US4675159A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method and device for disinfecting biological fluids and container for same
Assignee: HEGELAN KHALED AL AS ATTORNEY-IN-FACT FOR MARDAM-BEY AMER A AND WYNNE GREGORY P
•
Filing: 1985-09-29
•
Granted: 1987-06-23
•
Expires: 2005-09-29
Abstract
Abstract A technique and receptacle for disinfecting biological fluids such as whole blood is described in which the disinfectant is prepositioned in a receptacle for biological fluids utilized for clinical evaluation in an amount which is sufficient to disinfect the fluid without interfering with subsequent clinical evaluation. The invention is specifically directed to disinfecting viral contaminants in blood by providing a closed container for the blood specimen which contains an amount of an aldehyde based disinfectant such as glutaraldehyde sufficient to destroy without otherwise affecting the integrity of the specimen for future evaluation. The amount of aldehyde based disinfectant positioned in the container is adjusted to provide an ultimate concentration in the blood specimen of aldehyde of about 0.1 to 2.5 weight percent and is buffered to a pH of about 7.2 to 8.5 percent preferably about 7.4. To increase the stability and shelf life of the sample container and disinfectant, activation or buffering to the indicated pH range does not take place until or just prior to introduction of the specimen into the container. In a particularly preferred embodiment of the invention, the closed sample container is evacuated and provided with an elastomeric stopper adapted to receive the hollow needle of a syringe whereby the blood specimen is introduced into the container directly from the donor.
Inventors
- 👤 Habib Al-Sioufi
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 18:03
CPC Classifications
B; B01; B01L; B01L3/00; B01L3/50; B01L3/508; B01L3/5082; A; A01; A01N; A01N35/00; A01N35/02; A61; A61L; A61L2/00; A61L2/16; A61L2/18; A61L2103/00; A61L2103/05
Claims Analysis
Total Claims: 31
Claim 1
Independent Claim
111 words
An evacuated receptacle for holding a specimen of biological fluid for clinical evaluation, comprising a vessel closed at one of its ends by an elastomeric stopper adapted to be penetrated by means for introducing said specimen therein, said vessel also containing prior to introduction of said specimen about 0.1 to 2.5 weight percent based on the total fluid and disinfectant of a disinfectant for viral infection present in the specimen which disinfectant is one or more compounds or mixtures thereof selected from the group consisting of glutaraldehyde and formaldehyde said disinfectant being buffered substantially at the time said biological fluid is introduced therein to a pH of about 7.2 to 8.5.
Claim 2
Dependent Claim
111 words
An evacuated receptacle for holding a specimen of biological fluid for clinical evaluation, comprising a vessel closed at one of its ends by an elastomeric stopper adapted to be penetrated by means for introducing said specimen therein, said vessel also containing prior to introduction of said specimen about 0.1 to 2.5 weight percent based on the total fluid and disinfectant of a disinfectant for viral infection present in the specimen which disinfectant is one or more compounds or mixtures thereof selected from the group consisting of glutaraldehyde and formaldehyde said disinfectant being buffered substantially at the time said biological fluid is introduced therein to a pH of about 7.2 to 8.5.
Claim 3
Dependent Claim
16 words
The receptacle of claim 1 in which said vessel also contains an activator for said disinfectant.
Claim 4
Dependent Claim
16 words
The receptacle of claim 1 wherein both ends of said vessel are closed by elastomeric stoppers.
Claim 5
Dependent Claim
69 words
The receptacle of claim 3 wherein both of said stoppers are provided with cavities adapted to retain material until said biological fluid is introduced into said receptacle, the stopper adapted for penetration by said means for introducing the fluid being also adapted to release said material retained therein on penetration, and the other of said stoppers being provided with separate means to release material contained therein into said receptacle.
Claim 6
Dependent Claim
17 words
The receptacle of claim 4 wherein the material retained in one of said stoppers is said disinfectant.
Claim 7
Dependent Claim
46 words
The receptacle of claim 5 wherein said disinfectant is glutaraldehyde and said biological fluid is blood, said glutaraldehyde being present in an amount such that introduction of said blood dilutes its concentration to about 0.1 to 2.5 weight percent based on the combined blood and glutaraldehyde.
Claim 8
Dependent Claim
38 words
The receptacle of the claim 5 wherein an alkaline buffering agent is also retained in one of said stoppers in an amount sufficient to adjust the pH of the blood in said receptacle to about 7.2 to 8.5.
Claim 9
Dependent Claim
32 words
The receptacle of claim 4 wherein said means to release material into the receptacle is an externally provided means for penetrating an envelope or barrier confining said material within said other stopper.
Claim 10
Dependent Claim
12 words
The receptacle of claim 8 wherein said penetration means is a pin.
Claim 11
Dependent Claim
20 words
the receptacle of claim 1 wherein said disinfectant is disposed in the end of said vessel remote from said stopper.
Claim 12
Dependent Claim
18 words
The receptacle of claim 10 wherein the concentration of said disinfectant is about 0.13 to 2.0 weight percent.
Claim 13
Dependent Claim
17 words
The receptacle of claim 1 wherein said disinfectant is coated onto the inside walls of said vessel.
Claim 14
Dependent Claim
16 words
The receptacle of claim 1 which also contains an effective amount of anticoagulant for said blood.
Claim 15
Dependent Claim
30 words
The receptacle of claim 1 which also includes an effective amount of a substance or substances to enhance cell permeability selected from the group consisting of dimethyl sulfoxide and glycerol.
Claim 16
Dependent Claim
40 words
The receptacle of claim 14 wherein an alkaline buffering agent is disposed therein and separated from said glutaraldehyde prior to introducing said biological fluid, in an amount sufficient to accomplish said buffering when said fluid is introduced into the receptacle.
Claim 17
Dependent Claim
60 words
The receptacle of claim 15 wherein either said disinfectant of said buffering agent is disposed in a cavity in said stopper such that introduction of biological fluid through said stopper causes said disinfectant or agent to be released into said vessel and whichever of the agent or disinfectant is not disposed in said stopper is otherwise present in said vessel.
Claim 18
Dependent Claim
29 words
The receptacle of claim 15 wherein said buffering agent is selected from the group consisting of sodium bicarbonate, sodium phenate, alkanols or 2-4 carbons, phenol, and quaternary ammonium compounds.
Claim 19
Dependent Claim
28 words
The receptacle of claim 1 wherein said disinfectant is buffered to a pH of about 7.4 by introduction of a said biological fluid and said fluid is blood.
Claim 20
Dependent Claim
83 words
In an evacuated receptacle for receiving and holding a specimen of blood for clinical evaluation comprising a closed vessel provided with at least one elastomeric stopper to effect said closure, the improvement which comprises: said receptacle containing prior to introduction of the blood an effective amount of glutaraldehyde such that introduction therein of said blood results in a glutaraldehyde concentration of about 0.1 to 2.5 weight percent based on the total of blood and glutaraldehyde and a pH of about 7.2 to 8.5.
Claim 21
Dependent Claim
83 words
In an evacuated receptacle for receiving and holding a specimen of blood for clinical evaluation comprising a closed vessel provided with at least one elastomeric stopper to effect said closure, the improvement which comprises: said receptacle containing prior to introduction of the blood an effective amount of glutaraldehyde such that introduction therein of said blood results in a glutaraldehyde concentration of about 0.1 to 2.5 weight percent based on the total of blood and glutaraldehyde and a pH of about 7.2 to 8.5.
Claim 22
Dependent Claim
42 words
The receptacle of claim 19 wherein an alkaline buffering agent is disposed therein separate from said glutaraldehyde prior to introducing said blood therein in an amount sufficient to accomplish buffering of the blood and glutaraldehyde to a pH of 7.2 to 8.5.
Claim 23
Dependent Claim
27 words
The receptacle of claim 19 wherein said at least one elastomeric stopper is adapted to receive a hollow syringe needle for introducing said blood into said receptacle.
Claim 24
Independent Claim
95 words
A method for destroying viral contamination in a specimen of biological fluid which comprises providing an evacuated container for said fluid having predisposed therein an aldehyde or mixture of aldehydes in an amount sufficient to be lethal to said viral contamination in the biological fluid to be placed in said container without otherwise interfering with subsequent biomedical evaluation of said specimen, said amount of aldehyde being present in said container in a concentration of about 0.1 to 2.5 weight percent based on the total fluid and aldehyde and a pH of about 7.2 to 8.5.
Claim 25
Independent Claim
95 words
A method for destroying viral contamination in a specimen of biological fluid which comprises providing an evacuated container for said fluid having predisposed therein an aldehyde or mixture of aldehydes in an amount sufficient to be lethal to said viral contamination in the biological fluid to be placed in said container without otherwise interfering with subsequent biomedical evaluation of said specimen, said amount of aldehyde being present in said container in a concentration of about 0.1 to 2.5 weight percent based on the total fluid and aldehyde and a pH of about 7.2 to 8.5.
Claim 26
Dependent Claim
11 words
The method of claim 22 wherein said biological fluid is blood.
Claim 27
Dependent Claim
122 words
An evacuated receptacle for receiving and retaining a specimen of blood for clinical evaluation, comprising a closed, elongated cylinder having an elastomeric stopper closing at least one of its ends and adapted to receive and be penetrated by means for introducing said blood specimen into said cylinder; the interior of said cylinder being provided prior to introducing said blood specimen with an aldehyde disinfectant for viral contamination and preservation of said specimen in an amount sufficient for said disinfection but insufficient to effect clinical evaluation of said specimen, the amount of said aldehyde beinig further sufficient to insure a concentration of about 0.1 to 2.5 weight percent based on the combined sample and disinfectant and a pH of about 7.2 to 8.5.
Claim 28
Dependent Claim
122 words
An evacuated receptacle for receiving and retaining a specimen of blood for clinical evaluation, comprising a closed, elongated cylinder having an elastomeric stopper closing at least one of its ends and adapted to receive and be penetrated by means for introducing said blood specimen into said cylinder; the interior of said cylinder being provided prior to introducing said blood specimen with an aldehyde disinfectant for viral contamination and preservation of said specimen in an amount sufficient for said disinfection but insufficient to effect clinical evaluation of said specimen, the amount of said aldehyde beinig further sufficient to insure a concentration of about 0.1 to 2.5 weight percent based on the combined sample and disinfectant and a pH of about 7.2 to 8.5.
Claim 29
Dependent Claim
35 words
The receptacle of claim 24 which also contains separate from the aldehyde an alkaline buffering agent in an amount sufficient to result in said pH of 7.2 to 8.5 on introduction of said blood specimen.
Claim 30
Dependent Claim
10 words
The receptacle of claim 24 wherein said aldehyde is glutaraldehyde.
Claim 31
Dependent Claim
16 words
The receptacle of claim 24 in which said aldehyde is a mixture of formaldehyde and glutaraldehyde.
References Cited (Backward Citations)
US3901219A
Cited
US4189382A
Cited
JPS54105877A
Cited
US4336880A
Cited
US4294707A
Cited
US4308232A
Cited
FR2463621A1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1990-06-22 | 1990-12-22 | 1991-06-23 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1994-06-22 | 1994-12-22 | 1995-06-23 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1998-06-22 | 1998-12-22 | 1999-06-23 | $7700.00 | Window Closed / Lapsed |