`
`1111111111111101111111111111111111)1,112110111110121!1)141,11111111111111111111111110111111
`
`US 20070276449A1
`
`(19) United States
`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2007/0276449 A1
`(12) Patent Application Publication (10) Pub. No.: US 2007/0276449 Al
`Nov. 29, 2007
`(43) Pub. Date:
`Nov. 29, 2007
`Gunter et al.
`Gunter et al.
`(43) Pub. Date:
`
`(54) INTERACTIVE TRANSCUTANEOUS
`INTERACTIVE TRANSCUTANEOUS
`(54)
`ELECTRICAL NERVE STIMULATION
`ELECTRICAL NERVE STIMULATION
`DEVICE
`DEVICE
`
`(75)
`(75)
`
`Inventors: M. Lee Gunter, League City, TX (US);
`Inventors: M. Lee Gunter, League City, TX (US);
`Michael Distler, Kemalt, TX (US);
`Michael Distler, Kemalt, TX (US);
`Viktoriya V. Gunter, League City, TX
`Viktoriya V. Gunter, League City, TX
`(US)
`(US)
`Correspondence Address:
`Correspondence Address:
`Hugh R. Kress
`Hugh R. Kress
`ARNOLD & FERRERA, L.L.P.
`ARNOLD & FERRERA, L.L.P.
`2401 Fountainview
`2401 Fountainview
`Suite 630
`Suite 630
`Houston, TX 77.057 (US)
`Houston, TX 77057 (US)
`Assignee: Med-Lectric Corporation
`(73)
`(73) Assignee: Med-Lectric Corporation
`Appl. No.:
`(21)
`(21) Appl. No.:
`(22)
`Filed:
`(22) Filed:
`
`11/153,814
`11/153,814
`
`Jun. 15, 2005
`Jun. 15, 2005
`
`Publication Classification
`Publication Classification
`
`(51)
`Int. C.
`(51) Int. Cl.
`A6 IN L/04
`A 61N 1/04
`
`(2006.01)
`(2006.01)
`
`(52) U.S. Cl. ................................................................ 607/46
` 607/46
`(52) U.S. Cl.
`
`(57)
`(57)
`
`ABSTRACT
`ABSTRACT
`
`A wireless, handheld electrical therapy device delivers elec
`A wireless, handheld electrical therapy device delivers elec-
`trical pulses to a treatment area of a patient. In one embodi
`trical pulses to a treatment area of a patient. In one embodi-
`ment, the device comprises a microcontroller-based pulse
`ment, the device comprises a microcontroller-based pulse
`generator circuit selectively operable in a plurality of thera
`generator circuit selectively operable in a plurality of thera-
`peutic modes. The device comprises an ergonomic housing
`peutic modes. The device comprises an ergonomic housing
`adapted to be comfortably grasped by a user. A plurality of
`adapted to be comfortably grasped by a user. A plurality of
`electrodes are disposed on a Surface of the housing. In
`electrodes are disposed on a surface of the housing. In
`operation, a user brings the electrodes into contact with a
`operation, a user brings the electrodes into contact with a
`patient’s skin at a location on the patient to be treated.
`patient's skin at a location on the patient to be treated.
`Electrical pulses are delivered between the electrodes,
`Electrical pulses are delivered between the electrodes,
`thereby electrically stimulating neural tissue at the treatment
`thereby electrically stimulating neural tissue at the treatment
`location. In one embodiment, the device is operable in a
`location. In one embodiment, the device is operable in a
`manual mode wherein the user selects from among a plu
`manual mode wherein the user selects from among a plu-
`rality of therapeutic regimens each corresponding to a set of
`rality of therapeutic regimens each corresponding to a set of
`predetermined operational parameters. Among the variable
`predetermined operational parameters. Among the variable
`operational parameters are pulse amplitude, frequency, dura
`operational parameters are pulse amplitude, frequency, dura-
`tion, damping, and shape. In another embodiment of the
`tion, damping, and shape. In another embodiment of the
`invention, the device is operable in an automatic mode
`invention, the device is operable in an automatic mode
`wherein electrical conditions at the skin Surface are periodi
`wherein electrical conditions at the skin surface are periodi-
`cally sensed and the operational parameters automatically
`cally sensed and the operational parameters automatically
`adjusted to achieve optimal therapeutic effectiveness.
`adjusted to achieve optimal therapeutic effectiveness.
`
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`Petitioner - Avation Medical, Inc.
`Ex. 1032, p. 1
`
`

`

`Patent Application Publication Nov. 29, 2007 Sheet 1 of 7
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`US 2007/0276449 A1
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`Petitioner - Avation Medical, Inc.
`Ex. 1032, p. 2
`
`

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`Patent Application Publication Nov. 29, 2007 Sheet 2 of 7
`
`US 2007/0276449 A1
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`Petitioner - Avation Medical, Inc.
`Ex. 1032, p. 3
`
`

`

`Patent Application Publication Nov. 29, 2007 Sheet 3 of 7
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`Petitioner - Avation Medical, Inc.
`Ex. 1032, p. 4
`
`

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`Patent Application Publication Nov. 29, 2007 Sheet 4 of 7
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`Petitioner - Avation Medical, Inc.
`Ex. 1032, p. 5
`
`..•
`

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`Patent Application Publication Nov. 29, 2007 Sheet 5 of 7
`
`IV 617179LZO/LOOZ SR US 2007/0276449 A1
`
`= Input A
`Name
`= 9/25/2004
`Date
`= 3:57:14 PM
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`MODULATION 1:3 2K OHM LOAD 110 V PEAK 15.5 HZ
`
`Figure 5
`
`Petitioner - Avation Medical, Inc.
`Ex. 1032, p. 6
`
`

`

`Patent Application Publication Nov. 29, 2007 Sheet 6 of 7
`
`IV 617179LZO/LOOZ SR US 2007/0276449 A1
`
`64
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`Name
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`= 9/25/2004
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`Maximum = -18 V
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`X2: 27.4 ms
`dX: 24.8 ms
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`Y2: -4 2V
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`Petitioner - Avation Medical, Inc.
`Ex. 1032, p. 7
`
`

`

`Patent Application Publication Nov. 29, 2007 Sheet 7 of 7
`
`IV 617179LZO/LOOZ SR US 2007/0276449 A1
`
`= Input A
`Name
`= 9/25/2004
`Date
`= 3:57:14 PM
`Time
`= 10 V/Div
`Y Scale
`Y at 50% = 0 V
`= 5 ms/Div
`X Scale
`= -10.0 ms
`X at 0%
`= 250 (254)
`X Size
`Minimum = Overload
`Maximum = -14.0 V
`
`X1: 2.6 ms
`X2: 27.4 ms
`dX: 24.8 ms
`Y1: -0.4 0.8V
`Y2: -0.4 0.8V
`dY: -0.4 0.8V
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`Petitioner - Avation Medical, Inc.
`Ex. 1032, p. 8
`
`

`

`US 2007/0276449 A1
`US 2007/0276449 Al
`
`1
`
`Nov. 29, 2007
`Nov. 29, 2007
`
`INTERACTIVE TRANSCUTANEOUSELECTRICAL
`INTERACTIVE TRANSCUTANEOUS ELECTRICAL
`NERVE STIMULATION DEVICE
`NERVE STIMULATION DEVICE
`
`FIELD OF THE INVENTION
`FIELD OF THE INVENTION
`0001. This invention relates generally to the field of
`[0001] This invention relates generally to the field of
`therapeutic devices, and more particularly relates to an
`therapeutic devices, and more particularly relates to an
`interactive device for electrical stimulation of body tissue.
`interactive device for electrical stimulation of body tissue.
`
`BACKGROUND OF THE INVENTION
`BACKGROUND OF THE INVENTION
`nerve stimulation
`0002 Transcutaneous electrical
`stimulation
`nerve
`electrical
`[0002] Transcutaneous
`(TENS) has been an accepted mode of physical therapy for
`(TENS) has been an accepted mode of physical therapy for
`many years, and is well characterized in the literature. U.S.
`many years, and is well characterized in the literature. U.S.
`Pat. No. 4,147,171 to Greene et al., entitled “Transcutaneous
`Pat. No. 4,147,171 to Greene et al., entitled "Transcutaneous
`Pain Control and/or Muscle Stimulating Apparatus.” is
`Pain Control and/or Muscle Stimulating Apparatus," is
`representative of relatively early electrotherapeutic devices.
`representative of relatively early electrotherapeutic devices.
`On the other hand, U.S. Pat. No. 6,445,955 to Michelson et
`On the other hand, U.S. Pat. No. 6,445,955 to Michelson et
`al., entitled “Miniature Wireless Transcutaneous Electrical
`al., entitled "Miniature Wireless Transcutaneous Electrical
`Neuro or Muscular Stimulation Unit, represents a more
`Neuro or Muscular Stimulation Unit," represents a more
`state-of-the-art implementation of a TENS unit.
`state-of-the-art implementation of a TENS unit.
`0003 TENS has primarily been understood as being
`[0003] TENS has primarily been understood as being
`intended to provide pain relief via a nerve signal blocking
`intended to provide pain relief via a nerve signal blocking
`mechanism. TENS devices typically deliver monophasic or
`mechanism. TENS devices typically deliver monophasic or
`biphasic electrical stimulating pulses between 10 milliam
`biphasic electrical stimulating pulses between 10 milliam-
`peres (mA) and 100 mA in amplitude. Pulse amplitude,
`peres (mA) and 100 mA in amplitude. Pulse amplitude,
`pulse width, and pulse rate are often user-adjustable. The
`pulse width, and pulse rate are often user-adjustable. The
`stimulus pulse is typically delivered between a pair of
`stimulus pulse is typically delivered between a pair of
`electrodes that are manually disposed over major muscle
`electrodes that are manually disposed over major muscle
`groups or nerves that are to receive the stimulation. A variety
`groups or nerves that are to receive the stimulation. A variety
`of TENS devices are commercially available for clinical and
`of TENS devices are commercially available for clinical and
`public use.
`public use.
`0004 Microcurrent electrotherapy, or microcurrent elec
`[0004] Microcurrent electrotherapy, or microcurrent elec-
`trical neuromuscular stimulation (MENS) is gaining popu
`trical neuromuscular stimulation (MENS) is gaining popu-
`larity in clinical practice for decreasing or eliminating pain
`larity in clinical practice for decreasing or eliminating pain
`and stimulating healing processes. MENS is typically used
`and stimulating healing processes. MENS is typically used
`for pain relief and more typically for tissue healing by
`for pain relief and more typically for tissue healing by
`affecting the injured tissue at a cellular level. However, the
`affecting the injured tissue at a cellular level. However, the
`exact mechanisms by which microcurrent therapy works
`exact mechanisms by which microcurrent therapy works
`have yet to be completely understood.
`have yet to be completely understood.
`0005 Present day electrotherapy units have a number of
`[0005] Present day electrotherapy units have a number of
`limitations which affect their functionality as an electro
`limitations which affect their functionality as an electro-
`therapy tool. First, there are a number of problems with
`therapy tool. First, there are a number of problems with
`attaching external electrodes. Electrodes must adhere to the
`attaching external electrodes. Electrodes must adhere to the
`skin either with an adhesive or tape. Over time, the adhesive
`skin either with an adhesive or tape. Over time, the adhesive
`or tape becomes loose, rendering the therapy ineffective.
`or tape becomes loose, rendering the therapy ineffective.
`This holds true particularly with active patients, even those
`This holds true particularly with active patients, even those
`doing light exercise or normal daily activities. Second, the
`doing light exercise or normal daily activities. Second, the
`placement of external electrodes must be done properly. The
`placement of external electrodes must be done properly. The
`average patient has a poor understanding of anatomical
`average patient has a poor understanding of anatomical
`features, leading to underutilization of the electrodes or,
`features, leading to underutilization of the electrodes or,
`worse yet, improperly placed electrodes, potentially leading
`worse yet, improperly placed electrodes, potentially leading
`to unnecessary or improper treatment.
`to unnecessary or improper treatment.
`0006.
`Third, the wires and electrodes are challenging to
`[0006] Third, the wires and electrodes are challenging to
`place in or through clothing, so as to be inconspicuous
`place in or through clothing, so as to be inconspicuous
`despite the relatively small size of the device delivering the
`despite the relatively small size of the device delivering the
`electrotherapy. Problems with prior art electrotherapy
`electrotherapy. Problems with prior art electrotherapy
`devices include, without limitation, detachment of lead
`devices include, without limitation, detachment of lead
`wires from the electrodes or stimulator during patient move
`wires from the electrodes or stimulator during patient move-
`ments, interference of lead wires with daily activities, and
`ments, interference of lead wires with daily activities, and
`bulkiness that leads to decreased use of the stimulator unit.
`bulkiness that leads to decreased use of the stimulator unit.
`0007 Certain of the known deficiencies in prior art
`[0007] Certain of the known deficiencies in prior art
`electrotherapeutic devices are acknowledged in the above
`electrotherapeutic devices are acknowledged in the above-
`
`referenced Michelson et al. 955 patent. For example, the
`referenced Michelson et al. '955 patent. For example, the
`955 patent emphasizes the small size of the disclosed
`'955 patent emphasizes the small size of the disclosed
`device, facilitating its insertion into a splint, bandage, brace
`device, facilitating its insertion into a splint, bandage, brace
`or cast. However, the device disclosed in the 955 patent
`or cast. However, the device disclosed in the '955 patent
`does not appear to fully address the issues of proper elec
`does not appear to fully address the issues of proper elec-
`trode placement and adhesion of the electrodes to the
`trode placement and adhesion of the electrodes to the
`patient’s skin. Further, although the 955 patent character
`patient's skin. Further, although the '955 patent character-
`izes the device disclosed therein as "wireless,' this is
`izes the device disclosed therein as "wireless," this is
`believed to be a misleading characterization. In each
`believed to be a misleading characterization. In each
`embodiment disclosed in the 955 patent, the electrodes are
`embodiment disclosed in the '955 patent, the electrodes are
`carried on an electrode assembly separate from the stimu
`carried on an electrode assembly separate from the stimu-
`lator device itself. That is, the 955 patent at best merely
`lator device itself. That is, the '955 patent at best merely
`substitutes conductive tapes or elastomers for “wires,” in
`substitutes conductive tapes or elastomers for "wires," in
`establishing a connection between the pulse generator and
`establishing a connection between the pulse generator and
`the separate electrodes or electrode assemblies.
`the separate electrodes or electrode assemblies.
`0008 Accordingly, there remains an ongoing need for a
`[0008] Accordingly, there remains an ongoing need for a
`different electrotherapy delivery mechanism and portable
`different electrotherapy delivery mechanism and portable
`electrotherapy device capable of delivering multiple modes
`electrotherapy device capable of delivering multiple modes
`of operations to an injured site and a variety of injury-related
`of operations to an injured site and a variety of injury-related
`conditions.
`conditions.
`
`SUMMARY OF THE INVENTION
`SUMMARY OF THE INVENTION
`0009. In view of the foregoing, the present invention is
`In view of the foregoing, the present invention is
`[0009]
`directed to a hand-held electrotherapy device which can be
`directed to a hand-held electrotherapy device which can be
`used by either hand of a clinician or patient. Further, the
`used by either hand of a clinician or patient. Further, the
`device is capable of delivering a variety of waveforms to
`device is capable of delivering a variety of waveforms to
`patient tissue, with varying amplitude according to the
`patient tissue, with varying amplitude according to the
`patient's comfort level, so as to be capable of treating a
`patient's comfort level, so as to be capable of treating a
`variety of physical conditions both acute and chronic.
`variety of physical conditions both acute and chronic.
`0010. In one embodiment, the invention comprises a
`In one embodiment, the invention comprises a
`[0010]
`hand-held unit having three built-in (integral) electrodes
`hand-held unit having three built-in (integral) electrodes
`thereon. The electrodes are located opposite the control
`thereon. The electrodes are located opposite the control
`interface, which faces the operator. An internal electronics
`interface, which faces the operator. An internal electronics
`unit contains an electronic control circuit and at least one
`unit contains an electronic control circuit and at least one
`power source (battery) to provide operational power to the
`power source (battery) to provide operational power to the
`device. An LED panel containing an array of indicators, is
`device. An LED panel containing an array of indicators, is
`provided on a rear Surface of the housing, allowing the
`provided on a rear surface of the housing, allowing the
`operator to Verify the modes and intensity of operation.
`operator to verify the modes and intensity of operation.
`0011. The control circuit regulates operation of the elec
`[0011] The control circuit regulates operation of the elec-
`tronics through a plurality of different modes, each being
`tronics through a plurality of different modes, each being
`intended to administer treatment via a specific waveform. In
`intended to administer treatment via a specific waveform. In
`one embodiment, eight levels of intensity are available.
`one embodiment, eight levels of intensity are available.
`0012. The operating keys are arranged in such a way that
`[0012] The operating keys are arranged in such a way that
`one can easily and quickly change any setting Suitable to
`one can easily and quickly change any setting suitable to
`one’s tolerance to the stimulating pulses. In accordance with
`one's tolerance to the stimulating pulses. In accordance with
`one aspect of the invention, and unlike prior art electro
`one aspect of the invention, and unlike prior art electro-
`therapy devices, the electrodes need not be placed directly
`therapy devices, the electrodes need not be placed directly
`on the injured site, but rather only generally in the area of
`on the injured site, but rather only generally in the area of
`treatment. Due to the nature of the waveforms generated by
`treatment. Due to the nature of the waveforms generated by
`the device, a treatment site receives a wide range of treat
`the device, a treatment site receives a wide range of treat-
`ment and effectively treats an area greater than the precise
`ment and effectively treats an area greater than the precise
`area of immediate contact with the electrodes.
`area of immediate contact with the electrodes.
`0013 In accordance with another aspect of the invention,
`In accordance with another aspect of the invention,
`[0013]
`aside from the ease and facility of use compared with prior
`aside from the ease and facility of use compared with prior
`art devices, the present invention emits a unique Sound when
`art devices, the present invention emits a unique sound when
`placed on the skin. On an injured site, there is little or no
`placed on the skin. On an injured site, there is little or no
`Sound emitted. As treatment progresses, the sound increases
`sound emitted. As treatment progresses, the sound increases
`in intensity, such that along with the LED display, the device
`in intensity, such that along with the LED display, the device
`indicates both visually and aurally the progression of treat
`indicates both visually and aurally the progression of treat-
`ment.
`ment.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1032, p. 9
`
`

`

`US 2007/0276449 A1
`US 2007/0276449 Al
`
`2
`
`Nov. 29, 2007
`Nov. 29, 2007
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`BRIEF DESCRIPTION OF THE DRAWINGS
`0014. The foregoing and other features and aspects of the
`[0014] The foregoing and other features and aspects of the
`present invention will be best understood with reference to
`present invention will be best understood with reference to
`the following detailed description of a specific embodiment
`the following detailed description of a specific embodiment
`of the invention, when read in conjunction with the accom
`of the invention, when read in conjunction with the accom-
`panying drawings, wherein:
`panying drawings, wherein:
`0.015
`FIGS. 1a, 1b, and 1c are rear, side, and front views,
`[0015] FIGS. la, lb, and lc are rear, side, and front views,
`respectively, of a wireless, handheld electrotherapy device in
`respectively, of a wireless, handheld electrotherapy device in
`accordance with one embodiment of the invention;
`accordance with one embodiment of the invention;
`0016 FIG. 2 is a functional block diagram of the opera
`[0016] FIG. 2 is a functional block diagram of the opera-
`tional circuitry in the device of FIGS. 1a, 1b, and 1c.
`tional circuitry in the device of FIGS. la, lb, and lc;
`0017 FIG. 3 is a schematic diagram of the operational
`[0017] FIG. 3 is a schematic diagram of the operational
`circuitry in the device from FIG. 2;
`circuitry in the device from FIG. 2;
`0018 FIG. 4 is a plot of a voltage waveform generated by
`[0018] FIG. 4 is a plot of a voltage waveform generated by
`the device from FIG. 2;
`the device from FIG. 2;
`0.019
`FIG. 5 is a plot of a voltage waveform of a therapy
`[0019] FIG. 5 is a plot of a voltage waveform of a therapy
`regimen delivered by the device from FIG. 2;
`regimen delivered by the device from FIG. 2;
`0020 FIG. 6 is a plot of a voltage waveform of another
`[0020] FIG. 6 is a plot of a voltage waveform of another
`therapy regimen delivered by the device from FIG. 2; and
`therapy regimen delivered by the device from FIG. 2; and
`0021
`FIG. 7 is a plot of a voltage waveform of another
`[0021] FIG. 7 is a plot of a voltage waveform of another
`therapy regimen delivered by the device from FIG. 2.
`therapy regimen delivered by the device from FIG. 2.
`
`DETAILED DESCRIPTION OF A SPECIFIC
`DETAILED DESCRIPTION OF A SPECIFIC
`EMBODIMENT OF THE INVENTION
`EMBODIMENT OF THE INVENTION
`0022. In the disclosure that follows, in the interest of
`In the disclosure that follows, in the interest of
`[0022]
`clarity, not all features of actual implementations are
`clarity, not all features of actual implementations are
`described. It will of course be appreciated that in the
`described. It will of course be appreciated that in the
`development of any such actual implementation, as in any
`development of any such actual implementation, as in any
`Such project, numerous engineering and technical decisions
`such project, numerous engineering and technical decisions
`must be made to achieve the developers specific goals and
`must be made to achieve the developers' specific goals and
`Subgoals (e.g., compliance with system and technical con
`subgoals (e.g., compliance with system and technical con-
`straints), which will vary from one implementation to
`straints), which will vary from one implementation to
`another. Moreover, attention will necessarily be paid to
`another. Moreover, attention will necessarily be paid to
`proper engineering and programming practices for the envi
`proper engineering and programming practices for the envi-
`ronment in question. It will be appreciated that such a
`ronment in question. It will be appreciated that such a
`development effort might be complex and time-consuming,
`development effort might be complex and time-consuming,
`but would nevertheless be a routine undertaking for those of
`but would nevertheless be a routine undertaking for those of
`ordinary skill in the relevant fields.
`ordinary skill in the relevant fields.
`0023. Furthermore, for the purposes of the present dis
`[0023] Furthermore, for the purposes of the present dis-
`closure, the terms “comprise' and “comprising shall be
`closure, the terms "comprise" and "comprising" shall be
`interpreted in an inclusive, non-limiting sense, recognizing
`interpreted in an inclusive, non-limiting sense, recognizing
`that an element or method step said to “comprise' one or
`that an element or method step said to "comprise" one or
`more specific components may include additional compo
`more specific components may include additional compo-
`nents.
`nentS.
`0024 Referring to FIGS. 1a, 1b, and 1c, there are shown
`[0024] Referring to FIGS. la, lb, and lc, there are shown
`rear, side, and front views, respectively, of a handheld,
`rear, side, and front views, respectively, of a handheld,
`wireless electrotherapy device 10 in accordance with one
`wireless electrotherapy device 10 in accordance with one
`embodiment of the invention. As shown in FIGS. 1a, 1b, and
`embodiment of the invention. As shown in FIGS. la, lb, and
`1c, device 10 comprises an external housing 12 having a
`lc, device 10 comprises an external housing 12 having a
`symmetrical, ergonomic design such that it can be easily
`symmetrical, ergonomic design such that it can be easily
`grasped with one hand at a base portion thereof designated
`grasped with one hand at a base portion thereof designated
`generally with reference numeral 14.
`generally with reference numeral 14.
`0025. With reference specifically to FIG. 1a, a plurality
`[0025] With reference specifically to FIG. la, a plurality
`of control buttons 16-1, 16-2, 16-3, and 16-4 (collectively,
`of control buttons 16-1, 16-2, 16-3, and 16-4 (collectively,
`control buttons 16) are disposed on the back of housing 12.
`control buttons 16) are disposed on the back of housing 12.
`The respective functions of these buttons are as follows:
`The respective functions of these buttons are as follows:
`
`Button
`Button
`
`16-1
`16-1
`16-2
`16-2
`16-3
`16-3
`16-4
`16-4
`
`Function
`Function
`
`on off
`on/off
`power increase
`power increase
`mode select
`mode select
`activate treatment
`activate treatment
`
`0026 Notably, buttons 16 are positioned on the back of
`[0026] Notably, buttons 16 are positioned on the back of
`housing 12 in Such a way as to be readily actuated by the
`housing 12 in such a way as to be readily actuated by the
`index finger of an operator grasping device 10 at lower
`index finger of an operator grasping device 10 at lower
`region 14 as previously described.
`region 14 as previously described.
`0027 Positioned above buttons 16-1 through 16-4 is an
`[0027] Positioned above buttons 16-1 through 16-4 is an
`array of LED indicators 18-1 through 18-5 (collectively,
`array of LED indicators 18-1 through 18-5 (collectively,
`indicators 18). The functions of these respective indicators
`indicators 18). The functions of these respective indicators
`are as follows:
`are as follows:
`
`Indicator
`Indicator
`
`Function
`Function
`
`18-1
`18-1
`18-2
`18-2
`18-3
`18-3
`18-4
`18-4
`18-5
`18-5
`
`Auto mode indicator (on/off)
`Auto mode indicator (on/off)
`Amplitude modulation indicator (on/off)
`Amplitude modulation indicator (on/o11)
`Frequency modulation indicator (on/off)
`Frequency modulation indicator (on/oft)
`Dosage level achievement indicator (on/off)
`Dosage level achievement indicator (on/of)
`Output intensity indicator (variable intensity)
`Output intensity indicator (variable intensity)
`
`0028 Referring to FIGS. 1b and 1c, disposed generally
`[0028] Referring to FIGS. lb and lc, disposed generally
`on a distal face portion of the Surface of housing 12 are a
`on a distal face portion of the surface of housing 12 are a
`plurality of electrodes 20. In the preferred embodiment,
`plurality of electrodes 20. In the preferred embodiment,
`three electrodes 20 are provided, as will be hereinafter
`three electrodes 20 are provided, as will be hereinafter
`discussed in further detail.
`discussed in further detail.
`0029. A battery compartment 22 is shown in FIG. 1a. A
`[0029] A battery compartment 22 is shown in FIG. la. A
`jack 24 is provided for an external battery charger (not
`jack 24 is provided for an external battery charger (not
`shown) to be connected to device 10 to recharge the battery.
`shown) to be connected to device 10 to recharge the battery.
`0030. With reference to the side view of FIG. 1b, in one
`[0030] With reference to the side view of FIG. lb, in one
`embodiment, a jack 26 for interfacing device 10 with a
`embodiment, a jack 26 for interfacing device 10 with a
`computer or other external programming/control system
`computer or other external programming/control system
`(also not shown) is provided. For example, jack 26 may be
`(also not shown) is provided. For example, jack 26 may be
`a USB port for interfacing device 10 with a personal
`a USB port for interfacing device 10 with a personal
`computer or the like.
`computer or the like.
`0031. Likewise, a jack 28 may be provided for permitting
`[0031] Likewise, a jack 28 may be provided for permitting
`device to be used with an external electrode assembly. While
`device to be used with an external electrode assembly. While
`not the preferred method of using device 10, there are some
`not the preferred method of using device 10, there are some
`instances where the use of an external electrode to apply
`instances where the use of an external electrode to apply
`electrotherapeutic pulses may be necessary, such as treat
`electrotherapeutic pulses may be necessary, such as treat-
`ment to areas of a patient's face, for example.
`ment to areas of a patient's face, for example.
`0032 Finally, as shown in FIG. 1a, in one embodiment of
`[0032] Finally, as shown in FIG. la, in one embodiment of
`the invention, an optional alphanumeric display 30 may be
`the invention, an optional alphanumeric display 30 may be
`provided for displaying operational data, instructions for
`provided for displaying operational data, instructions for
`use, device settings, and other information.
`use, device settings, and other information.
`0033 Turning to FIG. 2, there is shown a simplified block
`[0033] Turning to FIG. 2, there is shown a simplified block
`diagram of the electrical components of device 10 in accor
`diagram of the electrical components of device 10 in accor-
`dance with one embodiment of the invention. As shown in
`dance with one embodiment of the invention. As shown in
`FIG. 2, device 10 comprises a microcontroller 40, which
`FIG. 2, device 10 comprises a microcontroller 40, which
`among other functions serves as a waveform generator for
`among other functions serves as a waveform generator for
`generating electrotherapy pulses delivered to patient tissue
`generating electrotherapy pulses delivered to patient tissue
`via electrodes 20 carried on the surface of housing 20. In the
`via electrodes 20 carried on the surface of housing 20. In the
`presently preferred embodiment, microcontroller 40 is an
`presently preferred embodiment, microcontroller 40 is an
`Atmel AT89C2051 microcontroller commercially available
`Atmel AT89C2051 microcontroller commercially available
`
`Petitioner - Avation Medical, Inc.
`Ex. 1032, p. 10
`
`

`

`US 2007/0276449 A1
`US