Apparatus And Method Of Use For An Adjustable Radial And Ulnar Compression Wristband

Abstract

An adjustable radial and ulnar vascular compression wristband and its method of use assists in achieving partial or full occlusion of a blood vessel to achieve patent hemostasis when applied to a patient's wrist during or following a medical procedure. At least two adjustably inflatable non-adjacent balloons on the wristband apply preferential compression to portions of the circumference of the wrist, including in particular those portions overlying the ulnar and radial arteries.

We claim: 
     
         1 . A method of using a wristband, for the purpose of achieving patent hemostasis of a puncture site in an artery in a wrist, generally including the following steps:
 i) Securing the wristband onto the wrist.   ii) Initial inflation of the balloon overlying the radial artery.   iii) Removing the sheath or cannula from a puncture site in the radial artery of the wrist and fully inflating the balloon.   iv) Inflating the balloon overlying the ulnar artery.   v) Achieving patent hemostasis.   vi) Removing the wristband from the wrist.   
     
     
         2 . A method of using an adjustable wristband for securement around a wrist of a patient that has at least a strap having at least two inflatable balloons, more particularly at least a radial balloon and an ulnar balloon, the wristband having the purpose of achieving patent hemostasis of a puncture site in a radial artery in which a sheath or cannula is inserted, the method generally including the following steps:
 a) Placement and securement of the wristband onto the wrist.   b) Initial inflation of the radial balloon overlying the radial artery.   c) Removing the sheath or cannula from a puncture site in the radial artery of the wrist and fully inflating the radial balloon.   d) Inflating the ulnar balloon overlying the ulnar artery.   e) Achieving patent hemostasis in the radial artery.   f) Removing the wristband from the wrist.   
     
     
         3 . The wristband and method of  claim 2  wherein each of the balloons is more particularly affixed to a valve/connector for the purpose of attaching a syringe or pump, one balloon at a time, for the purpose of injecting air into or removing air from each balloon, the radial balloon for applying compression over the radial artery and, separately, the ulnar balloon for applying compression of the ulnar artery, the valve/connectors opening when a syringe or pump is attached to it and closing when such syringe or pump is removed thereby maintaining without change the air inside the balloons, and the strap more particularly including at one end a hook material and at an opposite end a loop material for the purpose of securing the wristband around the wrist. 
     
     
         4 . The wristband and method of  claim 3 , more particularly step (a), wherein a user fits the wristband around the wrist and, by attaching the loop material to the hook material on the strap, fastens it so that the uninflated radial balloon is positioned over the radial artery and puncture site, and the uninflated ulnar balloon is positioned over the ulnar artery, marks or lines placed on the radial balloon or strap assisting in this positioning. 
     
     
         5 . The wristband and method of  claim 3 , wherein at least one of the at least two balloons is movable along the length of the strap. 
     
     
         6 . The method of  claim 3 , more particularly step (b), wherein a user attaches the syringe or pump to the radial balloon's valve/connector and injects air into the radial balloon to increase compression onto the skin surface of the wrist, thereby partially compressing the radial artery such that blood flow continues to pass through the radial artery. 
     
     
         7 . The wristband and method of  claim 3 , more particularly step (c), wherein the user pulls the sheath or cannula from the puncture site and, on complete removal of the sheath or cannula, the syringe or pump is used to further inflate the radial balloon to provide increased compression over the radial artery such that there is no bleeding from the puncture site. 
     
     
         8 . The wristband and method of  claim 3 , more particularly step (d), wherein the user disconnects the syringe or pump from the radial balloon's valve/connector, then connects it to the ulnar balloon's valve/connector and injects air or gas into the ulnar balloon to increase compression onto the skin surface of the wrist, to compress the ulnar artery to slow or completely occlude blood flow therethrough. 
     
     
         9 . The wristband and method of  claim 3 , more particularly step (e), wherein the user assesses the distal pulses of the radial and ulnar arteries to detect pulses distal to the points of compression, so that if a distal radial artery pulse is not detected, the syringe or pump is connected to the radial balloon's valve/connector and used to gradually remove air or gas from the radial balloon until a distal radial artery pulse is detected without concomitant bleeding from the puncture site. 
     
     
         10 . The wristband and method of  claim 3 , more particularly step (f), wherein once hemostasis is achieved at the puncture site and arteriotomy, the user connects the syringe or pump to the radial balloon's valve/connector and slowly withdraws air or gas from the radial balloon until it is empty and then separates the hook material from the loop material and removes the wristband from the patient's wrist. 
     
     
         11 . The wristband and method of  claim 3  wherein during deployment of the wristband onto the wrist following inflation of the radial and ulnar balloons, the syringe or pump may be periodically connected to the valve/connectors of the radial or ulnar balloons and used to inject or withdraw air or gas from said balloons to adjust the compression applied to the ulnar or radial arteries so as to achieve and maintain patent hemostasis. 
     
     
         12 . The wristband and method of  claim 5 , more particularly step (a), wherein a user fits the wristband around the wrist and, by attaching the loop material to the hook material on the strap, fastens it so that the uninflated radial balloon is positioned over the radial artery and puncture site and the uninflated ulnar balloon is positioned over the ulnar artery, wherein the user moves the at least one of the movable balloons along the length of the strap for positioning over the ulnar or radial arteries. 
     
     
         13 . The method of  claim 11 , more particularly wherein the syringe or pump may be used to gradually inject additional air or gas into the ulnar balloon until the distal radial artery pulse is detected without concomitant bleeding from the puncture site. 
     
     
         14 . A method of using a wristband, for the purpose of achieving hemostasis at a puncture site in a radial artery of a wrist, the wristband comprising at least a strap, an ulnar balloon and a radial balloon each affixed to a valve/connector for removable attachment to a syringe or pump, the strap having hook material at one end and loop material at the opposite end, the method including the following steps:
 a) While a sheath is in the puncture site and radial and ulnar balloons are uninflated, the wristband is placed around the wrist such that the radial balloon is positioned over the radial artery and the ulnar balloon is placed over the ulnar artery.   b) The wristband is fastened by attaching the hook material at one end of the strap to the loop material at the other end of the strap.   c) The syringe or pump is attached to the valve/connector of the radial balloon and is used to inject air into the radial balloon to partially inflate it, so as to apply compression to the radial artery.   f) While the syringe or pump is still attached to the valve/connector of the radial balloon, which still applies compression to the radial artery, the sheath is removed from the puncture site and the syringe or pump is used to inject more air into the radial balloon to increase compression over the radial artery so that there is no bleeding at the puncture site.   g) The syringe or pump is removed from the radial balloon's valve/connector, such removal closing the valve/connector such that the radial balloon maintains without change the volume of air inside it.   h) The syringe or pump is attached to the valve/connector of the ulnar balloon and is used to inject air into the ulnar balloon to inflate it, so as to apply compression to the ulnar artery.   i) The syringe or pump is removed from the ulnar balloon's valve/connector, such removal closing the valve/connector such that the ulnar balloon maintains without change the volume of air inside it.   
     
     
         15 . The method of  claim 14 , which further includes the following steps:
 j) The syringe or pump may be connected to the valve/connector of at least one of the ulnar balloon or radial balloon and used to inject or withdraw air from that balloon for the purpose of increasing or decreasing compression applied by that balloon, so as to achieve patent hemostasis, and then removed from that valve/connector, such removal closing the valve/connector such that the balloon maintains without change the volume of air inside it.   k) Once hemostasis is achieved at the puncture site and arteriotomy, the syringe or pump is connected to the radial balloon's valve/connector and is used to withdraw air from the radial balloon until it is empty.   l) Once the radial balloon is empty, the hook material is separated from the loop material and the wristband is removed from the patient's wrist.   
     
     
         16 . A method of achieving patent hemostasis of a puncture site in a radial artery in a wrist that has a sheath inserted into it, generally including the following steps in sequence:
 i) First applying compression to the radial artery in the vicinity of the puncture site, while the sheath is inside the puncture site, so as to slow or stop the flow of blood through the radial artery.   ii) Removing the sheath from the puncture site and increasing or maintaining compression to the radial artery so as to stop bleeding from the puncture site.   iv) Applying compression to the ulnar artery to slow or stop the flow of blood therethrough, while compression continues to be applied to the radial artery.   v) Adjusting compression applied to the radial and ulnar arteries such that patent hemostasis is achieved.   
     
     
         17 . The method of  claim 16 , wherein steps (i) through (v) are more particularly performed using a wristband having the purpose of applying compression separately to a radial artery and an ulnar artery.