Proprietary fiber connector and electronic security system

• US 5,742,718 A
• Filed: 08/13/1996
• Issued: 04/21/1998
• Est. Priority Date: 08/13/1996
• Status: Expired due to Fees

• Current Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Roush, Mark, Harman, Stuart D.
• Primary Examiner(s): Lee, John D.
• Assistant Examiner(s): KIM, ELLEN E
• Application Number:
  US08/696,301
• Time in Patent Office: 616 Days
• Field of Search: 385/53, 385/88, 385/92
• US Class Current: 385/53
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00725 Calibration or performance testing
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• 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: G02B 2006/4297 having protection means, e.g. protecting humans against accidental exposure to harmful laser radiation
• CPC Class Codes: G02B 6/3813 for transmission of high energy beam coupling high energy sources and light guides G02B6/4296
• CPC Class Codes: G02B 6/3869 Mounting ferrules to connector body, i.e. plugs
• CPC Class Codes: G02B 6/38875 Protection from bending or twisting
• CPC Class Codes: G02B 6/4296 coupling with sources of high radiant energy, e.g. high power lasers, high temperature light sources

Abstract

A laser connector and electronic security system for a laser delivery system controls connection of the delivery system to a source of laser energy for medical procedures by storing encrypting codes to allow access by authorized, unused, delivery assemblies. The connector is specially dimensioned to further control delivery system access to the source, and the electronic security system utilizes EEPROM memory to allow storage and accumulation of information about the laser parameters used in the medical procedure. The connector and electronic security system is particularly suitable for pulsed laser transmyocardial revascularization (TMR) procedures and enables automatic power level calibration in accordance with the connected delivery system specifications, maximum time of usage settings, storage of the number/power level of the pulses delivered, and storage of the total number of TMR channels created.

Claims

1. A proprietary connector and electronic security system for coupling only proprietary electromagnetic (EM) energy medical delivery device for a medical procedure to a EM energy source comprising:

a) the medical EM energy delivery device adapted to be coupled to the medical EM energy delivery device having a central processing unit (CPU),

b) a connector adapted for attaching a proximal end of one of the only proprietary EM energy delivery device to the EM energy source, and

c) electronic memory means for storing data of at least one security code and data corresponding to usage of the connector, the memory means is attached and juxtaposed to the connector and is adapted for communication with the CPU,

whereby input of the data of at least one security code and data corresponding to usage of the connector causes the CPU to enable the EM energy source thereby ensuring reliable and safe use of the medical EM energy delivery device.

2. The proprietary connector and electronic security system of claim 1 wherein the connector is a fiber optic connector, the proprietary medical EM energy delivery device is a fiber optic delivery device, and the EM energy source is a laser, the fiber optic connector comprising:

a connector body having a length of approximately 1.2 inches, the connector body defining a fiber ferrule end and a strain relief end, the fiber ferrule end being approximately 0.46 inches long and 0.16 inches in diameter, the strain relief end being approximately 0.70 inches in length; and

keeper nut means adapted for attaching to the connector body and to the laser, the keeper nut means being approximately 0.9 inches long, 0.5 inches wide, and having approximately 40, 5/16 inch internal threads.

3. The proprietary connector and electronic security system of claim 2 wherein the fiber ferrule end further comprises a lumen surrounded by a counter bored well having a copper insert, the lumen sized to define a width substantially 5 microns larger than a diameter of a proximal end of a fiber of the fiber optic delivery device.

4. The method of claim 3 further including the step of storing data during a transmyocardial revascularization (TMR) procedure wherein the electronic memory means stores data of at least one calibration factor, a date of the TMR procedure, a start time of the TMR procedure, a record of a first connection of the laser to the optical fiber, a number of pulses and energy emitted per formed channel and number of channels formed.

5. The proprietary connector and electronic security system of claim 2 wherein the connector body is of unitary construction.

6. The proprietary connector and electronic security system of claim 2 further comprising retainer means for securing the connector body within the keeper nut means when the keeper nut means is attached to the laser by the internal threads.

7. The proprietary connector and electronic security system of claim 2 further comprising a strain relief means for attachment over the strain relief end.

8. The proprietary connector and electronic security system of claim 7 wherein the strain relief means comprises at least two sleeves, a first sleeve for attachment over the strain relief end and a second sleeve for attaching the electronic memory means to the fiber optic connector.

9. The proprietary connector and electronic security system of claim 8 wherein the second sleeve attaches a tether means extending to the electronic memory means.

10. The proprietary connector and electronic security system of claim 1 wherein the electronic memory means comprises at least one interface and at least one data module, the at least one interface establishing communication between the data module and the CPU, the data module having memory for storage of at least one security code and storage of data accumulated during the medical procedure.

11. The proprietary connector and electronic security system of claim 10 wherein the data module comprises at least one read/write semiconductor device.

12. The proprietary connector and electronic security system of claim 10 wherein the data module is a smart card.

13. The proprietary connector and electronic security system of claim 12 wherein the smart card stores data of product type, serial number, calibration factor, date of use, elapsed laser procedure time, number of performed medical procedures, laser operating parameters during the medical procedure, number and power level of laser pulses transmitted.

14. The proprietary connector and electronic security system of claim 10 wherein the memory comprises at least one storage table for storing the at least one security code and at least one calibration factor, and at least one table for writing the data accumulated during the medical procedure.

15. The proprietary connector and electronic security system of claim 14 wherein the at least one calibration factor is a power setting for the EM energy source, and the data in the writing table is at least a date and a start time of the procedure and record of first use of the proprietary EM energy delivery device.

16. The proprietary connector and electronic security system of claim 14 wherein the medical procedure is transmyocardial revascularization, the laser is a pulsed laser, and the data in the table for writing additionally is at least a total number of pulses delivered and a total number of channels created during the transmyocardial revascularization procedure.

17. The proprietary connector and electronic security system of claim 16 wherein the CPU comprises means for recognizing and comparing a plurality of encrypted codes;

means for automatically calibrating the laser in response to downloading of a calibration factor from the electronic memory means;

means for determining a total number of laser pulses delivered per channel;

means for storing power settings for each of the total number of laser pulses delivered;

means for determining a total number of laser channels created in a transmyocardial revascularization procedure, and clock means.

18. The proprietary connector and electronic security system of claim 17 wherein the means for recognizing means for automatically calibrating, means for determining a total number of laser pulses delivered per channel, means for storing power settings, and means for determining a total number of laser channels created is programming for the CPU.

19. The proprietary connector and electronic security system of claim 10 wherein the at least one security code is at least one encrypted code programmed into the data module and the CPU, the CPU includes means for comparing the at least one security code and usage data prior to enabling the EM energy source.

20. The method of claim 11 further including the step of storing data during a medical procedure in the electronic memory means, the data contains at least one calibration factor, a date of the medical procedure, a start time of the medical procedure, a record of a first connection of the EM energy source to the medical EM energy delivery device.

21. The method of claim 1 wherein the EM energy source is a laser and the EM energy delivery device is an optical fiber.

22. A proprietary connector and security system for coupling only a proprietary medical fiber optic laser delivery device for a laser source comprising:

the medical fiber optic laser delivery device adapted to be connected to the laser source;

electronic memory means attached to the fiber optic delivery device and adapted to communicate with a central processing unit (CPU) that controls the laser source, the electronic memory means comprising at least one interface and at least one data module, the at least one interface adapted for establishing communication between the data module and the CPU, the data module having mad/write memory for storage of at least one security code and data corresponding to usage of the proprietary connector, and storage of data accumulated during the medical procedure;

a connector body having a length of approximately 1.2 inches, the connector body defining a fiber ferrule end and a strain relief end;

the fiber ferrule end adapted for attachment to a fitting of the laser source and being approximately 0.46 inches long, 0.16 inches in diameter, and defining a lumen having a diameter of approximately 0.062 inches;

the strain relief end adapted for attachment of the specific fiber optic laser delivery device and being approximately 0.70 inches in length and defining a lumen having a diameter of approximately 0.125 inches;

keeper nut means for attachment to the connector body and adapted for attachment to the fitting of the laser source, the keeper nut means being approximately 0.9 inches long, 0.5 inches wide, and having approximately 40, 5/16 inch internal threads; and

retainer means for attachment over the connector body for securing the connector body within the keeper nut means;

whereby the laser source is enabled when the CPU processes and in accordance with the at least one security code and acceptable data corresponding to usage of the proprietary connector, thereby ensuring reliable and safe use of the medical fiber optic laser delivery device.

23. The proprietary connector and electronic security device of claim 22 wherein the medical procedure is transmyocardial revascularization, the laser is a pulsed laser, the data module is a smart card with data related to product type and serial number, and the read/write memory comprises at least one storage table for storing the at least one security code and at least one calibration factor, the read/write memory further, having at least one table for writing at least a date of the procedure, a start time of the procedure, a record of a first connection of the fiber optic delivery device to the laser and a number of pulses and energy emitted per formed channel, number of channels created.

24. A method of ensuring reliable and safe use of a proprietary medical electromagnetic (EM) energy delivery device for a medical procedure with discrete components requiring connection comprising the steps of:

a) providing a connector with an electronic security system for coupling only the proprietary medical EM energy delivery device to a EM energy source, wherein the EM energy source is adapted to be coupled to the medical EM energy delivery device and has a central processing unit (CPU), the connector is adaptable for attachment of a proximal end of the EM energy delivery device to the source of EM energy, and an electronic memory means for storing at least one security code and data corresponding to usage of the connector, the memory means forms part of the proprietary connector which communicates with the CPU;

b) connecting the EM energy source to the medical EM energy delivery device; and

c) processing the at least one security code and the data corresponding to usage of the EM energy delivery device stored in the electronic memory means by the CPU; and

d) enabling the EM energy source by the CPU when the at least one security code and acceptable data corresponding to usage of the connector are in accordance with required data.