SYSTEM AND METHOD OF STERILIZING AN IMPLANTABLE MEDICAL DEVICE

• US 20090202387A1
• Filed: 02/08/2008
• Published: 08/13/2009
• Est. Priority Date: 02/08/2008
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Leuenberger, Mark, Ortiz, Mark S., Dlugos, Daniel F. JR., Plescia, David N.
• Granted Patent: US 8,114,345 B2
• Time in Patent Office: Days
• 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. An implantable medical system, comprising:

an implantable medical device configured to be disposed within a patient'"'"'s peritoneal cavity; and

an internal control module in electrical communication with at least one of the implantable medical device and an external device, and further including circuitry components resistant to an amount of a type of radiation.

2. The system of claim 1, wherein the circuitry components are resistant to an amount of radiation encountered during sterilization of the implantable medical device.

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

4. The system of claim 1, wherein at least one of the circuitry components are fabricated at least in part from a radiation compliant material.

5. The system of claim 4, wherein the radiation compliant material is selected from the group consisting of a ceramic material, titanium, gold, silver, tantalum, platinum, palladium, and rhodium.

6. The system of claim 1, wherein the internal control module includes a circuit board fabricated at least in part from a radiation compliant material.

7. The system of claim 1, wherein the internal control module includes a radiation hardened component selected from the group consisting of a magnetic random access memory component, a surface acoustical wave device, and a component fabricated utilizing magnetic field based technology.

8. The system of claim 1, wherein the circuitry components are present in at least one of a sensor, a microprocessor, a microcontroller, a gate array, an application specific integrated circuit, a memory device, and signal conditioning circuitry.

9. The system of claim 1, wherein at least one of the circuitry components is fabricated at least in part from gallium arsenide.

10. The system of claim 1, wherein at least one of the circuitry components is fabricated utilizing silicon-on-insulator technology.

11. The system of claim 10, wherein the at least one circuitry component includes at least one silicon layer having a top face and a bottom face, and the circuitry components further include at least one insulator layer disposed on at least one face of the silicon layer.

12. The system of claim 11, wherein the insulator layer is selected from the group consisting of sapphire and silicon dioxide.

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

14. The system of claim 13, wherein the amount of radiation is any amount up to about 100 kGy.

15. An implantable system, comprising:

an implantable medical device configured to be disposed within a patient'"'"'s peritoneal cavity; and

an implantable control module having any number of electronic components configured to be resistant to a pre-determined dose of radiation

16. The system of claim 15, wherein the implantable medical device is a restriction device configured to form a restriction in a pathway.

17. The system of claim 15, wherein the pre-determined dose of radiation is capable of sterilizing the implantable medical device.

18. The system of claim 17, wherein the radiation is selected from the group consisting of gamma radiation, x-ray radiation, and electron beam radiation.

19. The system of claim 17, wherein the pre-determined dose of radiation is any amount up to about 100 kGy.

20. The system of claim 15, wherein at least one of the electronic components is fabricated utilizing silicon-on-insulator technology.

21. The system of claim 15, wherein at least one of the electronic components is a surface acoustic wave device.

22. The system of claim 15, wherein at least one of the electronic components is fabricated utilizing gallium arsenide technology.

23. The system of claim 15, wherein at least one of the electronic components is fabricated utilizing magnetic field based technology.

24. 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; and

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

25. The method of claim 24, wherein the implantable medical device is a restriction device configured to form a restriction in a pathway.

26. The method of claim 24, wherein at least one of the electronic components are fabricated utilizing silicon-on-insulator technology.

27. The method of claim 24, wherein the radiation is selected from the group consisting of gamma radiation, x-ray radiation, and electron beam radiation.

28. The method of claim 24, wherein the pre-determined dose of radiation is any amount up to about 100 kGy.

29. The method of claim 24, further comprising delivering at least one additional dose of a pre-determined amount of radiation.