U.S. patent application number 16/940133 was filed with the patent office on 2020-12-31 for cardiac implantable electronic device pocket compression apparatus and method of mitigating localized bleeding using same.
The applicant listed for this patent is Dhanunjaya Lakkireddy, Srijoy Mahapatra. Invention is credited to Dhanunjaya Lakkireddy, Srijoy Mahapatra.
Application Number | 20200405321 16/940133 |
Document ID | / |
Family ID | 1000005079996 |
Filed Date | 2020-12-31 |
United States Patent
Application |
20200405321 |
Kind Code |
A1 |
Lakkireddy; Dhanunjaya ; et
al. |
December 31, 2020 |
CARDIAC IMPLANTABLE ELECTRONIC DEVICE POCKET COMPRESSION APPARATUS
AND METHOD OF MITIGATING LOCALIZED BLEEDING USING SAME
Abstract
A method mitigates pocket bleeding and hematoma formation in a
patient by providing a pliable wrap having a solid block coupled
with the wrap, and then securing the pliable wrap around the torso
of the patient to align the solid block with the located localized
torso area. The solid block at least in part covers the localized
torso area. The wrap is secured to cause the wrap to apply a force,
to the solid block, that produces a corresponding pressure on the
localized torso area. The force applied to the solid block is high
enough to cause the pressure to hinder blood flow to the localized
torso area to promote clotting at the localized torso area. At the
same time, the force applied to the solid block is low enough to
cause the pressure to permit blood flow to the localized torso area
to promote healing.
Inventors: |
Lakkireddy; Dhanunjaya;
(Leawood, KS) ; Mahapatra; Srijoy; (Edina,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Lakkireddy; Dhanunjaya
Mahapatra; Srijoy |
Leawood
Edina |
KS
MN |
US
US |
|
|
Family ID: |
1000005079996 |
Appl. No.: |
16/940133 |
Filed: |
July 27, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15292697 |
Oct 13, 2016 |
10722244 |
|
|
16940133 |
|
|
|
|
62240967 |
Oct 13, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/12004
20130101; A41D 13/1245 20130101; A61B 17/1325 20130101 |
International
Class: |
A61B 17/132 20060101
A61B017/132; A41D 13/12 20060101 A41D013/12 |
Claims
1. (canceled)
2. A medical device for mitigating pocket bleeding and hematoma
formation in the patient, the medical device comprising: a pliable
wrap sized to wrap around at least a portion of a torso of a
patient, the wrap being configured to form a loop when wrapped
around the patient; a block of non-inflatable solid material
configured to couple with the wrap and positioned between the wrap
and a localized area of the patient during use, the wrap configured
to transfer a force to the block toward the localized area of the
patient when wrapped around the patient to apply pressure to the
localized area of the patient, the force being a function of the
pliability of the wrap, the pressure being sufficient to hinder but
not completely prevent blood flow in the localized area of the
patient's body.
3. The medical device as defined by claim 2, wherein the wrap
comprises an elastic material.
4. The medical device as defined by claim 2, wherein the wrap
comprises neoprene.
5. The medical device as defined by claim 2, wherein the wrap
includes straps to adjust the pressure applied to the localized
area by the block.
6. The medical device as defined by claim 2, wherein the localized
area is on the patient's chest, and the wrap is a vest configured
to hold the block against the localized area.
7. The medical device as defined by claim 2, wherein the wrap
includes a pouch, the block being secured to the wrap within
pouch.
8. The medical device as defined by claim 7, wherein the pouch is
sealable so that, when the pouch is sealed, the pouch mitigates
motion of the block relative to the wrap.
9. The medical device as defined by claim 2, wherein the block has
a wedge shape with a narrow face positioned to face the patient
when the medical device is worn by the patient.
10. An apparatus for applying pressure to a localized area of a
patient's body, the apparatus comprising: a pressure transmitting
means for applying pressure to the patient's localized area; and a
medical device means for wrapping around at least a portion of the
patient, the pressure transmitting means positioned between the
medical device means and the patient's localized area, wherein the
pressure is sufficient to hinder but not completely prevent blood
flow in the localized area of the patient's body.
11. The apparatus of claim 10, wherein the medical device means
comprises neoprene.
Description
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
[0001] Any and all applications for which a foreign or domestic
priority claim is identified in the Application Data Sheet as filed
with the present application are hereby incorporated by reference
under 37 CFR 1.57.
[0002] This patent application is a continuation of U.S.
application Ser. No. 15/292,697, filed Oct. 13, 2016, entitled,
"Cardiac Implantable Electronic Device Pocket Compression Apparatus
and Method of Mitigating Localized Bleeding Using Same," which
claims priority from provisional U.S. patent application No.
62/240,967, filed Oct. 13, 2015, entitled, "Implantable Cardiac
Device Pocket Compression Apparatus," and naming Dhanunjaya
Lakkireddy and Srijoy Mahapatra as inventors [practitioner's file
4179/1001], the disclosure of which is incorporated herein, in its
entirety, by reference.
BACKGROUND OF THE INVENTION
Field of the Invention
[0003] The invention generally relates to a medical apparatus and,
more particularly, the invention relates to a treatment apparatus
for use in connection with cardiac device implantations.
Description of the Related Art
[0004] Several hundred thousands of patients receive subcutaneous
cardiac devices (pacemakers, defibrillators, resynchronization
therapy devices, loop recorders) throughout the world each year,
with many thousands in the United States alone. With increasing
advances in medical devices and the advent of life saving
implantable cardioverter defibrillators along with cardiac
resynchronization therapy, cardiac device therapy placed in the
chest through the infraclavicular/subclavian approach has become
very common. Usually, after sterile preparation, a small incision
is made below the clavicle either on the right or left side. A
subcutaneous pocket is created, bleeders are secured, and access to
the subclavian vein or cephalic vein is obtained under the guidance
of fluoroscopy. Then pacing or defibrillator leads may be placed in
the appropriate chambers of the heart. These leads may be secured
to the fascia over the pectoralis muscle and the end of which may
be usually plugged into the ports in the device generator. The
portion of the leads and the generator may be placed in the pocket
and closed in two or three layers of suture. Bleeders may be
secured before closing the pocket. Sterile strips may be placed
over the closed incision and allowed to heal over the next few
days.
[0005] Based on prior research, pocket bleeding and hematoma
formation may be seen in about 4.9% patients and the incidence may
be higher in those receiving defibrillators compared to pacemakers.
Pocket bleeding can prolong hospital stay in 1.5% of patients who
receive these devices up to 2.5 days with about 0.5% requiring
repeat hospitalization and close to 1% needing pocket revision and
hematoma evacuation. The risk of post device bleeding and hematoma
formation may be significantly higher (e.g., up to 12%-20%) in
those patients who may be bridged with anticoagulants like heparin
and enoxaparin. Even in those cases where warfarin is continued
throughout the procedure, the risk of post procedural bleeding may
be up to 2-6%. Often, large hematomas and subsequent evacuations
lead to increased incidence of infection.
[0006] Commonly, small swelling or hematoma left untreated and
healing are left to normal body processes. However, hematomas and
pocket bleeding can be serious enough in a certain percentage of
patients as described above, requiring immediate attention. This
can significantly increase the cost of treatment, and the amount of
lost wages. This can also add a significant morbidity to the
patient's health. Patients with device site hematomas and bleeding
are at higher risk for infections which often require
hospitalizations, intravenous antibiotic therapy and device
extraction that leads to significant procedural risks, costs and
patient comfort
SUMMARY OF THE INVENTION
[0007] In accordance with one embodiment of the invention, a
medical device for applying pressure to a localized area of
patient's body includes a pliable wrap for wrapping around at least
a portion of the patient, and a block of solid, non-inflatable
material positioned between the wrap and the localized area of the
patient. The wrap may be a vest for holding the block against the
patient's torso, or a sleeve to hold the block against a patient's
arm or a leg, to name but a few examples. In some embodiments, the
wrap includes an elastic material, such as neoprene for example,
and may also include straps to adjust the pressure applied to a
localized area on the patient by the block.
[0008] The block is sized and shaped to apply pressure to the
localized area of the patient, which pressure is sufficient to
hinder but not completely prevent blood flow in the localized area
of the patient's body. For example, the block may have a wedge
shape with a narrow face positioned to face the patient when the
medical device is worn by the patient.
[0009] Some embodiments include a sealable pouch in the medical
device for securing the block in position, and some embodiments
also include an absorbent sheath around the block within the pouch.
Moreover, some embodiments include at least one filler member
within the pouch to secure the location of the block within the
pouch. Other embodiments secure the block with one or more straps,
or a hook-and-loop fastener such as Velcro.
[0010] In accordance with another embodiment of the invention, a
method of mitigating pocket bleeding and hematoma formation in a
patient locates a localized torso area of the patient that may be
subject to bleeding and/or hematoma formation. The localized torso
area is at least in part covered by a bandage and/or dressing.
Next, the method provides a pliable wrap having a non-inflatable
solid block coupled with the wrap, and then secures the pliable
wrap around the torso of the patient to align the solid block with
the located localized torso area. The solid block is secured
between at least a portion of the wrap and the bandage and/or
dressing, at least in part covering the localized torso area. The
wrap is secured to cause the wrap to apply a force, to the solid
block, that produces a corresponding pressure on the localized
torso area. The force applied to the solid block is high enough to
cause the pressure to hinder blood flow to the localized torso area
to promote clotting at the localized torso area. At the same time,
the force applied to the solid block is low enough to cause the
pressure to permit blood flow to the localized torso area to
promote healing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Those skilled in the art should more fully appreciate
advantages of various embodiments from the following description
discussed with reference to the drawings summarized immediately
below.
[0012] FIG. 1 schematically illustrates a front view of the outer
surface of a compression vest in a detached configuration in
accordance with illustrative embodiments;
[0013] FIG. 2 schematically illustrates a rear view of the inner
surface of a compression vest in a detached configuration in
accordance with illustrative embodiments;
[0014] FIG. 3A schematically illustrates details of a fabric for a
compression vest in accordance with illustrative embodiments;
[0015] FIG. 3B schematically illustrates a compression block urged
towards a patient's body by a garment;
[0016] FIG. 3C schematically illustrates pressure gradient within a
patient;
[0017] FIG. 4 schematically illustrates a front view in an attached
configuration in accordance with illustrative embodiments;
[0018] FIG. 5 schematically shows a rear view in an attached
configuration in accordance with illustrative embodiments;
[0019] FIGS. 6A-6B schematically illustrate an incision on the
chest of a patient;
[0020] FIGS. 6C-6D schematically illustrate a front view in an
attached configuration on a patient and a rear view in an attached
configuration on a patient, respectively, in accordance with
illustrative embodiments;
[0021] FIGS. 7A-7D schematically illustrate embodiments of
compression blocks for use with a compression garment in accordance
with illustrative embodiments;
[0022] FIGS. 7E-7F schematically illustrate cross sections of
embodiments of compression blocks;
[0023] FIG. 7G schematically illustrates an embodiment of a
compression block in a sheath;
[0024] FIG. 8 schematically illustrates an embodiment of a
compression sleeve;
[0025] FIG. 9 is a flow chart illustrating a method of using a
garment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0026] Illustrative embodiments mitigate pocket bleeding and
hematoma formation in a patient by providing constant, adjustable
pressure to a localized area of the patient's body. To that end, a
mechanical, noninvasive garment has adjustable levels of
compression to treat and/or substantially reduce the likelihood of
hematomas from cardiac devices, such as pacemakers, defibrillators,
loop recorders, and pressure monitoring systems placed underneath
the skin in the human chest/torso. Among other configurations, the
garment may be formed as a single unit with straps, and includes a
compression block in a pouch of the garment. During use, the block
applies specific pressure to a targeted area of the patient. The
garment may be worn in a similar manner to a jacket, i.e., over the
shoulder that is closest to the cardiac device. A first shoulder
strap can be adjusted for appropriate contact, while a second strap
(e.g., around the chest) may be adjusted to selectively apply
pressure to the block, consequently applying pressure to the
targeted area. Illustrative embodiments may be used over a device
pocket (formed in a patient's body), which may have a hematoma, or
may be used in a prophylactic fashion to avoid (or at least
substantially reduce the likelihood that) a hematoma when they are
expected.
[0027] During use, the patient may move around without being
limited to a bed or chair. The garment also may enable the patient
to carry on activities of daily living with minimal limitation.
Accordingly, the garment may decrease the incidence of hematoma
formation after cardiac device placement, especially when device
implantation was done while the patient was on therapeutic
anticoagulation. For patients on anticoagulants (e.g., heparin or
enoxaparin), the garment may be used immediately after device
implantation until the patient's anticoagulation levels settle to a
prescribed therapeutic range. Also, the garment can compress a
hematoma of the pocket that has already formed. As a result, the
garment may reduce pain and suffering for the patient, decrease
duration of hospitalization, decrease recurrent hospitalizations
and additional interventions (e.g., reopening the device pocket and
hematoma evacuations). Consequently, the garment potentially can
reduce significant health care costs. Details of illustrative
embodiments are discussed below.
[0028] FIGS. 1 and 2 respectively show front and rear views of
illustrative embodiments of a garment or vest 100 in a detached
configuration. It should be noted that the specific dimensions in
the drawing are exemplary only and thus, are not intended to limit
various illustrative embodiments. FIGS. 6B and 6C schematically
illustrate front and rear views, respectively, of a vest 100 worn
by a patient.
[0029] The vest 100 is a single structure configured to anchor over
the patient's shoulder and wrap around (e.g., form a loop around)
the patient's upper chest in a circumferential fashion.
[0030] The vest 100 includes a waist band 110 configured to wrap
around the patient's torso and secure the vest 100 to the patient.
To that end, the waist band 110 includes a waist strap 220 coupled
to a back flap 221. The waist strap 220 includes a hook and loop
patch 113 (e.g., Velcro) configured to removably and adjustably
couple to a counterpart hook and loop patch 114 on a front flap
222. The waist strap 220 may be useful in adjusting the
top-to-bottom stretch and compression of the vest 100.
[0031] The vest 100 also includes left and right shoulder portions
101 and 105 extending from the waist band 110. In use, when worn by
a patient, the left and right shoulder portions 101 and 105 are
physically coupled by a shoulder strap 120, to secure the vest 100
around the patient's shoulder. For example, the strap 120 may go
over the ipsilateral shoulder connecting the scapular portion 105
to the pectoral 101 portion of the vest.
[0032] Together, the shoulder strap 120 and waist strap 220 provide
stretch and compression of the vest 100 in four directions (e.g.,
left and right across the patient's torso, and up and down relative
to the patient's shoulders).
[0033] The vest 100 also includes at least one structure (e.g.,
210; 211) for securing a compression block 700 (described below) to
the vest 100. In illustrative embodiments, the structure 210; 211
may be a pouch, or sealable pouch, to hold the compression block
700. In some embodiments, the structure 210; 211 may include
straps, belts, hook and loop fasteners, or other devices.
[0034] More specifically, a pouch 210 holds the compression block
700 adjacent to an area on a patient's body where pressure is
desired. In illustrative embodiments, the pouch 210, 211 is on or
in the inner surface 202 of the vest 100, so that the vest 100
presses the block 700 towards the patient.
[0035] Chest pads 103 and/or 104 hold a compression block 700 on
the incision site (650) on patient's chest. In some embodiments,
chest pad 103 and/or 104 of the vest 100 may have a surface that is
larger than their respective pouches 210, 211. Moreover, the chest
pads 103 and 104 provide a surface for applying a compressive force
to the compression block 700 inside a pouch 210,211. The amount of
compressive force applied by chest pads 103 and 104 to the
compression block 700 may be adjusted using a shoulder strap 120
and/or a waist strap 220.
[0036] Some embodiments may come pre-attached at the shoulder strap
and can be worn around the shoulder like a sling. Such embodiments
may omit the waist band 110 and its strap 220.
[0037] The vest 100 includes a stretchable body (e.g., waist strap
110 and/or shoulder portions 101 and 105) made up of stretchy or
elastic materials, such as 2 mm thickness SBR Neoprene VELCRO
compatible UBL finish, for example. In addition, as schematically
illustrated in FIG. 3A, such materials may be waterproof and/or
insulated. Moreover, the outer surface 102 of the vest may be
VELCRO compatible and the inner surface 101 may be smooth and
impervious to water.
[0038] FIG. 3B schematically illustrates a compression block 700
urged against a patient's body 350 by the stretchy material of a
vest 100. In the embodiment of FIG. 3B, a bandage or dressing 355
is positioned between the compression block 700 and the patient
350. When worn by a patient, tension in the material of the vest
100 imparts a force to the compression block 700. The amount of the
force may be adjusted by adjusting the straps 120 and/or 220. In
addition, the amount of the force may be a function of the elastic
properties and/or tightness of the material of the vest 100, in
that the more the vest material is stretched, the greater the force
it applies to the compression block 700. As discussed below, this
force produces a pressure to the patient's body 350 (e.g., a
portion of the patient's torso).
[0039] That force is high enough to cause the pressure to hinder
blood flow to the localized torso area. Specifically, in
illustrative embodiments, this pressure eventually aids in causing
capillaries in the local area under pressure to coagulate, thus
reducing and eventually stopping bleeding from the site. In
addition, this pressure also preferably is low enough to mitigate
the effect of a hematoma in that localized area. While a
sufficiently high pressure is desired, such pressure also
preferably is low enough to permit blood flow to the localized
torso area. Accordingly, while reducing blood to the area to stop
bleeding, blood still flows to the area to promote tissue health.
As discussed below, a medical professional preferably can select
the appropriate pressure to meet these competing demands.
[0040] The amount, location and gradient of the applied force may
influence the efficacy of the vest 100. For example, as
schematically by the compression gradient line 360 illustrated in
FIG. 3C, the compression applied by the compression block 700 is
high immediately beneath the compression block 700, but dissipates
with distance from the block. The relatively high compression
beneath the compression block 700 (e.g., at point at point 361),
and relatively lower compression away from the block (e.g., at
point 362) forces fluids within a hematoma or pocket outward from
under the compression block 700. The structure of the compression
block 700 directly impacts efficacy. Specifically, the inventors
recognized that a solid compression block 700 produces a
better-defined gradient than, for example, a bladder, which can be
inflated. Accordingly, illustrative embodiments of the vest 100 and
its compression block 700 should be beneficial to a patient with
either or both a hematoma, and a high risk for pocket hematoma.
[0041] Specifically, various embodiments may be useful, for
example, to:
[0042] 1. Patients undergoing cardiac device implantation
(pacemakers, cardioverter defibrillators, cardiac resynchronization
therapy pacemakers & defibrillators, loop recorders, cardiac
chamber pressure monitors) and chemotherapy ports who develop
bleeding into the pocket and hematoma,
[0043] 2. Patients who may be on antiplatelet and or
anticoagulation therapy and may be at high risk for bleeding and
hematoma formation,
[0044] 3. Patients who may be on bridging therapy with heparin or
enoxaparin immediately after cardiac device implantation for
mechanical prosthetic valves, deep venous thrombosis, high risk
atrial fibrillation patients, intracardiac thrombi etc.,
[0045] 4. Patients who may be high risk for bleeding into
pocket--elderly, renal failure, prolonged intervention, prior
device extraction, pocket revisions, bleeding disorders etc.,
and/or
[0046] 5. Patients who had a cardiac implantable electronic device
("CIED") placed and developed a hematoma that needs that needs
further care.
[0047] FIG. 4 and FIG. 5 show that the fabric pad may be folded
approximately at its middle.
[0048] FIG. 6A, FIG. 6B and FIG. 6C schematically illustrate the
patient with an incision 650 dressed on the left hand side of the
body. FIG. 6B schematically illustrates a localized area 655
defined at least in part by the area where a compression block 700
meets a patient's body. For example, FIG. 6B schematically
illustrates a localized area 655 near a patient's incision 650 and
suture 651.
[0049] FIG. 6C schematically shows a front view in an attached
configuration on the patient, while FIG. 6D shows a rear view of
the vest 100 in an attached configuration on the patient. In some
embodiments, from the front of the patient, the apparatus may be
dressed on the patient and may approximately look like the front
view illustrated in FIG. 6C. From the back of the patient, the
dressed apparatus may approximately look like the rear view
illustration in FIG. 6D. In other embodiments, the incision may be
dressed on the right hand side of the body. In some embodiments,
the adjustments described in reference to FIG. 1 may also be made
when the vest is on the patient.
[0050] FIGS. 7A-7C schematically illustrate a compression block 700
in accordance with illustrative embodiments. The block 700 is
solid, and in some embodiments is somewhat compressible. As a
somewhat compressible member, the face of the block 700 preferably
conforms to some extent with a facing surface of the portion of the
patient to which it applies a pressure. The block 700 is not
pneumatic, e.g., it is not an inflatable or deflatable bladder.
Moreover, the block 700 is not formed from or include ice, which
the inventors believe would be too hard and possibly injure the
patient. In some embodiments, the compression block 700 may be made
of gel foam, polystyrene foam (e.g., STYROFOAM), or other
appropriate material can be placed to enhance the
compression/pressure applied to the local area, as described
further below.
[0051] The inventors have found that a solid compression block
provides advantages over a bladder. For example, an inflatable
bladder requires additional components, such as a pump mechanism to
inflate the bladder, and a release mechanism to deflate the
bladder. Such mechanisms increase the cost and complexity of the
bladder, while decreasing the bladder's reliability and ease of
use. In contrast, a solid block 700 is simple, durable, and
reliable.
[0052] Moreover, the inventors believe that a bladder (whether
inflatable or otherwise) deforms with an increase of internal
pressure, and/or pressure against the patient, resulting a
variable, and less precise pressure gradient and distribution or
dispersal of pressure against the patient. Such an undesirable
distribution of pressure can cause complications or impede the
healing process. In contrast, pressure applied by a block 700 is
more readily focused on a desired area, with less distortion and
uncertainty.
[0053] As compared to a bladder, a solid block 700 may provide a
more effective pressure suited to patient comfort.
[0054] For example, the location of pressure applied to a patient
by a solid block 700 results in part from the size of the surface
of the block that faces the patient. To that end, embodiments of
block 700 may have surfaces of varying shapes and sizes.
[0055] In some embodiments, the block 700 has a square or
rectangular cross section, as schematically illustrated in FIG. 7E
and FIG. 7F, respectively, while in other embodiments, the block
700 has a trapezoidal cross section as schematically illustrated in
FIG. 7A. For example, the top 701 of the block 700 may have the
shape of the frustum of a pyramid. The height and length of the
block 700 may be selected so as to cover the incision 650 and/or
suture 651.
[0056] Illustrative embodiments of the block 700 have multiple
surfaces, such as base surface 711, and narrower top surface 701.
The localized area of pressure applied to the patient depends on
which of those surfaces faces the patient. For example, a surface
of the block 700 to be positioned facing the patent may be
determined by a user based on the size of the incision 650, the
suture 651, and/or the size of the desired localized area 655.
[0057] Further, in some embodiments, the pressure applied to a
patient by a solid block 700 results in part from the interaction
of the block 700 with pliable nature of the material of a garment
100. For example, pressure applied to the localized area may be
determined at least in part by the elasticity of the garment, the
position of straps, and the surface area of the block. In some
embodiments, in which the material of the garment is elastic, the
pressure delivered to the patent depends in part on the force
applied by the fabric, and the compressibility of the block
700.
[0058] In some embodiments, the material selected for the
compression block 700 may be foamed polystyrene. For example, the
block may be an arteriotomy pressure point pad available from
Steri-Systems Corp., P.O. Box 909, 1314 Fourth Avenue, Auburn, Ga.
30011 (Mfg. SKU: 100W; National Stock Number (NSN)
6515-01-464-2574). The density of the foamed polystyrene may vary.
In preferred embodiments, material with 1 pound per cubic foot may
be selected. However, preferred embodiments could vary density,
such as from 0.5 to 1.5 pounds per cubic foot.
[0059] In some embodiments, the block 700 is non-compressible, or
minimally compressible. If the block is too hard (e.g., steel;
ice), the block 700 may fail to conform at all to the surface of
the patient, and/or it may dig into the patient and distort the
application of applied pressure.
[0060] To that end, in some embodiments, a minimally compressible
block 700 may by a firm polystyrene material, or another material
having a Young's modulus of between 2.0.times.10.sup.-10
dynes/cm.sup.2 and 5.0.times.10.sup.-10 dynes/cm.sup.2, and may be
a polystyrene having a Young's modulus of 3.43.times.10.sup.-10
dynes/cm.sup.2. In some embodiments, the block 700 may have a
Young's modulus similar to that of polystyrene at 3 to 3.5 GPa. As
another example, the block 700 of some embodiments may have a
Young's modulus similar to that of Dow Chemical Company's Styrofoam
Highload 60 product has a vertical compressive strength of 60 psi
(pounds per square inch), meaning that the product experiences 10%
deformation under 60 psi of pressure.
[0061] FIG. 7D schematically illustrates an embodiment that
includes a filler block 730 configured to fit into a garment pouch,
e.g., 210, alongside a compression block 700. When placed in a
garment pouch, e.g., 210, a filler block 730 occupies space within
the garment pouch 210 and forces the compression block 700 to one
side or another of the garment pouch 210, thereby allowing
adjustment and fine-tuning of the position of the compression block
700 relative to the garment 100, and relative to the localized area
655. In some embodiments, two or more filler blocks 730 may be used
to position a compression block 700 within a pouch 210.
[0062] FIG. 8 schematically illustrates an alternative embodiment
in which the garment 100 is in the form of a compression sleeve
800. The sleeve 800 of this embodiment is configured to wrap around
a patient's limb, such as an arm or leg, and to be secured in
position by one or more straps 810. The compression sleeve 800
includes a pouch 210 on an inner surface 801 for securing a
compression block 700 between the inner surface 801 and the
patient. In some embodiments, the sleeve 800 includes a stretchy
material to apply pressure to the compression block 700, as
described above in connection with the vest 100.
[0063] FIG. 9 is a flow chart illustrating a method of using a
garment to selectively apply pressure to a localized area of a
patient's body. The method may explain, for example, a method of
mitigating pocket bleeding and hematoma formation in a patient.
[0064] The process begins at step 900, in which a medical
professional or other user locates a localized area 655 of the
patient's body (e.g., FIGS. 6A-6D). For example, the localized area
655 may be over a patient's incision 650, or a suture 651 closing
an incision in the patient's torso. The localized torso area has a
topography, and may be at least in part covered by a bandage and/or
dressing.
[0065] Next, step 902 secures a pliable wrap (i.e., the garment
100) around the torso of the patient as discussed above. To that
end, the garment 100 is secured so that the block is aligned with
the part of the patient's torso requiring pressure. Among other
things, as noted above, the patient may have undergone surgery to
receive an implantable device. Accordingly, the garment 100 is
oriented so that the block is over at least a part of the patient's
torso needing the pressure. At this point in the process, the block
is between the patient's body (e.g., the bandage and/or dressing
355) and the wrap.
[0066] The wrap thus applies a force to the solid block, which
produces a corresponding pressure on the localized torso area. This
force is due to the cooperation of the material forming the wrap
and straps, as well as the material properties of the block. The
medical professional ensures that the force is neither too high nor
too low. Specifically, the force preferably is high enough to cause
the pressure to hinder blood flow to the localized torso area.
Accordingly, such a force should minimize or eventually stop
bleeding at the local site. Importantly, however, the pressure also
preferably is low enough to cause the pressure to permit blood flow
to the localized torso area. In some embodiments, the force may be
in a sufficient amount to cause the face of the block adjacent to
the body to conform to some extent to the topography of at least a
portion of the local region. This may further enhance the effect
and controllability on hematomas and blood flow.
[0067] After the wrap has been secured for some prescribed amount
of time (e.g., 30-90 minutes), a medical professional may check the
progress of the localized torso area (step 903).
[0068] To that end, the medical professional may remove the wrap to
view the localized torso area after the prescribed time period. If
the medical professional recognizes fluid discharge from the
localized torso area, then the wrap may not have been secured with
a sufficient force. In that case, the process continues to step
904, in which the medical professional re-secures the wrap with a
greater force than the force applied when initially secured. This
greater force preferably is high enough to produce a greater block
pressure to hinder blood flow to the localized torso area, but
again, low enough to cause the pressure to permit blood flow to the
localized torso area. Of course, when re-secured, the medical
professional secures the wrap so that the block aligns with the
local torso area being treated.
[0069] Alternatively, if in his/her professional judgement the
local area is not bleeding/discharging fluid too much, then the
medical professional will re-secure the wrap in the same manner
(i.e., aligning the block with the local area) at approximately the
same force.
[0070] Although the method illustrated by the flow chart in FIG. 9
is directed to a garment for use on a patient's torso, the method
could also be applied to the use of garments on a patient's limb,
such as sleeve 800 for example.
[0071] The following is a listing of reference numbers used
herein:
[0072] 100: Compression vest
[0073] 101: Left shoulder portion, or scapular end, of vest
[0074] 102: Outer surface of vest
[0075] 103: Left chest pad portion of vest
[0076] 104: Right chest pad portion of vest
[0077] 105: Right shoulder portion, or pectoral portion, of
vest
[0078] 110: Waist strap or main body of vest
[0079] 112: Right end of waist strap
[0080] 113: Velcro fastener
[0081] 114: Opposing Velcro fastener
[0082] 116: Left end of waist strap
[0083] 202: Inner surface of vest
[0084] 210: Left pouch
[0085] 211: Right pouch
[0086] 220: Waist strap
[0087] 221: Back flap
[0088] 222: Front flap
[0089] 350: Surface of patient's body
[0090] 355: Bandage or dressing
[0091] 360: Gradient graph
[0092] 361: Pressure point
[0093] 362: Lesser pressure point
[0094] 650: Incision site
[0095] 651: Suture
[0096] 655: Localized area
[0097] 700: Compression block
[0098] 701: Top of compression block
[0099] 711: Bottom of compression block
[0100] 730: Filler block
[0101] 740: Sheath
[0102] 800: Sleeve
[0103] 801: Inner surface of sleeve
[0104] 810: Sleeve straps
[0105] Accordingly, unlike a tourniquet, when secured to the
patient, the pressure that the garment applies is not sufficient to
completely prevent blood flow. Rather, the garment applies a
pressure sufficient to hinder but not completely prevent blood flow
in the localized area 655 of the patient's body.
[0106] It is expressly understood that many other embodiments and
modifications may be contemplated as included within the apparatus
although not specifically illustrated. For example, it may be
expressly contemplated that VELCRO fasteners may be placed in
different positions or switched, namely a felt fastener exchange
for hook fastener and vice versa. In a similar manner, although
VELCRO may be preferred attachment means, any other appropriate
attachment means, including bonded pressure adhesives, now known or
later devised, may also be equivalently substituted. Still further,
although it may be expressly contemplated that no strap, tape, or
other means may be necessary to secure the compression block to the
vest 100, the inclusion of such elements in some embodiments may be
contemplated.
[0107] Complementary VELCRO fasteners can also be provided on the
outside ends of the waist band 110 so that waist band 110 can be
stretched and overlapped at its opposing ends and thus connected
together.
[0108] Although the above discussion discloses various exemplary
embodiments, it should be apparent that those skilled in the art
can make various modifications that may achieve some of the
advantages of the embodiments described herein without departing
from the true scope of the inventive concepts. All such variations
and modifications are intended to be within the scope of the
present inventions as defined in any appended claims.
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