(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property
`Organization
`International Bureau
`
`
`
`
`
`111111111111110111111110111111111111111011111111111111111111111111111101111111111111111111
`
`(43) International Publication Date
`16 December 2004 (16.12.2004)
`
`PCT
`
`(10) International Publication Number
`WO 2004/108209 Al
`
`(51) International Patent Classification7: A61N 1/04, 1/32
`
`(21) International Application Number:
`PCT/US2004/01 819 8
`
`(22)
`
`International Filing Date:
`
`4 June 2004 (04.06.2004)
`
`(25)
`
`Filing Language:
`
`(26)
`
`Publication Language:
`
`(30)
`
`Priority Data:
`60/476,351
`
`English
`
`English
`
`6 June 2003 (06.06.2003) US
`
`(71) Applicant (for all designated States except US): PRIZM
`MEDICAL, INC. [US/US]; 3400 Corporate Way, Suite 1,
`Duluth, GA 30096 (US).
`
`(72) Inventor; and
`(75) Inventor/Applicant (for US only): JOHNSON, James,
`P. [US/US]; 5853 Ridgetop Drive, Gainesville, GA 30504
`(US).
`
`(74) Agent: GROFF, Bradley, K.; Gardner & Groff, PC, Pa-
`per Mill Village, Bldg. 23, 600 Village Trace, Suite 300,
`Marietta, GA 30067 (US).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN,
`CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FT,
`GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE,
`KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD,
`MG, MK, MN, MW, MX, MZ, NA, NI, NO, NZ, OM, PG,
`PH, PL, VT, RO, RU, SC, SD, SE, SG, SK, SL, SY, TJ, TM,
`TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, YU, ZA, ZM,
`ZW.
`
`(84)
`
`Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FT,
`
`[Continued on next page]
`
`(54) Title: ELECTRICAL STIMULATOR AND GARMENT ELECTRODE CONNECTION SYSTEM
`
`(57) Abstract: An electronic stimulator for delivery of energy to a
`treated body portion through a garment or other form of electrode, and
`a method of treatment using said stimulator. A connector strap com-
`prising diode bridge circuitry maintains proper polarity on the elec-
`trodes regardless of the orientation of connection between the stimu-
`lator and the electrode.
`
`112o
`
`100
`
`112c
`
`13o
`
`114
`
`110
`
`114
`
`112b
`
`WO 2004/108209 Al
`
`

`

`WO 2004/108209 Al
`WO 2004/108209 A1 ANNIE OMBIEHIMIIHEIHMEMONIMENHINIE
`1111111111111111 IIIIII IIIII 11111111111111111111 IIIII 111111111111111 lllll 11111111111111111111111
`
`FR, GB, GR, HU, IE, IT, LU, MC, NL, PL, PT, RO, SE, SI,
`before the expiration of the time limit for amending the
`FR, GB, GR, HU, IE, IT, LU, MC, NL, PL, PT, RO, SE, SI, — before the expiration of the time limit for amending the
`SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
`claims and to be republished in the event of receipt of
`SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
`claims and to be republished in the event of receipt of
`GW, ML, MR, NE, SN, TD, TG).
`amendments
`GW, ML, MR, NE, SN, TD, TG).
`amendments
`
`Published:
`Published:
`-
`with international search report
`-
`with international search report
`
`For two-letter codes and other abbreviations, refer to the "Guid(cid:173)
`For two-letter codes and other abbreviations, refer to the "Guid-
`ance Notes on Codes and Abbreviations" appearing at the begin(cid:173)
`once Notes on Codes and Abbreviations" appearing at the begin-
`ning of each regular issue of the PCT Gazette.
`ning of each regular issue of the PCT Gazette.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1007, p. 2
`
`

`

`WO 2004/108209
`WO 2004/108209
`
`PCT/0S2004/018198
`PCT/US2004/018198
`
`1
`1
`
`ELECTRICAL STIMULATOR AND GARMENT ELECTRODE
`ELECTRICAL STIMULATOR AND GARMENT ELECTRODE
`CONNECTION SYSTEM
`CONNECTION SYSTEM
`
`Cross-Reference to Related Applications:
`Cross-Reference to Related Applications:
`
`This application claims priority to U.S. Provisional Patent Application Serial
`This application claims priority to U.S. Provisional Patent Application Serial
`5 No. 60/476,351, filed June 6, 2003, which is hereby incorporated by reference
`5 No. 60/476,351, filed June 6, 2003, which is hereby incorporated by reference
`herein for all purposes. U.S. Patent Numbers 4,554,923; 4,664,118 and 5,374,283;
`herein for all purposes. U.S. Patent Numbers 4,554,923; 4,664,118 and 5,374,283;
`and U.S. Patent Application Serial No. 10/460,084 filed June 12, 2003 (Publication
`and U.S. Patent Application Serial No. 10/460,084 filed June 12, 2003 (Publication
`No. US-2004-0030270-A1), are also hereby incorporated by reference herein for all
`No. US-2004-0030270-A 1 ), are also hereby incorporated by reference herein for all
`purposes.
`purposes.
`
`10
`10
`
`Field of the Invention:
`Field of the Invention:
`
`The present invention relates generally to an electrical stimulator, and to
`The present invention relates generally to an electrical stimulator, and to
`connectors and therapeutic garment systems used in connection therewith. More
`connectors and therapeutic garment systems used in connection therewith. More
`particularly, the invention relates to a pulsed electrical stimulator for direct
`particularly,
`the
`invention relates to a pulsed electrical stimulator for direct
`attachment onto a garment electrode, for providing electrical stimulation to nerve,
`attachment onto a garment electrode, for providing electrical stimulation to nerve,
`15 muscle, skin, circulatory and/or other tissue of a human or animal subject.
`15 muscle, skin, circulatory and/or other tissue of a human or animal subject.
`
`Background of the Invention:
`Background of the Invention:
`
`--
`
`•
`
`"-•
`
`Electrical stimulation has been found to provide therapeutic benefit to various
`Electrical stimulation has been found to provide therapeutic benefit to various
`biological tissue. For example, transcutaneous electrical nerve stimulation (TENS)
`biological tissue. For example, transcutaneous electrical nerve stimulation (TENS)
`_
`has--5een-use-d fo treat -neuromusc-uiar~(ri}ii"r1eia11d -ottierconeiitlons-by-st1-m ulatio~~-;i
`has been used to treat neuromuscular injuries and other conditions by stimulation of
`20 muscle and nerve tissue. Electrical stimulation has also been found to increase
`20 muscle and nerve tissue. Electrical stimulation has also been found to increase
`circulation, promoting faster healing of injuries and preventing adverse conditions
`circulation, promoting faster healing of injuries and preventing adverse conditions
`resulting from poor circulation. For example, many diabetics suffer from poor
`resulting from poor circulation. For example, ·many diabetics suffer from poor
`circulation in their extremities. Foot ulceration caused by poor circulation often
`circulation in their extremities. Foot ulceration caused by poor circulation often
`progresses to more severe tissue damage and even loss of limb in many subjects.
`' progresses to more severe tissue damage and even loss of limb in many subjects.
`25 These conditions are commonly aggravated as a result of venous stasis or impaired
`25 These conditions are commonly aggravated as a result of venous stasis or impaired
`function of venous valves in the extremities.
`function of venous valves in the extremities.
`
`Electrical stimulation may be delivered to treated tissue by one or more
`Electrical stimulation may be delivered to treated tissue by one or more
`electrodes, such as adhesive patch electrodes or garment electrodes. U.S. Patent
`electrodes, such as adhesive patch electrodes or garment electrodes. U.S. Patent
`
`Petitioner - Avation Medical, Inc.
`Ex. 1007, p. 3
`
`

`

`WO 2004/108209
`WO 2004/108209
`
`PCT/0S2004/018198
`PCT/US2004/018198
`
`2
`2
`
`Numbers 4,554,923; 4,664,118 and 5,374,283 disclose various forms of garment
`Numbers 4,554,923; 4,664,118 and 5,374,283 disclose various forms of garment
`electrodes for applying electrical stimulation from an electronic stimulator to a
`electrodes for applying electrical stimulation from an electronic stimulator to a
`treated body part. U.S. Patent Application Serial No. 10/460,084 filed June 12,
`treated body part. U.S. Patent Application Serial No. 10/460,084 filed June 12,
`2003 (Publication No. US-2004-0030270-A1) discloses a garment electrode
`2003 (Publication No. US-2004-0030270-A1) discloses a garment electrode
`capable of applying compression, preferably gradient compression, to a treated
`capable of applying compression, preferably gradient compression, to a treated
`body part. Compression applied in combination with electrical stimulation has been
`body part. Compression applied in combination with electrical stimulation has been
`found to provide many benefits for human and/or animal patients with venous
`found to provide many benefits for human and/or animal patients with venous
`disease or related and similar conditions.
`disease or related and similar conditions.
`
`Many previously known electrical stimulators have been found lacking in one
`Many previously known electrical stimulators have been found lacking in one
`or more aspects. For example, many known stimulators are large, heavy and
`or more aspects. For example, many known stimulators are large, heavy and
`unwieldy to connect to the stimulator electrodes used in connection therewith, and
`unwieldy to connect to the stimulator electrodes used in connection therewith, and
`tend to be uncomfortable in use. And some known stimulators have been found to
`tend to be uncomfortable in use. And some known stimulators have been found to
`be unduly complex in their construction and use, resulting in undue expense and
`be unduly complex in their construction and use, resulting in undue expense and
`the potential for incorrect application, as for example by misconnection of electrical
`the potential for incorrect application, as for example by misconnection of electrical
`contacts. Also, known electrical stimulators are typically worn attached to the user's
`contacts. Also, known electrical stimulators are typically worn attached to the user's
`belt, and long wire leads are connected to transmit the electrical energy signal to
`belt, and long wire leads are connected to transmit the electrical energy signal to
`electrodes attached to remote locations on the user's body. These wire leads can
`electrodes attached to remote locations on the user's body. These wire leads can
`be inconvenient to connect, and can limit the user's motion or become disconnected
`be inconvenient to connect, and can limit the user's motion or become disconnected
`as the user moves. Also, known means of connection between the stimulator and
`as the user moves. Also, known means of connection between the stimulator and
`too .. e.lacirmie_s ___ musLb.e- .car,afuJL¥----coru:iected~tCh .. prm.dde- ~proper . pGla~it.y" -0f. .. ,tt;ie.
`the electrodes_ _rnu_s_t_ _be_ carefully _ connected _to_ provide—proper polarity_ -of—the
`delivered stimulation energy, and therapeutic benefit may be impaired if the polarity
`delivered stimulation energy, and therapeutic benefit may be impaired if the polarity'
`is reversed due to inadvertent misconnection of the leads.
`is reversed due to inadvertent misconnection of the leads ..
`
`Thus it can be seen that needs exist for improvements in electrical
`Thus it can be seen that needs exist for improvements in electrical
`stimulation devices and therapies, and to improved garment electrode connection
`stimulation devices and therapies, and to improved garment electrode connection
`systems used in connection therewith. It is to the provision of devices, systems and
`systems used in connection therewith. It is to the provision of devices, systems and
`methods meeting these and other needs that the present invention is primarily
`methods meeting these and other needs that the present invention is primarily
`directed.
`directed.
`
`5
`5
`
`10
`10
`
`15
`15
`
`20
`~0
`
`25
`25
`
`Petitioner - Avation Medical, Inc.
`Ex. 1007, p. 4
`
`

`

`WO 2004/108209
`WO 2004/108209
`
`PCT/US2004/018198
`PCT/US2004/018198
`
`3
`3
`
`5
`5
`
`10
`10
`
`15
`15
`
`20
`20
`
`25
`25
`
`Summary of the Invention:
`Summary of the Invention:
`
`In its various embodiments, the present invention provides an improved
`In its various embodiments, the present invention provides an improved
`stimulator and garment electrode system for delivering therapeutic energy to treated
`stimulator and garment electrode system for delivering therapeutic energy to treated
`tissue of a human or animal subject. For example, in one aspect, the invention is
`tissue of a human or animal subject. For example, in one aspect, the invention is
`an electrical stimulator for use in connection with garment electrodes and other
`an electrical stimulator for use in connection with garment electrodes and other
`electrodes for affixation to the body of a human or animal subject. The stimulator of
`electrodes for affixation to the body of a human or animal subject. The stimulator of
`the present invention preferably comprises an energy source and means for
`the present invention preferably comprises an energy source and means for
`applying energy from the energy source to the treated body portion. The electrical
`applying energy from the energy source to the treated body portion. The electrical
`stimulator is preferably relatively small and lightweight, and is simple in construction
`stimulator is preferably relatively small and lightweight, and is simple in construction
`and use thereby reducing cost and preventing inadvertent misuse as by improper
`and use thereby reducing cost and preventing inadvertent misuse as by improper
`connection of electrical contacts.
`connection of electrical contacts.
`
`In example embodiments, the electrical stimulator of the present invention is
`In example embodiments, the electrical stimulator of the present invention is
`particularly adapted for direct attachment onto a garment electrode worn by the
`particularly adapted for direct attachment onto a garment electrode worn by the
`wearer, thereby eliminating the need for long wire leads extending from a belt-worn
`wearer, thereby eliminating the need for long wire leads extending from a belt-worn
`stimulator to a remote electrode position.
`stimulator to a remote electrode position.
`
`In further example embodiments, the stimulator of the present invention is
`In further example embodiments, the stimulator of the present invention is
`programmable, enabling use of various treatment regimens.
`In still further
`programmable, enabling use of various treatment regimens.
`In still further
`embodiments, the stimulator includes sensors or other input means and onboard
`embodiments, the stimulator includes sensors or other input means and onboard
`for collecting and storing biometric data and patient compliance
`memory,
`memory,
`for collecting and storing biometric data and patient compliance
`information; and/or a transmitter, display or other output means for monitoring by
`information; and/or a transmitter, display or other output means for monitoring by
`the subject and/or a medical caregiver.
`the subject and/or a medical caregiver.
`
`In another aspect, the present invention is an improved therapeutic system
`In another aspect, the present invention is an improved therapeutic system
`for delivering energy to a treated body portion of a human or animal subject, the
`for delivering energy to a treated body portion of a human or animal subject, the
`system including an electrode for application to the treated body portion, and an
`system including an electrode for application to the treated body portion, and an
`electronic stimulator attached directly to the electrode, the electronic stimulator
`electronic stimulator _attached directly to the electrode, the electronic stimulator
`delivering energy to the electrode. The electrode may for example be a garment
`delivering energy to the electrode. The electrode may for example be a garment
`electrode such as a stocking, sleeve, wrap, glove, or other type of garment to be
`electrode such as a stocking, sleeve, wrap, glove, or other type of garment to be
`worn over one or more body parts of a human or animal subject, at least a portion of
`wo_rn over one or more body parts of a human or animal subject, at least a portion of
`the garment comprising a conductive material for delivering therapeutic energy to a
`the garment comprising a conductive material for delivering therapeutic energy to a
`
`Petitioner - Avation Medical, Inc.
`Ex. 1007, p. 5
`
`

`

`WO 2004/108209
`WO 2004/108209
`
`PCT/0S2004/018198
`PCT/US2004/018198
`
`4
`4
`
`treated body part. Optionally, the garment electrode is a compression garment,
`treated body part. Optionally, the garment electrode is a compression garment,
`which further optionally provides gradient compression.
`which further optionally provides gradient compression.
`
`In another aspect, the invention is a therapeutic stimulator including an
`In another aspect, the invention is a therapeutic stimulator including an
`energy source, at least one electrical connection for delivering energy from the
`energy source, at least one electrical connection for delivering energy from the
`energy source to an electrode, and means for direct attachment of the stimulator to
`energy source to an electrode, and means·tor direct attachment of the stimulator to
`the electrode.
`the electrode.
`
`5
`5
`
`In still another aspect, the invention is a connector for delivering energy from
`In still another aspect, the invention is a connector for delivering energy from
`an electronic stimulator to a treated body portion of a human or animal subject,
`an electronic stimulator to a treated body portion of a human or animal subject,
`comprising a flexible strap, and a diode bridge within said strap for maintaining
`comprising a flexible strap, and a diode bridge within said strap for maintaining
`proper polarity of the delivered energy.
`1 O proper polarity of the delivered energy.
`10
`
`15
`15
`
`io
`20
`
`25
`25
`
`In another aspect, the invention is a connector strap for providing electrical
`In another aspect, the invention is a connector strap for providing electrical
`connection between an electronic stimulator and a pair of electrodes. The
`connection between an electronic stimulator and a pair of electrodes. The
`connector strap preferably includes first and second inner contacts, and first and
`connector strap preferably includes first and second inner contacts, and first and
`second outer contacts. The connector strap preferably also includes a first
`second outer contacts. The connector strap preferably also includes a first
`conductor path between the first inner contact and the first outer contact, the first
`conductor path between the first inner contact and the first outer contact, the first
`conductor path including a first diode; a second conductor path between the first
`conductor path including a first diode; a second conductor path between the first
`inner contact and the second outer contact, the second conductor path including a
`inner contact and the second outer contact, the second conductor path including a
`second diode; a third conductor path between the second inner contact and the first
`second diode; a third conductor path between the second inner contact and the first
`outer contact, the third conductor path including a third diode; and a fourth
`outer contact, the third conductor path including a third diode; and a fourth
`conductor path between the second inner contact and the second outer contact, the
`conaudor path between the se66nd inner confad and the second'outer contact, the
`fourth conductor path including a fourth diode.
`fourth conductor path including a fourth diode.
`
`In yet another aspect, the invention is a method of treating a body portion of
`In yet another aspect, the invention is a method of treating a body portion of
`a human or animal subject, the method including steps of applying a garment
`a human or animal subject, the method including steps of applying a garment
`electrode to a body portion to be treated, and delivering therapeutic energy to the
`electrode to a body portion to be treated, and delivering t~erapeutic energy to the
`electrode from an electronic stimulator attached directly to the electrode.
`electrode
`from an electronic stimulator attached directly to
`the electrode.
`Optionally, the stimulator is connected to the garment electrode using connecting
`Optionally, the stimulator is connected to the garment electrode using connecting
`means for maintaining proper polarity of energy delivered therethrough. The
`means for maintaining proper polari~y of energy delivered therethrough. The
`garment electrode optionally also provides compression, and more preferably
`garment electrode optionally also provides compression, and more preferably
`gradient compression.
`gradient compression.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1007, p. 6
`
`

`

`WO 2004/108209
`WO 2004/108209
`
`PCT/0S2004/018198
`PCT/US2004/018198
`
`5
`5
`
`5
`5
`
`10
`10
`
`In particularly preferred embodiments, the garment electrode and connection
`In particularly preferred embodiments, the garment electrode and connection
`system of the present invention are used in combination with the electrical
`system of the present invention are used in combination with the electrical
`stimulator of the present invention, to form a therapeutic system for improving
`stimulator of the present invention, to form a therapeutic system for improving
`circulation and/or enhancing healing.
`It will be recognized, however, that the
`circulation and/or enhancing healing.
`It will be recognized, however, that the
`garment electrode connection system and the electrical stimulator of the present
`garment electrode connection system and the electrical stimulator of the present
`invention have separate and individual utility, independent of one another, as well
`invention have separate and individual utility, independent of one another, as well
`as in combination.
`as in combination.
`
`These and other aspects, features and advantages of the invention will be
`These and other aspects, features and advantages of the invention will be
`understood with reference to the drawing figures and detailed description herein,
`understood with reference to the drawing figures and detailed description herein,
`and will be realized by means of the various elements and combinations particularly
`and will be realized by means of the various elements and combinations particularly
`pointed out in the appended claims. It is to be understood that both the foregoing
`pointed out in the appended claims.
`It is to be understood that both the foregoing
`general description and the following brief description of the drawings and detailed
`general description and the following brief description of the drawings and detailed
`invention are exemplary and explanatory of preferred
`description of the
`description of
`the
`invention are exemplary and explanatory of preferred
`embodiments of the invention, and are not restrictive of the invention, as claimed.
`embodiments of the invention, and are not restrictive of the invention, as claimed.
`
`15 Brief Description of the Drawing Figures:
`15 Brief Description of the Drawing Figures:
`
`Figure 1 shows a perspective view of an electrical stimulator and therapeutic
`Figure 1 shows a perspective view of an electrical stimulator and therapeutic
`garment connection system according to an example embodiment of the present
`garment connection system according to an example embodiment of the present
`invention.
`invention.
`
`Figure 2 shows a front elevational view of an electrical stimulator according_
`·- .F~re 2 shovvs.a front elevational view _of an electrical stimulat9r acco;d!ng_
`to an example embodiment of the present invention.
`to an example embodiment of the present invention.
`
`20
`20
`
`Figure 3 shows a rear elevational view of the electrical stimulator of Fig. 2.
`Figure 3 shows a rear elevational view of the electrical stimulator of Fig. 2.
`
`Figure 4 shows a side view of the electrical stimulator of Fig. 2.
`Figure 4 shows a side view of the electrical stimulator of Fig. 2.
`
`Figures 5a — 5d show a connector strap component according to an example
`Figures 5a - 5d show a connector strap component according to an example
`embodiment of the present invention.
`embodiment of the present invention.
`
`25
`25
`
`Figure 6 shows a therapeutic stimulation waveform delivered according to an
`Figure 6 shows a therapeutic stimulation waveform delivered according to an
`example form of the present' invention.
`example form of the present' invention.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1007, p. 7
`
`

`

`WO 2004/108209
`WO 2004/108209
`
`PCT/0S2004/018198
`PCT/US2004/018198
`
`6
`6
`
`Detailed Description of Preferred Embodiments:
`Detailed Description of Preferred Embodiments:
`
`The present invention may be understood more readily by reference to the
`The present invention may be understood more readily by reference to the
`following detailed description of the invention taken in connection with the
`following detailed description of the
`invention taken
`in connection with
`the
`accompanying drawing figures, which form a part of this disclosure. It is to be
`accompanying drawing figures, which form a part of this disclosure.
`It is to be
`understood that this invention is not limited to the specific devices, methods,
`understood that this invention is not limited to the specific devices, methods,
`conditions or parameters described and/or shown herein, and that the terminology
`conditions or parameters described and/or shown herein, and that the terminology
`used herein is for the purpose of describing particular embodiments by way of
`used herein is for the purpose of describing particular embodiments by way of
`example only and is not intended to be limiting of the claimed invention. Also, as
`example only and is not intended to be limiting of the claimed invention. Also, as
`used in the specification including the appended claims, the singular forms "a," "an,"
`used in the specification including the appended claims, the singular forms "a," "an,"
`and "the" include the plural, and reference to a particular numerical value includes
`and "the" include the plural, and reference to a particular numerical value includes
`at least that particular value, unless the context clearly dictates otherwise. Ranges
`at least that particular value, unless the context clearly dictates otherwise. Ranges
`may be expressed herein as from "about" or "approximately" one particular value
`may be expressed herein as from "about" or "approximately" one particular value
`and/or to "about" or "approximately" another particular value. When such a range is
`and/or to "about" or "approximately" another particular value. When such a range is
`expressed, another embodiment includes from the one particular value and/or to the
`expressed, another embodiment includes from the one particular value and/or to the
`other particular value. Similarly, when values are expressed as approximations, by
`other particular value. Similarly, when values are expressed as approximations, by
`use of the antecedent "about," it will be understood that the particular value forms
`use of the antecedent "about," it will be understood that the particular value forms
`another embodiment.
`another embodiment.
`
`Figure 1 shows a system according to an example form of the present
`Figure 1 shows a system according to an example form of the present
`invention, including a garment electrode 100 having an electrical stimulator 110
`invention, including a garment electrode 100 having an electrical stimulator 11 0
`-di rectlratta eh ed-thereto-bra connector-strap. The-garment electrade-is -depicted
`-direetly=,-att-aehed,,·therete:d,ra--eonr;eetor-strap: •·Tlie=garment~le-ctrod'e'-'is ·,d-eprcted
`as a stocking, but other embodiments of the invention include a sleeve, wrap, glove,
`as a stocking, but other embodiments of the invention include a sleeve, wrap, glove,
`or other type of garment electrode to be worn over one or more body parts of a
`or other type of garment electrode to be worn over one or more body parts of a
`human or animal subject. The garment 100 preferably comprises one or more
`human or animal subject. The garment 100 preferably comprises one or more
`electrically conductive portions. For example, fibers, loops, rings, strips, panels,
`electrically conductive portions. For example, fibers, loops, rings, strips, panels,
`links or other elements of silver, copper, gold, other metals, and/or other conductive
`links or other elements of silver, copper, gold, other metals, and/or other conductive
`materials can be incorporated into the garment. Alternatively, non-conductive fibers
`materials can be incorporated into the garment. Alternatively, non-conductive fibers
`or other elements of the garment 100 can be impregnated with a conductive
`or other elements of the garment 100 can be impregnated with a conductive
`material, coated with a conductive material, or otherwise rendered conductive. The
`material, coated with a conductive material, or otherwise rendered conductive. The
`garment 100 or one or more portion(s) thereof is alternatively formed of non-
`garment 100 or one or more portion( s) _ thereof is alternatively formed of non-
`conductive knitted microfiber fabric or other non-conductive material and is plated
`conductive knitted microfiber fabric or other non-conductive material and is plated
`
`5
`5
`
`10
`10
`
`15
`15
`
`20
`20
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`25
`25
`
`30
`30
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`Petitioner - Avation Medical, Inc.
`Ex. 1007, p. 8
`
`

`

`WO 2004/108209
`WO 2004/108209
`
`PCT/0S2004/018198
`PCT/US2004/018198
`
`7
`7
`
`on one or more faces with a conductive material, or otherwise rendered electrically
`on one or more faces with a conductive material, or otherwise rendered electrically
`In preferred embodiments, the garment electrode .100 preferably
`conductive.
`In preferred embodiments, the garment electrode .100 preferably
`conductive.
`comprises a first conductive region 112a to apply therapeutic energy having a first
`comprises a first conductive region 112a to apply therapeutic energy having a first
`electrical polarity, and a second conductive region 112b to apply energy with a
`electrical polarity, and a second conductive region 112b to apply energy with a
`second electrical polarity opposite the first polarity; with the first and second
`second electrical polarity opposite the first polarity; with the first and second
`conductive regions 112a, 112b separated by a non-conductive region 112c..
`conductive regions 112a, 112b separated by a non-conductive region 112c.
`
`One or more metallic snap connectors, permanent or detachable electrical
`One or more metallic snap connectors, permanent or detachable electric:;al
`couplings, and/or other type of connection means is/are preferably provided on the
`couplings, and/or other type of connection means is/are preferably provided on the
`electrode 100 for attaching the electrical stimulator 110 to the electrode. The
`electrode 100 for attaching the electrical stimulator 110 to the electrode. The
`stimulator 110 and/or an intermediate connector strap component preferably
`stimulator 110 and/or an
`intermediate connector strap component preferably
`comprise(s) two or more cooperating contacts 114, such as for example metallic
`comprise(s) two or more cooperating contacts 114, such as for example metallic
`snap connectors, for engaging and forming an electrically conductive connection
`snap connectors, for engaging and forming an electrically conductive connection
`with cooperating connection means of the electrode 112. In the embodiment shown
`with cooperating connection means of the electrode 112. In the embodiment shown
`in Fig. 1, an intermediate connector strap 130 is permanently or detachably
`in Fig. 1, an intermediate connector strap 130 is permanently or detachably
`connected to the stimulator, and is detachably connected to the garment electrode
`connected to the stimulator, and is detachably connected to the. garment electrode
`by snap connectors 114.
`by snap connectors 114.
`
`5
`5
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`10
`10
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`15
`15
`
`20
`20
`
`The stimulator and connection system of the present invention are also
`The stimulator and connection system of the present invention are also
`suitable for use in combination with adhesive single-pole patch electrodes and/or
`suitable for use in combination with adhesive single-pole patch electrodes and/or
`other varieties of electrodes. However, it has been di