Patent US5268144A successfully refreshed from Google Patents.
US5268144A
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Method for sterilizing a medical unit
Assignee: Fresenius SE and Co KGaA
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Filing: 1992-07-29
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Granted: 1993-12-07
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Expires: 2012-07-29
Abstract
Abstract This invention relates to a method for sterilizing a medical unit having at least two connections for a fluid flow pathway where a sterilizing medium flows through the medical unit. Medical units of this type are e.g. medical filters, in particular dialyzers. A high degree of sterility is here required. This is accomplished through the steps of: (a) inserting the medical unit into a system under pressure-tight coupling of the at least two connections to a feed conduit and discharge conduit of the system under atmospheric conditions; (b) passing the sterilizing medium from the system through the medical unit for a given period of time; (c) closing the at least two connections in the coupled state and in a germproof manner, without the same being opened, on completion of the sterilization operation; and (d) removing said medical unit from said system as a sterile medical unit with closed connections. All steps, including the removal of the medical unit, are therefore carried out in a system where the sterility obtained is constantly maintained. This "inline sterilization" guarantees a high degree of sterility of the medical units treated.
Inventors
- 👤 Klaus Heilmann
- 👤 Bernd Mathieu
- 👤 Michael Rink
- 👤 Wolfram Weber
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-09 00:50
CPC Classifications
A; A61; A61L; A61L2/00; A61L2/16; A61L2/18; A61L2/02; A61L2/04; B; B01; B01D; B01D65/00; B01D65/02; B01D65/022; A61M; A61M1/00; A61M1/14; A61M1/16; A61M1/168; A61M1/169; B01D2321/00; B01D2321/08; B01D2321/16; B01D2321/162
Claims Analysis
Total Claims: 25
Claim 1
Independent Claim
135 words
A method for sterilizing a medical unit comprising at least two connections for a fluid flow pathway where a sterilizing medium flows through said unit, comprising the steps of: (a) inserting a medical unit comprising at least two connections into a sterilization system under pressure-tight coupling of said at least two connections to a feed conduit and a discharge conduit under atmospheric conditions; (b) passing a sterilizing medium from said sterilization system through said medical unit for a given period of time; (c) closing said at least two connections in the coupled state and in a germproof manner within the same being opened on completion of the sterilization operation of step (b); and (d) removing said medical unit from said sterilization system as a sterile medical unit with said at least two connections remaining closed.
Claim 2
Independent Claim
135 words
A method for sterilizing a medical unit comprising at least two connections for a fluid flow pathway where a sterilizing medium flows through said unit, comprising the steps of: (a) inserting a medical unit comprising at least two connections into a sterilization system under pressure-tight coupling of said at least two connections to a feed conduit and a discharge conduit under atmospheric conditions; (b) passing a sterilizing medium from said sterilization system through said medical unit for a given period of time; (c) closing said at least two connections in the coupled state and in a germproof manner within the same being opened on completion of the sterilization operation of step (b); and (d) removing said medical unit from said sterilization system as a sterile medical unit with said at least two connections remaining closed.
Claim 3
Dependent Claim
20 words
The method of claim 1 wherein said sterilizing medium is water vapor at a temperature of 105° C or greater.
Claim 4
Dependent Claim
14 words
The method of claim 1 wherein said sterilizing medium is a peracetic acid solution.
Claim 5
Dependent Claim
30 words
The method of claim 1 wherein prior to the treatment of said medical unit with said sterilizing medium, a fluid from said sterilization system is flushed through said medical unit.
Claim 6
Dependent Claim
11 words
The method as of claim 4 wherein said fluid is water.
Claim 7
Dependent Claim
31 words
The method of claim 1 wherein on completion of the sterilization operation said medical unit is flushed with a sterile fluid prior to the closing of said at least two connections.
Claim 8
Dependent Claim
11 words
The method of claim 6 wherein said sterile fluid is water.
Claim 9
Dependent Claim
14 words
The method of claim 7 wherein said sterile fluid is a cooled sterilizing medium.
Claim 10
Dependent Claim
14 words
The method of claim 6 wherein said sterile fluid is a cooled sterilizing medium.
Claim 11
Dependent Claim
27 words
The method of claim 6 wherein at least a part of said sterile fluid remains in said medical unit when said at least two connections are closed.
Claim 12
Dependent Claim
28 words
The method of claim 1 wherein a drying operation with a sterile gas is carried out prior to closing said at least two connections of said medical unit.
Claim 13
Dependent Claim
19 words
The method of claim 11 wherein said sterile gas is air at a temperature of 100° C. or greater.
Claim 14
Independent Claim
167 words
A method of sterilizing a medical unit having at least two connections for a fluid flow pathway wherein a sterilizing medium flows through said medical unit, said method comprising the steps of: (a) inserting and temporarily fastening a medical unit having at least two connections in a closed sterilization system defining a circuit under pressure-tight coupling of one of said at least two connections to a feed conduit and the other of said at least two connections to a discharge conduit under atmospheric conditions; (b) passing a sterilizing medium to said feed conduit, through said medical unit, and into said discharge conduit for a given period of time; (c) closing said at least two connections upon completion of the sterilization operation of step (b) in the coupled state and in a germproof manner without said at least two connections being opened to the atmosphere; and (d) removing said medical unit from said sterilization system as a sterile medical unit with said at least two connections remaining closed.
Claim 15
Independent Claim
167 words
A method of sterilizing a medical unit having at least two connections for a fluid flow pathway wherein a sterilizing medium flows through said medical unit, said method comprising the steps of: (a) inserting and temporarily fastening a medical unit having at least two connections in a closed sterilization system defining a circuit under pressure-tight coupling of one of said at least two connections to a feed conduit and the other of said at least two connections to a discharge conduit under atmospheric conditions; (b) passing a sterilizing medium to said feed conduit, through said medical unit, and into said discharge conduit for a given period of time; (c) closing said at least two connections upon completion of the sterilization operation of step (b) in the coupled state and in a germproof manner without said at least two connections being opened to the atmosphere; and (d) removing said medical unit from said sterilization system as a sterile medical unit with said at least two connections remaining closed.
Claim 16
Dependent Claim
21 words
The method of claim 13 wherein said sterilizing medium is pressurized water at a temperature of about 105° C. or greater.
Claim 17
Dependent Claim
14 words
The method of claim 13 wherein said sterilizing medium is a peracetic acid solution.
Claim 18
Dependent Claim
30 words
The method of claim 13 wherein prior to the treatment of said medical unit with said sterilizing medium, a fluid from said sterilization system is flushed through said medical unit.
Claim 19
Dependent Claim
10 words
The method of claim 16 wherein said fluid is water.
Claim 20
Dependent Claim
30 words
The method of claim 13 wherein upon completion of the sterilization operation, said connected medical unit is flushed with a sterile fluid until said at least two connections are closed.
Claim 21
Dependent Claim
11 words
The method of claim 18 wherein said sterile fluid is water.
Claim 22
Dependent Claim
14 words
The method of claim 18 wherein said sterile fluid is a cooled sterilizing medium.
Claim 23
Dependent Claim
27 words
The method of claim 18 wherein at least a part of said sterile fluid remains in said medical unit when said at least two connections are closed.
Claim 24
Dependent Claim
28 words
The method of claim 13 wherein a drying operation with a sterile gas is carried out prior to closing said at least two connections of said medical unit.
Claim 25
Dependent Claim
19 words
The method of claim 22 wherein said sterile gas is air at a temperature of 100° C. or greater.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 1996-12-06 | 1997-06-07 | 1997-12-07 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2000-12-06 | 2001-06-07 | 2001-12-07 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2004-12-06 | 2005-06-07 | 2005-12-07 | $7700.00 | Window Closed / Lapsed |