# US 2016/0354500 A1 · Protective agents against e-beam irradiation for proteins in optical sensing chemistry

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2016/0354500 A1
- Document ID: US20160354500A1
- Status: Published application
- Kind: A1
- Application number: 14/728,442
- Filed: 2015-06-02
- Published: 2016-12-08
- Earliest claimed: 2015-06-02
- Assignees: Medtronic MiniMed, Inc.
- Applicants: Medtronic MiniMed, Inc.
- Inventors: Tri T. Dang; Sarkis Aroyan; Jesper Svenning Kristensen
- Web page: https://patentgrep.com/patent/US20160354500A1

## CPC

- A61L 2/087: Particle radiation, e.g. electron-beam, alpha or beta radiation
- C12Q 1/006: {for glucose}
- G01N 33/66: involving blood sugars, e.g. galactose
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- G01N 2400/00: Assays, e.g. immunoassays or enzyme assays, involving carbohydrates
- A61L: METHODS 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 (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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

Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization.

## Claims

### Claim 1

A method of inhibiting damage to a saccharide sensor that can result from a radiation sterilization process, the method comprising combining the saccharide sensor with an aqueous radioprotectant formulation during the sterilization process, wherein:
the saccharide sensor comprises mannose binding lectin;
the aqueous radioprotectant formulation comprises a saccharide selected for its ability to bind the mannose binding lectin, the aqueous radioprotectant formulation further comprises at least one reactive oxygen species that includes sodium nitrate; and
performing the sterilization process under conditions selected so that the saccharide binds the mannose binding lectin and the reactive oxygen species absorbs free electron energy generated by the radiation sterilization process, wherein said conditions include a temperature below 10° C., thereby inhibiting damage to the saccharide sensor.

### Claim 2

(canceled)

### Claim 3 (depends on 1)

The method of claim 1, wherein the reactive oxygen species further comprises a, sulphate, phosphate or benzoyl peroxide.

### Claim 4 (depends on 1)

The method of claim 1, wherein the radioprotectant formulation further comprises mannitol.

### Claim 5 (depends on 1)

The method of claim 1, wherein the aqueous radioprotectant formulation comprises sodium nitrate, sucrose, and mannitol.

### Claim 6

(canceled)

### Claim 7 (depends on 1)

The method of claim 1, wherein the saccharide comprises glucose, mannose, fructose, melizitose, N-acetyl-D-glucosamine, sucrose or trehalose.

### Claim 8 (depends on 1)

The method of claim 1, wherein:
the saccharide sensor comprises a fluorophore; and
the aqueous radioprotectant formulation comprises a fluorophore quenching composition selected for its ability to quench the fluorophore.

### Claim 9 (depends on 1)

The method of claim 1, wherein the radiation sterilization process comprises electron beam irradiation.

### Claim at position 10

10-20. (canceled)

### Claim 21

A method of inhibiting damage to a saccharide sensor that can result from a radiation sterilization process, the method comprising combining the saccharide sensor with an aqueous radioprotectant formulation during the sterilization process, wherein:
the saccharide sensor comprises mannose binding lectin;
the aqueous radioprotectant formulation comprises a saccharide selected for its ability to bind the mannose binding lectin, the aqueous radioprotectant formulation further comprises at least one reactive oxygen species that includes a nitrate; and
performing the sterilization process under conditions selected so that the saccharide binds the mannose binding lectin and the reactive oxygen species absorbs free electron energy generated by the radiation sterilization process, wherein said conditions include a temperature below 10° C., thereby inhibiting damage to the saccharide sensor.

### Claim 22

A method of inhibiting damage to a saccharide sensor that can result from a radiation sterilization process, the method comprising combining the saccharide sensor with an aqueous radioprotectant formulation during the sterilization process, wherein:
the saccharide sensor comprises mannose binding lectin;
the aqueous radioprotectant formulation comprises a saccharide selected for its ability to bind the mannose binding lectin, the aqueous radioprotectant formulation further comprises at least one reactive oxygen species that includes a phosphate; and
performing the sterilization process under conditions selected so that the saccharide binds the mannose binding lectin and the reactive oxygen species absorbs free electron energy generated by the radiation sterilization process, wherein said conditions include a temperature below 10° C., thereby inhibiting damage to the saccharide sensor.

### Claim 23

A method of inhibiting damage to a saccharide sensor that can result from a radiation sterilization process, the method comprising combining the saccharide sensor with an aqueous radioprotectant formulation during the sterilization process, wherein:
the saccharide sensor comprises mannose binding lectin;
the aqueous radioprotectant formulation comprises a saccharide selected for its ability to bind the mannose binding lectin, the aqueous radioprotectant formulation further comprises at least one reactive oxygen species that includes a benzoyl peroxide; and
performing the sterilization process under conditions selected so that the saccharide binds the mannose binding lectin and the reactive oxygen species absorbs free electron energy generated by the radiation sterilization process, wherein said conditions include a temperature below 10° C., thereby inhibiting damage to the saccharide sensor.