U.S. patent application number 13/033430 was filed with the patent office on 2012-05-03 for thermostimulation apparatus.
Invention is credited to Louise MOHN.
Application Number | 20120109232 13/033430 |
Document ID | / |
Family ID | 43479254 |
Filed Date | 2012-05-03 |
United States Patent
Application |
20120109232 |
Kind Code |
A1 |
MOHN; Louise |
May 3, 2012 |
THERMOSTIMULATION APPARATUS
Abstract
A thermostimulation apparatus is disclosed that includes heating
and cooling means, and in various embodiments the heating and
cooling means are heating and cooling pads, or at least one pad
capable of both heating and cooling, the latter possibly being one
or more Peltier elements. Certain embodiments also include heat
sink means and heat exchanger means, and/or electrical stimulation,
and the cooling means can include a refrigerant.
Inventors: |
MOHN; Louise; (London,
GB) |
Family ID: |
43479254 |
Appl. No.: |
13/033430 |
Filed: |
February 23, 2011 |
Current U.S.
Class: |
607/3 |
Current CPC
Class: |
A61N 1/36021 20130101;
G08B 5/22 20130101; A61F 2007/0093 20130101; A61N 1/37235 20130101;
A61F 7/02 20130101; A61N 2005/067 20130101; A61F 2007/0096
20130101; A61B 2018/00988 20130101; A61F 2007/0295 20130101; A61B
2017/00084 20130101; A61B 90/90 20160201; A61F 7/00 20130101; A61N
2005/0626 20130101; A61N 1/0492 20130101; A61N 1/0456 20130101;
A61F 2007/0058 20130101; A61F 2007/0075 20130101 |
Class at
Publication: |
607/3 |
International
Class: |
A61N 1/36 20060101
A61N001/36; A61F 7/00 20060101 A61F007/00 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 28, 2010 |
EP |
10189306.3 |
Claims
1. A thermostimulation apparatus comprising means for providing
heating and cooling.
2. The apparatus according to claim 1 comprising at least one
heating pad and at least one cooling pad.
3. The apparatus according to claim 2, wherein the at least one
heating pad comprises means for providing electrical stimulation
and means for providing heat.
4. The apparatus according to claim 3, wherein the pad comprises a
top layer, a bottom layer for contacting the area to be treated,
and a first and a second middle layer for supporting the
stimulation means and the heating means.
5. The apparatus according to claim 2, wherein the cooling pad
comprises means to receive a refrigerant in a liquid state or in a
gaseous state.
6. The apparatus according to claim 5, further comprising means to
vaporize a liquid refrigerant.
7. The apparatus according to claim 1 or 2, comprising at least one
pad capable of providing both heating and cooling.
8. The apparatus according to claim 7, wherein the pad comprises
one or more Peltier elements.
9. The apparatus according to claim 7, wherein the pad comprises a
heat sink means.
10. The apparatus according to claim 7, wherein the pad comprises a
heat exchanger means.
11. The apparatus according to claim 7, wherein the pad comprises a
thermocouple connected to a central processing unit to regulate the
temperature of the pad.
12. A pad as defined in claim 2 for use with a thermostimulation
apparatus.
13. A method for muscle treatment comprising the use of a
thermostimulation apparatus as claimed in claim 1.
14. A method for muscle treatment comprising the use of a pad as
defined in claim 2.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of European Patent
Application No. EP 10189306.3, filed Oct. 28, 2010, the contents of
which are incorporated herein by reference.
BACKGROUND AND SUMMARY OF THE INVENTION
[0002] The present invention relates to a thermostimulation
apparatus. More specifically, the present invention relates to a
thermostimulation apparatus capable of providing both heating and
cooling.
[0003] For a variety of therapeutic applications, several treatment
modalities are currently known in the art including electrical
stimulation, heat therapy and thermostimulation. Electrical
stimulation involves the application of an electrical current to a
single muscle or a group of muscles. The resulting contraction can
produce a variety of effects from strengthening injured muscles and
reducing edema to relieving pain and promoting healing.
[0004] Many electrical stimulation systems are limited to two to
four channels and therefore allow only two to four pads to be
applied to a patient. The pads are usually quite small and
typically powered with a battery. This results in the application
of a small amount of power and a low treatment depth of the
resulting electric field. The shallow depth of the electric field
generated by conventional electrical stimulation systems limits
performance and patient benefit. Some systems have attempted to
address this limitation by applying more current, often from a line
or main supply source. However, the small size of conventional
electrical stimulation pads is such that on the application of
larger amounts of power, i.e. the use of higher currents, patients
often report the experience of pain or discomfort.
[0005] Heat therapy itself is very useful as it has a number of
effects such as relaxation of muscle spasm and increased blood flow
that promotes healing. However, combination therapy, i.e. the
synergistic use of other modalities such as massage, ultrasound
and/or electrical stimulation has been found to be more effective
than heat therapy alone.
[0006] Thermostimulation is one such combination therapy that
involves the use of heat therapy and electrical stimulation
simultaneously. With thermostimulation, the healing benefits of
heat are provided along with the strengthening, toning, pain
relieving and healing benefits of electrical stimulation. Moreover,
the application of heat has been found effective in that it allows
the patient to tolerate higher currents. This yields higher
electric fields strengths, greater depths of penetration and
therefore, more positive results than could be achieved with
electrical stimulation without heat.
[0007] Therapeutic hypothermia can also be used for treatment of
different conditions either as a therapeutic or protective measure.
Local injuries or pain are often treated with heating, cooling or a
combination of both to speed up the healing process. In practice,
the administration of therapeutic hypothermia involves the
application of cooling blankets or wraps with a water-circulation
technology. These are susceptible to leakage and are not
recommended for use in combination with electrically powered
equipment.
[0008] Hence, a need remains in the art for an improved apparatus
or method for thermostimulation therapy that is more safe and
effective, and which can provide therapeutic treatment with the
application of both heating and cooling.
[0009] According to a first aspect of the invention, there is
provided a thermostimulation apparatus comprising means for
providing heating and cooling.
[0010] In a preferred embodiment, the thermostimulation apparatus
comprises at least one heating pad and at least one cooling
pad.
[0011] Preferably, the at least one heating pad comprises means for
providing electrical stimulation and means for providing heat. The
heating pad may comprise a top layer, a bottom layer for contacting
the area to be treated, and a first and a second middle layer for
supporting the stimulation means and the heating means.
[0012] Preferably, the cooling pad comprises means to receive a
refrigerant in a liquid state or in a gaseous state.
[0013] In another preferred embodiment, the thermostimulation
apparatus comprises at least one pad capable of providing both
heating and cooling.
[0014] The combined heating and cooling pad preferably comprises
one or more Peltier elements. The pad may further comprise heat
sink means and/or heat exchanger means.
[0015] Preferably, the pads according to the invention comprise a
thermocouple connected to a central processing unit to regulate the
temperature of the pad.
[0016] According to a second aspect of the invention, there is
provided a heating pad, a cooling pad and a combined heating and
cooling pad for use with a thermostimulation apparatus as described
above.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The invention will be further described with reference to
the drawings and figures, in which:
[0018] FIG. 1 is a block diagram of a thermostimulation apparatus
according to the invention;
[0019] FIG. 2 is a flow chart showing the different parts of the
thermostimulation apparatus according to the invention;
[0020] FIG. 3 is a diagram of a heating and electrical stimulation
pad for use with the thermostimulation apparatus according to the
invention;
[0021] FIGS. 4A, 4B, 4C and 4D are schematic representation of the
three layers of the heating and electrical stimulation pad of FIG.
3, as seen from the top;
[0022] FIGS. 5A, 5B, 5C and 5D are schematic representations of the
three layers of the heating and electrical stimulation pad of FIG.
3 as seen from the bottom;
[0023] FIG. 6 is a schematic representation of the layers of FIGS.
5B and 4C;
[0024] FIG. 7 is a schematic representation of an apparatus
according to the invention with a cooling pad;
[0025] FIG. 8 is a schematic representation of the top view of a
middle layer of a cooling pad as shown in FIG. 7;
[0026] FIG. 9 is a schematic representation of the top view of a
combined heating and cooling pad according to the invention;
and
[0027] FIG. 10 is a schematic representation of the bottom view of
a combined heating and cooling pad according to the invention.
DETAILED DESCRIPTION OF THE FIGURES AND ILLUSTRATIVE EMBODIMENTS OF
THE INVENTION
[0028] Referring to FIG. 1, there is illustrated a
thermostimulation apparatus 1 (or "cTEMS2" apparatus) according to
the invention. The apparatus may comprise a display and control
unit 2 (for example an iPad.RTM.).
[0029] The apparatus 1 may also comprise one or more, and
preferably up to twenty, interface cards 3 and optional interface
cards 4. Each interface card 3 is adapted to receive a pad for the
application of electromagnetic stimulation, heating and/or cooling
to a patient. Preferably, each interface card 3 has its own Central
Processing Unit (or "CPU") 5. Each interface card 3 may be adapted
to receive bio-feedback from thermocouples or temperature sensors
such as Pt1000.RTM. or Pt100.RTM. located the pad(s). The apparatus
1 may further comprise one or more optional interface cards 4 for
example for bio-impedance measurements 16 for bio-feed back control
of tissue properties for optimizing the effect output to the pad,
for ultrasound 17, laser 18 and RF/microwave treatments.
[0030] The apparatus is preferably powered from the mains 6, and
all the accessories connected to the interface cards 3, 4 may be
powered from the mains 6 via the apparatus 1 through Power Supply
Units (or "PSU") 8.
[0031] In use, a further Central Processing Unit (or "CPU") 7
receives protocol messages from the display and control unit 2 via
Blue Tooth.RTM. or Wi-Fi.RTM. connection 9, interprets these
messages and distributes the settings to the appropriate
interface(s) or pad(s). The CPU 7 may also receive messages and
alarm signals from the interface(s) or pad(s), act on these
messages, and send status information to the user interface 2.
[0032] FIG. 2 shows a flow chart providing an overview of an
apparatus according to the invention and each part will be
described in further detail below. Three types of pads are
illustrated, namely a combined electromagnetic muscle stimulation
and heating pad 19, a cooling pad using either cryogenic technology
20 or liquid in combination with a heat sink 21, a combined cooling
and heating pad using Peltier elements 22.
[0033] The pad interface drives the currents and voltages needed to
provide the wanted electromagnetic (EM) pulses at the pad. It also
monitors the actual currents and voltages, and limits these at
maximum values. In addition the pad interface delivers the current
needed for heating. It is extremely important that the individual
pad interfaces are electrically isolated. If not, the current may
be driven between pads, resulting in a current through the body.
The design includes a pre-set hardwired current limiting.
[0034] A microcontroller may be added to each pad and/or optional
interface. This enables the use of a bus solution with a protocol
for communication to the CPU. The need for cabling is thus greatly
reduced. This microcontroller may also monitor EM voltage/current
and limit these appropriately. An alarm is raised if limits are
overridden. Normal operation for the pad interface for stimulation
and heat 19 is preferably to continuously cycle the pulse sequence
stored in RAM until otherwise instructed. The pulse sequences are
downloaded to the interface via for example I.sup.2C. A set of
commands, also via I.sup.2C, enables the activation of new pulse
sequences, reading of temperature values and status, and so
forth.
[0035] FIG. 3 shows a pad 19 for use with the thermostimulation
apparatus of the present invention adapted to provide heat and
electromagnetic stimulation to a patient.
[0036] If the device has no functionality built in for feedback
control of temperature via input from a thermocouple in the pad, a
shielded pad cable 23 may be supplied with a with a connector 24,
for example a 4-pin connector, for connection to the device and a
temperature controlling unit 25 between the pad and the apparatus.
The LCD display of this unit will indicate when the pad is
connected, heating, the set point, and when the set point is
reached as well as errors. Failure will be alarmed visually by
error messages and with a buzzer. The system may be set up so that
in case of either software or hardware failure current to the
heating pads will be cut.
[0037] Preferably the pad comprises a temperature feedback control
means, for example an external temperature controller device is
added between the apparatus and the pad. If the apparatus has a
built in temperature control means, then there is usually no need
for the external temperature controller device 25 and the cable 23
may be mounted for example with a 6-pin connector 24 as further
explained below. An 8-pin connector may be used to reduce assembly
costs.
[0038] With reference to FIGS. 4A-4D and FIGS. 5A-5D, the heating
and stimulation pad 19 may comprise four layers, namely a top layer
19a, a first middle layer 19c, a second middle layer 19d and a
bottom layer 19d.
[0039] Within the context of this application, the expression
"bottom layer" refers to the layer which is in contact with the
skin of the patient; the expression "top layer" refers to the
outermost layer (i.e. the furthest away from the skin of the
patient) and the expression "middle layer" refers to any layer
located between the bottom and the top layer. The expression "top
surface" refers to the surface, in use, facing away from the
patient; and the "bottom surface" to the surface, in use, facing
towards from the patient
[0040] The top layer 19a (see for example FIG. 4) preferably
comprises a nonconductive thermoplastic polymer so that the
electromagnetic stimulation and heat are directed towards the
patient and there are no losses.
[0041] The first middle layer 19b (see FIG. 4C for top surface and
FIG. 5D for bottom surface) preferably comprises a silicon polymer,
a thermoplastic layer or one or more flexible print (PCBs).
Thermoplastic polymers are preferred to silicon polymers because
they are easier to manipulate during the moulding process. In
addition, silicon polymers are a tendency to not stick as well as
thermoplastic polymers, which is why it is preferred to include one
or more holes in the middle layers to improve adhesion of the top
and bottom layers. The top surface may comprise a thermocouple 12
(for example Pt1000.RTM.) which may be covered with silicon rubber;
a LED 26, which may be used to indicate proper connection to the
thermostimulation apparatus; and a connector 27, for example a 6
points connector, for mounting the cable 23 to the thermocouple 12,
to the stimulation electrodes 10 and to the heating element 28.
[0042] The second middle layer 19c (see FIG. 4D for top surface and
FIG. 5C for bottom surface) preferably comprises a silicon polymer.
The top side of the second middle layer 19c may comprise the
heating element 28, which is preferably a twisted wire glued to the
surface. One or more stimulation wires 29 may be glued to the
bottom surface of the second middle layer 19c.
[0043] The bottom layer 19d (see FIG. 5B) may comprise a
nonconductive thermoplastic polymer. The bottom side of the bottom
19c may comprise one or more (preferably two) stimulation
electrodes that preferably comprise conductive thermoplastic
polymer.
[0044] The pads described in this application are preferably
produced by injection moulding of pre-designed plastic polymers.
Preferably, thermoplastic polymers are used for maximum control of
the moulding process, quality (surface etc.), and bonding
properties. Both middle layers preferably comprise a plurality,
preferably three, elongated holes 23 to secure proper bonding
between the top and the bottom layers 19a, 19d in the moulding
process.
[0045] FIG. 6 is a schematic top view of a bottom layer 19c with a
second middle layer (not seen) and a first middle layer 19b. A
print or soft print (PCB) may be provided on the top surface of the
first middle layer 19b with a LED 26, which in use is visible
through the top layer 19a and indicating when the pad 19 is
properly connected to the thermostimulation apparatus.
[0046] Preferably, the print comprises a 6 points connector 27,
i.e. two for the heating element 28, two for the stimulation
electrodes 10 and two for the thermocouple 12. FIG. 6 includes a
cross-sectional view of the cable 23 (see bottom left), with two
wires for the heating element 28, two for the stimulation
electrodes 10 and two for the thermocouple 12. FIG. 6 also includes
a schematic view (bottom right) of a cable 23 mounted with a
connector for stabilization during the moulding process.
Polyurethane (PU) cables 23 are preferred for maximum bonding to
pads to prevent cracks that allow water to enter the pads and
create short cuts.
[0047] FIG. 7 is a diagram illustrating the principle of the
cooling pads 20, 21 according to the invention. Each cooling pad
20, 21 is adapted to receive using a cooling media or refrigerant
and the control unit may regulate the supply of refrigerant to each
cooling pad. The cooling device is preferably external to the
thermostimulation apparatus and involves either gas (for example a
cryogenic cooler), or a liquid cooler (for example a cooling bath
with thermostat control). For both systems, the cooling pads may be
flushed by a cooling media (gas or liquid) from a cooling device 30
through a feeding conduit 31 and a return conduit 32.
[0048] For the cryogenic system 20, the refrigerant is a liquid
forced to vaporize in the cooling pad 20, it will then condensate
in a heating sink within the cryogenic cooler 30. The refrigerant
may be water, or preferably water with an additive such as
iso-propanol to prevent freezing in the cooling system. The
refrigerant is forced to vaporize in a reservoir in the cooling
device, and cryogenic vapor is feed to the cooling pad through the
feeding conduit 31. Alternatively, the refrigerant may be feed
through the feeding conduit 31 to the cooling pad, and forced to
vaporize in the cooling pad. Either way, the resultant vapor is
returned to the apparatus via a return conduit 32. Alternatively,
the liquid refrigerant is Argon or liquid Nitrogen.
[0049] When using the liquid system 21, there is no change in the
physical state in the loop. Both external cooling systems may be
controlled by feedback from thermocouple 12 through the cable 23 to
the pad interface 3.
[0050] The cooling pad according to the invention preferably
comprises a top layer, a middle layer and a bottom layer. Both the
top and bottom layers comprising plastic polymer, preferably
"cooling plastic polymers" and/or high heat conductive
thermoplastic polymers for uniform distribution of the
temperature.
[0051] The middle layer 20a, 21a comprising a plastic polymer,
preferably a thermoplastic low conductivity polymer and has a top
surface and a bottom surface. Preferably one surface (see FIG. 8)
of the middle layer 20a, 21a comprises an electrical connection to
the thermocouple 12 via cable 23 and the other surface (see FIG. 7)
comprises one or more glued conduits 31, 32 (preferably in
polyurethane) in fluid connection with the external cooling
system.
[0052] A thermocouple 12 is preferably placed on the cooling
surface where the conduit 31, 32 is located. The cable 23 is
preferably covered with polyurethane, shielded and only two wires
are needed. Feedback is sent from the thermocouple 12 to the
thermostimulation apparatus and the temperature may be regulated so
that the skin temperature does not decrease below 1.degree. C. A
control unit connected to the thermocouple 12 may be used to
regulate the refrigerant flow and thus the temperature of the
cooling pad. Preferably the surface temperature of the cooling pad
is higher than 1.degree. C., and preferably less then 42.degree. C.
If required, a heating means may be provided in the
thermostimulation apparatus or in the cooling pad, for further
regulation of the refrigerant temperature in the cooling pad.
[0053] FIG. 9 is a diagram illustrating the principle of the
combined heating and cooling pads 22 according to the invention,
using one or more Peltier effect thermoelectric elements. In this
embodiment, there is no need for an external cooling device, as the
temperature can be controlled by feedback from a thermocouple 12
similar to that described above in relation to the heating and
stimulation pads. By switching polarity, the pads 22 can be used
for heating. The temperature difference between the two sites is
typically up to 60.degree. C. Therefore, the pad was designed to
allow for maximum heath dissipation from the surface of the top
layer 22a as outlined in FIGS. 9 and 10. Heating and cooling
temperature may be pre-selected and controlled using suitable
control means.
[0054] The combined heating and cooling pad preferably comprises a
top layer 22a, a middle layer 33 and a bottom layer 22b. FIG. 9 is
a schematic top view of the top layer 22a and the middle layer 33
and FIG. 10 is a schematic bottom view of the bottom layer 22b and
the middle layer 33.
[0055] Preferably, the top layer 22a comprises a heat sink means,
and/or "cooling plastic polymers" or high heat conductive
thermoplastic polymers for maximum dissipation of heat.
Alternatively, the heat sink means comprises an air cooled fin
array (for example a larger surface on the top side with a heat
conductive polymer) or liquid in adjacent the top layer 22a. The
liquid may for example be located in the pocket or jacket and
connected to a cooling system. Since the difference between the top
and bottom surfaces can be approximately 60 degrees, it implies
that the top surface temperature would be more than 60 degrees and
need to be dissipated.
[0056] The combined heating and cooling pad may comprise a heat
exchanger means to establish heat exchange between the Peltier
element and the patient's skin. The heat exchanger means may
comprise comprises a heat fluid flow path and/or a thermal contact
pad for establishing thermal contact with the patient's skin.
[0057] The middle layer 33 may comprise one or more holes 23 to
obtain maximum bonding between the top and bottom layers 22a, 22b
in the moulding process. The top and bottom layers 22a, 22b
preferably comprise non- or low conductive thermoplastic
polymer.
[0058] The bottom surface of the middle layer 33 may comprise one
or more Peltier elements 15 and may further comprise a thermocouple
covered with plastic polymers 12.
[0059] The top surface of the middle layer 33 may comprise a
connector 27 and the LED 26. Four welding/connector points (i.e.
the connector 27) for the Peltier elements are shown, but not the
wires connecting the elements. The connector 27 may be attached to
the welding/connector points. The figure also shows a cross section
of a shielded polyurethane cable 23, with two wires for the
(parallel coupled) Peltier elements 23 and two for the thermocouple
12 (for temperature feedback). Electrical current is supplied from
the thermostimulation apparatus 1 to the Peltier elements 23 via
connector 27
[0060] The thermostimulation apparatus described in this
application may comprise a control system and/or one or more pads
with temperature feedback as described in any one of U.S. patent
applications U.S. Ser. No. 12/592,498, U.S. Pat. No. 592,492, U.S.
Ser. No. 12/592,470 and U.S. Ser. No. 12/592,493.
[0061] The thermostimulation apparatus and the pads described in
this application are particularly advantageous for the treatment of
muscular injuries, rehabilitation, but also relaxation and
massaging.
* * * * *