1. A device for use in lyophilizing a substance and storing therein the lyophilized substance, wherein the device is penetrable by a needle for filling the device with the substance to be lyophilized, and a resulting needle hole in the device is laser resealable by transmitting thereon laser radiation from a laser source, the device comprising:
a body defining a chamber for receiving therein the substance to be lyophilized;
a needle penetrable and laser resealable portion that is pierceable with a needle to form a needle aperture therethrough to fill the chamber with the substance to be lyophilized through the needle, and is laser resealable to hermetically seal the needle aperture by applying laser radiation thereto; and
a filter connectable in fluid communication between an interior and exterior of the chamber that permits fluid to flow therethrough in a direction from the interior to the exterior of the chamber, and substantially prevents contaminants from flowing therethrough in a direction from the exterior to the interior of the chamber.
2. A device as defined in claim 1, further comprising a securing member coupled to the body for securing the needle penetrable and laser resealable portion thereto.
3. A device as defined in claim 2, wherein the needle penetrable and laser resealable portion defines at least one first vent aperture, the securing member defines at least one second vent aperture in fluid communication with the at least one first vent aperture, and the filter is located therebetween.
4. A device as defined in claim 3, wherein the needle penetrable and laser resealable portion defines a plurality of first vent apertures angularly spaced relative to each other, the securing member defines a plurality of second vent apertures angularly spaced relative to each other, and at least a plurality of the second vent apertures are in fluid communication with respective first vent apertures.
5. A device as defined in claim 4, wherein the first vent apertures define a first cross-sectional flow area for permitting fluid to flow therethrough, the second vent apertures define a second cross-sectional flow area for permitting fluid to flow therethrough, and the second cross-sectional flow area is greater than the first cross-sectional flow area.
6. A device as defined in claim 4, wherein the first vent apertures define a first annular array of vent apertures, and the second vent apertures defining a second annular array of vent apertures.
7. A device as defined in claim 6, wherein the first annular array defines a first inner diameter and a first outer diameter, the second annular array defines a second inner diameter and a second outer diameter, the second outer diameter is approximately equal to or greater than the first outer diameter, and the second inner diameter is approximately equal to or less than the first inner diameter.
8. A device as defined in claim 4, wherein at least a plurality of first vent apertures are in fluid communication with respective second vent apertures at substantially any angular position of the needle penetrable and laser resealable portion relative to the securing member, or at substantially any angular position of the securing member relative to the needle penetrable and laser resealable portion.
9. A device as defined in claim 1, wherein the body forms at least one of a vial, a container, and a syringe, and the needle penetrable and laser resealable portion is defined by a stopper.
10. A device as defined in claim 2, wherein the filter is located between the needle penetrable and laser resealable portion and the securing member.
11. A device as defined in claim 10, wherein the filter is at least one of (i) fixedly secured to the needle penetrable and laser resealable portion and (ii) mechanically connected between the needle penetrable and laser resealable portion and the securing member.
12. A device as defined in claim 11, wherein the filter includes a porous material having a pore size distribution within the range of about 0.05 microns to about 5 microns.
13. A device as defined in claim 12, wherein the filter material is hydrophobic.
14. A device as defined in claim 2, further comprising a cover connected to at least one of the securing member, the body, and the needle penetrable and laser resealable portion, and covering an exposed portion of the needle penetrable and laser resealable portion.
15. A device as defined in claim 14, wherein the cover forms a substantially fluid-tight seal between the needle penetrable and laser resealable portion and the ambient atmosphere, and forms a barrier to the transmission of moisture and vapor therethrough.
16. A device as defined in claim 15, wherein the cover includes a frangible portion that is movable between a closed position connected to the cover and substantially sealing the needle penetrable and laser resealable portion from the ambient atmosphere, and an open position removed from the cover and exposing at least a portion of the needle penetrable and laser resealable portion.
17. A device as defined in claim 1, further comprising a sealing member overlying the filter and sealing the filter from the ambient atmosphere.
18. A device as defined in claim 17, further comprising a cover connected to at least one of the securing member, the body, and the needle penetrable and laser resealable portion, with the sealing member located therebetween.
19. A device as defined in claim 18, wherein the sealing member is secured to an underside of the cover.
20. A device as defined in claim 1, wherein the needle penetrable and laser resealable portion defines a predetermined wall thickness in an axial direction thereof, is laser resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto, 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, 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.
21. A device as defined in claim 20, 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
22. A device as defined in claim 20, 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.
23. A device as defined in claim 22, wherein the first material is a styrene block copolymer and the second material is an olefin.
24. A device as defined in claim 20, wherein the predetermined amount of pigment is within the range of about 0.3% to about 0.6% by weight.
25. A device as defined in claim 1, 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 and penetrable by the needle for introducing the predetermined substance therethrough and into the device.
26. A device as defined in claim 25, 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.
27. A device for use in lyophilizing a substance and storing therein the lyophilized substance, wherein the device is penetrable by a needle for filling the device with the substance to be lyophilized, and a resulting needle hole in the device is laser resealable by transmitting thereon laser radiation from a laser source, the device comprising:
first means for forming an aseptic chamber for receiving therein the substance to be lyophilized;
second means for piercing with a needle to form a needle aperture therethrough and fill the chamber with the substance to be lyophilized through the needle, and for laser resealing to hermetically seal the needle aperture by applying laser radiation thereto; and
third means connectable in fluid communication between an interior and exterior of the chamber for permitting fluid to flow therethrough from the interior to the exterior of the chamber, and for filtering out and substantially preventing any contaminants from flowing therethrough from the exterior to the interior of the chamber.
28. A device as defined in claim 27, wherein the first means is a body of the device defining therein the chamber; the second means is a needle penetrable and laser resealable portion that is pierceable with a needle to form a needle aperture therethrough to fill the chamber with the substance to be lyophilized through the needle, and is laser resealable to hermetically seal the needle aperture by applying laser radiation thereto; and the third means is a filter connectable in fluid communication between an interior and exterior of the chamber that permits fluid to flow therethrough in a direction from the interior to the exterior of the chamber, and substantially prevents contaminants from flowing therethrough in a direction from the exterior to the interior of the chamber.
29. A device as defined in claim 27, further comprising third means for fixedly securing the second means to the first means; and fourth means for covering at least one of the second and third means.
30. A device as defined in claim 29, wherein the third means is a securing member coupled to the first means for securing the second means thereto; and the fourth means is a cover connected to at least one of the first means, the second means and the third means, and covering an exposed portion of the second means.
31. A device as defined in claim 5, wherein at least a plurality of first vent apertures are angularly spaced relative to each other at a first acute angle, and at least a plurality of second vent apertures are angularly spaced relative to each other at a second acute angle greater than the first acute angle.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A fabricated apparatus having an interior space, comprising:
a strut;
a first beam;
a second beam;
a lift-eye housing interfacing with the strut and the first beam and the second beam, the lift-eye housing having an opening formed therein, wherein the lift-eye housing is contained entirely within a framework of the strut and the first beam and the second beam so as not to encroach into the interior space of the fabricated apparatus; and
a lift-eye, coupled between a set of cheek plates, disposed within the lift-eye housing and configured to support the weight of the fabricated apparatus, the lift-eye being reversibly pivotable between a stowed position within the lift-eye housing and a deployed position where a distal portion of the lift-eye projects out of the opening.
2. The apparatus of claim 1, wherein the lift-eye housing is disposed directly along a top portion of the strut.
3. The apparatus of claim 2, wherein the lift-eye housing comprises an outer wall and an inner wall, the inner wall of the lift-eye housing abutting against and connected to an end portion of the first beam.
4. The apparatus of claim 3, wherein the lift-eye housing comprises an end wall that abuts against and is connected to an end portion of the second beam.
5. The apparatus of claim 3, further comprising a removable pivot pin passing through the lift-eye housing, the lift-eye, and the set of cheek plates.
6. The apparatus of claim 5, further comprising an exterior sidewall adjacent the outer wall, wherein the removable pivot pin passes through the exterior sidewall.
7. The apparatus of claim 5, wherein the removable pivot pin is accessible from outside the fabricated apparatus.
8. The apparatus of claim 1, wherein the lift-eye includes a finger-grip slot disposed in the distal portion.
9. A fabricated apparatus, comprising:
a first exterior sidewall, a second exterior sidewall, and an upper wall intersecting at a corner;
a lift-eye housing disposed at the corner and having an outer wall, an inner wall, and an opening facing in the direction of the upper wall;
a lift-eye, coupled to a set of cheek plates, disposed within the lift-eye housing, and configured to support the weight of the apparatus, the lift-eye being configured to reversibly pivot between a stowed position within the lift-eye housing and a deployed position where a distal portion of the lift-eye projects out of the opening; and
a removable pivot pin extending through the lift-eye housing and the lift-eye, the pivot pin being configured to be accessed from outside the fabricated apparatus.
10. The apparatus of claim 9, wherein the removable pivot pin passes through the second exterior sidewall of the fabricated apparatus, and through the outer wall and the inner wall of the lift-eye housing.
11. The apparatus of claim 9, comprising a strut disposed between and supporting the first exterior sidewall and the second exterior sidewall, wherein the lift-eye housing is disposed directly along the top of the strut.
12. The apparatus of claim 9, comprising a first beam disposed between and connecting the first exterior sidewall and the upper wall, wherein the inner wall of the lift-eye housing abuts against an end of the first beam.
13. The apparatus of claim 9, comprising a second beam disposed between and connecting the second exterior sidewall and the upper wall, wherein the outer wall of the lift-eye housing abuts against an end of the second beam.
14. The apparatus of claim 9, wherein the lift-eye includes a finger-grip slot disposed in the distal portion.
15. The apparatus of claim 9, wherein the lift-eye and set of cheek plates include a pivot pin hole, wherein the pivot pin hole is configured to encompass and help retain the removable pivot pin.
16. The apparatus of claim 9, wherein the lift-eye comprises an operation hole, wherein the operation hole is configured to enable connection between the lift-eye and a connecting device.
17. The apparatus of claim 9, wherein the lift-eye is removable from the lift-eye housing by removing the removable pivot pin from the lift-eye housing and the lift-eye.
18. A fabricated apparatus having an interior space, comprising:
a strut;
a first beam;
a second beam;
a lift-eye housing interfacing with the strut and the first beam and the second beam, the lift-eye housing having an opening formed therein; and
a lift-eye, coupled to a set of cheek plates, disposed within the lift-eye housing, and configured to support the weight of the fabricated apparatus, the lift-eye being reversibly pivotable between a stowed position within the lift-eye housing and a deployed position where a distal portion of the lift-eye projects out of the opening.
19. The apparatus of claim 18, wherein the lift-eye housing is disposed directly along a top portion of the strut.
20. The apparatus of claim 19, wherein the lift-eye housing comprises an outer wall and an inner wall, the inner wall of the lift-eye housing abutting against and connected to an end portion of the first beam.
21. The apparatus of claim 20, further comprising a removable pivot pin passing through the lift-eye housing, the lift-eye, and the set of cheek plates.
22. The apparatus of claim 21, wherein the removable pivot pin is accessible from outside the fabricated apparatus.