U.S. patent application number 09/428196 was filed with the patent office on 2002-05-16 for electrical stimulation compress.
Invention is credited to AXELGAARD, JENS, CORNELL, GEORGE, HEARD, STEVE.
Application Number | 20020058982 09/428196 |
Document ID | / |
Family ID | 23697936 |
Filed Date | 2002-05-16 |
United States Patent
Application |
20020058982 |
Kind Code |
A1 |
AXELGAARD, JENS ; et
al. |
May 16, 2002 |
ELECTRICAL STIMULATION COMPRESS
Abstract
An electrical stimulation device method provides for exact
repeatable positioning of stimulation pads onto a body part. The
device includes a flexible member for contacting a body part and
hook/loop members for tightly supporting the flexible member
against the body part. At least one electrical bus is provided
which may include a connector for enabling connection of the bus to
an electrical lead wire and an electrical contact disposed on the
inside of the flexible member. A conductive pad is provided which
has dimensions substantially smaller than the dimensions of the
flexible member and includes a cover adhesive layer for removably
adhering the conductive pad to the flexible member inside with a
first side of the cover layer covering the bus contact and an
electrical communication therewith. A current controlling media is
adhered to a second side of the cover layer and a base layer
disposed on the current controlling media is provided for removably
adhering the conductive pad to the body part.
Inventors: |
AXELGAARD, JENS; (FALLBROOK,
CA) ; CORNELL, GEORGE; (RAMONA, CA) ; HEARD,
STEVE; (ESCONDIDO, CA) |
Correspondence
Address: |
WALTER A HACKLER
2372 S E BRISTOL SUTIE B
NEWPORT BEACH
CA
92660
|
Family ID: |
23697936 |
Appl. No.: |
09/428196 |
Filed: |
October 27, 1999 |
Current U.S.
Class: |
607/152 |
Current CPC
Class: |
A61N 1/0456 20130101;
A61N 1/0452 20130101; A61N 1/0476 20130101 |
Class at
Publication: |
607/152 |
International
Class: |
A61N 001/00 |
Claims
What is claimed is:
1. An electrical stimulation device for application to a body part,
the device comprising: a flexible member for contacting a body
part; means for tightly supporting said flexible member against the
body part; at least one electrical bus, said electrical bus having
means, for enabling connection of the bus to an electrical lead
wire and an electrical contact disposed on an inside of said
flexible member; and a conductive pad having dimensions
substantially smaller than dimensions of said flexible member, said
conductive pad comprising: cover electrically conductive gel
adhesive layer means for removably adhering said conductive pad to
the flexible member inside with a first side of the cover layer
means covering the bus contact and in electrical communication
therewith; a current controlling media adhered to a second side of
the cover layer; and base electrically conductive gel adhesive
layer means, disposed on said current controlling media, for
removably adhering said conductive pad to said body part.
2. The device according to claim 1 wherein the cover layer means
and the base layer means have adhesive properties enabling removal
of the conductive pad from said body part by separation of the
flexible member from said body part, the conductive pad remaining
adhered to said flexible member during such separation.
3. The device according to claim 1 wherein the cover layer means
and the base layer means have adhesive properties enabling sliding
of the conductive pad along said body part without separation of
the conductive pad from said flexible member.
4. The device according to claim 1 wherein said flexible member has
sufficient resiliency to act as a brace for said body part.
5. The device according to claim 1 further comprising a plurality
of electrical busses disposed in a spaced apart relationship with
one another in said flexible member, and a plurality of conductive
pads each having dimension substantially smaller than the flexible
member dimensions.
6. The device according to claim 5 wherein each conductive pad has
sufficient conductiveness to enable efficient electrical coupling
between the busses and said body part independent of placement of
each conductive pad on the flexible member inside as long as each
conductive pad covers a respective buss contact.
7. The device according to claim 1 wherein said current controlling
media comprises a scrim.
8. The device according to claim 1 wherein said current controlling
media comprises a third gel.
9. An electrical stimulation device for application to a body part,
the device comprising: a flexible member for contacting a body
part; means for tightly supporting said flexible member against the
body part; at least one electrical bus, said electrical bus having
means, for enabling connection of the bus to an electrical lead
wire and an electrical contact disposed on an inside of said
flexible member; and a conductive pad having dimensions
substantially smaller than dimensions of said flexible member, said
conductive pad comprising: multilayer means for providing
electrical interface between the body part and said electrical bus,
said multilayer means including first layer means, comprising an
electrically conductive gel having a relatively low peel strength,
for removably contacting the body part, and second layer means,
comprising an electrically conductive gel having a relatively high
peel strength, for contacting the flexible member inside and
contacting said electrical bus.
10. The device according to claim 9 wherein the first layer means
and the second layer means have adhesive properties enabling
removal of the conductive pad from said body part by separation of
the flexible member from said body part, the conductive pad
remaining adhered to said flexible member during such
separation.
11. The device according to claim 9 wherein the first layer means
and the second layer means have adhesive properties enabling
sliding of the conductive pad along said body part without
separation of the conductive pad from said flexible member.
12. The device according to claim 9 wherein said flexible member
has sufficient resiliency to act as a brace for said body part.
13. The device according to claim 9 further comprising a plurality
of electrical bus disposed in a spaced apart relationship with one
another in said flexible member, and a plurality of conductive pads
each having dimensions substantially smaller than the flexible
member dimensions.
14. The device according to claim 13 wherein each conductive pad
has sufficient conductive to enable efficient electrical coupling
between one of the buses and said body part independent of
placement, each conductive pad on the flexible member inside as
long as each conductive pad covers a respective buss contact.
15. The device according to claim 9 wherein said current controller
media comprises a scrim.
16. The device according to claim 9 wherein said current conductive
media comprises a third gel.
17. A method for applying and positioning an electrical stimulation
device onto a body part, said method comprising the steps of: a)
removably adhering a plurality of stimulation electrodes to a body
part with a relatively low peel strength electrically conductive
layer; b) electrically stimulating the body part with the
stimulation electrodes; c) determining body part response to the
electrical stimulation; d) removing and reapplying at least one of
the stimulation electrodes and repeating steps b and c until a
desired body part response is obtained; e) disposing a flexible
member onto the body part and removably adhering the flexible
member to the plurality of electrical stimulators with a relatively
high peel strength layer; f) removing the flexible member from the
body part with the electrical stimulators adhered thereto; g)
marking the flexible member to indicate the positions of the
electrical stimulators thereon; h) removing the electrical
stimulators from the flexible member; i) removably adhering a
plurality of conductive pads to the marked positions, each pad
being electrically coupled to a respective electrical bus in the
flexible member; and j) disposing the flexible member over the body
part to removably adhere the conductive pads in position
corresponding to the electrical stimulators.
18. The method according to claim 17 wherein the conductive pads
are adhered to the flexible member with a relatively high peel
strength layer and adhered to the body part with a relatively low
peel strength layer and adhered to the body part with a relatively
low peel strength layer to enable repeated disposal and removal of
the flexible layer on the body part, without disturbing the
relative positioning of the conductive pads adhered thereto.
19. The method according to claim 17 wherein the conductive pads
are adhered to the flexible member with a relatively low peel
strength layer and adhered to the body part with a relatively high
peel strength to enable the conductive pads to remain adhered to
the body part when the flexible member is removed from the body
part.
20. A method for applying and positioning an electrical stimulation
device onto a body part, said method comprising the steps of: a)
removably adhering a plurality of conductive pads to a body part
with a relatively low peel strength electrically conductive layer;
b) disposing a flexible member onto the body part and removably
adhering the flexible member to the plurality of conductive pads
with a lower peel strength layer, each pad being electrically
coupled to a respective electrical bus extending through the
flexible member; c) electrically stimulating the body part with
electrical pulses applied through the buses and pads; d)
determining body part response to the electrical stimulation; e)
removing the flexible member from the body part, the conductive
pads remaining adhered to the body part; f) removing and reapplying
at least one of the conductive pads and repeating steps b, c and d,
until a desired body part response is obtained; g) applying a
relatively high peel strength layer to the conductive pads adhered
to the body part; and h) disposing the flexible member onto the
body part and adhering the flexible member to the conductive pads
with the relatively high peel strength adhesive.
21. The method according to claim 20 further comprising the step of
removing the flexible member from the body part with the conductive
pads adhered thereto and marking the flexible member to indicate
the position of the conductive pads thereon.
22. The method according to claim 21 further comprising the step of
adhering replacement conductive pads on the flexible member at the
marked position
23. A method for applying and positioning an electrical stimulation
device onto a body part, said method comprising the steps of: a)
removably adhering a plurality of stimulation electrodes to a body
part with a relatively low peel strength electrically conductive
layer; b) electrically stimulating the body part with the
stimulation electrodes; c) determining body part response to the
electrical stimulation; d) removing and reapplying at least one of
the stimulation electrodes and repeating steps b and c until a
desired body part response is obtained; e) marking the body part to
indicate the position of the electrode; f) Replacing the electrode
with conductive pads; g) disposing a flexible member onto the body
part and conductive pads; and h) removing the flexible member with
the conductive pads adhered thereto.
24. The method according to claim 23 further comprising the step of
marking the flexible member to indicate the position of the
conductive pads thereon.
25. The method according to claim 24 further comprising the step of
replacing the conductive pads on the flexible member with other
conductive pads using the indication marking as a reference for
proper placement on the flexible member.
Description
[0001] The present invention generally relates to a stimulation
electrode system and more specifically is directed to an electrical
stimulation compress, band, or brace device.
[0002] Transcutaneous electrical nerve stimulation is used, for
example, in post-operative and chronic pain control.
[0003] On the other hand, muscle stimulation is useful, for
example, in maintenance and development of muscle tissue and is a
particularly important function in sports medicine.
[0004] While significant advantages afforded through the use of
electrical stimulation of nerves and muscles, its effectiveness can
be enhanced when used in combination with a supporting compress,
band or brace, which may not only provide for immobilization of the
body part, but also proper placement and positioning of electrical
stimulation electrodes with respect to the body part.
[0005] The use of stimulation electrodes necessarily mandates
effective electrical coupling of the electrode to the skin. In
order to accomplish this coupling, prior art devices have
incorporated many types of conductive fluids and/or gels.
[0006] One type of electrode used for temporary application of
muscle stimulation includes a flat, smooth contacting surface with
a separate conductive cream or gel applied to the skin to
electrically couple the electrode thereto. Experience with this
system has shown that the cream and gel is messy to use and remove
and the electrodes are not suitable for curved body parts. In
addition, subsequent to use of the electrode, the cream or gel must
be cleaned and washed from the skin and the electrode.
[0007] Another type of electrode more suitable for longer term
application of electrical stimulation or monitoring includes a
flexible conductive fabric or film material. In combination
therewith, a conductive adhesive gel is utilized to perform a dual
function of both electrically coupling the electrode to the body
and adhering the electrode to the skin. While this type of
electrode is effective, a great number of electrodes may be
required to provide a long term treatment for certain conditions.
When the electrodes are used in combination with a compress, band,
brace gauntlet or other supporting garment or bandage, it is
impractical to dispose of the supporting system due to loss of
efficacy of the stimulation electrodes.
[0008] The present invention is directed to an electrical
stimulation device which includes reusable compresses, bands,
braces and the like, to a body part in which the electrical
stimulation electrode is removably attached thereto.
[0009] This is accomplished in part through the use of electrical
conductive pads, removably and electrically coupled to a compress
or the like, which enables removable adherence to a body part.
[0010] A method encompassed by the present invention enables the
precise placement of stimulation electrodes on a body part
utilizing in combination electrical electrodes, or pads, with
differential release adhesive thereon and a brace or compress.
SUMMARY OF THE INVENTION
[0011] An electrical stimulation device in accordance with the
present invention for application to a body in part generally
includes a flexible member for contacting a body part. The flexible
member may have sufficient resiliency to act as a brace compress,
splint or other function. Means are provided for tightly supporting
the flexible member against the body part.
[0012] At least one electrical bus is provided which includes
means, for enabling connection of the bus to an electrical lead
wire. The bus also includes an electrical contact disposed on an
inside of the flexible member.
[0013] A conductive pad is provided which has dimensions
substantially smaller than dimensions of a flexible member. This
enables the positioning of the conductive pad at one of an array of
positions on the inside of the flexible member as long as it is
placed in electrical communication with the contact on the inside
of the flexible member.
[0014] A conductive pad generally includes cover electrically
conductive gel adhesive layer means for removably adhering the
conductive pad to the flexible member inside, with a first side of
the cover layer means covering the bus contact and in electrical
communication therewith.
[0015] A current controlling media is provided and adhered to a
second side of the cover layer, and base electrically conductive
gel adhesive layer means, disposed on the current controlling
media, provides for removably adhering the conductive pad to the
body part.
[0016] The electrical pad is, in fact, a multi-layer means, having
differential release properties, for providing electrical interface
between the patient's skin and the electrical bus. In this context,
the multi-layer means includes a first layer (i.e., the base layer)
comprising an electrically conductive gel having a relatively low
peel strength, for removably contacting a body part, and a second
layer means, (i.e., the cover layer), which comprises an
electrically conductive gel having a relatively high peel strength,
for contacting the flexible member inside and the electrical bus
therein.
[0017] Thus, the cover layer means and the base layer means have
adhesive properties enabling removal of the conductive pad from the
body part by separation of the flexible member from the body part
with the conductive pad remaining adhered to the flexible member
during such separation. Subsequently, the pad may be removed from
the flexible member inside surface and replaced due to the
removable adhesive properties of the cover layer, or second layer
means. Alternatively, as will be hereinafter discussed in greater
detail, the adhesive properties of the layers may be selected in
order that the flexible member may be removed with the pads
remaining adhered to the body part.
[0018] In addition, the cover layer means and the base layer means
may have adhesive properties enabling sliding of the conductive pad
along the body part without separation of the conductive pad from
the flexible member. This is important in positioning the device on
the body. Thus, when the device is applied to the body, it may be
moved into proper positioning which entails sliding the conductive
pad along the body part without separation and misalignment of the
conductive pad from the flexible member. The sliding property also
facilitates placement, since adherence without the ability of
translational movement, or sliding, would make placement of the
device on a body part more difficult. Without the sliding property,
the initial placement of the device on the body part would have to
be exact. This, of course, does not allow for precise positioning
of the electrical pads.
[0019] The device in accordance with the present invention may
include a plurality of electrical busses disposed in a spaced apart
relationship with one another in the flexible member and a
plurality of conductive pads, each having dimensions substantially
smaller than the flexible member dimensions. This arrangement
allows for the exact relative positioning of pads with one another
while at the same time allows a range of placement of each pad with
respect to one another on the flexible member as long as each is
utilized in contact with one of the busses. Thus, the flexible
member can be uniformly made for use with patients having various
size body parts, with the difference in size accommodated for by
different spacing arrangements between the conductive pads on the
flexible member.
[0020] The current controlling member may be a third gel, a
conductive scrim, a conductive cloth, a conductive film or the
like.
[0021] A method in accordance with the present invention for
applying and positioning an electrical stimulation device on a body
part generally includes the steps of removably adhering a plurality
of conductive pads to a body part with a relative low peel strength
electrically conductive layer. Thereafter, a flexible member is
disposed onto the body part and removably adhered to the plurality
of conductive pads with a lower peel strength layer. Each pad is
electrically coupled to a respective electrical bus extending
through the flexible member.
[0022] The body part is stimulated with electrical pulses and pads
and the body part response to the electrical stimulation is
determined.
[0023] The flexible member is removed from the body part and the
conductive pads remain adhered to the body part. At least one of
the conductive pads is removed and reapplied and the steps of
disposing the flexible member onto the body part over the pads,
electrical stimulation of the body part and a determination of the
response to the electrical stimulation is repeated until a desired
body part response is obtained.
[0024] Thereafter, a relatively high peel strength layer is applied
to the conductive pads and the flexible member is disposed over the
body part and adhered to the conductive pads with a relatively high
strength adhesive.
[0025] This enables the pads to be removed from the body part with
the flexible member.
[0026] The method further includes marking the flexible pads with
the position of the conductive pads and, as necessary, replacing
the conductive pads on the flexible member at the marked
positions.
[0027] This method ensures proper relative placement of the
conductive pads onto the body part for the most efficient muscle
stimulation.
[0028] As an alternative, separate stimulation electrodes may be
utilized in the method of the present invention. In this instance,
a plurality of stimulation electrodes are removably adhered to a
body part with a relatively low peel strength electrically
conductive layer. The body part is then stimulated with the
stimulation electrode and the body part response to the electrical
stimulation is determined.
[0029] Thereafter, at least one of the stimulation electrodes is
removed and reapplied and the steps of electrically stimulating the
body and determining the response thereto is repeated until a
desired body part response is obtained.
[0030] At that point, a flexible member is disposed onto the body
part and removably adhered to the plurality of stimulation
electrodes with a relatively high peel strength layer. The flexible
member is removed from the body part with the stimulation
electrodes adhered thereto.
[0031] The flexible member is then marked to indicate the positions
of the stimulation electrodes thereon and the stimulation
electrodes removed from the flexible member.
[0032] A plurality of conductive pads are then removably adhered to
the marked positions on the flexible members with each pad being
electrically coupled to a respective electrical bus in the flexible
member. The flexible member is then disposed over the body part to
removably adhere the conductive pads in positions corresponding to
the stimulation electrodes.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] The advantages and features of the present invention will be
better understood by the following description when considered in
conjunction with the accompanying drawings, in which:
[0034] FIG. 1 is a perspective view of an outside of a flexible
member in accordance with the present invention generally showing a
means for tightly supporting the flexible member against a body
part, not shown, along with a plurality of electrical busses;
[0035] FIG. 2 is a perspective view of an inside of the flexible
member shown in FIG. 1, also showing cooperative means for tightly
supporting the flexible member against a body part, also not shown
in FIG. 2, as well as a reverse side of the electrical busses;
[0036] FIG. 3 is a plan view of the inside of the flexible member
shown in FIG. 2 shown with a plurality of conductive pads placed
thereon and removably adhered to the flexible member inside and in
electrical contact with the busses; and
[0037] FIG. 4 is an exploded view of an electrical pad suitable for
use with the flexible member shown in FIGS. 1-3 which, in
combination therewith, provides for an electrical stimulation
device in accordance with the present invention for application to
a body part; and
[0038] FIGS. 5-7 illustrate the method of the present
invention.
DETAILED DESCRIPTION
[0039] With reference to FIGS. 1 and 2, there is shown an
electrical stimulation device 10 for application to a body part
(not shown) which generally includes a flexible member 12 for
contacting a body part. The size and shape of the flexible member
12 may be varied considerably from that illustrated in the Figures
of the present application, depending upon the body part to be
contacted by the flexible member. It should be readily appreciated
that the flexible member would have different dimensions and sizes
for use on an arm, on a leg or other body part, the illustrated
flexible member 12 being selected for use on a patient's limb,
i.e., arm or leg.
[0040] It should also be appreciated that the material of
construction of flexible member is varied as long as it is not
electrically conductive. In fact, the stiffness of the member may
be selected in order that the member 12 functions as a brace, a
compress, bandage or other suitable application to a body part.
[0041] Micro hooks 16, disposed on an outside 18 of the flexible
member (shown in FIG. 1) and micro loops 22 on an inside 24 of the
flexible member 12 (shown in FIG. 2) attached to fingers 26 of the
flexible member may provide a means for tightly supporting the
flexible member against the body part (again not shown in the
Figures).
[0042] A plurality of electrical buses extend through the flexible
member 12 and, on the outside 18, of the flexible member 12,
include snaps 34, or the like, which provides a means for enabling
connection of the buses to one or more electrical lead wires, not
shown.
[0043] On the inside 24 of the flexible member, each bus 32,
includes an electrical contact 36 as shown in FIG. 2.
[0044] With reference to FIGS. 3 and 4, the present invention
includes at least one, and preferably a plurality of conductive
pads 40, having dimensions substantially smaller than the
dimensions of the flexible member 12. This difference in overall
dimensions between the pad 40 and flexible member 12, enables a
variety of placement patterns, or arrays, of the conductive pads
onto the inside 24 of the flexible member 12. This allows for
precise alignment of the pads 40 onto a body part (not shown) and
also to accommodate for patient having different sizes of body
parts. The only limitation of placement of the pads 40 on the
inside 24 of the flexible member 12 is the condition that the
conductive pads 40 each cover a contact 36 of the electrical bus
32.
[0045] With specific reference to FIG. 4, each conductive pad 40
includes a cover electrically conductive gel adhesive layer 42
which provides a means for removably adhering the conductive pad 40
to the flexible member inside 24 with a first side of the cover
layer covering the bus contact 36 and in electrical communication
therewith.
[0046] A current controlling media 50 is adhered to a second side
52 of the gel layer 42. This conductive media may be of a number of
configurations including a metal scrim, or a conductive gel, a
conductive fabric, a conductive film, or a conductive film with
conductive traces, as is well known in the art. See U.S. Pat. No.
5,904,712.
[0047] The pad 40 further includes a base electrically conductive
gel adhesive layer 56 disposed on the current controlling
conductive media 50 which provides a means for removably adhering
the conductive pad 40 to the body part.
[0048] Thus, the conductive pad 40 is, in fact, a multi-layer means
for providing an electrical interface between the body part and the
electrical bus 32 with the multi-layer means including a first
layer, or as hereinabove designated, a base layer comprising an
electrically conductive gel having a relatively low peel strength
for removably contacting the body part, and a second layer,
hereinabove referred to as the cover layer, comprising an
electrically conductive gel having a relatively high peel strength,
for contacting the flexible member inside and contacting the
electrical bus.
[0049] Thus, the cover, or second, layer and the base, or first,
layer have adhesive properties enabling removal of the conductive
pad 40 from the body part by separation of the flexible member 12
from the body part, with the conductive pad 40 remaining adhered to
the flexible member inside 24 during such separation. Accordingly,
the flexible member can be applied and removed to the body part
without disturbing the relative placement of the pads 40 on the
flexible member inside surface 24.
[0050] Further, the cover or second, layer and the base, or first,
layer may have adhesive properties enabling sliding of the
conductive pad 40 across a body part without separation of the
conductive pad 40 from the flexible member 12. Importantly, as
hereinabove noted, this feature enables the device 10 to be
properly fixed to the body part by the hook 16 and loops 22 by
exactly positioning the pads 40 to desired locations without
complete removal of the device 10 from the body part and
reapplication.
[0051] All of the layers 42, 50 of the pad 40 are described in U.S.
patent application Ser. No. 09/021,009, now U.S. Pat. No.
.sub.------------, entitled MEDICAL ELECTRODE AND METHOD OF
MANUFACTURE. This referenced application Ser. No. 09/021,009, is
totally incorporated herein by this specific reference thereto
including all drawings and specifications for teaching a person
skilled in the art how to make and use the conductive pads 40 in
accordance with the present invention.
[0052] Further description of the conductive organic polymers that
may be used in preparing the layers 42, 56 may be derived from the
copolymerization of a mixture of monomeric acrylic acid and
N-vinyl-pyrollidone. These polymers are set forth in U.S. Pat. No.
5,868,136, which is to be incorporated herewith in its entirety
including all drawings and specification to describe generally
suitable polymers.
[0053] With reference to FIGS. 5-7, there is illustrated a method
in accordance with the present invention for applying and
positioning an electrical stimulation device 60 onto a body part
62.
[0054] As is well known in the art, stimulation electrodes must be
accurately placed on a body part in order to ensure effective
stimulation. This is particularly true when multiple electrodes are
utilized. Unfortunately, the precise placement of the electrodes is
not easily accomplished by a patient utilizing a stimulation device
over a long period of time. While a qualified physician or
attendant can properly place electrodes on a patient's body, such
procedures are not amenable to long term use in which the
electrodes are replaced. The present invention enables the device
60 to be utilized by a patient with repeated applications and
changes of electrodes while maintaining the precise positioning of
the electrodes with respect to the body parts to effect efficient
stimulation.
[0055] As illustrated in FIGS. 5-7, the flexible member 64 which
may be identical to the flexible member 12 hereinabove described,
includes a plurality of buses 68 therethrough, also hereinabove
described.
[0056] As shown in FIG. 5, the method includes removably adhering a
plurality of conventional stimulation electrodes, or pads 70 to a
body part with a relatively low peel strength electrically
conductive layer as hereinabove discussed in connection with the
pads 40. Thereafter, the electrodes, or pads 70 may be separately
electrified to stimulate the body part 62 and the body part
response to such electrical stimulation is determined in a
conventional manner.
[0057] Thereafter, one of the stimulation electrodes 70 may be
removed and reapplied as indicated by the dashed line 70A in FIG.
5. The body part is again electrically stimulated with the
electrodes 70, 70A and the body part response is determined. This
procedure is repeated until a desired body part response is
obtained.
[0058] Thereafter, the flexible member 64 is disposed onto the body
part 62 and removably adhered to the electrode 70, the adherence
being made with a relatively high peel strength layer.
[0059] As shown in FIG. 6, the flexible member 64 is removed with
the electrodes 70 adhered thereto.
[0060] The positions of the electrodes 70 are then marked onto the
flexible member 64 and replaced with conductive pads 40 which are
in contact with the electrical busses 68 in the flexible member 64.
Because the flexible member 64 is marked, repeated replacement of
conductive pads 40 (not shown in FIGS. 5-7) with precise relative
spacing is enabled. Thus, a patient can replace conductive pads and
reapply the device 60 while ensuring proper placement of the pads
40 onto the body part 62.
[0061] As hereinabove described, the stimulation electrodes 70 may
be replaced by the conductive pads 40 after placement of the
electrode 70 onto the body part 64 is determined.
[0062] Alternatively, the conductive pads 40 themselves may be used
to determine the exact placement.
[0063] In this procedure, a plurality of conductive pads 40 are
removably adhered to the body part 60 with a relatively low peel
strength electrically through a conductive layer. The flexible
member 64 is disposed on the body part 62 and removably adhered to
the plurality of conductive pads 40 with a low peel strength layer,
each pad 40 being electrically coupled to a respective bus 68
extending through the flexible member 64.
[0064] The body part is electrically stimulated with electrical
pulses applied through the buses 68 and pads 40. The body part 62
response is determined and the flexible member 64 is removed from
the body part with the conductive pads 40 remaining adhered to the
body part 62. At least one of the conductive pads 40 is removed and
reapplied and the steps of stimulation and determination of body
response are repeated until a desired body part response is
obtained.
[0065] Thereafter, a relatively high peel strength layer is applied
to the conductive pads adhered to the body part and the flexible
member 64 is disposed onto the body part and adhered to the
flexible member with the relatively high peel strength
adhesive.
[0066] Thus, the use of adhesive layers having relatively high peel
strength which provide a differential release enables the
performance of the method in accordance with the present
invention.
[0067] In accordance with the present invention, the conductive
pads 40 may be adhered to the flexible member 64 with a relatively
high peel strength layer and adhered to the body part with a
relatively low peel strength layer to enable repeated disposal and
removal of the flexible layer 64 to the body part 62 without
disturbing the relative positioning of the conductive pads adhered
thereto.
[0068] Alternatively, the conductive pads 40 may be adhered to the
flexible member 64 with a relatively low peel strength layer and
adhered to the body part with a relatively high peel strength layer
to enable the conductive pads to remain adhered to the body part 62
when the flexible member 64 is removed from the body part 62. This
enables repeated application of the flexible member and replacement
of the conductive pads 40 thereon through the use of the markings
on the flexible member 64 indicating the proper positioning of the
conductive pads 40 thereon.
[0069] In a further embodiment of the method in accordance with the
present invention, a patient may be stimulated with electrodes 70
that are moved until the desired response is obtained. Then the
patient's skin is marked with an easily removable marker where the
electrodes are placed. The standard stimulation electrodes 70 are
then replaced with the conductive pads 40 using the marks as
guidance. The flexible member 64 is then placed over the pads 40 in
its optimum position. The flexible member 64 is removed with the
pads 40. The outline of the pads 40 is marked with a permanent
marker on the inside of the flexible member 64 for future
reference. The flexible member is ready for use. The pads 40 can be
replaced as desired by using the marked reference outlines for
correct and accurate placement. This can be done by the patient
since no further pad adjustment is necessary to effect proper
stimulation.
[0070] Although there has been hereinabove described a specific
embodiment of the present invention for the purpose of illustrating
the manner in which the invention may be used to advantage, it
should be appreciated that the invention is not limited thereto.
Accordingly, any and all modifications, variations, or equivalent
arrangements which may occur to those skilled in the art should be
considered to be within the scope of the present invention as
defined in the appended claims.
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