Methods and apparatus for a manual radial artery compression device
Inventors
Finkielsztein, Sergio • Finkielsztein, Marco
Assignees
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Publication Number
US-9867625-B2
Publication Date
2018-01-16
Expiration Date
Abstract
A vascular compression apparatus and method for applying pressure onto an area of a patient generally including a blood vessel and a wound site, such as a blood vessel puncture after a cannulated procedure, for the purpose of controlling bleeding and achieving hemostasis.
Core Innovation
The invention relates to a self-contained manual radial artery compression system adapted for adjustable hemostasis at a percutaneous radial access site. A radial artery compression device allows a user to provide varying degrees of pressurization against a patient's radial artery to maintain a desired degree of hemostasis at the access site by preventing blood from flowing out through an opening in the patient's radial artery.
The radial artery compression device includes a body carrying a pump having a check valve, a pressure bladder, and a pressure control mechanism that can be activated to release fluid from the pressure bladder, thereby reducing a pressure in the pressure bladder. The pump, the pressure bladder, and the pressure control mechanism are disposed on a single plane and form a unit, enabling placement of the pressure bladder adjacent the wrist. Securing means secure the body to the underside of a wrist of a patient in the area of the radial artery so that the pressure bladder can be positioned against the wrist.
The user activates the pump to inflate the pressure bladder between a first position and at least a second position to provide varying degrees of pressurization to the wrist. In the first position, the pressure bladder applies a first amount of pressurization, and in a second position it provides a second greater amount of pressurization by actuation of the pump. After activation of the pressure control mechanism, the pressure bladder is deflated to a third position that provides a third amount of pressurization that is greater than the first amount and less than the second amount. Optional refinements described include a compressive pad using a hemostatic agent, a restrictor to direct force, and a wrist brace to limit rotation or movement.
Claims Coverage
The independent claim is clm-00001. It specifies a manual radial artery compression system with an integrated pump/pressure bladder/pressure control mechanism unit on a single plane, a wrist-underside securing arrangement, and multiple pressure bladder positions to provide varying degrees of pressurization for hemostasis at a percutaneous access site. The main inventive features are reflected in the structural and operational relationships among the pump, bladder, pressure control mechanism, and wrist positioning.
Manual varying-pressurization radial artery hemostasis
A radial artery compression device adapted to allow a user to provide varying degrees of pressurization against a patient's radial artery to maintain a desired degree of hemostasis at a percutaneous access site by preventing blood from flowing out through an opening in the patient's radial artery.
Integrated pump, bladder, and pressure control mechanism on a single plane
A pump having a check valve, a pressure bladder, and a pressure control mechanism that can be activated to release fluid from the pressure bladder, wherein the pump, the pressure bladder and the pressure control mechanism are disposed on a single plane and form a unit.
Wrist underside securing means for adjacent bladder placement
Securing means to secure the body to the underside of a wrist of a patient in the area of the radial artery such that the pressure bladder can be positioned adjacent the wrist of the patient.
Pressure bladder first, second, and third pressurization positions via pump inflation and pressure release
The user activates the pump to inflate the pressure bladder between a first position and at least a second position to provide varying degrees of pressurization, wherein the first position provides a first amount of pressurization, the second position provides a second greater amount of pressurization via pump actuation, and deflation to a third position via activation of the pressure control mechanism provides a third amount of pressurization greater than the first amount and less than the second amount.
Across the independent claim, the invention is defined by user-provided varying pressurization for radial-artery hemostasis at a percutaneous access site, an integrated pump/check-valve and bladder with a pressure control mechanism arranged on a single plane, securing means for positioning the bladder adjacent the underside of the patient’s wrist, and specific pressure states achieved by pump inflation and pressure control deflation.
Stated Advantages
Improved hemostasis within 1 hour for tested groups.
Reported success rates within 10/30/60 minutes for tested groups using the invention with a poly-N-acetyl glucosamine patch.
No local complications for the tested groups, including ecchymosis/oozing/hematoma.
Documented Applications
Clinical trial use at a percutaneous radial access site, reporting hemostasis timing and local complications for tested groups using the invention with a poly-N-acetyl glucosamine patch.
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