Cryoprobe incorporating electronic module, and system utilizing same

• US 20090306639A1
• Filed: 06/08/2009
• Published: 12/10/2009
• Est. Priority Date: 06/06/2008
• Status: Abandoned Application

• Current Assignee: Galil Medical Ltd. (Boston Scientific Corporation)
• Original Assignee: Galil Medical Ltd. (Boston Scientific Corporation)
• Inventors: Ofir, Gil, Nevo, Yoav
• Application Number:
  US12/457,338
• Publication Number:
  US 20090306639A1
• Time in Patent Office: Days
• US Class Current: 606/21
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00482 with a code
• 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 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A cryotherapy system comprises a cryoprobe comprising, for example, either an electronic module including a memory or a response module operable to respond to a query signal with a response signal. A communications interface uses these modules to establish a unique identification of the cryoprobe, and a control module regulates delivery of cryogen to the cryoprobe according to calculations at least partially based on stored data associated with that unique cryoprobe identification.

Claims

1. A cryotherapy system comprising

a) at least one cryoprobe which comprises

i) a treatment head coolable by delivery thereto of a cryogen;

and

ii) a response module operable to receive a query signal from a controller and to send a response signal in response to said query signal;

b) a cryogen supply; and

c) a cryogen control module which comprises

i) an inquiry mechanism operable to send an inquiry signal to said cryoprobe and to uniquely identify said cryoprobe upon receipt of a response signal sent by said cryoprobe in answer to said inquiry signal;

ii) a first memory for recording information about uniquely identified cryoprobes;

iii) a cryogen flow control mechanism for regulating flow of cryogen from said cryogen supply to said cryoprobe; and

iv) a first calculation module for calculating cryogen flow commands which influence operation of said cryogen flow control mechanism, said calculation being based at least in part on information associated with said uniquely identified cryoprobe and stored in said first memory.

2. The system of claim 1, wherein said response module comprises a second calculator operable to calculate said response signal as a mathematical function of a value presented by said inquiry signal.

3. The system of claim 1, wherein said response module is operable to recognize when a received inquiry code possesses a predetermined characteristic, and to emit a characteristic response when an inquiry code having said predetermined characteristic is recognized.

4. The system of claim 3, wherein said predetermined characteristic is a digital code uniquely associated with said cryoprobe.

5. The system of claim 1, wherein said inquiry signal is sent when an electronic communications pathway is first established between said controller and said cryoprobe.

6. The system of claim 1, further comprising

d) an information source physically distinct from said controller and from said cryoprobe, readable by said controller and comprising information characterizing said cryoprobe.

7. The system of claim 6, wherein said second memory device comprises a recordable magnetic strip.

8. The system of claim 6, wherein said second memory device comprises an optically readable code.

9. The system of claim 1, wherein said controller is programmed to record results of operational testing of said cryoprobe.

10. The system of claim 9, wherein said controller is operable to record information attesting to said cryoprobe having undergone operational testing, and to prevent clinical use of said cryoprobe if such information has not been so recorded.

11. The system of claim 1, wherein said controller is programmed to record events of usage of said cryoprobe, and to prevent supply of cryogen to said cryoprobe if more than a predetermined amount of usage has been recorded.

12. The system of claim 6, wherein said information characterizing said cryoprobe comprises manufacturing specifications describing said cryoprobe.

13. The system of claim 1, wherein said controller is operable to receive and record sensor values detected during testing of said cryoprobe, and is further operable to calculate cryogen supply parameters for use during operation of said cryoprobe as a function of said recorded values.

14. A method for cryosurgery, comprising

a) reading information descriptive of a cryoprobe into a controller;

b) using said controller to associate said read information with a cryoprobe by

i) sending an inquiry signal based on said read information to a cryoprobe,

ii) receiving a response signal from said cryoprobe in response to said inquiry signal; and

iii) associating said read information with said cryoprobe if and only if said response signal conforms to predetermined criteria; and

c) using said controller to calculate commands controlling supply of cryogen to said cryoprobe, said calculation being at least partially based on read information which said controller has associated with said cryoprobe in response to said response signal.

15. The method of claim 14, wherein said read information comprises a code which, when sent to said cryoprobe in an inquiry signal, will provoke a response signal which uniquely identifies said cryoprobe.

16. The method of claim 14, wherein said read information comprises at least one of a group consisting of

a) information characterizing a usage history of said cryoprobe;

b) data derived from an operational test of said cryoprobe;

c) a type designation for said cryoprobe; and

d) a descriptive characterization of said cryoprobe.

17. A method for regulating use of a cryoprobe, comprising:

a) reading information descriptive of a cryoprobe into a controller;

b) associating said read information with a cryoprobe attached to a controller by

i) sending an inquiry signal based on said read information to a cryoprobe,

ii) receiving a response signal from said cryoprobe in response to said inquiry signal; and

iii) associating said read information with said cryoprobe and with a unique identity tag if and only if said response signal conforms to predetermined criteria;

c) recording an activity history of said cryoprobe by recording probe usage events related to use of said cryoprobe in a memory record associated with said unique identity tag; and

c) regulating use of said cryoprobe by controlling cryogen flow as a function of recorded information associated with said unique identity tag.

18. A method of charging a customer for cryoprobe use, comprising:

a) supplying to a customer a plurality of cryoprobes, each associated with a unique identifying tag;

b) using a cryosurgery control module to record usage statistics for each of said cryoprobes when said cryoprobes are used; and

c) charging a customer according to said recorded usage statistics.

19. A cryotherapy system comprising

a) a cryoprobe which comprises

i) a treatment head coolable by delivery thereto of a cryogen;

and

ii) an embedded electronic module which comprises a memory and a communication interface;

b) a cryogen supply; and

c) a cryogen control module operable to regulate flow of cryogen from said cryogen supply to said cryoprobe in response to information received from said embedded electronic module,

wherein at least one of a group consisting of said electronic module and said control module is programmed to record operational testing of said cryoprobe, and said control module is operable to prevent clinical use of said cryoprobe if said cryoprobe has not been operationally tested.

20. The system of claim 19, wherein at least one of a group consisting of said electronic module and said control module is programmed to record events of usage of said cryoprobe, and said control module is programmed to prevent supply of cryogen to said cryoprobe if more than a predetermined amount of usage has been recorded.

21. The system of claim 19, wherein operating values detected during testing of said cryoprobe are written into said memory of said electronic module and are useable by said control module during calculation of cryogen supply parameters used during operation of said cryoprobe.

22. A method for regulating use of a cryoprobe, comprising:

a) recording a unique identification code in a read-only memory embedded in a cryoprobe;

b) recording an activity history of said cryoprobe by recording probe usage events associated with said unique identification code; and

c) regulating use of said probe by identifying said cryoprobe by reading said unique identification code from said read-only memory, and choosing between supplying cryogen to said probe and denying supply of cryogen to said probe, said choice being determined algorithmically as a function of a recorded probe activity history identified by said unique identification code.

23. A method for cryosurgery, comprising:

a) recording, in an electronic module embedded in a cryoprobe, information characterizing said probe; and

b) algorithmically regulating use of said probe by choosing between supplying cryogen to said probe and denying supply of cryogen to said probe, said choice being determined algorithmically based on a reading of said recorded probe characterization and upon a recorded history of usage of said cryoprobe.

24. A method charging a customer for cryoprobe use, comprising:

a) supplying to a customer a plurality of cryoprobes each of which comprises an electronic module which comprises a read-only memory holding a unique identity number;

b) using a cryosurgery control module to record usage statistics for each of said cryoprobes when said cryoprobes are used; and

c) charging a customer according to said recorded usage statistics.