Closys Corporation

St. Croix Surgical Systems, LLC

Karol Leon Nowakowski

Daniel Grant Ericson

Edward T Joseph

James E Olson

Provided are approaches to establish a failsafe barrier to internal bleeding from percutaneous wounds to protect a patient from failed wound closure devices or related complications due to a variety of contributing factors such as state of systemic anticoagulation, errors in surgical procedure, variability in patient anatomy, and the like. Systems include a clotting agent to encase, and thus isolate, substantially the entire wound access area from the rest of the patient and an instrument, such as an intravascular introducer sheath, inserted through a wound at an access site on a vessel, for delivering the clotting agent to the entire enveloping tissue region around the accessed area as a mold cavity to be filled with the clotting agent. With benefits of patient safety, user simplicity, and low healthcare cost driving the effort, autologous whole blood is the preferred injected agent.

Failsafe percutaneous wound barrier

In a preferred embodiment, a method for closing a subcutaneous arterial wound is provided which utilizes a patient's whole blood by homogenously exposing the patient's whole blood to a porous matrix to initiate the clotting cascade of the patient's whole blood and situating the patient's whole blood at a position proximate the arterial wound as the patient's whole blood is clotting. The method may include holding a subcutaneous mass comprising the patient's whole blood in position proximate the arterial wound as the patient's whole blood continues to clot, whereby a hemostatic closure comprising the patient's whole blood is formed.

Methods of closing wounds

A method for closing a subcutaneous arterial wound is provided which utilizes a patient's whole blood by homogenously exposing the patient's whole blood to a porous matrix to initiate the clotting cascade of the patient's whole blood and situating the patient's whole blood at a position proximate to the arterial wound as the patient's whole blood is clotting. The method may include holding a subcutaneous mass comprising the patient's whole blood in position proximate the arterial wound as the patient's whole blood continues to clot, whereby a hemostatic closure comprising the patient's whole blood is formed.

Apparatus for closing wounds

Wound closure methods and apparatuses are provided which utilize blood fluid by activating the clotting cascade of the blood fluid outside the body within a substantially enclosed sterile container then introducing coagulated blood to the wound site to complete clotting. Methods and apparatuses for providing ways of inhibiting anticoagulants and slowing fibrin clot degradation are also disclosed. Kits for practicing the invention singularly or in combination with and/or associated with preferred procedures are also disclosed.

Wound closure methods and apparata are provided which utilize blood fluid by activating the clotting cascade of the blood fluid outside the body within a substantially enclosed sterile container then introducing the blood fluid to the wound site to complete clotting. Methods and apparata for providing ways of inhibiting anticoagulants and slowing fibrin clot degradation are also disclosed. Kits for practicing the invention singularly or in combination with and/or associated with preferred procedures are also disclosed.

Clotting cascade initiating apparatus and methods of use and methods of closing wounds

Wound closure methods and apparatuses are provided which utilize blood fluid by activating the clotting cascade of the blood fluid outside the body within a substantially enclosed sterile container then introducing coagulated blood to the wound site. Methods and apparatuses for providing ways of inhibiting anticoagulants and slowing fibrin clot degradation are also disclosed. Kits for practicing the invention singularly or in combination with and/or associated with preferred procedures are also disclosed.

Wound closure methods and apparatuses are provided which utilize blood fluid by activating the clotting cascade of the blood fluid outside the body within a substantially enclosed sterile container then introducing the blood fluid to the wound site. Methods and apparatuses for providing ways of inhibiting anticoagulants and slowing fibrin clot degradation are also disclosed. Kits for practicing the invention singularly or in combination with and/or associated with preferred procedures are also disclosed.

A wound closure apparatus and associated methods are provided which utilize blood fluid by activating the clotting cascade of blood fluid within a substantially enclosed sterile container then introducing the blood fluid to the wound site to complete clotting. An apparatus for providing ways of inhibiting anticoagulating agents and slowing fibrin clot degradation are also disclosed. Kits are also disclosed. The invention provides a clotting cascade initiation apparatus including a substantially enclosed sterile containment chamber within which an aliquot of blood fluid, either autologous or from donor sources, can be received and retained. In preferred embodiments, the sterile containment chamber further includes a heparin binding agent which will bind heparin and remove it from the blood fluid. In further embodiments, the containment chamber will also include a procoagulating agent, wherein a clotting cascade can be initiated when the blood fluid is accepted into the sterile containment chamber.

Wound closure methods and apparatus are provided which utilize blood fluid by activating the clotting cascade of the blood fluid outside the body within a substantially enclosed sterile container then introducing the blood fluid to the wound site to complete clotting. Methods and apparatus for providing ways of inhibiting anticoagulants and slowing fibrin clot degradation are also disclosed. Kits for practicing the invention singularly or in combination with and/or associated with preferred procedures are also disclosed.

Wound closure methods and apparatus are provided which utilize blood fluid by activating the clotting cascade of blood fluid outside the body within a substantially enclosed sterile container then introducing the blood fluid to the wound site to complete clotting. Methods and apparatus for providing ways of inhibiting anti-coagulating agents and slowing fibrin clot degradation are also disclosed. Kits for practicing the invention singularly or in combination with and/or associated with preferred procedures are also disclosed. The present invention provides improved methods of creating hemostasis or control of bleeding at the site of wounds, particularly wounds created in arteries during procedures employing percutaneous access. The invention preferably includes the steps of acquiring an aliquot of a patient's blood, i.e., autologous blood, removing a negatively charged anti-coagulating agent, preferably heparin, from the blood, and preferably initiating the blood's natural clotting cascades and transporting the thus treated blood to the site of the wound where the clotting cascade will be completed producing a clot at the wound site that will create a condition of hemostasis. The invention further provides a clotting cascade initiation apparatus including a substantially enclosed sterile containment chamber within which an aliquot of blood fluid, either autologous or from donor sources, can be received and retained. In preferred embodiments, the sterile containment chamber further includes a heparin binding agent which will bind heparin and remove it from the blood fluid. In further embodiments the containment chamber will also include a procoagulating agent, wherein a clotting cascade can be initiated when the blood fluid is accepted into the sterile containment chamber.

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Circle Pines, MN, United States of America

Karol Leon Nowakowski