Method to stop bleeding, with short hemostasis duration using a low dose of anticoagulant

Inventors

PANCHOLY, SAMIR BIPIN

Assignees

Vasoinnovations Inc

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Publication Number

US-12178436-B2

Patent

Publication Date

2024-12-31

Expiration Date


Abstract

Disclosed are methods and devices for obtaining patent hemostasis of the radial artery by compressing the uninstrumented ulnar artery to increase radial artery flow. The device comprises a band having an inflatable bladder for applying blunt pressure to the ulnar artery. The method comprises applying a pressure to the homolateral ulnar artery and applying a pressure to the radial artery at the access site to obtain hemostasis at the access site. The method further comprises administering an anticoagulant to a patient at a dose ranging from about 20 units per kg of body weight to about 30 units per kg of body weight.

Core Innovation

The invention provides a method of obtaining patent hemostasis of a radial artery of a patient during a catheterization procedure at a radial artery access site. The method includes administering a dose of anticoagulant during the catheterization procedure, where the dose is less than an equivalent of 50 units of unfractionated heparin per kg of body weight, and applying compressive pressure to the radial artery at the access site for a duration of time of about 60 minutes.

After attaining patent hemostasis, the compressive pressure to the radial artery is reduced after about 60 minutes of compression. The anticoagulant is administered such that step (a) precedes all other steps, and the compressive pressure is gradually reduced after about 60 minutes of compression.

The invention also includes monitoring and/or confirming patency of the radial artery by sensing skin blood flow and/or pulsation at a finger-tip or other location downstream of the access site. In an aspect of the method, the compressive pressure to the radial artery is applied using a first band comprising at least a first inflatable bladder, where the inflatable bladder applies a compressive pressure to the radial artery at the access site.

Claims Coverage

The partial content identifies three independent claims: clm-00001, clm-00019, and clm-00020. Across these claims, the coverage focuses on low-dose anticoagulation relative to an unfractionated heparin equivalence threshold, controlled radial access-site compressive pressure for about 60 minutes with subsequent reduction, obtaining patent hemostasis, downstream monitoring and/or confirmation of radial patency by sensing skin blood flow and/or pulsation, and use of a band with an inflatable bladder for radial compression.

Low-dose anticoagulant preceding radial compression

Administering a dose of anticoagulant during the catheterization procedure, wherein the dose of anticoagulant is less than an equivalent of 50 units of unfractionated heparin per kg of body weight, with the administering preceding all other steps.

Radial access-site compressive pressure for about 60 minutes

Applying compressive pressure to the radial artery at the access site for a duration of time of about 60 minutes to obtain patent hemostasis of the radial artery.

Gradual reduction of radial compression after about 60 minutes

Reducing the compressive pressure to the radial artery after about 60 minutes of compression, including gradually reduced after about 60 minutes of compression.

Downstream monitoring and/or confirmation of radial patency

Monitoring and/or confirming patency of the radial artery by sensing skin blood flow and/or pulsation at a finger-tip or other location downstream of the access site.

Inflatable-bladder radial compression band

Applying the compressive pressure to the radial artery using a first band comprising at least a first inflatable bladder, the inflatable bladder applying compressive pressure to the radial artery at the access site.

Timing of anticoagulant relative to catheter and introducer sheath

Administering anticoagulant at any time after introduction of a catheter or an introducer sheath and before removal of the catheter or the introducer sheath, or administering before introduction of a catheter and/or an introducer sheath.

Across the independent claims, the inventive coverage is centered on patent hemostasis of a radial artery during radial catheterization using a low anticoagulant dose relative to an unfractionated heparin equivalence threshold, applying compressive pressure at the radial access site for about 60 minutes, then reducing that compression after about 60 minutes. Additional claim coverage includes downstream monitoring and/or confirmation of radial patency by sensing skin blood flow and/or pulsation and applying radial compressive pressure with a band comprising at least one inflatable bladder, with specified timing of anticoagulant administration relative to catheter/introducer sheath insertion and removal.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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