Methods and apparatus for a manual vascular compression device
Inventors
Finkielsztein, Sergio • Finkielsztein, Marco • Vournakis, John N.
Assignees
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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. The vascular compression apparatus includes a handle, a shaft and a pad. The shaft extends generally downward from the center of the bottom side of the handle. The pad is connected generally off-center of its top side to the bottom end of the shaft. The bottom side of the pad is convex to allow the vascular compression device to be rocked back and forth. In use, the pad is generally placed proximal to the catheter insertion site and over the blood vessel containing the catheter. The device is rocked proximally to control blood flow while removing the catheter. After the catheter is removed from the puncture site, the device is rocked distally to the puncture site, where pressure is applied until hemostasis is achieved.
Core Innovation
The invention relates to a handheld vascular compression apparatus for applying pressure to tissue in proximity to a puncture site in a body surface and a blood vessel. The apparatus includes a handle for manual operation, a shaft extending generally perpendicularly from the handle, and an oval knob pad with a convex bottom side that makes contact with the body surface. The pad is connected on the top side to and extends from a distal end of the shaft through a center of gravity of the handle, and the apparatus is configured to withstand downward pressure sufficient to cause a complete occlusion of an artery.
A key aspect is the off-center geometry and the resulting manual rocking operation. The proximal end of the shaft is connected to the handle at a point off center of a bottom side of the handle, and the handle and shaft are formed as a single member. The pad is rigidly connected to the shaft such that manually moving the handle rocks the pad along the body surface in a first direction to allow a catheter to be removed, and in a second opposed direction to provide compression along an angle of the catheter track from the body surface to the blood vessel.
In related embodiments, a groove for guiding a catheter is formed in a surface of the convex bottom side of the oval pad, and the device is configured to allow rocking proximally for proximal control of blood flow while retrieving the device from a puncture site, followed by distal rocking to the puncture site to achieve hemostasis. Additional embodiments include a vessel alignment guide comprising one or more markings disposed on a top surface of the handle for aligning the apparatus with a blood vessel, and the device can be provided in mostly rigid material, optionally with a transparent material and with other surface features for grip, stability, or catheter guidance.
Claims Coverage
The independent claim set includes three independent claims, each centered on a handheld/manual vascular compression apparatus using a mostly rigid structure with an oval-knob convex pad and rocking-based operation, with additional independent-claim-specific structural features including an off-center shaft connection, a catheter-guiding groove, and a vessel alignment guide with markings.
Oval knob convex pad for contacting the body surface
A pad having a long axis and a short axis and having a top side and a bottom side, connected on the top side to and extending from a distal end of the shaft through a center of gravity of the handle, wherein the pad, when viewed from the side, is shaped as an oval knob and has a convex bottom side to make contact with the body surface; and wherein the pad is rigidly connected to the shaft.
Mostly rigid material withstands complete arterial occlusion
The apparatus is made of mostly rigid material that is sturdy enough to withstand the application of downward pressure sufficient to cause a complete occlusion of an artery.
Off-center connection enables opposed-direction rocking for catheter removal and compression along catheter track
The proximal end of the shaft is connected to the handle at a point off center of a bottom side of the handle; and the handheld vascular compression apparatus is configured to be operated by manually moving the handle to thereby rock the pad along the body surface in a first direction to allow a catheter to be removed, and in a second opposed direction to provide compression along an angle of the catheter track from the body surface to the blood vessel.
Handle and shaft formed as a single member for manual operation
The handle and shaft are formed as a single member.
Catheter-guiding groove in convex pad surface
An oval pad having a top side and a bottom side and connected on the top side to a distal end of the shaft wherein the pad has a convex bottom side, which makes contact with the body surface; and a groove for guiding a catheter formed in a surface of the convex bottom side of the pad and extending less than the entire height of the pad.
Rocking for proximal control and distal hemostasis
The device is configured to allow a user to rock the pad proximally, for proximal control of blood flow while retrieving a device from a puncture site, followed by distal rocking of the device to the puncture site to achieve hemostasis.
Vessel alignment guide with markings
A vessel alignment guide comprising one or more markings disposed on a top surface of the handle for aligning the apparatus with a blood vessel.
Across the independent claims, the inventive coverage is directed to a handheld/manual vascular compression device with a mostly rigid oval knob convex pad contacting the body surface, a rocking-based operation enabling catheter removal followed by compression to achieve hemostasis/complete arterial occlusion, and independent-claim-specific features including an off-center handle/shaft connection, a catheter-guiding groove, and vessel alignment markings on the handle.
Stated Advantages
Enables compression sufficient to cause a complete occlusion of an artery.
Allows a catheter to be removed while operating the device.
Provides compression along an angle of the catheter track from the body surface to the blood vessel.
Provides proximal control of blood flow while retrieving a device from a puncture site.
Achieves hemostasis by distal rocking to the puncture site.
Enables alignment of the apparatus with a blood vessel using vessel alignment guide markings.
Documented Applications
Applying pressure to tissue in proximity to a puncture site in a body surface and a blood vessel for bleeding control/hemostasis, including femoral compression.
Used during retrieval of a catheter from a puncture site, with rocking in a direction that allows catheter removal while controlling proximal blood flow.
Proximal and distal rocking operation to control blood flow and achieve hemostasis at the puncture site.
Formation of a kit concept combining the vascular compression apparatus with an external vascular closure device (e.g., SyvekPatch) as a sterile kit.
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