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Publication Number

US-10888334-B2

Patent

Publication Date

2021-01-12

Expiration Date


Abstract

A hemostatic device is provided to stop bleeding at a puncture site on an artery 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 compression member 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 compression member and a second balloon provided on the inner peripheral side in the second half of the curved compression member. The bleeding from a first artery is stopped by compressing the first artery at the puncture site using inflation of the first balloon and blood flow in the first artery is increased by compression of a second artery using inflation of the second balloon.

Core Innovation

A hemostatic device is provided that includes a flexible band configured to be wrapped around an individual's arm in which a radial artery and an ulnar artery are located. The flexible band has a longitudinal extent and is secured in a wrapped state by two parts that engage one another. A compression member connected to the flexible band is more rigid than the flexible band and includes a first portion and a second portion spaced apart in the longitudinal direction.

A first inflatable member is connected to the flexible band so that the first portion of the compression member overlies the first inflatable member, positioning it between the first portion and the individual's arm when wrapped. A first lumen introduces fluid into the interior of the first inflatable member to expand the first inflatable member and press a part of the radial artery to be subjected to hemostasis. A second inflatable member is similarly positioned between the second portion of the compression member and the individual's arm, and a second lumen introduces fluid to expand the second inflatable member and press a part of the ulnar artery.

The device further includes an auxiliary balloon having an interior that expands upon being inflated in response to introducing fluid, where the auxiliary balloon is disposed between the second portion of the compression member and the second inflatable member. When the auxiliary balloon is inflated, it presses the second inflatable member on the ulnar artery. The document also describes transparent flexible materials and rigid curved compression features, and maintaining patency by monitoring flow and modulating compression over time to reduce harm from sustained occlusion.

Claims Coverage

The partial content includes three independent claims, each centered on a flexible band with inflatable members that compress a radial artery puncture site while using an auxiliary balloon to compress an ulnar artery, thereby addressing radial artery occlusion while obtaining patent hemostasis.

Flexible band with rigid spaced compression portions and two independently inflatable artery-compressing members

A flexible band configured to be wrapped around an individual's arm with a compression member more rigid than the flexible band, the compression member including a first portion and a second portion spaced apart in a longitudinal direction, a first inflatable member positioned between the first portion and the arm for pressing a part of the radial artery, and a second inflatable member positioned between the second portion and the arm for pressing a part of the ulnar artery.

Auxiliary balloon pressing the ulnar-artery inflatable member

An auxiliary balloon disposed between the second portion of the compression member and the second inflatable member, where the auxiliary balloon expands upon inflating so that it presses the second inflatable member on the ulnar artery.

Flexible band with radial and longitudinally spaced inflatable members plus overlapping auxiliary balloon

A flexible band wrapped around an arm including a first inflatable member to press a part of the radial artery to be subjected to hemostasis and a second inflatable member disposed at a position spaced from the first inflatable member in a longitudinal direction, together with an auxiliary balloon that is disposed between the flexible band and the second inflatable member so that at least a portion of the auxiliary balloon overlaps the second inflatable member to press it when the auxiliary balloon is inflated.

Method of radial patent hemostasis using auxiliary balloon ulnar compression

Wrapping a flexible band around at least a portion of a patient's wrist at a puncture site located in a radial artery so that the first inflatable member overlies the radial artery, securing the device in a wrapped state, inflating the first inflatable member after securing, and inflating the auxiliary balloon and the second inflatable member such that the auxiliary balloon pressing the inflated second inflatable member on an ulnar artery compresses the ulnar artery for a period of time to obtain patent hemostasis of the radial artery.

Across the independent claims, the inventive core is the combination of a flexible arm-wrapping band with a more rigid compression member having spaced portions, two inflatable members for radial-artery and ulnar-artery compression, and an auxiliary balloon that presses the ulnar-artery inflatable member, including an overlap arrangement. The method claim applies this structure by securing the wrapped device, inflating the radial-artery inflatable portion after securing, and inflating the auxiliary balloon and second inflatable member to achieve patent hemostasis.

Stated Advantages

obtaining patent hemostasis of the radial artery

compressing the ulnar artery for a period of time to increase radial artery flow and reduce radial artery occlusion

reducing harm from sustained pressing force by modulating compression pressure over time

Documented Applications

Hemostasis for an arterial puncture site located in a radial artery of a patient's wrist using a flexible band with inflatable members and auxiliary ulnar-artery compression.

Example volunteer testing comparing smaller versus larger ulnar balloon widths with effects described as radial perfusion and venous congestion.

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