System and method of sterilizing an implantable medical device

• US 8,114,345 B2
• Filed: 02/08/2008
• Issued: 02/14/2012
• Est. Priority Date: 02/08/2008
• Status: Expired due to Fees

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Dlugos, Daniel F. Jr., Ortiz, Mark S., Plescia, David N., Leuenberger, Mark
• Primary Examiner(s): Joyner, Kevin
• Application Number:
  US12/028,344
• Publication Number:
  US 20090202387A1
• Time in Patent Office: 1,467 Days
• Field of Search: 422/22, 606/157, 607/60
• US Class Current: 422/22
• CPC Class Codes: A61F 5/005 Gastric bands
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/082 X-rays
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

An implantable system having internal circuitry configured to withstand a pre-determined amount of sterilization radiation is provided. In general, the system includes an internal control module in electrical communication with an implantable medical device. The internal control module can include a circuit board configured to withstand radiation and/or any number of integrated circuits (e.g., application specific integrated circuits) wherein the circuits or at least some portion thereof are fabricated so as to withstand some amount of radiation. For example, some portion of the circuitry can be fabricated utilizing radiation compliant material(s), silicon-on-insulator technology, and/or gallium arsenide technology. Additionally, the circuitry can include various components which are inherently resistant to such radiation (e.g., components fabricated utilizing magnetic field based technology, surface acoustical wave devices, etc.). A method of sterilizing an implantable medical device via radiation is also provided.

Claims

1. A method for sterilizing an implantable medical device, comprising:

providing an implantable medical device configured to be disposed within a patient'"'"'s peritoneal cavity, the implantable medical device in electrical communication with an internal control module having any number of electronic components configured to be resistant to a pre-determined dose of radiation, at least one of the electronic components comprising a magnetoresistive random access memory (MRAM), at least one of the electronic components being configured to sense a fluid pressure within the implantable medical device; and

delivering a pre-determined dose of radiation to the implantable medical device.

2. The method of claim 1, wherein the implantable medical device is a restriction device configured to form a restriction in a pathway.

3. The method of claim 1, wherein at least one of the electronic components are fabricated utilizing silicon-on-insulator technology.

4. The method of claim 1, wherein the radiation is selected from the group consisting of gamma radiation, x-ray radiation, and electron beam radiation.

5. The method of claim 1, wherein the pre-determined dose of radiation is any amount up to about 100 kGy.

6. The method of claim 1, further comprising delivering at least one additional dose of a pre-determined amount of radiation.

7. A method for sterilizing an implantable medical device, comprising:

providing an implantable medical device having located therein, any number of electronic components configured for controlling the implantable medical device, at least one of the electronic components comprising a magnetoresistive random access memory (MRAM), wherein at least one of the electronic components is fabricated using silicon-on-insulator technology with a sapphire insulator; and

delivering radiation to the implantable medical device to sterilize the implantable medical device.

8. The method of claim 7, wherein the implantable medical device is a restriction device configured to form a restriction in a pathway.

9. The method of claim 7, wherein the radiation is delivered in a pre-determined dose up to about 100 kGy.

10. The method of claim 7, wherein the radiation is selected from the group consisting of gamma radiation, x-ray radiation, and electron beam radiation.

11. A method for sterilizing an implantable medical device, comprising:

providing an implantable medical device having located therein, any number of electronic components configured for controlling the implantable medical device, at least one of the electronic components comprising a magnetoresistive random access memory (MRAM), wherein at least one of the electronic components is fabricated using silicon-on-insulator technology with a silicon dioxide insulator; and

delivering radiation to the implantable medical device to sterilize the implantable medical device.

12. The method of claim 11, wherein the implantable medical device is a restriction device configured to form a restriction in a pathway.

13. The method of claim 11, wherein the radiation is delivered in a pre-determined dose up to about 100 kGy.