`US 20160129274Al
`
`c19) United States
`c12) Patent Application Publication
`PARK
`
`c10) Pub. No.: US 2016/0129274 Al
`May 12, 2016
`(43) Pub. Date:
`
`(54) WEARABLE ENERGY DELIVERY SYSTEM
`
`(71) Applicant: Sam Boong PARK, Saratoga, CA (US)
`
`(72)
`
`Inventor: Sam Boong PARK, Saratoga, CA (US)
`
`(21) Appl. No.: 14/537,354
`
`(22) Filed:
`
`Nov. 10, 2014
`
`Publication Classification
`
`(51)
`
`Int. Cl.
`A61N2/00
`A61N2/02
`A61N 1104
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`(2006.01)
`(2006.01)
`
`A61F 7102
`A61N 1136
`(52) U.S. Cl.
`CPC . A61N 21002 (2013.01); A61F 7102 (2013.01);
`A61N 1136014 (2013.01); A61N 110484
`(2013.01); A61N 2102 (2013.01); A61F
`2007/0233 (2013.01)
`
`(57)
`
`ABSTRACT
`
`A wearable energy delivery system can be integrated with a
`wearable item to provide therapy to the user, including pain
`therapy, healing therapy, and muscle stimulation. Integration
`of the energy delivery system with apparel provides conve(cid:173)
`nience to the user and allows hands free use of the system,
`which can be used during exercise or normal wear.
`
`112
`
`110
`
`/
`
`119
`
`Allergan EX1073
`Page 1
`
`
`
`Patent Application Publication May 12, 2016 Sheet 1 of 29
`
`US 2016/0129274 Al
`
`100
`
`_____________ \ ----------------------------
`
`110
`
`120
`
`---------------------------------------------~
`
`... "
`
`130
`
`Fig. 1
`
`Allergan EX1073
`Page 2
`
`
`
`Patent Application Publication May 12, 2016 Sheet 2 of 29
`
`US 2016/0129274 Al
`
`110
`
`/
`
`112
`
`119
`
`Fig. 2A
`
`Allergan EX1073
`Page 3
`
`
`
`Patent Application Publication May 12, 2016 Sheet 3 of 29
`
`US 2016/0129274 Al
`
`110
`
`119
`
`119
`
`Fig. 2B
`
`/_/-+----+ ......... J. 1 1
`I E:J
`:
`:
`111 _
`---------}-
`
`I
`
`I
`
`,
`
`119
`
`119
`
`Fig. 2C
`
`Allergan EX1073
`Page 4
`
`
`
`Patent Application Publication May 12, 2016 Sheet 4 of 29
`
`US 2016/0129274 Al
`
`110
`
`112
`
`Fig. 2D
`
`Allergan EX1073
`Page 5
`
`
`
`Patent Application Publication May 12, 2016 Sheet 5 of 29
`
`US 2016/0129274 Al
`
`110
`
`/
`
`112
`
`114
`
`I
`I
`I
`I
`l
`I
`\
`
`\
`
`/
`
`/
`
`/
`
`/
`I
`I
`I
`I
`\
`
`'
`'
`'
`'
`'
`
`'-
`
`/
`
`/
`
`'
`
`'
`
`'
`'
`
`\
`
`/
`
`'
`'
`
`\
`
`114
`
`I
`\
`I
`I
`I
`I
`
`I
`l
`I
`I
`
`I
`
`/
`
`'
`
`---
`
`/
`. /
`
`------
`
`118
`
`Fig. 3A
`
`Allergan EX1073
`Page 6
`
`
`
`Patent Application Publication May 12, 2016 Sheet 6 of 29
`
`US 2016/0129274 Al
`
`110
`
`/
`
`112
`
`118
`
`118
`
`Fig. 3B
`
`Allergan EX1073
`Page 7
`
`
`
`Patent Application Publication May 12, 2016 Sheet 7 of 29
`
`US 2016/0129274 Al
`
`114
`
`/
`
`110
`
`112
`
`114
`
`114
`
`114
`
`Fig. 4A
`
`Allergan EX1073
`Page 8
`
`
`
`Patent Application Publication May 12, 2016 Sheet 8 of 29
`
`US 2016/0129274 Al
`
`114
`
`/
`
`110
`
`112
`
`114
`
`114
`
`114
`
`Fig. 4B
`
`Allergan EX1073
`Page 9
`
`
`
`Patent Application Publication May 12, 2016 Sheet 9 of 29
`
`US 2016/0129274 Al
`
`/
`
`110
`
`112
`
`114
`
`114
`
`Fig. 4C
`
`Allergan EX1073
`Page 10
`
`
`
`Patent Application Publication May 12, 2016 Sheet 10 of 29
`
`US 2016/0129274 Al
`
`112
`
`/
`
`110
`
`114
`
`112
`
`112
`
`112
`
`Fig. 4D
`
`Allergan EX1073
`Page 11
`
`
`
`Patent Application Publication May 12, 2016 Sheet 11 of 29
`
`US 2016/0129274 Al
`
`110
`
`/
`
`112
`
`114
`
`Fig. 5A
`
`Allergan EX1073
`Page 12
`
`
`
`Patent Application Publication May 12, 2016 Sheet 12 of 29
`
`US 2016/0129274 Al
`
`110
`
`/
`
`112
`
`114
`
`\
`I
`
`i
`
`112
`
`114
`
`Fig. SB
`
`Allergan EX1073
`Page 13
`
`
`
`Patent Application Publication May 12, 2016 Sheet 13 of 29
`
`US 2016/0129274 Al
`
`110
`
`/
`
`114
`
`112
`
`Fig. SC
`
`Allergan EX1073
`Page 14
`
`
`
`Patent Application Publication May 12, 2016 Sheet 14 of 29
`
`US 2016/0129274 Al
`
`110
`
`/
`
`114
`
`112
`
`114
`
`112
`
`Fig. 5D
`
`Allergan EX1073
`Page 15
`
`
`
`Patent Application Publication May 12, 2016 Sheet 15 of 29
`
`US 2016/0129274 Al
`
`110
`
`114
`
`114
`
`Fig. 6A
`
`Allergan EX1073
`Page 16
`
`
`
`Patent Application Publication May 12, 2016 Sheet 16 of 29
`
`US 2016/0129274 Al
`
`114
`
`Fig. 6B
`
`Allergan EX1073
`Page 17
`
`
`
`Patent Application Publication May 12, 2016 Sheet 17 of 29
`
`US 2016/0129274 Al
`
`112
`
`110
`
`~
`
`114
`
`Fig. 6C
`
`114
`
`118
`
`Allergan EX1073
`Page 18
`
`
`
`Patent Application Publication May 12, 2016 Sheet 18 of 29
`
`US 2016/0129274 Al
`
`110
`
`112
`
`118
`
`Fig. 6D
`
`Allergan EX1073
`Page 19
`
`
`
`Patent Application Publication May 12, 2016 Sheet 19 of 29
`
`US 2016/0129274 Al
`
`110
`
`114
`
`114
`
`Fig. 7A
`
`Allergan EX1073
`Page 20
`
`
`
`Patent Application Publication May 12, 2016 Sheet 20 of 29
`
`US 2016/0129274 Al
`
`110
`
`112
`
`114
`
`Fig. 7B
`
`Allergan EX1073
`Page 21
`
`
`
`Patent Application Publication May 12, 2016 Sheet 21 of 29
`
`US 2016/0129274 Al
`
`112
`
`110
`
`II
`
`.
`
`114
`
`114
`
`Fig. 7C
`
`Allergan EX1073
`Page 22
`
`
`
`Patent Application Publication May 12, 2016 Sheet 22 of 29
`
`US 2016/0129274 Al
`
`120
`
`120
`
`FRONT
`
`120
`
`BACK
`
`120
`
`120
`
`--
`
`--
`
`Fig. 8
`
`Allergan EX1073
`Page 23
`
`
`
`Patent Application Publication May 12, 2016 Sheet 23 of 29
`
`US 2016/0129274 Al
`
`TOPS
`
`110
`
`BOTTOMS
`
`110
`
`SHOES
`
`110
`
`110
`
`SOCKS
`
`110
`
`Fig. 9
`
`110
`
`Allergan EX1073
`Page 24
`
`
`
`Patent Application Publication May 12, 2016 Sheet 24 of 29
`
`US 2016/0129274 Al
`
`122
`
`Fig. 10
`
`Allergan EX1073
`Page 25
`
`
`
`Patent Application Publication May 12, 2016 Sheet 25 of 29
`
`US 2016/0129274 Al
`
`UJ
`
`-<
`......
`......
`
`Allergan EX1073
`Page 26
`
`
`
`Patent Application Publication May 12, 2016 Sheet 26 of 29
`
`US 2016/0129274 Al
`
`/,/ \., .. ,,
`
`co
`,.....,
`
`,....;
`
`bf)
`~
`
`Allergan EX1073
`Page 27
`
`
`
`Patent Application Publication May 12, 2016 Sheet 27 of 29
`
`US 2016/0129274 Al
`
`LU
`
`1
`
`r···
`
`.........................• l
`
`l
`[ .................. .
`r
`
`............. ,
`
`l
`
`r··························
`
`f
`
`···························!
`
`I
`
`u ,.....
`......
`
`Allergan EX1073
`Page 28
`
`
`
`Patent Application Publication May 12, 2016 Sheet 28 of 29
`
`US 2016/0129274 Al
`
`//..-' \\
`
`l
`
`l
`
`l
`
`bf)
`
`iI:
`
`Allergan EX1073
`Page 29
`
`
`
`Patent Application Publication May 12, 2016 Sheet 29 of 29
`
`US 2016/0129274 Al
`
`\._\_
`.//
`
`I
`
`I
`
`I
`
`I
`
`I
`
`......
`......
`
`Allergan EX1073
`Page 30
`
`
`
`US 2016/0129274 Al
`
`May 12, 2016
`
`1
`
`WEARABLE ENERGY DELIVERY SYSTEM
`
`BACKGROUND OF THE INVENTION
`
`[0001] The present invention relates generally to energy
`delivery systems. More particularly, the invention relates to a
`wearable energy delivery system that operates while the user
`is engaged in physical activity.
`[0002] Musculoskeletal pain is very common. In some
`cases, such pain is chronic and typically treated with drugs,
`such as ibuprofen or acetaminophen. Such drugs can be effec(cid:173)
`tive in managing mild to moderate pain, but chronic use of
`these drugs is associated with undesirable gastrointestinal
`and renal side effects as well as liver toxicity.
`[0003] Delivery of energy (e.g., heat, magnetic, electro(cid:173)
`magnetic, infrared, ultrasonic, vibration, radio frequency,
`etc.) to problem areas of the body has been used to treat pain,
`and also to provide wound healing therapy. Electrostimula(cid:173)
`tion has also been used for centuries for pain control. It is
`known that a static magnet has little effect on pain manage(cid:173)
`ment and wound healing. However, pulsed electromagnetic
`energy can create an electrical potential within cells. Low(cid:173)
`frequency pulsed electromagnetic fields (PEMF), at about
`1000 Hz or less, have been used as therapy for chronic pain as
`well as wound and bone healing. PEMF is within the devel(cid:173)
`oping field of biomagnetics, which also includes transcuta(cid:173)
`neous electrical nerve stimulation (TENS). TENS is the use of
`an electric current to provide nerve stimulation for therapeu(cid:173)
`tic purposes, and has been used to treat pain. Massage has also
`been used to treat pain, reduce anxiety and depression, and
`temporarily reduce blood pressure.
`[0004] Although drug therapy and PEMF therapy can be
`effective in managing pain, there are continuing efforts to
`develop new devices that are not only effective for pain relief
`but also are provide convenience to the user for managing
`pain as well as firming muscles and enabling the user to be
`enhance athletic performance.
`
`SUMMARY OF THE INVENTION
`
`[0005]
`In accordance with an embodiment, a wearable
`pulsed electromagnetic energy delivery device is provided.
`The wearable energy delivery device includes an article of
`clothing, an energy delivery head and a power supply unit.
`The energy delivery head is configured to generate a pulsed
`electromagnetic field (PEMF), and the energy delivery head
`is integrated with the article of clothing. The power supply
`unit is arranged to be carried by the article of clothing. At least
`one wire couples the power supply unit to the energy delivery
`head, and the wire is integrated with the article of clothing.
`The wearable pulsed electromagnetic energy delivery device
`is arranged to deliver therapeutic pulsed electromagnetic
`energy to a wearer of the article of clothing without requiring
`power from a device not carried by the article of clothing.
`[0006]
`In accordance with another embodiment, a system is
`provided. The system includes a wearable pulsed electromag(cid:173)
`netic energy delivery device and a mobile user interface. The
`wearable pulsed electromagnetic energy delivery device
`includes an energy delivery head configured to generate a
`pulsed electromagnetic field (PEMF) and a power control unit
`arranged to generate an electrical waveform used by the
`energy delivery head to generate the pulsed electromagnetic
`field. The wearable pulsed electromagnetic energy delivery
`device is arranged to deliver therapeutic pulsed electromag(cid:173)
`netic energy to a wearer of the pulsed electromagnetic energy
`
`delivery device without requiring power from an external
`device not carried by the pulsed electromagnetic energy
`delivery device. The mobile user interface is executable on a
`computing device separate from the wearable device, and the
`mobile user interface is arranged to utilize resources of the
`computing device to communicate wirelessly with the power
`control unit and is configured to permit a user to direct opera(cid:173)
`tion of the wearable pulsed electromagnetic energy delivery
`device via the computing device.
`[0007]
`In accordance with yet another embodiment, a wear(cid:173)
`able energy delivery device is provided. The wearable energy
`delivery device includes an energy delivery head and a power
`control unit. The energy delivery head is configured to emit at
`least two different types of energy selected from the group
`consisting of pulsed electromagnetic field (PEMF) energy,
`pulsed electrical energy, and heat energy. The power control
`unit is operably connected to the energy delivery head by at
`least one wire. The energy delivery head and the wire are
`attached to an article of clothing.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0008] The invention, together with further objects and
`advantages thereof, may best be understood by reference to
`the following description taken in conjunction with the
`accompanying drawings in which:
`[0009] FIG. 1 is a schematic diagram of a wearable energy
`delivery system in accordance with an embodiment.
`[0010] FIG. 2Ais atopviewofanembodimentofanenergy
`delivery head.
`[0011] FIGS. 2B and 2C are side cross-sectional view
`embodiments of an energy delivery head.
`[0012] FIG. 2D is a top view of another embodiment of an
`energy delivery head.
`[0013] FIG. 3A is a plan view of the working surface of an
`energy delivery head of a wearable energy delivery system in
`accordance with an embodiment.
`[0014] FIG. 3B is a side view of the energy delivery head of
`shown in FIG. 3A
`[0015] FIGS. 4A-4D show different embodiments of the
`energy delivery head showing the working surface.
`[0016] FIGS. SA-SD show different configurations of an
`energy delivery head having a PEMF coil and another energy
`source nested within one another.
`[0017] FIGS. 6A-6C are perspective views of different
`embodiments of the energy delivery head showing flex points
`or strips.
`[0018] FIG. 6D is a side view of the embodiment shown in
`FIG. 6C.
`[0019] FIG. 7A is a top view of an energy delivery head
`having a PEMF coil stacked over electrodes in accordance
`with an embodiment.
`[0020] FIG. 7B is a side view of the energy delivery head
`shown in FIG. 7A.
`[0021] FIG. 7C is a bottom view of the energy delivery head
`shown in FIGS. 7A and 7B.
`[0022] FIG. 8 shows different embodiments of power con(cid:173)
`trol units and energy delivery heads on a variety of wearable
`items.
`[0023] FIG. 9 shows some exemplary locations for energy
`delivery heads on a variety of wearable items.
`[0024] FIG. 10 shows an example of decorative wiring in
`clothing.
`[0025] FIGS. llA-llE show different embodiments of
`exemplary energy delivery patterns.
`
`Allergan EX1073
`Page 31
`
`
`
`US 2016/0129274 Al
`
`May 12, 2016
`
`2
`
`[0026]
`It is to be understood that, in the drawings, like
`reference numerals designate like structural elements. Also, it
`is understood that the depictions in the figures are diagram(cid:173)
`matic and not to scale.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`[0027] The present invention relates generally to making
`devices for personal well being, specifically the use of an
`energy delivery system for pain management therapy, firming
`and toning of skin and muscles, and enhanced athletic per(cid:173)
`formance, and apparatuses therefor.
`[0028] Referring initially to FIG. 1, a wearable energy
`delivery system 100 in accordance with one embodiment of
`the invention will be described. In the illustrated embodi(cid:173)
`ment, a wearable energy delivery system 100 includes an
`energy delivery head 110 and a power control unit 120. A user
`interface 130, which can be part of the wearable energy deliv(cid:173)
`ery system 100 or on a separate device can be used to control
`the power control unit 120, which controls the energy deliv(cid:173)
`ery head 110. In FIG. 1, the user interface 130 is shown as
`being on a smartphone. However, it will be understood that
`the user interface 130 can be on any type of device, such as a
`computer, tablet, a user interface unit dedicated to the system
`100, or even on the power control unit 120 or the energy
`delivery head 110.
`[0029] The energy delivery head 110, which is integrated
`with a wearable item ( e.g., an article of clothing, such as a
`shirt, pants, shorts, bra, hat, shoe, wristband, watch, socks,
`etc.), delivers energy, such as PEMF, energy sensory pulse or
`electrical sensory pulse (ESP), TENS, electrical muscle
`stimulation (EMS), neuromuscular electrical stimulation
`(NMES), static magnetic, ultrasonic, percussion, radio fre(cid:173)
`quency (RF), vibration, and heat (near and far infrared)
`energy (or any combination thereof) to problem or target
`areas of the user's body. The energy delivery head 110 is
`powered by the power control unit 120 and controlled using
`the user interface 130. The energy delivery head 110 can be
`provided in any location in the wearable item such that it
`delivers energy located to the corresponding part of the body
`that requires pain relief, cellular repair, energy balancing,
`better blood circulation, etc. For example, the energy delivery
`head 110 can be integrated with a wearable item, such as a
`shoe or sock to provide therapy to feet. Alternatively, the
`energy delivery head 110 can be integrated in running tights
`or shorts to provide muscle stimulation or pain relief to legs
`during exercise. As noted above, the energy delivery head 110
`can also be integrated with other wearable items, such as wrist
`bands, shirts, bras, etc.
`[0030]
`In the embodiments described herein, the wearable
`energy delivery system 100 is capable of delivering one or
`more types of energy (alone or in combinations) to provide
`healing and/or pain therapy to affected areas of the body. A
`combination of different energies can provide short-term pain
`relief, long-term pain relief, surface healing, shallow depth
`healing, and/or deep healing depending on the energy com(cid:173)
`binations and configuration of the wearable energy delivery
`system 100. Each type of energy can be chosen for its unique
`healing property and different types of energies can be com(cid:173)
`bined to provide multiple modes of healing and/or pain man(cid:173)
`agement with one or more energy therapies. The wearable
`energy delivery system 100 can be used for many different
`applications, including firming and tightening of skin and
`muscles, especially in the gluteal, abdominal, and pectoral
`
`muscles, pain relief, massage, muscle soreness therapy,
`wound therapy, healing therapy, and energizing muscles.
`[0031] According to an embodiment, the energy delivery
`head 110 is capable of delivering at least two different types
`of energy simultaneously to target areas of the user's body.
`For example, in the embodiment illustrated in FIGS. 3A and
`3B, the energy delivery head 110 can simultaneously deliver
`PEMF as well as another type of energy, such as, for example,
`TENS. In some embodiments, the user can use the user inter(cid:173)
`face 130 to choose whether the energy delivery head 110
`delivers one type of energy or more than one type of energy
`(and different combinations thereof). In the illustrated
`embodiment, PEMF can provide healing energy and better
`blood circulation to muscle tissue for long term benefits,
`whereas TENS therapy can provide quick pain relief by over(cid:173)
`whelming nerve signals and blocking pain.
`[0032] As noted above, PEMF therapy can provide healing
`energy to the tissues of the affected area. The United States
`Food and Drug Administration (FDA) has approved the use of
`PEMF for bone healing, trans-cranial magnetic therapy, and
`pain therapy. PEMF is provided without any sensation to the
`patient and PEMF can provide deep tissue relief when suffi(cid:173)
`cient intensity of PEMF is delivered. TENS can be used to
`block the pain, but can also be used to heal the tissue if a
`sufficient intensity of TENS energy is delivered to the
`affected area.
`[0033] Combining PEMF and TENS allows for delivery of
`both quick and long lasting therapy to the affected area.
`Energy delivery can be staggered between the energy sources
`or they can be delivered simultaneously ( or a combination
`thereof) depending on the desired therapy needs. The quick
`action pain relief provided by TENS along with the longer(cid:173)
`term cellular repair from PEMF can provide very effective
`treatment. Depending on the energy density of each of the
`energy sources, different depths of treatment is also possible.
`The combination of TENS and PEMF can provide therapy to
`deeper tissue without the excessive energy delivery required
`by the use of TENS alone (to provide deeper tissue relief),
`which could cause excessive muscle or nerve twitching.
`[0034] Different energy sources provide therapy to differ(cid:173)
`ent depths of the body tissue. For example, TENS and heat
`energy can provide therapy to more shallow areas, whereas
`PEMF can be used to penetrate to deeper tissue. Thus, a
`combination of PEMF with TENS or heat energy, for
`example, can provide both shallow and deep tissue therapy to
`the affected area during the same treatment session.
`[0035] The time effect of the pain relief is also different for
`different energy sources. For example, TENS and heat energy
`typically provide immediate and short-term pain relief,
`whereas PEMF typically provides healing therapy to the cells
`that are causing the pain for actual repair of the cells. A
`combination of PEMF with TENS or heat energy, for
`example, can provide both short-term and long-term pain
`relief. Typically, TENS provides shallow therapeutic effects
`and PEMF can provide deeper therapeutic effects depending
`on the energy settings of each energy mode. In order for
`TENS alone to provide deep tissue therapy, the intensity of
`the energy (voltage and current) must be increased, which
`typically results in excess twitching of the muscles and
`nerves. PEMF can provide deep tissue therapy without
`adverse muscle and nerve effects.
`[0036]
`If PEMF is combined with heat energy (near or far
`infrared), the heating effect will provide a soothing effect to
`skin and short-term relief, and PEMF will provide long-term
`
`Allergan EX1073
`Page 32
`
`
`
`US 2016/0129274 Al
`
`May 12, 2016
`
`3
`
`healing therapeutic effects to the affected area. Typically, heat
`energy provides shallow therapeutic effects and, as noted
`above, PEMF can provide deeper therapeutic effects depend(cid:173)
`ing on the energy settings of each energy mode. Similar types
`of short and long-term benefits can be achieved by combining
`other types of energy, such as ultrasonic, percussion, radio(cid:173)
`frequency, etc.
`
`[0037] FIGS. 2A-2D show embodiments of an energy
`delivery head 110 formed from a flexible material, such as a
`flex circuit, flexible PC board, flexible wires, etc. An electro(cid:173)
`magnetic coil 112 can be embedded within the flexible mate(cid:173)
`rial or can be on the surface of the energy delivery head 110.
`The energy delivery head 110 can be any size and formed of
`any number oflayers of flexible material. Each flexible mate(cid:173)
`rial layer can include an electromagnetic coil 112 that has one
`layer of trace or coil wire 117. Alternatively, each flexible
`material layer can have an electromagnetic coil 112 that has
`multiple layers of trace or coil wire 117, as shown in FI GS. 2B
`and 2C. Multiple flexible material layers can be bonded or
`laminated together to create a more powerful magnetic field.
`The advantage of using multiple flexible material layers is
`that the multiple thin layers are more flexible than a single
`thick flexible material layer having multiple layers of traces
`117. Multiple flexible material layers can be bonded together
`to make one thick piece or multiple flexible material layers
`can be loosely fastened together for more flexibility of the
`energy delivery head 110. The traces or coil wire 117 can be
`embedded in the flexible material, as shown in FIG. 2B, or can
`be embedded in as well as on the surface of the flexible
`material, as shown in FIG. 2C.
`
`[0038] As shown in FIGS. 2A-2D, multiple openings 119
`can be provided as attachment points for the energy delivery
`head 110 to facilitate attachment of the energy delivery head
`110 to the wearable item. For example, the openings 119 can
`be used to sew or otherwise attach the energy delivery head
`110 to the wearable item. The openings 119 can be positioned
`anywhere on the energy delivery head 110. As shown in FIG.
`2D, the openings 119 can even be positioned in a decorative
`pattern. The electromagnetic coil 112 can also be positioned
`to form a decorative pattern, as shown in FIG. 2D. The energy
`delivery head 110 can be attached to the wearable item in
`different ways. For example, the energy delivery head 110 can
`be sewn, laminated, snapped, or woven into the wearable
`item.
`
`[0039] FIG. 3A is a plan view of the working surface of the
`energy delivery head 110 in accordance with an embodiment,
`and FIG. 3B is a side view of the energy delivery head 110
`shown in FIG. 3A.As shown in FIG. 3A, the working surface,
`which contacts the skin (or clothing of the user), has an
`electromagnetic coil 112 and two other energy sources 114,
`such as electrodes. The electromagnetic coil 112 can be
`embedded within the energy delivery head 110. The user
`interface 130, which is operably connected to the energy
`delivery head 110, is used to activate the electromagnetic coil
`112 to deliver the pulsed electromagnetic energy to the user.
`As discussed above, PEMF has been used for pain therapy as
`well as healing therapy.
`
`[0040] However, PEMF cannot be sensed by the user so the
`user may not be aware that the PEMF is being delivered or the
`user may not believe that the PEMF is effective since it is not
`sensed by the user. Thus, a device that delivers only a type of
`energy, such as PEMF, that cannot be sensed by the user may
`
`be less effective because the user cannot feel the PEMF being
`applied, and therefore the user may not believe that the PEMF
`is working.
`[0041] Thus, in the embodiments shown in FIGS. 3-5, the
`energy delivery head 110 can also deliver at least two differ(cid:173)
`ent types of energy. In some embodiments, at least one of the
`energies is capable of being sensed by the user. For example,
`in addition to delivering an energy that cannot be sensed ( e.g.,
`PEMF), the energy delivery head 110 can emit an energy that
`can be sensed so that the user realizes the wearable energy
`delivery system 100 is working. Realizing that the system is
`working can provide the added benefit of a placebo effect, as
`described in more detail below.
`[0042] For example, in the illustrated embodiment, the
`energy delivery head 110 can also deliver via electrodes 114
`an energy that can be sensed, such as ESP or TENS, in
`addition to the PEMF from the electromagnetic coil 112. ESP,
`which can deliver electrical pulses at relatively low fre(cid:173)
`quency, can provide a tingling sensation so that the user can
`feel the wearable energy delivery system 100 working, which
`can provide the benefit of a placebo effect. According to an
`embodiment the energy delivery head 110 delivers ESP at a
`frequency in a range of about 0.1-100 Hz. In this embodi(cid:173)
`ment, the frequency is more preferably about 0 .1-17 Hz, and
`even more preferably about 0.1-5 Hz.
`[0043] Similarly, as TENS is electro-stimulation of the
`nerves, the user feels the delivery of TENS as opposed to
`PEMS, which does not provide any sensation to the user. In
`addition to the therapeutic benefits provided by TENS, there
`may also be the additional benefit of a placebo effect because
`the user can feel the TENS as opposed to not feeling the
`PEMF. According to an embodiment, the pulsed electrical
`energy (i.e., ESP or TENS) is pulsed between the pulses of the
`PEMF energy.
`[0044] As noted above, an energy that can be sensed, such
`as ESP or TENS, can provide the benefit of a placebo effect.
`As ESP and TENS are felt by the user, the perception that the
`ESP or TENS is working may help a user achieve a sense of
`well-being, which may bring about a positive physical
`response in addition to the psychological response. Thus, the
`combined energy delivery can have not only a cumulative
`therapeutic effect from two ( or more) different types of ener(cid:173)
`gies, but also a placebo effect if at least one of the energies is
`sensed by the user. Furthermore, both ESP and TENS require
`skin contact as opposed to PEMF, which does not require skin
`contact, so the mere contact of the energy delivery head 110
`to the skin may provide a placebo effect.
`[0045]
`In some embodiments, the wearable energy delivery
`system 100 provides indication that the wearable energy
`delivery system 100 is operating if the wearable energy deliv(cid:173)
`ery system 100 is delivering only PEMF or PEMF in combi(cid:173)
`nation with another energy that cannot be sensed so that the
`user knows that the wearable energy delivery system 100 is
`working (i.e., emitting energy). For example, the energy
`delivery head 110 can emit a light, whether blinking or not, or
`a sound to indicate that the wearable energy delivery system
`100 is working. According to another embodiment, a display
`on the wearable energy delivery system 100 can provide an
`indication, such as a blinking heart or energy levels, that the
`device is working. Alternatively, a similar display on a sepa(cid:173)
`rate device, such as a computer, smartphone, smart watch,
`tablet, etc., can provide such an indication. The user interface
`130 for controlling the wearable energy delivery system 100
`can be separate from the energy delivery head 110 and/or
`
`Allergan EX1073
`Page 33
`
`
`
`US 2016/0129274 Al
`
`May 12, 2016
`
`4
`
`power control unit 120. In some embodiments, the user inter(cid:173)
`face 130 is actually on another device, such as a computer,
`smartphone, smart watch, tablet, etc.
`[0046] Regardless of the location of the user interface 130,
`it can be used for controlling the energy emitted from the
`energy delivery head 110. The user interface 13 0 can include
`a display, knobs, levers and/or buttons and the like to control
`the energy delivery head 110. In some embodiments, the
`display can be a touchscreen display and separate knobs,
`levers, and buttons may not be necessary. The user interface
`130 can be used to, for example, turn on the wearable energy
`delivery system 100, select the energy or energies emitted
`from the energy delivery head 110, control the intensity of the
`energy or energies, and control the duration of the energy
`emission from the energy delivery head 110.
`[0047] According to an embodiment, the system 100 has a
`"sleep" mode in which only an energy that cannot be sensed
`(e.g., PEMF) is delivered. A user can select sleep mode ifhe
`or she desires continued therapy while sleeping. It will be
`understood that, in sleep mode, it is desirable to deliver an
`energy that cannot be sensed so that the user can sleep without
`being disturbed by a sensation, such as a tingling sensation
`which can be provided by TENS. Thus, the energy delivery
`head 100 can be integrated with sleep apparel (i.e., pajamas).
`[ 0048]
`In other embodiments, the energy delivery head 110
`can deliver other combinations of different types of energies
`instead of or in addition to PEMF and TENS. Other types of
`energy that can be delivered by the energy delivery head 110
`include: magnetic energy from a permanent magnet, heat
`energies, near and far infrared, percussion, ultrasonic, and
`vibration. Magnetic energy cannot be sensed by the user as
`opposed to percussion, ultrasonic, vibration, and heat ener(cid:173)
`gies.
`[0049] The energy delivery head 110 can be configured in
`different ways to deliver energies indifferent ways. As shown
`in the illustrated embodiment of FIG. 3, for an energy delivery
`head 110 for emitting both PEMF and TENS, the electromag(cid:173)
`netic coil 112 is positioned in the center of the working
`surface of the energy delivery head 110 and the electrodes 114
`are positioned on both sides of the electromagnetic coil 112.
`The electromagnetic coil 112 delivers PEMF while the elec(cid:173)
`trodes 114 deliver TENS to the user.
`[0050] The configuration shown in FIG. 3 provides short
`and long term benefits, as described above. A wearable
`energy delivery system 100 having an energy delivery head
`110 with the configuration shown in FIG. 3 can be placed
`around the affected area to provide combined therapy. TENS
`from the electrodes 114 can provide short-term relief from
`pain in the affected area in a larger scale and shallow tissue
`level due to current flow between the two electrodes 114.
`PEMF from the electromagnetic coil 112 located between the
`TENS electrodes 114 provides more concentrated and deeper
`therapy to the affected area that is simultaneously receiving
`pain relief from TENS.
`[0051] FIGS. 4A-4D illustrate some exemplary configura(cid:173)
`tions for the energy delivery head 110. In some configura(cid:173)
`tions, the energy delivery head 110 can have more than one
`electromagnetic coil 112. Similarly, the energy delivery head
`110 can have any number of other energy sources 114. For
`TENS, the energy delivery head can have any number of
`electrodes 114 to deliver TENS so long as there are at least
`two electrodes 114. The electrodes 114 can be positioned in
`different configurations on the energy delivery head 110 to
`provide the desired effect. The energy delivery head 110 can
`
`also be any shape or size. For example, as shown in FIGS. 4A
`and 4B, the electrodes 114 can be positioned in a circle around
`the electromagnetic coil(s) 112 on a circular energy delivery
`head 110. Although a circular energy delivery head 110 is
`illustrated, it will be understood that the energy delivery head
`110 can have any other shape. The energy delivery head 110
`can be any size or shape suitable for delivering energies to
`target areas ofa user's body. For example, the energy delivery
`head 110 can be circular, oval, triangular, rectangular, octago(cid:173)
`nal, or any other shape.
`[0052] This configuration of four or more electrodes 114
`around an electromagnetic coil(s) 112 operates on the same
`principle as the configuration shown in FIG. 3, but the greater
`number of electrodes 114 provides an even larger area of
`therapy for short-term and shallow pain relief while providing
`deep tissue healing with PEMF from the electromagnetic coil
`112. The greater the number of electrodes, the lar