ii) for a predetermined time; and

(iii) at a predetermined wavelength.