IP Library › Granted Patent US 10,722,651
Granted Patent B2
US 10,722,651 · App. 15/355,852 · Granted Jul 28, 2020

Method for producing a sterilized subcutaneous access device and a sterilized subcutaneous access device

Inventors: Herbert Harttig (Neustadt, DE); Frederic Wehowski (Hockenheim, DE)
Assignee: Roche Diabetes Care, Inc.
A61M5/1723A61L2/08A61M5/14248H01M2/08H01M6/40A61L2202/24A61M2205/8206H01M2220/30
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Quick Facts
Patent No.
US 10,722,651
App. No.
15/355,852
Granted
Jul 28, 2020
Kind
B2
Abstract

The application relates to a method for producing a sterilized subcutaneous access device, the method comprising: producing a device carrier unit, comprising providing a carrier, producing a subcutaneous access part on the carrier, the subcutaneous access part being provided with at least one of a sensor device for detecting an analyte present in a bodily fluid and an infusion device for infusion of a substance, and producing an electronic assembly on the carrier, the producing comprising printing a battery on a carrier material, and sterilizing the device carrier unit by radiation sterilization, the sterilizing comprising exposing the printed battery to the radiation applied for sterilization. Furthermore, the application relates to a sterilized subcutaneous access device.

Claims (28)

1. A method for producing a sterilized subcutaneous access device, comprising:

producing a device carrier unit, comprising:

providing a carrier;

producing a subcutaneous access part on the carrier, the subcutaneous access part having at least one of a sensor device for detecting an analyte present in a bodily fluid and an infusion device for infusion of a substance; and

producing an electronic assembly on the carrier, the producing comprising printing a battery on a carrier material; and

sterilizing the device carrier unit by radiation, the sterilizing comprising exposing the printed battery to the radiation applied for sterilization and shielding a part of the electronic assembly from the radiation applied for sterilization; and

wherein the printed battery has a zinc-manganese dioxide chemistry with zinc chloride as the electrolyte and has a discharge curve after being sterilized by radiation that is without significant loss of performance relative to a discharge curve of the printed battery before being sterilized.

2. Method according to claim 1 , wherein the shielding comprises permanently shielding the part of the electronic assembly by a radiation shielding device provided on the carrier unit.

3. Method according to claim 1 , wherein the producing comprises producing the printed battery on a device carrier unit part made of a flexible material.

4. Method according to claim 1 , wherein the producing comprises covering the printed battery with a cover layer.

5. Method according to claim 1 , wherein the producing comprises providing the printed battery outside a device housing in which part of the electronic assembly is received.

6. Method according to claim 5 , wherein the printed battery at least partially surrounds a housing of the device carrier unit.

7. Method according to claim 1 , wherein the producing comprises providing the printed battery on a device carrier unit flange.

8. Method according to claim 1 , wherein the producing comprises providing the printed battery on an adhesive patch part of the device carrier unit.

9. Method according to claim 1 , wherein the producing comprises connecting the printed battery to at least one other device of the electronic assembly by one or more printed conductor paths.

10. Method according to claim 1 , wherein the sterilizing comprises applying electron radiation.

11. Method according to claim 1 , wherein the printing comprises printing an antenna device.

12. Method according to claim 1 wherein the step of producing an electronic assembly on the carrier comprises providing the printed battery on an adhesive patch part of the device carrier unit outside of a device housing in which the part of the electronic assembly shielded from radiation is received and wherein the part of the electronic assembly shielded from radiation comprises a printed circuit board.

13. Method according to claim 12 wherein temporary shielding which is not part of the sterilized subcutaneous access device is used to shield the part of the electronic assembly shielded from radiation and wherein the device housing which receives the part of the electronic assembly shielded from radiation is not shielded by the temporary shielding.

14. A method for producing a sterilized subcutaneous access device, comprising:

producing a device carrier unit, comprising:

providing a carrier;

producing a subcutaneous access part on the carrier, the subcutaneous access part having at least one of a sensor device for detecting an analyte present in a bodily fluid and an infusion device for infusion of a substance; and

producing an electronic assembly on the carrier, the producing comprising printing a battery on a carrier material;

sterilizing the device carrier unit by radiation, the sterilizing comprising exposing the printed battery to the radiation applied for sterilization and shielding a part of the electronic assembly from the radiation applied for sterilization; and

wherein the sterilizing radiation is applied at an energy in the range from 5 to 15 MeV and in a dose of 20 to 30 kGy.

15. Method according to claim 14 , wherein the printed battery has a zinc-manganese dioxide chemistry with zinc chloride as the electrolyte and has a discharge curve after being sterilized by radiation that is without significant loss of performance relative to a discharge curve of the printed battery before being sterilized.

16. Method according to claim 12 wherein the sterilizing radiation is applied at an energy in the range from 5 to 15 MeV and in a dose of 20 to 30 kGy.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 7, 2017
From: HARTTIG, HERBERT; WEHOWSKI, FREDERIC
To: ROCHE DIABETES CARE GMBH
Reel/Frame 042928/0193 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 7, 2017
From: ROCHE DIABETES CARE GMBH
To: ROCHE DIABETES CARE, INC.
Reel/Frame 042928/0238 →
Priority Claims (1)
EP 14169086 · May 20, 2014 · regional
Continuity (2)
Continuation PCTEP2015060513 · May 12, 2015
Related Publication 20170065767A1 · Mar 9, 2017