# US 11,998,918 B2 · Bag containing a reference fluid

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- Number: US 11,998,918 B2
- Document ID: US11998918B2
- Status: Granted
- Kind: B2
- Application number: 16/499,487
- Filed: 2018-03-27
- Published: 2020-02-06
- Granted: 2024-06-04
- Earliest claimed: 2017-04-03
- Assignees: Radiometer Medical ApS
- Applicants: Radiometer Medical ApS
- Inventors: Torben Rydal; Hans Peter Blaabjerg Jakobsen
- Web page: https://patentgrep.com/patent/US11998918B2

## CPC

- B01L 3/505: {Flexible containers without fluid transport within}
- B01L 3/523: {with means for closing or opening}
- B32B 3/266: {characterised by an apertured layer, the apertures going through the whole thickness of the layer, e.g. expanded metal, perforated layer, slit layer regular cells B32B3/12}
- B32B 7/12: using interposed adhesives or interposed materials with bonding properties
- B32B 15/085: comprising polyolefins
- B32B 15/088: comprising polyamides
- B32B 15/09: comprising polyesters
- B32B 15/20: comprising aluminium or copper {(B32B15/016 and B32B15/017 take precedence)}
- B32B 27/08: of synthetic resin
- B32B 27/34: comprising polyamides
- B32B 27/36: comprising polyesters
- B01L 2200/026: Fluid interfacing between devices or objects, e.g. connectors, inlet details
- B01L 2200/0689: Sealing
- B01L 2200/12: Specific details about manufacturing devices
- B01L 2200/141: Preventing contamination, tampering
- B01L 2200/148: Specific details about calibrations
- B01L 2300/044: pierceable, e.g. films, membranes
- B01L 2300/0887: Laminated structure
- B32B 27/32: comprising polyolefins {(comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30)}
- B32B 2250/03: 3 layers
- B32B 2250/04: 4 layers
- B32B 2250/40: Symmetrical or sandwich layers, e.g. ABA, ABCBA, ABCCBA
- B32B 2255/10: on synthetic resin layer or on natural or synthetic rubber layer
- B32B 2255/20: Inorganic coating
- B32B 2307/31: Heat sealable
- B32B 2307/518: bi-axially
- B32B 2307/714: Inert, i.e. inert to chemical degradation, corrosion
- B32B 2307/7242: Non-permeable
- B32B 2307/7244: Oxygen barrier
- B32B 2439/46: Bags
- G01N 2496/00: Reference solutions for assays of biological material
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The invention relates to a sealed bag containing a reference fluid for the calibration or quality control of a sensor element for measuring body fluid parameters, the bag comprising peripheral walls of a first layered material. The bag further comprises an access port formed by an opening in the first layered material, wherein the opening is sealed by a cover of a second layered material, wherein the second layered material is more resistant to oxidation by the reference fluid than the first layered material.

## Claims

### Claim 1

A sealed bag containing a reference fluid for the calibration or quality control of a sensor element for measuring body fluid parameters, the bag comprising:
peripheral walls of a first layered material; and
an access port formed by an opening in the first layered material,
wherein the opening is sealed by a cover of a second layered material, the second layered material being more resistant to oxidation by the reference fluid than the first layered material, and
wherein the reference fluid comprises at least one analyte selected from the group consisting of CO2, O2, K+, Na+, Ca2+, Cl−, glucose, lactate, haemoglobin, creatinine, creatine, and urea.

### Claim 2 (depends on 1)

The sealed bag according to claim 1, wherein the first layered material comprises an inner polymer layer in contact with the reference fluid, an outer polymer layer, and a gas barrier layer between the inner and outer polymer layers.

### Claim 3 (depends on 2)

The sealed bag according to claim 2, wherein the gas barrier layer of the first layered material is made of aluminum.

### Claim 4 (depends on 1)

The sealed bag according to claim 1, wherein the inner polymer layer of the first layered material is made of a heat-sealable material.

### Claim 5 (depends on 1)

The sealed bag according to claim 1, wherein an inner polymer layer of the first layered material is made of polyolefin.

### Claim 6 (depends on 1)

The sealed bag according to claim 1, wherein an outer polymer layer of the first layered material is made of polyethylene terephthalate or polyamide.

### Claim 7 (depends on 1)

The sealed bag according to claim 1, wherein the second layered material comprises at least a first polymer layer, a second polymer layer, and a first gas barrier layer between the first and second polymer layers.

### Claim 8 (depends on 7)

The sealed bag according to claim 7, wherein the first gas barrier layer of the second layered material is made of aluminum oxide or silicon oxide.

### Claim 9 (depends on 7)

The sealed bag according to claim 7, wherein the first polymer layer of the second layered material is made of a heat-sealable material.

### Claim 10 (depends on 7)

The sealed bag according to claim 7, wherein the first polymer layer of the second layered material is made of polyolefin.

### Claim 11 (depends on 7)

The sealed bag according to claim 7, wherein the second polymer layer of the second layered material is made of polyethylene terephthalate or polyamide.

### Claim 12 (depends on 7)

The sealed bag according to claim 7, wherein the second layered material comprises at least a first additional polymer layer between the first and second polymer layers.

### Claim 13 (depends on 12)

The sealed bag according to claim 12, wherein the second layered material further comprises a second additional polymer layer between the first and second polymer layers.

### Claim 14 (depends on 12)

The sealed bag according to claim 12, wherein the first and/or second additional polymer layers of the second layered material are made of polyethylene terephthalate.

### Claim 15 (depends on 7)

The sealed bag according to claim 7, wherein the second layered material further comprises a second gas barrier layer.

### Claim 16 (depends on 15)

The sealed bag according to claim 15, wherein the second gas barrier layer of the second layered material is made of aluminum oxide or silicon oxide.

### Claim 17 (depends on 1)

The sealed bag according to claim 1, wherein at least one of the layers composing the first layered material is a bi-axially oriented polymer.

### Claim 18 (depends on 1)

The sealed bag according to claim 1, wherein at least one of the layers composing the second layered material is a bi-axially oriented polymer.

### Claim 19 (depends on 1)

The sealed bag according to claim 1, wherein the cover is attached to the peripheral wall from the inside of the bag.

### Claim 20 (depends on 1)

The sealed bag according to claim 1, wherein the cover is attached to an attachment portion of the peripheral wall at the periphery around the opening.

### Claim 21 (depends on 1)

The sealed bag according to claim 1, wherein the first and second layered materials are joined to each other with the inner polymer layer of the first layered material in sealing engagement with the first polymer layer of the second layered material.

### Claim 22 (depends on 1)

The sealed bag according to claim 1, wherein the reference fluid comprises creatinine and/or creatine.

### Claim 23 (depends on 1)

The sealed bag according to claim 1, wherein the reference fluid comprises oxygen.

### Claim 24 (depends on 1)

The sealed bag according to claim 1, further comprising a sealing element adapted for being pierced by an access probe.

### Claim 25 (depends on 1)

The sealed bag according to claim 1, further comprising a support element attached to an inner surface of the bag.

### Claim 26 (depends on 25)

The sealed bag according to claim 25, wherein the support element and the inner surface of the bag are made from the same material.

### Claim 27 (depends on 25)

The sealed bag according to claim 25, wherein the support element comprises at least one passage for receiving an access probe.

### Claim 28 (depends on 27)

The sealed bag according to claim 27, wherein the opening is aligned with the passage through the support element.

### Claim 29 (depends on 25)

The sealed bag according to claim 25, wherein the cover is arranged between the support element and the peripheral wall around the opening.

### Claim 30 (depends on 1)

A reference fluid bag assembly comprising a sealed bag according to claim 1, and an access probe adapted for insertion into the sealed bag through the access port by piercing the second layered material, the access probe being further adapted for withdrawing the reference liquid there through.

### Claim 31 (depends on 30)

A container adapted for providing an analysis instrument for measuring parameters of a body fluid with a plurality of reference fluids for sensor calibration and/or sensor quality control, the container comprising at least one bag assembly according to claim 30.