Apparatus and method to stop bleeding

Inventors

PANCHOLY, SAMIR BIPIN • SARDESAI, NOLAN RAJENDRA • PANSE, MILIND PADMAKAR • Sardesai, Rajendra Gurudas

Assignees

Vasoinnovations Inc

Abstract

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

Core Innovation

The disclosed invention relates to obtaining hemostasis at a puncture site of a radial artery on a wrist of a patient using a hemostatic device applied to the wrist with a flexible band that is wrapped around at least a portion of the wrist. A member of the hemostatic device that is more rigid than the flexible band includes an inner peripheral surface facing the wrist, and at least a first balloon is positioned between the wrist and the member while the balloon is in an uninflated state during application.

After positioning the at least first balloon over the puncture site, the first balloon is inflated to apply a radial compressive force directly against the puncture site. The radial compressive force is defined such that, when a palmar aspect of the wrist is substantially parallel to a horizontal plane, the total radial compressive force has a direction oblique to the horizontal plane pointing away from a center portion of the wrist and pointing in an outward direction, so that a component of the radial compressive force will not affect an ulnar artery for a purpose of avoiding an impact at a location of the ulnar artery.

In the described approach, hemostasis is obtained by maintaining inflation of the at least first balloon and the radial compressive force against the puncture site for a duration of time at least until hemostasis of the radial artery. The document further describes positioning and inflating at least a second balloon at an ulnar pressure site on the ipsilateral ulnar artery to apply an ulnar compressive force, including embodiments in which the ulnar pressure site is the Guyon’s canal, and maintaining or timing the ulnar compressive force in relation to obtaining radial-artery hemostasis.

The background problem described is that applying radial compression can cause an impact at a location of the ulnar artery and can contribute to radial-artery occlusion incidence. The disclosed structure and force direction are therefore configured to avoid affecting the ulnar artery while providing radial compressive force sufficient to stop radial-artery bleeding, and the ulnar compressive force is used to affect interdependent artery flow and to reduce incidence of occlusion of the radial artery.

Claims Coverage

The document includes two independent methods focused on hemostasis at a radial artery puncture site using a wrist-wrappable hemostatic device with a flexible band and at least a first balloon applying a radial compressive force with an oblique outward direction that avoids affecting the ulnar artery. Across the families, inventive features include the radial-balloon positioning and oblique force definition, and additional inventive features include use of a second, ulnar-placed balloon at an ulnar pressure site (including Guyon’s canal) and optional independent, simultaneous adjustment of radial and ulnar compressive forces, as well as timing relationships and patency monitoring.

Across the independent methods, the main claim coverage centers on applying a flexible-band hemostatic device with at least one balloon inflated to create an oblique outward radial compressive force that avoids affecting the ulnar artery, and maintaining that radial compression until radial-artery hemostasis. The claimed coverage further expands with the use of a second balloon to apply ulnar compressive force at an ulnar pressure site (including Guyon’s canal), including timing relationships and simultaneous independent adjustment of radial and ulnar forces to reduce radial-artery occlusion incidence.

Stated Advantages

Documented Applications