U.S. patent application number 15/908882 was filed with the patent office on 2018-09-06 for hemostatic device.
This patent application is currently assigned to TERUMO KABUSHIKI KAISHA. The applicant listed for this patent is TERUMO KABUSHIKI KAISHA. Invention is credited to Shuhei MATSUSHITA, Hiroshi YAGI.
Application Number | 20180250017 15/908882 |
Document ID | / |
Family ID | 58187780 |
Filed Date | 2018-09-06 |
United States Patent
Application |
20180250017 |
Kind Code |
A1 |
MATSUSHITA; Shuhei ; et
al. |
September 6, 2018 |
HEMOSTATIC DEVICE
Abstract
A hemostatic device includes a flexible band allowed to be
wrapped around a wrist in which a radial artery and an ulnar artery
run, a hook and loop fastener that secures the band in a state of
being wrapped around the wrist, an inflatable portion connected to
the band and allowed to press a puncture site of the radial artery
by being inflated in response to injection of a fluid, and a
pressing member disposed at a different position from a position of
the inflatable portion in a longitudinal direction of the band and
allowed to press the ulnar artery. Further, a length of the
pressing member along the longitudinal direction of the band is
shorter than a width of the pressing member along a direction
orthogonal to the longitudinal direction of the band.
Inventors: |
MATSUSHITA; Shuhei; (Hadano,
JP) ; YAGI; Hiroshi; (Ichinomiya, JP) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TERUMO KABUSHIKI KAISHA |
Tokyo |
|
JP |
|
|
Assignee: |
TERUMO KABUSHIKI KAISHA
Tokyo
JP
|
Family ID: |
58187780 |
Appl. No.: |
15/908882 |
Filed: |
March 1, 2018 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
PCT/JP2016/075912 |
Sep 2, 2016 |
|
|
|
15908882 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/1325 20130101;
A61B 17/135 20130101; A61B 2017/00557 20130101 |
International
Class: |
A61B 17/135 20060101
A61B017/135 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 3, 2015 |
JP |
2015-174197 |
Sep 3, 2015 |
JP |
2015-174198 |
Sep 3, 2015 |
JP |
2015-174201 |
Claims
1. A hemostatic device comprising: a flexible band configured to be
wrapped around an arm in which a radial artery and an ulnar artery
are located, the flexible band possessing a longitudinal extent
that extends in a longitudinal direction; a securing portion that
secures the flexible band on the arm while the flexible band is
wrapped around the arm in a wrapped state; an inflatable member
connected to the flexible band and expandable upon being inflated
in response to introducing fluid into an interior of the inflatable
member to press a part of the radial artery to be subjected to
hemostasis, the inflatable member possessing oppositely facing
surfaces; a pressing member disposed at a position spaced from a
position of the inflatable member in the longitudinal direction of
the flexible band to press the ulnar artery, the pressing member
possessing oppositely facing surfaces; and the pressing member
possessing a length along the longitudinal direction of the
flexible band that is shorter than a width of the pressing member
along a direction orthogonal to the longitudinal direction of the
flexible band.
2. The hemostatic device according to claim 1, wherein the band
possesses a width in the direction orthogonal to the longitudinal
direction of the band, the width of the pressing member being less
than or equal to the width of the band.
3. The hemostatic device according to claim 1, wherein the
inflatable member possesses a width in the longitudinal direction
of the band, the length of the pressing member being shorter than
the length of the inflatable member.
4. The hemostatic device according to claim 1, wherein the pressing
member is inflatable to outwardly expand when a fluid is injected
into the pressing member, and a volume of the inflatable member in
an inflated state is larger than a volume of the pressing member in
an inflated state.
5. The hemostatic device according to claim 1, further comprising a
first tube in communication with the interior of the inflatable
member to introduce the fluid into the interior of the inflatable
member, and a second tube in communication with an interior of the
pressing member to introduce fluid into the interior of the
pressing member.
6. The hemostatic device according to claim 1, further comprising a
plate that is more rigid than the flexible band, the plate being
mounted on the flexible band so that the plate and the flexible
band move together as a unit, the plate including an inner surface
that faces toward the arm when the flexible band is wrapped around
the arm in the wrapped state, the inner surface of the plate
including a center inner surface portion, a first curved inner
surface portion and a second curved inner surface portion, the
center inner surface portion being positioned between the first and
second inner surface portions along the longitudinal direction of
the flexible band, the inflatable member overlapping with the first
curved inner surface portion and the pressing member overlapping
with the second curved inner surface portion, the center inner
surface portion being exposed between the pressing member and the
inflatable member.
7. The hemostatic device according to claim 1, further comprising a
plate that is more rigid than the flexible band, the plate being
mounted on the flexible band so that the plate and the flexible
band move together as a unit, the plate including an inner surface
that faces toward the arm when the flexible band is wrapped around
the arm in the wrapped state, the inner surface of the plate
including a center inner surface portion, a first curved inner
surface portion and a second curved inner surface portion, the
center inner surface portion being positioned between the first and
second inner surface portions along the longitudinal direction of
the flexible band, the inflatable member being connected to the
flexible band at a connection, the connection being located so that
during use of the hemostatic device, the inflatable member is
positioned between the central portion and the connection
portion.
8. A hemostatic device comprising: a flexible band configured to be
wrapped around an arm in which a radial artery and an ulnar artery
are located, the flexible band possessing a longitudinal extent
that extends in a longitudinal direction, the flexible band being
made of a material; a securing portion that secures the flexible
band on the arm while the flexible band is wrapped around the arm
in a wrapped state; a support plate held by the flexible band and
made of a material more rigid than the material from which the
flexible band is made; an inflatable member connected to the
flexible band and expandable upon being inflated in response to
introducing fluid into an interior of the inflatable member to
press a part of the radial artery to be subjected to hemostasis; a
pressing member disposed at a position spaced from a position of
the inflatable portion in the longitudinal direction of the
flexible band and configured to press the ulnar artery; the
inflatable member possessing a first surface disposed on a side
that will face the arm when the flexible band is in the wrapper
state and a second surface disposed on a side facing the band; the
pressing member including a third surface disposed on a side that
will face the arm when the flexible band is in the wrapper state
and a fourth surface disposed on a side facing the band; and a
length of a perpendicular line from the support plate to the first
surface is longer than a length of a perpendicular line from the
support plate to the third surface when the inflatable portion is
inflated in a state in which at least a part of the second surface
of the inflatable portion and at least a part of the fourth surface
of the pressing member are in contact with a portion of the band in
which the support plate is disposed.
9. The hemostatic device according to claim 8, wherein a surface
area of the first surface of the inflatable portion in an inflated
state is larger than a surface area of the third surface of the
pressing member.
10. The hemostatic device according to claim 8, wherein a length of
the pressing member along the longitudinal direction of the band is
shorter than a length of the inflatable portion along the
longitudinal direction of the band.
11. The hemostatic device according to claim 8, wherein the
pressing member is inflated by being injected with a fluid, and a
volume of the inflatable member in the inflated state is larger
than a volume of the pressing member in an inflated state.
12. The hemostatic device according to claim 8, wherein the support
plate includes an inner surface that faces toward the arm when the
flexible band is wrapped around the arm in the wrapped state, the
inner surface of the plate including a center inner surface
portion, a first curved inner surface portion and a second curved
inner surface portion, the center inner surface portion being
positioned between the first and second inner surface portions
along the longitudinal direction of the flexible band, the
inflatable member overlapping with the first curved inner surface
portion and the pressing member overlapping with the second curved
inner surface portion, the center inner surface portion being
exposed between the pressing member and the inflatable member.
13. The hemostatic device according to claim 8, wherein the support
plate includes an inner surface that faces toward the arm when the
flexible band is wrapped around the arm in the wrapped state, the
inner surface of the plate including a center inner surface
portion, a first curved inner surface portion and a second curved
inner surface portion, the center inner surface portion being
positioned between the first and second inner surface portions
along the longitudinal direction of the flexible band, the
inflatable member being connected to the flexible band at a
connection, the connection being located so that during use of the
hemostatic device, the inflatable member is positioned between the
central portion and the connection portion.
14. A hemostatic device comprising: a flexible band configured to
be wrapped around an arm in which a radial artery and an ulnar
artery are located, the flexible band possessing a longitudinal
extent that extends in a longitudinal direction; a securing portion
that secures the flexible band on the arm while the flexible band
is in a state of being wrapped around the arm; an inflatable member
connected to the band and expandable upon being inflated in
response to introducing fluid into an interior of the inflatable
portion to press a part of the radial artery to be subjected to
hemostasis, the inflatable member possessing oppositely facing
surfaces; a pressing member disposed at a position spaced from a
position of the inflatable portion in the longitudinal direction of
the band to press the ulnar artery, the pressing member possessing
oppositely facing surfaces; and the pressing member including a
main body and a projection disposed on the main body and protruding
with respect to the main body.
15. The hemostatic device according to claim 14, wherein the main
body is inflatable by being injected with a fluid, the projection
communicating with the main body so that the projection inflates
together with the main body in response to injection of the fluid,
and the projection includes a part protruding outwardly with
respect to the main body when the main body and the projection are
inflated.
16. The hemostatic device according to claim 15, wherein the
pressing member possesses a shape in which a length of an outer
periphery shortens from an outer surface side toward an inner
surface side of the band when the pressing member is inflated and
deformed.
17. The hemostatic device according to claim 14, wherein the main
body is inflatable by virtue of a fluid being injected into an
interior of the main body, and the projection is made of a harder
material than a material of the main body and is attached to an
outer surface of the main body.
18. The hemostatic device according to claim 14, wherein a length
of the projection along the longitudinal direction of the band is
shorter than a length of the main body along the longitudinal
direction of the band.
19. The hemostatic device according to claim 14, wherein a length
of the projection along a width direction orthogonal to the
longitudinal direction of the band is less than or equal to a
length of the main body along the width direction.
20. The hemostatic device according to claim 14, wherein the
projection has a shape continuously extending along a direction
orthogonal to the longitudinal direction of the band.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation of International
Application No. PCT/JP2016/075912 filed on Sep. 2, 2016, which
claims priority to Japanese Application No. 2015-174197 filed on
Sep. 3, 2015, Japanese Application No. 2015-174198 filed on Sep. 3,
2015 and Japanese Application No. 2015-174201 filed on Sep. 3,
2015, the entire content of all four of which is incorporated
herein by reference.
TECHNICAL FIELD
[0002] The present invention generally relates to a hemostatic
device for performing hemostasis by pressing a punctured site.
BACKGROUND ART
[0003] Recently, treatment/examination, etc. have been
percutaneously performed by puncturing a blood vessel such as a
radial artery, etc. of an arm, introducing an introducer sheath to
a puncture site, and inserting a catheter, etc. into a lesion of
the blood vessel, etc. through a lumen of the introducer sheath.
When such a procedure is performed, it is necessary to perform
hemostasis at the puncture site after withdrawing the introducer
sheath. To perform hemostasis, there has been a known hemostatic
device including a band for wrapping around the puncture site of
the arm, a securing portion that secures the band in a state of
being wrapping around the puncture site, and an inflatable portion
that can press the puncture site by inflating in response to
injection of a fluid. An example of such a device is disclosed in
Japanese Application No. 2004-154413. This hemostatic device
performs hemostasis by directly applying a pressing force acting
from the inflatable portion to the puncture site.
SUMMARY OF THE INVENTION
[0004] A radial artery and an ulnar artery branch from a brachial
artery near an elbow and are connected to each other in a palm. For
this reason, when only the radial artery is pressed (compressed)
for a long time, blood may hardly flow to the radial artery, and a
blood flow rate of the ulnar artery may excessively increase. As a
result, a blood flow rate of the radial artery decreases, so that
the blood vessel occludes or the amount of platelets, etc.
decreases, thereby requiring a long time for hemostasis at the
puncture site. For this reason, for example, it is known to press
the ulnar artery to reopen the occluded radial artery after
performing hemostasis at the puncture site of the radial artery. An
example of this is described in the following non-patent
document--Ivo Bernat, M D et al., "Efficacy and Safety of Transient
Ulnar Artery Compression to Recanalize Acute Radial Artery
Occlusion After Transradial Catheterization", American Journal of
Cardiology (U.S.), 2011, 107(11), p. 1698-1701.
[0005] In response to such a problem, for example, when a pressing
member for pressing the ulnar artery is further provided in the
above-described hemostatic device, it is considered that an
excessive increase in blood flow flowing to the ulnar artery may be
prevented by pressing the ulnar artery, thereby suppressing a
decrease in blood flow rate of the radial artery at the time of
pressing the radial artery.
[0006] However, in the hemostatic device configured as described
above, when the pressing member presses a wide range along a
circumferential direction of the arm, a tendon, a nerve, etc.
around the ulnar artery are also pressed, which causes numbness or
pain.
[0007] The hemostatic device disclosed here is configured to
enhance the hemostatic effect by suppressing a decrease in blood
flow rate of a radial artery, and reducing numbness or pain caused
by pressing an ulnar artery.
[0008] A hemostatic device disclosed here includes: a flexible band
configured to be wrapped around an arm in which a radial artery and
an ulnar artery are located, with the flexible band possessing a
longitudinal extent that extends in a longitudinal direction; a
securing portion that secures the flexible band on the arm while
the flexible band is wrapped around the arm in a wrapped state; an
inflatable member connected to the flexible band and expandable
upon being inflated in response to introducing fluid into an
interior of the inflatable member to press a part of the radial
artery to be subjected to hemostasis, with the inflatable member
possessing oppositely facing surfaces; and a pressing member
disposed at a position spaced from a position of the inflatable
member in the longitudinal direction of the flexible band to press
the ulnar artery, with the pressing member possessing oppositely
facing surfaces. The pressing member possessing a length along the
longitudinal direction of the flexible band that is shorter than a
width of the pressing member along a direction orthogonal to the
longitudinal direction of the flexible band.
[0009] According to the hemostatic device configured as described
above, it is possible to enhance hemostatic effect by suppressing a
decrease in blood flow rate of a radial artery. In addition, the
length of the pressing member along the longitudinal direction of
the band is shorter than the width of the pressing member along the
direction orthogonal to the longitudinal direction of the band. For
this reason, a part in which the pressing member comes into contact
with the arm at the time of mounting the hemostatic device on the
arm has a shape extending along running of the ulnar artery. In
this way, it is possible to narrow a range of a part other than the
ulnar artery (a tendon, a nerve, etc.) pressed by the pressing
member while favorably pressing the ulnar artery by the pressing
member. As a result, it is possible to reduce numbness or pain
caused by pressing the ulnar artery.
[0010] The hemostatic device can also include a plate that is more
rigid than the flexible band and that is mounted on the flexible
band so that the plate and the flexible band move together as a
unit. The plate includes an inner surface that faces toward the arm
when the flexible band is wrapped around the arm in the wrapped
state. The inner surface of the plate includes a center inner
surface portion, a first curved inner surface portion and a second
curved inner surface portion, with the center inner surface portion
being positioned between the first and second inner surface
portions along the longitudinal direction of the flexible band. The
inner surface of the center portion may have a radius of curvature
greater than the radius of curvature of the first and second curved
inner surface portions.
[0011] According to another aspect, a hemostatic device comprises:
a flexible band configured to be wrapped around an arm in which a
radial artery and an ulnar artery are located, wherein the flexible
band possesses a longitudinal extent that extends in a longitudinal
direction; a securing portion that secures the flexible band on the
arm while the flexible band is wrapped around the arm in a wrapped
state; a support plate held by the flexible band and made of a
material more rigid than the material from which the flexible band
is made; and an inflatable member connected to the flexible band
and expandable upon being inflated in response to introducing fluid
into an interior of the inflatable member to press a part of the
radial artery to be subjected to hemostasis. A pressing member is
disposed at a position spaced from a position of the inflatable
portion in the longitudinal direction of the flexible band and
configured to press the ulnar artery, and the inflatable member
possesses a first surface disposed on a side that will face the arm
when the flexible band is in the wrapper state and a second surface
disposed on a side facing the band. The pressing member includes a
third surface disposed on a side that will face the arm when the
flexible band is in the wrapper state and a fourth surface disposed
on a side facing the band. The length of a perpendicular line from
the support plate to the first surface is longer than a length of a
perpendicular line from the support plate to the third surface when
the inflatable portion is inflated in a state in which at least a
part of the second surface of the inflatable portion and at least a
part of the fourth surface of the pressing member are in contact
with a portion of the band in which the support plate is
disposed.
[0012] In accordance with another aspect, a hemostatic device
comprises: a flexible band configured to be wrapped around an arm
in which a radial artery and an ulnar artery are located, wherein
the flexible band possesses a longitudinal extent that extends in a
longitudinal direction; a securing portion that secures the
flexible band on the arm while the flexible band is in a state of
being wrapped around the arm; an inflatable member connected to the
band and expandable upon being inflated in response to introducing
fluid into an interior of the inflatable portion to press a part of
the radial artery to be subjected to hemostasis, wherein the
inflatable member possesses oppositely facing surfaces; and a
pressing member disposed at a position spaced from a position of
the inflatable portion in the longitudinal direction of the band to
press the ulnar artery, with the pressing member possessing
oppositely facing surfaces. The pressing member includes a main
body and a projection disposed on the main body and protruding with
respect to the main body.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a plan view of a hemostatic device according to a
first embodiment viewed from an inner surface side.
[0014] FIG. 2 is a cross-sectional view taken along the section
line 2-2 of FIG. 1.
[0015] FIG. 3 is a perspective view illustrating a state of
mounting the hemostatic device according to the first
embodiment.
[0016] FIG. 4 is a cross-sectional view taken along the section
line 4-4 of FIG. 3.
[0017] FIG. 5 is a cross-sectional view taken along the section
line 5-5 of FIG. 3.
[0018] FIG. 6 is a cross-sectional view taken along the section
line 6-6 of FIG. 3.
[0019] FIG. 7(A) is a schematic view illustrating a pressing member
according to Modification 1 of the first embodiment, FIG. 7(B) is a
schematic view illustrating a pressing member according to
Modification 2 of the first embodiment, FIG. 7(C) is a schematic
view illustrating a pressing member according to Modification 3 of
the first embodiment, and FIG. 7(D) is a schematic view
illustrating a pressing member according to Modification 4 of the
first embodiment.
[0020] FIG. 8(A) is a schematic view illustrating a pressing member
according to Modification 5 of the first embodiment, and FIG. 8(B)
is a schematic view illustrating a pressing member according to
Modification 6 of the first embodiment.
[0021] FIG. 9 is a plan view of a hemostatic device according to a
second embodiment viewed from an inner surface side.
[0022] FIG. 10 is a cross-sectional view taken along the section
line 10-10 of FIG. 9.
[0023] FIG. 11 is a cross-sectional view illustrating a dimension
example of an inflatable portion and a dimension example at the
time of inflating a pressing member of the hemostatic device
according to the second embodiment.
[0024] FIG. 12 is a perspective view illustrating a state of
mounting the hemostatic device according to the second embodiment
around an arm.
[0025] FIG. 13 is a cross-sectional view taken along the section
line 13-13 of FIG. 12.
[0026] FIG. 14 is a cross-sectional view taken along the section
line 14-14 of FIG. 12.
[0027] FIG. 15 is a cross-sectional view taken along the section
line 15-15 of FIG. 12.
[0028] FIG. 16 is a schematic view illustrating a hemostatic device
according to a modification of the second embodiment.
[0029] FIG. 17 is a plan view of a hemostatic device according to a
third embodiment viewed from an inner surface side.
[0030] FIG. 18 is a cross-sectional view taken along the section
line 18-18 of FIG. 17.
[0031] FIG. 19 is a perspective view illustrating a state of
mounting the hemostatic device according to the third
embodiment.
[0032] FIG. 20(A) is a cross-sectional view taken along the section
line 20A-20A of FIG. 19, and FIG. 20(B) is a perspective view
schematically illustrating a pressing member.
[0033] FIG. 21 is a cross-sectional view taken along the section
line 21-21 of FIG. 19.
[0034] FIG. 22 is a cross-sectional view taken along the section
line 22-22 of FIG. 19.
[0035] FIG. 23(A) is a cross-sectional view corresponding to FIG.
20(A), as a diagram illustrating a state of mounting a hemostatic
device according to Modification 1 of the third embodiment, and
FIG. 23(B) is a perspective view schematically illustrating a
pressing member.
[0036] FIG. 24 is a cross-sectional view corresponding to FIG. 18,
as a cross-sectional view illustrating a hemostatic device
according to Modification 2 of the third embodiment.
[0037] FIG. 25(A) is a cross-sectional view corresponding to FIG.
20(A), as a diagram illustrating a state of mounting a hemostatic
device according to Modification 2 of the third embodiment, and
FIG. 25(B) is a perspective view schematically illustrating a
pressing member.
DETAILED DESCRIPTION
[0038] Hereinafter, embodiments of the hemostatic device,
representing examples of the inventive hemostatic device disclosed
here, will be described with reference to the accompanying
drawings. The description below does not restrict a technical scope
or a meaning of terms described in claims. In addition, a ratio of
dimensions in the drawings is exaggerated for convenience of
description and illustration, and may be different from an actual
ratio.
First Embodiment
[0039] As illustrated in FIG. 4, a hemostatic device 10 according
to a first embodiment is used to perform hemostasis at a puncture
site 220 after withdrawing an introducer sheath indwelled in the
puncture site 220 (corresponding to a part to be subjected to
hemostasis) formed in a radial artery 210 of a wrist 200
(corresponding to an arm) to insert a catheter, etc. performing
treatment/examination, etc. into a blood vessel.
[0040] As illustrated in FIG. 1 and FIG. 2, the hemostatic device
10 includes a band 20 for wrapping around the wrist 200, a hook and
loop fastener 30 (corresponding to a securing portion) for securing
the band 20 while the band is in a wrapped state in which the band
is wrapped around the wrist 200, a plate 40, a first inflatable
portion 50 (corresponding to an inflatable portion or inflatable
member/element), a second inflatable portion 60 (corresponding to a
pressing member), a marker 70, a first injection portion 80, and a
second injection portion 81.
[0041] In this specification, a side (mounting surface side) of the
band 20 facing a body surface of the wrist 200 is referred to as an
"inner surface side", and an opposite side of the band 20 is
referred to as an "outer surface side" when the band 20 is wrapped
around the wrist 200.
[0042] In addition, in the drawings, a longitudinal direction of
the band 20 is indicated as an arrow X, and a direction orthogonal
to the longitudinal direction of the band 20 is indicated as an
arrow Y.
[0043] The band 20 may be a flexible band-shaped member possessing
a longitudinal extent that extends in the longitudinal direction.
As illustrated in FIG. 4, the band 20 is wrapped around an outer
periphery of the wrist 200 substantially once. As illustrated in
FIG. 2, a curved plate holding portion 21 that holds the curved
plate 40 is formed at a central portion of the band 20 (central
portion in the longitudinal direction X of the band 20). The curved
plate holding portion 21 may be doubled by separate band-shaped
members joined to an outer surface side (or inner surface side)
using a method such as fusing (heat-fusing, high-frequency fusing,
ultrasonic fusing, etc.), adhesion (adhesion by an adhesive or a
solvent), etc. and holds the curved plate 40 positioned in a gap
between the two separate band-shaped members.
[0044] A male side (or a female side) 31 of the hook and loop
fastener 30 generally referred to as Magic Tape (registered
trademark), etc. may be disposed on the outer surface side of the
band 20 near a left end of FIG. 1, and a female side (or a male
side) 32 of the hook and loop fastener 30 may be disposed on the
inner surface side of the band 20 near a right end of FIG. 1. As
illustrated in FIG. 3 and FIG. 4, the band 20 may be wrapped around
the wrist 200, and the male side 31 and the female side 32 are
joined together, thereby mounting the band 20 on the wrist 200. The
means for securing the band 20 to the wrist 200 in a wrapped state
is not limited to the hook and loop fastener 30. For example, the
means for securing may correspond to a snap, a button, a clip, or a
frame member passing an end portion of the band 20.
[0045] A constituent material forming the band 20 is not
particularly limited as long as the material has flexibility, and
examples of the material for forming the band 20 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,
silicone, polyurethane, various thermoplastic elastomers such as
polyamide elastomers, polyurethane elastomers and polyester
elastomers, and an arbitrary combination of the above (blend resin,
polymer alloy, laminate, etc.).
[0046] The band 20 is preferably substantially transparent.
However, the band 20 may not be transparent, and may be translucent
or colored transparent. In this way, the puncture site 220 may be
visually recognized from the outer surface side, and the marker 70
described below may be relatively easily positioned in the puncture
site 220.
[0047] As illustrated in FIG. 2, the plate 40 may be a curved plate
40 held in the band 20 by being inserted into or positioned in the
doubly formed curved plate holding portion 21 of the band 20. At
least a portion of the curved plate 40 may have a shape curved
toward the inner surface side (outer surface side). The plate 40 in
the illustrated example includes an inner surface on the side of
the inflatable members 50, 60, and the plate 40 is curved so that
portions of the inner surface of the plate are curved. The curved
plate 40 may be made of a more rigid material than the material of
the band 20 (the plate 40 is more rigid than the flexible band 20)
and may maintain a substantially constant shape.
[0048] The curved plate 40 may have a shape elongated in the
longitudinal direction (a direction of an arrow X) of the band 20.
A central portion 41 of the curved plate 40 in the longitudinal
direction may have a flat plate shape almost without being curved,
and a first curved portion 42 (left side of FIG. 2) and a second
curved portion 43 (right side of FIG. 2) curved toward an inner
peripheral side and along the longitudinal direction of the band 20
(a circumferential direction of the wrist 200) are formed at both
sides of the central portion 41, respectively. FIGS. 2 and 4 show
that the first curved portion 42 possesses a radius of curvature
smaller than the inner surface of central portion 41. Additionally,
FIGS. 2 and 4 show that the first curved portion 42 possesses a
curvature (curvature is a reciprocal of a radius of curvature)
greater than the curvature of the inner surface of central portion
41. FIGS. 2 and 4 also illustrate that the second curved portion 43
possesses a radius of curvature smaller than the inner surface of
central portion 41, and that the second curved portion 43 possesses
a curvature greater than the curvature of the inner surface of the
central portion 41.
[0049] A constituent material forming the curved plate 40 is not
particularly limited as long as the puncture site 220 can be
visually recognized. Examples of the material include acrylic
resins, polyvinyl chloride (particularly rigid polyvinyl chloride),
polyolefins such as polyethylene, polypropylene and polybutadiene,
polystyrene, poly(4-methyl pentene-1), 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 or aliphatic
polyamides, and fluorocarbon resins such as
polytetrafluoroethylene.
[0050] Similarly to the band 20, the curved plate 40 is preferably
substantially transparent. However, the curved plate 40 may not be
transparent, and may be translucent or colored transparent. In this
way, the puncture site 220 may be reliably visually recognized from
the outer surface side, and the marker 70 described below may be
relatively easily positioned in the puncture site 220. The curved
plate 40 may not have a non-curved part such as the central portion
41, that is, may be curved over an entire length of the plate
40.
[0051] The first inflatable portion 50 and the second inflatable
portion 60 are connected to the band 20. The first inflatable
portion 50 and the second inflatable portion 60 inflate by being
injected with a fluid (gas such as air or liquid). The first
inflatable portion 50 presses the puncture site 220 located in the
radial artery 210 of the wrist 200. The second inflatable portion
60 presses an ulnar artery 230 and the vicinity of the ulnar artery
230 by pressing the body surface of the wrist 200.
[0052] As illustrated in FIG. 2, the first inflatable portion 50
may be located to overlap the vicinity of a part between the first
curved portion 42 and the central portion 41.
[0053] A constituent material forming the first inflatable portion
50 is not particularly limited as long as the material has
flexibility. For example, it is possible to use the same material
as the constituent material forming the band 20 mentioned above. In
addition, the first inflatable portion 50 may be preferably made of
the same or a similar material as or to that of the band 20. In
this way, joining the first inflatable portion 50 to the band 20 by
fusing may be relatively easily performed, and manufacture may be
rather easily performed.
[0054] Similarly to the band 20 and the curved plate 40, the first
inflatable portion 50 is preferably substantially transparent. In
this way, the puncture site 220 may be visually recognized from the
outer surface side, and the marker 70 described below may be
relatively easily positioned in the puncture site 220.
[0055] For example, as illustrated in FIG. 2, a structure of the
first inflatable portion 50 may be formed in a shape of a bag
obtained by overlapping two sheet materials made of the
above-described materials and joining edge portions using a method
such as fusing, adhesion, etc. As illustrated in FIG. 1, an
external shape of the first inflatable portion 50 may be a
rectangle in a state of not being inflated.
[0056] As illustrated in FIG. 2, the first inflatable portion 50
may be connected to the band 20 through a first holding portion 51
having flexibility. The first holding portion 51 is preferably
provided on the first curved portion 42 side of the curved plate
40. In addition, the first holding portion 51 is preferably made of
the same material as that of the first inflatable portion 50. In
this way, joining the first holding portion 51 of the first
inflatable portion 50 to the band 20 by fusing may be rather easily
performed, and manufacture may be rather easily performed.
[0057] As illustrated in FIG. 2, the second inflatable portion 60
may be disposed at a different position from that of the first
inflatable portion 50 in the longitudinal direction of the band 20.
Specifically, the second inflatable portion 60 is disposed to
overlap the vicinity of a part between the second curved portion 43
and the central portion 41.
[0058] Similarly to the first inflatable portion 50, a constituent
material forming the second inflatable portion 60 preferably
corresponds to a material having flexibility. For example, it is
possible to use the same material as the constituent material
forming the band 20 mentioned above. When the same material as that
of the band 20 is used, it is possible to rather easily join the
second inflatable portion 60 to the band 20 by fusing. Similar to
the band 20 and the curved plate 40, the second inflatable portion
60 is preferably substantially transparent.
[0059] Similarly to the first inflatable portion 50, a structure of
the second inflatable portion 60 may be formed in a shape of a bag
obtained by overlapping two sheet materials made of the
above-described materials and joining edge portions using a method
such as fusing, adhesion, etc.
[0060] As illustrated in FIG. 2, the second inflatable portion 60
may be connected to the band 20 through a second holding portion 61
having flexibility. The second holding portion 61 is preferably
provided on the second curved portion 43 side of the curved plate
40. In addition, the second holding portion 61 is preferably made
of the same material as that of the second inflatable portion 60.
In this way, joining the second holding portion 61of the second
inflatable portion 60 to the band 20 by fusing may be rather easily
performed, and manufacture may be relatively easily performed.
[0061] As illustrated in FIG. 1, a dimension of the second
inflatable portion 60 (a length L2 of the second inflatable portion
60) along the longitudinal direction of the band 20 (the direction
of the arrow X) is shorter than a dimension of the second
inflatable portion 60 (a width W2 of the second inflatable portion
60) along a direction orthogonal to the longitudinal direction of
the band 20 (a direction of the arrow Y). That is, when an aspect
ratio of the second inflatable portion 60 is defined as a value
obtained by dividing the length L2 of the second inflatable portion
60 by the width W2 of the second inflatable portion 60, the aspect
ratio of the second inflatable portion 60 is preferably a value
less than 1.
[0062] In addition, as illustrated in FIG. 1, the width W2 of the
second inflatable portion 60 may be less than or equal to a width
W3 of the band 20. Further, the second inflatable portion 60 may be
attached to the band 20 on the inside of an outer edge of the band
20 in the longitudinal direction.
[0063] In addition, the length L2 of the second inflatable portion
60 may be shorter than a length L1 of the first inflatable portion
50 along the longitudinal direction of the band 20. For example,
when the length L1 of the first inflatable portion 50 is 25 to 40
mm, the length L2 of the second inflatable portion 60 may be 20 mm
or less. That is, the length L1 of the first inflatable portion 50
may be 25 mm to 40 mm, in which case the length L2 of the second
inflatable portion 60 is 20 mm or less.
[0064] In addition, a volume of the first inflatable portion 50 in
an inflated state is larger than a volume of the second inflatable
portion 60 in an inflated state. In other words, the interior
volume of the first inflatable portion 50 while inflated during use
is larger than the interior volume of the second inflatable portion
60 while inflated during use. In the present embodiment, the first
inflatable portion 50 and the second inflatable portion 60 are made
of the same material. Further, in a state in which the first
inflatable portion 50 and the second inflatable portion 60 are not
inflated, the length L1 of the first inflatable portion 50 may be
longer (greater) than the length L2 of the second inflatable
portion 60, and the width W1 of the first inflatable portion 50 may
be longer (greater) than the width W2 of the second inflatable
portion 60. In this way, the volume of the first inflatable portion
50 in the inflated state is larger than the volume of the second
inflatable portion 60. The volume of the first inflatable portion
50 in the inflated state may be larger than the volume of the
second inflatable portion 60 by setting an elastic modulus of the
constituent material forming the first inflatable portion 50 to be
larger than an elastic modulus of the constituent material forming
the second inflatable portion 60.
[0065] In addition, a relationship between a length L3 of the first
curved portion 42 and a length L4 of the second curved portion 43
along a longitudinal direction of the curved plate 40 corresponds
to a relationship between the length L1 of the first inflatable
portion 50 and the length L2 of the second inflatable portion 60.
Specifically, as illustrated in FIG. 2 and FIG. 4, the length L3 of
the first curved portion 42 provided on a side where the first
inflatable portion 50 is located may be longer than the length L4
of the second curved portion 43 provided on a side where the second
inflatable portion 60 is located. For this reason, when the
hemostatic device 10 is mounted on the wrist 200, the first
inflatable portion 50 and the second inflatable portion 60 may be
pressed against the wrist 200 by conforming the first curved
portion 42 and the second curved portion 43 to shapes of the first
inflatable portion 50 and the second inflatable portion 60, which
are inflated, respectively.
[0066] As illustrated in FIG. 2, the marker 70 may be provided on
the outer surface side of the first inflatable portion 50, that is,
on a surface of the first inflatable portion 50 not facing the body
surface of the wrist 200. When such a marker 70 is provided in the
first inflatable portion 50, the first inflatable portion 50 may be
rather easily positioned with respect to the puncture site 220, and
thus a position shift of the first inflatable portion 50 is
suppressed.
[0067] A shape of the marker 70 is not particularly limited.
Examples of the shape include a circle, a triangle, a rectangle,
etc. In the present embodiment, the shape corresponds to the
rectangle.
[0068] A size of the marker 70 is not particularly limited.
However, for example, when the shape of the marker 70 is a
rectangle, a length of a side of the rectangular mark is preferably
in a range of 1 to 4 mm. When the length of the side is 5 mm or
more, the size of the marker 70 becomes larger when compared to a
size of the puncture site 220, and thus it is difficult to position
a central portion of the first inflatable portion 50 in the
puncture site 220.
[0069] A material forming the marker 70 is not particularly
limited. Examples thereof include an oily coloring agent such as
ink, a resin kneaded with a pigment, etc.
[0070] A color of the marker 70 is not particularly limited so long
as the color allows the first inflatable portion 50 to be
positioned at the puncture site 220. However, a green-based color
(green color) is preferable. When the green-based color is adopted,
it is relatively easy to visually recognize the marker 70 on blood
or skin, and thus the first inflatable portion 50 is more easily
positioned in the puncture site 220.
[0071] In addition, the marker 70 is preferably translucent or
colored transparent. In this way, the puncture site 220 may be
visually recognized from an outer surface side of the marker
70.
[0072] The manner in which the marker 70 is provided on the first
inflatable portion 50 is not particularly limited. For example, it
is possible to print the marker 70 on the first inflatable portion
50, to fuse the marker 70 to the first inflatable portion 50, to
apply an adhesive to one surface of the marker 70 to paste the
marker 70 to the first inflatable portion 50, etc.
[0073] The marker 70 may be provided on the inner surface side of
the first inflatable portion 50. In this instance, the marker 70 is
preferably provided on an inner surface, etc. of the first
inflatable portion 50 so as not to directly come into contact with
the puncture site 220. The first injection portion 80 and the
second injection portion 81 are parts for injecting a fluid into
the first inflatable portion 50 and the second inflatable portion
60, respectively, and are connected to the first inflatable portion
50 and the second inflatable portion 60, respectively, as
illustrated in FIG. 1.
[0074] The first injection portion 80 includes a flexible first
tube 82 having a proximal portion connected to the first inflatable
portion 50 and a lumen communicating with the inside (interior) of
the first inflatable portion 50, a first bag body 84 disposed at a
distal portion of the first tube 82 to communicate with the lumen
of the first tube 82, and a tube-shaped first connector 86
connected to the first bag body 84. A check valve (not illustrated)
may be incorporated in the first connector 86.
[0075] Similarly, the second injection portion 81 includes a
flexible second tube 83 having a proximal portion connected to the
second inflatable portion 60 and a lumen communicating with an
inside (interior) of the second inflatable portion 60, a second bag
body 85 disposed at a distal portion of the second tube 83 to
communicate with the lumen of the second tube 83, and a tube-shaped
second connector 87 connected to the second bag body 85. A check
valve (not illustrated) may be incorporated in the second connector
87.
[0076] At the time of inflating (expanding) the first inflatable
portion 50, a tip of a syringe (not illustrated) is inserted into
the first connector 86 to open the check valve, and a plunger of
this syringe is pushed to inject a fluid in the syringe into the
first inflatable portion 50 through the first injection portion 80.
When the first inflatable portion 50 expands, the first bag body 84
communicating with the first inflatable portion 50 through the
first tube 82 also expands, and it is possible to visually confirm
that the first inflatable portion 50 can be pressed without leakage
of the fluid. When the tip of the syringe is withdrawn from the
first connector 86 after the fluid is injected into the first
inflatable portion 50, the check valve incorporated in the first
connector 86 is closed to prevent leakage of the fluid, and so the
first inflatable portion 50 is maintained in the expanded state.
When the same operation is performed with respect to the second
injection portion 81 connected to the second inflatable portion 60,
the expanded state of the second inflatable portion 60 is
maintained.
[0077] Next, a description will be given of an operation using the
hemostatic device 10 according to the present embodiment.
[0078] Before the hemostatic device 10 is mounted on the wrist 200,
the first inflatable portion 50 and the second inflatable portion
60 are in a state of not being inflated (i.e., the first inflatable
portion 50 and the second inflatable portion 60 are deflated or
substantially empty). When the wrist 200 is punctured, the puncture
site 220 with respect to the radial artery 210 is normally biased
to a thumb side of the right hand wrist 200. Normally, the
introducer sheath is indwelled in the puncture site 220. The band
20 is wrapped around the wrist 200 in which the introducer sheath
is indwelled, the first inflatable portion 50 and the band 20 are
positioned such that the marker 70 provided in the first inflatable
portion 50 overlaps the puncture site 220, and the male side 31 and
the female side 32 of the hook and loop fastener 30 are brought
into contact with each other and joined to each other, thereby
mounting the band 20 on the wrist 200.
[0079] The hemostatic device 10 may be mounted on the wrist 200
such that the first injection portion 80 and the second injection
portion 81 face a downstream side of a blood flow of the radial
artery 210. In this way, the first injection portion 80 and the
second injection portion 81 may be operated without interfering
with manipulation on the upstream side of the wrist or a device
(for example, a sphygmomanometer, etc.) located on the upstream
side. In addition, when the hemostatic device 10 is mounted on the
right hand wrist 200 such that the first injection portion 80 and
the second injection portion 81 face the downstream side, the first
inflatable portion 50 is located on the radial artery 210 biased to
the thumb side of the wrist 200, and the second inflatable portion
60 is located around the ulnar artery 230. In the case of the
artery, the upstream side of the blood vessel refers to a direction
of the blood vessel approaching a heart. In addition, the
downstream side of the blood vessel refers to a direction of the
blood vessel away from the heart.
[0080] After the hemostatic device 10 is mounted on the wrist 200,
the syringe (not illustrated) is connected to the first connector
86 of the first injection portion 80, the fluid is injected into
the first inflatable portion 50 as described above, and the first
inflatable portion 50 is inflated to press the puncture site 220 as
illustrated in FIG. 4 and FIG. 5. A degree of inflation of the
first inflatable portion 50, that is, a pressing force to the
puncture site 220 located in the radial artery 210 may be rather
easily adjusted depending on the case according to an injection
amount of the fluid at this time.
[0081] After the first inflatable portion 50 is inflated, the
syringe is detached from the first connector 86. Then, the
introducer sheath is withdrawn from the puncture site 220. In this
way, the first inflatable portion 50 maintains an inflated state,
and a state of pressing the puncture site 220 is maintained.
[0082] Subsequently, the syringe (not illustrated) is connected to
the second connector 87 of the second injection portion 81, the
fluid is injected into the second inflatable portion 60 as
described above, and the second inflatable portion 60 is inflated
to press the ulnar artery 230 as illustrated in FIG. 4 and FIG. 6.
A degree of inflation of the second inflatable portion 60, that is,
a pressing force to the vicinity of the ulnar artery 230 may be
relatively easily adjusted according to an injection amount of the
fluid at this time.
[0083] When the first inflatable portion 50 and the second
inflatable portion 60 are inflated, the curved plate 40 is
separated from the body surface of the wrist 200 and hardly comes
into contact with the wrist 200. In addition, when the first
inflatable portion 50 and the second inflatable portion 60 are
inflated after the hemostatic device 10 is mounted, inflation of
the first inflatable portion 50 and the second inflatable portion
60 in a direction away from the body surface of the wrist 200 is
suppressed by the curved plate 40, and a pressing force of the
first inflatable portion 50 and the second inflatable portion 60 is
concentrated on the wrist 200 side. For this reason, a pressing
force from the first inflatable portion 50 intensively acts on the
vicinity of the puncture site 220, and thus the hemostatic effect
may be improved.
[0084] In addition, when the first inflatable portion 50 presses
the radial artery 210, the second inflatable portion 60 may press
the ulnar artery 230, thereby preventing an excessive increase in
the blood flow flowing to the ulnar artery 230, and suppressing a
decrease in the blood flow rate of the radial artery 210. In this
way, occlusion of the blood vessel may be prevented, and a decrease
in the amount of the platelets, etc. may be suppressed, thereby
performing hemostasis at the puncture site 220 in a relatively
short time.
[0085] The pressing force of the first inflatable portion 50 and
the second inflatable portion 60 may be adjusted by adjusting the
amount of the fluid injected into the first inflatable portion 50
and the second inflatable portion 60 depending on the progress of
hemostasis or the elapsed time.
[0086] When hemostasis is completed, the pressing force of the
first inflatable portion 50 to the puncture site 220 may be further
reduced and the hemostatic device 10 is removed.
[0087] When hemostasis in the puncture site 220 is completed and
the hemostatic device 10 is removed, the first inflatable portion
50 is contracted, and then the male side 31 and the female side 32
of the hook and loop fastener 30 are peeled off or separated to
remove the hemostatic device 10 from the wrist 200. The first
inflatable portion 50 may not be contracted when the hemostatic
device 10 is removed.
[0088] As described above, the hemostatic device 10 according to
the present embodiment includes the flexible band 20 that can be
wrapped around the wrist 200 in which the radial artery 210 and the
ulnar artery 230 run, the hook and loop fastener 30 that secures
the band 20 in a state of being wrapped around the wrist 200, the
first inflatable portion 50 connected to the band 20 and allowed to
press the puncture site 220 of the radial artery 210 by being
inflated in response to injection of the fluid, and the second
inflatable portion 60 disposed at a different position from that of
the first inflatable portion 50 in the longitudinal direction of
the band 20 and allowed to press the ulnar artery 230. Further, the
length L2 of the second inflatable portion 60 along the
longitudinal direction of the band 20 is shorter than the width W2
of the second inflatable portion 60 along the direction orthogonal
to the longitudinal direction of the band 20.
[0089] According to the hemostatic device 10 configured as
described above, it is possible to enhance the hemostatic effect by
suppressing a decrease in blood flow rate of the radial artery. In
addition, the length L2 of the second inflatable portion 60 is
shorter than the width W2 of the second inflatable portion 60. For
this reason, a part of the second inflatable portion 60 coming into
contact with the wrist 200 may have a shape extending along running
of the ulnar artery 230 (i.e., extending along the direction of
extent of the ulnar artery 230). As a result, it is possible to
further narrow a range in a part (a tendon, a nerve, etc.) other
than the ulnar artery 230 pressed by the second inflatable portion
60 while favorably pressing the ulnar artery 230. That is, the
inflated second portion 60 is able to press on the ulnar artery
230, yet is not so likely to press on other parts not intended to
be pressed. For this reason, it is possible to reduce numbness or
pain at the time of using the hemostatic device 10.
[0090] In addition, the width W2 of the second inflatable portion
60 may be less than or equal to the width W3 of the band 20. For
this reason, the second inflatable portion 60 does not protrude
outward from the band 20, and the second inflatable portion 60 may
be configured not to interfere with manipulation performed around a
mounting position of the hemostatic device 10, another device,
etc.
[0091] In addition, the length L2 of the second inflatable portion
60 is shorter than the length L1 of the first inflatable portion 50
along the longitudinal direction of the band 20. The first
inflatable portion 50 needs to tightly press the puncture site 220
to perform hemostasis, and thus preferably presses not only the
puncture site 220 but also the vicinity thereof. On the other hand,
it is sufficient for the second inflatable portion 60 to be able to
press only the ulnar artery 230 to prevent an excessive increase in
the blood flow rate of the ulnar artery 230. When the length L2 of
the second inflatable portion 60 is shorter than the length L1 of
the first inflatable portion 50, it is possible to narrow a range
in a part (a tendon, a nerve, etc.) other than the ulnar artery 230
pressed by the second inflatable portion 60 while ensuring a range
pressed by the first inflatable portion 50.
[0092] In addition, the second inflatable portion 60 can be
inflated by injection of a fluid, and the volume of the first
inflatable portion 50 in the inflated state may be larger than the
volume of the second inflatable portion 60 in the inflated state.
The first inflatable portion 50 requires a relatively strong
compressive force to perform hemostasis. On the other hand, it is
sufficient for the second inflatable portion 60 to be able to press
the ulnar artery 230 to such an extent as to prevent an excessive
increase in the blood flow rate of the ulnar artery 230, and a
strong pressing force required by the first inflatable portion 50
is unnecessary. When the volume in the inflated state is large, the
wrist 200 is more strongly pressed. Thus, when the volume of the
first inflatable portion 50 in the inflated state is larger than
the volume of the second inflatable portion 60 in the inflated
state, it is possible to decrease a pressing force by the second
inflatable portion 60 while ensuring a pressing force by the first
inflatable portion 50.
Modification of First Embodiment
[0093] First, a description will be given of second inflatable
portions 160, 260, 360, and 460 according to Modifications 1 to 4.
In the description below, features that are the same or similar to
those described above are identified by the same reference numerals
and a detailed description of such features is not repeated.
[0094] While an external shape of the second inflatable portion 60
according to the above-described embodiment is a rectangle in a
state of not being inflated (see FIG. 1), the external shape of the
second inflatable portion 160 according to Modification 1 is a
trapezoidal shape (see FIG. 7(A)). The second inflatable portion
160 may be connected to the band 20 through a second holding
portion 161. In addition, a maximum length L21 of the second
inflatable portion 160 along the longitudinal direction of the band
20 (a maximum separation distance between two sides of the
trapezoidal extending along a Y direction) may be shorter than a
maximum width W21 of the second inflatable portion 160 along the
direction orthogonal to the longitudinal direction of the band
20.
[0095] In addition, the external shape of the second inflatable
portion 260 according to Modification 2 is a hexagonal shape (see
FIG. 7(B)). The second inflatable portion 260 may be connected to
the band 20 through a second holding portion 261. In addition, a
maximum length L22 of the second inflatable portion 260 along the
longitudinal direction of the band 20 (a maximum separation
distance among distances between apexes of the hexagon facing each
other along the longitudinal direction of the band 20) is shorter
than a maximum width W22 of the second inflatable portion 260 along
the direction orthogonal to the longitudinal direction of the band
20.
[0096] In addition, the external shape of the second inflatable
portion 360 according to Modification 3 is a cross shape including
a rectangle elongated in the direction orthogonal to the
longitudinal direction of the band 20 and two protrusions
protruding outward in rectangular shapes along the longitudinal
direction of the band 20 from substantially central parts of two
long sides of the rectangle, respectively (see FIG. 7(C)). The
second inflatable portion 360 may be connected to the band 20
through a second holding portion 361. In addition, a maximum length
L23 of the second inflatable portion 360 along the longitudinal
direction of the band 20 (a distance between an edge portion of one
protrusion extending in a Y direction and an edge portion of the
other protrusion extending in the Y direction) may be shorter than
a maximum width W23 of the second inflatable portion 360 along the
direction orthogonal to the longitudinal direction of the band
20.
[0097] In addition, the external shape of the second inflatable
portion 460 according to Modification 4 is an elliptical shape (see
FIG. 7(D)). The second inflatable portion 460 may be connected to
the band 20 through a second holding portion 461. In addition, a
maximum length L24 of the second inflatable portion 460 along the
longitudinal direction of the band 20 may be shorter than a maximum
width W24 of the second inflatable portion 460 along the direction
orthogonal to the longitudinal direction of the band 20.
[0098] According to a hemostatic device 10 according to the
above-described Modifications 1 to 4, a part of the second
inflatable portions 160, 260, 360, and 460 coming into contact with
the wrist 200 at the time of mounting the hemostatic device 10 on
the wrist 200 may have a shape extending along running of the ulnar
artery 230 (i.e., the direction of extent of the ulnar artery 230).
For this reason, it is possible to favorably press the ulnar artery
230 by the second inflatable portions 160, 260, 360, and 460, and
it is possible to reduce a press range (range or area at which
pressure is applied) of a part (a tendon, a nerve, etc.) other than
the ulnar artery 230. As a result, it is possible to reduce
numbness or pain felt by a user at the time of using the hemostatic
device 10.
[0099] As described above in Modifications 1 to 4, the external
shape of the second inflatable portion in plan view in a state of
not being inflated is not limited to the rectangular shape
described in the above embodiment when the maximum length of the
second inflatable portion along the longitudinal direction of the
band 20 may be shorter than the maximum length of the second
inflatable portion along the direction orthogonal to the
longitudinal direction of the band 20.
[0100] Next, a description will be given of second inflatable
portions 560 and 660 according to Modifications 5 and 6.
[0101] The second inflatable portion 60 according to the
above-described embodiment is configured by overlapping two flat
and rectangular sheets and joining edge portions of the overlapping
sheets (see FIG. 1). On the other hand, the second inflatable
portion 560 according to Modification 5 may be configured by
overlapping a sheet, whose central part protrudes, with one flat
sheet and joining edge portions of the two sheets such that the
external shape of the second inflatable portion 560 in an inflated
state corresponds to a shape of a truncated prism (see FIG. 8(A)).
The second inflatable portion 560 may be connected to the band 20
through a second holding portion 561.
[0102] The second inflatable portion 560 comes into contact with
the band 20 on a first surface 562 whose area is largest in an
inflated state and comes into contact with a wrist 200 on a second
surface 563 side corresponding to a tapered end surface in the
shape of the truncated prism. Further, a length L25 of the second
surface 563 along the longitudinal direction of the band 20 is
shorter than a width W25 of the second surface 563 along the
direction orthogonal to the longitudinal direction of the band
20.
[0103] According to a hemostatic device 10 according to the
above-described Modification 5, a part of the second inflatable
portion 560 coming into contact with the wrist 200 at the time of
mounting the hemostatic device 10 on the wrist 200 may have a shape
extending along the running (direction of extent) of the ulnar
artery 230. For this reason, it is possible to press the ulnar
artery 230 by the second inflatable portion 560, and it is possible
to reduce a press range (range or area at which pressure is
applied) other than the ulnar artery 230 such as a tendon, a nerve,
etc. around the ulnar artery 230. As a result, it is possible to
reduce numbness or pain felt by the user at the time of using the
hemostatic device 10.
[0104] In this way, when the above relationship between the length
L25 and W25 of the second surface 563 holds, a relationship between
a length L26 of the first surface 562 along the longitudinal
direction of the band 20 and a width W26 of the first surface 562
along the direction orthogonal to the longitudinal direction of the
band 20 is not limited. For example, the length L26 of the first
surface 562 may be greater than or equal to the width W26 of the
first surface 562.
[0105] In addition, an external shape of the second inflatable
portion 660 according to Modification 6 in an inflated state
corresponds to a triangular prism unlike Modification 5 (see FIG.
8(B)). In this case, the ulnar artery 230 is pressed around a
tapered distal portion of the triangular prism. For this reason, a
part of the second inflatable portion 660 coming into contact with
the wrist 200 at the time of mounting the hemostatic device 10 on
the wrist 200 may have a shape extending along running (direction
of extent) of the ulnar artery 230. Therefore, it is possible to
favorably press the ulnar artery 230 by the second inflatable
portion 660, and it is possible to reduce a press range (range or
area at which pressure is applied) of a part (a tendon, a nerve,
etc.) other than the ulnar artery 230. As a result, it is possible
to reduce numbness or pain felt by the user at the time of using
the hemostatic device 10.
[0106] The hemostatic devices according to the first embodiment and
the modifications of the first embodiment described above may be
appropriately modified while still being within the scope of the
description in the claims.
[0107] For example, each portion included in the hemostatic device
may be replaced with a portion having a desired configuration
capable of exerting the same or similar function. In addition, an
arbitrary component may be added.
[0108] In addition, the invention is not limited to the hemostatic
device used by being mounted on the wrist, and is applicable to a
hemostatic device used by being mounted on any part of the arm in
which the radial artery and the ulnar artery run.
[0109] In addition, the pressing member may not be inflated by
being injected with the fluid. For example, the pressing member may
be made of a material such as metal, plastic, etc.
[0110] In addition, it is possible to provide an auxiliary
compressing portion that compresses the first inflatable portion to
overlap with the first inflatable portion between the first
inflatable portion and the band in order to adjust a pressing
direction of the first inflatable portion. For example, the
auxiliary compressing portion may be inflated by being injected
with a fluid similar to the first inflatable portion, or it is
possible to use a sponge-like substance, an elastic material, an
aggregate of fibers such as cotton, a combination thereof, etc.
[0111] In addition, the external shape of the first inflatable
portion is not limited to the rectangle in the state in which the
first inflatable portion is not inflated. For example, it is
possible to adopt a circle, an ellipse, or a polygon such as a
pentagon.
[0112] In addition, the marker may not be provided in the first
inflatable portion, and may be provided in the band, the curved
plate, or the auxiliary compressing portion. In addition, the
marker may be more preferably provided to overlap the central
portion of the first inflatable portion.
[0113] In addition, a projection provided on a pressing member of a
hemostatic device according to a third embodiment described below
may be provided on the pressing member (second inflatable portion)
of the hemostatic device according to the first embodiment and the
pressing member (second inflatable portion) of the hemostatic
device according to Modifications of the first embodiment.
Second Embodiment
[0114] Next, a description will be given of a hemostatic device
according to a second embodiment of the hemostatic device disclosed
here.
[0115] As illustrated in FIG. 13, a hemostatic device 10 according
to the second embodiment of the invention is used to perform
hemostasis at a puncture site 220 after withdrawing an introducer
sheath indwelled in the puncture site 220 (corresponding to a part
to be subjected to hemostasis) formed in a radial artery 210 of a
wrist 200 to insert a catheter, etc. performing
treatment/examination, etc. into a blood vessel.
[0116] As illustrated in FIG. 9 and FIG. 10, the hemostatic device
10 includes a band 20 for wrapping around the wrist 200, a hook and
loop fastener 30 (corresponding to a securing portion) for securing
the band 20 in a state of being wrapped around the wrist 200, a
curved plate 40 (corresponding to a support plate), a first
inflatable portion 50 (corresponding to an inflatable portion or
inflatable member/element), a second inflatable portion 60
(corresponding to a pressing member), a marker 70, a first
injection portion 80, and a second injection portion 81.
[0117] In the description here, a side (mounting surface side) of
the band 20 facing a body surface of the wrist 200 is referred to
as an "inner surface side", and an opposite side of the band is
referred to as an "outer surface side" when the band 20 is wrapped
around the wrist 200.
[0118] In addition, in the drawings, a longitudinal direction of
the band 20 is indicated as an arrow X, and a direction orthogonal
to the longitudinal direction of the band 20 is indicated as an
arrow Y.
[0119] The band 20 may be a flexible band-shaped member. As
illustrated in FIG. 13, the band 20 may be wrapped around an outer
periphery of the wrist 200 substantially once. As illustrated in
FIG. 10, a curved plate holding portion 21 that holds the curved
plate 40 is formed at a central portion of the band 20. The curved
plate holding portion 21 may be doubled by separate band-shaped
members joined to an outer surface side (or inner surface side)
using a method such as fusing (heat-fusing, high-frequency fusing,
ultrasonic fusing, etc.), adhesion (adhesion by an adhesive or a
solvent), etc. and holds the curved plate 40 inserted into a gap
therebetween.
[0120] A male side (or a female side) 31 of the hook and loop
fastener 30 generally referred to as Magic Tape (registered
trademark), etc. may be disposed on the outer surface side of the
band 20 near a left end of FIG. 9, and a female side (or a male
side) 32 of the hook and loop fastener 30 may be disposed on the
inner surface side of the band 20 near a right end of FIG. 9. As
illustrated in FIG. 12 and FIG. 14, the band 20 is wrapped around
the wrist 200, and the male side 31 and the female side 32 are
joined together, thereby mounting the band 20 on the wrist 200.
Means for securing the band 20 to the wrist 200 in a wrapped state
is not limited to the hook and loop fastener 30. For example, the
means may correspond to a snap, a button, a clip, or a frame member
passing an end portion of the band 20.
[0121] A constituent material forming the band 20 is not
particularly limited as long as the material has flexibility, and
examples thereof 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, silicone, polyurethane, various
thermoplastic elastomers such as polyamide elastomers, polyurethane
elastomers and polyester elastomers, and an arbitrary combination
of the above (blend resin, polymer alloy, laminate, etc.).
[0122] The band 20 is preferably substantially transparent.
However, the band 20 may not be transparent, and may be translucent
or colored transparent. In this way, the puncture site 220 may be
visually recognized from the outer surface side, and the marker 70
described below may be rather easily positioned in the puncture
site 220.
[0123] As illustrated in FIG. 10, the curved plate 40 may be held
in the band 20 by being inserted into or positioned in the doubly
formed curved plate holding portion 21 of the band 20. The curved
plate 40 may be made of a material more rigid than the material of
the band 20 so that the plate 40 is more rigid that the flexible
band 20 and may maintain a substantially constant shape.
[0124] The curved plate 40 may have a shape elongated in the
longitudinal direction of the band 20 (a direction of the arrow X).
A central portion 41 of the curved plate 40 in the longitudinal
direction may have a flat plate shape almost without being curved,
and a first curved portion 42 (left side of FIG. 10) and a second
curved portion 43 (right side of FIG. 10) curved toward an inner
peripheral side and along the longitudinal direction of the band 20
(a circumferential direction of the wrist 200) are formed at both
sides of the central portion 41, respectively.
[0125] A constituent material forming the curved plate 40 is not
particularly limited as long as the puncture site 220 can be
visually recognized. Examples of the material include acrylic
resins, polyvinyl chloride (particularly rigid polyvinyl chloride),
polyolefins such as polyethylene, polypropylene and polybutadiene,
polystyrene, poly(4-methyl pentene-1), 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 or aliphatic
polyamides, and fluorocarbon resins such as
polytetrafluoroethylene.
[0126] Similar to the band 20, the curved plate 40 is preferably
substantially transparent. However, the curved plate 40 may not be
transparent, and may be translucent or colored transparent. In this
way, the puncture site 220 may be reliably visually recognized from
the outer surface side, and the marker 70 described below may be
easily positioned in the puncture site 220. The curved plate 40 may
not have a non-curved part such as the central portion 41, that is,
may be curved over an entire length of the plate.
[0127] The first inflatable portion 50 and the second inflatable
portion 60 are connected to the band 20. The first inflatable
portion 50 and the second inflatable portion 60 inflate by being
injected with a fluid (gas such as air or liquid). The first
inflatable portion 50 presses the puncture site 220 located in the
radial artery 210 of the wrist 200. The second inflatable portion
60 presses the ulnar artery 230 and the vicinity of the ulnar
artery 230 by pressing the body surface of the wrist 200.
[0128] As illustrated in FIG. 10, the first inflatable portion 50
may be located to overlap the vicinity of a part between the first
curved portion 42 and the central portion 41.
[0129] A constituent material forming the first inflatable portion
50 is not particularly limited as long as the material has
flexibility. For example, it is possible to use the same material
as the constituent material forming the band 20 mentioned above. In
addition, the first inflatable portion 50 is preferably made of the
same or a similar material as or to that of the band 20. In this
way, joining the first inflatable portion 50 to the band 20 by
fusing may be rather easily performed, and manufacture may be
relatively easily performed.
[0130] Similar to the band 20 and the curved plate 40, the first
inflatable portion 50 may be preferably substantially transparent.
In this way, the puncture site 220 may be visually recognized from
the outer surface side, and the marker 70 described below may be
easily positioned in the puncture site 220.
[0131] For example, as illustrated in FIG. 10, a structure of the
first inflatable portion 50 may be formed in a shape of a bag
obtained by overlapping two sheet materials made of the
above-described materials and joining edge portions using a method
such as fusing, adhesion, etc. As illustrated in FIG. 9, an
external shape of the first inflatable portion 50 may be a
rectangle in a state of not being inflated.
[0132] As illustrated in FIG. 10, the first inflatable portion 50
is connected to the band 20 through a first holding portion 51
having flexibility. The first holding portion 51 is preferably
provided on the first curved portion 42 side of the curved plate
40. In addition, the first holding portion 51 is preferably made of
the same material as that of the first inflatable portion 50. In
this way, joining to the band 20 by fusing may be easily performed,
and manufacture may be easily performed.
[0133] As illustrated in FIG. 10, the second inflatable portion 60
may be disposed at a different position from that of the first
inflatable portion 50 in the longitudinal direction of the band 20.
Specifically, the second inflatable portion 60 may be disposed to
overlap the vicinity of a part between the second curved portion 43
and the central portion 41.
[0134] Similar to the first inflatable portion 50, a constituent
material forming the second inflatable portion 60 preferably
corresponds to a material having flexibility. For example, it is
possible to use the same material as the constituent material
forming the band 20 mentioned above. When the same material as that
of the band 20 is used, it is possible to rather easily join the
second inflatable portion 60 to the band 20 by fusing. Similar to
the band 20 and the curved plate 40, the second inflatable portion
60 is preferably substantially transparent.
[0135] Like the first inflatable portion 50, a structure of the
second inflatable portion 60 may be formed in a shape of a bag
obtained by overlapping two sheet materials made of the
above-described materials and joining edge portions using a method
such as fusing, adhesion, etc. Even though a member (the second
inflatable portion 60) that inflates by being injected with a fluid
is given as an example of the pressing member that presses the
ulnar artery 230 in the present embodiment, the pressing member may
be configured differently than described above. For example, the
pressing member that presses the ulnar artery 230 may correspond to
a relatively rigid member such as plastic, metal, etc. or may
correspond to a sponge-like substance, an elastic material, an
aggregate of fibers such as cotton, or an elastic member formed by
combining these materials.
[0136] As illustrated in FIG. 10, the second inflatable portion 60
may be connected to the band 20 through a second holding portion 61
having flexibility. The second holding portion 61 is preferably
provided on the second curved portion 43 side of the curved plate
40. In addition, the second holding portion 61 is preferably made
of the same material as that of the second inflatable portion 60.
In this way, joining to the band 20 by fusing may be relatively
easily performed, and manufacture may be rather easily
performed.
[0137] As illustrated in FIG. 11, a surface of the first inflatable
portion 50 disposed on the wrist 200 side is a first surface 50a, a
surface of the first inflatable portion 50 disposed on the band 20
side is a second surface 50b, a surface of the second inflatable
portion 60 disposed on the wrist 200 side is a third surface 60a,
and a surface of the second inflatable portion 60 disposed on the
band 20 side is set to a fourth surface 60b. In a state in which at
least a portion of the second surface 50b of the first inflatable
portion 50 and at least a portion of the fourth surface 60b of the
second inflatable portion 60 are brought into contact with a range
of the band 20 in which the curved plate 40 is disposed, a length
H1 of a perpendicular line from the curved plate 40 (line H1 is
perpendicular to the portion of the plate intersected by the line
H1) to the first surface 50a at the time of inflating the first
inflatable portion 50 is longer than a length 112 of a
perpendicular line from the curved plate 40 (line H2 is
perpendicular to the portion of the pate intersected by the line
H2) to the third surface 60a at the time of inflating the second
inflatable portion 60.
[0138] Even though the length of the perpendicular line from the
curved plate 40 to the first surface 50a differs depending on the
position on the curved plate 40 set to a start point of the
perpendicular line, the above-mentioned "length H1 of the
perpendicular line from the curved plate 40 to the first surface
50a" is defined as a maximum length of a perpendicular line from a
surface of the curved plate 40 on the wrist 200 side to the first
surface 50a in the present embodiment. Similarly, "the length H2 of
the perpendicular line from the curved plate 40 to the third
surface 60a" is defined as a maximum length of a perpendicular line
from a surface of the curved plate 40 on the wrist 200 side to the
third surface 60a. Specifically, as illustrated in FIG. 11, a start
point on the curved plate 40 side is selected to set an approximate
center of the first surface 50a at which the curved plate 40 and
the first surface 50a are most distant from each other as an end
point, thereby defining the length H1 of the perpendicular line
from the curved plate 40 to the first surface 50a. Similarly, a
start point on the curved plate 40 side is selected to set an
approximate center of the third surface 60a at which the curved
plate 40 and the third surface 60a are most distant from each other
as an end point, thereby defining the length H2 of the
perpendicular line from the curved plate 40 to the third surface
60a.
[0139] Positions corresponding to the start points of the
respective perpendicular lines H1 and H2 may allow comparison of a
distance between the curved plate 40 and the first surface 50a with
a distance between the curved plate 40 and the third surface 60a,
and are not limited to the above definitions. For example, a
surface of the curved plate 40 opposite to the surface on the wrist
200 side may be set as a start point of the perpendicular line.
[0140] An external shape, a structure, an elastic modulus of a
constituent material, etc. of each of the first inflatable portion
50 and the second inflatable portion 60 are preferably selected or
designed as appropriate such that the length H1 of the
perpendicular line is longer than the length H2 of the
perpendicular line.
[0141] In the present embodiment, the first inflatable portion 50
and the second inflatable portion 60 are made of the same material,
and an external shape of the first inflatable portion 50 is larger
than an external shape of the second inflatable portion 60 in a
state of not being inflated, so that the length H1 of the
perpendicular line is longer than the length H2 of the
perpendicular line in an inflated state. Specifically, a dimension
of the first inflatable portion 50 (the length L1 of the first
inflatable portion 50) along the longitudinal direction of the band
20 may be longer than a dimension of the second inflatable portion
60 (the length L2 of the second inflatable portion 60) along the
longitudinal direction of the band 20. In addition, a dimension of
the first inflatable portion 50 (the width W1 of the first
inflatable portion 50) along the direction orthogonal to the
longitudinal direction of the band 20 is longer than a dimension of
the second inflatable portion 60 (the width W2 of the second
inflatable portion 60) along the direction orthogonal to the
longitudinal direction of the band 20.
[0142] It is possible, for example, to include a structure in which
the length H1 of the perpendicular line is longer than the length
H2 of the perpendicular line by changing a material of a part of
the second inflatable portion 60 to provide a portion that rarely
inflates (inflates relatively little) in a direction of the
perpendicular line. Alternatively, for example, the first
inflatable portion 50 may be made of a material having a higher
elastic modulus than that of the second inflatable portion 60, and
the first inflatable portion 50 may be configured to be able to
inflate more than the second inflatable portion 60, so that the
length H1 of the perpendicular line is longer than the length H2 of
the perpendicular line.
[0143] In addition, in the present embodiment, a description has
been given of a case in which the external shape of the first
inflatable portion 50 and the external shape of the second
inflatable portion 60 are similar to each other. However, for
example, even in a case in which the external shape of the first
inflatable portion 50 and the external shape of the second
inflatable portion 60 are not similar to each other, effects
described below may be obtained similarly to the present embodiment
by setting a maximum length of the perpendicular line from the
curved plate 40 to the first surface 50a to be longer than a
maximum length of the perpendicular line from the curved plate 40
to the third surface 60a.
[0144] In addition, as described above, the length L1 of the first
inflatable portion 50 may be longer than the length L2 of the
second inflatable portion 60, and the width W1 of the first
inflatable portion 50 may be longer than the width W2 of the second
inflatable portion 60. For this reason, a surface area of the first
surface 50a of the first inflatable portion 50 in an inflated state
is larger than a surface area of the third surface 60a of the
second inflatable portion 60 in an inflated state. In addition, the
first inflatable portion 50 can be inflated more than the second
inflatable portion 60 in the longitudinal direction of the band 20,
the direction orthogonal to the longitudinal direction of the band
20, and the direction of the perpendicular line mentioned above.
For this reason, the volume of the first inflatable portion 50 in
the inflated state is larger than the volume of the second
inflatable portion in the inflated state.
[0145] The length L1 of the first inflatable portion 50 may be
longer than the length L2 of the second inflatable portion 60, and
the width W1 of the first inflatable portion 50 may be the same as
the width W2 of the second inflatable portion 60. In this case, the
surface area of the first surface 50a of the first inflatable
portion 50 in the inflated state may be larger than the surface
area of the third surface 60a of the second inflatable portion 60
in the inflated state. In addition, the volume of the first
inflatable portion 50 in the inflated state may be larger than the
volume of the second inflatable portion 60 in the inflated
state.
[0146] In addition, both the first inflatable portion 50 and the
second inflatable portion 60 according to the present embodiment
are inflated by being injected with a fluid and formed using the
same member. For this reason, when the external dimensions (L1, W1)
of the first inflatable portion 50 and the external dimensions (L2,
W2) of the second inflatable portion 60 are the same, a difference
is not recognized at a glance, and there is a possibility that the
first inflatable portion 50 and the second inflatable portion 60
will be mistaken (i.e., that the first inflatable portion 50 will
be positioned to apply pressure to the ulnar artery 230 while the
second inflatable portion 60 is positioned to apply pressure to the
radial artery 210). However, as described above, when the
respective inflatable portions 50 and 60 are formed such that the
external dimensions (L1, W1) of the first inflatable portion 50 and
the external dimensions (L2, W2) of the second inflatable portion
60 are different from each other, it is possible to rather easily
distinguish between the first inflatable portion 50 and the second
inflatable portion 60 having different appearance sizes.
[0147] In addition, a relationship between a length L3 of the first
curved portion 42 and a length L4 of the second curved portion 43
along a longitudinal direction of the curved plate 40 corresponds
to a relationship between the length L1 of the first inflatable
portion 50 and the length L2 of the second inflatable portion 60.
Specifically, as illustrated in FIG. 10 and FIG. 13, the length L3
of the first curved portion 42 provided on a side where the first
inflatable portion 50 is located may be longer than the length L4
of the second curved portion 43 provided on a side where the second
inflatable portion 60 is located. For this reason, when the
hemostatic device 10 is mounted on the wrist 200, the first
inflatable portion 50 and the second inflatable portion 60 may be
pressed against the wrist 200 by conforming the first curved
portion 42 and the second curved portion 43 to shapes of the first
inflatable portion 50 and the second inflatable portion 60, which
are inflated, respectively.
[0148] As illustrated in FIG. 10, the marker 70 is provided on the
second surface 50b. When such a marker 70 is provided in the first
inflatable portion 50, the first inflatable portion 50 may be
relatively easily positioned with respect to the puncture site 220,
and thus a position shift of the first inflatable portion 50 is
suppressed.
[0149] A shape of the marker 70 is not particularly limited.
Examples of the shape include a circle, a triangle, a rectangle,
etc. In the present embodiment, the shape of the marker 70 is a
rectangle.
[0150] A size of the marker 70 is not particularly limited.
However, for example, when the shape of the marker 70 is the
rectangle, a length of a side of the rectangular marker is
preferably in a range of 1 to 4 mm. When the length of the side is
5 mm or more, the size of the marker 70 is larger when compared to
a size of the puncture site 220, and thus it is difficult to
position a central portion of the first inflatable portion 50 in
the puncture site 220.
[0151] A material of the marker 70 is not particularly limited.
Examples of the material for the marker 70 include an oily coloring
agent such as ink, a resin kneaded with a pigment, etc.
[0152] A color of the marker 70 is not particularly limited when
the color allows the first inflatable portion 50 to be positioned
in the puncture site 220. However, a green-based color is
preferable. When the green-based color is adopted, it is rather
easy to visually recognize the marker 70 on blood or skin, and thus
the first inflatable portion 50 is more easily positioned in the
puncture site 220.
[0153] In addition, the marker 70 is preferably translucent or
colored transparent. In this way, the puncture site 220 may be
visually recognized from an outer surface side of the marker
70.
[0154] The manner in which the marker 70 is provided in the first
inflatable portion 50 is not particularly limited. Examples of
providing the marker at the first inflatable portion 50 include
printing the marker 70 on the first inflatable portion 50, fusing
the marker 70 to the first inflatable portion 50, applying an
adhesive to one surface of the marker 70 to paste the marker 70 to
the first inflatable portion 50, etc.
[0155] The marker 70 may be provided on the inner surface side of
the first inflatable portion 50. In this instance, the marker 70 is
preferably provided on an inner surface, etc. of the first
inflatable portion 50 so as not to directly come into contact with
the puncture site 220.
[0156] The first injection portion 80 and the second injection
portion 81 are parts for injecting a fluid into the first
inflatable portion 50 and the second inflatable portion 60,
respectively, and are connected to the first inflatable portion 50
and the second inflatable portion 60, respectively, as illustrated
in FIG. 9.
[0157] The first injection portion 80 includes a flexible first
tube 82 having a proximal portion connected to the first inflatable
portion 50 and a lumen communicating with an inside of the first
inflatable portion 50, a first bag body 84 disposed at a distal
portion of the first tube 82 to communicate with the lumen of the
first tube 82, and a tube-shaped first connector 86 connected to
the first bag body 84. A check valve (not illustrated) is
incorporated in the first connector 86.
[0158] Similarly, the second injection portion 81 includes a
flexible second tube 83 having a proximal portion connected to the
second inflatable portion 60 and a lumen communicating with an
inside of the second inflatable portion 60, a second bag body 85
disposed at a distal portion of the second tube 83 to communicate
with the lumen of the second tube 83, and a tube-shaped second
connector 87 connected to the second bag body 85. A check valve
(not illustrated) may be incorporated in the second connector 87.
The second tube 83 is preferably disposed on the same side as a
side where the first tube 82 is disposed with respect to the band
20. In this way, it is possible to inject a fluid into the first
tube 82 and the second tube 83 from the same side. For this reason,
when the same syringe is used for the first tube 82 and the second
tube 83, it is possible to easily perform an operation of inserting
and withdrawing the syringe.
[0159] At the time of inflating (expanding) the first inflatable
portion 50, a tip of a syringe (not illustrated) is inserted into
the first connector 86 to open the check valve, and a plunger of
this syringe is pushed to inject a fluid in the syringe into the
first inflatable portion 50 through the first injection portion 80.
When the first inflatable portion 50 expands, the first bag body 84
communicating with the first inflatable portion 50 through the
first tube 82 also expands, and it is possible to visually confirm
that the first inflatable portion 50 can be pressed without leakage
of the fluid. When the tip of the syringe is withdrawn from the
first connector 86 after the fluid is injected into the first
inflatable portion 50, the check valve incorporated in the first
connector 86 is closed to prevent leakage of the fluid, and an
expanded state of the first inflatable portion 50 is maintained.
When the same operation is performed with respect to the second
injection portion 81 connected to the second inflatable portion 60,
an expanded state of the second inflatable portion 60 is
maintained.
[0160] Next, a description will be given of a manner of using the
hemostatic device 10 according to the present embodiment.
[0161] Before the hemostatic device 10 is mounted on the wrist 200,
the first inflatable portion 50 and the second inflatable portion
60 are in a state of not being inflated. When the wrist 200 is
punctured, the puncture site 220 with respect to the radial artery
210 is normally biased to a thumb side of the right hand wrist 200.
Normally, the introducer sheath is indwelled in the puncture site
220. The band 20 is wrapped around the wrist 200 in which the
introducer sheath is indwelled, the first inflatable portion 50 and
the band 20 are positioned such that the marker 70 provided in the
first inflatable portion 50 overlaps the puncture site 220, and the
male side 31 and the female side 32 of the hook and loop fastener
30 are brought into contact with each other and joined to each
other, thereby mounting the band 20 on the wrist 200.
[0162] The hemostatic device 10 may be mounted on the wrist 200
such that the first injection portion 80 and the second injection
portion 81 face a downstream side of a blood flow of the radial
artery 210. In this way, the first injection portion 80 and the
second injection portion 81 may be operated without interfering
with manipulation on the upstream side of the wrist or a device
(for example, a sphygmomanometer, etc.) located on the upstream
side. In addition, when the hemostatic device 10 is mounted on the
right hand wrist 200 such that the first injection portion 80 and
the second injection portion 81 face the downstream side, the first
inflatable portion 50 is located on the radial artery 210 biased to
the thumb side of the wrist 200, and the second inflatable portion
60 is located around the ulnar artery 230. In the case of the
artery, the upstream side of the blood vessel refers to a direction
of the blood vessel approaching a heart. In addition, the
downstream side of the blood vessel refers to a direction of the
blood vessel away from the heart.
[0163] After the hemostatic device 10 is mounted on the wrist 200,
the syringe (not illustrated) is connected to the first connector
86 of the first injection portion 80, the fluid is injected into
the first inflatable portion 50 as described above, and the first
inflatable portion 50 is inflated to press the puncture site 220 as
illustrated in FIG. 13 and FIG. 14. A degree of inflation of the
first inflatable portion 50, that is, a pressing force applied to
the puncture site 220 located in the radial artery 210 may be
rather easily adjusted depending on the case according to an
injection amount of the fluid at this time.
[0164] After the first inflatable portion 50 is inflated, the
syringe is detached from the first connector 86. Then, the
introducer sheath is withdrawn from the puncture site 220. In this
way, the first inflatable portion 50 maintains an inflated state,
and a state of pressing the puncture site 220 is maintained.
[0165] Subsequently, the syringe (not illustrated) is connected to
the second connector 87 of the second injection portion 81, the
fluid is injected into the second inflatable portion 60 as
described above, and the second inflatable portion 60 is inflated
to press the vicinity of the ulnar artery 230 as illustrated in
FIG. 13 and FIG. 15. A degree of inflation of the second inflatable
portion 60, that is, a pressing force applied to the vicinity of
the ulnar artery 230 may be rather easily adjusted according to an
injection amount of the fluid at this time.
[0166] When the first inflatable portion 50 and the second
inflatable portion 60 are inflated, the curved plate 40 is
separated from the body surface of the wrist 200 and hardly comes
into contact with the wrist 200. In addition, when the first
inflatable portion 50 and the second inflatable portion 60 are
inflated after the hemostatic device 10 is mounted, inflation of
the first inflatable portion 50 and the second inflatable portion
60 in a direction away from the body surface of the wrist 200 is
suppressed by the curved plate 40, and a pressing force of the
first inflatable portion 50 and the second inflatable portion 60 is
concentrated on the wrist 200 side. For this reason, a pressing
force from the first inflatable portion 50 intensively acts on the
vicinity of the puncture site 220, and thus the hemostatic effect
may be improved.
[0167] In addition, when the first inflatable portion 50 presses
the radial artery 210, the second inflatable portion 60 may press
the ulnar artery 230, thereby preventing an excessive increase in
the blood flow flowing to the ulnar artery 230, and suppressing a
decrease in the blood flow rate of the radial artery 210. In this
way, occlusion of the blood vessel may be prevented, and a decrease
in the amount of the platelets, etc. may be suppressed, thereby
performing hemostasis at the puncture site 220 in a relatively
short time.
[0168] In addition, as illustrated in FIG. 13, FIG. 14, and FIG.
15, in a state in which the hemostatic device 10 is mounted on the
wrist 200, the respective inflatable portions 50 and 60 are
inflated until a length of a perpendicular line H1 indicating an
indication of an inflation state of the first inflatable portion 50
becomes longer than a length of a perpendicular line H2 indicating
an indication of an inflation state of the second inflatable
portion 60. In this way, when compared to a part of the second
inflatable portion 60 coming into contact with the wrist, a part of
the first inflatable portion 50 coming into contact with the wrist
is convexly deformed toward the wrist and presses the puncture site
220 and the vicinity thereof with a larger pressing force than a
pressing force applied to the ulnar artery 230 by the second
inflatable portion 60.
[0169] The pressing force of the first inflatable portion 50 and
the second inflatable portion 60 may be adjusted by adjusting the
amount of the fluid injected into the first inflatable portion 50
and the second inflatable portion 60 depending on the progress of
hemostasis or the elapsed time.
[0170] When hemostasis is completed, the pressing force of the
first inflatable portion 50 to the puncture site 220 is further
reduced and the hemostatic device 10 is removed.
[0171] When hemostasis in the puncture site 220 is completed and
the hemostatic device 10 is removed, the first inflatable portion
50 is contracted, and then the male side 31 and the female side 32
of the hook and loop fastener 30 are peeled off or separated to
remove the hemostatic device 10 from the wrist 200. The first
inflatable portion 50 may not be contracted when the hemostatic
device 10 is removed.
[0172] As described above, the hemostatic device 10 according to
the present embodiment includes the flexible band 20 that can be
wrapped around the wrist in which the radial artery 210 and the
ulnar artery 230 run or are located, the hook and loop fastener 30
that secures the band 20 to the wrist 200 in a wrapped state, the
curved plate 40 held by the band 20 and formed using a harder
material than the material forming the band 20, the first
inflatable portion 50 connected to the band 20 and allowed to press
the puncture site 220 of the radial artery 210 by being inflated in
response to injection of the fluid, and the second inflatable
portion 60 disposed at a different position from that of the first
inflatable portion 50 in the longitudinal direction of the band 20
and allowed to press the ulnar artery 230. The first inflatable
portion 50 has the first surface 50a disposed on the wrist 200 side
and the second surface 50b disposed on the band 20 side. The second
inflatable portion 60 has the third surface 60a disposed on the
wrist 200 side and the fourth surface 60b disposed on the band 20
side. In a state in which at least a portion of the second surface
50b in the first inflatable portion 50 and at least a portion of
the fourth surface 60b in the second inflatable portion 60 are
brought into contact with a range of the band 20 in which the
curved plate 40 is disposed, the length H1 of the perpendicular
line from the curved plate 40 to the first surface 50a at the time
of inflating the first inflatable portion 50 may be longer than the
length H2 of the perpendicular line from the curved plate 40 to the
third surface 60a at the time of inflating the second inflatable
portion 60.
[0173] According to the hemostatic device 10 configured as
described above, the hemostatic effect may be enhanced by
moderately suppressing a decrease in the blood flow rate of the
radial artery 210. In addition, the length H1 of the perpendicular
line from the curved plate 40 to the first surface 50a at the time
of inflating the first inflatable portion 50 may be longer than the
length H2 of the perpendicular line from the curved plate 40 to the
third surface 60a at the time of inflating the second inflatable
portion 60. For this reason, in the state in which the hemostatic
device 10 is mounted on the wrist 200, a pressing force applied to
the ulnar artery 230 by the second inflatable portion 60 may be
smaller than a pressing force applied to the puncture site 220 by
the first inflatable portion 50. As a result, it is possible to
reduce numbness or pain caused by pressing the ulnar artery 230 by
decreasing the pressing force applied to the ulnar artery 230 by
the second inflatable portion 60 while ensuring the pressing force
applied to the puncture site 220 by the first inflatable portion
50.
[0174] In addition, the surface area of the first surface 50a of
the first inflatable portion 50 in the inflated state may be larger
than the surface area of the third surface 60a of the second
inflatable portion 60 in the inflated state. For this reason, in
the state in which the hemostatic device 10 is mounted on the wrist
200, an area of a part in which the first inflatable portion 50
comes into contact with the wrist 200 becomes larger than an area
of a part in which the second inflatable portion 60 comes into
contact with the wrist 200. As a result, it is possible to ensure
the pressing force applied to the puncture site 220 by the first
inflatable portion 50 and stably press the puncture site 220 by
pressing a relatively extensive range, and it is possible to
decrease the pressing force applied to the ulnar artery 230 by the
second inflatable portion 60 and reduce numbness or pain caused by
pressing the ulnar artery 230.
[0175] In addition, the length L2 of the second inflatable portion
60 along the longitudinal direction of the band 20 may be shorter
than the length of the first inflatable portion 50 along the
longitudinal direction of the band 20. For this reason, it is
possible to narrow a range in a part (a tendon, a nerve, etc.)
other than the ulnar artery 230 pressed by the second inflatable
portion 60 while ensuring a range pressed by the first inflatable
portion 50. As a result, it is possible to reduce numbness or pain
caused by pressing the ulnar artery 230.
[0176] In addition, the second inflatable portion 60 can be
inflated by injection of a fluid, and the volume of the first
inflatable portion 50 in the inflated state may be larger than the
volume of the second inflatable portion 60 in the inflated state.
When the volume in the inflated state is large, the wrist 200 is
more strongly pressed. Thus, when the volume of the first
inflatable portion 50 in the inflated state is larger than the
volume of the second inflatable portion 60, it is possible to
decrease the pressing force applied to the ulnar artery 230 by the
second inflatable portion 60 while ensuring the pressing force
applied to the puncture site 220 by the first inflatable portion
50.
Modification of Second Embodiment
[0177] In the hemostatic device 10 according to the second
embodiment, a member (inflatable portion) that presses the puncture
site 220 includes the single first inflatable portion 50 that
inflates by injection of a fluid. Meanwhile, as illustrated in FIG.
16, a hemostatic device 100 according to a modification of the
second embodiment has a feature in that a fluid is injected in
common with the second embodiment. However, the hemostatic device
100 is different from the second embodiment in that a member
(inflatable portion 150) that presses the puncture site 220
includes two members corresponding to a main compression portion
151 and an auxiliary compressing portion 152.
[0178] In addition, in the hemostatic device 10 according to a
second embodiment, the member (pressing portion) that presses the
ulnar artery 230 includes the single second inflatable portion 60
that can inflate by injection of a fluid. On the other hand, in the
hemostatic device 100 according to the modification of the second
embodiment, a member (pressing member 160) that presses the ulnar
artery 230 includes two members corresponding to a hard member
(relatively hard member) 161 and a soft member (relatively soft
member) 162. Other aspects and configurations of the modification
of the second embodiment are substantially the same as in the
second embodiment. Hereinafter, a detailed description will be
given of the hemostatic device 100 according to the modification of
the second embodiment. In the description below, features that are
the same or similar to those described above are identified by the
same reference numerals and a detailed description of such features
is not repeated.
[0179] As illustrated in FIG. 16, the inflatable portion 150
includes the main compression portion 151 that presses the puncture
site 220 of the radial artery 210 and the auxiliary compressing
portion 152 disposed to overlap a part between the main compression
portion 151 and the band 20. The main compression portion 151 and
the auxiliary compressing portion 152 are located to overlap the
vicinity of a part between the first curved portion 42 and the
central portion 41.
[0180] The main compression portion 151 and the auxiliary
compressing portion 152 inflate by injection of a fluid (gas such
as air or liquid). The main compression portion 151 and the
auxiliary compressing portion 152 communicate with each other, a
communication path 154 that can allow communication between an
inside of the main compression portion 151 and an inside of the
auxiliary compressing portion 152 is provided, and the same
injection portion (not illustrated) as that of the second
embodiment is provided in one of the compression portions. For this
reason, when one of the main compression portion 151 or the
auxiliary compressing portion 152 is injected with a fluid and
inflated, the other one inflates together. The inflated main
compression portion 151 presses the puncture site 220 located in
the radial artery 210 of the wrist 200. The inflated auxiliary
compressing portion 152 presses the main compression portion 151 to
adjust a pressing direction of the main compression portion 151.
The auxiliary compressing portion is not limited to a portion
inflated by being injected with a fluid as in the second
embodiment. For example, it is possible to use a sponge-like
substance, an elastic material, an aggregate of fibers such as
cotton, or a combination thereof.
[0181] A constituent material forming the main compression portion
151 and the auxiliary compressing portion 152 is not particularly
limited as long as the material has flexibility. For example, it is
possible to use the same material as the constituent material
forming the band 20 of the second embodiment mentioned above. In
addition, the main compression portion 151 and the auxiliary
compressing portion 152 are preferably made of the same or a
similar material as or to that of the band 20. In this way, joining
the main compression portion 151 and the auxiliary compressing
portion 152 to the band 20 by fusing may be rather easily
performed, and manufacture may be relatively easily performed.
[0182] Similar to the band 20 and the curved plate 40, the main
compression portion 151 and the auxiliary compressing portion 152
are preferably substantially transparent. In this way, the puncture
site 220 may be visually recognized from the outer surface side,
and a marker 70 provided in the auxiliary compressing portion 152
may be relatively easily positioned in the puncture site 220.
[0183] Similar to the first inflatable portion 50 according to the
second embodiment, structures of the main compression portion 151
and the auxiliary compressing portion 152 may be formed in a shape
of a bag by overlapping two rectangular sheet materials and joining
edge portions using a method such as fusing, adhesion, etc.
[0184] The auxiliary compressing portion 152 may be connected to
the band 20 through a holding portion 153 having flexibility. The
holding portion 153 is preferably provided on the first curved
portion 42 side of the curved plate 40. In addition, the holding
portion 153 is preferably made of the same material as that of the
main compression portion 151 and the auxiliary compressing portion
152. In this way, joining to the band 20 by fusing may be rather
easily performed, and manufacture may be rather easily
accomplished.
[0185] The pressing member 160 includes the hard member (relatively
harder member) 161 that presses the vicinity of the ulnar artery
230 and the soft member (relatively softer member) 162 which is
softer than the hard member 161 and disposed to overlap a part
between the hard member 161 and the band 20. The hard member 161
and the soft member 162 overlap the vicinity of a part between the
second curved portion 43 and the central portion 41.
[0186] For example, the hard member 161 may be made of a hard
material (relatively harder member) such as metal, plastic, etc.
The soft member (relatively softer member) 162 may be softer than
the hard member 161. For example, it is possible to use a
sponge-like substance, an elastic material, an aggregate of fibers
such as cotton, or a material obtained by combining these
materials. In addition, for example, the soft member 162 may be
configured to be inflated by being injected with a fluid (air,
liquid, etc.). The hard member 161 presses the ulnar artery 230.
The soft member 162 mitigates a pressing force applied to the hard
member 161 by the curved plate 40 between the curved plate 40 and
the hard member 161.
[0187] The external shapes of ach of the hard member 161 and the
soft member 162 correspond to a cylindrical shape having an
elliptical cross section. However, so long as the ulnar artery 230
can be pressed, the external shapes of the hard member 161 and the
soft member 162 are not limited to the cylindrical shape. For
example, it is possible to adopt a polygonal prism such as a
quadrangular prism, a triangular prism, etc.
[0188] The hard member 161 and the soft member 162 are joined to
each other using a method such as fusing (heat-fusing,
high-frequency fusing, ultrasonic fusing, etc.), adhesion (adhesion
by an adhesive or a solvent), etc. The soft member 162 and the band
20 are joined to each other using the same method.
[0189] In the present modification, a surface of the inflatable
portion 150 disposed on the wrist 200 side (a surface of the main
compression portion 151 disposed on the wrist 200 side) is a first
surface 150a, and a surface of the inflatable portion 150 disposed
on the band 20 side (a surface of the auxiliary compressing portion
152 disposed on the wrist 200 side) is a second surface 150b. In
addition, a surface of the pressing member 160 disposed on the
wrist 200 side (a surface of the hard member 161 disposed on the
wrist 200 side) is a third surface 160a, and a surface of the
pressing member 160 disposed on the band 20 side (a surface of the
soft member 162 disposed on the wrist 200 side) is a fourth surface
160b. In a state in which at least a part of the second surface
150b in the inflatable portion 150 and at least a part of the
fourth surface 160b in the pressing member 160 are brought into
contact with a range of the band 20 in which the curved plate 40 is
disposed, a length H11 of a perpendicular line from the curved
plate 40 to the first surface 150a at the time of inflating the
inflatable portion 150 is longer than a length H12 of a
perpendicular line from the curved plate 40 to the third surface
160a.
[0190] According to the hemostatic device 100 configured as
described above, it is possible to enhance the hemostatic effect by
moderately suppressing a decrease in the blood flow rate of the
radial artery 210. In addition, the length H11 of the perpendicular
line from the curved plate 40 to the first surface 150a at the time
of inflating the inflatable portion 150 may be longer than the
length H12 of the perpendicular line from the curved plate 40 to
the third surface 160a of the pressing member 160. For this reason,
in the state in which the hemostatic device 100 is mounted on the
wrist 200, a pressing force applied to the ulnar artery 230 by the
pressing member 160 may be smaller than a pressing force applied to
the puncture site 220 by the inflatable portion 150. As a result,
it is possible to reduce numbness or pain caused by pressing the
ulnar artery 230 by decreasing the pressing force applied to the
ulnar artery 230 by the pressing member 160 while ensuring the
pressing force applied to the puncture site 220 by the inflatable
portion 150.
[0191] In addition, the pressing member 160 includes the soft
member 162 between the hard member 161 and the curved plate 40, and
the soft member 162 mitigates the pressing force applied from the
curved plate 40 to the hard member 161 at the time of mounting the
hemostatic device 100 on the wrist 200. In this way, when the wrist
200 is pressed by the hard member 161 which is solid, it is
possible to reduce numbness or pain caused by pressing the ulnar
artery 230 by providing the soft member 162 between the hard member
161 and the curved plate 40.
[0192] As described above in the modification of the second
embodiment, when each of the inflatable portion and the pressing
member has a structure in which a plurality of members is stacked,
each surface on the wrist 200 side in a member disposed closest to
the wrist 200 side may be set to the first surface or the third
surface, each surface on the band 20 side in a member disposed
closest to the band 20 side may be set to the second surface or the
fourth surface, and the above-described length relationship of the
perpendicular lines may be satisfied.
[0193] The hemostatic devices according to the second embodiment
and the modification of the second embodiment described above may
be appropriately modified while still being within the scope of the
description in claims.
[0194] For example, each portion included in the hemostatic device
may be replaced with a portion having an arbitrary configuration
capable of exerting the same function. In addition, an arbitrary
component may be added.
[0195] In addition, the invention is not limited to the hemostatic
device used by being mounted on the wrist, and is applicable to a
hemostatic device used by being mounted on any part of the arm in
which the radial artery and the ulnar artery run.
[0196] In addition, shapes of the members (the first inflatable
portion and the main compression portion) that press the puncture
site, the auxiliary member (the auxiliary compressing portion), and
the member (the second inflatable portion) that presses the ulnar
artery in a state of not being inflated are not limited to the
rectangle. For example, the shapes may be a circle, an ellipse, and
a polygon such as a pentagon.
[0197] In addition, the marker may not be provided in the
inflatable portion, and may be provided in the band, the curved
plate, and the auxiliary compressing portion. In addition, the
marker is more preferably provided to overlap the central portion
of the inflatable portion.
[0198] In addition, similar to the pressing member of the
hemostatic device according to the first embodiment described
above, in the pressing member (second inflatable portion) of the
hemostatic device according to the second embodiment and the
pressing member of the hemostatic device according to the
modification of the second embodiment, the dimension (length) along
the longitudinal direction of the band may be shorter than the
dimension (width) along the direction orthogonal to the
longitudinal direction of the band.
[0199] In addition, in the pressing member (second inflatable
portion) of the hemostatic device according to the second
embodiment and the pressing member of the hemostatic device
according to the modification of the second embodiment, it is
possible to provide a projection provided in a pressing member of a
hemostatic device according to a third embodiment described below.
When the projection is provided in the pressing member (second
inflatable portion) of the hemostatic device according to the
second embodiment and the pressing member of the hemostatic device
according to the modification of the second embodiment as described
above, a surface disposed on the arm side of the projection
corresponds to a third surface, and a length of a perpendicular
line on the inflatable portion side (a length of a perpendicular
line from the support plate to the first surface) L1 may be longer
than a length of a perpendicular line on the pressing member side
(a length of a perpendicular line from the support plate to the
third surface) L2.
Third Embodiment
[0200] Next, a description will be given of the hemostatic device
according to the third embodiment of the hemostatic device
disclosed here.
[0201] As illustrated in FIG. 20(A), the hemostatic device 10
according to the third embodiment, representing another embodiment
of the inventive hemostatic device disclosed here, is used to
perform hemostasis at a puncture site 220 after withdrawing an
introducer sheath indwelled in the puncture site 220 (corresponding
to a part to be subjected to hemostasis) formed in a radial artery
210 of a wrist 200 to insert a catheter, etc. performing
treatment/examination, etc. into a blood vessel.
[0202] As illustrated in FIG. 17 and FIG. 18, the hemostatic device
10 includes a band 20 for wrapping around the wrist 200, a hook and
loop fastener 30 (corresponding to a securing portion) for securing
the band 20 in a state of being wrapped around the wrist 200, a
curved plate 40, an inflatable portion or inflatable element/member
50, a pressing member 60, a marker 70, a first injection portion
80, and a second injection portion 81.
[0203] In this description, a side (mounting surface side) of the
band 20 facing a body surface of the wrist 200 is referred to as an
"inner surface side", and an opposite side thereof is referred to
as an "outer surface side" when the band 20 is wrapped around the
wrist 200.
[0204] In addition, in the drawings, a longitudinal direction of
the band 20 is indicated as an arrow X, a direction orthogonal to
the longitudinal direction of the band 20 is indicated as an arrow
Y, and a direction orthogonal to the arrow Y and the arrow X is
indicated as an arrow Z.
[0205] The band 20 may be a flexible band-shaped member. As
illustrated in FIG. 20(A), the band 20 may be wrapped around an
outer periphery of the wrist 200 substantially once. As illustrated
in FIG. 18, a curved plate holding portion 21 that holds the curved
plate 40 is formed at a central portion of the band 20. The curved
plate holding portion 21 is doubled by separate band-shaped members
joined to an outer surface side (or inner surface side) using a
method such as fusing (heat-fusing, high-frequency fusing,
ultrasonic fusing, etc.), adhesion (adhesion by an adhesive or a
solvent), etc. and holds the curved plate 40 inserted into a gap
therebetween.
[0206] A male side (or a female side) 31 of the hook and loop
fastener 30 generally referred to as Magic Tape (registered
trademark), etc. may be disposed on the outer surface side of the
band 20 near a left end of FIG. 17, and a female side (or a male
side) 32 of the hook and loop fastener 30 may be disposed on the
inner surface side of the band 20 near a right end of FIG. 17. As
illustrated in FIG. 19 and FIG. 20(A), the band 20 may be wrapped
around the wrist 200, and the male side 31 and the female side 32
are joined together, thereby mounting the band 20 on the wrist 200.
Means for securing the band 20 to the wrist 200 in a wrapped state
is not limited to the hook and loop fastener 30. For example, the
means may correspond to a snap, a button, a clip, or a frame member
passing an end portion of the band 20.
[0207] A constituent material of the band 20 is not particularly
limited as long as the material has flexibility, and examples
thereof 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, silicone, polyurethane, various
thermoplastic elastomers such as polyamide elastomers, polyurethane
elastomers and polyester elastomers, and an arbitrary combination
of the above (blend resin, polymer alloy, laminate, etc.).
[0208] The band 20 is preferably substantially transparent.
However, the band 20 may not be transparent, and may be translucent
or colored transparent. In this way, the puncture site 220 may be
visually recognized from the outer surface side, and the marker 70
described below may be easily positioned in the puncture site
220.
[0209] As illustrated in FIG. 18, the curved plate 40 may be held
in the band 20 by being inserted into or positioned in the doubly
formed curved plate holding portion 21 of the band 20. The curved
plate 40 may be made of a harder material than the material of the
band 20 and maintains a substantially constant shape.
[0210] The curved plate 40 may have a shape elongated in the
longitudinal direction of the band 20 (a direction of the arrow X).
A central portion 41 of the curved plate 40 in the longitudinal
direction may have a flat plate shape almost without being curved,
and a first curved portion 42 (left side of FIG. 18) and a second
curved portion 43 (right side of FIG. 18) curved toward an inner
peripheral side and along the longitudinal direction of the band 20
(a circumferential direction of the wrist 200) are formed at both
sides of the central portion 41, respectively.
[0211] A constituent material forming the curved plate 40 is not
particularly limited as long as the puncture site 220 can be
visually recognized. Examples of the material include acrylic
resins, polyvinyl chloride (particularly rigid polyvinyl chloride),
polyolefins such as polyethylene, polypropylene and polybutadiene,
polystyrene, poly(4-methyl pentene-1), 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 or aliphatic
polyamides, and fluorocarbon resins such as
polytetrafluoroethylene.
[0212] Similar to the band 20, the curved plate 40 is preferably
substantially transparent. However, the curved plate 40 may not be
transparent, and may be translucent or colored transparent. In this
way, the puncture site 220 may be reliably visually recognized from
the outer surface side, and the marker 70 described below may be
easily positioned in the puncture site 220. The curved plate 40 may
not have a non-curved part such as the central portion 41, that is,
may be curved over an entire length of the plate.
[0213] The inflatable portion 50 and the pressing member 60 are
connected to the band 20. The inflatable portion 50 and the
pressing member 60 inflate by being injected with a fluid (gas such
as air or liquid). The inflatable portion 50 presses the puncture
site 220 located in the radial artery 210 of the wrist 200. The
pressing member 60 presses the ulnar artery 230 by pressing the
body surface of the wrist 200.
[0214] As illustrated in FIG. 18, the inflatable portion 50 is
located to overlap the vicinity of a part between the first curved
portion 42 and the central portion 41.
[0215] A constituent material forming the inflatable portion 50 is
not particularly limited as long as the material has flexibility.
For example, it is possible to use the same material as the
constituent material forming the band 20 mentioned above.
[0216] Similar to the band 20 and the curved plate 40, the
inflatable portion 50 is preferably substantially transparent. In
this way, the puncture site 220 may be visually recognized from the
outer surface side, and the marker 70 described below may be rather
easily positioned in the puncture site 220.
[0217] For example, as illustrated in FIG. 18, a structure of the
inflatable portion 50 may be formed in a shape of a bag obtained by
overlapping two sheet materials made of the above-described
materials and joining edge portions using a method such as fusing,
adhesion, etc. As illustrated in FIG. 17, an external shape of the
inflatable portion 50 is a rectangle in a state of not being
inflated.
[0218] As illustrated in FIG. 18, the inflatable portion 50 is
connected to the band 20 through a first holding portion 51 having
flexibility. The first holding portion 51 is preferably provided on
the first curved portion 42 side of the curved plate 40. In
addition, the first holding portion 51 is preferably made of the
same material as that of the inflatable portion 50. In this way,
joining to the band 20 by fusing may be relatively easily
performed, and manufacture may be rather easily accomplished.
[0219] As illustrated in FIG. 18, the pressing member 60 is
disposed at a different position from that of the inflatable
portion 50 in the longitudinal direction of the band 20.
Specifically, the pressing member 60 is disposed to overlap the
vicinity of a part between the second curved portion 43 and the
central portion 41.
[0220] The pressing member 60 is configured to be able to inflate
by being injected with a fluid. The pressing member 60 includes a
main body 61 forming a main part of the pressing member 60 and a
projection 62 communicating with the main body 61 so as to inflate
in response to injection of a fluid. In a state in which the main
body 61 and the projection 62 inflate, the projection 62 includes a
part protruding with respect to the main body 61. That is, in the
inflated state, the projection 62 projects outwardly away from the
main body 61. The main body 61 and the projection 62 are made of
the same material and integrally formed, respectively.
[0221] As illustrated in FIG. 17, and FIG. 18, a length L2 of the
projection 62 along the longitudinal direction of the band 20 is
shorter than a length L1 of the main body 61 along the longitudinal
direction of the band 20. More preferably, the length L2 of the
projection 62 along the longitudinal direction of the band 20 is
less than or equal to half the length L1 of the main body 61 along
the longitudinal direction of the band 20. In this way, since the
length L1 of the main body 61 disposed on the outer surface side is
longer than the length L2 of the projection 62, it is possible to
apply a pressing force to the projection 62 over the whole of the
band 20 in width direction. Therefore, when the pressing member 60
is inflated, the projection 62 is held on the inner surface side of
the main body 61, and a pressing direction of the projection 62 is
defined based on a pressing direction of the main body 61. In this
way, it is possible to prevent the projection 62 from pressing the
wrist 200 in an unintended direction.
[0222] The projection 62 may be formed in a convex shape as
illustrated in FIG. 18 and FIG. 20(A) and may have a shape
continuously extending along a width direction of the band 20 (a
direction of the arrow Y) as illustrated in FIG. 17 and FIG. 20(B).
In this way, a part of the projection 62 coming into contact with
the wrist 200 may have a shape extending along running (direction
of extent) of the ulnar artery 230.
[0223] In addition, as illustrated in FIG. 17, a length W2 of the
projection 62 along the width direction of the band 20 may be less
than or equal to a length W1 of the main body 61. In this way,
since the length W2 of the projection 62 is relatively short, an
area of the projection 62 coming into contact with the wrist 200
decreases correspondingly, and it is possible to narrow a range
pressed by the pressing member 60. As a result, it is possible to
restrict pressing a part other than the ulnar artery 230 such as a
tendon, a nerve, etc. around the ulnar artery 230, and to reduce
occurrence of numbness or pain on the wrist 200 due to pressing
over a long period of time.
[0224] In addition, the length L2 of the projection 62 along the
longitudinal direction of the band 20 may be shorter than the
length W2 of the projection 62 along the width direction of the
band 20. For this reason, a part of the pressing member 60 coming
into contact with the wrist 200 may have a shape extending along
running (direction of extent) of the ulnar artery 230. As a result,
it is possible to further narrow a range of a part other than the
ulnar artery 230 (a tendon, a nerve, etc.) pressed by the pressing
member 60 while favorably pressing the ulnar artery 230. For this
reason, it is possible to reduce numbness or pain at the time of
using the hemostatic device 10.
[0225] As illustrated in FIG. 18, the pressing member 60 may be
connected to the band 20 through a second holding portion 63 having
flexibility. The second holding portion 63 is preferably provided
on the second curved portion 43 side of the curved plate 40. In
addition, the second holding portion 63 may preferably made of the
same material as that of the pressing member 60. In this way,
joining the second holding portion 63 to the band 20 by fusing may
be rather easily performed, and manufacture may be relatively
accomplished.
[0226] Similar to the inflatable portion 50, a constituent material
forming the pressing member 60 preferably corresponds to a material
having flexibility. For example, it is possible to use the same
material as the constituent material forming the band 20 mentioned
above. Similar to the band 20, the curved plate 40, and the
inflatable portion 50, it is preferable that the pressing member 60
is substantially transparent.
[0227] Similar to the inflatable portion 50, a structure of the
pressing member 60 may be in a shape of a bag obtained by
overlapping two sheet materials made of the above-described
materials and joining edge portions using a method such as fusing,
adhesion, etc. As illustrated in FIG. 17, an external shape of the
pressing member 60 may be a rectangle in a state of not being
inflated.
[0228] As illustrated in FIG. 18, the marker 70 is provided on the
outer surface side of the inflatable portion 50, that is, on a
surface of the inflatable portion 50 not facing the body surface of
the wrist 200. When such a marker 70 is provided in the inflatable
portion 50, the inflatable portion 50 may be rather easily
positioned with respect to the puncture site 220, and thus a
position shift of the inflatable portion 50 is suppressed.
[0229] A shape of the marker 70 is not particularly limited.
Examples of the shape include a circle, a triangle, a rectangle,
etc. In the present embodiment, the shape corresponds to the
rectangle.
[0230] A size of the marker 70 is not particularly limited.
However, when the shape of the marker 70 is rectangular, for
example, a length of a side of the rectangular marker is preferably
in a range of 1 to 4 mm. When the length of the side of the
rectangular marker is 5 mm or more, the size of the marker 70
becomes larger when compared to a size of the puncture site 220,
and thus it is difficult to position a central portion of the
inflatable portion 50 in the puncture site 220.
[0231] A material forming the marker 70 is not particularly
limited. Examples of such material include an oily coloring agent
such as ink, a resin kneaded with a pigment, etc.
[0232] A color of the marker 70 is not particularly limited so long
as the color allows the inflatable portion 50 to be positioned in
the puncture site 220. However, a green-based color is preferable.
When the green-based color is adopted, it is relatively easy to
visually recognize the marker 70 on blood or skin, and thus the
inflatable portion 50 is more easily positioned in the puncture
site 220.
[0233] In addition, the marker 70 is preferably translucent or
colored transparent. In this way, the puncture site 220 may be
visually recognized from an outer surface side of the marker
70.
[0234] The manner in which the marker 70 is provided at the
inflatable portion 50 is not particularly limited. Examples include
printing the marker 70 on the inflatable portion 50, fusing the
marker 70 to the inflatable portion 50, applying an adhesive to one
surface of the marker 70 to paste the marker 70 to the inflatable
portion 50, etc.
[0235] The marker 70 may be provided on the inner surface side of
the inflatable portion 50. In this instance, the marker 70 is
preferably provided on an inner surface, etc. of the inflatable
portion 50 so as not to directly come into contact with the
puncture site 220.
[0236] The first injection portion 80 and the second injection
portion 81 are parts for injecting a fluid into the inflatable
portion 50 and the pressing member 60, respectively, and are
connected to the inflatable portion 50 and the pressing member 60,
respectively, as illustrated in FIG. 17.
[0237] The first injection portion 80 includes a flexible first
tube 82 having a proximal portion connected to the inflatable
portion 50 and a lumen communicating with an inside of the
inflatable portion 50, a first bag body 84 disposed at a distal
portion of the first tube 82 to communicate with the lumen of the
first tube 82, and a tube-shaped first connector 86 connected to
the first bag body 84. A check valve (not illustrated) is
incorporated in the first connector 86.
[0238] Similar, the second injection portion 81 includes a flexible
second tube 83 having a proximal portion connected to the pressing
member 60 and a lumen communicating with an inside of the pressing
member 60, a second bag body 85 disposed at a distal portion of the
second tube 83 to communicate with the lumen of the second tube 83,
and a tube-shaped second connector 87 connected to the second bag
body 85. A check valve (not illustrated) may be incorporated in the
second connector 87. The second tube 83 may preferably disposed on
the same side as a side where the first tube 82 is disposed with
respect to the band 20. In this way, it is possible to inject a
fluid into the first tube 82 and the second tube 83 from the same
side. For this reason, when the same syringe is used for the first
tube 82 and the second tube 83, it is possible to rather easily
perform an operation of inserting and withdrawing the syringe.
[0239] At the time of inflating (expanding) the inflatable portion
50, a tip of a syringe (not illustrated) is inserted into the first
connector 86 to open the check valve, and a plunger of this syringe
is pushed to inject a fluid in the syringe into the inflatable
portion 50 through the first injection portion 80. When the
inflatable portion 50 expands, the first bag body 84 communicating
with the inflatable portion 50 through the first tube 82 also
expands, and it is possible to visually confirm that the inflatable
portion 50 can be pressed without leakage of the fluid. When the
tip of the syringe is withdrawn from the first connector 86 after
the fluid is injected into the inflatable portion 50, the check
valve incorporated in the first connector 86 is closed to prevent
leakage of the fluid, and an expanded state of the inflatable
portion 50 is maintained. When the same operation is performed with
respect to the second injection portion 81 connected to the
pressing member 60, an expanded state of the pressing member 60 is
maintained. In this way, as illustrated in FIG. 20 to FIG. 22, the
inflatable portion 50 and the pressing member 60 inflate.
[0240] Next, a description will be given of a manner of using the
hemostatic device 10 according to the present embodiment.
[0241] Before the hemostatic device 10 is mounted on the wrist 200,
the inflatable portion 50 and the pressing member 60 are in a state
of not being inflated. When the wrist 200 is punctured, the
puncture site 220 with respect to the radial artery 210 is normally
biased to a thumb side of the right hand wrist 200. Normally, the
introducer sheath is indwelled in the puncture site 220. The band
20 is wrapped around the wrist 200 in which the introducer sheath
is indwelled, the inflatable portion 50 and the band 20 are
positioned such that the marker 70 provided in the inflatable
portion 50 overlaps the puncture site 220, and the male side 31 and
the female side 32 of the hook and loop fastener 30 are brought
into contact with each other and joined to each other, thereby
mounting the band 20 on the wrist 200.
[0242] The hemostatic device 10 may be mounted on the wrist 200
such that the first injection portion 80 and the second injection
portion 81 face a downstream side of a blood flow of the radial
artery 210. In this way, the first injection portion 80 and the
second injection portion 81 may be operated without interfering
with manipulation on the upstream side of the wrist or a device
(for example, a sphygmomanometer, etc.) located on the upstream
side. In addition, when the hemostatic device 10 is mounted on the
right hand wrist 200 such that the first injection portion 80 and
the second injection portion 81 face the downstream side, the
inflatable portion 50 is located on the radial artery 210 biased to
the thumb side of the wrist 200, and the pressing member 60 is
located on the ulnar artery 230. In the case of the artery, the
upstream side of the blood vessel refers to a direction of the
blood vessel approaching a heart. In addition, the downstream side
of the blood vessel refers to a direction of the blood vessel away
from the heart.
[0243] After the hemostatic device 10 is mounted on the wrist 200,
the syringe (not illustrated) is connected to the first connector
86 of the first injection portion 80, the fluid is injected into
the inflatable portion 50 as described above, and the inflatable
portion 50 is inflated to press the puncture site 220 as
illustrated in FIG. 20(A) and FIG. 21. A degree of inflation of the
inflatable portion 50, that is, a pressing force to the puncture
site 220 located in the radial artery 210 may be rather easily
adjusted depending on the case according to an injection amount of
the fluid at this time.
[0244] After the inflatable portion 50 is inflated, the syringe is
detached from the first connector 86. Then, the introducer sheath
is withdrawn from the puncture site 220. In this way, the
inflatable portion 50 maintains an inflated state, and a state of
pressing the puncture site 220 is maintained.
[0245] Subsequently, the syringe is connected to the second
connector 87 of the second injection portion 81, and the fluid is
injected into the pressing member 60 as described above, thereby
inflating the pressing member 60. A degree of inflation of the
pressing member 60, that is, a pressing force to the ulnar artery
230 may be rather easily adjusted according to an injection amount
of the fluid at this time. In addition, the injection amount of the
fluid may be appropriately adjusted depending on the progress of
hemostasis or the elapsed time.
[0246] When the inflatable portion 50 and the pressing member 60
are inflated, the curved plate 40 is separated from the body
surface of the wrist 200 and hardly comes into contact with the
wrist 200. In addition, when the inflatable portion 50 and the
pressing member 60 are inflated after the hemostatic device 10 is
mounted, inflation of the inflatable portion 50 and the pressing
member 60 in a direction away from the body surface of the wrist
200 is suppressed by the curved plate 40, and a pressing force of
the inflatable portion 50 and the pressing member 60 is
concentrated on the wrist 200 side. For this reason, a pressing
force from the inflatable portion 50 intensively acts on the
vicinity of the puncture site 220, and thus the hemostatic effect
may be improved.
[0247] In addition, when the inflatable portion 50 presses the
radial artery 210, the ulnar artery 230 may be pressed, thereby
preventing an excessive increase in the blood flow flowing to the
ulnar artery 230, and suppressing a decrease in the blood flow rate
of the radial artery 210. In this way, occlusion of the blood
vessel may be prevented, and a decrease in the amount of the
platelets, etc. may be suppressed, thereby performing hemostasis at
the puncture site 220 in a relatively short time.
[0248] When hemostasis is completed, the pressing force of the
inflatable portion 50 to the puncture site 220 is further reduced
and the hemostatic device 10 is removed.
[0249] When hemostasis in the puncture site 220 is completed and
the hemostatic device 10 is removed, the inflatable portion 50 is
contracted, and then the male side 31 and the female side 32 of the
hook and loop fastener 30 are peeled off or separated to remove the
hemostatic device 10 from the wrist 200. The inflatable portion 50
may not be contracted when the hemostatic device 10 is removed.
[0250] As described above, the hemostatic device 10 according to
the present embodiment includes the flexible band 20 that can be
wrapped around the wrist 200 in which the radial artery 210 and the
ulnar artery 230 run, the hook and loop fastener 30 that secures
the band 20 to the wrist 200 in a wrapped state, the inflatable
portion 50 connected to the band 20 and allowed to press a part of
the radial artery 210 to be subjected to hemostasis by being
inflated in response to injection of the fluid, and the pressing
member 60 disposed at a different position from that of the
inflatable portion 50 in the longitudinal direction of the band 20
and allowed to press the ulnar artery 230. The pressing member 60
includes the main body 61 and the projection 62 which is disposed
on the main body 61 and may have a shape protruding with respect to
the main body 61.
[0251] According to the hemostatic device 10 configured as
described above, it is possible to apply a sufficient pressing
force to the ulnar artery 230 by the projection 62 receiving a
pressing force from the main body 61, and to adjust a pressing
direction of the projection 62 by the main body 61. In this way, it
is possible to restrict pressing a part other than the ulnar artery
230 such as a tendon, a nerve, etc. around the ulnar artery 230,
suppress a position shift of a part in which the wrist 200 is
pressed by the projection 62, and reduce occurrence of numbness or
pain on the wrist 200 due to pressing over a long period of
time.
[0252] In addition, the main body 61 can be inflated by being
injected with a fluid, the projection 62 communicates with the main
body 61 so as to inflate in response to injection of a fluid, and
the projection 62 includes a part protruding with respect to the
main body 61 in a state in which the main body 61 and the
projection 62 inflate. In this way, the main body 61 and the
projection 62 may be inflated by a single inflation operation, and
thus the inflation operation is facilitated.
[0253] In addition, the length L2 of the projection 62 along the
longitudinal direction of the band 20 may be shorter than the
length L1 of the main body 61 along the longitudinal direction of
the band 20. In this way, it is possible to apply a pressing force
to an outer surface of the projection 62 over the whole band 20 in
the longitudinal direction. Therefore, when the pressing member 60
is inflated, the projection 62 is held on the inner surface side of
the main body 61, and a pressing direction of the projection 62 is
defined based on a pressing direction of the main body 61. In this
way, it is possible to prevent the projection 62 from pressing the
wrist 200 in an unintended direction.
[0254] In addition, the length W2 of the projection 62 along the
width direction of the band 20 (the direction of the arrow Y) may
be less than or equal to the length W1 of the main body 61. In this
way, since the length W2 of the projection 62 is relatively short,
it is possible to narrow a range pressed by the pressing member 60.
As a result, it is possible to restrict pressing a part other than
the ulnar artery 230 such as a tendon, a nerve, etc. around the
ulnar artery 230, and to reduce occurrence of numbness or pain on
the wrist 200 due to pressing over a long period of time.
[0255] In addition, the projection 62 may have a shape continuously
extending along the width direction of the band 20 (the direction
of the arrow Y). In this way, a part of the projection 62 coming
into contact with the wrist 200 may have a shape extending along
running (direction of extent) of the ulnar artery 230. As a result,
it is possible to favorably press the ulnar artery 230. For this
reason, it is possible to further reduce occurrence of numbness or
pain on the wrist 200 due to pressing for a long period of
time.
Modification 1 of Third Embodiment
[0256] A hemostatic device 11 according to Modification 1 of the
third embodiment is different from the third embodiment only in the
shape of the pressing member 160, and the other aspects and
configurations of the hemostatic device are substantially the same
as that of the above-described third embodiment. In the description
below, features that are the same or similar to those described
above are identified by the same reference numerals and a detailed
description of such features is not repeated.
[0257] Similar to the third embodiment, a pressing member 160
includes a main body 161 forming a main part and a projection 162
inflated and deformed together with the main body 161 in response
to injection of a fluid to protrude from a part of a surface on an
inner surface side of the main body 161 as shown in FIG. 23(A) and
FIG. 23(B). The main body 161 is made of the same material as that
of the projection 162 and integrally formed.
[0258] A cross-sectional shape of the pressing member 160 according
to Modification 1 in an inflated state may be a triangle as
illustrated in FIG. 23(A), and a three-dimensional shape of the
pressing member 160 may be a shape similar to a triangular prism as
illustrated in FIG. 23(B). The projection 162 is formed by a
tapered distal end having a triangular shape and a peripheral
portion (a distal portion) (a part surrounded by a broken line of
FIG. 23(A)), and may have a shape continuously extending along the
width direction of the band 20 (the direction of the arrow Y). For
this reason, when the hemostatic device 11 is mounted on the wrist
200, a part of the pressing member 160 coming into contact with the
wrist may have a shape extending along running (direction of
extent) of the ulnar artery 230. Therefore, it is possible to
favorably press the ulnar artery 230 by the pressing member 160,
and to reduce a press range of a part (a tendon, a nerve, etc.)
other than the ulnar artery 230. As a result, it is possible to
reduce occurrence of numbness or pain on the wrist 200 at the time
of mounting the hemostatic device 11.
[0259] Further, as illustrated in FIG. 23(B), similar to the third
embodiment, a length L12 of the projection 162 along the
longitudinal direction of the band 20 may be shorter than a length
L11 of the main body 161 along the longitudinal direction of the
band 20. In addition, a length W12 of the projection 162 along the
width direction of the band 20 may be less than or equal to a
length W11 of the main body 161.
[0260] As illustrated in FIG. 23(A), the pressing member 160 may be
configured such that a length of an outer periphery R gradually
shortens from the outer surface side toward the inner surface side
of the band 20 (a direction of the arrow Z) at the time of being
inflated and deformed. Here, the outer periphery R refers to a
periphery of a Z (arrow Z) axis of the pressing member 160 as
indicated by a broken line in FIG. 23(B).
[0261] According to the hemostatic device 11 according to
Modification 1 of the third embodiment, the pressing member 160 may
have a shape in which a length of the outer periphery R shortens
from the outer surface side toward the inner surface side of the
band 20 (the direction of the arrow Z) at the time of being
inflated and deformed. In this way, on the outer surface side of
the band 20, the outer periphery R of the pressing member 160 is
relatively large, that is, an area is large in plan view in the
direction of the arrow Z. Therefore, an area in which the pressing
member 160 comes into contact with the inner surface of the band 20
on the outer surface side correspondingly increases. In this way, a
securing force of the pressing member 160 by the band 20 increases.
As a result, the pressing member 160 is more stable at the time of
mounting on the wrist 200, and thus it is possible to prevent a
position shift of a part in which the wrist 200 is pressed by the
pressing member 160.
Modification 2 of Third Embodiment
[0262] In a hemostatic device 12 according to Modification 2 of the
third embodiment, as illustrated in FIG. 24, FIG. 25(A), and FIG.
25(B), a main body 261 and a projection 262 included in a pressing
member 260 are configured as separate members. The other aspects
and configurations are substantially the same as that of the
above-described third embodiment. In the description below,
features that are the same or similar to those described above are
identified by the same reference numerals and a detailed
description of such features is not repeated.
[0263] As illustrated in FIG. 25(A), the main body 261 may be made
of a flexible material, and presses the projection 262 by inflating
in response to injection of a fluid.
[0264] The projection 262 may be made of a harder material than the
material forming the main body 261, and presses the ulnar artery
230 by receiving a pressing force from the main body 261. In the
present embodiment, as illustrated in FIG. 25(B), the projection
262 may have a circular cross section and may have a shape
continuously extending along the width direction of the band 20 (a
direction of an arrow Y). That is, the projection 262 may be formed
by a cylindrical rod-shaped member. The projection 262 may be
disposed on a surface (outer surface) of the main body 261 on an
inner surface side of the main body 261. The projection 262 may be
fixed to the main body 261 by an adhesive, an adhesive tape,
etc.
[0265] As illustrated in FIG. 24, similar to the third embodiment,
a length L22 of the projection 262 along the longitudinal direction
of the band 20 may be shorter than a length L21 of the main body
261 along the longitudinal direction of the band 20. In addition,
as illustrated in FIG. 25(B), a length W22 of the projection 262
along the width direction of the band 20 (the direction of the
arrow Y) may be less than or equal to a length W21 of the main body
261. That is, the main body 261 may be disposed to cover a surface
of the projection 262 on the outer surface side between the
projection 262 and the band 20. In this way, when the main body 261
is inflated, the projection 262 is held on the inner surface side
of the main body 261, and it is possible to adjust a direction in
which the wrist 200 is pressed by the projection 262.
[0266] A constituent material forming the main body 261 is not
particularly limited as long as the material is a flexible
material. For example, it is possible to use the same material as
the constituent material forming the band 20 mentioned above.
[0267] A constituent material forming the projection 262 is not
particularly limited as long as the material is harder than that
material of the main body 261. For example, it is possible to use
an elastic material such as a sponge-like substance, an aggregate
of fibers such as cotton, metal, a rigid material such as plastic,
or a combination thereof.
[0268] As described above, according to the hemostatic device 12
according to Modification 2 of the third embodiment, the main body
261 may be inflated by being injected with a fluid, and the
projection 262 may be made of a harder material than that of the
main body 261 and attached to an outer surface of the main body
261. In this way, a shape of the projection 262 rarely changes due
to an inflation degree of the main body 261. Therefore, a change of
a range in which the wrist 200 is pressed by the projection 262 is
relatively small, and thus it is possible to suppress a variation
in the pressing range for each manipulation. As a result, it is
possible to restrict pressing a part other than the ulnar artery
230 such as a tendon, a nerve, etc. around the ulnar artery 230,
and to reduce occurrence of numbness or pain on the wrist 200 due
to pressing over a long period of time.
[0269] The hemostatic devices according to the third embodiment and
the modifications of the third embodiment described above may be
appropriately modified while still being within the scope of the
description in the claims.
[0270] For example, each portion included in the hemostatic device
may be replaced with a portion having an arbitrary configuration
capable of exerting the same function. In addition, an arbitrary
component may be added.
[0271] In addition, the invention is not limited to the hemostatic
device used by being mounted on the wrist, and is applicable to a
hemostatic device used by being mounted on any part of the aim in
which the radial artery and the ulnar artery run.
[0272] In addition, an external shape of the inflatable portion is
not limited to a rectangle in a state of not being inflated. For
example, the external shape may correspond to a circle, an ellipse,
and a polygon such as a pentagon. In this case, a central portion
of the inflatable portion corresponds to a center of a shape
forming the external shape of the inflatable portion.
[0273] In addition, the marker may not be provided in the
inflatable portion, and may be provided in the band or the curved
plate. In addition, the marker is more preferably provided to
overlap the central portion of the inflatable portion.
[0274] In addition, in the third embodiment and Modification 1 of
the third embodiment, a description has been given of a
configuration in which the pressing member can be inflated by being
injected with a fluid. In Modification 2 of the third embodiment, a
description has been given of a configuration in which the pressing
member is based on the main body that can be inflated by being
injected with a fluid and the projection made of the harder
material than that of the main body. The pressing member according
to the invention is not limited to these configurations as long as
the ulnar artery can be pressed. For example, the whole pressing
member may be formed by a sponge-like substance, an elastic
material, etc. Alternatively, it is possible to have a
configuration including a main body formed by a sponge-like
substance, an elastic material, etc. and a projection that can be
inflated by being injected with a fluid.
[0275] The detailed description above describes embodiments of a
hemostatic device representing examples of the inventive hemostatic
device disclosed here. The invention is not limited, however, to
the precise embodiments and variations described. Various changes,
modifications and equivalents can be effected by one skilled in the
art without departing from the spirit and scope of the invention as
defined in the accompanying claims. It is expressly intended that
all such changes, modifications and equivalents which fall within
the scope of the claims are embraced by the claims.
* * * * *