U.S. patent application number 12/910743 was filed with the patent office on 2011-04-28 for therapeutic wrap.
Invention is credited to Krister Bowman, Mark H. Lowe.
Application Number | 20110098792 12/910743 |
Document ID | / |
Family ID | 43899079 |
Filed Date | 2011-04-28 |
United States Patent
Application |
20110098792 |
Kind Code |
A1 |
Lowe; Mark H. ; et
al. |
April 28, 2011 |
THERAPEUTIC WRAP
Abstract
Temperature-controlled therapy wrap for treatment of at least a
portion of an animate body including a fluid bladder including an
inlet, an outlet, and at least one fluidic channel connecting the
inlet to the outlet; and a thermal insulating member on the fluid
bladder only directly adjacent the inlet and extending along the at
least one fluidic channel. The therapy wrap may be adapted to
compensate for a temperature delta in the wrap. The therapy wrap
may include an insulating layer of one or more insulating members.
The insulating layer is dimensioned and configured to have
different coefficients of heat transfer. The insulating layer may
have varying thicknesses and materials to achieve varying heat
transfer rates. Also disclosed is a method of administering a
temperature-controlled treatment to an anatomical body part.
Inventors: |
Lowe; Mark H.; (Danville,
CA) ; Bowman; Krister; (Oakland, CA) |
Family ID: |
43899079 |
Appl. No.: |
12/910743 |
Filed: |
October 22, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61254064 |
Oct 22, 2009 |
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Current U.S.
Class: |
607/104 |
Current CPC
Class: |
A61F 7/02 20130101; A61F
2007/0231 20130101; A61F 7/0085 20130101; A61F 2007/0027 20130101;
A61F 2007/0054 20130101; A61F 2007/0246 20130101; A61F 2007/0039
20130101; A61F 2007/0091 20130101; A61F 2007/0029 20130101 |
Class at
Publication: |
607/104 |
International
Class: |
A61F 7/00 20060101
A61F007/00 |
Claims
1. A therapy wrap comprising: a fluid bladder including an inlet,
an outlet, and at least one fluidic channel connecting the inlet to
the outlet; and a thermal insulating member on the fluid bladder
only directly adjacent the inlet and extending along the at least
one fluidic channel.
2. The wrap of claim 1, further comprising another thermal
insulating member on the fluid bladder extending along the at least
one fluidic channel and separated from the thermal insulating
member.
3. The wrap of claim 2, wherein the insulating member is configured
to decrease the rate of heat transfer by a greater degree than the
another thermal insulating member.
4. The wrap of claim 2, wherein the insulating member and the
another insulating member have different coefficients of heat
transfer.
5. The wrap of claim 4, wherein the insulating member and the
another insulating member have essentially equal thickness.
6. The wrap of claim 2, wherein the insulating member and the
another insulating member are contiguous.
7. The wrap of claim 2, wherein the insulating member and the
another insulating member are integrally formed in an insulating
layer.
8. The wrap of claim 1, further comprising an expandable bladder on
a side of the bladder opposite the insulating member for exerting a
compressive force on the bladder.
9. A therapy wrap comprising: a fluid bladder including an inlet,
an outlet, and at least one fluidic channel connecting the inlet to
the outlet; and a thermal insulating layer affixed to the fluid
bladder and having a shape dimensioned and configured to correspond
to a perimeter of the bladder, the thermal insulating layer
comprising a thermal insulating member extending along the at least
one fluidic channel and positioned only directly adjacent the inlet
when the layer is affixed to the bladder.
10. The wrap of claim 9, wherein the thermal insulating layer
further comprises another insulating member extending along the at
least one fluidic channel and separated from the thermal insulating
member.
11. The wrap of claim 10, wherein the insulating member and the
another insulating member are contiguous.
12. The wrap of claim 10, wherein the insulating member and the
another insulating members are monolithically fanned in the
insulating layer.
13. The wrap of claim 12, wherein the insulating layer is
printed.
14. The wrap of claim 9, wherein the insulating layer is bonded to
the bladder.
15. The wrap of claim 9, further comprising a pocket for removably
securing the insulating layer.
16. The wrap of claim 9, wherein the at least one fluidic channel
has a serpentine shape, and the insulating member and the another
insulating member are positioned in a pattern corresponding to the
at least one fluidic channel.
17. The wrap of claim 9, wherein the at least one fluidic channel
extends from wall-to-wall in a width direction.
18. A method of administering a temperature-controlled treatment to
an anatomical body part, the method comprising: applying a therapy
wrap to an anatomical body part, the wrap comprising: an inlet; an
outlet; at least one fluidic channel connecting the inlet and the
outlet; and a thermal insulating layer between the wrap and the
body part extending along a flowpath of the at least one fluidic
channel in a first region only directly adjacent the inlet; flowing
a heat exchanging fluid from a reservoir through the inlet to the
at least one fluidic channel; and returning the fluid to the
reservoir from the outlet.
19. The method of claim 18, further comprising flowing the fluid
through a second region downstream from the first region, wherein
an overall coefficient of heat transfer in the second region is
less than an overall coefficient of heat transfer in the first
region.
20. The method of claim 18, further comprising decreasing the
thickness of the insulating layer downstream from the first region
to compensate for a temperature delta in the at least one fluidic
channel.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application No. 61/254,064 filed on Oct. 22, 2009, entitled,
"TEMPERATURE AND FLOW CONTROL METHODS IN A THERMAL THERAPY
DEVICE."
FIELD OF THE INVENTION
[0002] The present invention relates generally to therapy of an
animate body, and more particularly a therapeutic wrap of the type
having circulating fluid to provide cooling, heating, and/or
compression to a human or animal body part.
BACKGROUND OF THE INVENTION
[0003] It is now common to apply cold and compression to a
traumatized area of a human body to facilitate healing and prevent
unwanted consequences of the trauma. In fact, the acronym RICE
(Rest, Ice, Compression and Elevation) is now used by many.
[0004] Cold packing with ice bags or the like traditionally has
been used to provide deep core cooling of a body part. Elastic
wraps are often applied to provide compression.
[0005] It will be appreciated that these traditional techniques are
quite uncontrollable. For example, the temperature of an ice pack
will, of course, change when the ice melts, and it has been shown
that the application of elastic wraps and, consequently, the
pressure provided by the same, varies considerably even when the
wrappers are experienced individuals.
[0006] Because of these and other difficulties, many in the field
have turned to a more complicated animate body heat exchanger. Most
effective animate body heat exchangers typically include two major
components, an external compliant therapy component covering a body
part to be subjected to heat exchange, and a control component for
producing a flowing heat exchange liquid. Many control units also
produce and supply an air or other gas pressure needed to apply
pressure to a body part and to press the heat exchange liquid
toward such body part. This air pressure is directed to another
compliant bladder of the therapy component, which air pressure
bladder overlays the liquid bladder to press such liquid bladder
against the body part to be subjected to heat exchange, as well as
apply compression to the body part to reduce edema.
[0007] As can be seen, a commonly used external therapy component
uses a pair of compliant bladders to contain fluids; that is, it
preferably has both a compliant bladder for containing a
circulating heat exchange liquid and a gas pressure bladder which
overlays the liquid bladder for inhibiting edema and for pressing
the liquid bladder against the body part to be subjected to heat
exchange.
[0008] In general, the body heat exchanging component(s) of such an
apparatus has a pair of layers defining a flexible bladder through
which a liquid is circulated. This component is often referred to
as a "wrap." The liquid fed to the wrap is maintained at a desired
temperature. Generally, the desired temperature is lower than the
temperature expected for the body part, and typically is achieved,
at least in part, by passing the liquid through a heat exchanging
medium, such as by passing the same through an ice bath, or a
refrigeration unit. One such system is disclosed, for example, in
U.S. Pat. No. 6,178,562, the disclosure of which is herein
incorporated for all purposes by reference.
[0009] One issue with these types of therapeutic wraps is that the
fluid warms from the body part heat as it passes through the wrap.
Accordingly, the average temperature fluctuates and the amount of
heat transfer is inconsistent. In some cases, the fluid warms to a
degree that a portion of the wrap no longer provides therapy. To
counteract this effect, the flow rate can be increased or the fluid
can be cooled to a lower temperature. Increasing the flow rate
reduces the cooling effect of the wrap. Lowering the inlet
temperature leads to very low temperatures in the inlet area of the
wrap. If the temperature is too low, the wrap becomes uncomfortable
for the patient and can even lead to burns during extended periods
of use.
[0010] There is a need for a wrap that provides efficient heat
transfer over all of the treatment surface. There is a need for a
wrap that provides efficient heat transfer while reducing the need
to significantly increase or decrease the fluid temperature from
the reservoir. There is the need to provide a wrap that improves
patient comfort and/or reduces risks of injury to the body part
treated.
[0011] There remains a need to provide improved
temperature-controlled therapy apparatus and methods for their
use.
SUMMARY OF THE INVENTION
[0012] The present invention involves improvements in heat transfer
therapy apparatus and avoids disadvantages in the prior art.
[0013] Various aspects of the invention are directed to a therapy
wrap including a fluid bladder including an inlet, an outlet, and
at least one fluidic channel connecting the inlet to the outlet;
and a thermal insulating member on the fluid bladder only directly
adjacent the inlet and extending along the at least one fluidic
channel.
[0014] In various embodiments, the wrap includes another thermal
insulating member on the fluid bladder extending along the at least
one fluidic channel and separated from the thermal insulating
member.
[0015] The insulating member and the another insulating member may
be modified to achieve the desired variation in insulating effect.
In various embodiments, the insulating member is configured to
decrease the rate of heat transfer by a greater degree than the
another thermal insulating member. In various embodiments, the
insulating member and the another insulating member have different
coefficients of heat transfer. In various embodiments, the
insulating member and the another insulating member have
essentially equal thickness.
[0016] In various embodiments, the insulating member and the
another insulating member are contiguous. The insulating member and
the another insulating member may be integrally formed in an
insulating layer. The insulating member and the another insulating
member may be monolithically formed as the insulating layer.
[0017] In various embodiments, the wrap includes an expandable
bladder on a side of the bladder opposite the insulating member for
exerting a compressive force on the bladder.
[0018] Various aspects of the invention are directed to a therapy
wrap including a fluid bladder including an inlet, an outlet, and
at least one fluidic channel connecting the inlet to the outlet;
and a thermal insulating layer affixed to the fluid bladder and
having a shape dimensioned and configured to correspond to a
perimeter of the bladder, the thermal insulating layer comprising a
thermal insulating member extending along the at least one fluidic
channel and positioned only directly adjacent the inlet when the
layer is affixed to the bladder.
[0019] In various embodiments, the thermal insulating layer further
comprises another insulating member extending along the at least
one fluidic channel and separated from the thermal insulating
member. The insulating member and the another insulating member may
be contiguous. In various embodiments, the insulating member and
the another insulating members are monolithically formed in the
insulating layer.
[0020] In various embodiments, the insulating layer is printed. In
various embodiments, the insulating layer is bonded to the bladder.
In various embodiments, the wrap includes a pocket for removably
securing the insulating layer.
[0021] In various embodiments, the at least one fluidic channel has
a serpentine shape, and the insulating member and the another
insulating member are positioned in a pattern corresponding to the
at least one fluidic channel. In various embodiments, the at least
one fluidic channel extends from wall-to-wall in a width
direction.
[0022] Various aspects of the invention are directed to a method of
administering a temperature-controlled treatment to an anatomical
body part. The method includes applying a therapy wrap to an
anatomical body part, the wrap including an inlet; an outlet; at
least one fluidic channel connecting the inlet and the outlet; and
a thermal insulating layer between the wrap and the body part
extending along a flowpath of the at least one fluidic channel in a
first region only directly adjacent the inlet; flowing a heat
exchanging fluid from a reservoir through the inlet to the at least
one fluidic channel; and returning the fluid to the reservoir from
the outlet.
[0023] In various embodiments, the method includes flowing the
fluid through a second region downstream from the first region,
wherein an overall coefficient of heat transfer in the second
region is more than an overall coefficient of heat transfer in the
first region.
[0024] In various embodiments, the method includes decreasing the
thickness of the insulating layer downstream from the first region
to compensate for a temperature delta in the at least one fluidic
channel.
[0025] The wrap and method of the present invention have other
features and advantages which will be apparent from or are set
forth in more detail in the accompanying drawings, which are
incorporated in and form a part of this specification, and the
following Detailed Description of the Invention, which together
serve to explain the principles of the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 is a perspective view of one embodiment of the
invention;
[0027] FIG. 2 illustrates top plan views of modular portions of the
embodiment of FIG. 1;
[0028] FIG. 3 illustrates bottom plan views of the modular portions
of FIG. 2;
[0029] FIG. 3A is an enlarged section of a portion of one of the
modular portions of FIG. 3 illustrating a dot connection
pattern;
[0030] FIG. 4 illustrates coupling the modular portions of FIG.
2;
[0031] FIG. 5A illustrates the modular portions of FIG. 4 with one
modular portion enclosed in a pouch in the other or outer modular
portion;
[0032] FIG. 5B illustrates a variation of FIG. 5A where the inner
enclosed portion has the same dimension and the out modular
portion, which encloses the inner modular portion, is larger;
[0033] FIG. 6 is a sectional view taken along line 6-6 in FIG.
5A;
[0034] FIGS. 6A and 6B diagrammatically illustrate the true grain
orientation of the heat transfer device layers illustrated in FIG.
6 in accordance with one embodiment of the invention;
[0035] FIGS. 7A-C illustrate use of the embodiment of FIG. 1, where
FIG. 7A illustrates applying the apparatus to the arm of a human
user; FIG. 7B illustrates the apparatus wrapped around the arm; and
FIG. 7C illustrates the apparatus wrapped around the lower portion
or calf of the user;
[0036] FIG. 8 illustrates another embodiment of the invention;
[0037] FIGS. 9A-B illustrate use of the embodiment of FIG. 8, where
FIG. 9A illustrates the apparatus being wrapped around a human
patient's upper leg and knee and FIG. 9B illustrates the apparatus
fully wrapped around that region and ready for use;
[0038] FIG. 10 illustrates bottom plan views of modular portions of
another embodiment of the invention which, for example, is suitable
for coupling to the patient's body core region;
[0039] FIG. 11 illustrates top plan views of the modular portions
of FIG. 10;
[0040] FIG. 12 is a sectional view of the embodiment of FIG. 10
with the modular portions coupled;
[0041] FIG. 13A illustrates coupling of the modular portions so
that one modular portion is enclosed in a pouch in the other or
outer modular portion;
[0042] FIGS. 13B and 13C show two positions of the embodiment of
FIG. 10 after insertion of the one modular portion as shown in FIG.
13A, wherein FIG. 13B shows the belt or strap portions arranged
downward and FIG. 13C show the belt or strap portions arranged
upward;
[0043] FIGS. 14A-D diagrammatically depict use of the embodiment of
FIG. 10 where FIG. 14A show a first step in wrapping the apparatus
around the waist of a patient, FIG. 14B shows securing the
apparatus in place, FIG. 14C shows the apparatus being in its final
position and ready for use, and FIG. 14D shows the apparatus with
the straps repositioned and the apparatus being wrapped around the
upper torso of the patient;
[0044] FIG. 15 illustrates another embodiment of the invention,
which, for example, can be used to treat the ankle and foot region
of a patient;
[0045] FIG. 16 illustrates top plan views of modular portions of
the embodiment of FIG. 15;
[0046] FIG. 17 illustrates bottom views of the modular portions of
FIG. 16;
[0047] FIGS. 18A-C illustrate coupling the modular portions of the
embodiment of FIG. 16. where FIG. 18A illustrates a first stage of
inserting one modular portion into the other modular portion, FIG.
18B illustrates another stage of inserting the one modular portion
into the other, and FIG. 18C illustrates the one modular portion
fully inserted into the other modular portion;
[0048] FIGS. 19A-D illustrate use of the embodiment of FIG. 10,
where FIG. 19A shows a first stage in wrapping the device; FIG. 19B
illustrates securing mating hook and loop fastener portions around
the foot; FIG. 19C illustrates securing mating hook and loop
fastener portions at the forward portion of the lower leg of the
patient, and FIG. 19D illustrates securing mating hook and loop
fastener portions behind the ankle and region adjacent thereto;
[0049] FIG. 20 illustrates another embodiment of the invention,
which, for example, can be used to treat the shoulder of a
patient;
[0050] FIG. 21 illustrates top views of modular portions of the
embodiment of FIG. 20;
[0051] FIG. 22 illustrates bottom views of the modular portions of
FIG. 21;
[0052] FIGS. 23A-D illustrate coupling the modular portions of FIG.
20, where FIG. 23A illustrates a first stage where the modular
portions are generally aligned, FIG. 23B illustrate inserting a
portion of one modular portion into the other modular portion, FIG.
23C illustrates another stage where the one modular portion is
fully positioned in the other, and FIG. 23D illustrates edges or
flaps of the covering modular portion secured to enclose the other
modular portion; and
[0053] FIGS. 24A-D diagrammatically illustrate use of the
embodiment of FIG. 20 where FIG. 24A shows a first stage in pulling
the apparatus over the arm and toward the shoulder of a patient,
FIG. 24B illustrates wrapping the apparatus around the shoulder of
the patient and securing mating hook and loop fastener portions
around the arm; FIG. 24C illustrates securing mating hook and loop
fastener portions to secure portions that wrap around the chest of
the patient, and FIG. 24D illustrates the apparatus in position for
use with an optional strap having one end attached to the apparatus
and mating hook and loop fastener portions secured to one another
to form a loop for receiving the patient's arm.
[0054] FIG. 25 illustrates another embodiment of the invention,
which can be used in equine applications;
[0055] FIG. 26 illustrates bottom views of modular portions of the
embodiment of FIG. 25;
[0056] FIG. 27 illustrates top views of the modular portions of
FIG. 25;
[0057] FIG. 28 is a top schematic view of a wrap similar to that of
FIG. 2, illustrating a plurality of variable thickness insulating
members. FIG. 28A is an exploded section of a portion of FIG. 28,
illustrating a fluidic channel;
[0058] FIG. 29 is a top schematic view of a variable insulating
wrap similar to that of FIG. 28, illustrating a single insulating
member;
[0059] FIG. 30 is a cross-sectional view of a wrap similar to that
of FIG. 28, illustrating varying thicknesses of the insulating
members;
[0060] FIG. 31 is a cross-sectional view of a wrap similar to that
of FIG. 28, illustrating insulating members with equal thicknesses
and different coefficients of heat transfer;
[0061] FIG. 32 is a top schematic view of a variable insulating
wrap similar to that of FIG. 28, illustrating an elongated
insulating member extending along a fluidic channel from directly
adjacent the inlet and around a first corner of the wrap;
[0062] FIG. 33 is a top schematic view of a variable insulating
wrap similar to that of FIG. 32, illustrating another insulating
member extending along the fluidic channel and having a different
thermal insulating factor than the insulating member in the inlet
region;
[0063] FIG. 34 is a top schematic view of a variable insulating
wrap similar to that of FIG. 33, illustrating a third insulating
member in the outlet region;
[0064] FIG. 35 is a top schematic view of a variable insulating
wrap similar to that of FIG. 33, illustrating a plurality of
insulating members with different shapes;
[0065] FIG. 36 is a sectional view of a variable insulating wrap
similar to that of FIG. 28, illustrating assembly of the expandable
compression bladder, fluid bladder, and insulating layer;
[0066] FIG. 37A is a top plan view of a variable insulating wrap
similar to that of FIG. 28, illustrating a modified insulating
sleeve for receiving a fluid bladder; FIG. 37B is a top schematic
view of the bladder including a fluidic channel to be inserted into
the insulating sleeve of FIG. 37A;
[0067] FIG. 38 is a top schematic view of a variable insulating
wrap similar to that of FIG. 37, illustrating a plurality of
insulating members positioned based on a user's preferences;
and
[0068] FIG. 39 is a top schematic view of an insulating layer
similar to that of FIG. 28 positioned over another fluid bladder,
the fluid bladder configured to reduce kinking during flexure.
DETAILED DESCRIPTION OF THE INVENTION
[0069] Before the present invention is described, it is to be
understood that this invention is not intended to be limited to
particular embodiments or examples described, as such may, of
course, vary. Further, when referring to the drawings, like
numerals indicate like elements.
I) General Description
[0070] Various aspects of the invention are similar to the subject
matter described in: U.S. patent application Ser. No. 09/127,256
(filed Jul. 31, 1998) entitled, "Compliant Heat Exchange Panel"
issued on Apr. 3, 2007 as U.S. Pat. No. 7,198,093; U.S. patent
application Ser. No. 09/798,261 (filed Mar. 1, 2001) entitled,
"Shoulder Conformal Therapy Component of an Animate Body Heat
Exchanger"; U.S. patent application Ser. No. 09/901,963 (filed Jul.
10, 2001) entitled, "Compliant Heat Exchange Splint and Control
Unit"; U.S. patent application Ser. No. 09/771,123 (filed Jan. 26,
2001) entitled, "Wrist/Hand Conformal Therapy Component of an
Animate Body Heat Exchanger"; U.S. patent application Ser. No.
09/771,124 (filed Jan. 26, 2001) entitled, "Foot/Ankle Conformal
Therapy Component of an Animate Body Heat Exchanger"; U.S. patent
application Ser. No. 09/771,125 (filed Jan. 26, 2001) entitled,
"Conformal Therapy Component of an Animate Body Heat Exchanger
having Adjustable Length Tongue"; U.S. patent application Ser. No.
10/784,489 (filed Feb. 23, 2004) entitled, "Therapy Component of an
Animate Body Heat Exchanger" which is a continuation of U.S. patent
application Ser. No. 09/765,082 (filed Jan. 16, 2001) entitled,
"Therapy Component of an Animate Body Heat Exchanger and Method of
Manufacturing such a Component" issued on Feb. 24, 2004 as U.S.
Pat. No. 6,695,872 which is a continuation-in-part of U.S. patent
application Ser. No. 09/493,746 (filed Jan. 28, 2000) entitled,
"Cap And Vest Garment Components Of An Animate Body Heat Exchanger"
issued on Jan. 30, 2001 as U.S. Pat. No. 6,178,562; U.S. patent
application Ser. No. 10/122,469 (filed Apr. 12, 2002) entitled,
"Make-Break Connector For Heat Exchanger" issued on Mar. 29, 2005
as U.S. Pat. No. 6,871,878; U.S. patent application Ser. No.
10/637,719 (filed Aug. 8, 2003) entitled, "Apparel Including a Heat
Exchanger" issued on Sep. 19, 2006 as U.S. Pat. No. 7,107,629; U.S.
patent application Ser. No. 12/208,240 (filed Sep. 10, 2008)
entitled, "Modular Apparatus for Therapy of an Animate Body" which
is a divisional of U.S. patent application Ser. No. 10/848,097
(filed May 17, 2004) entitled, "Modular Apparatus for Therapy of an
Animate Body"; U.S. patent application Ser. No. 11/707,419 (filed
Feb. 13, 2007) entitled, "Flexible Joint Wrap"; U.S. patent
application Ser. No. 11/854,352 (filed Sep. 12, 2007) entitled,
"Make-Break Connector Assembly with Opposing Latches", U.S. patent
application Ser. No. 10/848,097 (filed May 17, 2004) entitled
"Modular Apparatus for Therapy of An Animate Body", published on
Nov. 17, 2005 as Publication No. 2005/0256556, which is
incorporated herein for all purposes by reference.
[0071] The above described applications and patents generally
describe thermal therapy devices, typically for cooling or heating
a body part. Performance of the thermal therapy device may be
improved by adjusting the flow rate, adjusting the temperature,
and/or providing additional features to the thermal therapy device.
In a typical return flow arrangement, the velocity of the fluid is
proportional to the flow rate.
[0072] Reducing the flow rate of the fluid of a given temperature
through the thermal therapy device will also reduce the amount of
energy removed from (or added to) the patient. Conversely,
increasing the flow rate will increase the amount of energy removed
from (or added to) a patient. In a cold therapy device, with the
wrap applied to a mammalian body, the temperature of the fluid
leaving the wrap is warmer than the temperature of the fluid
entering the wrap because the mammalian body is typically warmer
than the thermal fluid.
[0073] As the fluid flow rate into the wrap becomes slower, the
temperature delta increases as does the average wrap temperature.
To decrease the average wrap temperature, the flow may be increased
sufficiently. A slower flow rate, however, may lead to less
efficient heat transfer and other performance problems.
[0074] Lowering the temperature from the reservoir and entering the
wrap inlet generally leads to a lower average wrap temperature and
increased heat transfer. For example, if an average wrap
temperature of 5.degree. C. is desired, then a wrap inlet
temperature of 1.degree. C. may be needed. In this example, the
temperature delta across the wrap may be 10.degree. C., which is
quite large. Moreover, the inlet temperature is near freezing. For
use with humans, this may be uncomfortable at best and, at worst,
cause cold burns during extended periods of use.
[0075] As used herein, the "average temperature" of the wrap refers
to the average of the wrap inlet temperature and the wrap outlet
temperature. The difference between the wrap outlet temperature and
the wrap inlet temperature will be referred to as "temperature
delta" through the wrap. The temperature delta through the wrap
depends on the fluid flow rate, the heat load, and the specific
heat of the thermal fluid. The "maximum temperature" and "minimum
temperature" refers to the maximum and minimum temperatures at any
point in the wrap, and more specifically the fluidic channels.
II) General Therapy Wrap
[0076] Turning to the figures, FIG. 1 illustrates a modular heat
therapy device for use with a heat therapy system. The system
includes a modular heat transfer therapy apparatus, also referred
to as a "wrap", which includes a first modular member or portion
and a second modular member or portion. The first modular member or
portion comprises a heat transfer device, and the second modular
member portion forms a pouch into which the first modular member is
placed. The first modular member can be readily removed so that one
can clean either or both the first and second modular members
and/or replace either of the first and second modular members. For
example, the second modular member can be constructed of material
so that it is washable and reusable so that the second modular
member can be cleaned after being stained with blood or otherwise
soiled. This can happen, for example, when there is blood in the
area of the portion of the animate body being treated.
Alternatively, the second modular member can be made so that it is
a low-cost single-user disposable product. The ability to remove
the first modular member from the second modular member and clean
or replace the latter is especially advantageous when the apparatus
is used on different patients. Further, one can replace the first
or second modular member when portions thereof are beginning to
fail after a long period of use. With this construction, a faulty
heat exchanger can be easily replaced. The ability to replace one
modular member also can avoid the need to dispose of the entire
apparatus, thereby providing the ability to reduce cost over time.
The following description, which will readily make apparent many
other advantages of the invention, pertains to illustrative
examples and is not provided to limit the invention.
[0077] Referring to FIG. 1, a perspective view of one embodiment of
the invention is shown and generally designated with reference
numeral 100. Modular heat transfer therapy apparatus 100 generally
comprises first modular member 102 and second modular member 104,
which forms a cover for the first modular member and in FIG. 1 is
shown in the form of a sleeve. In other words, apparatus 100 is
adapted to be wrapped around at least a portion of a patient's body
and form a sleeve around that portion.
[0078] In FIG. 1, first modular member 102 is inside the second
modular member 104 and hidden from view. In the illustrative
embodiment, second modular member 104 comprises two compliant
bladders, outer bladder 106 (FIG. 2) and inner bladder 108 (FIG.
3), which form separate chambers such as chambers 106a and 108a for
different fluids. Compliant bladders 106 and 108 are generally
parallel to one another (see FIG. 6) and are made so as to preclude
fluid communication therebetween or between chambers 106a and 108a
during use. Bladders 106 and 108 can be formed from three sheets of
material with one forming a common inner wall for chambers 106a and
108a as will be described in more detail below.
[0079] More specifically, outer bladder 106 is adapted to receive a
first fluid such as a gas (e.g., air), which can be regulated to
provide the desired amount of inflation of the bladder or pressure
therein. This inflation or pressure affects the compressive force
applied to the animate body during use as will be further described
below. Inner bladder 108 is adapted to receive a fluid, such as a
coolant, which can be in the form of a cold liquid, to transfer
heat away from the animate body part. Alternatively, the fluid
supplied to inner bladder 108 can have a temperature higher than
ambient so as to heat the animate body part. In the example
illustrated in FIG. 1, a three port manifold 110 provides a port
for a fluid such as air to be introduced and exhausted from bladder
106 and fluid inlet and outlet ports for circulating fluid through
bladder 108. Each port is formed by a tubular member, which has one
end adapted to receive a hose connector as is known in the art and
another end adapted to be inserted into one of three tubes (not
shown) extending from the bladder (described below). Further, each
of the manifold fluid inlet and fluid outlet tubular members or
passageways can be provided with a valve such as a spring loaded
valve that is configured to allow the passage of fluid therethrough
when the fluid hose connectors are coupled to the manifold and to
prevent fluid flow therethrough when the fluid hose connectors are
uncoupled from the manifold as is known in the art. In this manner,
fluid such as a liquid coolant is blocked from exiting fluid
bladder 108 when the fluid hoses are uncoupled from the manifold.
The gas port does not include a valve. As described above, there
are three tubes extending from the bladders. One tube extends from
bladder 106 and two tubes extend from bladder 108. The tubes
extending from bladder 108 can be placed adjacent to the tube
extending from bladder 106 with the tube for bladder 106 above and
between the tubes for bladder 108. In manufacture, bladder 106 is
formed with an opening and bladder 108 is formed with two openings
to receive the tubes in the orientation described above. A tube,
such as a polyurethane tube, is positioned in each one of these
openings and then welded to a respective bladder to form a fluid
tight seal therewith. The tubes extending from the bladders
typically have an inner diameter of about 1/8-inch. The manifold
passageways typically have a diameter of about 1/4-inch. Manifold
110 can be inserted into the tubes to form a seal therewith. For
example, each manifold tubular member end portion that mates with
or is inserted into a respective tube extending from one or the
other bladder can be provided with tapered hose barbs to enhance
the seal as is well known in the art. A suitable manifold
construction is disclosed in U.S. Pat. Nos. 5,104,158 and
5,052,725, both to Meyer, et al. and both entitled Two Piece Female
Coupling. The disclosures of U.S. Pat. Nos. 5,104,158 and 5,052,725
are hereby incorporated herein for all purposes by reference. The
manifold, which carries or forms the tubular members, can be
configured to mate with the curves of the body when connected to
the modular apparatus. It also can be provided with a ridge for
finger placement to allow easier removal. A fluid circulation
control unit as diagrammatically represented in FIG. 7B and
generally designated with reference numeral 180 is coupled to
manifold 110 with tubing to fluidly communicate the therapy fluids
to bladders 106 and 108 as will be described in more detail below.
It should be understood that other manifold configurations and/or
couplings to provide fluid flow between the fluid source and the
bladders can be used as would be apparent to one of skill in the
art. For example, valves need not be provided in the liquid port
couplings.
[0080] Referring to FIG. 6, further details of one embodiment of
the heat transfer or heat exchange device will be described. The
illustrative heat transfer or heat exchange device includes
compliant bladder 108, which circulates heat exchange fluid or
liquid. This bladder is defined by a pair of generally parallel,
flexible, or in other words, compliant, and fluid- or liquid-tight,
walls or layers of material 152 and 154, which walls are sealed
together by, for example, RF welding along their perimeters.
Compliant gas pressure bladder 106 which overlays heat exchange
bladder 108 as illustrated to direct gas (most simply, air)
pressure against the heat exchange bladder 106 to press it towards
the portion of the body being treated. This compliant gas pressure
bladder 106 is also defined by a pair of generally parallel and
flexible walls or layers of material 150 and 152. In this
embodiment, wall 152 is a common wall, i.e., one side of the same
aids in defining gas pressure bladder 106 whereas the other side
aids in defining bladder 108. Thus, three compliant walls or sheets
of material are all that is necessary to define the two separate
bladders. Wall or layer 150 is also secured to walls 152 and 154
via RF welding along its perimeter.
[0081] The connections in the interior of heat exchange liquid
bladder 108 include a relatively uniform distribution of dot
connections as shown in FIG. 3A and designated with reference
character "D." This matrix of connections acts to disperse the
liquid throughout the bladder. This dispersion is further aided by
curvilinear fence connections provided for the purpose of directing
the flow of a liquid. These fence connections are indicated by the
reference numeral F in FIG. 3A. In the illustrative embodiment, the
dots are formed in a triangular grid.
[0082] During the manufacturing process, sheets of material
defining the walls 152 and 154 are RF welded together at the dot
connections and at the interior fences. At a later time, the wall
150 is RF welded to the other walls at the perimeter of the
bladder. This RF welding will also form a common border for walls
150, 152, and 154.
[0083] Referring to FIGS. 6A and 6B, the heat transfer or heat
exchange device is welded with each of the three layers having a
rotated true grain of about 10-30.degree. with respect to one
another. This grain rotation can dramatically improve resistance to
ripping of the heat exchanger. In the embodiment illustrated in
FIG. 6B, sheets 150, 152 and 154 have grain directions indicated
with arrows "A," "B" and "C," respectively. Grain direction B of
sheet 152 is offset in a counterclockwise direction from grain
direction A of sheet 150 by about 30.degree.. And grain direction C
of sheet 154 is offset in a clockwise direction from grain
direction A of sheet 152 by about 30.degree..
[0084] Each of the walls 150, 152 and 154 can be made of a nylon
material suitably coated with polyurethane to provide both the RF
welding qualities and the needed liquid or air impermeability. In
one embodiment of the invention, the heat transfer or heat exchange
device can comprise fabrics (e.g., nylon fabric) that are laminated
with asymmetric amounts of polyurethane. That is, the inner surface
of the outer wall of the coolant chamber has an extra heavy
coating, which corresponds to about a 5 oz coating of polyurethane,
while the inner surfaces of the other walls have standard coatings
corresponding to about 3 oz coatings of polyurethane. Accordingly,
the surfaces of the inner wall of the coolant and air chambers and
the inner surface of the outer wall of the air chamber have
standard 3 oz coatings. This construction only requires one
non-standard fabric (the fabric having the 5 oz coating), while
providing the extra polyurethane necessary to produce an extremely
robust weld capable of taking or withstanding over 25,000 cycles at
30 psi. This construction can reduce manufacturing costs. It also
facilitates using a lighter weight fabric, which can result in a
more flexible heat exchanger that can better fit to the body. In
another embodiment of the invention, the inner wall of the coolant
chamber has a 5 oz coating of polyurethane in order to facilitate a
yet stronger bond at the expense of increased manufacturing costs
due to the use of a second non-standard fabric. A finish on the
nylon material can also provide a permanent antimicrobial finish to
prevent mold growth.
[0085] Referring to FIGS. 2 and 3, top plan and bottom views of
second modular member 104 are shown. Modular member 104 comprises
an inner or front side portion 112 and an outer or back side
portion 114. Member 104 can be made from various materials and can
comprise inner and outer sheets of material that are sewn or fused
together. For example, the inner and outer sides can comprise two
sheets of fabric, which are sewn together to form seam 116. An
additional seam 118 is provided so that seams 116 and 118 form flap
or marginal portion 120 and the perimeter of pouch 122, which is
adapted to receive first modular member 102. Binding can be
provided around the perimeter of second modular member 104 as shown
in FIG. 6.
[0086] Outer back side portion 114 of second modular member has an
opening 124 formed therein for receiving first modular member 102
as shown in FIG. 4. A portion of back side 114, such as portion
126, can be pulled back (FIG. 2) to facilitate positioning the
remaining portion of first modular member 102 into the pouch.
Numeral 114a indicates the inner surface of back side portion 114
and is shown in the inner surface portion 126. Any suitable
fastening means can be used to close opening 124. For example,
zipper 127 can be provided along the sides of the opening.
[0087] Second modular member 104 also includes a fastener for
holding the apparatus in the desired location on the animate body.
Accordingly, when the apparatus is wrapped around a portion of or
the entire region being treated, the fastener holds the apparatus
in place during treatment. In the illustrative embodiment, a hook
and loop fastener is used. It should be understood that if the hook
and loop fastener wears out, the removable second modular member or
sleeve can be readily replaced.
[0088] Referring to FIG. 2, the loop material portion 128 of the
hook and loop fastener can be integrally formed with or placed over
essentially all of outer back side portion 114 of second modular
member 104. Alternatively, a strip of loop material can be
integrally formed with or placed over a portion or the entire
length (measured from the upper to lower edge of member 104 while
referring to FIG. 2) of outer back side portion 114 along the side
opposite flap 120. The hook material portion of the hook and loop
fastener is shown in FIG. 3 and generally designated with reference
numeral 130. Hook portion 130 can be in the form of a single strip
that extends along the height of inner front side portion 112
(measured from the upper to lower edge, of inner front side portion
112) or it can be integrally formed with front side portion 112 in
the same region. It can extend about 50% to 100% of the length of
portion 112. Alternatively, hook portion can comprise a plurality
of strips, which can be spaced along the length of portion 112.
[0089] In the illustrative embodiment, the active areas of the hook
and loop fastener are outside the seams forming pouch 122. When
compression increases, the forces may tend to resolve as shear
forces as compared to other forces that can peel the hook portion
from the loop portion.
[0090] According to one embodiment, loop portion 128 is non-stretch
material. What is meant by non-stretch material or non-stretchable
material is material that stretches less than or equal to 3% of its
length when held in tension under a load of no more than 10 pounds.
The non-stretch loop portion can improve the efficacy of
compression on the animate body when the apparatus is in place.
Loop portion 128 can be made of non-stretch material, which can be
woven or non-woven fabric. Alternatively, loop portion 128 can be
made by securing loop material or fabric to non-stretch backing
material, which can be woven or non-woven fabric. The non-stretch
backing material, for example, can be made of nylon or Tyvek.TM.
(strong yarn linear polyethylene). The non-stretch and loop
materials can be sewn, fused, or laminated together. Accordingly,
outer back side portion 114 can comprise first and second materials
where the first material is non-stretch material (e.g., non-stretch
woven or non-woven fabric), the second material is loop material
and the non-stretch material forms backing for the loop
material.
[0091] The second modular member 104 or sleeve also can have a
permanent antimicrobial finish to prevent mold growth, such as
finishes made according to military specification MIL.STD.810D. The
finish can be applied by placing the fabric in a chemical dip as is
known in the art. The second modular member or sleeve can act as a
blood barrier to prevent contamination of the heat exchanger and
reduce transmission of bacteria from patient to patient. For
example, the inner faces of the second modular member that form the
pouch and contact first modular member 102 can be nylon with a
durable water repellency (DWR) coating, which is typically a 1/2
ounce polyurethane coating.
[0092] FIG. 5A illustrates the modular portions of FIG. 4 with the
first modular member inside second modular member 104 and zipper
127 closing opening 124. In this state, the apparatus is ready to
apply to the portion of the body to be treated. Further, the pouch
that second modular member 104 forms allows first modular member
102 to float therein. In other words, beyond being confined in
pouch 122, there are no connections between first and second
modular members 120 and 104. This can provide a more evenly
distributed compression around the gas bladder, resulting in
improved therapy of the body being treated. Further, since the heat
exchange device can move within pouch 122, there is less chance
that a portion of the heat exchange device blocks coolant flow when
the apparatus is improperly applied to the portion of the body
being treated. For example, if an improper fold occurs in the heat
exchange device, the heat exchange device may self-correct its
position and relieve blockage of coolant flow.
[0093] An exemplary use of modular therapy apparatus 100 will be
made with reference to FIGS. 7A-C. This example is provided for
illustration and is not intended to limit the scope of the
invention. Referring to FIG. 7A, apparatus 100 is positioned
adjacent to a portion of a human patient's arm to be treated with
the apparatus in an open state. Apparatus 100, which is coupled to
fluid circulation and pressurizing unit 180, is then wrapped around
the patient's arm and the second modular member hook portion 130
along flap 120 fastened to a portion of the loop portion of member
104.
[0094] The control unit includes a mechanism for cooling and
circulating a liquid coolant, which includes a reservoir for
containing ice water. In a practical realization of this
embodiment, the liquid is normal tap water. This liquid was cooled
by placing ice into the ice box portion of the control unit,
resulting in temperatures ranging typically between 40.degree. F.
and 50.degree. F. In this connection, the control unit accepts
liquid that has been returned from the heat exchange bladder 108.
Before reintroducing the heat exchange liquid into bladder 108, it
can be mixed with the liquid in the reservoir or it can be directed
to bypass the reservoir. That is, the control unit is capable of
supplying liquid at other controlled temperatures by means of
mixing liquid chilled in the ice box and liquid warmed in the
bladder by means of contact with an animate body and returning the
mixed liquid to the bladder. The pressure of air furnished by the
control unit is generally about 0.25 to 1.5 psig.
[0095] It should be noted that the invention is applicable to many
other types of therapy components, and the particular liquid, its
temperature and pressure will be dependent upon the design and
purpose of such therapy components. This is also true of the air
pressure and in some instances it is cycled between two pressures
(typically between 1.5 and 0.25 psig). Similarly, the second
modular member can have various shapes to accommodate different
areas of an animate body. Typically, the area of one side of the
second modular member will range from about 1 to 6 square ft. In
the case of the knee application, this area will be about 6 square
ft. In the case of an elbow, this area will be about 1 to 1.5
square ft.
[0096] Although apparatus 100 has been described with a dual
bladder heat exchange device, a single bladder heat exchange device
can be used. In the single bladder embodiment, the bladder is
adapted circulate liquid or coolant.
[0097] FIG. 5B illustrates one variation of FIG. 5A. The embodiment
of FIG. 5B, is the same at that shown in FIG. 5A with the exception
that second modular member is modified (as indicated with reference
numeral 104') so that the portion of the second modular member
outside and to the left side of pouch 122 is larger. That portion
is indicated with reference numeral 121 and typically will have a
width of at least 1 inch a more specifically in the range of range
of 1 to 12 inches. A further seam 118' also can be provided. The
ability to enlarge the overall dimension of the second modular
member, while maintaining the configuration and dimension of pouch
122 unchanged facilitates using a single heat exchange device with
many differently sized second modular members or sleeves to treat
differently sized patients or different body portions. Accordingly,
another embodiment of the invention comprises a system for
treatment of differently sized members. The system includes a
plurality of differently sized second modular members each having a
pouch 122 of the same configuration and size and a plurality of
first modular members 102, each adapted to fit in any of the
pouches or each being of the same size and configuration. The
second modular member can be selected based on the animate body
portion being treated and combined with any one of the heat
exchange devices.
[0098] Referring to FIG. 8, another embodiment of the invention is
shown and generally designated with reference numeral 200. Modular
therapy apparatus 200 is the same as apparatus 100 with the
exception that it is larger and its configuration is slightly
modified so that it better adapted to from a sleeve around ones
upper leg and knee as shown in FIGS. 9A and 9B. Accordingly flap
220, which includes a hook portion that is hidden from view, is the
same as flap 120 with the exception that it is larger and its
configuration is slightly modified as shown in the drawings.
[0099] Referring to FIGS. 10 and 11, another embodiment of the
invention is shown and generally designated with reference numeral
300. As will be described in more detail below, apparatus 300 can
be used, for example, to treat the core or torso of a human body.
FIG. 10 illustrates bottom plan views of the modular portions of
apparatus 300 and FIG. 11 illustrates top plan views of the modular
portions of FIG. 10.
[0100] Apparatus 300 comprises first modular member 302 and second
modular member 304. First modular member 302 includes gas bladder
306 and fluid or coolant bladder 308. Bladders 306 and 308 form
chambers 306a and 308a, respectively. Except for the configuration
of first modular member 302, first modular member 302 is the same
as first modular member 102 and can be made in the same manner,
with the exception that a plurality of connections between the
walls defining the modular member or air bladder 302 can be
provided.
[0101] More specifically, and with reference to FIG. 12, which a
sectional view of apparatus 300, a plurality of connections between
the walls defining modular member or air bladder 302 can be
provided as described in U.S. Pat. No. 6,695,872 to Elkins, the
disclosure of which is hereby incorporated herein for all purposes
by reference. Such connections can minimize or eliminate
undesirable ballooning when the bladder is pressurized. In the
illustrative embodiment, in which the bladders are formed by RF
welding (see e.g., FIG. 12), this is simply achieved by forming
some of the connections normally provided in liquid bladder 308,
while sheet 350 is in place as will be described in more detail
below. The result is that these connections are also formed in air
bladder 306, that is, these connections are both within the liquid
bladder and in the air bladder. It appears functionally as if the
desired connections provided in the liquid bladder are
"telegraphed" also to appear in the air bladder. These connections
in the two bladders, of course, register with one another.
[0102] In the illustrative embodiment, the shape of gas pressure
bladder 306 conforms to the shape of the heat exchange bladder 308.
Fences or dividers in the heat exchange bladder to direct fluid
flow can be also provided in the gas pressure bladder. These
control fences are indicated by the reference numeral C in FIG. 12.
They can be provided in bladder 306 not only for the purpose of
directing the flow of a liquid or gas, but also to secure the walls
defining the gas pressure bladder together at various locations
within the interior of such bladder. These connections provided by
the fences C can prevent the gas bladder from "ballooning" out as
described above and causing the temperature control liquid bladder
not to conform to the body part. These fences register with the
comparable fences in the liquid bladder.
[0103] During the manufacturing process, sheets of material
defining the walls 352 and 354 are RF welded together at the dot
connections and if desired, at the interior fences. At a later time
the wall 350 is RF welded to the other walls at the perimeter of
the bladder with any interior fences being formed as needed. Such
fences C will thereby be formed in both bladders providing the
desired liquid flow directors in the liquid bladder and the
connections in the air bladder. This RF welding will also form a
common border for walls 350, 352, and 354.
[0104] The inner fences construction also can be provided in the
gas bladder of the embodiment of FIGS. 20-24, which is described in
detail below.
[0105] Second modular member 304 is the same as second modular
member 104 with the exception that second modular member is
differently configured and includes central portion 304a, and
straps or strap portions 304b and 304c. Strap portions 304b and
304c are secured to central portion 304a as will be described in
more detail below. Second modular member central portion 304a
comprises an inner or front side portion 312 and an outer or back
side portion 314. Central portion 304a can be made from various
materials and can comprise inner and outer sheets of material that
are sewn or fused together as previously described in connection
with member 104 and can include seam 316 which defines the
perimeter of pouch 322. Pouch 322 is adapted to receive first
modular member 302. Strap portions 304b and 304c can comprise one
or more layers of material. When more than one layer is used, the
layers can be sewn or fused together as would be apparent to one
skilled in the art.
[0106] Outer back side portion 314 of central portion 304a has an
opening 324 formed therein for receiving first modular member 302
as shown in FIG. 13A. Any suitable fastening means can be used to
close opening 124. For example, zipper 327 can be provided along
the sides of the opening (FIGS. 13B & C).
[0107] Second modular member 304 also includes a fastener for
holding the apparatus in the desired location on the animate body.
Accordingly, when the apparatus is wrapped around a portion of or
the entire region being treated, the fastener holds the apparatus
in place during treatment. As in the embodiments described above, a
hook and loop fastener is be used in this illustrative
embodiment.
[0108] Referring to FIG. 11, the loop material portion 328 of the
hook and loop fastener can be integrally formed with or placed over
essentially all of outer back side portion 314 of second modular
member 304. Therefore, the loop material portion can cover the
outer back side surface of center portion 304a, and strap portions
304b and 304c (FIG. 11). Alternatively, a strip of loop material
can be integrally formed with or placed over a portion or the
entire length (measured from the upper to lower edge of member 304)
adjacent the outer end of portion 304c and along interface with
center portion 304a. According to one embodiment, loop portion 328
is non-stretch material and can be made in the same manner as loop
portion 128 as described above.
[0109] The hook material portion of the hook and loop fastener that
fastens the apparatus to the animate body is shown in FIG. 10 and
generally designated with reference numeral 330. Hook portion 330
is positioned on the front side portion 312 of strap 304b and can
be in the form of a single strip that extends along the outer end
portion of strap 304b or it can be integrally formed with the front
side portion of 304b. It can extend about 50% to 100% of the length
of strap 304b. Alternatively, hook portion can comprise a plurality
of strips, which can be spaced from one another. Hook material
portions 330 also are provided along the inner end portions of
straps 304b and 304c. These portions are shown in dashed line in
FIG. 10.
[0110] In the illustrative embodiment, the active areas of the hook
and loop fastener on the outer end portions straps 304b and 304c
are outside the seam forming pouch 122. When compression increases,
the forces may tend to resolve as shear forces as compared to other
forces that can peel the hook portion from the loop portion. The
hook and loop fastener that operates between the inner end portions
of strap portions 304b and 304c and center portion 304a facilitate
removal of the strap portions. This, in turn, facilitates
replacement of either or both straps or repositioning of the
straps. For example, the straps can be portioned as shown in FIG.
13B, which may be preferred when treating the upper torso of a
patient. Alternatively, the straps can be removed and repositioned
as shown in FIG. 13C, which may be preferred when treating the
lower portion of the patient's torso.
[0111] FIGS. 14A-D diagrammatically depict use of the apparatus 300
where FIG. 14A show a first step in wrapping the apparatus around
the waist or lower portion of the torso of a patient, FIG. 14B
shows securing the apparatus in place, and FIG. 14C shows the
apparatus being in its final position and ready for use. FIG. 14D
shows the apparatus with the straps repositioned and the apparatus
being wrapped around the upper torso of the patient.
[0112] Referring to FIG. 15, another embodiment of the invention is
shown and generally designated with reference numeral 400. Modular
therapy apparatus 400 can be used, for example, to treat an ankle
and/or foot of a patient. FIG. 16 illustrates top plan views of
modular portions of apparatus 400 and FIG. 17 illustrates bottom
views of the modular portions of apparatus 400.
[0113] Apparatus 400 comprises first modular member 402 and second
modular member 404. First modular member 402 includes gas bladder
406 and fluid or coolant bladder 408. Bladders 406 and 408 form
chambers 406a and 408a, respectively. Except for the configuration
of first modular member 402, first modular member 402 is the same
as first modular member 102 and can be made in the same manner.
[0114] Second modular member 404 is the same as second modular
member 104 with the exception that second modular member is
differently configured, has differently positioned hook portions
and has heel alignment marker 405. Accordingly, member 404 can be
made from various materials and can comprise inner and outer sheets
of material that are sewn or fused together as previously described
in connection with member 104 and can include seam 416, which in
combination with seams 418, defines the perimeter of pouch 422.
Pouch 422 is adapted to receive first modular member 402.
[0115] Outer back side portion 414 has an opening 424 formed
therein for receiving first modular member 402 as shown in FIG. 16.
Zipper 427 can be provided along the sides of the opening (FIG.
18C).
[0116] Second modular member 404 also includes a fastener for
holding the apparatus in the desired location on the animate body
and can include the hook and loop fastener system described in
connection with apparatus 100. Referring to FIG. 11, the loop
material portion 428 of the hook and loop fastener can be
integrally formed with or placed over essentially all of outer back
side portion 414 of second modular member 404. Alternatively, a
strip of loop material can be integrally formed with or placed over
a portion of back side portion 414 that would cooperate with the
hook portions in accordance with FIGS. 17 and 19A-C. According to
one embodiment, loop portion 428 is non-stretch material and can be
made in the same manner as loop portion 128 as described above.
[0117] The hook material portion of the hook and loop fastener that
fastens the apparatus to the animate body is shown in FIG. 17 and
generally designated with reference numeral 430. Hook portions 430
can have a width of about 4 inches. In the illustrative embodiment,
the active areas of the hook and loop fastener are outside the
seams forming pouch 422, which can provide similar advantages to
those described above regarding force resolution when the apparatus
is under compression.
[0118] FIGS. 18A-C illustrate inserting the modular member 402 into
modular member 404. where FIG. 18A illustrates a first stage of
inserting modular member 402 into modular member 404. FIG. 18B
illustrates another stage portion into the other and FIG. 18C
illustrates member 402 fully inserted and zipper 327 closed.
[0119] FIGS. 19A-D illustrate use of the embodiment of FIG. 10.
First one places one's foot on inner side portion 412 with one's
heel aligned along U-shaped marker 405. Flap V is wrapped over the
foot and flap W secured thereto with hook portion 430 FIGS. 19A
& B). Flap X is wrapped around the ankle and leg and then flap
Y is wrapped thereover and secured thereto with hook portion 430
(FIG. 19C). Flap Z is then wrapped around the leg and over flap Y
and secured thereto with hook portion 430 (FIG. 19D).
[0120] Referring to FIG. 20, another embodiment of the invention is
shown and generally designated with reference numeral 500.
Apparatus 500 can be used to treat the shoulder of a patient. FIG.
21 illustrates top views of the modular members of the apparatus
500 and FIG. 22 illustrates bottom views of the modular members
shown in FIG. 21.
[0121] Apparatus 500 comprises first modular member 502 and second
modular member 504. First modular member 502 includes gas bladder
506 and fluid or coolant bladder 508. Bladders 506 and 508 form
chambers 506a and 508a, respectively.
[0122] First modular member 502 is the same as first modular member
102 except for the configuration of modular member 502, including
flap portions 562, and that it can include the inner fence
construction described above in connection with the embodiment of
FIGS. 10-14. Modular member 502 also differs from modular member
102 in that it includes a coupling mechanism for coupling these
flap portions. More specifically, flap portions 562 are coupled to
one another through elastic cord 560, which is laced through holes
formed in first modular member 502. The elastic cord substantially
maintains flaps 562 in the closed position shown in FIG. 21 when
bladder 506 is inflated and fluid circulated through bladder
508.
[0123] Second modular member 504 is the same as second modular
member 104 with the exception that second modular member is
differently configured and includes central portion 504a, and
straps or strap portions 504b, 504c, and 504d. Strap portions 504b,
c & d are secured to central portion 504a as will be described
in more detail below. Second modular member central portion 504a
comprises an inner or front side portion 512 and an outer or back
side portion 514. The arm sling 540 can be coupled to second
modular member 504 through a plurality of snap connectors "S" or
any other suitable connector including but not limited to hook and
loop fasteners. Central portion 504a can be made from various
materials and can comprise inner and outer sheets of material that
are sewn or fused together as previously described in connection
with member 104 and can include seam 516, which in combination seam
518, define the perimeter of pouch 522. Pouch 522 is adapted to
receive first modular member 502. Strap portions 504b, c, and d can
comprise one or more layers of material. When more than one layer
is used, the layers can be sewn or fused together as would be
apparent to one skilled in the art.
[0124] Outer back side portion 514 has an opening 524 formed
therein for receiving first modular member 502 as shown in FIG. 16.
Zipper 527 can be provided along the sides of the opening (FIG.
18C).
[0125] Second modular member 504 also includes a fastener for
holding the apparatus in the desired location on the animate body
and can include the hook and loop fastener system described in
connection with apparatus 100. Referring to FIG. 21, the loop
material portion 528 of the hook and loop fastener can be
integrally formed with or placed over essentially all of outer back
side portion 514 of second modular member 504. Alternatively, a
strip of loop material can be integrally formed with or placed over
a portion of back side portion 514 that would cooperate with the
hook portions described below. According to one embodiment, loop
portion 528 is non-stretch material and can be made in the same
manner as loop portion 128 as described above.
[0126] The hook material portion of the hook and loop fastener that
fastens the apparatus to the animate body and generally designated
with reference numeral 530. The hook portion of strap portion 504b
can comprise two sections, each having a length extending along the
length of the strap of about 4 or 5 inches. These sections can be
spaced apart by about 1 inch to facilitate or improve flexibility
of the end portion of the strap. In this manner, the strap can be
readily folded to provide length adjustment for differently sized
users. In the illustrative embodiment, the active areas of the hook
portion of the hook and loop fastener are outside the seams forming
pouch 522, which can provide similar advantages to those described
above regarding force resolution when the apparatus is under
compression.
[0127] FIGS. 23A-D illustrate coupling the modular members 502 and
504 where FIG. 23A illustrates aligning modular member 502 with
opening 524 in second modular member outer back side portion 514.
FIGS. 23B and C show insertion of modular member 502 into modular
member 504 and FIG. 24D shows back side portion 514 closed and
zipped up.
[0128] FIGS. 24A-D diagrammatically illustrate use of apparatus 500
where FIG. 24A shows a first stage in pulling the apparatus over
the patient's arm and toward the patient's shoulder. FIG. 24B
illustrates positioning the apparatus over the shoulder of the
patient and securing hook portions of straps 504c and 504d to
portions of central portion 504a which are constructed with loop
material to secure apparatus 500 to the patient's arm. Strap 504b
is then pulled under the patient's other shoulder and a portion of
its hook portion is ready to be fastened to the loop material of
central portion 504a (FIG. 24C). In FIG. 24C, the end portion of
strap 504b is folded back along the space between hook portions 530
and secured in that position by tucking into a pocket designed to
accept it. This facilitates shortening the strap for smaller
patients. The end portion of strap 504b can be unfolded to extend
the length of the strap for larger patients as shown in FIG. 24D.
FIG. 24D also shows optional strap 640, which can be used to hold
up the lower arm of the patient. Strap 540 can have a hook portion
on one end and snaps at the opposite end so that the hook portion
can be fastened to loop material the outer side portion 514 or
second modular member 504 and the snaps can be fastened to the
snaps on modular portion 504.
[0129] Referring to FIG. 25, a further embodiment of the invention
is shown and generally designated with reference numeral 600.
Apparatus 600 is especially suited for equine applications. In FIG.
25, apparatus 600 is shown wrapped around at horse's leg. The
therapy fluids are delivered though the hose 601, which has one end
coupled to apparatus 600 through manifold 110 and its other end
coupled to a therapy fluid circulation control unit such as control
unit 160. Accordingly, conduit 601 can have three channels for
fluid flow (e.g., two for liquid or gas coolant and one for gas).
When a single apparatus is used, conduit 601 is directly fluidly
coupled to a fluid circulation control unit. However, when it is
desired to treat two legs, a Y-connector can be provided as shown
in FIG. 25. One such Y-connector is diagrammatically shown and
indicated with reference numeral 603. In this case, another conduit
such as conduit 605 fluidly couples the Y-connector 603 with the
circulation control unit (not shown). The Y-connector facilitates
fluidly coupling each conduit 601, which is fluidly coupled to a
respective apparatus 600 through a manifold 110, to the circulation
control unit so that a plurality of legs (i.e., 2) can be treated
at the same time.
[0130] FIG. 26 illustrates bottom plan views of modular portions of
apparatus 600 and FIG. 17 illustrates top views of the modular
portions of apparatus 600. Apparatus 600 comprises first modular
member 602 and second modular member 604. First modular member 602
includes gas bladder 606 and fluid or coolant bladder 608. Bladders
606 and 608 form chambers 606a and 608a, respectively. Except for
the configuration of first modular member 602, first modular member
602 is the same as first modular member 102 and can be made in the
same manner.
[0131] Second modular member 604 is the same as second modular
member 104 with the exception that second modular member is
differently configured including differently configured hook
portions 630. Accordingly, member 604 can be made from various
materials and can comprise inner and outer sheets of material that
are sewn or fused together as previously described in connection
with member 104 and can include seam 616, which defines the
perimeter of pouch 622. Pouch 622 is adapted to receive first
modular member 602. Inner side portion 612 is placed against the
portion of the body being treated and outer back side portion 614
has an opening formed therein for receiving first modular member
602. The opening is shown closed with zipper 627 in FIG. 27.
[0132] Second modular member 604 also includes a fastener for
holding the apparatus in the desired location on the animate body
and can include the hook and loop fastener system described in
connection with apparatus 100. Referring to FIG. 27, the loop
material portion 628 of the hook and loop fastener can be
integrally formed with or placed over essentially all of outer back
side portion 614 of second modular member 604. Alternatively, it
can be integrally formed with or placed over the right portion of
zipper 627 or the side of zipper 627 opposite flaps 620. According
to one embodiment, loop portion 628 is non-stretch material and can
be made in the same manner as loop portion 128 as described
above.
[0133] The hook material portion(s) of the hook and loop fastener
that fastens the apparatus to the animate body is shown in FIG. 26
and generally designated with reference numeral 630. Hook portions
are integrally formed with or secured to flaps 620, which extend
outward form seam 618. Hook portions 630 are can have a width of
about 3 inches and a length of about 12 to 30 inches.
[0134] Regarding manufacture, it can be specialized to make the
first modular member, second modular member and any desired
configuration thereof. Further, a plurality of any of apparatus
200, 300, 400, 500, and 600 can be provided with differently sized
second modular members, but with same sized pouches and same sized
first modular members to facilitate component interchangeability in
a manner similar to that described in connection with FIG. 5B.
[0135] Variations and modifications of the devices and methods
disclosed herein will be readily apparent to persons skilled in the
art. As such, it should be understood that the foregoing detailed
description and the accompanying illustrations, are made for
purposes of clarity and understanding, and are not intended to
limit the scope of the invention, which is defined by the claims
appended hereto. Any feature described in any one embodiment
described herein can be combined with any other feature of any of
the other embodiment whether preferred or not.
III) Variable Insulation
[0136] In the case of cold wraps, a problem arises when the
temperature in the wrap rises above a therapeutic range. The
effectiveness of the wrap decreases when the average temperature or
the temperature near the outlet is too high. This can be
counterbalanced by increasing the flow rate and/or lowering the
inlet temperature. The lower the flow rate, the slower the fluid
velocity and the more the return fluid temperature will differ from
the inlet temperature. In this condition, the temperature of the
return flow is warmer. Another method to achieve a desired
temperature in the wrap and at the outlet is to use relatively slow
flow rates. Low flow rates, however, cause higher temperature
deltas between the inlet and outlet of the wrap, which provides for
uneven cooling. By contrast, lowering the temperature may lead to
patient discomfort and injury. Exceptionally low temperatures may
also require specialized equipment for greater cooling. Similar
problems may arise with hot therapy wraps. Although it is easier to
raise the reservoir temperature, excessively hot inlet temperatures
lead to patient discomfort and potential for severe burns.
[0137] A therapy wrap in accordance with various aspects of the
invention includes a variable insulating layer. "Variable
insulating" generally refers to providing an insulating element in
targeted locations and/or providing a variable thermal resistivity
along the wrap.
[0138] The insulating layer may improve the performance of the wrap
by, among other things, compensating for the temperature delta and
protecting the body part in selected areas. The insulating layer
may also serve to reduce the temperature delta by insulating a
portion of the flowpath from heat loss.
[0139] Turning to FIGS. 28 and 28A, the illustrated apparatus is a
therapy wrap, generally designated 800a, for providing
temperature-controlled therapy to an anatomical body part. Various
aspects of wrap 800a are similar to the apparatus described above.
In various embodiments, the body is a mammalian body, and
preferably a human body. In the case of a human body, the wrap may
be used on a knee, an elbow, a shoulder, a leg, and arm, and
more.
[0140] Wrap 800a includes a fluid bladder 808 and one or more
thermal insulating members 880. The fluid bladder includes an inlet
860 and outlet 862. A heat exchanging fluid from a reservoir is
introduced to the bladder through the inlet, typically using a
pump. Exemplary outlet 862 is connected to the reservoir so fluid
is returned and recirculated. The insulating members are attached
to one side of the fluid bladder.
[0141] Fluid bladder 808 is configured and constructed similar to
fluid bladder 108 described above and shown in FIGS. 3, 6, and 12,
and includes one or more fluidic channels 865 connecting the inlet
and the outlet. As described above and shown, for example, in FIGS.
3 and 3A, the fluid flowpath may be defined by a number of walls,
fences, and the like.
[0142] FIG. 28 illustrates the overlay of insulating members 880
and fluid bladder 808. The exemplary wrap includes two regions with
insulating members 880. A first region is in the inlet area (colder
fluid) adjacent inlet 860 and includes heavier insulation. A second
region is positioned near the outlet area (warmer fluid) near the
warmer return fluid channel leading to outlet 862 and does not
include any insulation. Elsewhere, the wrap includes medium
insulation--less than the first region. In the exemplary case, the
insulating member in the first region (inlet) is thicker, thereby
reducing the heat transfer rate in that region.
[0143] As shown in FIG. 28, when the insulating members are affixed
to the bladder, the insulating members are positioned along fluidic
channel 865, and consequently the fluid flowpath. In the exemplary
embodiment, the insulating members are generally positioned in
regions lying within the respective fluidic channels. In various
embodiments, the insulating members are separated from each other.
In various embodiments, two or more insulating members are
contiguous but separate elements.
[0144] "Fluidic channel" is to be understood as generally used in
the art. In various respects, "fluidic channel" refers to the fluid
pathway defined by the walls, fences, weld lines, dots, and the
like. Referring to FIG. 28A, the channel width is generally
designated "W". "Fluidic channel" may refer to the entire pathway
from wall-to-wall or a space in between in a width direction. For
example, the channel width may extend from a wall to a region
between the walls, designated W', or entirely within a space
between the walls, designated W''.
[0145] In various embodiments, each of the insulating members are
dimensioned to correspond to a respective one or more fluidic
channels. In various embodiments, the insulating members are
positioned in a pattern corresponding to a flowpath defined by one
or more fluidic channels. For example, the illustrated wrap
includes a serpentine shaped flowpath and the insulating members
have a corresponding pattern. The exemplary insulating members are
positioned entirely within the width of the fluidic channel. One
will appreciate from the description herein, however, that the
insulating members may have varying dimensions and be positioned in
varying locations along the fluid channels. As will be described in
more detail below, the wrap may also include one or more insulating
members positioned independently of the fluidic channels.
[0146] FIG. 29 illustrates another wrap 800b having a single
insulating member 880b positioned directly adjacent inlet 860 and
extending along a fluidic channel 865 from the inlet. The exemplary
insulating member is contiguous with the inlet along one edge and
extends into the fluidic channel at an opposite end.
[0147] In operation and use, the wrap including the insulating
members is used in a similar manner to the wrap and therapy systems
described above. A user applies the wrap similar to the
non-variable insulating wrap shown, for example, at least in FIGS.
7C, 9B, 14D, 15, 24D, and 25. The wrap is connected to a reservoir,
pump, and other system components. The user turns on the system to
flow fluid to the wrap for therapy. In the exemplary embodiment,
the fluid is returned to the reservoir from the wrap outlet and
recirculated. Unlike conventional wraps, the variable insulating
wrap allows for greater flexibility and improved performance.
[0148] In the case of cold wraps, the lowest temperature of the
fluid is generally at the inlet where the fluid from the reservoir
first enters the bladder. The fluid starts to warm as it exchanges
(receives) heat from the body part. Although the insulating member
extends downstream from the inlet, a key feature of the exemplary
insulating member is the fact that the insulating member starts at
the inlet where the fluid is coldest. Accordingly, the insulating
member provides an insulating effect in the region where the fluid
is coldest. This provides several benefits. For one, the body part
is thermally shielded from the fluid in the region of the lowest
temperature. This reduces the likelihood of frost bite or cold
burn. Second, the insulating member generally increases patient
comfort. Although the temperature delta in the wrap may be large,
the heat exchange in the inlet region is generally reduced,
essentially equilibrating or normalizing the heat transfer. In
turn, the "feel" of the wrap is more comfortable in the inlet
region. Alternatively, the inlet temperature may be decreased while
maintaining the same "feel" in the inlet region for the user. In
various aspects, the variable insulating layer compensates for the
temperature delta such that the surface temperature is consistent
or at least "feels" consistent to the user.
[0149] Insulating member 880 may be modified and varied using
conventional techniques as would be understood from the description
herein. FIGS. 30 and 31 illustrate cross-sections of exemplary
insulating members 880 and generally correspond to the wrap of FIG.
29. The exemplary wrap 800a includes fluid bladder 808, one or more
insulating members 880, and an expandable air bladder 806 for
applying a compressive force. The wrap is shown in the treatment
position adjacent a body part 801.
[0150] As shown in FIG. 30, the insulating effect of the insulating
member is modified by adjusting the thickness of the respective
members. In a first region, a first insulating member 880b' has a
maximum thickness t.sub.1 and tapers to a thickness t.sub.2. In a
second region, a second insulating member 880b'' has substantially
uniform thickness. The thickness in the second region is
essentially the same as the minimum thickness of the first region,
namely, t.sub.2. Moving to a third region, the bladder has little
or no insulating member. All things otherwise being the same, the
overall coefficient of heat transfer is reduced moving from the
first region to the third region. In other words, the rate of heat
transfer in the first region will be slower than the rate of heat
transfer in the second region. One will also appreciate that the
insulating members may be modified in other ways such as by
stacking layers of material to increase the thickness.
[0151] Suitable materials for the insulating member include, but
are not limited to, a foam, a plastic, a fibrous material, and
other insulating materials known in the art. For example, the
insulating member may be composed of a fabric, spray-on rubber
(e.g., poly(urethane)), glass fibers, and more. The insulating
member may also include structures and configurations for
controlled insulating effect. For example, in place of an
insulating member of a solid material, a housing may be provided
that encloses a defined volume of gas (e.g. air) of a known thermal
resistance. In another example, the insulating member may comprise
a bladder filled with a thermo-resistive gel with a predetermined
thermal resistance value.
[0152] In various embodiments, the insulating member is configured
and selected to compensate for a temperature delta in the wrap
and/or fluid temperature in the respective portion of the fluid
channel. In various embodiments, the insulating member is
configured or selected to have a predetermined overall coefficient
of heat transfer. By corollary, the insulating member may be
selected based on the material properties including, but not
limited to, thermal resistance (R-value). Generally, the material
properties, dimensions, and configuration are adjusted to provide
the desired insulating of the wrap at the desired location and/or a
variable amount of insulating.
[0153] FIG. 31 illustrates an exemplary wrap including a single
structure 880' in lieu of multiple insulating members 880. The
structure 880' is composed of different materials having different
coefficients of heat transfer. In contrast to the multiple discrete
insulating members of FIG. 30, the structure of FIG. 31 thus
includes a monolithic element that mimics the multiple insulating
members with zones of varying thermal resistivity. In this way, the
structure provides different overall heat transfer rates in
different locations in spite of the generally uniform thickness and
structure. In the alternative to the single structure, the wrap may
include two or more separate but adjacent insulating members of
equal thickness but different coefficients of heat transfer to
achieve the desired variable insulating effect.
[0154] Referring to FIGS. 32-35, the shapes and positions of the
insulating members may be modified depending on the application. By
comparison to FIG. 29, FIG. 32 illustrates a wrap with an
insulating member 880 extending further in the axial direction away
from the inlet. In use, the patient would generally be subjected to
a lower maximum cold temperature.
[0155] The wraps of FIGS. 33-35 include the insulating member of
FIG. 32 and additional insulating members 880' and 880''. In FIG.
33, an insulating member 880'' is provided at an edge of the wrap
opposite inlet 860 and outlet 862. In FIG. 34, a third insulating
member 880''' is provided adjacent the outlet. The wrap of FIG. 35
includes insulating members 880, 880', and 880''. Insulating member
880'' extends along a fluidic channel between the inlet and outlet
and has a diamond-shape. In the exemplary wrap, 880'' provides
thermal insulation in an area where therapy is not desirable either
for medical or patient-controlled reasons. For example, the
location of member 880'' may correspond to a bone area on the body
part or an area where there is no tissue to be treated. In another
example, the patient may have a "tender" area or some other reason
for desiring greater thermal insulation in a particular spot.
Although the insulating members are generally shown as being
polygonal, one will appreciate that other shapes may be
utilized.
[0156] The method of making and assembling the variable insulating
wrap above will now be described. The wrap may be manufactured
using the techniques described above and known in the art in
accordance with the description herein.
[0157] FIG. 36 illustrates a cross-section of a wrap 800c similar
to wrap 800b of FIG. 29. Although the exemplary wrap includes an
inlet, outlet, and additional port on a top side, one will
appreciate that the location and configuration of the ports can be
modified. For example, the ports can be provided at one end of the
sleeve in a vertical arrangement corresponding to the arrangement
of the fluid bladder and compression bladder.
[0158] The wrap includes a bladder 808c and compression bladder
806c. Bladder 808c and compression bladder 806c are fitted within a
sleeve body 872. The sleeve includes a connector 867 for quick and
easy connection of fluid inlet 860c, fluid outlet 862c, and a port
870 to compression bladder 806c. The sleeve is similar in many
respects to temperature therapy pads described above. The
illustrated sleeve is composed of nylon on one side and a loop
material (e.g. pile) on an opposite side.
[0159] In a region directly adjacent the inlet/outlet, an
insulating layer 880c' is positioned on the bladder. In a thickness
direction, the insulating layer is sandwiched between the fluid
bladder 808c and an inner surface of sleeve body 872. On an
opposite side, the compression bladder is sandwiched between the
fluid bladder and the sleeve body.
[0160] In part for ease of assembly, the exemplary insulating layer
includes a substrate 874c supporting an insulating member 880c. The
substrate and insulating member may be joined together permanently,
removable, or otherwise separate. In various embodiments, the
substrate dimensions correspond to the bladder periphery. In the
exemplary wrap of FIG. 36, the substrate is dimensioned to be
applied over the bladder whereby the insulation member aligns with
the desired fluidic channels. The substrate and bladder fit snugly
within the sleeve 872. The illustrated wrap is thus assembled by
inserting insulating layer 880c' into the sleeve 872 adjacent the
bladder 808c.
[0161] In the exemplary embodiment, the insulating member is bonded
to the bladder with an adhesive. As will be described below,
however, the insulation member may be attached to the bladder in
other manner. In some cases, the insulation is not attached to the
bladder at all. For example, the sleeve may be elastomeric with an
abrasive inner surface such that the insulation member is held in a
desired location with respect to the bladder without bonding and
the like.
[0162] In various embodiments, the one or more insulating members
are integrally formed in insulating layer 880c'. In various
embodiments, the insulating layer is monolithically formed in
essentially one step. By example, the insulating layer may be
formed by blow molding whereby the insulating members are formed
essentially simultaneously. The insulating members may also be
separately formed and thereafter joined to the substrate.
Similarly, the insulating layer and/or insulating member may be
formed concurrently with the bladder. Other manufacturing
techniques include, but are not limited to, spraying, molding, silk
screening, and adhesives. One will appreciate that manufacturing
techniques common in the polymer and semiconductor fields may also
be used such as etching, deposition, and lithography. Further
details regarding the components and manufacturing techniques that
may be used are disclosed in U.S. Pat. No. 7,198,093 to Elkins, the
entire contents of which are incorporated herein for all
purposes.
[0163] FIGS. 37A, 37B, and 38 illustrate another wrap configuration
whereby an insulating sleeve 872d is configured to receive a
bladder 808d in a pocket 820. Pocket 820 is similar in some
respects to pouch 122 and the openings described above and shown in
FIGS. 1-4. In contrast to sleeve 872, sleeve 872d includes
integrated insulating members 880d.
[0164] The wrap 800d is assembled by inserting the bladder into the
sleeve 872d. The sleeve, sleeve pocket, and bladder have
corresponding shapes and dimensions such that the bladder is
automatically aligned in the sleeve when inserted into the
pocket.
[0165] As shown in FIG. 38, the wrap 800e may include another
insulating member 880e positioned in a desired location on the
wrap. In the exemplary case, the wrap is customized based on a
user's preferences. The location of the insulating member 880e does
not necessarily correspond to a fluidic channel location 865e
(shown in FIG. 37B). Rather, the location of insulating member 880e
corresponds to a location where a user does not want therapy.
[0166] To assemble the wrap, one simply inserts a bladder 808e
having a desired variable insulating member pattern into the
insulating sleeve. In this manner, a user may customize the wrap
for his or her own comfort and needs. The insulating members may be
formed and attached to the sleeve using techniques similar to those
described above and shown at least in FIGS. 4, 10, 13A, 16, and
23B.
[0167] The above described embodiment may also provide
manufacturing and economic efficiencies. For example, a number of
the components may be standardized and supplied off-the-shelf or
sold as kits. In various embodiments, the wrap is assembled by
providing a plurality of insulating sleeves, each with a pouch
adapted to receive a bladder, selecting one of the insulating
sleeves, and inserting the bladder into the sleeve. The plurality
of sleeves may be dimensioned the same but include different
insulating member patterns. Thus, a user may select a desired
sleeve based on the variable insulating member pattern and then
assemble the wrap by inserting a standard bladder. The user may
further customize the wrap by inserting, removing, and/or modifying
insulating members. Conversely, the bladder may be configured to
receive a selected one of a set of insulating layers having one or
more insulating members.
[0168] Additionally, one will appreciate from the description
herein that the above described insulating members may be used with
a variety of other temperature-controlled therapy devices. For
example, FIG. 39 illustrates another wrap foamed by applying an
insulating layer 880f' having a number of insulating members 880f
to a fluid pad 810. The fluid pad is a conventional pad similar in
various respects to the pad described in U.S. Pat. No. 6,117,164 to
Gildersleeve et al., the entire contents of which is incorporated
herein for all purposes by this reference.
[0169] In contrast to the wrap 800 above which includes a
compressive bladder, pad 810 is designed to carry a heat exchanging
fluid only. The pad does not include a compression device for
applying a compressive force. Instead, the device is coupled to the
body part with a hook and loop fastener.
[0170] The exemplary fluid pad is a designed to fit over a knee or
shoulder. The pad includes a fluidic channel 865f for promoting a
desired flow even during joint flexure. In various embodiments, the
fluid channel and pad are dimensioned and configured to provide
kink resistance during flexure.
[0171] In the exemplary embodiment of FIG. 39, pad 810 includes a
central portion intended to be positioned over a joint. As the bone
in the joint may not need therapy or may be uncomfortable if
subjected to cooling, the exemplary wrap includes two insulating
members in the central region. Thus, the cooling is isolated to the
tissue around the joint bone.
[0172] As will be clear from the above example, the insulating
layer may be a separately-formed, independent member for use with a
variety of temperature-controlled therapy systems in accordance
with the invention.
[0173] For convenience in explanation and accurate definition in
the appended claims, the terms "up" or "upper", "down" or "lower",
"inside" and "outside" are used to describe features of the present
invention with reference to the positions of such features as
displayed in the figures.
[0174] In many respects the modifications of the various figures
resemble those of preceding modifications and the same reference
numerals followed by apostrophes or subscripts "a", "b", "c", and
"d" designate corresponding parts.
[0175] The foregoing descriptions of specific embodiments of the
present invention have been presented for purposes of illustration
and description. They are not intended to be exhaustive or to limit
the invention to the precise forms disclosed, and obviously many
modifications and variations are possible in light of the above
teaching. The embodiments were chosen and described in order to
best explain the principles of the invention and its practical
application, to thereby enable others skilled in the art to best
utilize the invention and various embodiments with various
modifications as are suited to the particular use contemplated. It
is intended that the scope of the invention be defined by the
Claims appended hereto and their equivalents.
* * * * *