Medical device recognition system with write-back feature

• US 20060111699A1
• Filed: 12/28/2005
• Published: 05/25/2006
• Est. Priority Date: 12/18/2002
• Status: Abandoned Application

• Current Assignee: Biolitec Unternehmensbeteiligungs II AG
• Original Assignee: CeramOptec Industries Incorporated (Biolitec AG)
• Inventors: Neuberger, Wolfgang
• Application Number:
  US11/320,389
• Publication Number:
  US 20060111699A1
• Time in Patent Office: Days
• US Class Current: 606/10
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2017/00725 Calibration or performance testing
• 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 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags

Abstract

A medical radiation treatment system is disclosed for identifying and monitoring the use of disposable or reusable optical fibers or other optical accessories. The treatment system comprises a radiation source unit connected to a recognition/control unit, and a medical radiation delivery system connected to an identification/recordation unit. This forms a read-write system to ensure that radiation parameters conform to delivery device characteristics, and to prevent the use of overused or incompatible delivery devices. This is achieved by reading previously encoded information in the identification/recordation unit that provides all usage history, including number of uses or total duration of use. The encoded information is updated after use, and preferably frequently or continuously during use, to guarantee a complete usage history even after an incomplete treatment. Additionally, the treatment system can differentiate between completed treatments, incomplete treatments and calibration, to retain an accurate record of all the stresses on a fiber. A transponder sends information to the source unit, and also receives and writes information to a non-volatile memory chip or other storage means. The identification/recordation unit, including the transponder and memory, is powered by sending/receiving means in the recognition/control unit without physical, optical or electrical connection between the source unit and delivery system.

Claims

1. A medical radiation treatment system with recognition and write-back capability for improved safety and efficiency, having a radiation source and a medical radiation delivery system, comprising:

a recognition/control unit, connected to said radiation source, comprising means for sending and receiving radio frequency signals, and means to control use of said medical radiation delivery system with said radiation source;

an identification/recordation unit attached to said medical radiation delivery system comprising a transponder and a read/write, nonvolatile memory;

wherein said memory stores information about said delivery system to be used by said control means to prevent improper use of said delivery system;

said transponder, being independent of any electrical connection with said irradiation source and accompanying sending/receiving means, is powered solely by said sending/receiving means in said recognition/control unit through said radio frequency waves traveling in free space from said sending/receiving means to said transponder, said transponder can transmit information from said memory to said control means, and can encode new information onto said memory as said optical delivery device is used with said radiation source; and

wherein, in a medical procedure, an optical connection is in place between said radiation source and said medical radiation delivery system, said transponder and said sending/receiving means in communication by means of said radio frequency waves before and during the medical procedure for improved safety and efficiency of use.

2. The medical radiation treatment system according to claim 1, wherein said radiation source is selected from a group consisting of a laser source, at least one LED, at least one superluminescent diode, and a high power lamp.

3. The medical radiation treatment system according to claim 1, wherein said optical delivery device is an optical fiber.

4. The medical radiation treatment a system according to claim 1 wherein said optical delivery device is enclosed in a seal pack, wherein said communications occurs before said medical procedure is commenced to verify that said optical delivery device in said enclosed seal pack is proper for said medical procedure.

5. The medical radiation treatment system according to claim 1, wherein said information comprises identification information, use information and calibration information.

6. The medical radiation treatment system according to claim 5, wherein said identification information comprises type, material makeup and diameter of said fiber

7. The medical radiation treatment system according to claim 5, wherein said use information comprises duration of use, number of treatments, parameters of past treatments, maximum number of uses, and maximum duration of use.

8. The medical radiation treatment system according to claim 5, wherein said use information comprises classifications selected from a group consisting of full-time use, aborted use, demonstrative use and use for calibration.

9. The medical radiation treatment system according to claim 5, wherein said control means allows commencement of treatment only if:

identification information sent from identification/recordation unit is compatible with laser source; and

amount of use of said delivery device is within maximum use parameters sent from identification unit.

10. The medical radiation treatment system according to claim 1, wherein said identification/recordation unit further comprises a removable blockage, wherein upon removal of said blockage, further information cannot be recorded onto said memory chip.

11. The medical radiation treatment system according to claim 1, wherein said recognition/control unit is permanently connected to said laser source.

12. The medical radiation treatment system according to claim 1, wherein said control means is a microprocessor and software designed to control output from said radiation source.

13. The medical radiation treatment system according to claim 1, wherein said means for sending and receiving radio frequency signals is selected from the group consisting of an antenna and said sending/receiving coil.

17. A method for preventing improper use of a medical radiation delivery system using the medical radiation treatment system of claim 1, comprising the steps of:

a. incorporating said delivery system and said radiation source to said medical radiation treatment system;

b. reading information about said delivery system from said identification/recordation unit on said delivery system;

c. determining whether said delivery system may be properly used with said radiation source; and

d. performing a medical treatment with said delivery device and said radiation source if said treatment system determines that said delivery system may be safely used.

18. A method for preventing improper use of a medical radiation delivery device according to claim 17, wherein said improper use is defined as use of said medical radiation delivery device after it has reached its “

safety limit”

, wherein further said “

safety limit”

is a preselected maximum amount of use of said delivery device.

19. A method for preventing improper use of a medical radiation delivery device according to claim 17, wherein misuse is defined as use of said delivery system with a radiation source that emits radiation parameters that are different than the parameters preselected for said delivery device.

20. A method for monitoring the use of limited usage radiation delivery devices using the medical radiation treatment system of claim 1, comprising the steps of

a. incorporating said delivery system to said medical radiation treatment system;

b. allowing said recognition/control unit to identify said delivery system;

c. performing a treatment with said treatment system; and

d. recording information about said treatment on said identification/recordation unit.

21. The method for monitoring the use of limited usage radiation delivery devices according to claim 20, wherein said information is selected from one or more of a group consisting of duration of use, treatment parameters and type of use.

22. The method for monitoring the use of limited usage radiation delivery devices according to claim 20, wherein said type of use is selected from a group consisting of full-time use, aborted use, demonstrative use and use for calibration.

23. The method for monitoring the use of limited usage radiation delivery devices according to claim 20, wherein said treatment parameters are selected from one or more of the group consisting of wavelength, power, pulse length and pulse rate.

24. The method for monitoring the use of limited usage radiation delivery devices according to claim 20, wherein step d is performed in a manner selected from one or more of a group consisting of continuously recording during said treatment, periodically recording during said treatment and recording after said treatment.

25. The method for monitoring the use of limited usage radiation delivery devices according to claim 20, comprising the further step of:

b1. Comparing use information located in said identification/recordation unit to preselected maximum use parameters.

b2. Preventing further use of said delivery system if said use information exceeds said parameters.

14. A method for identifying and calibrating a medical radiation delivery device, comprising the steps of:

a. inputting information into a memory in an identification/recordation unit attached to said delivery device, wherein said information comprises identification and maximum use information;

b. placing said delivery device in proximity to a radiation source without requiring a physical, electrical or optical connection;

c. allowing a recognition/control unit to determine whether said delivery device can properly be used with said radiation source, and whether said delivery device has been overused;

d. if said delivery device may be used with said source based on previously entered parameters into said recognition/control unit, optically connecting said delivery device to said radiation source.

15. A method for identifying and calibrating a medical radiation delivery device according to claim 14, comprising the further steps of:

c1. automatically transferring calibration information from said identification/recordation unit to said recognition/control unit;

e. allowing said recognition/control unit to modify said source to emit the proper radiation characteristics for said delivery device.

16. A method for identifying and calibrating a medical radiation delivery device according to claim 14, comprising the further step of:

e. applying radiation to a treatment area

f. recording use information during treatment to update said information contained in said memory located in said identification/recordation unit.