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`US 20120302821Al
`
`c19) United States
`c12) Patent Application Publication
`BURNETT
`
`c10) Pub. No.: US 2012/0302821 Al
`Nov. 29, 2012
`(43) Pub. Date:
`
`(54) METHOD AND APPARATUS FOR
`ELECTROMAGNETIC STIMULATION OF
`NERVE, MUSCLE, AND BODY TISSUES
`
`(75)
`
`Inventor:
`
`Daniel R. BURNETT, San
`Francisco, CA (US)
`
`(73) Assignee:
`
`EMKINETICS, INC., Campbell,
`CA (US)
`
`(21) Appl. No.:
`
`13/456,016
`
`(22) Filed:
`
`Apr. 25, 2012
`
`Related U.S. Application Data
`
`(63) Continuation of application No. PCT/US2010/
`054167, filed on Oct. 26, 2010.
`
`(60) Provisional application No. 61/279,883, filed on Oct.
`26, 2009.
`
`Publication Classification
`
`(51)
`
`Int. Cl.
`A61N 2102
`(2006.01)
`A61N 2104
`(2006.01)
`(52) U.S. Cl. ............................................. 600/14; 600/13
`ABSTRACT
`(57)
`
`In certain variations, systems and/or methods for electromag(cid:173)
`netic induction therapy are provided. One or more ergonomic
`or body contoured applicators may be included. The applica(cid:173)
`tors include one or more conductive coils configured to gen(cid:173)
`erate an electromagnetic or magnetic field focused on a target
`nerve, muscle or other body tissues positioned in proximity to
`the coil. One or more sensors may be utilized to detect stimu(cid:173)
`lation and to provide feedback about the efficacy of the
`applied electromagnetic induction therapy. A controller may
`be adjustable to vary a current through a coil to adjust the
`magnetic field focused upon the target nerve, muscle or other
`body tissues based on the feedback provide by a sensor or by
`a patient. In certain systems or methods, pulsed magnetic
`fields may be intermittently applied to a target nerve, muscle
`or tissue without causing habituation.
`
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`FIG.1
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`FIG.2
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`FIG. 3
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`FIG. 4
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`US 2012/0302821 Al
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`Nov. 29, 2012
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`1
`
`METHOD AND APPARATUS FOR
`ELECTROMAGNETIC STIMULATION OF
`NERVE, MUSCLE, AND BODY TISSUES
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`[0001] The present application claims benefit of priority to
`U.S. Provisional Patent Application Ser. No. 61/279,883 filed
`Oct. 26, 2009 which is incorporated by reference herein in its
`entirety for all purposes. The following applications are also
`incorporated herein by reference in their entirety for all pur(cid:173)
`poses: U.S. patent application Ser. No. 12/508,529 filed Jul.
`23, 2009, which is a continuation in part of U.S. patent appli(cid:173)
`cation Ser. No. 11/866,329 filed Oct. 2, 2007, which claims
`priority to U.S. Provisional Patent Application Ser. No.
`60/848,720 filed Oct. 2, 2006; U.S. patent application Ser.
`No. 12/695,087 filed Jan. 27, 2010, which is a continuation of
`U.S. patent application Ser. No. 11/332,797 filed Jan. 17,
`2006; U.S. patent application Ser. Nos. 12/509,362 filed Jul.
`24, 2009; Ser. No. 12/469,365 filed May 20, 2009 which is a
`continuation of U.S. patent application Ser. No. 11/866,329
`filed Oct. 2, 2007 which claims priority to U.S. Provisional
`Patent Application Ser. No. 60/848, 720 filed Oct. 2, 2006, and
`12/469,625 filed May 20, 2009 which is a continuation of
`U.S. patent application Ser. No. 11/866,329 filed Oct. 2, 2007
`which claims priority to U.S. Provisional Patent Application
`Ser. No. 60/848,720 filed Oct. 2, 2006; and 12/509,304 filed
`Jul. 24, 2009 which is a continuation of U.S. patent applica(cid:173)
`tion Ser. No. 12/508,529 filed Jul. 23, 2009 which is a con(cid:173)
`tinuation-in-part of U.S. patent application Ser. No. 11/866,
`329 filed Oct. 2, 2007 which claims priority to U.S.
`Provisional Patent Application Ser. No. 60/848,720 filed Oct.
`2, 2006; and 12/509,345 filed Jul. 24, 2009 which is a con(cid:173)
`tinuation of U.S. patent application Ser. No. 12/508,529 filed
`Jul. 23, 2009 which is a continuation-in-part of U.S. patent
`application Ser. No. 11/866,329 filed Oct. 2, 2007 which
`claims priority to U.S. Provisional Patent Application Ser.
`No. 60/848,720 filed Oct. 2, 2006.
`
`BACKGROUND
`
`[0002] The concept of pulsed electromagnetic stimulation
`(PES) was first observed by the renowned scientist Michael
`Faraday in 1831. Faraday was able to demonstrate that time
`varying, or pulsed electromagnetic fields have the potential to
`induce current in a conductive object. Faraday's experimental
`setup was simple. He found that by passing strong electric
`current through a coil of wire he was able to produce pulsed
`electromagnetic stimuli. This pulsed electromagnetic stimu(cid:173)
`lus was able to induce the flow of current in a nearby electri(cid:173)
`cally conductive body.
`In the years since the discoveries of Faraday, pulsed
`[0003]
`electromagnetic stimulators have found application in count(cid:173)
`less areas of scientific investigation. In 1965, the scientists
`Bickford and Freming demonstrated the use of electromag(cid:173)
`netic stimulation to induce conduction within nerves of the
`face. Later, in 1982 Polson et al., U.S. Pat. No. 5,766,124
`produced a device capable of stimulating peripheral nerves of
`the body. This device was able to stimulate peripheral nerves
`of the body sufficiently to cause muscle activity, recording the
`first evoked potentials from electromagnetic stimulation.
`[0004] One of the earliest practical applications of electro(cid:173)
`magnetic stimulating technology took the form of a bone
`growth stimulator-a device that employed low frequency
`
`pulsed electromagnetic fields (PEMF) to stimulate bone
`repair. They first found use approximately 20 years ago in the
`treatment of non healing fractures, and are slowly becoming
`the standard of care for this condition.
`[0005] As investigators have studied the effects of electro(cid:173)
`magnetic fields on fracture healing, it has been demonstrated
`that PEMFs can not only facilitate fracture healing but also
`promote numerous other positive effects on the human body,
`including: (1) causing muscles to contract, (2) altering nerve
`signal transmission to decrease experienced pain, and (3)
`causing new cell growth in cartilage. These powerful effects
`of pulsed electromagnetic stimulation have been well estab(cid:173)
`lished in laboratory studies of animal models and also in
`multiple large, double blind, placebo controlled studies of
`human subjects published in the medical literature.
`[0006] Erickson's U.S. Pat. No. 5,181,902, Jan. 26, 1993,
`which describes a device using a double transducer system
`with contoured, flat wound transducers intended to generate
`therapeutic flux-aided electromagnetic fields in the body. The
`device is suggested to be conformed to the contour of the
`patient's back and incorporates an adjustable belt into the
`design. This system, as it is described, is disadvantageous in
`at least two respects. First, the flat, wound nature of the coil in
`this device is limited in its delivery of pulsed electromagnetic
`fields to deep tissues of the body. Second, the rigid nature of
`this device, intended to provide bracing for patients recover(cid:173)
`ing from spinal fusion surgeries, may prove uncomfortable to
`some patients, especially in delivering therapy to regions of
`the body other than the back, such as the knee, elbow, hand, or
`other joints and tissues.
`[0007] U.S. Pat. No. 6,086,525, which discloses a device
`that has a single coil in the shape of a "C" where the intensity
`of the electromagnetic field is between the ends of the "C".
`That point must be employed directly over the target nerve or
`muscle to be stimulated. The coil is toroidal in configuration
`and utilizes a unique core of vanadium permendur in the
`preferred form. One of the disadvantages of this device is that
`it requires a trained technician to treat the patient and to
`properly hand hold the open end of the "C" over the targeted
`nerve or muscle to be stimulated. The device is not portable
`and is designed for use in hospitals or similar institutions.
`Also the vanadium permendur core is required to increase the
`strength of the electromagnetic field to be strong enough to be
`effectively used. The design, shape and configuration
`described in Davey and other prior art devices, require the
`electromagnetic stimulator to be hand operated during use.
`[0008] Tepper in U.S. Pat. No. 5,314,401, May 24, 1994
`describes a pulsed electromagnetic field transducer that is
`intended to be conformable to the contour of a patients body.
`The PEMF transducer in this application is described as hav(cid:173)
`ing a desired form and sufficient rigidity to maintain an ana(cid:173)
`tomical contour. This system is disadvantageous in a number
`of respects. First, the desired contouring of this device will
`require that a significant number of different sizes be manu(cid:173)
`factured to accommodate the contours of an endless variety of
`body shapes. Second, the intended device does not incorpo(cid:173)
`rate markings to ensure that the device is placed in a correct
`alignment over the targeted area of the body. Finally, this
`proposed device utilizes flat, wound coils, providing PEMFs
`that do not penetrate as deeply or as uniformly into body
`tissues as those fields produced by solenoid coils.
`In U.S. Pat. No. 6,179,770Bl, Jan. 30, 2001, Mould
`[0009]
`describes dual coil assemblies in a magnetic stimulator for
`neuro-muscular tissue, with cooling provided for the trans-
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`ducer coil. This device is intended to be held by a trained user
`over the targeted regions of the body in order to deliver PEMF
`therapy. The design of this device is limited by the difficult
`nature of manipulating a single coil and the cost-intensive
`requirement of using highly skilled medical personnel for
`operation.
`[0010] Parker in U.S. Pat. No. 6,155,966, Dec. 5, 2000
`describes a wearable article with a permanent magnet/elec(cid:173)
`tromagnet combination device to be used for toning tissue
`with focused, coherent EMF. This device is disadvantageous
`in several respects. First, this device is intended to be a hand(cid:173)
`held application, with the user applying the device to targeted
`areas of the body. The hand-held nature of this application
`creates an inherently inconsistent and non-uniform method
`for delivery, especially difficult with the intention of the
`device to provide a focused electromagnetic stimulus. Sec(cid:173)
`ond, the device combines a static magnet with the electro(cid:173)
`magnet assembly in an attempt to create a unipolar, negative
`polarity field. This form of electromagnetic field stimulation
`has not been demonstrated to be effective in the treatment of
`osteoarthritis, musculoskeletal pain, or atrophy treatment.
`[0011] March's U.S. Pat. No. 6,200,259 Bl, Mar. 13, 2001
`describes a device with electromagnetic field coils applied
`front and back to a patient for treating cardiovascular disease
`by angiogenesis. An EMF dosage plan contemplates, mul(cid:173)
`tiple coil implants and pulse variables including carrier fre(cid:173)
`quency, pulse shape, duty cycle, and total time exposed. This
`device describes the placement of coils around the regions of
`tissues in which collateralization of blood flow ( or angiogen(cid:173)
`esis) is desired. The design contemplates applications includ(cid:173)
`ing the use of coils embedded in a cloth wrap, which could be
`worn as a garment surrounding the body area of interest.
`Alternatively, an applicator with embedded coils to be placed
`around an arm or a leg to deliver the desired field is described.
`The use of PEMF in this application for the purpose of modu(cid:173)
`lation of angiogenesis shows significant promise. The
`description of this device, however, does not suggest any
`extension of the electromagnetic phenomenon in circum(cid:173)
`stances where PEMF stimulation can provide dramatic
`opportunities for the treatment of osteoarthritis, and muscu(cid:173)
`loskeletal pains including tendonitis, bursitis, and muscle
`spasms. Furthermore, this device is disadvantageous in the
`fact that it does not provide for the use of solenoid-type coils
`for the delivery of PEMF.
`[0012] Poison's U.S. Pat. No. 5,766,124, Jun. 16, 1998
`describes a magnetic stimulator of neuro-muscular tissue. A
`reserve capacitor providing more efficiency in the control
`circuitry is devised. The description of the device, however,
`describes the stimulating coil in broad, generic terms, and
`does not contemplate application of the coil in any type of
`body applicator or other specific method for delivering PEMF
`to targeted areas of the body. As a result, this device is disad(cid:173)
`vantageous, in the respect that is does not provide for any
`method or delivery system to provide consistent, uniform
`PEMF stimulation.
`[0013] Schweighofer's U.S. Pat. No. 6,123,658, Sep. 26,
`2000 describes a magnetic stimulation device which consists
`of a stimulation coil, a high-voltage capacitor, and a control(cid:173)
`lable network part. This device is intended to differentiate
`itself from low-voltage, low current devices by using a spe(cid:173)
`cific high-voltage, high current design to deliver PEMF for
`the purpose of triggering action potentials in deep neuromus(cid:173)
`cular tissue. This coil in this device is described as having a
`difficult and expensive to use hand-held configuration.
`
`[0014] Lin in U.S. Pat. No. 5,857,957, issued Jan. 12, 1999
`teaches the use of functional magnetic stimulation for the
`purpose of inducing a cough function in a mammalian sub(cid:173)
`ject. The description of the device provides for the use of
`hand-held stimulation coil, intended to be placed over the
`anterior chest of the subject for the purpose of stimulating
`nerves to induce a cough. This system is disadvantageous in
`the requirement of hand-held delivery which is difficult and
`inconsistent. The description contemplates use of the device
`in the induction of cough, and does not contemplate extension
`of the use of the device into other areas of neuromuscular
`stimulation.
`[0015] Tepper in U.S. Pat. No. 6,024,691, issued Feb. 15,
`2000 describes a cervical collar with integral transducer for
`PEMF treatment. The description of this device provides for
`the use of a single coil transducer, formed into the shape of a
`cervical collar. This system is disadvantageous in several
`respects. First, this device does not provide for the use of
`solenoid-type coils in the delivery of PEMF, which can pro(cid:173)
`vide a uniform and consistent signal. Second, the semi-rigid
`design of the collar complicates the delivery of PEMF to
`persons of differing body sizes. That is, for a person with a
`larger than average ( or smaller than average) size neck, the
`design and semi-rigid nature of the device would make an
`exacting fit difficult, thereby diminishing the effectiveness of
`any delivered therapy. Furthermore, this device is designed to
`immobilize the neck and is therefore not applicable to most
`patients. Lastly, the device must be lowered over the head
`making application difficult.
`[0016] Erickson in U.S. Pat. No. 5,401,233, issued Mar. 28,
`1995 describes a neck collar device for the delivery of PEMF
`therapy. The description of this device provides for the use of
`semi-rigid transducers, intended to be conformable to a
`selected anatomical contour. This device in disadvantageous
`in respects similar to those of Pollack U.S. Pat. No. 5,401,
`233, in that the device does not provide for the use of sole(cid:173)
`noid-type coils. Furthermore, this device is intended to pro(cid:173)
`vide bracing (as might be necessary for the treatment of
`fractures or after surgery). As a result, the rigidity of the
`device necessary to serve the bracing function makes the
`device less comfortable to wear, especially for a person who
`would not require bracing (such as in the treatment of arthri(cid:173)
`tis, muscle spasm, or other forms of musculoskeletal pain).
`[0017] Kalt in U.S. Pat. No. 5,518,495, issued May 21,
`1996 describes a coil wound on a large bobbin that permits the
`insertion of an arm or a leg into the field of the coil for PEMF
`type therapy. This device is disadvantageous in several
`respects. First, the described use of a bobbin, around which
`the wire for the stimulating coil is wound provides for the
`treatment of certain areas of the body, but is certainly limited
`in its ability to deliver therapy to areas of the body such as the
`hips, shoulder, back, neck, etc. That is, the constraints of our
`human anatomy make it nearly impossible to approximate a
`metal bobbin, and thus the stimulating coil, to regions of the
`body such as the ball and socket joints of the hip or shoulder,
`where the round metal bobbin would strike the torso before it
`allowed the stimulating coils to adequately blanket with
`therapy the arm and/or joint in the hip and shoulder. Similarly,
`the use of a metal bobbin for the delivery of PEMF stimula(cid:173)
`tion to the back would necessitate a large, cumbersome deliv(cid:173)
`ery system (into which the entire body would have to fit) in
`order to adequately deliver stimulation to targeted areas on
`the back or torso. Second, the device is described as a rigid
`bobbin through which the extremity is placed. This format
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`makes application more difficult in that the applicator cannot
`be worn and therefore does not provide for consistent ideal
`placement of the extremity to maximize field effects. In fact,
`most designs of a similar nature are clinic-based devices and,
`therefore, would not be amenable to home healthcare appli(cid:173)
`cations as with the current invention. Third, the device
`described magnetic field within the bobbin is intended to have
`a maximum magnetic flux density in the range of 4.5 to 6
`gauss. Studies (such as Track et al in the Journal ofRheuma(cid:173)
`tology 1994; 21(10): 1903-1911) have shown that PEMF
`stimulation in the range of 15-25 or more gauss are effective
`in the treatment of osteoarthritis or other musculoskeletal
`pain conditions.
`[0018] Pollack in U.S. Pat. No. 5,014,699, issued May 14,
`1991 describes a coil wound around the cast on an appendage
`for the delivery of PEMF treatment to fractured bone. The
`described device has shown promise for the treatment of
`fractured bone, especially nonunion or delayed healing frac(cid:173)
`tures. However, the description of the device does not provide
`for extension of this application to the treatment of other
`conditions, such as arthritis, musculoskeletal pain, or atrophy.
`[0019]
`Imran in US Pat App No 2006/0052839 filed Sep. 7,
`2005 describe the use of an implantable stimulator for the
`treatment of chronic back pain. While this modality may be
`effective at treating back pain, it requires a major surgery and
`will eventually suffer from habituation as the area around the
`needle fibroses and the nerve becomes deadened to repeated
`stimulation.
`
`SUMMARY
`
`[0020]
`In certain variations, systems for electromagnetic
`induction therapy may include one or more conductive coils
`disposed within or along an applicator. The coils may be
`configured to generate a magnetic field focused on a target
`nerve, muscle or other body tissues in proximity to the coil.
`One or more sensors may be utilized to detect electrical
`conduction in the target nerve, to detect a muscular response
`caused by an electrical conduction in the target nerve, or to
`detect stimulation of a nerve, muscle or other body tissues and
`to provide feedback about the efficacy of the applied electro(cid:173)
`magnetic induction therapy. A controller in communication
`with the sensor may be adjustable to vary a current through
`the at least one coil so as to adjust the magnetic field focused
`upon the target nerve, muscle or other body tissues. Option(cid:173)
`ally, a user or patient may detect stimulation of a nerve,
`muscle or body tissue and the therapy may be adjusted based
`on feedback from the user or patient.
`[0021]
`In certain variations, the applicator may be config(cid:173)
`ured to intermittently apply or deliver pulsed magnetic fields
`to a target nerve, muscle or tissue without causing habituation
`of the target nerve, muscle or tissue.
`[0022]
`In certain variations, methods of electromagnetic
`induction therapy may include one or more of the following
`steps. A first portion of a patient's body may be positioned
`relative to or in proximity to an applicator or an applicator
`may be positioned relative to or in proximity to a first portion
`of a patient's body, such that a target nerve, muscle or tissue
`within the first portion of the body is in proximity to one or
`more conductive coils disposed within or along the applica(cid:173)
`tor. A current may be passed through a coil to generate a
`magnetic field focused on the target nerve, muscle or tissue.
`An electrical conduction through the target nerve, a muscular
`response caused by an electrical conduction through the tar(cid:173)
`get nerve or stimulation of a nerve, muscle, or body tissue
`
`may be detected by a sensor positioned along a second portion
`of the body. A signal from the sensor indicative of the elec(cid:173)
`trical conduction or stimulation may be received, which pro(cid:173)
`vides feedback about the efficacy of the applied electromag(cid:173)
`netic induction therapy. The current may be adjusted by a
`controller in communication with the conductive coils based
`on the feedback.
`[0023] Optionally, a user may detect stimulation of a nerve,
`muscle or body tissue and the therapy may be adjusted based
`on feedback from the user. In certain variations, pulsed mag(cid:173)
`netic fields may be intermittently applied or delivered a target
`nerve, muscle or tissue without causing habituation of the
`target nerve, muscle or tissue. Such intermittent magnetic
`fields may be used to treat chronic conditions, e.g., chronic
`pain, without causing habituation.
`[0024]
`In certain variations, applicators may be ergonomic
`or may be designed or configured to accommodate, approxi(cid:173)
`mate or be positioned relative to or in proximity to specific
`regions of the body or anatomy. The specific regions of the
`body or anatomy may be positioned relative to the applica(cid:173)
`tors, or the applicators may be positioned relative to the
`specific regions of the body or anatomy to treat various con(cid:173)
`ditions, for example, osteoarthritis, arthritis, back or neck
`pain, atrophy or paralysis, chronic pain, phantom or neuro(cid:173)
`pathic pain, neuralgia, migraines, orthopedic conditions.
`[0025] Other features and advantages will appear hereinaf(cid:173)
`ter. The features and elements described herein can be used
`separately or together, or in various combinations of one or
`more of them.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0026] The drawings constitute a part of this specification
`and include exemplary embodiments of the invention, which
`may be embodied in various forms. It is to be understood that
`in some instances various aspects of the embodiments may be
`shown exaggerated or enlarged to facilitate an understanding
`of the embodiments.
`[0027] FIG. 1 is a schematic view of an apparatus for mag(cid:173)
`netic induction therapy according to a first variation.
`[0028] FIG. 2 is a schematic view of an apparatus for mag(cid:173)
`netic induction therapy according to a second variation.
`[0029] FIG. 3 is a schematic view of an apparatus for mag(cid:173)
`netic induction therapy according to a third variation.
`[0030] FIG. 4 is a schematic view of an apparatus for mag(cid:173)
`netic induction therapy according to a fourth variation.
`[0031] FIG. 5 is a schematic view of an apparatus for mag(cid:173)
`netic induction therapy according to a fifth variation.
`[0032] FIGS. 6A-6D are schematic illustrations depicting a
`first method of use of an apparatus for magnetic induction
`therapy. This method is based on adjusting the position of the
`conductive coils so to optimize a magnetic flow applied to a
`target nerve.
`[0033] FIGS. 7A-7D are schematic illustrations of a second
`method of use of an apparatus for magnetic induction therapy.
`This method is based on locking the conductive coils in
`position once electrical conduction in a target nerve has been
`detected.
`[0034] FIG. 8 is a schematic view of a variation that
`includes a plurality of sensors.
`[0035] FIGS. 9A-9D are schematic representations of dif(cid:173)
`ferent garments adapted to operate as apparatus for magnetic
`induction therapy.
`[0036] FIG. 10 is a schematic view of an apparatus for
`providing electrical stimulation.
`
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`[0037] FIG. 11 is a schematic view of another variation of
`an apparatus for providing electrical stimulation.
`[0038] FIG. 12 shows a schematic view of an energy emit(cid:173)
`ting system including a microneedle patch sensor.
`[0039] FIG.13-15 shows magnified bottom views of varia(cid:173)
`tions of microneedle patches.
`[0040] FIGS. 16-17 shows magnified side views of varia(cid:173)
`tions of a microneedle patch.
`[ 0041] FIG. 18 shows a magnified bottom perspective view
`of a microneedle patch.
`[0042] FIG. 19 shows a representative cross sectional view
`of the skin composed of an outer stratum comeum covering
`the epidermal and dermal layers of skin and the underlying
`subcutaneous tissue, with a variation of a microneedle patch
`attached thereto.
`[0043] FIG. 20a shows a magnified side view of a variation
`of a microneedle patch including multiple electrodes.
`[0044] FIG. 20b-20D show variations of a microneedle
`patches including multiple electrodes.
`[0045] FIG. 21 shows a schematic view of an energy emit(cid:173)
`ting system including a microneedle patch sensor placed
`behind a subject's knee.
`[0046] FIGS. 22-23 show schematic views of energy emit(cid:173)
`ting systems including an electrode needle and sensor.
`[0047] FIGS. 24-25 show schematic views of energy emit(cid:173)
`ting systems including an electrode needle without a sensor.
`[0048] FIG. 26 shows a schematic view of an energy emit(cid:173)
`ting system including a microneedle patch for providing
`stimulation.
`[0049] FIGS. 27-28 show schematic views of energy emit(cid:173)
`ting systems including an electrode needle and microneedle
`patch for providing stimulation.
`[0050] FIG. 29a-29d show a prospective, side, top and rear
`views of an energy emitting device in the form of a foot
`cradle.
`[0051] FIGS. 30A-30B show schematic views of an energy
`emitting device in the form of a knee support.
`[0052] FIGS. 31A-31B show a schematic view ofa varia(cid:173)
`tion of an arm applicator and a foot, knee or leg applicator.
`[0053] FIG. 32 shows a schematic view of a variation of a
`back applicator.
`[0054] F