Collection container assembly with nanocomposite barrier coating
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
B01L-003/14
B01L-003/00
A61B-005/15
A61B-005/154
출원번호
US-0383058
(2009-03-19)
등록번호
US-9782776
(2017-10-10)
발명자
/ 주소
Soskey, Paul R.
Parmer, Jr., Jerome F.
Goldberg, Harris A.
Karim, Douglas P.
Samantara, Laxmi
Feeney, Carrie A.
Farrell, Michele
출원인 / 주소
INMAT, INC.
대리인 / 주소
Ferrell, Michael W.
인용정보
피인용 횟수 :
0인용 특허 :
13
초록▼
An evacuated container assembly suitable for use in connection with blood collection including: (a) a container member formed of a first polymeric material and having a sidewall and one or more openings; (b) a nanocomposite barrier coating disposed on the container member having a thickness of up to
An evacuated container assembly suitable for use in connection with blood collection including: (a) a container member formed of a first polymeric material and having a sidewall and one or more openings; (b) a nanocomposite barrier coating disposed on the container member having a thickness of up to about 30 microns and being derived from an aqueous dispersion including (i) a dispersed barrier matrix polymer; and (ii) a substantially exfoliated silicate filler having an aspect ratio of more than 50; and (c) one or more sealing members disposed in the opening(s) operative to hermetically seal the cavity; wherein the cavity is evacuated and maintains a pressure below atmospheric pressure and exhibits a draw volume loss lower than that of a like assembly without a nanocomposite barrier film by a factor of at least 1.5.
대표청구항▼
1. An evacuated container assembly suitable for use in connection with biological sample collection comprising: (a) a container member formed of a first polymeric material and having a sidewall defining a cavity with an inner surface as well as one or more open ends;(b) a nanocomposite barrier coati
1. An evacuated container assembly suitable for use in connection with biological sample collection comprising: (a) a container member formed of a first polymeric material and having a sidewall defining a cavity with an inner surface as well as one or more open ends;(b) a nanocomposite barrier coating disposed on a container member surface having a thickness of up to about 30 microns and being derived from an aqueous dispersion including (i) a dispersed barrier matrix polymer; and (ii) a substantially exfoliated silicate filler having an aspect ratio of more than 50; and(c) a sealing member disposed in the opening(s) of the container member operative to hermetically seal the cavity;wherein the cavity is evacuated and maintains a pressure below atmospheric pressure and exhibits a draw volume loss lower than that of a like assembly without a nanocomposite barrier film by a factor of at least 1.5. 2. The evacuated container assembly according to claim 1, wherein the assembly is used in connection with blood collection. 3. The evacuated container assembly according to claim 1, wherein the assembly exhibits a draw volume loss lower than that of like assembly without a nanocomposite barrier film by a factor of at least 2. 4. The evacuated container assembly according to claim 1, wherein the assembly exhibits a draw volume loss lower than that of like assembly without a nanocomposite barrier film by a factor of at least 5. 5. The evacuated container assembly according to claim 1, wherein the assembly exhibits a draw volume loss lower than that of like assembly without a nanocomposite barrier film by a factor of at least 10. 6. The evacuated container assembly according to claim 1, wherein the assembly exhibits a draw volume loss lower than that of like assembly without a nanocomposite barrier film by a factor of at least 25. 7. The evacuated container assembly according to claim 1, wherein the assembly exhibits a draw volume loss lower than that of like assembly without a nanocomposite barrier film by a factor of at least 40 up to a factor of 100. 8. The evacuated container assembly according to claim 1, having an overall length, a predetermined volume, as well as an outside diameter and wherein the sealing member is needle pierceable. 9. The evacuated container assembly of claim 8, wherein the outside diameter is between 5 and 15 mm. 10. The evacuated container assembly of claim 8, wherein the total length is between 40 mm and 140 mm. 11. The evacuated container assembly of claim 8, wherein the maximum fill volume is between 400 ml and 30 cc. 12. The evacuated container assembly of claim 8, wherein the maximum fill volume is between 2 and 10 cc. 13. The evacuated container assembly of claim 1, wherein the sidewall has an average thickness between 5 mm and 1.5 mm, wherein a thickness of the nanocomposite barrier coating is less than 20 microns. 14. The evacuated container assembly of claim 1, wherein an average combined thickness of the barrier coating and the container member is less than 1.5 mm, and the percentage of the thickness contributed by the coating is less than 4% of the thickness. 15. The evacuated container assembly of claim 14, wherein the percentage of the thickness contributed by the coating is less than 3% of the thickness. 16. The evacuated container assembly of claim 14, wherein the percentage of the thickness contributed by the coating is less than 2% of the thickness. 17. The evacuated container assembly according to claim 1, wherein the container inner cavity has a clot-affecting material therein. 18. The evacuated container assembly according to claim 17, wherein the clot-affecting material is an anticoagulant. 19. The evacuated container assembly according to claim 18, wherein the anticoagulant is chosen from the group consisting of heparin, citrate, EDTA, CTAD and combinations thereof. 20. The evacuated container assembly according to claim 17, wherein the clot affecting material is a coagulant. 21. The evacuated container assembly according to claim 17, wherein the coagulant is chosen from the group of silica, thrombin, snake venom and combinations thereof. 22. The evacuated container assembly container according to claim 1, further comprising a topcoat layer disposed on the nanocomposite barrier coating. 23. The evacuated container assembly according to claim 22, wherein the topcoat layer comprises a vinyl acrylic resin. 24. The evacuated container assembly according to claim 1, further comprising an adhesive layer disposed between the container body and the nanocomposite barrier coating. 25. The evacuated container assembly according to claim 24, wherein the adhesive layer comprises a urethane resin. 26. The evacuated container assembly according to claim 24, wherein the adhesive layer comprises a surface modified by gas plasma treatment. 27. The evacuated container assembly according to claim 1, wherein the container member comprises a polyolefin based polymer. 28. The evacuated container assembly according to claim 1, wherein the container member comprises a polyester based polymer. 29. The evacuated container assembly according to claim 1, wherein the container member comprises a polymer selected form polypropylenes, polyethylene terephthalates and cyclic olefin copolymers. 30. The evacuated container assembly according to claim 1, wherein the container member is formed from polypropylene. 31. The evacuated container assembly according to claim 1, wherein the nanocomposite barrier coating has a thickness of up to 30 microns. 32. The evacuated container assembly according to claim 1, wherein the nanocomposite barrier coating has a thickness of from 2-20 microns. 33. The evacuated container assembly according to claim 1, wherein the nanocomposite barrier coating has a thickness of from 3-10 microns. 34. The evacuated container assembly container according to claim 1, wherein the nanocomposite barrier coating has a thickness of from 4-6 microns. 35. The evacuated container assembly according to claim 1, wherein the exfoliated silicate filler material includes a compound selected from the group consisting of bentonite, vermiculite, montmorillonite, nontronite, beidellite, volkonskoite, hectorite, saponite, laponite, sauconite, magadiite, kenyaite, ledikite, and combinations thereof. 36. The evacuated container assembly according to claim 1, wherein the exfoliated silicate filler material includes montmorillonite. 37. The evacuated container assembly according to claim 1, wherein the exfoliated silicate filler material comprises platelets with an average aspect ratio of at least 100. 38. The evacuated container assembly according to claim 1, wherein the exfoliated silicate filler material comprises platelets with an average aspect ratio of at least 250. 39. The evacuated container assembly according to claim 1, wherein the exfoliated silicate filler material comprises platelets with an average aspect ratio of at least 500. 40. The evacuated container assembly according to claim 1, wherein the exfoliated silicate filler material comprises platelets with an average aspect ratio of at least 1,000. 41. The evacuated container assembly container according to claim 1, wherein the exfoliated silicate filler material comprises platelets with an average aspect ratio of at least 5,000. 42. The evacuated container assembly according to claim 1, wherein the barrier matrix polymer includes a polymer selected from the group consisting of polyesters, polyamides, chlorinated polymers, polyolefins, polyurethanes, polyethers, polyketones, polycarbonates, acrylics, vinylics, fluoropolymers, and combinations thereof. 43. The evacuated container assembly tubular container according to claim 1, wherein the barrier matrix polymer includes a polyester resin. 44. The evacuated container assembly according to claim 1, wherein the barrier matrix polymer includes a sulfonated polyester resin. 45. The evacuated container assembly according to claim 1, wherein the barrier coating exhibits a characteristic oxygen permeability of less than 0.02 cc-mm/m2-day-atm. 46. The evacuated container assembly according to claim 1, wherein the coating exhibits a characteristic oxygen permeability of less than 0.01 cc-mm/m2-day-atm. 47. The evacuated container assembly according to claim 1, wherein the nanocomposite gas barrier coating disposed on the container member derived from an aqueous dispersion includes an invisible marker water soluble dye,wherein the invisible marker dye is selected and present in amounts effective to indicate the thickness of the coating and thereby uniformity thereof. 48. The evacuated container assembly according to claim 47, wherein the invisible marker dye has an absorption peak in the near infrared (NIR) region of the electromagnetic spectrum. 49. The evacuated container assembly according to claim 47, wherein the invisible marker dye has an absorption peak in the region of greater than about 700 nm to about 1200 nm. 50. The evacuated container assembly according to claim 47, wherein the invisible marker dye has an absorption peak in the region of about 750 nm to about 1000 nm. 51. The evacuated container assembly according to claim 47, wherein the invisible marker dye has an absorption peak in the region of about 750 nm to about 850 nm. 52. The evacuated container assembly according to claim 1, wherein said nanocomposite barrier coating is prepared from an aqueous dispersion which is concentrated by at least 5 percent by evaporating water from the dispersion prior to application on the container body. 53. The evacuated container assembly according to claim 1, prepared by way of a process comprising: (a) providing a container member formed of a first polymeric material and having a closed bottom, an open top and a sidewall therebetween;(b) treating the polymeric container member to increase its surface energy;(b) applying an aqueous nanocomposite barrier coating composition directly to the treated surface, the aqueous nanocomposite barrier composition including (i) a dispersed barrier matrix polymer; and (ii) a substantially exfoliated silicate filler having an aspect ratio of more than 50. 54. The evacuated container assembly according to claim 53, wherein the polymeric container member is gas plasma treated prior to applying the nanocomposite barrier composition. 55. The evacuated container assembly according to claim 54, wherein the polymeric container member is flame plasma treated prior to applying the nanocomposite barrier composition. 56. The evacuated container assembly of claim 1, wherein the sidewall has an average thickness between 5 mm and 1.5 mm, wherein a thickness of the nanocomposite barrier coating is less than 10 microns. 57. The evacuated container assembly of claim 1, wherein the sidewall has an average thickness between 5 mm and 1.5 mm, wherein a thickness of the nanocomposite barrier coating is less than 6 microns. 58. The evacuated container assembly as claimed in claim 1, wherein the substantially exfoliated filler material is present at between 20% to 50% by weight of the total solids of the nanocomposite barrier coating.
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