Medical treatment system with energy delivery device for limiting reuse

• US 7,118,564 B2
• Filed: 11/26/2003
• Issued: 10/10/2006
• Est. Priority Date: 11/26/2003
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Trusty, Robert Mason, Sheetz, Jane A., Ritchie, Paul G.
• Primary Examiner(s): Johnson, III, Henry M
• Application Number:
  US10/723,799
• Publication Number:
  US 20050113815A1
• Time in Patent Office: 1,049 Days
• Field of Search: 128/898, 606/2, 606/16
• US Class Current: 606/16
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2018/00636 Sensing and controlling the application of energy
• CPC Class Codes: A61B 2018/00988 Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• CPC Class Codes: A61B 2018/2261 with scattering, diffusion or dispersion of light

Abstract

The present invention provides an energy delivery device for use with a medical treatment system for the more efficacious treatment of patients during laser surgery which limits the number of uses or prevents reuse of the energy delivery device after a certain threshold limit has been reached. The energy delivery device comprises a diffusing optical fiber and a memory device having data programmed therein and being operatively connected to an energy generator the optical fiber includes a temperature sensor for generating a temperature signal in a closed loop manner. The data stored in the memory device includes a multiplicity of use parameters, usage limits, usage counts, and count limits all relating to the properties of the medical treatment system. The use parameters may include an elapsed time, a total treatment time, and a number of treatment sites. A main processor is also included for calculating a temperature from the temperature signal and for updating the use parameters in response to data received by the main processor. The main processor is also used to compare the use parameters to their corresponding usage limits. The main processor can create and increment a usage count when at least one of the use parameters exceeds its corresponding usage limit. Thereafter, the main processor compares the usage count to the count limit and disables the energy delivery device when the usage count exceeds a predetermined count limit.

Claims

1. A method for limiting the use of an energy delivery device having an optical fiber and a memory device, said optical fiber includes a multiplicity of use parameters and at least one usage limit corresponding to at least one of said use parameters stored in said memory device and wherein said optical fiber further comprises a temperature sensor, said method comprising the steps of:

generating a temperature signal using said temperature sensor; and

utilizing said temperature signal to determine whether at least one of said use parameters exceeds its corresponding usage limit; and

disabling said energy delivery device when said use parameter exceeds said usage limit.

2. The method for limiting the use of an energy delivery device according to claim 1, wherein said optical fiber further includes a date of manufacture, further comprising the steps of:

storing said date of manufacture in said memory device; and

utilizing said date of manufacture to determine whether said shelf life has expired.

3. The method for limiting the use of an energy delivery device according to claim 1, wherein said optical fiber further includes a shelf life, further comprising the steps of:

storing said shelf life in said memory device;

determining whether said shelf life has expired; and

disabling said energy delivery device when said shelf life has expired.

4. A method for limiting the use of an energy delivery device having an optical fiber and a memory device wherein, said optical fiber includes a shelf life and a multiplicity of use parameters and a date of manufacture and at least one usage limit corresponding to at least one of said use parameters, said optical fiber further comprises a temperature sensor at a distal end thereof, said method comprising the steps of:

storing said shelf life in said memory device;

storing said use parameters and said usage limit in said memory device;

storing said date of manufacture in said memory device;

utilizing said date of manufacture to determine whether said shelf life has expired;

disabling said energy delivery device when said shelf life has expired

determining whether at least one of said use parameters exceeds its corresponding usage limit;

generating a temperature signal using said temperature sensor; and

utilizing said temperature signal to determine whether at least one of said use parameters exceeds its corresponding usage limit; and

disabling said energy delivery device when said use parameter exceeds said usage limit.

5. A medical treatment system comprising:

an energy delivery device including an optical fiber and a memory device, said optical fiber including a temperature sensor at a distal end thereof for generating a temperature signal and said optical fiber having a predetermined usage limit, said usage limit stored in said memory device; and

a processor programmed to calculate a temperature from said temperature signal and for utilizing said temperature signal in determining when said usage limit has been exceeded, said processor disabling the use of said energy delivery device when said usage limit has been exceeded.

6. The medical treatment system according to claim 5, further comprising a shelf life stored in said memory device and wherein said shelf life is between about 1 month to about 60 months.

7. The medical treatment system according to claim 5, wherein said optical fiber has a specified date of manufacture and wherein said date of manufacture is stored in said memory device.

8. The medical treatment system according to claim 5, wherein said optical fiber further includes a plurality of use parameters and a count limit and at least one usage limit corresponding to at least one of said use parameters all stored in said memory device.

9. The medical treatment system according to claim 8, wherein said processor updates said use parameters in response to a calculation by said processor and said processor compares said use parameters to a corresponding usage limit.

10. The medical treatment system according to claim 9, wherein said processor creates and increments a usage count when at least one of said use parameters exceeds its corresponding usage limit, and said processor compares said usage count to said count limit and disables use of said energy delivery device when said usage count exceeds said count limit.

11. A medical treatment system for performing a medical procedure comprising:

an energy delivery device including an optical fiber and a memory device, said optical fiber including a temperature sensor at a distal end thereof for generating a temperature signal, said optical fiber having a multiplicity of use parameters and a count limit and at least one usage limit corresponding to at least one of said multiplicity of use parameters relating to said optical fiber, said multiplicity of use parameters and said at least one usage limit and said count limit being stored in said memory device, and said optical fiber and said memory device being connected to said energy delivery device, and wherein said multiplicity of use parameters include at least an elapsed time, a total treatment time, and a number of treatment sites; and

a processor programmed to calculate a temperature from said temperature signal, and said processor also programmed to update at least one of said multiplicity of use parameters in response to data received by said processor regarding said use parameter and said processor for comparing said use parameter to its corresponding usage limit, said processor creating and incrementing a usage count when at least one of said multiplicity of use parameters exceeds its usage limit, said processor comparing said usage count to said count limit and disabling said energy delivery device when said usage count exceeds said count limit.

12. The medical treatment system according to claim 11, wherein said optical fiber includes a predetermined shelf life and said shelf life is stored in said memory device.

13. The medical treatment system according to claim 12, wherein said processor determines when an actual date is beyond the expiration of said shelf life, and said processor disabling the use of said energy delivery device when said shelf life has expired.

14. The medical treatment system according to claim 13, wherein said at least one usage limit is an elapsed time limit, and wherein said elapsed time limit is between about one hour and about twelve hours.

15. The medical treatment system according to claim 12, wherein said shelf life is between about 1 month to about 60 months.

16. The medical treatment system according to claim 15, wherein said optical fiber has a primary count limit and a secondary count limit, said primary count limit and said secondary count limit being stored in said memory device, said processor comparing said usage count to said primary count limit and issuing a warning signal when said usage count exceeds said primary count limit and said processor comparing said usage count to said secondary count limit and disabling said energy delivery device when said usage count exceeds said secondary count limit.

17. The medical treatment system according to claim 12, wherein said optical fiber has a specified date of manufacture and said date of manufacture is stored in said memory device.

18. The medical treatment system according to claim 17, wherein said at least one usage limit further comprises a treatment time limit, and wherein said treatment time limit is about 36 minutes.

19. The medical treatment system according to claim 12, wherein said at least one usage limit further comprises a treatment site limit, and wherein said treatment site limit is about 12.

20. The medical treatment system according to claim 12, wherein data and information relating to the medical procedure or said medical treatment system can be read from said memory device after said energy delivery device has been disabled.