United States Patent (19)
`Erickson et al.
`
`||||||||||||||||
`US005181902A
`11
`Patent Number:
`5,181,902
`(45) Date of Patent:
`Jan. 26, 1993
`
`iss
`
`Primary Examiner-Lee S. Cohen
`(54) DOUBLE-TRANSDUCER SYSTEM FOR
`Assistant Examiner-John P. Lacyk
`PEMF THERAPY
`Attorney, Agent, or Firm-Baker & Botts
`75 Inventors: John H. Erickson, Plano; John C.
`(57)
`ABSTRACT
`Tepper, Carrollton, both of Tex.
`A PEMF double-transducer system (FIG. 1) used for
`(73) Assignee: American Medical Electronics, Inc.,
`PEMF therapy (such as after spinal fusion) uses a two
`Dallas, Tex.
`transducer configuration for generating flux-aided elec
`tromagnetic fields. The semi-rigid transducers (12, 14)
`(21) Appl. No.: 586,505
`are conformable, anatomically contoured and flat
`22 Filed:
`Sep. 21, 1990
`wound to enhance patient comfort, and incorporated
`t
`. Cl. ...............................................
`with an adjustable belt (16) to provide bracing. The belt
`s
`600As ...
`Field of search...e60/615 includes, compartments for a drive electronic module
`128/49 F, 802
`(22), and a rechargeable battery pack (24), making the
`system portable. The drive electronics (FIG. 3) includes
`a PEMF processor (41) that executes a PEMF program
`for providing pulsing current to the front and back
`transducers at predetermined intervals, thereby activat:
`ing the electromagnetic field according to a prescribed
`PEMF regimen.
`9 Claims, 2 Drawing Sheets
`
`56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`4,548,208 10/1985 Niemi ....................................
`600/14
`4654,574 3/1987 Thaer
`4,850,959 7/1989 Findl..................................... so/
`5,045,050 9/1991 Liboff et al. ............................ 600/9
`5,106,361 4/1992 Liboff et al. .......................... 600/15
`
`
`
`LUMENIS EX1031
`Page 1
`
`

`

`U.S. Patent
`
`Jan. 26, 1993
`
`Sheet 1 of 2
`
`5,181,902
`
`
`
`FIG. 2
`
`LUMENIS EX1031
`Page 2
`
`

`

`U.S. Patent
`
`Jan. 26, 1993
`
`Sheet 2 of 2
`
`5,181,902
`
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`LUMENIS EX1031
`Page 3
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`LUMENIS EX1031
`Page 3
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`

`

`DOUBLE-TRANSDUCER SYSTEM FOR PEMF
`THERAPY
`
`5
`
`10
`
`TECHNICAL FIELD OF THE INVENTION
`The invention relates generally to pulsed electromag
`netic field (PEMF) therapy, and more particularly re
`lates to a PEMF system that uses two transducers to
`provide PEMF therapeutic stimulation to a target area
`of the skeletal system (such as the spine), and a method
`of fabricating the system.
`BACKGROUND OF THE INVENTION
`Pulsed electromagnetic fields (PEMF) are low
`energy, time-varying magnetic fields that are used to
`15
`treat therapeutically resistant problems of the musculo
`skeletal system. Those problems include spinal fusion,
`ununited fractures, failed arthrodieses, osteonecrosis,
`and chronic refractory tendonitis, decubitus ulcers and
`ligament and tendon injuries.
`20
`The specific problem to which the invention is di
`rected is an improved PEMF spinal stimulation system
`for providing PEMF therapeutic stimulation to areas of
`the spinal column undergoing fusion or other repair
`25
`(such as treatment to salvage a failed fusion).
`For spinal PEMF therapy, an electromagnetic trans
`ducer is placed on the patient's back such that pulsing
`the transducer produces an applied or driving field that
`penetrates to the spinal column. The conventional ap
`proach has been to use a single flexibly packaged trans
`30
`ducer of wires coupled to a source of driving current.
`The flexible transducer is conformed to the contour of
`the patient's back, and strapped into place. By control
`ling the drive electronics, an appropriate PEMF ther
`apy can be administered.
`Current spinal PEMF systems are disadvantageous in
`at least two respects. To allow a patient to be ambula
`tory during therapy, additional bracing is usually re
`quired to prevent bending that might dislodge or stress
`the area undergoing treatment. Also, the single trans
`ducer configuration fails to take advantage of the flux
`aiding effect of a two transducer system to maximize
`field uniformity.
`Accordingly, a need exists for an improved PEMF
`system that can be used without additional bracing, and
`45
`provides more uniform active field to the target area
`than available using a single transducer configuration.
`SUMMARY OF THE INVENTION
`The present invention is a PEMF double-transducer
`system that takes advantage of flux-aiding to achieve
`improved field uniformity. The semi-rigid transducers
`are contoured and flat-wound to enhance patient com
`fort while obviating the need for additional bracing.
`In one aspect of the invention, the PEMF double
`55
`transducer system includes front and back transducers,
`both including at least a primary winding with a se
`lected number of turns encased in a shell that is at least
`semi-rigid. The transducers are anatomically contoured,
`and are physically coupled for releasably securing the
`transducers on either side of a target area for PEMF
`therapy. Drive electronics are coupled to the primary
`winding of both transducers for selectively generating
`electromagnetic fields, thereby implementing a pre
`scribed PEMF therapy program.
`65
`In more specific aspects of the invention, each trans
`ducer includes both primary and secondary windings,
`and the drive electronics includes an energy recovery
`
`5,181,902
`2
`circuit. The secondary windings and the energy recov
`ery circuit are active during a deemergization cycle to
`recover energy to conserve battery power-the second
`ary windings are also used to tailor the electromagnetic
`field.
`In an exemplary embodiment, the PEMF double
`transducer system is used for spinal PEMF therapy,
`such as for post fusion repair. For both transducers,
`primary, secondary and sense windings are flat wound,
`permitting the shell to be formed with a substantially
`flat cross sectional profile. The shell is a semi-rigid
`formable polyurethane elastomer.
`The drive electronics includes a PEMF processor
`that executes a PEMF program for controlling the
`activation of the electromagnetic fields (field strength
`and duty cycle). In addition to implementing the PEMF
`therapy program, the PEMF processor collects appro
`priate data in memory to enable the attending health
`care professional to monitor the course of the therapy.
`The transducers are incorporated with a belt that
`permits the transducers to be placed around a patient
`and secured in place in front and back of the patient.
`The belt includes compartments for a drive electronics
`module and (rechargeable) battery pack.
`Each transducer is fabricated as follows. Primary,
`secondary and sense windings of adhesive coated mag
`net wire are wound around a flat mandrel with an ap
`propriate anatomical shape for the transducer. The
`windings are bonded by heat curing the adhesive to
`obtain a flat-wound flexible winding bundle. The wind
`ing bundle is placed in a mold, and encapsulated in a
`semi-rigid shell. A bending fixture is used to configure
`the transducer with the selected anatomical contour.
`The technical advantages of the invention include the
`following. The PEMF double-transducer system in
`cludes two transducers, a Helmholtz design that is mag
`netic flux-aiding to optimize the electromagnetic field
`available for stimulating the target area, and to reduce
`system power consumption. The transducers are config
`ured with an anatomical contour, and with a substan
`tially flat cross sectional profile that provides a broad
`contact area, thereby enhancing patient comfort. The
`transducers are formable with a selected degree of ri
`gidity, and with a selected anatomical contour and pro
`file, providing a conformable brace without any special
`conforming assembly or process (such as heat). The
`transducers can be incorporated into a belt or other
`securing means to provide an integrated semi-bracing
`design for the PEMF device. Programmable drive elec
`tronics implement a PEMF program to control electro
`magnetic field activation according to a predetermined
`PEMF therapeutic regimen, and store and provide ap
`propriate data for monitoring the progress of the PEMF
`therapy. The transducers are incorporated with a belt
`that includes compartments for a drive electronics mod
`ule and a rechargeable battery pack to provide a inte
`grated, portable PEMF system.
`BRIEF DESCRIPTION OF THE DRAWINGS
`For a more complete understanding of the invention,
`and for further features and advantages, reference is
`now made to the following Detailed Description of an
`exemplary embodiment of the invention, taken in con
`junction with the accompanying Drawings, in which:
`FIG. 1 illustrates an exemplary spinal PEMF double
`transducer system according to the invention;
`
`35
`
`SO
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`LUMENIS EX1031
`Page 4
`
`

`

`5
`
`25
`
`5,181,902
`4.
`3
`the patient starts the PEMF program by turning on the
`FIG. 2 is a cross sectional view of a transducer show
`ing the flat-wound bundle of windings, and the encapsu
`drive electronics module.
`In accordance with the stored PEMF therapy pro
`lating shell; and
`gram, the PEMF processor correspondingly control the
`FIG. 3 is a schematic block diagram of the drive
`activation current supplied to the transducers, thereby
`electronics.
`controlling the electromagnetic fields in terms of ener
`DETAILED DESCRIPTION OF THE
`gization time, deenergization time and duty cycle (repe
`INVENTION
`tition rate). In addition to controlling the PEMF ther
`apy, the PEMF processor maintains treatment data that
`The Detailed Description of an exemplary embodi
`is available on request to the patient (through a small
`ment of the PEMF double-transducer system of the
`O
`display), and to a health care professional (via an I/O
`invention is organized as follows:
`port) for monitoring and analysis.
`1. Spinal PEMF System
`2. Transducer Fabrication. For an exemplary em
`2. Transducer Fabrication
`bodiment, the front and back flat-wound contoured
`3. Drive Electronics Module
`transducers are fabricated as follows.
`4. Conclusion
`FIG. 2 is a cross sectional view of a transducer (front
`The exemplary embodiment is a self-contained porta
`or back) 30 that includes primary, secondary and sense
`ble PEMF system for providing PEMF therapy to
`windings 32 encapsulated in a semi-rigid shell 34. The
`the spinal column, such as for fusion repair.
`primary, secondary and sense windings are not shown
`1. Spinal PEMF System. FIGURE illustrates an ex
`emplary spinal PEMF double-transducer system 10.
`differentiated in the FIG., nor is the total number of
`20
`windings shown meant to be accurate-the FIG. is
`The system includes front and back transducers 12 and
`14 incorporated with an adjustable belt 16.
`illustrative only.
`For the exemplary embodiment, a transducer in
`Transducers 12 and 14 are anatomically contoured to
`cludes two parallel primary windings of about 7 turns
`enhance patient comfort, with a substantially flat cross
`each, a secondary winding of about 35 turns, and a sense
`sectional profile that provides a broad contact area,
`winding of at least 1 turn. For the primary and second
`thereby enhancing patient comfort . The transducers
`ary windings, 18 gauge wire can be used, while 22
`are semi-rigid to maintain the selected contour and
`profile, and to provide bracing support as a fully inte
`gauge wire can be used for the sense winding. The
`approximate dimensions of the winding bundle are 0.75
`grated PEMF system. As described in Section 2, the
`by 0.12inches, while the approximate dimensions of the
`transducers include flat-wound primary, secondary and
`30
`sense windings encapsulated in a shell of a plasticized
`shell are 1.50 by 0.31 inches.
`The winding material is a commercially available
`elastomer material (such as polyurethane) with a se
`lected degree of rigidity.
`magnet wire that includes an overcoat of an adhesive,
`such as polyurethane adhesive coated wire. The shell is
`The transducers include both primary and secondary
`windings, with the secondary windings being used to
`a polyurethane-type elastomer material, also available
`commercially. Other shell materials can be used to pro
`provide energy recovery, and as a collateral function, to
`vide different degrees of transducer-shell rigidity,
`assist in tailoring the electromagnetic field output from
`thereby providing different bracing rigidity characteris
`the transducers. Alternatively, the advantages of the
`PEMF double-transducer system of the invention for
`tics.
`implementing a PEMF therapy could be obtained using
`The adhesive-coated primary, secondary and sense
`windings are wound simultaneously in a winding ma
`a pair of transducers, each with only a primary winding
`(i.e., with no energy recovery windings, but preferably
`chine around a flat mandrel of the appropriate shape for
`the transducer. The windings are maintained in the
`with an alternative efficient programmed energy for
`flat-wound position shown in the FIG. by parallel side
`mat).
`plates. Once wound, the start and finish wire ends for
`Adjustable belt 16 can be fastened by means of a
`45
`each winding are cut to provide leads for coupling to
`buckle 17. The belt includes compartments for a drive
`the drive electronics, and the winding assembly-wind
`electronics module 22, and a rechargeable battery pack
`ing bundle, mandrel and sideplates-is removed from
`24.
`the winding machine.
`The drive electronics module includes a PEMF pro
`The winding assembly is then placed in an oven for
`cessor for providing pulsing current to the front and
`50
`heat curing at the appropriate curing temperature. Heat
`back transducers at predetermined intervals, thereby
`activating the electromagnetic field according to a pre
`curing activates the adhesive coating, and the windings
`scribed preprogrammed PEMF regimen. The drive
`are bonded together to form the winding bundle 32.
`The winding assembly is removed from the oven and,
`electronics is coupled to the back transducer 14 by a
`after cooling, a sideplate is removed, allowing the
`cord 26.
`55
`The battery pack can be recharged using an AC
`bonded winding bundle to be removed. The winding
`adapter 28.
`bundle is now in a flexible, bonded unit.
`The winding bundle 32 is placed in a substantially flat
`In operation, a health care professional determines a
`mold of the appropriate shape, with the winding leads
`PEMF therapy that includes a regimen of PEMF stimu
`running out of the mold fill slot. The polyurethane type
`lation of a target area of the spine. The prescribed
`PEMF therapy regimen is translated into a PEMF pro
`elastomer material is then introduced into the mold to
`gram, which is programmed into a PEMF memory in
`form the shell 34.
`For the exemplary embodiment, a two component
`the drive electronics, either during manufacture or sub
`sequently.
`polyurethane elastomer is used: an isocyanate and a
`polyol. In a vacuum, the two components are mixed,
`To commence a PEMF therapy session, the patient
`and then poured into the mold, covering the winding
`arranges the contoured front and back transducers for
`bundle. These steps are performed in a vacuum to elimi
`comfort, and engages the buckle (adjusting the belt to
`control snugness). Once the PEMF system is in place,
`nate entrapped air which can cause voids that reduce
`
`35
`
`65
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`Page 5
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`

`

`15
`
`35
`
`5,181,902
`6
`5
`microseconds. A pulse train is output to the transducers
`structural integrity and are cosmetically undesirable.
`every 667,000 microseconds (every 667 milliseconds or
`The mold is placed in an oven for heat curing the poly
`urethane type elastomer material to form the encapsu
`one third of a second).
`The pulse trains from the interval timer/pulse
`lating shell 34.
`counter 46 are input to a transducer drive amplifier 62,
`After cooling, the potted transducer is removed from
`which control FET switches 64 and 65. The FET
`the mold. The transducer is cleaned of mold release, and
`switches control the activation current through the
`any flash is trimmed off.
`primary windings of the front and back windings 71 and
`Finally, the transducer is placed in a bending fixture,
`72, thereby controlling the energization and deenergiza
`and bent into the desired anatomical contour. The com
`pleted semi-rigid transducer is now ready to be incorpo
`tion of the transducers. When switched on (during a 65
`10
`microsecond on pulse), activation current from the
`rated into the belt, and coupled to the drive electronics.
`battery 50 flows through the primary windings, energiz
`3. Drive Electronics Module. The drive electronics
`ing the transducer. When switched off (during the 195
`module includes the PEMF processor and the associ
`ated PEMF memory for storing a PEMF therapy pro
`microsecond off period), current flows through the
`secondary windings as the transducer is deenergized.
`gram.
`The other ends of the primary windings for the front
`FIG. 3 is a schematic block diagram of drive elec
`and back transducers are coupled to the battery 50, as
`tronics 40, which includes a PEMF processor 41, with
`are the corresponding ends of the secondary windings
`associated IC (integrated circuit) components: an ad
`through diodes 81 and 82 (the other ends of the second
`dress latch and decoder circuit 42, a PEMF program
`ary windings are grounded). A group of four energy
`memory 43, a data memory and real time clock circuit
`20
`recovery capacitors 84 release energy during trans
`44, a 16 character dot matrix display module 45 and an
`ducer energization, and store energy during transducer
`interval timer/pulse counter 46. The PEMF processor
`deenergization. Thus, the energy recovery capacitors
`is coupled to these components by an address bus 47 and
`84 and the diodes 81 and 82 for an energy recovery
`a data bus 48.
`circuit that operates in conjunction with the secondary
`A PEMF program can be loaded into an EPROM or
`25
`winding to provide energy recovery, thereby conserv
`other memory and installed as PEMF program memory
`ing battery power.
`43; alternatively, the PEMF program can be read into
`The sense winding for each of the transducers is cou
`the PEMF program memory via an I/O port 49. Data
`pled through a field sense amplifier 90 to the PEMF
`collected during execution of the programmable PEMF
`processor 41. The field sense amplifier senses the elec
`program parameters- such as start time, stop time,
`30
`tromagnetic fields generated during transducer activa
`duration, and daily average -is stored in the data mem
`tion, and provides feedback to the PEMF processor for
`ory 44, and can be read out to a printer (or over a com
`monitoring the PEMF operation. The PEMF processor
`munications link) via the I/O port 49.
`causes appropriate monitoring data to be stored in the
`The PEMF processor 41 receives power from a
`data memory 44, and will cause an alarm signal in the
`power source, such as a 12 volt NICAD battery pack
`50, through a switching voltage regulator 52 (which
`case of malfunction.
`also provides +5 volts power to the other IC compo
`4. Conclusion. Although the invention has been de
`scribed with respect to a specific, exemplary embodi
`nents).
`ment, various changes and modifications may be sug
`PEMF processor 41, and the supporting IC TTL
`gested to one skilled in the art. For example, while the
`logic chips and display module, function conventionally
`exemplary embodiment is described in relation to a
`and are commercially available. For the exemplary
`spinal PEMF system, the PEMF double-transducer
`embodiment, PEMF processor 41 is an Intel 80C51
`system can be used to provide PEMF therapy for other
`processor. The address latch and decoder IC 42 is actu
`areas of the musculoskeletal system, such as the hip or
`ally two chips, a 74HC573 and 74HC138. The PEMF
`collar bone, with the transducers being being anatomi
`program memory is a 28648 Kbyte EEPROM that is
`45
`cally contoured positioning on either side of the target
`loaded with a PEMF program during manufacture, but
`area. Also, the exemplary PEMF system is completely
`that can be altered electrically while in use. The data
`portable, while the advantages of the invention can be
`memory and real time clock IC 44 is a Mostek
`obtained from a system designed to be non-portable.
`MK48T02, used to store representative data about the
`Therefore, it is intended that the invention encompass
`patient's use of the PEMF system based on the inter
`all changes and modifications that fall within the scope
`nally maintained clock and calendar. The 16-character
`of the appended claims.
`dot matrix display module 45 is a standard integrated
`display module package.
`What is claimed is:
`1. A PEMF double-transducer system for providing
`The interval timer/pulse counter IC 46 is an Intel
`PEMF therapeutic stimulation to the spine of a patient's
`82C54 that includes two general purpose counters con
`55
`body, comprising:
`trolled by the PEMF processor, executing the PEMF
`program, to establish the duty cycle of the pulse output.
`front and back transducers, both including at least a
`primary winding with a selected number of turns
`The pulse output, in turn, controls the energization and
`encapsulated in a shell, said shells being at least
`deenergization of the transducers, and thereby deter
`semi-rigid for providing support to the patient, said
`mines the activation of the magnetic fields used in the
`shells being anatomically contoured for situating
`PEMF therapy.
`on either side of a target area of the spine for
`For the exemplary embodiment, the PEMF program
`PEMF therapy and physically coupled for releas
`causes the interval timer/pulse counter IC 46 to output
`ably securing said transducers in place;
`a variable programmed train of, for example, 99 pulses
`drive electronics coupled to said primary winding of
`lasting 25,740 microseconds, with a pulse period of 65
`65
`both said front and back transducers for selectively
`microseconds on and 195 microseconds off. That is, for
`activating an electromagnetic field, thereby imple
`each pulse, the transducers are energized for 65 micro
`menting a prescribed PEMF therapy;
`seconds and then deenergized (recovery phase) for 195
`
`50
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`LUMENIS EX1031
`Page 6
`
`

`

`5,181,902
`8
`7
`ergy recovery capacitance coupled in parallel with said
`said drive electronics including a PEMF processor
`primary and secondary windings.
`and a PEMF program for controlling said proces
`sor to energize and deenergize said transducers to
`4. The PEMF double-transducer system of claim 1,
`implement a predetermined PEMF therapy pro
`wherein both front and back transducers further include
`gram for the patient's spine;
`a sense winding with a selected number of sense turns,
`said drive electronics also including circuitry for
`said sense winding being coupled to said drive electron
`monitoring the patient's use of the PEMF system
`ics for providing a feedback indication of the PEMF
`and the course of the PEMF therapy; and
`output from said transducers.
`a battery pack electrically connected to said drive
`5. The PEMF double-transducer system of claim 1,
`wherein the transducers have a substantially flat cross
`electronics
`sectional profile.
`a belt supporting the front and back transducers and
`having compartments containing the drive elec
`6. The PEMF double-transducer system of claim 5,
`tronics, the battery pack, and a buckle for releas
`wherein, for both the front and back transducers, the
`primary and secondary windings are flat. wound.
`ably securing the transducers in place such that the
`PEMF double transducer system is portable.
`7. The PEMF double-transducer system of claim 6,
`wherein the windings are adhesive coated magnet wire,
`2. The PEMF double-transducer system of claim 1,
`bonded into a winding bundle prior to encapsulation.
`wherein:
`8. The PEMF double-transducer system of claim 1,
`both front and back transducers further include a
`secondary winding with a selected number of
`wherein said encapsulating shell is a polyurethane elas
`20
`turns;
`toner.
`said drive electronics including an energy recovery
`9. The PEMF double-transducer system of claim 1,
`circuit coupled to said secondary winding for re
`wherein said drive electronics generates clock and cal
`covering energy during each activation of said
`endar data, and wherein said PEMF program collects
`clock and calendar data representative of the patient's
`transducers.
`use of the PEMF system.
`3. The PEMF double-transducer system of claim 2
`25
`wherein said energy recovery circuit includes an en
`
`O
`
`15
`
`x
`
`k
`
`30
`
`35
`
`45
`
`SO
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`55
`
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`LUMENIS EX1031
`Page 7
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`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`5,181,902
`PATENT NO. :
`January 26, 1993
`DATED
`:
`John H. Erickson et al.
`INVENTOR(S) :
`it is certified that error appears in the above-identified patent and that said Letters Patent is hereby
`Corrected as shown below:
`Column 3, line 19, underline "1. Spinal PEMF System".
`Column 3, line 19, after "FIGURE" insert - 1 -.
`
`Column 4, line 13, underline "2. Transducer Fabrication".
`Column 5, line 12, underline "3. Drive Electronics Module".
`Column 6, line 37, underline "4. Conclusion".
`Column 7, line 8, delete "and".
`Column 7, line 10, insert -; and -after "electronics".
`In abstract, sentence 8, delete "electronic" and insert -electronics--.
`
`Signed and Sealed this
`Eleventh Day of April, 1995
`
`Attesting Officer
`
`Commissioner of Patents and Trademarks
`
`BRUCE LEHMAN
`
`
`
`LUMENIS EX1031
`Page 8
`
`