U.S. patent application number 13/933025 was filed with the patent office on 2013-10-31 for method to stop bleeding at a puncture site of an artery of a patient's wrist.
This patent application is currently assigned to Terumo Kabushiki Kaisha. The applicant listed for this patent is TERUMO KABUSHIKI KAISHA. Invention is credited to Shigeki NUMATA, Satoshi WADA, Hiroshi YAGI.
Application Number | 20130289613 13/933025 |
Document ID | / |
Family ID | 29783091 |
Filed Date | 2013-10-31 |
United States Patent
Application |
20130289613 |
Kind Code |
A1 |
WADA; Satoshi ; et
al. |
October 31, 2013 |
METHOD TO STOP BLEEDING AT A PUNCTURE SITE OF AN ARTERY OF A
PATIENT'S WRIST
Abstract
A method to stop bleeding at a puncture site of an artery on a
wrist of a patient comprises wrapping a flexible band of a
hemostatic device around the patient's wrist, wherein the
hemostatic device also includes a curved plate, a balloon and a
marker for positioning the balloon at the puncture site, and
wherein the flexible band, the curved plate and the balloon are
substantially transparent. The balloon is positioned relative to
the puncture site using the marker so that the balloon overlies the
puncture site and is situated between the plate and the patient's
wrist. The method also involves introducing fluid into the balloon
after the wrapping the flexible band around the patient's wrist to
inflate the balloon so the balloon applies a compressive force to
the puncture site, and maintaining inflation of the balloon and
compression against the puncture site to stop bleeding from the
puncture site.
Inventors: |
WADA; Satoshi; (Shizuoka,
JP) ; NUMATA; Shigeki; (Shizuoka, JP) ; YAGI;
Hiroshi; (Shizuoka, JP) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TERUMO KABUSHIKI KAISHA |
Tokyo |
|
JP |
|
|
Assignee: |
Terumo Kabushiki Kaisha
|
Family ID: |
29783091 |
Appl. No.: |
13/933025 |
Filed: |
July 1, 2013 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13725406 |
Dec 21, 2012 |
8481805 |
|
|
13933025 |
|
|
|
|
12356969 |
Jan 21, 2009 |
8481803 |
|
|
13725406 |
|
|
|
|
10618964 |
Jul 15, 2003 |
7498477 |
|
|
12356969 |
|
|
|
|
Current U.S.
Class: |
606/202 |
Current CPC
Class: |
A61B 17/1325 20130101;
A61B 2090/3937 20160201; A61B 2017/12004 20130101; A61B 17/135
20130101; A61B 2017/00907 20130101 |
Class at
Publication: |
606/202 |
International
Class: |
A61B 17/132 20060101
A61B017/132 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 15, 2002 |
JP |
2002-206295 |
Nov 7, 2002 |
JP |
2002-323940 |
Dec 24, 2002 |
JP |
2002-373013 |
Claims
1. A method to stop bleeding at a puncture site of an artery on a
wrist of a patient comprising: wrapping a flexible band of a
hemostatic device around the wrist of the patient so that the
flexible band encircles the wrist of the patient, the hemostatic
device also comprising a plate made of a material more rigid than
the flexible band and having a curved portion, a balloon and a
visually identifiable marker used to position the balloon at the
puncture site, the flexible band, the plate and the balloon being
substantially transparent so that when the flexible band is wrapped
around the wrist of the patient, the puncture site is visible
through the plate, through the balloon and through the flexible
band, and the marker is visible to position the balloon at the
puncture site; positioning the balloon relative to the puncture
site through use of the marker to so that the balloon overlies the
puncture site and is situated between the plate and the wrist of
the patient; introducing fluid into the balloon after the wrapping
of the flexible band around the wrist of the patient to inflate the
balloon so that the balloon applies a compressive force to the
puncture site; and maintaining inflation of the balloon and
compression against the puncture site to stop the bleeding from the
puncture site.
2. The method of claim 1, wherein the balloon possesses oppositely
disposed sides, and wherein only one of the sides of the balloon is
connected to the flexible band while the opposite side of the
balloon is free.
3. The method of claim 1, wherein the positioning of the balloon
relative to the puncture site through use of the marker comprises
positioning the balloon such that the marker overlies the puncture
site.
4. The method of claim 1, wherein the marker is positioned to
identify a center of the balloon, and the positioning of the
balloon relative to the puncture site through use of the marker
comprises positioning the balloon such that the marker overlies the
puncture site.
5. The method of claim 1, wherein the balloon is in direct contact
with the wrist of the patient when the balloon is inflated.
6. The method of claim 1, wherein the marker is visible through the
flexible band and through the plate.
7. The method of claim 1, wherein the introducing of the fluid into
the balloon comprises introducing the fluid through a check valve
and through a tube connected to both the balloon and the check
valve, the check valve preventing the fluid which has been
introduced into the balloon from flowing out of the balloon to
maintain the balloon in an inflated stated.
8. The method of claim 1, wherein the introducing of the fluid into
the balloon comprises connecting a syringe containing the fluid to
a tube that is connected to the balloon and introducing the fluid
in the syringe into the balloon by way of the tube.
9. A method to stop bleeding at a puncture site of an artery on a
wrist of a patient comprising: wrapping a flexible band of a
hemostatic device around the wrist of the patient, the hemostatic
device also comprising a curved plate, a balloon and a marker used
to position the balloon at the puncture site, wherein the flexible
band, the curved plate and the balloon are substantially
transparent; the wrapping of the flexible band around the wrist of
the patient comprising wrapping the flexible band around the wrist
of the patient while using the marker to position the balloon in
overlying relation to the puncture site; introducing a fluid into
the balloon to inflate the balloon and apply a compressive force to
the puncture site that will stop bleeding from the puncture site,
the balloon being connected to the flexible band along only one
side of the balloon; and maintaining inflation of the balloon and
the compressive force to the puncture site.
10. The method of claim 9, wherein the marker is positioned to
identify a center of the balloon, and wherein the using of the
marker to position the balloon relative to the puncture site
comprises positioning the marker so that the marker overlies the
puncture site.
11. The method of claim 9, wherein the wrapping of the flexible
band around the wrist of the patient while using the marker to
position the balloon in overlying relation to the puncture site
involves wrapping the flexible band around the wrist of the patient
while positioning the balloon such that the marker overlies the
puncture site.
12. The method of claim 9, wherein the balloon is in direct contact
with the wrist of the patient when the balloon is inflated.
13. The method of claim 9, wherein the marker is visible through
the flexible band and through the plate.
14. The method of claim 9, wherein the introducing of the fluid
into the balloon to inflate the balloon and apply a compressive
force to the puncture site comprises introducing the fluid through
a tube that is in fluid communication with an interior of the
balloon so that the fluid flows through the tube and into the
interior of the balloon; and further comprising: following the
introducing of the fluid into the balloon to inflate the balloon,
maintaining inflation of the balloon by way of a check valve
positioned along the tube that prevents the fluid in the interior
of the balloon from leaking out of the interior of the balloon.
15. The method of claim 9, wherein the introducing of the fluid
into the balloon comprises connecting a syringe containing the
fluid to a tube that communicates with an interior of the balloon
and introducing the fluid in the syringe into the interior of the
balloon by way of the tube.
16. A method to stop bleeding at a puncture site of an artery on a
wrist of a patient comprising: wrapping a flexible band of a
hemostatic device around the wrist of the patient so that the
flexible band encircles the wrist of the patient, the hemostatic
device also comprising a plate made of a material more rigid than
the flexible band and having a curved portion, a balloon, and a
visually identifiable marker used to position the balloon at the
puncture site, the flexible band, the plate and balloon being
substantially transparent so that when the flexible band is wrapped
around the wrist of the patient, the puncture site is visible
through the plate, through the balloon and through the flexible
band, and the marker is visible to position the balloon at the
puncture site; positioning the balloon relative to the puncture
site through use of the marker so that the balloon overlies the
puncture site and is situated between the plate and the wrist of
the patient; introducing fluid into the balloon after the wrapping
of the flexible band around the wrist of the patient to inflate the
balloon so that the balloon applies a compressive force to the
puncture site; the introducing of the fluid into the balloon
comprising introducing the fluid into a tube that is in
communication with an interior of the balloon and that has a check
valve along its length so that the fluid flows through the check
valve and the tube, and enters the interior of the balloon;
maintaining inflation of the balloon and compression against the
puncture site to stop the bleeding from the puncture site; and the
maintaining of the inflation of the balloon comprising the check
valve preventing the fluid in the interior of the balloon from
leaking to outside the balloon.
17. The method of claim 16, wherein the introducing of the fluid
into the interior of the balloon comprises connecting a syringe
containing the fluid to the tube and introducing the fluid in the
syringe into the interior of the balloon by way of the tube.
18. The method of claim 16, wherein the introducing of the fluid
into the interior of the balloon comprises connecting a syringe
containing the fluid to the tube at a position upstream of the
check valve so that the check valve is positioned between the
balloon and the syringe, and introducing the fluid in the syringe
into the interior of the balloon by way of the tube and the check
valve.
19. The method of claim 16, wherein the marker is positioned to
identify a center of the balloon, and wherein the using of the
marker to position the balloon relative to the puncture site
comprises positioning the marker so that the marker overlies the
puncture site.
20. The method of claim 16, wherein the wrapping of the flexible
band around the wrist of the patient comprises wrapping the
flexible band around the wrist of the patient and positioning the
balloon such that the marker overlies the puncture site.
Description
[0001] This application is a continuation of U.S. application Ser.
No. 13/725,406 filed on Dec. 21, 2012 which is a continuation of
U.S. application Ser. No. 12/356,969 filed on Jan. 21, 2009 which
is a divisional of U.S. application Ser. No. 10/618,964 filed on
Jul. 15, 2003, the entire content of all of which is incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a hemostatic device, and
more particularly to a hemostatic device which is attached to a
patient's limb at a site on the limb where bleeding is to be
stopped and which, by the inflation of a balloon, applies pressure
to the site so as to stop bleeding.
[0004] 2. Background Art
[0005] When a procedure involving the percutaneous insertion of an
instrument such as a catheter into a blood vessel is carried out
for medical treatment, examination or diagnosis, bleeding at the
puncture site must be stopped following subsequent withdrawal and
removal of the catheter. Hemostatic devices which are attached by
being wrapped around the portion of an arm or leg where the
puncture site is located and compress the puncture site where
bleeding is to be stopped are already known in the prior art (e.g.,
JP 3031486 U).
[0006] In such prior-art hemostatic devices, the pressure applied
to the site where bleeding is to be stopped is directed in a
substantially vertically downward direction, and the hemostatic
effect in this pressing direction is inadequate. Therefore,
complete hemostatis sometimes does not occur or takes a long time
to achieve.
[0007] Moreover, prior-art hemostatic devices apply pressure not
only to the puncture site where bleeding is to be stopped, but to
the surrounding area as well. Hence, other tissues are also
compressed, including other blood vessels and nerves, sometimes
resulting in numbness and poor blood circulation.
[0008] To keep this from happening, a health care practitioner such
as a physician or nurse must lower the compressive force over time
by carrying out manual operations to reduce the balloon pressure or
loosen the band, which is inefficient and inconvenient.
[0009] In addition, when using such prior-art hemostatic devices,
the health care practitioner visually sights the balloon into place
over the puncture site. It has been pointed out that this makes the
balloon difficult to position properly. In fact, due to poor
positioning of the balloon, a hematoma may form or blood leakage
may occur because of the inability to stop bleeding.
SUMMARY
[0010] The method disclosed here provides excellent hemostatic
effect. The method spontaneously (that is, without manipulation by
a health care practitioner such as a physician or nurse--sometimes
referred to hereinafter as the "operator") eases over time the
pressure applied by the balloon, thus helping to prevent harmful
effects from the continued application of pressure, such as
numbness, pain and vascular blockage. The method also enables a
balloon for compressing a puncture site (a site where blood flow is
to be stopped) to be easily positioned at the site, and thus
minimizes blood leakage and hematoma formation due to poor
positioning of the balloon.
[0011] According to one aspect, a method to stop bleeding at a
puncture site of an artery on a wrist of a patient comprises:
wrapping a flexible band of a hemostatic device around the wrist of
the patient so that the flexible band encircles the wrist of the
patient, the hemostatic device also comprising a plate made of a
material more rigid than the flexible band and having a curved
portion, a balloon and a visually identifiable marker used to
position the balloon at the puncture site, the flexible band, the
plate and the balloon being substantially transparent so that when
the flexible band is wrapped around the wrist of the patient, the
puncture site is visible through the plate, through the balloon and
through the flexible band, and the marker is visible to position
the balloon at the puncture site; positioning the balloon relative
to the puncture site through use of the marker to so that the
balloon overlies the puncture site and is situated between the
plate and the wrist of the patient; introducing fluid into the
balloon after the wrapping of the flexible band around the wrist of
the patient to inflate the balloon so that the balloon applies a
compressive force to the puncture site; and maintaining inflation
of the balloon and compression against the puncture site to stop
the bleeding from the puncture site.
[0012] These and other aspects of the method will become more
apparent upon consideration of the following detailed description
and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a bottom view of a first embodiment of the
hemostatic device according to the invention. This shows the side
of the device that serves as the inside surface when the device is
attached to the wrist of a patient.
[0014] FIG. 2 is a sectional view showing the same hemostatic
device as in FIG. 1 during use.
[0015] FIG. 3 is a sectional view showing a second embodiment of
the hemostatic device according to the invention.
[0016] FIG. 4 is a sectional view showing a third embodiment of the
hemostatic device according to the invention.
[0017] FIG. 5 is a bottom view of a fourth embodiment of the
hemostatic device according to the invention. This shows the side
of the device that serves as the inside surface when the device is
attached to the wrist of a patient.
[0018] FIG. 6 is a sectional view showing the same hemostatic
device as in FIG. 5 during use.
[0019] FIG. 7 is a graph of the change over time in balloon
internal pressure in the examples of the invention and the
comparative examples which are described later in this
specification.
DETAILED DESCRIPTION OF THE INVENTION
First Embodiment
[0020] As noted above, FIG. 1 is a bottom view of a first
embodiment of the hemostatic device according to the invention.
This shows the side of the device that serves as the inside surface
when the device is attached to the wrist of a patient. FIG. 2 is a
sectional view showing the same hemostatic device attached and in
use on the wrist.
[0021] The hemostatic device 1 shown in FIGS. 1 and 2 is used to
stop bleeding at a puncture site 510 following the removal of an
instrument such as a catheter which was inserted percutaneously
into an artery through a puncture formed somewhere on a limb, such
as at a wrist 500, for a medical purpose such as treatment,
examination or diagnosis. This hemostatic device 1 has a band 2
which is adapted to be wrapped around the wrist 500, a surface
fastener 3 for securing the band 2 in a wrapped state to the wrist
500, a curved plate 4, a main balloon 5 and a secondary balloon
6.
[0022] The band 2 is a flexible belt-like member. As shown in FIG.
2, the band 2 is attached to the wrist 500 by being wrapped one
full turn around the outside of the wrist 500 and having portions
of the band 2 near both ends thereof mutually overlap. The
overlapping portions of the band 2 are then secured, or joined, by
means of the subsequently described surface fastener 3.
[0023] The material making up the band 2 is not subject to any
particular limitation, as far as the puncture site 510 can be seen
therethrough. Illustrative examples include polyvinyl chloride,
polyolefins such as polyethylene, polypropylene, polybutadiene and
ethylene-vinyl acetate copolymers (EVA), polyesters such as
polyethylene terephthalate (PET) and polybutylene terephthalate
(PBT), polyvinylidene chloride, silicones, polyurethanes various
thermoplastic elastomers such as polyamide elastomers, polyurethane
elastomers and polyester elastomers, and any combinations of the
above in the form of, for example, resin blends, polymer alloys or
laminates.
[0024] It is preferable for the band 2 to be substantially
transparent to ensure that the puncture site 510 is visible
therethrough.
[0025] The material making up the band 2 is in the form of a sheet
which may be of any suitable thickness. For the band 2 to have a
tensile modulus and an elongation percentage within the
subsequently described ranges, it is preferable for the sheet-like
material of which it is made to have a thickness of about 0.1 to
0.5 mm, and especially about 0.2 to 0.3 mm.
[0026] The band 2 may have near the center thereof a curved plate
holder 21 for holding the subsequently described curved plate 4. In
the embodiment shown in FIG. 1, the curved plate holder 21 is
composed in part of a separate strip-like member joined to the
outside (or inside) surface of the band 2 by a suitable method such
as welding (e.g., heat welding, high-frequency welding, ultrasonic
welding) or adhesion (such as with an adhesive or solvent) so as to
form a double layer construction. The curved plate 4 is inserted
into a gap in the double layer and thereby held.
[0027] The band 2 has attached to it, on the inside surface (the
front side in the plane of FIG. 1) thereof near the left end in
FIG. 1, the male side (or female side) 31 of a surface fastener 3
such as a velcro-type hook and loop fastener (e.g., the product
commonly known in Japan as Magic Tape.RTM.). Similarly, the band 2
has attached to it, on the outside surface (the back side in the
plane of FIG. 1) near the right end in FIG. 1, the female side (or
male side) 32 of a surface fastener 3. As shown in FIG. 2, the band
2 is attached to the wrist 500 by joining together the male side 31
and the female side 32 of this surface fastener 3. The means that
may be employed to secure the band 2 in a wrapped state to the
wrist 500 are not limited only to surface fasteners 3. Other
suitable means include snaps, buttons, clips, and members such as
buckles through which the ends of the band 2 are passed.
[0028] The curved plate 4 is inserted into the gap in the double
layer construction of the curved plate holder 21 on the band 2, and
is thereby held on the band 2.
[0029] The curved plate 4 is shaped so that at least a portion
thereof is curved toward an inner peripheral side of the plate 4.
This curved plate 4 is constructed of a material more rigid than
the band 2 and maintains a substantially fixed shape.
[0030] As is apparent from FIG. 1, in this embodiment, the curved
plate 4 has a shape that is elongated in the lengthwise direction
of the band 2. As shown in FIG. 2, the curved plate 4 has a center
portion 41 in the lengthwise direction thereof which is
substantially uncurved and thus shaped as a flat plate. The curved
plate 4 also has, on either side of this center portion 41, curved
portions 42 which curve toward the inner peripheral side of the
plate 4 and along the lengthwise direction of the band 2
(circumferential direction of the wrist 500). The curved portions
42 have a radius of curvature R2 which is smaller than the radius
of curvature R1 of the center portion 41 (in the illustrated
arrangement, R1 is substantially infinite).
[0031] The material making up the curved plate 4 is not subject to
any particular limitation, as far as the puncture site 510 can be
seen therethrough. Examples of materials of which the curved plate
4 may be made include acrylic resins, polyvinyl chloride
(particularly rigid polyvinyl chloride), polyolefins such as
polyethylene, polypropylene and polybutadiene, polystyrene,
poly(4-methyl-1-pentene), polycarbonates, ABS resins, polymethyl
methacrylate (PMMA), polyacetals, polyarylates, polyacrylonitriles,
polyvinylidene fluorides, ionomers, acrylonitrile-butadiene-styrene
copolymers, polyesters such as polyethylene terephthalate (PET) and
polybutylene terephthalate (PBT), butadiene-styrene copolymers,
aromatic and aliphatic polyamides, and fluorocarbon resins such as
polytetrafluoroethylene.
[0032] It is preferable for the curved plate 4 to be substantially
transparent to ensure that the puncture site 510 is externally
visible.
[0033] Alternatively, the curved plate 4 may have no uncurved
portion such as center portion 41, and may thus be curved over its
entire length.
[0034] The method of providing the curved plate 4 on the band 2 is
not limited to the illustrated arrangement, and may involve joining
the curved plate 4 to the inside surface or outside surface of the
band 2 by a suitable method such as welding or adhesion. The band 2
need not encircle the wrist 500 completely. For example, another
acceptable arrangement is one in which the band 2 is connected to
both ends of the curved plate 4. It is thus not essential for a
portion of the band 2 to overlap with the curved plate 4.
[0035] The band 2 or curved plate 4 has connected to the inner side
thereof a balloon 5 made of a flexible material. The balloon 5
inflates when a fluid (a gas such as air, or a liquid) is
introduced therein, thus applying pressure to the puncture site 510
on the wrist 500.
[0036] The balloon 5 is positioned near one end of the curved plate
4 in the lengthwise direction thereof. That is, in the arrangement
shown in FIG. 2, the balloon 5 is in a position that overlaps with
substantially the right half of the curved plate 4.
[0037] The material making up the balloon 5 is not subject to any
particular limitation provided it is a material that allows the
puncture site 510 to be seen. For example, a material similar to
that making up the band 2 may be used. To facilitate joining of the
balloon 5 with the band 2 by welding, and thus make the hemostatic
device 1 easier to manufacture, it is preferable for the balloon 5
to be made of a material which is of the same nature or type as
that making up the band 2.
[0038] It is desirable for the balloon 5 to be substantially
transparent to ensure that the puncture site is externally
visible.
[0039] The material making up the balloon 5 is in the form of a
sheet which may be of any suitable thickness. For the balloon 5 to
have a tensile modulus and an elongation percentage within the
subsequently described ranges, it is preferable for the sheet-like
material of which it is made to have a thickness of about 0.1 to
0.5 mm, and especially about 0.2 to 0.3 mm.
[0040] The balloon 5 may have a construction in which the edges of
sheets made of the above-described material are sealed together by
a suitable process such as welding or adhesion to form a sort of
pouch. In the arrangement shown in FIG. 1, the balloon 5 is
substantially square in the uninflated state.
[0041] The balloon 5 is connected to the band 2 by a flexible
connector 11. In the present embodiment, the balloon 5 is connected
to the band 2 by a connector 11 only on the side of one end of the
curved plate 4; that is, only on the right side in FIG. 2. The
connector 11 has a relatively short length, thereby keeping the
balloon 5 tethered in a position deviated to one end of the curved
plate 4. The connector 11 is preferably made of the same material
as the balloon 5.
[0042] In the present embodiment, because only one side of the
balloon 5 is connected to the band 2 by the connector 11, when the
hemostatic device 1 is attached to the wrist 500 in the state shown
in FIG. 2, the balloon 5 assumes a somewhat tilted orientation. As
a result, the pressing force F applied to the puncture site 510
acts in an oblique direction.
[0043] As shown in FIG. 1, the balloon 5 has connected thereto an
inflator 7 for introducing a fluid into the balloon 5. The inflator
7 is composed of a flexible tube 71 which is connected at a
proximal end thereof to the balloon 5 and which has a lumen that
communicates with the interior of the balloon 5, a bulb 72 which is
provided at the distal end of the tube 71, and a tubular connector
73 which is joined to the bulb 72. The tube 71 may include a
connector or other means (not shown) which is connected to the
balloon 5 side thereof and adapted to allow the tube 71 to be
detached from the hemostatic device 1 of the present invention.
[0044] Inflation of the balloon 5 is carried out by inserting the
protruding tip of a syringe (not shown) into the connector 73 and
pushing a plunger on the syringe so as to introduce fluid within
the syringe through the inflator 7 into the balloon 5. Once fluid
has been injected into the balloon 5 and the protruding tip of the
syringe is withdrawn from the connector 73, a check valve within
the connector 73 closes, preventing the fluid from leaking out and
thus maintaining the balloon 5 in an inflated state.
[0045] As shown in FIG. 2, a secondary balloon 6 composed of a
flexible material may be provided between the curved plate 4 and
the above-described balloon 5 (sometimes referred to hereinafter as
the "main balloon" to avoid confusion) in such a way that all or
part of the secondary balloon 6 overlaps with the main balloon 5.
This secondary balloon 6 functions as a pressing member for
pressing against the main balloon 5.
[0046] Under the pressure of the fluid with which it is filled, the
secondary balloon 6 applies to the main balloon 5 a pressing force
(arrow fin FIG. 2) which is directed toward substantially the
center 520 of the wrist 500. Under the influence of this pressing
force f from the secondary balloon 6, the main balloon 5 in turn
applies to the puncture site 510 a compressive force (arrow F in
FIG. 2) that acts in an oblique or inclined direction (toward the
center 520 of the wrist 500) rather than vertically downward (that
is, in a vertical direction with respect to the surface of the
wrist 500). This arrangement provides a better hemostatic effect
and is thus able to more reliably stop bleeding than when
compression is applied to the puncture site 510 in a vertically
downward direction.
[0047] In the arrangement illustrated in FIG. 2 in which the
hemostatic device 1 is shown wrapped about the wrist 500, the main
balloon 5 is not in contact with the curved plate 4 through the
band 2. However, a portion of the main balloon 5 may be in contact
with the curved plate 4 through the band 2.
[0048] The material making up the secondary balloon 6 is not
subject to any particular limitation, as far as the puncture site
510 can be seen therethrough. For example, materials similar to the
above-described materials making up the band 2 and the main balloon
5 may be used. It is preferable for the secondary balloon 6 to be
substantially transparent to ensure that the puncture site 510 is
externally visible. The material making up the secondary balloon 6
is in the form of a sheet which may have a thickness like that of
the material making up the main balloon 5. The secondary balloon 6
may also have a construction like that of the main balloon 5.
[0049] In the present embodiment of the invention, the secondary
balloon 6 has a smaller width in the lengthwise direction of the
band 2 than the main balloon 5. Hence, the secondary balloon 6 is
smaller in size than the main balloon 5 and thus applies pressure
locally to the main balloon 5. This enables the direction of the
pressing force F applied by the main balloon 5 to the puncture site
510 to be more reliably inclined.
[0050] Moreover, the secondary balloon 6 is positioned near the
right end of the curved plate 4 in the lengthwise direction
thereof, as shown in FIG. 2. This enables the pressing force f
applied by the secondary balloon 6 to the main balloon 5 to be made
more reliably directed toward the center 520 of the wrist 500. In
turn, the direction of the pressing force F applied by the main
balloon 5 to the puncture site 510 can be more reliably
inclined.
[0051] In this embodiment, as mentioned above, the curved plate 4
has, on the side on which the main balloon 5 is positioned (the
right side in FIG. 2), a curved portion 42 with a radius of
curvature smaller than that of the center portion 41 of the curved
plate 4. The secondary balloon 6 contacts, through the band 2, the
curved portion 42 of the curved plate 4 or a portion to the right
side thereof in FIG. 2. In this way, the direction of the force
incurred by the secondary balloon 6 from the curved plate 4, i.e.,
the normal direction of the curved plate 4 where it contacts the
secondary balloon 6 through the band 2, is inclined toward the
center 520 of the wrist 500. As a result, the directions of
pressing force f and pressing force F can be more reliably
inclined.
[0052] In this embodiment, a portion of the main balloon 5 and a
portion of the secondary balloon 6 are joined together by a
suitable method such as welding or adhesion. At the resulting
junction, an opening 12 is formed as a means for communicating
between the interior of the main balloon 5 and the interior of the
secondary balloon 6. When a fluid is injected into the main balloon
5 in the manner described above, some of the injected fluid flows
through the opening 12 into the secondary balloon 6, so that the
secondary balloon 6 inflates as the main balloon 5 inflates. In
this way, both balloons can be inflated in a single operation,
providing excellent ease of use and efficiency.
[0053] In addition to being joined to the main balloon 5 in the
vicinity of the opening 12, the secondary balloon 6 may also be
joined to the main balloon 5 at a place near the connector 11 (on
the right end in FIG. 2). This enables pressure to be more reliably
applied to the main balloon 5 and increases the upward pushing
force upon the curved plate 4, making it easier to move the curved
plate 4 away from the wrist 500.
[0054] In a different arrangement than that shown in FIGS. 1 and 2,
inflation of the secondary balloon 6 by the introduction of a fluid
may be carried out separately from inflation of the main balloon
5.
[0055] Moreover, the secondary balloon 6 need not be adapted to
inflate with the injection of a fluid at the time of use as in the
present embodiment. Instead, it may be filled with a fluid and
inflated to begin with; that is, prior to the time of use.
[0056] In this invention, the pressing member which presses against
the main balloon 5 is not limited to a secondary balloon 6. Other
types of pressing members that may be used for this purpose include
pads made of a spongy substance, an elastomeric material, an
assemblage of fibers such as cotton, or combinations thereof.
[0057] A method of using the above-described hemostatic device 1 of
the invention is described below.
(1) Before attaching the hemostatic device 1 to a patient's limb,
the main balloon 5 and the secondary balloon 6 are placed in an
uninflated state. In cases where the procedure is carried out at
the wrist 500, the site of puncture 510 into an artery is generally
on the inner side of the wrist 500 (where the tendons are located)
and on the thumb side. There will be times where an introducer
sheath (not shown) is inserted and in place at the puncture site
510, and other times where no such sheath is present. The method of
using the inventive hemostatic device 1 is the same in both cases.
While compressing the puncture site 510 with a finger or other
suitable means, the operator positions the main balloon 5 over the
puncture site 510, wraps the band 2 around the wrist 500, and
secures, or joins, the band 2 near both ends thereof with a surface
fastener 3.
[0058] In a method of using the hemostatic device 110 according to
the subsequently described fourth embodiment of the invention, the
operator typically wraps the band 2 around a wrist 500 where an
introducer sheath may or may not be inserted and in place,
positions the main balloon 5 (band 2) so that a marker 8 provided
on the balloon 5 lies over the puncture site 510, and secures, or
joins, the band 2 near both ends thereof with a surface fastener
3.
(2) Once the hemostatic device 1 has been attached to the wrist
500, a syringe (not shown) is connected to the connector 73 on the
inflator 7 and a fluid is introduced into the main balloon 5 and
the secondary balloon 6 as described above, thereby inflating the
main balloon 5 and the secondary balloon 6. In the present
invention, the degree of inflation by the main balloon 5 and the
secondary balloon 6, i.e., the compressive force applied to the
puncture site 510, can easily be adjusted for the particular
medical case and circumstances by varying the amount of fluid
introduced at this time, making operation of the hemostatic device
1 very easy and efficient. (3) Once the main balloon 5 and the
secondary balloon 6 have been inflated, the syringe is separated
from the connector 73. If an introducer sheath is in place at the
puncture site 510, it is removed at this point.
[0059] If the connector 73 has a check valve, the check valve is
closed after the syringe is removed, which will prevent the sudden
leakage of fluid. Thus, the main balloon 5 and the secondary
balloon 6 remain inflated and so compression against the puncture
site 510 is maintained (see FIG. 2). In this state, the main
balloon 5 applies pressure locally to the puncture site 510 and its
environs. Moreover, inflation of the main balloon 5 and the
secondary balloon 6 causes the curved plate 4 to move away from the
surface of the wrist 500 so that it does not readily come into
contact with the wrist 500. Accordingly, compressive forces are
concentrated at the puncture site 510 and its environs, resulting
in an excellent hemostatic effect while avoiding the compression of
other tissues, including blood vessels not requiring hemostatis and
nerves, and thus effectively preventing undesirable effects such as
numbness of the hand and poor circulation.
(4) In the fifth embodiment of the invention described later in
this specification, after inflation of the main balloon 5 is
complete, the internal pressure of the balloon 5 gradually
decreases. The internal pressure 60 minutes after inflation falls
to about 20 to 70% of the initial internal pressure. As a result,
the compressive force applied to the puncture site 510 eases over
time, making it possible to prevent the harmful effects of a
sustained compressive force, such as numbness, pain, and the
occlusion of blood vessels (poor blood circulation). (5) When
bleeding is determined to have stopped to a sufficient degree, the
hemostatic device 1 of the invention is removed from the puncture
site 510. The length of time from the completion of balloon 5
inflation until removal of the hemostatic device 1 (referred to
hereinafter as the "hemostatic device attachment time") is not
subject to any particular limitation. Hemostatis using this device
may be carried out for a period of, for example, 150 to 360
minutes. The hemostatic device attachment time may be selected as
appropriate for the individual patient and his or her medical
condition.
[0060] Second to fifth embodiments of the inventive hemostatic
device are described below in conjunction with the attached
drawings, with particular reference to those features which differ
from the foregoing first embodiment of the invention. Descriptions
of like features are omitted.
Second Embodiment
[0061] FIG. 3 is a sectional view showing a hemostatic device
according to a second embodiment of the invention during use.
[0062] The hemostatic device 10 in this embodiment has the same
features as the hemostatic device 1 in the above-described first
embodiment, except that the secondary balloon 6 is connected to the
band 2 via a flexible connector 13.
[0063] In the present embodiment, the secondary balloon 6, by being
connected to the band 2 via a connector 13 on the same side as the
connector 11 for the main balloon 5 (i.e., the right side in FIG.
3), more easily and reliably assumes a tilted orientation. This
more readily allows the pressing force f applied to the main
balloon 5 to act in an oblique direction (that is, in a direction
which causes the main balloon 5 to face substantially the center
520 of the wrist 500), thus enabling a better hemostatic effect to
be achieved.
Third Embodiment
[0064] FIG. 4 is a sectional view showing a hemostatic device
according to a third embodiment of the invention during use.
[0065] The hemostatic device 100 in this embodiment has the same
features as the above-described first embodiment, except that it
lacks a secondary balloon 6.
[0066] That is, in the present embodiment, there is no secondary
balloon 6. Instead, the main balloon 5 comes into contact with the
curved plate 4 through the band 2. Moreover, the balloon 5 is
connected to the band 2 only on one side through a connector 11,
thus giving the balloon 5 a somewhat tilted orientation, as shown
in FIG. 4. This enables the compression force F applied to the
puncture site 510 to act in an oblique direction (that is, in a
direction facing the center 520 of the wrist 500). As in the first
embodiment described above, the result is that a better hemostatic
effect can be obtained.
[0067] Moreover, as in the first embodiment, the balloon 5 is
positioned on the connector 11 side (the right side in FIG. 4) with
respect to the curved plate 4. The curved plate 4 has a center
portion 41 and, on the side on which the balloon 5 is positioned
(the right side in FIG. 4), a curved portion 42 with a smaller
radius of curvature than the center portion 41. On the right side
(in FIG. 4) of the curved portion 42, the curved plate 4 pushes the
balloon 5 (through the intervening band 2) in a direction facing
the center portion 520 of the wrist 500. Hence, in this embodiment,
the compressive force F acts more reliably in an oblique
direction.
Fourth Embodiment
[0068] FIG. 5 is a bottom view of a fourth embodiment of the
hemostatic device of the invention. This shows the side of the
device that serves as the inside surface when the device is
attached to the wrist of a patient. FIG. 6 is a sectional view
showing the same hemostatic device as in FIG. 5 when attached and
in use on the wrist of a patient.
[0069] As shown in FIG. 5, the hemostatic device 110 of the present
embodiment has a marker 8 provided on the inside surface of the
main balloon 5; that is, the surface which comes into contact with
the puncture site 510 (the front side in the plane of FIG. 5).
Providing such a marker 8 on the balloon 5 in the hemostatic device
110 of this embodiment facilitates proper positioning of the
balloon 5 at the puncture site 510, which in turn helps prevent
blood leakage and hematoma formation due to poor positioning of the
balloon 5.
[0070] As shown in FIG. 5, it is preferable for the marker 8 to be
provided at the center of the balloon 5; that is, to be centered at
the intersection of the diagonals for the square shape of the
balloon 5. Because this enables the center of the balloon 5 to be
properly positioned at the puncture site 510, when the balloon 5
has been inflated, the compressive force applied by the balloon 5
acts reliably upon the puncture site 510.
[0071] The marker 8 is not limited to any particular shape.
Examples of suitable shapes include circular, triangular and square
shapes. In FIG. 5, the marker 8 has a square shape.
[0072] No particular limitation is imposed on the size of the
marker 8. However, when the marker 8 is square, for example, it is
preferable for the length of one side of the square to be in a
range of 1 to 4 mm. If the length of one side is 5 mm or more, the
marker 8 becomes large relative to the size of the puncture site
510, which may make the center of the balloon 5 difficult to
position properly over the puncture site 510.
[0073] The marker 8 may be made of any suitable material, including
oil-based coloring materials such as inks, and pigment-containing
resins.
[0074] The color of the marker 8 is not subject to any particular
limitation, insofar as it is a color that enables the balloon 5 to
be properly positioned at the puncture site 510.
[0075] However, a greenish color is preferred because this makes
the marker 8 readily visible on blood and the skin, thus enabling
the balloon 5 to be more easily positioned at the puncture site
510.
[0076] It is also desirable for the marker 8 to be translucent so
as to enable the puncture site 510 to be visible from outside of
the marker 8.
[0077] No particular limitation is imposed on the method used to
place the marker 8 on the balloon 5. Examples of suitable methods
include printing the marker 8 onto the balloon 5, welding the
marker 8 to the balloon 5, and applying an adhesive to one side of
the marker 8 and affixing it to the balloon 5.
[0078] It is also possible to place the marker 8 on the outside
surface of the balloon 5; that is, on the side opposite the surface
of the balloon 5 that comes into direct contact with the puncture
site 510 (the back side in the plane of FIG. 5).
[0079] Alternatively, instead of being placed on the main balloon
5, the marker 8 may be placed on the band 2, on the curved plate 4,
or on the subsequently described secondary balloon 6. In such
cases, it is advantageous for the marker 8 to be placed in such a
way that it can be positioned over the center of the main balloon
5.
[0080] In the hemostatic device 110 of the present embodiment, the
band 2 should be made of a material which allows the puncture site
510 to be seen. Those materials mentioned earlier in connection
with the band in the first embodiment of the hemostatic device are
widely used for the material of the band 2 in this embodiment.
Further, it is preferable for the band 2 to be substantially
transparent so that the puncture site 510 can be reliably seen from
the outside and the marker 8 can be easily and properly positioned
at the puncture site 510.
[0081] In the hemostatic device 110 of this embodiment, the curved
plate 4 should be made of a material which allows the puncture site
510 to be seen. Those materials mentioned earlier in connection
with the curved plate in the first embodiment of the hemostatic
device are widely used for the material of the curved plate 4 in
this embodiment. Further, it is preferable for the curved plate 4
in the present embodiment to be substantially transparent so that
the puncture site 510 is reliably visible from the outside and the
marker 8 can be easily and properly positioned at the puncture site
510.
[0082] In the hemostatic device 110 of this embodiment, the main
balloon 5 should be made of a material which allows the puncture
site 510 to be seen. Those materials mentioned earlier in
connection with the main balloon in the first embodiment of the
hemostatic device are widely used for the material of the main
balloon 5 in this embodiment. Further, it is desirable for the main
balloon 5 to be substantially transparent so that the puncture site
510 is reliably visible from the outside and the marker 8 can be
easily and properly positioned at the puncture site 510.
[0083] In the hemostatic device 110 of this embodiment, the second
balloon 6 should be made of a material which allows the puncture
site 510 to be seen. Those materials mentioned earlier in
connection with the second balloon in the first embodiment of the
hemostatic device are widely used for the material of the second
balloon 6 in this embodiment. Further, it is preferable for the
secondary balloon 6 to be substantially transparent so that the
puncture site 510 is reliably visible from the outside and the
marker 8 can be easily and properly positioned at the puncture site
510. By adopting an arrangement in which, as shown in FIG. 6, the
secondary balloon 6 is connected to the band 2 through a connector
13 on the same side (the right side in FIG. 6) as the connector 11
for the main balloon 5, the same effect can be achieved as in the
second embodiment described earlier.
Fifth Embodiment
[0084] In the hemostatic device of the present embodiment, the
balloon 5 is constructed so that, following complete inflation
thereof, the internal pressure decreases over time, the internal
pressure 60 minutes after inflation becoming 20 to 70%, and
preferably 30 to 60%, of the initial internal pressure. Here,
"initial internal pressure" refers to the pressure within the
balloon 5 ten seconds after inflation is complete; that is, after
the balloon 5 has been inflated to a degree sufficient to achieve a
compressive force suitable to stop bleeding.
[0085] By means of such an arrangement, the compressive force
applied by the balloon 5 relaxes suitably (neither too much nor too
little) with the passage of time, making it possible to effectively
prevent the harmful effects of a sustained compressive force, such
as numbness, pain and vascular blockage (poor circulation) at the
puncture site 510 and areas peripheral thereto. In particular, the
decrease in the internal pressure of the balloon 5 occurs
spontaneously without requiring some sort of manual operation (such
as the loosening of a valve to reduce pressure or release gas) by a
physician, nurse or other health care practitioner. This makes it
possible to avoid the trouble and inconvenience associated with
such operations.
[0086] If the internal pressure 60 minutes after balloon inflation
exceeds 70% of the initial internal pressure, the compressive force
(internal pressure) at the time of inflation of the balloon 5
remains at substantially the same level. In such a case, the
ability to avoid harm from a sustained compressive force is
limited.
[0087] On the other hand, if the internal pressure 60 minutes after
balloon inflation is less than 20% of the initial internal
pressure, the percent decrease in the internal pressure of the
balloon 5 is too large. The compressive force of the balloon 5
diminishes before sufficient hemostasis has occurred, which may
result in blood leakage at the puncture site 510.
[0088] Specific arrangements for lowering the internal pressure of
the balloon 5 over time in the manner described above are given
below.
A. Make the band 2 and/or the balloon 5 of a material which is
flexible and easily deformed (extended).
[0089] The band 2 and/or balloon 5 gradually deform under the
internal pressure and resilience of the inflated balloon 5 so as to
conform to the shape of the puncture site 510. As a result, the
internal pressure of the balloon 5 decreases, easing the
compressive force applied to the puncture site 510. That is, the
decrease in the compressive force acting upon the puncture site 510
is controlled by the physical properties (tensile modulus,
thickness, elongation percentage, etc.) of the materials making up
the band 2 and/or balloon 5.
[0090] Specifically, the band 2 has a tensile modulus of preferably
not more than 10 gf/mm.sup.2, and most preferably 2 to 9
gf/mm.sup.2.
[0091] The band 2 wrapped around the wrist 500 has an elongation
percentage 180 minutes after balloon inflation of preferably 1 to
7%, and more preferably 3 to 6%.
B. Control the gas permeability of the balloon 5. This enables gas
within the balloon 5 to pass through the sheet material making up
the balloon 5 and be slowly released to the exterior. As a result,
the internal pressure of the balloon 5 gradually decreases, easing
the compressive force applied to the puncture site 510. C. Control
the gas permeability of the secondary balloon 6 which communicates
with the main balloon 5. The gas within the secondary balloon 6
passes through the sheet material of which the secondary balloon 6
is made and is gradually released to the exterior. This brings
about a gradual decline in the internal pressure of both the
secondary balloon 6 and also the main balloon 5 that communicates
with it, easing the compressive force applied to the puncture site
510. D. Control the gas permeability of the tube 71 which
communicates with the balloon 5 and/or the bulb 72. In this way,
the gas within the balloon 5 passes through the tube 71 and/or bulb
72 and is slowly released to the exterior, allowing the internal
pressure of the balloon 5 to gradually decrease and thus easing the
compressive force applied to the puncture site 510. E. Make the gas
backflow-preventing effect of the check valve within the connector
73 incomplete so that a small amount of gas leaks out through the
check valve. As a result, a small amount of gas within the balloon
5 is steadily discharged to the exterior through the check valve
within the connector 73, gradually lowering the internal pressure
of the balloon 5 and easing the compressive force applied to the
puncture site 510. F. Combinations of any two or more of above
arrangements A to E.
[0092] Methods A to F above have the advantage of enabling control
of the interior pressure within the balloon 5 (i.e., pressure
reduction over time) to be achieved with a simple arrangement.
Method A in particular enables the interior pressure of the balloon
5 to be controlled by suitable selection of the constituent
materials and dimensions of the band 2 and the balloon 5.
[0093] In the hemostatic device of the present embodiment, the
internal pressure of the balloon 5 gradually decreases shortly
after inflation has been completed. The internal pressure 60
minutes after dilation falls to about 20 to 70% of the initial
internal pressure. This eases the compressive force applied to the
puncture site 510, making it possible to prevent various harmful
effects due to the sustained application of a compressive force,
such as numbness, pain and vascular blockage (poor
circulation).
[0094] Once it is determined that sufficient hemostasis has been
achieved, the hemostatic device is removed from the puncture site
510. The time until removal of the hemostatic device following
complete inflation of the balloon (i.e., the hemostatic device
attachment time) is not subject to any particular limitation,
although removal is typically carried out after about 150 to 360
minutes. This hemostatic device attachment time can be selected as
appropriate for the particular patient and his or her
condition.
EXAMPLES
[0095] Examples of the invention and comparative examples are given
below by way of illustration and not by way of limitation.
Example 1
[0096] A main balloon and a secondary balloon were each fabricated
from a substantially transparent polyvinyl chloride sheet having a
tensile modulus of 8 gf/mm.sup.2 and a thickness of 0.3 mm. In
addition, a band was fabricated from a substantially transparent
polyvinyl chloride sheet also having a tensile modulus of 8
gf/mm.sup.2 and a thickness of 0.3 mm. The band had a length of 190
mm and a width of 40 mm. The main balloon, secondary balloon and
band were welded together at the necessary places to form a
hemostatic device according to the fifth embodiment of the
invention having the construction shown in FIG. 1. A curved plate
made of substantially transparent polycarbonate resin and curved at
both ends was inserted into a curved plate holder on the band.
[0097] This hemostatic device was wrapped around the wrist and the
balloon was inflated by injecting air into the balloon through the
connector 73 on the inflator 7 until the balloon internal pressure
reached about 150 mmHg. Next, the internal pressure of the balloon
was measured, first 10 seconds after full inflation of the balloon
(initial internal pressure), then 10, 30, 60, 120 and 180 minutes
after full inflation. The results of measurement are shown in Table
1 below and FIG. 7.
[0098] In addition, 180 minutes after inflation, the hemostatic
device was removed from the wrist and the length of the band was
measured. The band had a length of 197 mm, representing an
elongation percentage of 3.6%.
TABLE-US-00001 TABLE 1 Example 1 Time elapsed after Internal
pressure of Pressure as a percentage of balloon inflation balloon
(mmHg) initial internal pressure 10 seconds 161 100 10 minutes 128
79.5 30 minutes 108 67.0 60 minutes 79 49.0 120 minutes 66 40.9 180
minutes 64 39.7
Example 2
[0099] A main balloon and a secondary balloon were each fabricated
from a substantially transparent polyvinyl chloride sheet material
having a tensile modulus of 3 gf/mm.sup.2 and a thickness of 0.2
mm. In addition, a band was fabricated from a substantially
transparent polyvinyl chloride sheet material also having a tensile
modulus of 3 gf/mm.sup.2 and a thickness of 0.2 mm. The band had a
length of 190 mm and a width of 40 mm. The main balloon, secondary
balloon and band were welded together at the necessary places to
form a hemostatic device according to the fifth embodiment of the
invention having the construction shown in FIG. 1. A curved plate
made of substantially transparent polycarbonate resin and curved at
both ends was inserted into a curved plate holder on the band.
[0100] This hemostatic device was wrapped around the wrist and the
balloon was inflated by injecting air into the balloon through the
connector 73 on the inflator 7 until the balloon internal pressure
reached about 150 mmHg. Next, the internal pressure of the balloon
was measured, first 10 seconds after full inflation of the balloon
(initial internal pressure), then 10, 30, 60, 120 and 180 minutes
after full inflation. The results of measurement are shown in Table
2 below and FIG. 7.
[0101] In addition, 180 minutes after inflation, the hemostatic
device was removed from the wrist and the length of the band was
measured. The band had a length of 201 mm, representing an
elongation percentage of 5.8%.
TABLE-US-00002 TABLE 2 Example 2 Time elapsed after Internal
pressure of Pressure as a percentage of balloon inflation balloon
(mmHg) initial internal pressure 10 seconds 152 100 10 minutes 133
87.5 30 minutes 110 72.4 60 minutes 84 55.2 120 minutes 59 38.8 180
minutes 40 26.3
Comparative Example 1
[0102] A main balloon and a secondary balloon were each fabricated
from a substantially transparent polyvinyl chloride sheet material
having a tensile modulus of 16 gf/mm.sup.2 and a thickness of 0.3
mm. In addition, a band was fabricated from a substantially
transparent polyvinyl chloride sheet material having a tensile
modulus of 17 gf/mm.sup.2 and a thickness of 0.5 mm. The band had a
length of 190 mm and a width of 40 mm. The main balloon, secondary
balloon and band were welded together at the necessary places to
form a hemostatic device having the construction shown in FIG. 1. A
curved plate made of substantially transparent polycarbonate resin
and curved at both ends was inserted into a curved plate holder on
the band.
[0103] This hemostatic device was wrapped around the wrist and the
balloon was inflated by injecting air into the balloon through the
connector 73 on the inflator 7 until the balloon internal pressure
reached about 150 mmHg. Next, the internal pressure of the balloon
was measured, first 10 seconds after full inflation of the balloon
(initial internal pressure), then 10, 30, 60, 120 and 180 minutes
after full inflation. The results of measurement are shown in Table
3 below and FIG. 7.
[0104] In addition, 180 minutes after inflation, the hemostatic
device was removed from the wrist and the length of the band was
measured. The band had a length of 191 mm, representing an
elongation percentage of 0.5%.
TABLE-US-00003 TABLE 3 Comparative Example 1 Time elapsed after
Internal pressure of Pressure as a percentage of balloon inflation
balloon (mmHg) initial internal pressure 10 seconds 155 100 10
minutes 131 84.5 30 minutes 122 78.7 60 minutes 113 73.9 120
minutes 108 69.6 180 minutes 106 68.3
Comparative Example 2
[0105] A hemostatic device manufactured by Nippon Sherwood Medical
Industries Ltd. under the trade name Radiseal was furnished for
use. In this hemostatic device, the band was composed of a
polyvinyl chloride sheet having a thickness of about 0.5 mm and the
balloon was composed of a polyvinyl chloride sheet having a
thickness of about 0.3 mm. The device lacked a secondary balloon
and was constructed such that, when inflated, the balloon pressed
against substantially the center of the wrist.
[0106] This hemostatic device was wrapped around the wrist and the
balloon was inflated by introducing air from an inflator until the
balloon internal pressure reached about 150 mmHg. Next, the
internal pressure of the balloon was measured, first 10 seconds
after full inflation of the balloon (initial internal pressure),
then 10, 30, 60, 120 and 180 minutes after full inflation. The
results of measurement are shown in Table 4 below and FIG. 7
TABLE-US-00004 TABLE 4 Comparative Example 2 Time elapsed after
Internal pressure of Pressure as a percentage of balloon inflation
balloon (mmHg) initial internal pressure 10 seconds 153 100 10
minutes 136 88.8 30 minutes 130 84.9 60 minutes 125 81.6 120
minutes 117 76.4 180 minutes 113 73.8
Comparative Example 3
[0107] A main balloon and a secondary balloon were each fabricated
from a substantially transparent polyvinyl chloride sheet material
having a tensile modulus of 16 gf/mm.sup.2 and a thickness of 0.3
mm. In addition, a band was fabricated from a substantially
transparent polyvinyl chloride sheet material having a tensile
modulus of 17 gf/mm.sup.2 and a thickness of 0.5 mm. The band had a
length of 190 mm and a width of 40 mm. The main balloon, secondary
balloon and band were welded together at the necessary places. In
addition, the sheet material making up the secondary balloon was
pierced in three places with a needle to form small holes and
thereby increase the gas permeability of the secondary balloon.
This yielded a hemostatic device having the construction shown in
FIG. 1. A curved plate made of substantially transparent
polycarbonate resin and curved at both ends was inserted into a
curved plate holder on the band.
[0108] This hemostatic device was wrapped around the wrist and the
balloon was inflated by injecting air into the balloon through the
connector 73 on the inflator 7 until the balloon internal pressure
reached about 150 mmHg. Next, the internal pressure of the balloon
was measured, first 10 seconds after full inflation of the balloon
(initial internal pressure), then 10, 30, 60, 120 and 180 minutes
after full inflation. The results of measurement are shown in Table
5 below and FIG. 7.
TABLE-US-00005 TABLE 5 Comparative Example 3 Time elapsed after
Internal pressure of Pressure as a percentage of balloon inflation
balloon (mmHg) initial internal pressure 10 seconds 154 100 10
minutes 107 69.5 30 minutes 56 36.4 60 minutes 27 17.5 120 minutes
15 9.7 180 minutes 6 3.9
[0109] In both Examples 1 and 2 according to the invention, no
numbness, pain or poor circulation arose in the wrist or areas
peripheral thereto, such as the palm and fingers, when the
hemostatic device was attached or even later when the hemostatic
device was removed from the wrist 180 minutes after inflation of
the balloon.
[0110] By contrast, in Comparative Examples 1 and 2, some numbness
of the fingers was sensed when the hemostatic device was attached
and when the hemostatic device was removed from the wrist 120
minutes or 180 minutes after inflation of the balloon.
[0111] In Comparative Example 3, a sense of pressure by the balloon
at the wrist ceased almost entirely to be felt 30 to 60 minutes
after balloon inflation. The hemostatic effects were thus
presumably insufficient in this case.
[0112] The illustrated embodiments of the hemostatic device of the
invention have been described above, although many modifications
and variations may be made thereto in light of the above teachings.
It is therefore to be understood that the invention may be
practiced otherwise than as specifically described without
departing from the scope of the appended claims. For example,
various parts of the hemostatic device having the specific
configurations shown and described herein may be substituted with
parts of similar function but having other configurations.
Moreover, other suitable components may be added to the hemostatic
device as described herein.
[0113] The hemostatic device of the invention is not limited to use
on the wrist alone, and can be employed as a hemostatic device for
attachment and use on any portion of a patient's arm or leg
(referred to collectively in this specification as "limbs").
[0114] As described above and demonstrated in the examples, the
hemostatic device of the invention provides excellent hemostatic
effects and moreover prevents harmful effects such as numbness and
poor circulation in areas peripheral to the site of attachment
thereof.
[0115] An even better hemostatic effect can be obtained when the
balloon is in a position deviated to one end of the curved plate in
the lengthwise direction of the band, and especially when the
curved plate has, on the side on which the balloon is positioned, a
portion with a smaller radius of curvature than the center portion
of the curved plate.
[0116] By providing a marker for positioning the balloon at the
site where bleeding is to be stopped, the balloon can easily be
properly positioned and blood leakage or hematoma formation due to
incorrect placement of the balloon can be prevented.
[0117] In embodiments of the inventive hemostatic device in which
the internal pressure of the inflated balloon decreases over time,
the compressive force applied by the balloon relaxes suitably
(neither too much nor too little) with the passage of time,
enabling the effective prevention of harm from a sustained
compressive force, such as numbness, pain or vascular blockage
(poor circulation) at the puncture site and areas peripheral
thereto.
[0118] In such embodiments, the decrease in the internal pressure
of the balloon occurs spontaneously without requiring some sort of
manual operation (such as the loosening of a valve to reduce
pressure or release gas) by a physician, nurse or other health care
practitioner. This makes it possible to avoid the trouble and
inconvenience associated with such operations.
* * * * *