CA2464099A1 - Sterile device and method for producing same - Google Patents

Sterile device and method for producing same Download PDF

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Publication number
CA2464099A1
CA2464099A1 CA002464099A CA2464099A CA2464099A1 CA 2464099 A1 CA2464099 A1 CA 2464099A1 CA 002464099 A CA002464099 A CA 002464099A CA 2464099 A CA2464099 A CA 2464099A CA 2464099 A1 CA2464099 A1 CA 2464099A1
Authority
CA
Canada
Prior art keywords
sterile
new
sterilizing
package
buffer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002464099A
Other languages
French (fr)
Other versions
CA2464099C (en
Inventor
Aaron Swanson
Jennifer Reynolds
Rajiv Shah
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Minimed Inc
Original Assignee
Medtronic Minimed, Inc.
Aaron Swanson
Jennifer Reynolds
Rajiv Shah
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Minimed, Inc., Aaron Swanson, Jennifer Reynolds, Rajiv Shah filed Critical Medtronic Minimed, Inc.
Publication of CA2464099A1 publication Critical patent/CA2464099A1/en
Application granted granted Critical
Publication of CA2464099C publication Critical patent/CA2464099C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18Liquid substances or solutions comprising solids or dissolved gases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/206Ethylene oxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495Calibrating or testing of in-vivo probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S422/00Chemical apparatus and process disinfecting, deodorizing, preserving, or sterilizing
    • Y10S422/905Miscellaneous liquid sterilization means

Abstract

A sterile device immersed (10) in a sterile buffer (14) and a method for providing same. The sterile device (10) may be a medical device such as a biosensor (50) having a biomolecule (60) as a sensing element such as, for example, a glucose oxidase enzyme. The buffer may be a bicarbonate solution.
Both the device (10) and the buffer (14) may be packaged and stored over long term while maintaining sterilization. The sterilization method may comprise a combination of gaseous, liquid and light sterilization.

Claims (87)

IN THE CLAIMS
1. An sterile apparatus comprising:
a sterile buffer for hydration;
a sterile device for use in a sterile application, the sterile device being immersed in the sterile buffer; and a sterile package, wherein the sterile package encloses the sterile device and the sterile buffer.
2. The apparatus of Claim 1, wherein the sterile device is a medical device.
3. The apparatus of Claim 1, wherein the sterile device is a sensor.
4. The apparatus of Claim 3, wherein the sensor includes a hydrated element.
5. The apparatus of Claim 1, wherein the sterile device is implantable.
6. The apparatus of Claim 1, wherein the sterile package is transparent.
7. The apparatus of Claim 1, wherein the sterile package is translucent.
8. The apparatus of Claim 1, wherein the sterile package is optically transmissive.
9. The apparatus of Claim 1, wherein the sterile device, sterile buffer and sterile package have been sterilized using light.
10. The apparatus of Claim 1, wherein the sterile device comprises a gas-sterilized device.
11. The apparatus of Claim 1, wherein the sterile device comprises a liquid-sterilized device.
12. The apparatus of Claim 3, wherein the sensor comprises a biomolecule.
13. The apparatus of Claim 12, wherein the biomolecule is glucose oxidase.
14. A method for sterilizing an apparatus comprising:
placing the apparatus in a buffer;
enclosing the apparatus and the buffer in a package; and sterilizing the package using light.
15. The method of Claim 14, further comprising sterilizing the apparatus in a gas; and sterilizing the apparatus in a liquid.
16. The method of Claim 14, wherein sterilizing the package using light comprises sterilizing the package using a broad spectrum pulse light.
17. The method of Claim 15, wherein sterilizing the apparatus in a gas comprises sterilizing the apparatus in ethylene oxide.
18. The method of Claim 15, wherein sterilizing the apparatus in a liquid comprises sterilizing the apparatus in glutaraldehyde.
19. The method of Claim 14, wherein packaging the apparatus in a buffer comprises packaging the apparatus in a bicarbonate solution.
20. The method of Claim 14, wherein packaging the apparatus in a buffer comprises packaging an apparatus comprising a biosensor.
21. The method of Claim 20, wherein the biosensor comprises a biomolecule.
22. The method of Claim 21, wherein the biomolecule comprises a glucose oxidase enzyme.
23. (Original) An sterile apparatus comprising:

a sterile package; and a sterile device for use in a sterile application, the sterile device being enclosed by the sterile package.
24. (Original) The apparatus of Claim 23, wherein the sterile device is a medical device.
25. (Original) The apparatus of Claim 23, wherein the sterile device is a sensor.
26. (Original) A sterile, implantable medical device for in vivo implantation comprising: a sterile electronic circuit; a sterile biological molecule for use as an agent in generating a signal to be used by the sterile electronic circuit; and a sterile reservoir for housing the sterile biological molecule.
27. (Original) The device of Claim 26, further comprising a sterile package for packaging the device.
28. (Original) The device of Claim 27, wherein the device is packaged in a wet, sterile buffer solution.
29. (Original) The device of Claim 28, wherein the device requires no rinsing before implantation.
30. (Original) The device of Claim 26, wherein the sterile biological molecule is a sensor matrix protein.
31. (Original) The device of Claim 26, wherein the sterile electronic circuit is an integrated circuit.
32. (Original) The device of Claim 26, wherein the sterile reservoir is a polymer.
33. (Original) The device of Claim 26, further comprising a permeable window covering the biological molecule.
34. (Original) The device of Claim 26, wherein the device may be used without an acclimation period.
35. (Original) The device of Claim 27, wherein the package is optically transmissive.
36. (Original) A method for producing a sterile, implantable medical device for in vivo implantation comprising: preparing a device substrate for sterilization;
affixing non-biological elements to the substrate; sterilizing the non-biological elements and the,substrate with a gaseous sterilant; affixing biological elements to the substrate;
sterilizing the biological elements with a wet sterilant; packaging the substrate, the non-biological and biological elements into a wet buffer; and sterilizing the substrate, the non-biological and biological elements packaged in the wet buffer using light.
37. (Original) The method of Claim 36, wherein sterilizing the non-biological elements and the substrate with a gaseous sterilant comprises sterilizing the non-biological elements and the substrate with ethylene oxide.
38. (Original) The method of Claim 36, wherein biological elements are affixed to the substrate after sterilizing the non-biological elements and the substrate with a gaseous sterilant.
39. (Original) The method of Claim 36, wherein sterilizing the biological elements with a wet sterilant comprises sterilizing the biological elements with glutaraldehyde.
40. (Original) The method of Claim 36, wherein sterilizing the substrate, the non-biological and biological elements packaged in the wet buffer using light comprises sterilizing the substrate, the non-biological and biological elements packaged in the wet buffer using a broad spectrum pulse light.
41. (Original) The method of Claim 36, wherein sterilizing the biological elements with a wet sterilant comprises: preparing a sterilization chamber; preparing the wet sterilant;
pre-warming the wet sterilant; loading sensors into the chamber; exposing the sensors to the wet sterilant; rinsing the sensors a first time; and rinsing the sensors a second time.
42. (Original) The method of Claim 41 wherein rinsing the sensors a first time and a second time comprises rinsing the sensors with a bicarbonate buffer.
43. (Original) The method of Claim 36, further comprising implanting the device in vivo.
44. (Original) The method of Claim 43, wherein implanting the device in vivo comprises implanting the device in vivo without rinsing.
45. (New) A sterile, implantable medical device for in vivo implantation comprising: a sterile electronic circuit;

a sterile biological molecule for use as an agent in generating a signal to be used by the sterile electronic circuit; and a sterile reservoir for housing the sterile biological molecule, wherein the sterile biological molecule is a sensor matrix protein.
46. (New) The device of Claim 45, further comprising a sterile package for packaging the device.
47. (New) The device of Claim 46, wherein the device is packaged in a wet, sterile buffer solution.
48. (New) The device of Claim 47, wherein the device requires no rinsing before implantation.
49. (New) The device of Claim 45, wherein the sterile electronic circuit is an integrated circuit.
50. (New) The device of Claim 45, wherein the sterile reservoir is a polymer.
51. (New) The device of Claim 45, further comprising a permeable window covering the biological molecule.
52. (New) The device of Claim 45, wherein the device may be used without an acclimation period.
53. (New) The device of Claim 46, wherein the package is optically transmissive.
54. (New) A sterile, implantable medical device for in vivo implantation comprising: a sterile electronic circuit;

a sterile biological molecule for use as an agent in generating a signal to be used by the sterile electronic circuit;

a sterile reservoir for housing the sterile biological molecule; and a permeable window covering the biological molecule.
55. (New) The device of Claim 54, further comprising a sterile package for packaging the device.
56. (New) The device of Claim 55, wherein the device is packaged in a wet, sterile buffer solution.
57. (New) The device of Claim 56, wherein the device requires no rinsing before implantation.
58. (New) The device of Claim 54, wherein the sterile biological molecule is a sensor matrix protein.
59. (New) The device of Claim 54, wherein the sterile electronic circuit is an integrated circuit.
60. (New) The device of Claim 54, wherein the sterile reservoir is a polymer.
61. (New) The device of Claim 54, wherein the device may be used without an acclimation period.
62. (New) The device of Claim 55, wherein the package is optically transmissive.
63. (New) A sterile apparatus comprising:

a sterile buffer for hydration;

a sterile device for use in a sterile application, the sterile device immersed in the sterile buffer;

a sterile package; and a barrier for separating the sterile device from the sterile package, wherein the sterile package encloses the sterile device, the barrier and the sterile buffer.
64. (New) The apparatus of Claim 63, wherein the barrier is a permeable window.
65. (New) The apparatus of Claim 63, wherein the sterile device is a medical device.
66. (New) The apparatus of Claim 63, wherein the sterile device is a sensor.
67. (New) The apparatus of Claim 66, wherein the sensor includes a hydrated element.
6~. (New) The apparatus of Claim 63, wherein the sterile device is implantable.
69. (New) The apparatus of Claim 63, wherein the sterile package is transparent.
70. (New) The apparatus of Claim 63, wherein the sterile package is translucent.
71. (New) The apparatus of Claim 63, wherein the sterile package is optically transmissive.
72. (New) The apparatus of Claim 63, wherein the sterile device, sterile buffer and sterile package have been sterilized using light.
73. (New) The apparatus of Claim 63, wherein the sterile device comprises a gas-sterilized device.
74. The apparatus of Claim 63, wherein the sterile device comprises a liquid-sterilized device.
75. The apparatus of Claim 66, wherein the sensor comprises a biomolecule.
76. The apparatus of Claim 75, wherein the biomolecule is glucose oxidase.
77. A method for sterilizing an apparatus comprising:

placing the apparatus in a buffer;

placing a barrier between the apparatus and a package;
enclosing the apparatus and the buffer in the package; and sterilizing the package using light.
78. The method of Claim 77, wherein the barrier is a permeable window.
79. The method of Claim 77, further comprising sterilizing the apparatus in a gas;
and sterilizing the apparatus in a liquid.
80. The method of Claim 77, wherein sterilizing the package using light comprises sterilizing the package using a broad spectrum pulse light.
81. The method of Claim 79, wherein sterilizing the apparatus in a gas comprises sterilizing the apparatus in ethylene oxide.
82. The method of Claim 79, wherein sterilizing the apparatus in a liquid comprises sterilizing the apparatus in glutaraldehyde.
83. The method of Claim 77, wherein packaging the apparatus in a buffer comprises packaging the apparatus in a bicarbonate solution.
84. The method of Claim 77, wherein packaging the apparatus in a buffer comprises packaging an apparatus comprising a biosensor.
85. (New) The method of Claim 84, wherein the biosensor comprises a biomolecule.
86. (New) The method of Claim 85, wherein the biomolecule comprises a glucose oxidase enzyme.
87. (New) A sterile apparatus comprising:

a sterile buffer for hydration;

a water soluble support;

a sterile device for use in a sterile application, the sterile device being immobilized onto the water soluble support, the sterile device and the water soluble support being immersed in the sterile buffer; and a sterile package, wherein the sterile package encloses the sterile device and the sterile buffer.
CA2464099A 2001-10-23 2002-09-27 Sterile device and method for producing same Expired - Fee Related CA2464099C (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US33597801P 2001-10-23 2001-10-23
US60/335,978 2001-10-23
US33563801P 2001-10-24 2001-10-24
US60/335,638 2001-10-24
US10/034,505 2001-12-28
US10/034,505 US6923936B2 (en) 2001-10-23 2001-12-28 Sterile device and method for producing same
PCT/US2002/030944 WO2003035117A1 (en) 2001-10-23 2002-09-27 Sterile device and method for producing same

Publications (2)

Publication Number Publication Date
CA2464099A1 true CA2464099A1 (en) 2003-05-01
CA2464099C CA2464099C (en) 2010-03-30

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ID=27364672

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2464099A Expired - Fee Related CA2464099C (en) 2001-10-23 2002-09-27 Sterile device and method for producing same

Country Status (7)

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US (3) US6923936B2 (en)
EP (1) EP1443974B1 (en)
JP (1) JP4348183B2 (en)
AT (1) ATE549039T1 (en)
CA (1) CA2464099C (en)
DK (1) DK1443974T3 (en)
WO (1) WO2003035117A1 (en)

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