HEMOSTATIC DEVICE

• US 20160338709A1
• Filed: 08/05/2016
• Published: 11/24/2016
• Est. Priority Date: 07/15/2002
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Original Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Inventors: WADA, Satoshi, NUMATA, Shigeki, YAGI, Hiroshi
• Granted Patent: US 10,219,809 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2090/3937 Visible markers

Abstract

A hemostatic device includes a flexible band adapted to be wrapped around a patient'"'"'s limb at a site on the limb where bleeding is to be stopped, a portion for securing the band in a wrapped state to the limb, a curved plate which is made of a material more rigid than the band and at least a portion of which is curved toward the inner peripheral side thereof, a main balloon which is provided on the inner peripheral side of the curved plate and which inflates when a fluid is introduced therein, and a pressing member which is provided between the curved plate and the main balloon so that at least a portion thereof overlaps with the balloon and which is adapted for pressing against the balloon. The device provides an excellent hemostatic effect and prevents numbness and poor circulation in areas peripheral to the site of attachment.

Claims

1. A hemostatic device comprising:

a flexible band configured to be wrapped around a wrist of a patient at a site where bleeding is to be stopped so that the flexible band is in a wrapped state on the patient'"'"'s wrist;

a fastener to secure the flexible band in the wrapped state around the patient'"'"'s wrist;

a curved plate possessing an inner surface and an outer surface, the curved plate defining a concave curve along the inner surface;

a balloon positionable between the curved plate and the patient'"'"'s wrist in the wrapped state of the flexible band, the balloon including a center, the balloon being inflatable upon introducing gas into the balloon when the flexible band is in the wrapped state with the balloon positioned between the patient'"'"'s wrist and the plate to apply a compressive force to the site where bleeding is to be stopped;

a marker located to position the center of the balloon at the site where bleeding is to be stopped;

the band, the balloon and the curved plate being fabricated from substantially transparent materials permitting visualization of the site where bleeding is to be stopped when the flexible band is in the wrapped state with the balloon positioned between the patient'"'"'s wrist and the curved plate; and

the balloon being made of a gas permeable material selected so that after the balloon is inflated by the gas, the gas in the balloon is gradually released through the gas permeable material to outside the balloon to gradually decrease the compressive force applied to the site where bleeding is to be stopped.

2. The hemostatic device according to claim 1, wherein the gas permeable material from which the balloon is fabricated is a gas permeable material that allows release of the gas through the gas permeable material to the outside of the balloon so that an internal pressure in the balloon 60 minutes after inflation of the balloon to an initial internal pressure is equal to or less than 70% of the initial internal pressure and is equal to or greater than 20% of the initial internal pressure, the initial internal pressure being the internal pressure in the balloon ten seconds after the balloon is inflated to a degree sufficient to produce a compressive force to stop bleeding.

3. The hemostatic device according to claim 1, wherein the gas permeable material from which the balloon is fabricated is a gas permeable material that allows release of the gas through the gas permeable material to the outside of the balloon so that an internal pressure in the balloon 60 minutes after inflation of the balloon to an initial internal pressure is less than the initial internal pressure and is equal to or greater than 20% of the initial internal pressure, the initial internal pressure being the internal pressure in the balloon ten seconds after the balloon is inflated to a degree sufficient to produce a compressive force to stop bleeding.

4. The hemostatic device according to claim 1, wherein the balloon is a first balloon, further comprising a second balloon positionable between the curved plate and the patient'"'"'s wrist in the wrapped state of the flexible band.

5. The hemostatic device according to claim 1, wherein the second balloon is inflatable to an initial internal pressure is a different size than the first balloon positionable between the curved plate and the first balloon in the wrapped state of the flexible band.

6. The hemostatic device according to claim 1, further comprising a connector connecting the balloon to the flexible band.

7. A hemostatic device comprising:

a band made of flexible material allowing the band to be wrapped around a wrist of a patient at a site where bleeding is to be stopped so that the band is in a wrapped state on the patient'"'"'s wrist;

a fastener to secure the flexible band in the wrapped state around the patient'"'"'s wrist;

a plate possessing an inner surface and an outer surface, at least a portion of the plate being curved so that the plate includes a curved plate portion, the curved plate portion defining a concave curve along the inner surface of the plate that faces toward the patient when the band is in the wrapped state;

a balloon positionable between the plate and the patient'"'"'s wrist when the band is in the wrapped state, the balloon being inflatable upon introducing gas into the balloon when the band is in the wrapped state with the balloon positioned between the patient'"'"'s wrist and the plate to apply a compressive force to the site where bleeding is to be stopped;

the band, the balloon and at least a part of the plate being substantially transparent to permit visualization through the band, the plate and the balloon of the site where bleeding is to be stopped when the band is in the wrapped state with the balloon positioned between the patient'"'"'s wrist and the plate; and

the balloon being made of a material which is permeable to the gas in the balloon after the gas is introduced into the balloon to inflate the balloon and which is selected so that the gas in the balloon is gradually released through the gas permeable material to outside the balloon to gradually decrease the compressive force applied to the site where bleeding is to be stopped.

8. The hemostatic device according to claim 7, wherein the material from which the balloon is fabricated is a gas permeable material that allows release of the gas through the gas permeable material to the outside of the balloon so that an internal pressure in the balloon 60 minutes after inflation of the balloon to an initial internal pressure is equal to or less than 70% of the initial internal pressure and is equal to or greater than 20% of the initial internal pressure, the initial internal pressure being the internal pressure in the balloon ten seconds after the balloon is inflated to a degree sufficient to produce a compressive force to stop bleeding.

9. The hemostatic device according to claim 7, wherein the material from which the balloon is fabricated is a gas permeable material that allows release of the gas through the gas permeable material to the outside of the balloon so that an internal pressure in the balloon 60 minutes after inflation of the balloon to an initial internal pressure is less than the initial internal pressure and is equal to or greater than 20% of the initial internal pressure, the initial internal pressure being the internal pressure in the balloon ten seconds after the balloon is inflated to a degree sufficient to produce a compressive force to stop bleeding.

10. The hemostatic device according to claim 7, further comprising a marker on the balloon to facilitate positioning of the balloon at the site where bleeding is to be stopped.

12. The hemostatic device according to claim 7, further comprising a marker on the plate balloon to facilitate positioning of the balloon at the site where bleeding is to be stopped.

13. The hemostatic device according to claim 7, wherein the balloon is a first balloon, and further comprising a second balloon positionable between the plate and the patient'"'"'s wrist when the band is in the wrapped state.

14. The hemostatic device according to claim 7, wherein the second balloon is inflatable and is smaller in size than the first balloon when initially inflated for use.

15. The hemostatic device according to claim 7, further comprising a connector connecting the balloon to the flexible band.

11. The hemostatic device according to claim 11, further comprising a marker on the band to facilitate positioning of the balloon at the site where bleeding is to be stopped.

16. A method to stop bleeding at a puncture site of an artery on a wrist of a patient, the method comprising:

wrapping a band of a hemostatic device around the wrist of the patient, the hemostatic device also comprising a plate that includes a portion which is curved, a balloon and a marker, the flexible band, the curved plate and the balloon being substantially transparent;

the wrapping of the band around the wrist of the patient comprising wrapping the band around the wrist of the patient while the balloon is in an uninflated state so that the balloon is between the plate and the wrist of the patient;

positioning the balloon in overlying relation to the puncture site, the positioning of the balloon in overlying relation to the puncture site being accomplished by visually observing the marker;

introducing fluid into the balloon to increase internal pressure in the balloon and inflate the balloon to apply a compressive force to the puncture site selected to stop bleeding at the puncture site;

after inflating the balloon to apply the compressive force to the puncture site to help stop bleeding at the puncture site, gradually decreasing the internal pressure in the balloon while maintaining the compressive force against the puncture site; and

the gradual decrease of the internal pressure in the balloon being performed without any manual operation.

17. The method according to claim 16, wherein the gradual decrease of the internal pressure in the balloon includes gradually decreasing the internal pressure in the balloon so that the internal pressure in the balloon 60 minutes after inflation of the balloon to an initial internal pressure is less than the initial internal pressure and is equal to or greater than 20% of the initial internal pressure, the initial internal pressure being the internal pressure in the balloon ten seconds after the balloon is inflated to a degree sufficient to produce the compressive force to stop bleeding.

18. The method according to claim 16, wherein the gradual decrease of the internal pressure in the balloon includes gradually decreasing the internal pressure in the balloon so that the internal pressure in the balloon 60 minutes after inflation of the balloon to an initial internal pressure is equal to or less than 70% of the initial internal pressure and is equal to or greater than 20% of the initial internal pressure, the initial internal pressure being the internal pressure in the balloon ten seconds after the balloon is inflated to a degree sufficient to produce the compressive force to stop bleeding.

19. The method according to claim 16, wherein the balloon includes a center, and the positioning of the balloon in overlying relation to the puncture site includes positioning the center of the balloon above the puncture site.