U.S. patent application number 16/130201 was filed with the patent office on 2019-01-17 for apparatus and method to stop bleeding.
This patent application is currently assigned to VASOINNOVATIONS, INC.. The applicant listed for this patent is SAMIR BIPIN PANCHOLY, MILIND PADMAKAR PANSE, NOLAN RAJENDRA SARDESAI, RAJENDRA GURUDAS SARDESAI. Invention is credited to SAMIR BIPIN PANCHOLY, MILIND PADMAKAR PANSE, NOLAN RAJENDRA SARDESAI, RAJENDRA GURUDAS SARDESAI.
Application Number | 20190015110 16/130201 |
Document ID | / |
Family ID | 58053771 |
Filed Date | 2019-01-17 |
![](/patent/app/20190015110/US20190015110A1-20190117-D00000.png)
![](/patent/app/20190015110/US20190015110A1-20190117-D00001.png)
![](/patent/app/20190015110/US20190015110A1-20190117-D00002.png)
![](/patent/app/20190015110/US20190015110A1-20190117-D00003.png)
![](/patent/app/20190015110/US20190015110A1-20190117-D00004.png)
![](/patent/app/20190015110/US20190015110A1-20190117-D00005.png)
![](/patent/app/20190015110/US20190015110A1-20190117-D00006.png)
![](/patent/app/20190015110/US20190015110A1-20190117-D00007.png)
![](/patent/app/20190015110/US20190015110A1-20190117-D00008.png)
![](/patent/app/20190015110/US20190015110A1-20190117-D00009.png)
![](/patent/app/20190015110/US20190015110A1-20190117-D00010.png)
View All Diagrams
United States Patent
Application |
20190015110 |
Kind Code |
A1 |
PANCHOLY; SAMIR BIPIN ; et
al. |
January 17, 2019 |
APPARATUS AND METHOD TO STOP BLEEDING
Abstract
A hemostatic device is provided to stop bleeding at a puncture
site on the wrist of a patient, the device comprising a transparent
flexible band to be wrapped at the site where the bleeding is to be
stopped, a curved frame having an inner peripheral side and
possessing a first curved portion in its first half and a second
curved portion in its second half, a first balloon provided on the
inner peripheral side in the first half of the curved frame and a
second balloon provided on the inner peripheral side in the second
half of the curved frame. The bleeding from a first artery is
stopped by compressing the first artery at the puncture site using
inflation of the first balloon and the blood flow in the first
artery is increased by compression of a second artery using
inflation of the second balloon.
Inventors: |
PANCHOLY; SAMIR BIPIN;
(CLARKS SUMMIT, PA) ; SARDESAI; NOLAN RAJENDRA;
(ARCADIA, CA) ; PANSE; MILIND PADMAKAR;
(RIVERSIDE, CA) ; SARDESAI; RAJENDRA GURUDAS;
(ARCADIA, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PANCHOLY; SAMIR BIPIN
SARDESAI; NOLAN RAJENDRA
PANSE; MILIND PADMAKAR
SARDESAI; RAJENDRA GURUDAS |
CLARKS SUMMIT
ARCADIA
RIVERSIDE
ARCADIA |
PA
CA
CA
CA |
US
US
US
US |
|
|
Assignee: |
VASOINNOVATIONS, INC.
SOUTH PASADENA
CA
|
Family ID: |
58053771 |
Appl. No.: |
16/130201 |
Filed: |
September 13, 2018 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15588586 |
May 5, 2017 |
|
|
|
16130201 |
|
|
|
|
15150394 |
May 9, 2016 |
9668744 |
|
|
15588586 |
|
|
|
|
14819383 |
Aug 5, 2015 |
9332994 |
|
|
15150394 |
|
|
|
|
13941219 |
Jul 12, 2013 |
9308000 |
|
|
14819383 |
|
|
|
|
62288982 |
Jan 29, 2016 |
|
|
|
62089281 |
Dec 9, 2014 |
|
|
|
62096857 |
Dec 25, 2014 |
|
|
|
62103063 |
Jan 13, 2015 |
|
|
|
62142195 |
Apr 2, 2015 |
|
|
|
62157419 |
May 5, 2015 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/3215 20130101;
A61B 5/0295 20130101; A61B 17/1325 20130101; A61B 2017/12004
20130101; A61B 17/135 20130101 |
International
Class: |
A61B 17/132 20060101
A61B017/132; A61B 5/0295 20060101 A61B005/0295; A61B 17/135
20060101 A61B017/135 |
Claims
1. A method directed at obtaining hemostasis of a radial artery
after performing a catheterization procedure on a wrist of a
patient at an access site of the radial artery, comprising
performing the following steps: (a) wrapping and securing a band
around the wrist of the patient at the access site where bleeding
is to be stopped, said band comprising a first balloon and a second
balloon; (b) positioning the first balloon to provide a first
compressive force on an ulnar artery, wherein the first balloon is
located substantially in a palmar aspect of the band proximate to a
base of a palm whereby the first compressive force is focal at a
Guyon's canal, and wherein a width of the first balloon is less
than 70% of the width of the band whereby inflation of the first
balloon does not influence perfusion of the radial artery; (c)
positioning the second balloon to provide a second compressive
force on the radial artery at the access site that is about 2 cm
from the base of the palm, wherein the band is configured to locate
a substantial part of the second balloon distal from the base of
the palm, whereby when the band is wrapped around the wrist
positioning the first balloon to provide a focal compressive force
at the Guyon's canal, the second balloon positions itself to cover
the access site; (d) applying the first compressive force on the
ulnar artery at the Guyon's canal by inflating the first balloon;
(e) applying a second compressive force on the radial artery at the
access site by inflating the second balloon; (f) continuing to
apply the first compressive force to the ulnar artery at the
Guyon's canal; (g) continuing to apply the second compressive force
for a duration of time until at least hemostasis of the radial
artery is obtained, wherein the first compressive force on the
ulnar artery and the second compressive force on the radial artery
are maintained simultaneously.
2. The method of claim 1, wherein applying the second compressive
force in step (e) comprises applying the second compressive force
directly against the access site, the second compressive force in
totality being in an oblique direction with respect to the surface
of the wrist.
3. The method of claim 1, wherein the first compressive force in
step (f) is reduced to zero before obtaining hemostasis of the
radial artery.
4. The method of claim 1, wherein the first compressive force in
step (f) is maintained at least until hemostasis of radial artery
is obtained.
5. The method of claim 1, wherein the first compressive force is
applied before the second compressive force is applied.
6. The method of claim 1, wherein the second compressive force is
applied before the first compressive force is applied.
7. The method of claim 1, wherein the first compressive force fully
compresses the ulnar artery.
8. The method of claim 1, wherein the first compressive force
partially compresses the ulnar artery.
9. The method of claim 1, further comprising compressing the radial
artery at a point upstream and proximal to the puncture site
thereby decreasing radial artery pressure, as well as flow at the
access site.
10. The method of claim 1, further comprising monitoring patency of
the radial artery.
11. The method of claim 1, wherein the width of the band is in a
range of 40 mm to 55 mm.
12. The method of claim 1, wherein the band possesses a central
line of axis traversing from a first end of the band through a
center to a second end of the band, said axis dividing the band in
a first half and a second half of the band, the first balloon
located substantially in the first half of the band and the second
balloon located substantially in the second half of the band.
13. The method of claim 1, wherein the width of the second balloon
is substantially same as the width of the band.
14. A method directed at obtaining hemostasis of a radial artery
after performing a catheterization procedure on a wrist of a
patient at an access site of the radial artery, comprising
performing the following steps: (a) wrapping and securing a band
around the wrist of the patient at the access site where bleeding
is to be stopped, said band comprising a first balloon and a second
balloon; (b) positioning the first balloon to provide a first
compressive force on an ulnar artery, wherein the first balloon is
located substantially in a palmar aspect of the band proximate to a
base of a palm whereby the first compressive force is focal at a
Guyon's canal, and wherein a width of the first balloon is less
than 70% of the width of the band whereby inflation of the first
balloon does not influence perfusion of the radial artery; (c)
positioning the second balloon to provide a second compressive
force on the radial artery at the access site, wherein the width of
the second balloon is substantially same as the width of the band;
(d) applying the first compressive force on the ulnar artery at the
Guyon's canal by inflating the first balloon; (e) applying a second
compressive force on the radial artery at the access site by
inflating the second balloon; (f) continuing to apply the first
compressive force to the ulnar artery at the Guyon's canal; (g)
continuing to apply the second compressive force for a duration of
time until at least hemostasis of the radial artery is obtained,
wherein the first compressive force on the ulnar artery and the
second compressive force on the radial artery are maintained
simultaneously.
15. The method of claim 14, wherein the first compressive force in
step (f) is reduced to zero before obtaining hemostasis of the
radial artery.
16. The method of claim 14, wherein the first compressive force in
step (f) is maintained at least until hemostasis of radial artery
is obtained.
17. The method of claim 14, wherein the first compressive force is
applied before the second compressive force.
18. The method of claim 14, wherein the second compressive force is
applied before the first compressive force.
19. The method of claim 14, wherein the width of the band is in a
range of 40 mm to 55 mm.
20. A method directed at obtaining hemostasis of a radial artery
after performing a catheterization procedure on a wrist of a
patient at an access site of the radial artery, comprising
performing the following steps: (a) wrapping and securing a band
around the wrist of the patient at the access site where bleeding
is to be stopped, said band comprising a first balloon and a second
balloon; (b) positioning the first balloon to provide a first
compressive force on an ulnar artery, wherein the first balloon is
located substantially in a palmar aspect of the band proximate to a
base of a palm whereby the first compressive force is focal at a
Guyon's canal; (c) positioning the second balloon to provide a
second compressive force on the radial artery at the access site;
(d) applying the first compressive force on the ulnar artery at the
Guyon's canal by inflating the first balloon; (e) applying a second
compressive force on the radial artery at the access site by
inflating the second balloon; (f) continuing to apply the first
compressive force to the ulnar artery at the Guyon's canal; (g)
continuing to apply the second compressive force for a duration of
time until at least hemostasis of the radial artery is obtained,
wherein the first compressive force on the ulnar artery and the
second compressive force on the radial artery are maintained
simultaneously, and the first compressive force in step (f) is
reduced to zero before obtaining hemostasis of the radial artery or
maintained to compress the ulnar artery only partially at least
until hemostasis of radial artery is obtained.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of co-pending application
[0002] U.S. patent application Ser. No. 15/588,586 filed May 5,
2017, which claims priority from [0003] U.S. patent application
Ser. No. 15/150,394 filed May 9, 2016, now U.S. Pat. No. 9,668,744,
[0004] Provisional Application No. 62/288,982, filed Jan. 29, 2016,
and is a continuation-in-part of [0005] U.S. patent application
Ser. No. 14/819,383, filed Aug. 5, 2015, now U.S. Pat. No.
9,332,994, which is a continuation-in-part of [0006] U.S. patent
application Ser. No. 13/941,219, filed Jul. 12, 2013 now U.S. Pat.
No. 9,308,000, and claims benefit of [0007] U.S. Provisional Patent
Application No. 62/089,281, filed Dec. 9, 2014, [0008] U.S.
Provisional Patent Application No. 62/096,857, filed Dec. 25, 2014,
[0009] U.S. Provisional Patent Application No. 62/103,063, filed
Jan. 13, 2015, [0010] U.S. Provisional Patent Application No.
62/142,195, filed Apr. 2, 2015, and [0011] U.S. Provisional Patent
Application No. 62/157,419, filed May 5, 2015, the entire content
of all above ten applications is incorporated herein by
reference.
FIELD
[0012] Embodiments described herein concern devices and methods for
obtaining hemostasis after puncturing a blood pathway, including
without limitation puncture of radial or ulnar artery.
BACKGROUND
[0013] Blood vessel puncture is commonly needed for performance of
endovascular procedures. Smaller caliber arteries, including
radial, ulnar and pedal arteries, are easier to manage after the
procedure because bleeding can be controlled more easily with
external pressure. However, occlusion of these arteries occurs more
frequently compared to larger arteries, which frequently results in
permanent loss of patency.
[0014] Radial artery occlusion refers to the blockage of the radial
artery and is a consequence of radial artery cannulation that
obliterates the radial artery lumen. Hemostatic devices, which are
attached by being wrapped around the portion of an arm where the
puncture site (also referred to as the access site) is located and
compress the puncture site where bleeding is to be stopped, are
already known in the prior art (e.g., U.S. Pat. No. 7,498,477 B2,
U.S. Pat. No. 8,481,803, U.S. Pat. No. 8,481,805, JP 3,031,486 U).
In prior-art hemostatic devices, pressure applied to the puncture
site may lead to radial artery occlusion making it not available
for access in the future.
[0015] Radial artery occlusion, after transradial access occurs in
2-10% of patients, and is frequently associated with obliteration
of radial artery lumen, making that radial artery not suitable for
future access for endovascular procedures, invasive monitoring, or
its utility as a bypass conduit. Prevention of radial artery
occlusion is of paramount importance to avoid loss of a major
source of blood supply, future repeat access and other utilities of
radial artery, after transradial access. Maintenance of radial
artery flow during hemostatic compression has been shown to lower
the risk of radial artery occlusion (PROPHET Trial, Pancholy S et
al, Catheterization and Cardiovascular Interventions 2008:72(3);
335-340). A decrease in duration of compression has also been shown
to lower the risk of radial artery occlusion (Pancholy S et al,
Catheterization and Cardiovascular Interventions 2012:79(1):78-81).
Thus maintaining blood flow in the radial artery, while compressing
the access site after instrumentation, is known to reduce the risk
of post-instrumentation radial artery occlusion. Patent hemostasis
is therefore understood to mean achieving the cessation of bleeding
at the cannulation wound (access site) of the radial artery, while
blood is allowed to flow through that artery.
[0016] In an article entitled Efficacy and Safety of Transient
Ulnar Artery Compression to Recanalize Acute Radial Artery
Occlusion After Transradial Catheterization (Am J Cardiol 2011;
107:1698-1701) Ivo Bernat, MD and others discuss a method directed
to open an occluded radial artery after the radial artery becomes
occluded. In this study, in patients with radial artery occlusion,
3-4 hours after hemostasis of the radial artery, ulnar artery
compression was applied to attempt recanalization of radial artery.
Bernat et. al. achieved higher success rates at reopening of the
radial artery by administration of heparin and compression of the
ipsilateral ulnar artery
SUMMARY
[0017] Transradial, as well as transulnar, puncture is increasingly
used for obtaining vascular access for endovascular procedures. In
one embodiment, a hemostatic device comprises two balloons wherein,
after transradial access, the bleeding from the radial artery is
stopped by compressing the radial artery at the puncture site using
inflation of a first balloon and the radial artery flow is
increased by occlusive compression of ipsilateral ulnar artery
using inflation of a second balloon. The method maintains blood
flow in the radial artery while compressing the access site, after
removal of catheter, thereby reducing the risk of
post-instrumentation radial artery occlusion. In one embodiment,
the first balloon is located over the radial artery to cover a
puncture site that is generally about 2 cm. from the base of a
palm, and the second balloon is located over the ulnar artery at a
position proximate to the base of the palm (Guyon's canal) thereby
compressing the ulnar artery at a location where it is most
accessible for compression.
[0018] In another embodiment, two balloons are part of a band and
the band is wrapped around a limb. The center of the first balloon
and the center of the second balloon are offset from each other in
relation to the central line of axis of the band. In yet another
embodiment, the first balloon is larger than the second balloon. In
another embodiment, the balloons are rectangular in shape. In one
embodiment the first balloon extends the entire width of the band.
In one embodiment, the width of the band is greater than 40 mm. In
another embodiment, the width of the band is greater than 45 mm. In
yet another embodiment, the band has a width of about 55 mm.
[0019] In another embodiment, the hemostatic device comprises a
flexible band adapted to be wrapped and secured around a hand of a
patient at a site on the hand where bleeding is to be stopped, a
compression member having an inner peripheral side, which
compression member is made of a material more rigid than the band,
a first balloon provided on the inner peripheral side at a position
deviated to the center portion of the compression member in
lengthwise direction of the band, and the first balloon is
connected to the band by a connector on a side of the first balloon
adjacent the center portion of the compression member, wherein the
first balloon inflates when a fluid is introduced therein; and a
second balloon provided on the inner peripheral side of the
compression member at a position deviated to an edge of the
compression member from the center portion of the compression
member in widthwise direction of the band, and the second balloon
is connected to the band by a connector on a side of the second
balloon adjacent to the edge of the compression member, wherein the
second balloon inflates when a fluid is introduced therein. In one
embodiment, the compression member is a curved frame with rungs. In
some embodiments, rungs may be equidistant from each other along
the length of the frame. In other embodiments, the rungs may be
staggered whereby some rungs are close to each other while the
others are spread out. In another embodiment, the frame has rungs
in a central portion and curved solid pieces at the proximal and
distal end of the frame. In yet another embodiment, the compression
member is a curved plate.
[0020] In some embodiments, at least a portion of the compression
member is curved toward the inner peripheral side at proximal and
distal ends of the compression member. In one embodiment, the
radius of curvature of the compression member at proximal end is
about the same as radius of curvature of the compression member at
distal end. In another embodiment, the compression member may have
a contoured shape whereby the band presses snugly the wrist and the
base of the palm, and the contoured shape facilitates compression
of the ulnar artery at the base of the palm.
[0021] In one embodiment, the curved compression member possesses a
first curved portion in a first half of the compression member
located between a center and a first end of the compression member,
a second curved portion in a second half of the compression member
located between the center and a second end of the curved
compression member, and an axis traversing from the first end of
the curved compression member, through the center of the
compression member, to the second end of the curved compression
member. A first balloon is provided on the inner peripheral side in
the first half of the curved compression member at a position
offset to the center of the curved compression member from the
first end of the curved compression member, the first balloon
having a plurality of linear sides and is connected to the band by
a connector only on a first linear side of the first balloon, said
first linear side being adjacent the center of the curved
compression member and perpendicular to the axis of the curved
compression member. In another embodiment, the first balloon has a
first surface and at least a second linear side in contact with the
band, wherein the first balloon inflates when a fluid is introduced
therein and upon inflation the first surface and at least the
second linear side of the first balloon are capable of moving out
of contact with the band. In another embodiment, a second balloon
is provided on the inner peripheral side in the second half of the
curved compression member at a position offset to an edge of the
curved compression member from the center of the curved compression
member, the second balloon having a plurality of linear sides and
is connected to the band by a connector only on a first linear side
of the second balloon, said first linear side of the second balloon
being adjacent the edge of the curved compression member and
parallel to the axis of the curved compression member. In another
embodiment, the second balloon has a second surface and at least a
second linear side in contact with the band, wherein the second
balloon inflates when the fluid is introduced therein and upon
inflation the second surface and at least the second linear side of
the second balloon are capable of moving out of contact with the
band.
[0022] In yet another embodiment, the second balloon is provided on
the inner peripheral side in the second half of the curved
compression member at a position offset to the center of the curved
compression member from the second end of the curved compression
member, the second balloon having a plurality of linear sides and
is connected to the band by a connector only on a first linear side
of the second balloon, said first linear side of the second balloon
being adjacent the center of the curved compression member and
perpendicular to the axis of the curved compression member.
[0023] In operation, a method of catheterization of the radial
artery comprises inserting a sheath into the radial artery of a
patient at an access site. The desired catheterization procedure is
then performed using the sheath or catheter to access the radial
artery. In one embodiment, once the catheterization procedure is
complete, an ulnar pressure is applied to the ipsilateral ulnar
artery at an ulnar pressure site while the sheath remains inserted
in the radial artery. The sheath is then removed from the radial
artery while maintaining the ulnar pressure to the ulnar artery.
Once the sheath is removed, and while continuing to apply the ulnar
pressure, pressure is applied to the radial artery at the access
site to obtain hemostasis at the access site. In another
embodiment, once the catheterization procedure is complete, a
radial pressure is applied to the radial artery at the access site.
An ulnar pressure is then applied to the ulnar artery at the ulnar
pressure site while maintaining the pressure on the radial artery.
In yet another embodiment, application of pressure to the radial
artery at the access site to obtain hemostasis at the access site
is accomplished while maintaining the ulnar pressure to the ulnar
artery.
[0024] In another embodiment, vasodilator medication such as
nitroglycerine is disposed on at least a portion of the
skin-contacting surface of the balloon pressing on the puncture
site to reduce spasm. Spasm may play a role in the process of
interruption of the flow, which then leads to thrombosis and
resultant lumen obliteration with fibrosis. Prevention and relief
of spasm may help lower the probability of occlusion.
[0025] In yet another embodiment, a composition is disposed on at
least a portion of the skin-contacting region of the balloon. The
composition includes at least a hydrocolloid component and an oil
component. In one embodiment, a release-coated liner is included on
the skin-contacting side of the balloon. The liner is retained in
place prior to use and is removed just prior to application to
user's skin. The release-coated liner may be any release-coated
liner known in the art that is compatible with the composition
disposed on the skin-contacting side of the balloon.
BRIEF DESCRIPTION OF DRAWINGS
[0026] FIG. 1 is a schematic front view (FIG. 1A) and a schematic
side view (FIG. 1B) of an embodiment of the hemostatic device 100
comprising at least two balloons 101 and 103, and a compression
member that is a curved frame with rungs 104 and that is placed in
a sleeve 118 formed by a covering 110 attached to a strap 108.
[0027] FIG. 2 is a schematic three-dimensional view (FIG. 2A), a
schematic top view (FIG. 2B) and a schematic front view (FIG. 2C)
of an embodiment of the compression member 200 that is a curved
frame with rungs, and comprising rungs 221 located between two
curved beams 223 and 225.
[0028] FIG. 3 is a schematic front view (FIG. 3A) and a schematic
side view (FIG. 3B) of an embodiment of the hemostatic device 300
comprising at least two balloons 301 and 303, and a compression
member that is a curved plate 304 and that is placed in a sleeve
318 formed by a covering 310 attached to a strap 308.
[0029] FIG. 4 is a schematic three-dimensional view (FIG. 4A), a
schematic top view (FIG. 4B) and a schematic front view (FIG. 4C)
of an embodiment of the compression member 400 that is a curved
plate.
[0030] FIG. 5 is a schematic view of hemostatic device 500 with two
balloons 501 and 503. FIG. 5A is a schematic top view that shows a
side of the device that serves as the inside surface when the
device is attached to the wrist of a patient. FIG. 5B is a
schematic front view of the device.
[0031] FIG. 6 is schematic sectional view showing hemostatic device
of FIG. 1 in use. FIG. 6A shows a schematic sectional front view of
an embodiment of the hemostatic device applied on a forearm of a
patient. The two balloons 601, 603 are located between the forearm
of the patient and the strap 608 that goes around the forearm of
the patient. FIG. 6B is a schematic sectional side view of a part
of the embodiment of the hemostatic device showing balloon 603
pressing on the ulnar artery 607.
[0032] FIG. 7 is a schematic view of an embodiment of the
hemostatic device showing placement of balloon 701 over radial
artery 705 and balloon 703 over ulnar artery 707.
[0033] FIG. 8 is a schematic view of an embodiment of the
hemostatic device wrapped around the wrist of a patient wherein
FIG. 8A is an anterior view and FIG. 8B is a posterior view.
[0034] FIG. 9 is a schematic view of a balloon 900 wherein a
surface of the balloon to be in contact with skin is disposed with
a composition 905 and a liner 907.
[0035] FIG. 10 is a schematic front view (FIG. 10A) and a schematic
side view (FIG. 10B) of an embodiment of the hemostatic device
comprising at least two balloons 151 and 153, and a compression
member that is a curved frame with rungs 154 in a central portion
of the frame and curved solid pieces 155 at the proximal and distal
end of the frame, the frame being placed in a sleeve 168 formed by
a covering 160 attached to a strap 158.
[0036] FIG. 11 is a schematic three-dimensional view (FIG. 11A), a
schematic top view (FIG. 11B) and a schematic front view (FIG. 11C)
of an embodiment of the compression member that is a curved frame
with rungs, and comprising rungs 261 located between two curved
beams 263 and 265, and curved solid pieces 264 at the proximal and
distal end of the frame.
[0037] FIG. 12 is a schematic front view (FIG. 12A) and a schematic
side view (FIG. 12B) of an embodiment of the hemostatic device
comprising at least two balloons 351 and 353, and a compression
member that is a curved frame with rungs 354 in a central portion
of the frame and curved solid pieces 355 at the proximal and distal
end of the frame, the frame being placed in a sleeve 368 formed by
a covering 360 attached to a strap 358.
[0038] FIG. 13 is a schematic front view (FIG. 13A) and a schematic
side view (FIG. 13B) of an embodiment of the hemostatic device
comprising at least one balloon 451, and a compression member that
is a curved frame with rungs 454 in a central portion of the frame
and curved solid pieces 455 at the proximal and distal end of the
frame, the frame being placed in a sleeve 468 formed by a covering
460 attached to a strap 458.
DETAILED DESCRIPTION
[0039] Embodiments described herein provide the user a safe, simple
and reliable device and method to apply pressure at the access site
of artery, e.g., radial artery to obtain hemostasis and also to
apply pressure to another artery, e.g., ulnar artery using the same
device.
[0040] In one embodiment of the invention (see FIG. 1), hemostatic
device 100 is a flexible band comprising a flexible strap 108
adapted to be wrapped and secured by binders 112 and 114 around the
wrist of a patient at a puncture site on the hand where bleeding is
to be stopped, a curved frame 104, a first balloon 101, and a
second balloon 103. The curved frame 104 has an inner peripheral
side and is made of a material such that the frame is more rigid
than the flexible strap 108. In one embodiment, the frame is made
of hard plastic and substantially fixed in shape. In another
embodiment, the frame is made of material (e.g. plastic) that is
bendable so that the frame does not maintain a substantially fixed
shape and flexes with the balloons as the balloons expand and
contract with pressure. In another embodiment, the spacing between
the rungs in the frame is increased to make the frame more
flexible. In yet another embodiment, the spacing between the rungs
in the frame is decreased to make the frame less flexible. At least
a portion of the frame is curved toward the inner peripheral side.
The first balloon 101 is provided on the inner peripheral side at a
position deviated to the center portion of the curved frame from
the first end of the curved frame in lengthwise direction of the
band, i.e., the first balloon 101 is provided on the inner
peripheral side in a first half of the curved frame at a position
offset to the center of the curved frame from the first end of the
curved frame, and the first balloon is connected to the strap 108
by a connector 102 on a side of the first balloon adjacent the
center portion of the curved frame. The first balloon inflates when
a fluid is introduced therein. The second balloon 103 is provided
on the inner peripheral side of the curved frame at a position
deviated to an edge of the curved frame from the center portion of
the curved frame in widthwise direction of the band, i.e., the
second balloon 103 is provided on the inner peripheral side in a
second half of the curved frame at a position offset to an edge of
the curved frame from the center of the curved frame, and the
second balloon is connected to the strap 108 by a connector (not
shown) on a side of the second balloon adjacent the edge of the
curved frame. The second balloon 103 inflates when the fluid is
introduced therein. In one embodiment, the band 100 is adapted to
be wrapped around the wrist with a surface fastener, e.g., Hook and
Loop 112 and 114 for securing the band around the wrist. In some
embodiments, pledgets (not shown) are provided for patient comfort.
In one embodiment, the pledgets are made of foam.
[0041] In one embodiment, band may have a first sleeve for holding
the frame 104. In the embodiment shown in FIG. 1, the first sleeve
is a double layer construction formed by connecting a piece of film
110 to strap 108 of the band at a center portion of the band. The
connection may be done by a suitable method such as welding (e.g.,
heat welding, high-frequency welding, ultrasonic welding) or
adhesion/gluing (such as with an adhesive or solvent) so as to form
a double layer construction. The frame 104 is inserted into a gap
118 in the double layer and thereby held. In one embodiment, in
addition to the center portion of the band, at least one side end
portion of the band has a sleeve. As shown in FIG. 1, band may have
a second sleeve 116 at a side end portion of the band. The second
sleeve is a double layer construction formed by connecting a piece
of film 106 to strap 108 of the band. The connection may be done by
a suitable method similar to that used for constructing the first
sleeve.
[0042] The material of construction of the films or sheets used to
fabricate the strap, the balloons and the sleeves of the band 100
is preferably substantially transparent whereby patient's arm can
be seen through the band. Examples of the material of construction
include polyvinyl chloride, polyolefins such as polyethylene,
polypropylene, polybutadiene and ethylene-vinyl acetate copolymers
(EVA), polyesters such as polyethylene terephthalate (PET) and
polybutylene terephthalate (PBT), polyvinylidene chloride,
silicones, polyurethanes various thermoplastic elastomers such as
polyamide elastomers, polyurethane elastomers and polyester
elastomers, and any combinations of the above in the form of, for
example, resin blends, polymer alloys or laminates. The sheet
making up the band may be of any suitable thickness. In one
embodiment, the thickness of the sheet material is in the range of
about 0.1 to about 0.5 mm, and in some embodiments about 0.2 to
about 0.3 mm. The band can be secured using hook and loop type
fasteners or other suitable fasteners such as buttons, clips and
buckles.
[0043] The frame 200 (see FIG. 2) is curved at both proximal and
distal ends, the curvature being toward an inner peripheral side.
In one embodiment, the radius of curvature R.sub.1 at the proximal
end is substantially the same as the radius of curvature R.sub.2 at
the distal end. In another embodiment R.sub.1=R.sub.2. In another
embodiment, the frame is symmetrical about its center. In one
embodiment, the frame is constructed of a material more rigid than
the band, but maintains some flexibility whereby the frame conforms
to the contour of the wrist and flexes with the expansion and
contraction of balloons. In another embodiment, the frame maintains
a substantially fixed shape.
[0044] In one embodiment, the frame 200 in FIG. 2 may be
constructed out of material that is substantially transparent. In
another embodiment, the material of construction of the frame may
not be transparent. Examples of materials of construction of the
frame include acrylic resins, polyvinyl chloride (rigid polyvinyl
chloride and flexible polyvinyl chloride), polyolefins such as
polyethylene, polypropylene and polybutadiene, polystyrene,
poly(4-methyl-1-pentene), polycarbonates, ABS resins, polymethyl
methacrylate (PMMA), polyacetals, polyarylates, polyacrylonitriles,
polyvinylidene fluorides, ionomers, acrylonitrile-butadiene-styrene
copolymers, polyesters such as polyethylene terephthalate (PET) and
polybutylene terephthalate (PBT), butadiene-styrene copolymers,
aromatic and aliphatic polyamides, and fluorocarbon resins such as
polytetrafluoroethylene. The frame may also be made of a metal or
metal alloy.
[0045] The curved frame compression member 200 has gaps between the
rungs 221 that provide visibility of the puncture site. The rungs
are held between two beams 223 and 225. The rungs and beams can
have various shapes, e.g., circular, square, rectangular and
elliptical. In one embodiment, the frame is entirely curved. In
another embodiment, the frame is straight in the center and curved
at its ends. In one embodiment, rungs 221 are circular and each
rung has a diameter of about 2 mm. In another embodiment, beams
223, 225 are also circular with diameter of about 3 mm. In yet
another embodiment, the gap 204 between the rungs is about 2 mm. In
one embodiment, the width of the frame is about 4 mm less than the
width of the strap 108 of the band 100 in FIG. 1. In yet another
embodiment, the gap 204 between the rungs in the center portion of
the frame is greater than the gap 204 between the rungs near the
proximal and distal ends of the frame. In another embodiment, the
curved frame compression member has rungs in the center portion of
the frame and solid curved pieces at the proximal and distal ends
of the compression member. In one embodiment, the thickness of
solid piece is about 2 mm. The width of the solid pieces may be
about 4 mm less than the width of the strap of the band, thereby
keeping on either side of the curved frame a gap of about 2 mm
between the edge of the curved frame and the edge of the strap of
the band.
[0046] In another embodiment of the invention (See FIG. 3),
hemostatic device comprises a flexible band 300. The band has a
flexible strap 308 having an inner peripheral side and adapted to
be wrapped and secured using binders 312 and 314 around a limb of a
patient at a site on the limb where bleeding is to be stopped, a
plate 304 made of a material more rigid than the band and at least
a portion of the plate is curved toward its inner peripheral side
at proximal and distal ends of the plate. In one embodiment, the
plate 304 is of substantially fixed shape. In another embodiment,
the plate 304 is flexible and does not maintain a substantially
fixed shape. The material of construction of plate 304 is same as
material of construction of frame 200 discussed before. In one
embodiment, the plate 304 is placed in a sleeve 318 formed by a
covering 310 attached to the strap 308 on the outer peripheral side
of the strap at a center portion of the band. In another
embodiment, both the covering 310 and the strap 308 are made of
flexible plastic and are transparent. The covering 310 can be
attached to strap 308 using known techniques, for example
ultrasonic welding. In one embodiment, in addition to the center
portion of the band, at least one side end portion of the band has
a sleeve 316. The sleeve at a side end portion of the band may also
be a double layer construction formed by connecting a piece of film
306 to strap 308 on the outer peripheral side of the strap 308. The
connection may be done by a suitable method similar to that used
for constructing the sleeve at center portion of the band. The
plastic sheet material used to make the strap of the band could
also be used to make the sleeves.
[0047] The first balloon 301 is provided on the inner peripheral
side at a position deviated to the center portion of the curved
plate from the first end of the curved plate in lengthwise
direction of the band, and the first balloon is connected to the
strap 308 by a connector 302 on a side of the first balloon
adjacent the center portion of the curved plate. The first balloon
inflates when a fluid is introduced therein. The second balloon 303
is provided on the inner peripheral side of the curved plate at a
position deviated to an edge of the curved plate from the center
portion of the curved plate in widthwise direction of the band, and
the second balloon is connected to the strap 308 by a connector
(not shown) on a side of the second balloon adjacent the edge of
the curved plate. The second balloon 303 inflates when the fluid is
introduced therein. In one embodiment, the band 300 is adapted to
be wrapped around the wrist with a surface fastener, e.g., Hook and
Loop 312 and 314 for securing the band around the wrist.
[0048] The plate 400 (see FIG. 4) is curved at both proximal and
distal ends, the curvature being toward an inner peripheral side.
In one embodiment, the radius of curvature R.sub.1 at the proximal
end is about the same as the radius of curvature R.sub.2 at the
distal end. In another embodiment, the plate 404 is symmetrical
about its center. In one embodiment, the plate is constructed of a
material more rigid than the band, but maintains some flexibility
whereby the plate conforms to the contour of the wrist and flexes
with the expansion and contraction of balloons. In another
embodiment, the plate maintains a substantially fixed shape. The
plate 400 may be constructed using same materials as used to
construct frame 200 in FIG. 2. In one embodiment, the thickness of
plate is about 2 mm. The width of the plate may be about 4 mm less
than the width of the strap of the band, thereby keeping on either
side of the plate a gap of about 2 mm between the edge of the plate
and the edge of the strap of the band.
[0049] In another embodiment of the invention (See FIG. 5),
hemostatic device 500 comprises a flexible band. The band has a
flexible strap 508 having an inner peripheral side and adapted to
be wrapped and secured using binders 512 and 514 around a limb of a
patient at a site on the limb where bleeding is to be stopped. The
band has a center portion and two side portions on either side of
the center portion. In one embodiment, the center portion has a
first sleeve 518 formed by a covering 510 attached to strap 508. A
compression member (not shown) is placed in the first sleeve 518.
In one embodiment, the compression member is a curved frame (see
FIG. 2). In another embodiment, the compression member is a curved
plate (see FIG. 4). In one embodiment, both the covering 510 and
the strap 508 are made of flexible plastic and are transparent. The
covering 510 can be attached to strap 508 using known techniques,
for example ultrasonic welding. A first balloon 501 is provided on
the inner peripheral side at a position deviated to the center
portion of the first sleeve 518 from the proximal end of the first
sleeve in lengthwise direction of the band, and the first balloon
is connected to the strap 508 of the band by a connector 502 on a
side of the first balloon adjacent the center portion of the first
sleeve 518. In one embodiment, the width of the first balloon is
about the same as the width of the strap 508 of the band, and the
length of the first balloon is about half the length of the first
sleeve 518. The first balloon 501 inflates when a fluid is
introduced therein. The second balloon 503 is provided on the inner
peripheral side of the first sleeve 518 at a position deviated to
an edge of the first sleeve from the center portion of the first
sleeve in widthwise direction of the band, and the second balloon
is connected to the strap 508 of the band by a connector 504 on a
side of the second balloon adjacent an edge of the first sleeve
518. The width of the second balloon 503 is about half the width of
the strap 508 of the band and the length of the second balloon is
about half the length of the first sleeve 518. In another
embodiment, the width of the second balloon is about 70% of the
width of the band. In yet another embodiment, the width of the
second balloon is about 60% of the width of the band. In a further
embodiment, the width of the second balloon is about 50% of the
width of the band. In another embodiment, the width of the second
balloon is about the same as the width of the strap 508 of the
band. The second balloon 503 inflates when the fluid is introduced
therein.
[0050] The compression member possesses a first curved portion in a
first half of the compression member located between a center and a
first end of the compression member, a second curved portion in a
second half of the compression member located between the center
and a second end of the compression member, and an axis traversing
from the first end of the compression member, through the center of
the compression member, to the second end of the compression
member. A first balloon 501 is provided on the inner peripheral
side in the first half of the compression member at a position
offset to the center of the compression member from the first end
of the compression member, the first balloon having a plurality of
linear sides and is connected to the band by a connector 502 only
on a first linear side of the first balloon, said first linear side
being adjacent the center of the compression member and
perpendicular to the axis of the compression member. In one
embodiment, the first balloon has a first surface and at least a
second linear side in contact with the band, wherein the first
balloon inflates when a fluid is introduced therein and upon
inflation the first surface and at least the second linear side of
the first balloon are capable of moving out of contact with the
band. A second balloon 503 is provided on the inner peripheral side
in the second half of the compression member at a position offset
to an edge of the compression member from the center of the
compression member, the second balloon having a plurality of linear
sides and is connected to the band by a connector 504 only on a
first linear side of the second balloon, said first linear side of
the second balloon being adjacent the edge of the compression
member and parallel to the axis of the compression member. In
another embodiment, the second balloon has a second surface and at
least a second linear side in contact with the band, wherein the
second balloon inflates when the fluid is introduced therein and
upon inflation the second surface and at least the second linear
side of the second balloon are capable of moving out of contact
with the band.
[0051] In yet another embodiment, the second balloon is provided on
the inner peripheral side in the second half of the curved
compression member at a position offset to the center of the curved
compression member from the second end of the curved compression
member, the second balloon having a plurality of linear sides and
is connected to the band by a connector only on a first linear side
of the second balloon, said first linear side of the second balloon
being adjacent the center of the curved compression member and
perpendicular to the axis of the curved compression member.
[0052] The material of construction of the balloons is preferably
transparent and may be the same as used to make the band. In one
embodiment, the material of construction of the balloon could be
sheets of thickness similar to that used to make the strap of the
band. In another embodiment, the sheets used to make balloons could
be thinner than the sheets used to make the strap of the band. In
one embodiment, the strap is made of polyvinyl chloride film of
thickness 20 mils (0.508 mm) and a balloon is made of polyvinyl
chloride film of thickness 10 mils (0.254 mm). The balloons could
have any shape such as square, rectangular, circular and
elliptical. The balloons can be made by sealing sheet cut to
appropriate shape and sealed at the edge using sealing technique
such as adhesion or welding. The balloons are connected to the band
by flexible connectors 502 and 504 that could be made of same
material as the balloon and the band. In one embodiment, the band
and the compression member are substantially transparent. In
another embodiment, the balloon 503 is made of translucent or
opaque material and the balloon 501 is made of substantially
transparent material.
[0053] As shown in FIG. 5, the first balloon 501 has connected
thereto a tube 521 for introducing a fluid into the first balloon,
and the second balloon 503 has connected thereto a tube 525 for
introducing a fluid into the second balloon. In one embodiment, the
tubes are transparent and flexible. Tube 521 is connected at a
proximal end thereof to the first balloon 501 at 522. Tube 525 is
connected at a proximal end thereof to the second balloon 503 at
526. Tube 521 may include an adapter 523 that is connected to the
distal side of the tube, and tube 525 may include an adapter 527
that is connected to the distal side of the tube. In one
embodiment, adapter 523 is identifiably different from adapter 527
so that a user knows to select the appropriate adapter that
connects to the balloon user wants to inflate. The identifiable
differentiation of the adapters may be through visual distinction
comprising color, shape, texture or combination thereof. Inflation
of the balloon is carried out by inserting the protruding tip of a
syringe (not shown) into the adapter and pushing a plunger on the
syringe so as to introduce fluid within the syringe through the
inflator into the balloon. Once fluid has been injected into the
balloon and the protruding tip of the syringe is withdrawn from the
adapter, a check valve within the adapter closes, preventing the
fluid from leaking out and thus maintaining the balloon in an
inflated state. In another embodiment, a two-way or three-way valve
is used to direct the flow of fluid into and out of the balloon,
and to prevent the fluid from leaking out and thus maintaining the
balloon in an inflated state.
[0054] In one embodiment, in addition to the center portion of the
band, at least one side end portion of the band has a sleeve. As
shown in FIG. 5, the band may have a second sleeve 516 at one side
end portion of the band. The second sleeve is a double layer
construction formed by connecting a piece of film 506 to strap 508
of the band. The connection may be done by a suitable method
similar to that used for constructing the first sleeve. The second
sleeve 516 may be used to hold tubes 521, 525 and adapters 523, 527
when the band is wrapped around the wrist of a patient (See FIG.
8). In one embodiment, the width of the second sleeve 516 is less
than the width of the band. In another embodiment, the width of the
second sleeve 516 is about the same as the width of the band.
[0055] The technique of providing a compression member on the band
is not limited to the illustrated arrangement, and may involve
joining the compression member(s) to the inside surface or outside
surface of the band by a suitable method such as welding or
adhesion. It is not necessary that the band encircle the limb,
e.g., wrist completely. For example, another arrangement may be the
band is held in place by tie down that holds the band firmly on the
wrist. In another embodiment, the band does not have any
compression member to enhance rigidity.
[0056] FIG. 6 is a sectional view showing a band in a wrapped state
to the wrist 611. The band is attached to the wrist by connecting
together surface fasteners (e.g. hook and loop fasteners) 612 and
614. Other means for securing the band in a wrapped state around
the wrist include buttons, clips, snaps, zippers, and buckles
through which the ends of the band pass. A frame 604 is placed in a
sleeve formed by a covering 610 attached to the strap 608 on the
outer peripheral side of the strap at a center portion of the band.
One side of balloon 601 is connected to the strap 608 of the band
by connector 602 at a position deviated to the center portion of
the curved frame 604 from the end of the curved frame in lengthwise
direction of the band. As a result, the balloon assumes an
orientation whereby the pressing force F1 applied to the puncture
site on the radial artery 605 acts generally in an outward
direction away from the center portion of the wrist (See FIG. 6A).
Consequently, force F1 does not have an impact at the location of
the ulnar artery 607. On the other hand, if the balloon 601 was
connected to the band at a position deviated to the end of the
curved frame, the balloon would assume an orientation whereby the
pressing force would be in an oblique direction towards the center
portion of the wrist whereby a component of the force F1 would
affect the ulnar artery 607.
[0057] The ulnar artery 607 is compressed by balloon 603, which is
provided on the inner peripheral side of the curved frame 604 at a
position deviated to an edge of the curved frame from the center
portion of the curved frame in widthwise direction of the band, and
balloon 603 is connected to the band by a connector 606 on a side
of balloon 603 adjacent to an edge of the curved frame 604 (see
FIG. 6B). In the present embodiment where one side of balloon 603
is connected by a connector at an edge of the band and the width of
the balloon 603 is shorter than the width of the strap 608, balloon
603 assumes an orientation whereby component of the force F2 in the
cross-sectional plane of the wrist is generally vertical (see FIG.
6A). The force F2 may have a component in a direction towards the
elbow, but a negligible component in a direction towards the radial
artery. Therefore, operation of balloon 603 to pressurize or
depressurize the ulnar artery will not generally affect operation
of balloon 601 to pressurize or depressurize the radial artery, and
vice versa.
[0058] FIG. 7 is a schematic of a band 708 wrapped around a wrist
whereby balloon 701 compresses the radial artery 705 and balloon
703 compresses the ulnar artery 707. In the embodiment in FIG. 7,
the balloon 703 is located at or near the base of the palm (Guyon's
canal) 704 thereby compressing the ulnar artery 707 at a location
where it is most accessible for compression and the balloon 701 is
located over the puncture site, which is generally about 2 cm. from
the base of a palm. The pressure applied to the radial artery and
the ulnar artery could be simultaneously and independently
manipulated to optimize the pressure at which the bleeding from the
radial artery stops while at the same time a high enough pressure
is applied to the ulnar artery to prevent or minimize occlusion of
the radial artery. In one embodiment, mark or marks (not shown) may
be placed on the radial balloon 701 to help a user visually place a
central portion of the radial balloon 701 on the radial artery 705
at or near the puncture site of the artery. Mark or marks may also
be placed on the compression member and the sleeve holding the
compression member to help a user in the placement of the radial
balloon 701 on the puncture site. Mark may be a dot, a line, a
square, a triangle or any other shape that helps in the
placement.
[0059] FIG. 8 is a schematic illustration showing an anterior view
(FIG. 8A) and a posterior view (FIG. 8B) of an embodiment of a band
808 wrapped around the wrist of a patient. One side of radial
balloon 801 is connected to the band by connector 832 such that the
connector 832 is positioned towards the center portion of the
wrist. The radial balloon 801 is inflated or deflated by passing
fluid (a gas such as air or a liquid such as saline) through tube
821 using a syringe (not shown) that is connected to adapter 823.
The ulnar balloon 803 is inflated or deflated by passing fluid (a
gas such as air or a liquid such as saline) through tube 825 using
a syringe (not shown) that is connected to adapter 827. A balloon
will inflate when a fluid is introduced therein, thereby applying
pressure to the skin of the patient where the balloon is located.
In one embodiment, the fluid is introduced using a syringe. The
syringe may have markers to determine the amount of fluid that will
be inserted into a balloon. The syringe may also have an outlet
that can be connected to a pressure measuring device such as a
manometer. In another embodiment, the balloons may have an outlet
that can be connected to a pressure measuring device. The pressure
measurement helps the user to inflate the balloon to a pressure
that is not significantly higher than the systolic pressure of the
patient, thereby allowing robust hemostasis but preventing grossly
excessive compression by inordinate pressure, thereby lowering the
probability of lumen compression to the point of occlusion, and
flow cessation.
[0060] The edge of the band is positioned close to the base of the
palm 834. The band 808 may have a sleeve 806 at a side end portion
of the band. The sleeve is a double layer construction and tubes
821, 825 and adapters 823 and 827 may be inserted in the sleeve 806
so that the tubes do not dangle when a patient moves his/her
hand.
[0061] FIG. 9 shows an embodiment of balloon 900 where the surface
of the balloon 901 in contact with skin is coated with a
composition 905. In one embodiment, composition 905 may comprise a
hydrocolloid adhesive or zinc oxide-based adhesive that can be
advantageously used upon the surface of the balloon when pressing
the balloon on the skin of the patient.
[0062] The hydrocolloid or zinc oxide-based adhesive can be used
either alone or in combination with another medical grade adhesive.
Hydrocolloid and zinc oxide-based adhesives have less of a tendency
to excoriate the skin of a patient when removed. This can be
particularly important for patients whose skin is more sensitive or
fragile. In one embodiment, the coated composition 905 has a
peel-off laminate (liner) 907 that is removed before placing the
balloon on the puncture site. In another embodiment, the
composition also contains antimicrobials. In one embodiment, the
composition contains oil. Such compositions are known in the art
and commercially available. See, e.g., compositions and laminates
sold by Vancive Medical Technologies, Avery Dennison business. In
some embodiments, connector 902 may be provided to connect the
balloon to the band. In another embodiment, vasodilator medication
is present on the surface of a balloon pressing on the puncture
site to reduce spasm. Spasm is thought to play a role in the
process of interruption of the flow that then leads to thrombosis
and resultant lumen obliteration with fibrosis. Prevention and
relief of spasm may help lower the probability of occlusion. An
example of such vasodilator medication is nitroglycerine. In one
embodiment, the surface of balloon in contact with the puncture
site is disposed with nitroglycerine.
[0063] An embodiment of the hemostatic device depicted in FIG. 10
is similar to that depicted in FIG. 1, except that the hemostatic
device in FIG. 10 uses an embodiment of the frame depicted in FIG.
11. The embodiment of frame depicted in FIG. 11 comprises a
plurality of rungs 261 in the center portion of the frame and
curved solid pieces 264 at the proximal and distal ends of the
frame. The balloon 151 is connected to the strap 158 by a connector
152 on a side of the balloon 151 adjacent the center portion of the
curved frame. As shown in FIG. 10, in one embodiment, the band may
have a second sleeve 166 at a side end portion of the band. The
second sleeve is a double layer construction formed by connecting a
piece of film 156 to strap 158 of the band. In another embodiment,
the band may not have a second sleeve. Two fasteners 162 and 164
holds the band around a wrist of a patient.
[0064] In another embodiment of the hemostatic device (see FIG.
12), a fastener 362 is located on the covering 360 attached to a
strap 358. The covering 360 forms a sleeve 368 to hold the frame. A
fastener 364 is located on the strap 358 and connecting the two
fasteners 362 and 364 holds the band around a wrist of a patient.
In yet another embodiment, the covering 360 may be a continuous
portion of the strap 358 turned to loop around the frame, thereby
forming a sleeve to hold the frame. The balloon 351 is connected to
the strap 358 by a connector 352 on a side of the balloon 351
adjacent the center portion of the curved frame. As shown in FIG.
12, in one embodiment, the band may have a second sleeve 366 at a
side end portion of the band. The second sleeve is a double layer
construction formed by connecting a piece of film 356 to strap 358
of the band. In another embodiment, the band may not have a second
sleeve. An embodiment of the hemostatic device depicted in FIG. 13
is similar to that depicted in FIG. 12, except that the embodiment
in FIG. 13 has a single balloon 451 to press on the radial
artery.
[0065] An embodiment of the band of the present invention is used
in a method directed at minimizing occurrences of radial artery
occlusion during the catheterization procedure of the radial
artery. In one embodiment, once the catheterization procedure is
complete, an ulnar pressure is applied to the ipsilateral ulnar
artery at an ulnar pressure site while a sheath, e.g., a catheter,
remains inserted in the radial artery. The sheath is then removed
from the radial artery while maintaining the pressure to the ulnar
artery. Once the sheath is removed, and while continuing to apply
the ulnar pressure, pressure is applied to the radial artery at the
access site to obtain hemostasis at the access site. In another
embodiment, once the catheterization procedure is complete, a
radial pressure is applied to the radial artery at the access site.
The radial pressure may be applied while a sheath, e.g., a
catheter, remains inserted in the radial artery or after the sheath
is removed from the radial artery. An ulnar pressure is then
applied to the ipsilateral ulnar artery at an ulnar pressure site.
In one embodiment, the ulnar pressure is continuously and
simultaneously applied with the radial pressure to obtain
hemostasis of the radial artery. In another embodiment, ulnar
pressure is gradually reduced to zero before obtaining hemostasis.
In yet another embodiment, the pressures applied to the radial
artery and the ulnar artery are simultaneously and independently
manipulated to optimize the pressure at which the bleeding from the
radial artery stops while at the same time a high enough pressure
is applied to the ulnar artery to prevent or minimize occlusion of
the radial artery.
[0066] The radial pressure is applied by inflating a radial
balloon, e.g., balloon 601 in FIG. 6. The radial balloon is
positioned over the access site of the radial artery 605. Upon
inflation of the radial balloon, the radial balloon assumes an
orientation whereby the pressing force applied to the puncture site
on the radial artery 605 acts generally in an outward direction
away from the center portion of the wrist. The pressing force
applied to the puncture site on the radial artery 605 is
directionally away from the ulnar artery. Upon inflation of the
ulnar balloon, the pressing force on the ulnar artery may have a
component in a direction towards the elbow, but a negligible
component in a direction towards the radial artery. The pressing
force applied on the ulnar artery is directionally away from the
radial artery. Therefore, operation of the ulnar balloon 603 to
pressurize or depressurize the ulnar artery 607 will not generally
affect operation of balloon 601 to pressurize or depressurize the
radial artery 605, and vice versa.
[0067] The radial artery and the ulnar artery are the two conduits
for the flow of oxygenated blood to the hand. The arteries are
interconnected and therefore form an interdependent flow network.
When flow is reduced in one of the arteries, by compression for
example, flow increases in the other artery. When the ulnar artery
is compressed, flow in the ulnar artery is reduced, which causes an
increase in pressure and flow in the radial artery.
[0068] In an embodiment, a further step includes confirming that
the application of ulnar pressure has reduced blood flow through
the ulnar artery. This is done by monitoring flow of the ulnar
artery prior to and after applying the ulnar pressure. In a further
embodiment, monitoring flow of the ulnar artery includes sensing
skin blood flow and/or pulsation at a fingertip or other location
downstream of the ulnar pressure site. Digital plethysmography is
employed in one embodiment.
[0069] In another embodiment, the method further includes
confirming patency of the radial artery during the step of applying
a pressure to the radial artery. Confirmation of patency is
accomplished by sensing skin blood flow and/or pulsation at a
fingertip or other location downstream of the access site. Other
sensing locations both upstream and downstream may be used to
confirm patency of the radial artery. In one embodiment, the
sensing is performed while the ulnar artery is fully compressed
(allowing no flow through the ulnar artery) and/or partially
compressed (allowing less flow than when not compressed at all).
Patency is confirmed, in an embodiment, by obtaining a metric
relating to the sensing and comparing the metric with a standard
metric for the patient, or with a previously-sensed metric. Metric
is understood to mean a sensible, quantifiable value or reading,
relating to the characteristic sensed. Digital plethysmography may
be employed to obtain the metrics. Other sensing modes may be
employed, so long as the selected mode is capable of confirming
patency in one form or another.
Example 1
[0070] A band was fabricated from a substantially transparent
polyvinyl chloride sheet material having a thickness of 0.5 mm. The
band had a length of 240 mm and a width of 55 mm. A radial artery
balloon and an ulnar artery balloon were each fabricated from a
substantially transparent polyvinyl chloride sheet material having
a thickness of 0.25 mm. The radial artery balloon had the dimension
of 38 mm.times.55 mm and the ulnar artery balloon had the dimension
of 38 mm.times.38 mm. The radial artery balloon, ulnar artery
balloon and band were welded together at the necessary places to
form a hemostatic device having the construction according to FIG.
5. Two adapters with check valves were connected to the two
balloons via ducts as shown in FIG. 5. A curved frame was made of 2
mm diameter rungs, with spacing between the rungs of 2 mm (center
to center distance between the rungs was 4 mm). The rungs were held
between two parallel beams of diameter 3 mm. The frame was curved
at both ends, and had identical radius of curvature at both ends.
The radius of curvature at each end was 20 mm. The frame had a
center portion that was straight and had a length of 28 mm. The
width of the frame was 52 mm. The frame was constructed according
to FIG. 2. Hook and loop (Velcro) fasteners were used to fasten.
This hemostatic device was wrapped around the wrist of normal
volunteers and the two balloons were inflated by injecting air into
the balloons using a 20 mL syringe with a luer lock. It was
observed that inflation of the radial balloon did not influence
perfusion of the fingers via the ulnar artery. A 20 mL inflation of
the radial artery balloon lead to complete obliteration of
antegrade radial flow, although there was no influence on perfusion
through the ulnar artery. On the ulnar side, with a shorter width
(38 mm) balloon, full 15 mL inflation of ulnar balloon did not
influence the status of flow in the radial artery.
[0071] Any constricting girdle-like device would be expected, even
at a lower pressure to first constrict the veins and cause venous
congestion in the fingers. It was surprising to observe a complete
lack of venous congestion, and no symptoms of venous congestion
were reported by any of the volunteers. On several occasions, 2
hour application of the band was performed as would be performed
clinically for hemostasis. Venous congestion did not occur.
Symptoms related to pressure at the ulnar tuberosity were also not
reported by the volunteers. This is likely because of (i) focal
pressure application by the orientation of the balloons, leaving
probably enough soft tissue space (in the central compartment of
the forearm where most large veins are located) for the venous
return to occur, and (ii) a decrease in magnitude of required
pressure because of the design features such as orientation and
sizes of the two balloons, their location in the band, and the
shape and structure of the frame.
Comparative Example 2
[0072] A band similar to that used in EXAMPLE 1 was fabricated, the
only difference being, in COMPARATIVE EXAMPLE 2, the width of the
ulnar balloon was nearly the same as the width of the band. In
EXAMPLE 1, the ulnar balloon had a width of 38 mm, which is about
70% of the width of the band. With the larger ulnar balloon of
COMPARATIVE EXAMPLE 2, inflation of the ulnar balloon was noted to
influence the perfusion of radial artery. This was particularly
pronounced in small forearms where the larger ulnar balloon may
assume an orientation such that the force applied to the wrist when
the ulnar balloon is inflated impacts the radial artery.
[0073] Tests have shown that the location of the ulnar balloon on
the forearm aspect of the band increased the efficacy of the
balloon to compress and occlude ulnar artery. Moving the balloon
towards the hand and especially gluing it to the palmar aspect of
the band increased the efficacy of the ulnar balloon to focally
compress and occlude ulnar artery without any other effects or
symptoms.
[0074] An embodiment of the band of the present invention may also
be used in a method directed at minimizing occurrences of ulnar
artery occlusion during the catheterization procedure of the ulnar
artery. In one embodiment, once the catheterization procedure is
complete, a radial pressure is applied to the radial artery at a
radial pressure site while a sheath, e.g., a catheter, remains
inserted in the ulnar artery. The sheath is then removed from the
ulnar artery while maintaining the pressure to the radial artery.
Once the sheath is removed, and while continuing to apply the
radial pressure, pressure is applied to the ulnar artery at the
access site to obtain hemostasis at the access site. In another
embodiment, once the catheterization procedure is complete, an
ulnar pressure is applied to the ulnar artery at the access site.
The ulnar pressure may be applied while a sheath, e.g., a catheter,
remains inserted in the ulnar artery or after the sheath is removed
from the ulnar artery. A radial pressure is then applied to the
radial at a radial pressure site. In one embodiment, the radial
pressure is continuously and simultaneously applied with the ulnar
pressure to obtain hemostasis of the ulnar artery. In another
embodiment, radial pressure is gradually reduced to zero before
obtaining hemostasis of the ulnar artery. In yet another
embodiment, the pressures applied to the radial artery and the
ulnar artery are simultaneously and independently manipulated to
optimize the pressure at which the bleeding from the ulnar artery
stops while at the same time a high enough pressure is applied to
the radial artery to prevent or minimize occlusion of the ulnar
artery.
[0075] An embodiment of the band of the present invention may also
be used in a method directed to obtaining hemostasis of both radial
and ulnar artery when catheterization procedures are simultaneously
performed on both radial and ulnar arteries.
[0076] It will be appreciated that several of the above-disclosed
and other features and functions, or alternatives or varieties
thereof, may be desirably combined into many other different
systems or applications. Also that various alternatives,
modifications, variations or improvements therein may be
subsequently made by those skilled in the art which are also
intended to be encompassed by the following claims.
[0077] In the description above, for the purposes of explanation,
numerous specific requirements and several specific details have
been set forth in order to provide a thorough understanding of the
embodiments. It will be apparent however, to one skilled in the
art, that one or more other embodiments may be practiced without
some of these specific details. The particular embodiments
described are not provided to limit the invention, but to
illustrate it. The scope of the invention is not to be determined
by the specific examples provided above. In other instances,
well-known structures, devices, and operations have been shown in
block diagram form or without detail in order to avoid obscuring
the understanding of the description. Where considered appropriate,
reference numerals or terminal portions of reference numerals have
been repeated among the figures to indicate corresponding or
analogous elements, which may optionally have similar
characteristics.
[0078] It should also be appreciated that reference throughout this
specification to "one embodiment", "an embodiment", "one or more
embodiments", or "different embodiments", for example, means that a
particular feature may be included in the practice of the
invention. Similarly, it should be appreciated that in the
description various features are sometimes grouped together in a
single embodiment, figure, or description thereof for the purpose
of streamlining the disclosure and aiding in the understanding of
various inventive aspects. This method of disclosure, however, is
not to be interpreted as reflecting an intention that the invention
requires more features than are expressly recited in each claim.
Rather, as the following claims reflect, inventive aspects may lie
in less than all features of a single disclosed embodiment. In
another situation, an inventive aspect may include a combination of
embodiments described herein or in a combination of less than all
aspects described in a combination of embodiments.
* * * * *