Source: https://patents.google.com/patent/US10058334B1/en
Timestamp: 2019-08-23 09:15:36
Document Index: 630456476

Matched Legal Cases: ['Application No. 2002', 'Application No. 2002', 'Application No. 2002', 'Application No. 09', 'Application No. 03', 'Application No. 10', 'Application No. 09', 'Application No. 03', 'Application No. 03', 'Application No. 10', 'Application No. 09', 'Application No. 03', 'Application No. 09']

US10058334B1 - Method to stop bleeding - Google Patents
Method to stop bleeding Download PDF
US10058334B1
US10058334B1 US15/952,555 US201815952555A US10058334B1 US 10058334 B1 US10058334 B1 US 10058334B1 US 201815952555 A US201815952555 A US 201815952555A US 10058334 B1 US10058334 B1 US 10058334B1
US15/952,555
US20180228496A1 (en
2013-02-14 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=29783091&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US10058334(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
2013-05-07 Priority to US13/889,112 priority patent/US20130245675A1/en
2016-08-05 Priority to US15/229,455 priority patent/US10219809B2/en
2017-09-15 Priority to US15/705,483 priority patent/US20180000491A1/en
2018-04-13 Assigned to TERUMO KABUSHIKI KAISHA reassignment TERUMO KABUSHIKI KAISHA ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: NUMATA, SHIGEKI, WADA, SATOSHI, YAGI, HIROSHI
2018-04-13 Priority to US15/952,555 priority patent/US10058334B1/en
2018-04-13 Application filed by Terumo Corp filed Critical Terumo Corp
2018-08-16 Publication of US20180228496A1 publication Critical patent/US20180228496A1/en
2018-08-28 Publication of US10058334B1 publication Critical patent/US10058334B1/en
A method to stop bleeding at a puncture site of an artery on a patient's arm includes wrapping a flexible band of a hemostatic device around at least a portion of the patient's arm, wherein the hemostatic device also comprises a more rigid member that is more rigid than the flexible band, a balloon, and a visually identifiable marker. The method also involves wrapping the flexible band around at least the portion of the patient's arm while the balloon is in an uninflated state and while an introducer sheath is in place at the puncture site. The visually identifiable marker is used to position the balloon in overlying relation to the puncture site while viewing the puncture site through the balloon and through the more rigid member. Fluid is introduced into the balloon to inflate the balloon to apply a compression force against the puncture site.
This application is a continuation of U.S. application Ser. No. 15/705,483 filed on Sep. 15, 2017, which is a continuation of U.S. application Ser. No. 15/229,455 filed on Aug. 5, 2016, which is a continuation of U.S. application Ser. No. 13/889,112 filed on May 7, 2013, which is a continuation of U.S. application Ser. No. 12/356,969 filed on Jan. 21, 2009, which is a divisional application of U.S. application Ser. No. 10/618,964 filed on Jul. 15, 2003, and claims priority to Japanese Application No. 2002-206295 filed on Jul. 15, 2002, Japanese Application No. 2002-323940 filed on Nov. 7, 2002 and Japanese Application No. 2002-373013 filed on Dec. 24, 2002 the entire content of all of which is incorporated herein by reference.
The present invention relates to a hemostatic device and a method to stop bleeding, and more particularly to a hemostatic device which is attached to a patient's limb at a site on the limb where bleeding is to be stopped and which, by the inflation of a balloon, applies pressure to the site so as to stop bleeding.
The hemostatic device and method disclosed here exhibit an excellent hemostatic effect.
The hemostatic device and method disclosed here also spontaneously (that is, without manipulation by a health care practitioner such as a physician or nurse—sometimes referred to hereinafter as the “operator”) eases over time the pressure applied by the balloon, thus helping to prevent harmful effects from the continued application of pressure, such as numbness, pain and vascular blockage.
The disclosed hemostatic device and method enable a balloon for compressing a puncture site (a site where blood flow is to be stopped) to be easily positioned at the site, and thus minimizes blood leakage and hematoma formation due to poor positioning of the balloon.
According to one aspect, a method to stop bleeding at a puncture site of an artery on an arm of a patient comprises: wrapping a flexible band of a hemostatic device around at least a portion of the arm of the patient, wherein the hemostatic device also comprises a more rigid member that is more rigid than the flexible band, a balloon, and a visually identifiable marker used to position the balloon at the puncture site. The wrapping of the flexible band around at least the portion of the arm of the patient comprises wrapping the flexible band around at least the portion of the arm of the patient while the balloon is in an uninflated state and while an introducer sheath is in place at the puncture site of the artery on the arm of the patient. The method additionally involves using the visually identifiable marker to position the balloon in overlying relation to the puncture site while viewing the puncture site through the balloon and through the more rigid member, and introducing fluid into the balloon to inflate the balloon while the balloon is positioned in overlying relation to the puncture site. The introduction of the fluid into the balloon to inflate the balloon includes inflating the balloon to apply a compression force against the puncture site. The method also includes maintaining inflation of the balloon and the application of the compression force against the puncture site.
According to another aspect, a method to stop bleeding at a puncture site of an artery on an arm of a patient comprises wrapping a flexible band of a hemostatic device around at least a portion of the arm of the patient, wherein the hemostatic device also comprises a more rigid member that is more rigid than the flexible band, a balloon, and a visually identifiable marker used to position the balloon at the puncture site. The wrapping of the flexible band around at least the portion of the arm of the patient comprises wrapping the flexible band around at least the portion of the arm of the patient while the balloon is in an uninflated state and while an introducer sheath is in place at the puncture site of the artery on the arm of the patient. The method additionally involves using the visually identifiable marker to position the balloon in overlying relation to the puncture site while viewing the puncture site through a transparent portion of the balloon and through a transparent portion of the more rigid member, securing the flexible band in position around at least the portion of the arm of the patient while the balloon is in overlying relation to the puncture site so that the balloon is between a surface of the arm of the patient and the more rigid member, and introducing fluid into the balloon to inflate the balloon while the balloon is positioned in overlying relation to the puncture site. The introducing of the fluid into the balloon to inflate the balloon includes inflating the balloon to apply a compression force against the puncture site sufficient to stop bleeding at the puncture site when the compression force is maintained for a period of time. The method further involves maintaining inflation of the balloon and the application of the compression force against the puncture site to stop bleeding at the puncture site.
A further aspect of the disclosure here comprises a method to stop bleeding at a puncture site of an artery on an arm of a patient comprising wrapping a flexible band of a hemostatic device around at least a portion of the arm of the patient, with the hemostatic device also comprising a more rigid member that is more rigid than the flexible band, a balloon, and a visually identifiable marker used to position the balloon at the puncture site. The wrapping of the flexible band around at least the portion of the arm of the patient comprises wrapping the flexible band around at least the portion of the arm of the patient while the balloon is in an uninflated state and while an introducer sheath is in place at the puncture site of the artery on the arm of the patient. The method additionally includes using the visually identifiable marker to position the balloon in overlying relation to the puncture site, with the balloon being positioned in overlying relation to the puncture site while viewing the puncture site through a transparent portion of the balloon and through a transparent portion of the more rigid member, securing the flexible band in position around at least the portion of the arm of the patient while the balloon is in overlying relation to the puncture site so that the balloon is between a surface of the arm of the patient and the more rigid member, and introducing fluid into the balloon to increase an internal pressure in the balloon and inflate the balloon while the balloon is positioned in overlying relation to the puncture site. The introducing of the fluid into the balloon to inflate the balloon includes inflating the balloon to a degree sufficient to achieve a compressive force suitable to stop bleeding at the puncture site. After the inflating of the balloon to the degree sufficient to achieve the compressive force suitable to stop the bleeding at the puncture site, the internal pressure in the balloon is reduced over a period of time greater than ten minutes. The method further comprises determining that bleeding at the puncture site has stopped, and removing the hemostatic device from the arm of the patient.
These and other aspects, features and advantages of the hemostatic device and method disclosed here will become more apparent upon consideration of the following detailed description and the accompanying drawings.
If the internal pressure 60 minutes after balloon inflation exceeds 70% of the initial internal pressure, the compressive force (internal pressure) at the time of inflation of the balloon 5 remains at substantially the same level. There may be situations in which it may be desirable to avoid such a case.
On the other hand, if the internal pressure 60 minutes after balloon inflation is less than 20% of the initial internal pressure, the percent decrease in the internal pressure of the balloon 5 may be more than desired. There may be situations in which such decrease in the internal balloon pressure causes the compressive force of the balloon 5 to diminish before sufficient hemostasis has occurred, which may result in blood leakage at the puncture site 510.
Internal pressure Pressure as a
Time elapsed after of balloon percentage of initial
balloon inflation (mmHg) internal pressure
10 seconds 161 100
10 minutes 128 79.5
30 minutes 108 67.0
60 minutes 79 49.0
120 minutes 66 40.9
180 minutes 64 39.7
10 seconds 152 100
10 minutes 133 87.5
30 minutes 110 72.4
60 minutes 84 55.2
120 minutes 59 38.8
180 minutes 40 26.3
10 seconds 155 100
10 minutes 131 84.5
30 minutes 122 78.7
60 minutes 113 73.9
120 minutes 108 69.6
180 minutes 106 68.3
10 seconds 153 100
10 minutes 136 88.8
30 minutes 130 84.9
60 minutes 125 81.6
120 minutes 117 76.4
180 minutes 113 73.8
10 seconds 154 100
10 minutes 107 69.5
30 minutes 56 36.4
60 minutes 27 17.5
120 minutes 15 9.7
180 minutes 6 3.9
1. A method to stop bleeding at a puncture site of an artery on an arm of a patient, the method comprising:
wrapping a flexible band of a hemostatic device around at least a portion of the arm of the patient, the hemostatic device also comprising a more rigid member that is more rigid than the flexible band, a balloon, and a visually identifiable marker used to position the balloon at the puncture site;
the wrapping of the flexible band around at least the portion of the arm of the patient comprising wrapping the flexible band around at least the portion of the arm of the patient while the balloon is in an uninflated state and while an introducer sheath is in place at the puncture site of the artery on the arm of the patient;
using the visually identifiable marker to position the balloon in overlying relation to the puncture site while viewing the puncture site through the balloon and through the more rigid member;
introducing fluid into the balloon to inflate the balloon while the balloon is positioned in overlying relation to the puncture site;
the introducing of the fluid into the balloon to inflate the balloon including inflating the balloon to apply a compression force against the puncture site; and
maintaining inflation of the balloon and the application of the compression force against the puncture site.
2. The method according to claim 1, wherein the puncture site of the artery is on a wrist of the arm of the patient.
3. The method according to claim 1, wherein the puncture site of the artery is on an inner side of a wrist of the arm of the patient.
4. The method according to claim 1, further comprising removing the introducer sheath from the puncture site of the artery on the arm after the introducing of the fluid into the balloon to inflate the balloon.
5. The method according to claim 1, further comprising removing the introducer sheath from the puncture site of the artery on the arm after the balloon is fully inflated.
6. The method according to claim 1, wherein the inflation of the balloon causes the more rigid member to move away from a surface of the arm of the patient.
7. The method according to claim 1, wherein the introducing of the fluid into the balloon includes introducing fluid into a connector that is connected to a tube in fluid communication with an interior of the balloon so that the fluid flows through the tube and into the balloon.
8. The method according to claim 1, wherein the more rigid member is a curved more rigid member.
9. The method according to claim 1, wherein the more rigid member possesses an inner surface facing a surface of the arm of the patient during the introducing of the fluid into the balloon, at least a part of the inner surface of the more rigid member being curved.
10. A method to stop bleeding at a puncture site of an artery on an arm of a patient, the method comprising:
using the visually identifiable marker to position the balloon in overlying relation to the puncture site while viewing the puncture site through a transparent portion of the balloon and through a transparent portion of the more rigid member;
securing the flexible band in position around at least the portion of the arm of the patient while the balloon is in overlying relation to the puncture site so that the balloon is between a surface of the arm of the patient and the more rigid member;
the introducing of the fluid into the balloon to inflate the balloon including inflating the balloon to apply a compression force against the puncture site sufficient to stop bleeding at the puncture site when the compression force is maintained for a period of time; and
maintaining inflation of the balloon and the application of the compression force against the puncture site to stop bleeding at the puncture site.
11. The method according to claim 10, wherein the puncture site of the artery is on an inner side of a wrist of the arm of the patient.
12. The method according to claim 10, further comprising removing the introducer sheath from the puncture site of the artery on the arm after the introducing of the fluid into the balloon to inflate the balloon.
13. The method according to claim 10, further comprising removing the introducer sheath from the puncture site of the artery on the arm after the balloon is fully inflated.
14. The method according to claim 10, wherein the inflation of the balloon causes the more rigid member to move away from a surface of the arm of the patient.
15. The method according to claim 10, wherein the more rigid member possesses an inner surface facing a surface of the arm of the patient during the introducing of the fluid into the balloon, at least a part of the inner surface of the more rigid member being curved.
16. A method to stop bleeding at a puncture site of an artery on an arm of a patient, the method comprising:
using the visually identifiable marker to position the balloon in overlying relation to the puncture site, the balloon being positioned in overlying relation to the puncture site while viewing the puncture site through a transparent portion of the balloon and through a transparent portion of the more rigid member;
introducing fluid into the balloon to increase an internal pressure in the balloon and inflate the balloon while the balloon is positioned in overlying relation to the puncture site;
the introducing of the fluid into the balloon to inflate the balloon including inflating the balloon to a degree sufficient to achieve a compressive force suitable to stop bleeding at the puncture site;
after the inflating of the balloon to the degree sufficient to achieve the compressive force suitable to stop the bleeding at the puncture site, reducing the internal pressure in the balloon over a period of time greater than ten minutes;
determining that bleeding at the puncture site has stopped; and
removing the hemostatic device from the arm of the patient.
17. The method according to claim 16, wherein a time period between the inflating of the balloon to the degree sufficient to achieve the compressive force suitable to stop the bleeding at the puncture site and the removing of the hemostatic device from the arm of the patient is 150 minutes-360 minutes.
18. The method according to claim 16, wherein the puncture site of the artery is on an inner side of a wrist of the arm of the patient.
19. The method according to claim 16, further comprising removing the introducer sheath from the puncture site of the artery on the arm after the introducing of the fluid into the balloon to inflate the balloon.
20. The method according to claim 16, wherein the more rigid member possesses an inner surface facing a surface of the arm of the patient during the introducing of the fluid into the balloon, at least a part of the inner surface of the more rigid member being curved.
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:WADA, SATOSHI;NUMATA, SHIGEKI;YAGI, HIROSHI;REEL/FRAME:045533/0853