WO2004050173A1

WO2004050173A1 - Single-use cover system for electromagnetic treatment applicator

Info

Publication number: WO2004050173A1
Application number: PCT/US2003/038079
Authority: WO
Inventors: Frank R. George; Robert T. Bryant; Arthur A. Loya; Marla Meyer
Original assignee: Regenesis Biomedical, Inc.
Priority date: 2002-12-02
Filing date: 2003-12-01
Publication date: 2004-06-17
Also published as: CA2507452A1; CA2507452C; AU2003297591A1; EP1567222A4; EP1567222A1

Abstract

An electromagnetic treatment device (200) includes a treatment pad (206) and a generating unit (218) connected to the treatment pad by a coaxial cable (205). The treatment pad has an antenna (211) on one side of the treatment pad. The generating unit includes a start/stop button (220), a radio frequency generator (208) and a covertest board (212). A single-use cover system (201) includes the electromagnetic treatment device and a disposable cover (203) including a RFID tag (202). The single-use cover system verifies that the disposable cover is placed over the treatment pad properly and that the disposable cover has not been used previously.

Description

SINGLE-USE COVER SYSTEM FOR ELECTROMAGNETIC TREATMENT APPLICATOR

CROSS-REFERENCE TO RELATED APPLICATION

The present application is related to, and claims priority of, a United States provisional application entitled "SINGLE-USE COVER

SYSTEM FOR ELECTROMAGNETIC TREATMENT APPLICATOR", filed December 2, 2002, and accorded Serial No. 60/430,538, which application is assigned to the present assignee, and which is hereby fully incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to electromagnetic treatment devices, and more particularly, to a cover that protects an electromagnetic treatment device from biohazards, provides selective radio frequency shielding and restricts use of the device to a one-time use per cover, and to a system using the cover.

2. Description of the Related Art

Known prior art includes U.S. Patent No. 6,334,069 entitled PULSED ELECTROMAGNETIC ENERGY TREATMENT APPARATUS AND METHOD, issued December 25, 2001, to George et al., and U.S. patent application serial No. 09/661,604, entitled COVER FOR ELECTROMAGNETIC TREATMENT APPLICATOR, filed September 14, 2000 by George et al., which are assigned to the assignee of the present invention, and which are hereby fully incorporated by reference herein; and the PROVANT® Wound Closure System by Regenesis Biomedical, Inc., of

Scottsdale, AZ.

FIG. 1 shows a simplified block diagram of a prior art electromagnetic treatment device 100, which includes a prior art applicator 106, a prior art cover 103 and a prior art generating unit 118 including a prior art RF generator 108. The prior art cover 103 includes means for preventing operation of the prior art applicator 106 in the absence of the cover being on the applicator. The prior art cover 103 performs its intended function of preventing operation of the prior art applicator 106 without the prior art cover.

However, what is needed is a cover that prevents operation of an applicator without the cover and limits the use of the applicator to a single use for each cover, and a system for use with the cover. These and other objects of the present invention will become apparent to those skilled in the art as the description thereof proceeds.

SUMMARY OF THE INVENTION

Briefly described, and in accordance with a preferred embodiment thereof, the present invention relates to a disposable cover for a device used for therapeutically treating patients with dosages of electromagnetic energy. The device has a wireless transceiver. The cover includes a radio frequency shielding material on one side of the cover, and a wireless transceiver permanently attached to the disposable cover for communicating with the device.

Another aspect of the invention relates to a controller for controlling a device used for therapeutically treating patients with dosages of electromagnetic energy. The device has a cover. The controller includes a wireless transceiver for communicating with another wireless transceiver permanently attached to the cover, and a microcomputer programmed to allow activation of the device based upon a signal transmitted by the other wireless transceiver.

Still another aspect of the invention relates to a system that comprises a device for therapeutically treating patients with dosages of electromagnetic energy. The device has a first wireless transceiver. The system also comprises a controller that is coupled to the device, for controlling the device, and a cover for the device. The cover has a second wireless transceiver for communicating with the device.

Yet another aspect of the invention relates to a cover for a device used for therapeutically treating patients with dosages of electromagnetic energy. The device has a first wireless transceiver. The cover comprises a second wireless transceiver attached to the disposable cover for communicating with the device, and means for determining whether the cover is placed around the device. BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be described with greater specificity and clarity with reference to the following drawings, in which:

FIG. 1 is a simplified block diagram of a prior art device for electromagnetic treatments;

FIG. 2 is a simplified block diagram of an electromagnetic treatment device in accordance with the invention;

FIG. 3 is a flow diagram of the operation of the electromagnetic treatment device; FIG. 4 is a flow diagram of the operation of a microcomputer of the electromagnetic treatment device;

FIG. 5 is a flow diagram of the operation of a button debounce operation of the electromagnetic treatment device; .

FIG. 6 is a schematic diagram of a first embodiment of a covertest board of the electromagnetic treatment device;

FIG. 7 is a schematic diagram of a second embodiment of the covertest board of the electromagnetic treatment device;

FIG. 8 is a representation of a cover for the applicator of the electromagnetic treatment device; and FIG. 9 is a radio frequency identification tag.

DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 2 is a simplified functional block diagram of an electromagnetic treatment device 200 in accordance with the invention. The electromagnetic treatment device (hereinafter "device") 200 comprises at least one treatment pad, or applicator, 206; and a generating unit 218.

The treatment pad 206 has an antenna 211 on one side of the treatment pad. The generating unit 218 comprises a start/stop button 220, a radio frequency (hereinafter "RF") generator 208 and a covertest board 212. The single-use cover system 201 in accordance with the invention verifies that a disposable cover (hereinafter "cover") 203 is in place and that the cover has not been previously used. To use the device 200 equipped with the single-use cover system (hereinafter "system") 201, a user is first provided with at least one cover 203 that has a radio frequency identification (hereinafter "RFID") tag 202 affixed to the cover. Preferably, the RFID tag 202 is permanently affixed to the inside of the cover 203 Alternatively, the RFID tag 202 is detachably affixed. Alternatively, the RFID tag 202 is affixed to the outside of the cover 203 or is affixed within the material of the cover. In each of the embodiments, the RFID tag is affixed, or mounted, to one side of the cover 203. By the phrase "in place" it is meant that the cover 203 envelopes the treatment pad 206, and that the RFID tag 202, which is on the cover, is on the same side as the antenna 211, which is on the treatment pad, and that the RFID tag is aligned with the antenna. When the user presses the start/stop button 220, the system 201 checks whether the RFID tag 202 is present and checks whether the RFID tag has an "OK to use" code stored in it. If so, the system 201 allows the device 200 to start; if not, the system sounds an audible indicator 228.

A coaxial cable 205 connects the antenna 211 at the treatment pad 206 to the generating unit 218. A relay 210 is mounted to the covertest board 212. The coaxial cable 205 is connected to a terminal 201 of the relay. Another coaxial cable 207 connects the output 216 of the RF generator 208 to a terminal 209 of the relay 210. The treatment pad 206 is coupled to the RF generator 208 via the relay 210. The relay 210 is controlled by a microcomputer 214 that is mounted to the covertest board 212. The relay allows the treatment pad 206 to be coupled to either an output 216 of the RF generator 208 or to an output 219 of the RF transponder 204, via the coaxial cable 205. The RF transponder 204 is an electronic device that contains circuitry to send and receive data via a RF carrier wave and that has means to format the transmitted data for the expected RFID tag 202 and to decode the data received from the RFID tag 202. The RF transponder 204 also includes means to transfer the data to and from another computer. This means is normally implemented with a microcomputer. The start/stop button 220 is coupled to an input 222 of the microcomputer 214. A "running" signal, i.e., a signal that is active when treatment is in progress, is coupled to another input 224 of the microcomputer 214. An output 225 of the microcomputer 214 is coupled to a start/stop input 215 of the RF generator 208. Another output 226 of the microcomputer 214 is coupled to a sound generating device 228, such as a SONALERT® sound generating device manufactured by Malloy Sonalert Products, Inc., of Indianapolis, IN. Operation of the system 201 is controlled by software stored in the microcomputer 214.

FIG. 3 is a flow diagram 300 of the operation of the device 200. The operation begins with the device 200 being initialized 301. Whenever the start/stop button 220 is pushed 302, a pause occurs 303 for debounce, then the microcomputer 214 checks at step 304 the running signal. If the RF generator 208 is running, a pulse is sent out, at step 305, to the start/stop input 215 of the RF generator 208 to stop the current treatment. Then the microcomputer 214 enters a wait mode 306. Ifthe RF generator

208 is not running, the microcomputer 214 operates the relay 210 at step 307, waits a few milliseconds for the relay to mechanically switch, and then asks, at step 308, the RF transponder 204 to check whether there is an RFID tag 202 in range of its RF carrier wave. If there is a RFID tag 202, the RF transponder 204 is asked at step

309 whether the RFID tag 202 has the "OK to use" code stored therein. If the RFID tag 202 has the "OK to use" code, the RF transponder 204 is told to change the code to "used" and a ten (10) minute timer is started in software at step 310, and the relay 210 is released at step 311. After a few milliseconds to wait for the relay 210 to switch, the start/stop input 215 of the RF generator 208 is pulsed at step 311 to start a treatment. Then the microcomputer 214 goes back to the wait mode 306. If the RFID tag 202 does not have the "OK to use" code, the microcomputer 214 checks the timer at step 312. If the timer is active, the relay 210 is released at step 311. After a few milliseconds to wait for the relay 210 to switch, the start/stop input 215 of the RF generator 208 is pulsed at step 311 to start a treatment. Then the microcomputer 214 goes back to the wait mode 306. If the timer is not active, the microcomputer

214 waits 313 one (1) second, then sounds at step 318 the audible indicator 228. The one (1) second delay is so that the user will not think that the sounding of the audible indicator 228 is just an acknowledgment of the button having been pushed. Then the microcomputer 214 goes back to the wait mode 306.

Referring back to step 308, if there is no RFID tag 202, the relay 210 is released 314. After a few milliseconds to wait for the relay to switch, the start/stop input 215 on the RF generator 208 is pulsed at step 314 to start a treatment. The purpose of the sending of the pulse is to test the treatment pad 206 and the connecting cable 205 to be sure they are functioning properly and are not the cause of an inability to sense the RFID tag 202. After a delay 315 of one second (necessary to allow the RF generator 208 to complete its self-check), the running signal is tested at step 316 to see whether a treatment is still in progress. If the RF generator is running, i.e., the hardware is functioning properly, a pulse is sent out

319 to the start/stop input 215 of the RF generator 208 to stop the current treatment at step 317. The microcomputer 214 sounds the audible indicator 228 at step 318 to indicate that the current treatment session is finished. Then the microcomputer 214 goes back to the wait mode 306. If the RF generator is not running, i.e., the hardware is defective and presumably the service required light is flashing, then the microcomputer 214 goes back to the wait mode 306.

The result is that any time the user pushes 302 the start/stop button 220, the audible indicator 228 will be sounded at step 318 one second later if there is no RFID tag 202 present or if the RFID tag 202 that is present does not have the "OK to use" code. If the hardware of the treatment pad 206 is defective, the audible indicator 228 will not sound, but the service required light (not shown) will flash.

If the treatment pad hardware is operating properly, and the RFID tag 202 is present with the "OK to use"code, the treatment will start. If power to the RF generator 208 is not off, the treatment may be started with a RFID tag 202 that does not have the "OK to use" code if the treatment is started within a predetermined period of starting the RF generator 208 with a RFID tag that has the "OK to use" code. This allows the user to make adjustments in the position of the treatment pad 206 and then restart the treatment. Preferably, the predetermined period is ten (10) minutes. FIG. 4 is a flow diagram of the operation of the microcomputer

214 of the electromagnetic treatment device 200. Upon power-up, the microcomputer is initialized, at step 402. If, at step 404, the start/stop button 220 is not pushed, the microcomputer loops until it is pushed. If, at step 404, the start/stop button is pushed, the microcomputer enters the button debounce flow chart 500 (see FIG. 5). At step 408, the microcomputer checks whether a cycle is in progress, i.e., whether a RF treatment is in progress. The microcomputer does this by checking whether the running signal is present. If the running signal is not present, the microcomputer terminates treatment 410. If the running signal is present, the relay 210 is actuated such that RF communication is turned on

412. That is, the output 219 of the RF transponder 204 is coupled to coaxial cable 205. At step 414, the microcomputer checks whether the communication RF is turned on. If the communication RF is not turned on, the microcomputer activates at step 416 an audible indicator 228. If the communication RF is turned on, the microcomputer transmits a command at step 418 to read the contents stored in a memory of the RFED tag 202 at the cover 203. In step 420, the microcomputer determines whether the RFID tag 202 is present. If no RF signal is received from the RFID tag 202, the microcomputer turns on the RF treatment for one (1) second at step 422, in order to check for a break in the coaxial cable 205 or for other malfunctions that could account for a lack of a RF signal from the RFID tag. If a RF signal is received from the RFID tag 202, the microcomputer determines at step 424 whether the RFID tag transmitted the "OK to use" code. If the RFID tag 202 does not return an original factory code of "FFFF", the microcomputer determines that the RFED tag does not have the "OK to use" code, and the microcomputer then determines at step 426 whether a ten (10) minute timer is still counting, i.e., whether less than ten (10) minutes have elapsed since the start/stop button 220 was activated. If more than ten (10) minutes have elapsed since the start/stop button 220 was activated, the microcomputer activates the audible indicator at step 416. Referring back to step 424, if the RFID tag 202 returns the factory code of "FFFF", the microcomputer determines that the RFID tag has the "OK to use" code, and then, at step 428, the microcomputer writes "0000" over the "FFFF", and starts a ten (10) minute timer. At step 430, the microcomputer switches the relay 210 so that the RF generator 208 is connected to the coaxial cable 205. (Previously, the RF transponder 204 was connected to the coaxial cable 205 for RF communication of data between the RFID tag 202 and the RF transponder.) At step 432, the microcomputer activates the RF generator 208 to transmit therapeutic dosages of RF energy through coaxial cable 205 to the treatment pad 206. Referring back to step 426, if the ten (10) minute counter is still counting, the microcomputer performs step 430. This allows the treatment pad 206 to be started for a few minutes, and then turned off for repositioning, and then turned on again for completion of a session of therapy. Typically, a session of therapy is thirty (30) minutes.

FIG. 5 is a flow diagram of the operation of a button debounce operation of the electromagnetic treatment device 200. Upon power-up 502, the microcomputer clears and resets a button flag 504 and enters a button debounce wait loop 506. The microcomputer periodically checks to see if the button flag 508 has been set.

At step 508, the microcomputer checks whether the button flag has been set. If the button flag has not been set, the microcomputer then checks at step 510 whether the start/stop button has been pushed, i.e., is closed. If the start/stop button has not been pushed, i.e., is open, it returns to the button debounce wait-loop 506. If the start/stop button has been pushed, i.e., is closed, the microcomputer waits five (5) milliseconds at step 512 and again checks the status of the start/stop button at step 514. If the start/stop button is not closed, the microcomputer returns to the button debounce wait-loop 506. If the start/stop button is still closed, i.e., the user's finger remains on the start/stop button, the microcomputer sets the button flag at step 516, and returns to the button debounce wait loop after performing a button serve routine at step 518.

Referring again to step 508, if the check-button-flag is set, the microcomputer then checks the status of the start/stop button at step 520. If the start/stop button is closed at step 520, the microcomputer loops, i.e., waits, until the start/stop button is closed. If the start/stop button is open at step 520, the microcomputer waits five (5) milliseconds at step 522. At step 524, the microcomputer again checks the status of the start/stop button. If the start/stop button is closed, the microcomputer again loops, i.e., waits, until the start/stop button is closed. If the start/stop button is open, the microcomputer clears the button flag at step 504, and returns to the button debounce wait-loop 506.

FIG. 6 is a schematic diagram a circuit 600 of a first embodiment of a cover test board 212 of the electromagnetic treatment device 200. The circuit 600 is sourced from a 15 VDC supply at pin "1" of connector 602 via a +5 volt voltage regulator 606. A display (not shown) is coupled to connector 601. The display includes a thirty (30) minute digital countdown timer and the start/stop switch 220. Read/write functions of the RFID tag 202 are controlled from the microcomputer 214, preferably a model PIC16LC73 microcontroller manufactured by Microchip Technology Inc., of Chandler, AZ, clocked with a 20 MHz crystal 608.

Communication with the RFID tag 202 is via the RF transponder 204, preferably a 13.56 MHz GEMWAVE™ model S001 RFID plug-in coupler, manufactured by Gemplus International SA of Luxembourg. The RF transponder 204 is powered from the +5N voltage regulator 606, and controlled from the microcomputer 214. Communication for the RFID tag 202 is sent to the treatment pad 206 via matching network 610, through relay 210, and finally out through BΝC connector 613. Read/write operations for the RFID tag 202 are initiated when the user pushes the start/stop button 220 that sends a signal to the microcomputer 214 via connector 601 at pin "8". The relay 210 is energized by the microcomputer 214, allowing the RF transponder 204 to communicate with the RFID tag 202 on the treatment pad 206 through the closed contacts five and six of the relay 210. Two LEDs 621 and 622 are used to indicate power and communication to the RF transponder 204. If data returned from the RFID tag 202 is valid, the relay 210 is de-energized, a start signal is sent by the microcomputer via transistor 624, through connector 602 at pin "8", permitting the 27.12 MHz therapy energy to be sent to the treatment pad 206 via BΝC connectors 613 and 614. If the data returned from the RFID tag 202 is not valid, the audible indicator 228 produces a series of three beeps, and further operation is aborted. FIG. 7 is a schematic diagram of a circuit 700 of a second embodiment of a cover test board 212 of the electromagnetic treatment device 200. The circuit 700 includes a 13.56 MHz RF circuit 701 to communicate with the treatment pad RFID tag 202, thereby eliminating a need for the GEMWAVE model S001 RFID plug-in coupler.

FIG. 8 is a representation of the cover 203 for the applicator 206 of the electromagnetic treatment device 200. Preferably, the RFID tag 202 is attached near the center of one side of the cover 206. The cover 203 is open at one end 801 and closed at another end 802. There is a gusset at the other end 802 of the cover 203.

FIG. 9 is a simplified representation of the RFID tag 202. The RFID tag 202 is commercially available and comprises an antenna 901 and an integrated circuit 902. The integrated circuit comprises a radio transceiver and a microcomputer. The microcomputer contains electrically erasable programmable read-only memory, EEPROM. The integrated circuit 902 is powered by the same RF carrier wave, transmitted by the RF transponder 204, which also carries data to the RFID tag 202.

While the present invention has been described with respect to preferred embodiments thereof, such description is for illustrative purposes only, and is not to be construed as limiting the scope of the invention. Various modifications and changes may be made to the described embodiments by those skilled in the art without departing from the true spirit and scope of the invention as defined by the appended claims.

Claims

We claim:

1. A disposable cover for a device used for therapeutically treating patients with dosages of electromagnetic energy, the device having a wireless transceiver, the cover comprising: a) radio frequency shielding material on one side of the cover; and b) a wireless transceiver permanently attached to the disposable cover for communicating with the device.

2. A controller for controlling a device used for therapeutically treating patients with dosages of electromagnetic energy, the device having a cover, the controller comprising: a) a wireless transceiver for communicating with another wireless transceiver permanently attached to the cover; and b) a microcomputer programmed to allow activation of the device based upon a signal transmitted by the other wireless transceiver.

3. A system, comprising: a) a device for therapeutically treating patients with dosages of electromagnetic energy, said device having a wireless transceiver; b) a controller coupled to the device for controlling said device; and c) a cover for said device, said cover having a wireless transceiver for communicating with said device.

4. The system of claim 3, in which the communicating including means for activating dosages of electromagnetic energy from said device only if said cover has not previously covered said device during transmission of dosages of electromagnetic energy from said device for a predetermined period.

5. A cover for a device used for therapeutically treating patients with dosages of electromagnetic energy, the device having a wireless transceiver, said cover comprising: a) a wireless transceiver attached to said cover for communicating with the device; and b) means for determining whether said cover is placed around the device.

6. The cover of claim 5, in which said determining means also determines whether said cover is properly placed around the device.

7. The cover of claim 5, in which said determining means also determines whether said cover has been previously used for covering the device during transmission of dosages of electromagnetic energy from the device for a predetermined period.