Method to stop bleeding, with short hemostasis duration using a low dose of anticoagulant
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Publication Number
US-11350943-B2
Publication Date
2022-06-07
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 hemostasis of a radial artery of a patient during a catheterization procedure at a radial artery access site. During the catheterization procedure, an anticoagulant is administered first, and hemostatic pressure is applied to the radial artery at the access site for a duration of time at least until hemostasis is attained, while ulnar pressure is simultaneously applied to an ulnar artery at an ulnar pressure site.
The method maintains the hemostatic pressure to the radial artery and the ulnar pressure to the ulnar artery simultaneously, and then releases the ulnar pressure whereby the ulnar pressure is applied for only a part of the duration of time. Hemostasis is attained of the radial artery after the radial hemostatic pressure and the ulnar pressure have been applied in the recited order, and the hemostatic pressure to the radial artery is gradually reduced after about 60 minutes of hemostatic compression at the access site.
The invention further includes transradial hemostasis approaches and device embodiments directed to reducing radial artery occlusion by increasing radial artery flow via compression of the uninstrumented (homolateral) ulnar artery. In device form, an ulnar impingement band includes an inflatable bladder, with a trunk and limbs and connectors for securing over the wrist so that the bladder contacts an ulnar pressure site, including over Guyon’s canal.
The disclosure also describes shorter hemostatic compression durations and gradual weaning/reducing of radial compression to improve comfort and allow more patients to be treated, with optional confirmation of patency using fingertip/downstream skin blood-flow and/or pulsation sensing such as digital plethysmography.
Claims Coverage
The independent claim is directed to a step-sequence method for radial hemostasis that includes prior anticoagulant administration, simultaneous application of radial hemostatic pressure and ulnar pressure, subsequent release of the ulnar pressure before radial hemostasis is achieved, and gradual reduction of radial hemostatic pressure after about 60 minutes. Dependent claims further refine key inventive features such as timing, anticoagulant selection, quantitative compression duration, patency confirmation sensing, and specific ulnar-pressure delivery mechanics.
Anticoagulant administered before pressure steps
Administering a dose of anticoagulant to the patient during the catheterization procedure, wherein step (a) precedes all other steps.
Simultaneous radial hemostatic pressure and ulnar pressure
Applying a hemostatic pressure to the radial artery at the access site for a duration of time at least until hemostasis of the radial artery, and applying ulnar pressure to an ulnar artery at an ulnar pressure site while simultaneously maintaining the hemostatic pressure and the ulnar pressure.
Release ulnar pressure before radial hemostasis is attained
Releasing the ulnar pressure whereby the ulnar pressure is applied for only a part of the duration of time, with step (d) preceding step (e), and attaining hemostasis of the radial artery.
Gradual reduction of radial hemostatic pressure after about 60 minutes
Gradually reducing the hemostatic pressure to the radial artery after about 60 minutes of hemostatic compression of the radial artery at the access site.
Patency confirmation by sensing downstream skin blood flow and/or pulsation
Monitoring and/or confirming patency of the radial artery by sensing skin blood flow and/or pulsation at a finger-tip or other downstream location from the access site.
Inflatable-bladder ulnar band for applying ulnar pressure
Applying ulnar pressure by using a band having an inflatable bladder, securing the band over a wrist so the bladder contacts the ulnar pressure site, and inflating the bladder to compress the ulnar artery at the ulnar pressure site.
Overall, the claim set emphasizes an ordered sequence in which anticoagulation precedes simultaneous radial and ulnar pressure, the ulnar pressure is released before radial hemostasis is attained, and radial hemostatic pressure is gradually reduced after about 60 minutes, with refinements including optional downstream patency sensing and specific inflatable-bladder ulnar-pressure band mechanics.
Stated Advantages
Reduces radial artery occlusion.
Improves comfort during hemostasis by gradual weaning/reducing of radial compression.
Allows more patients to be treated.
Documented Applications
Transradial hemostasis during a catheterization procedure at a radial artery access site, using ulnar artery compression to reduce radial artery occlusion.
Using patency confirmation by sensing skin blood flow and/or pulsation at a finger-tip or other downstream location to monitor and/or confirm radial artery patency.
Hemostasis support for clinical use with an ulnar impingement band having an inflatable bladder, secured over the wrist including over Guyon’s canal.
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