TRAINER CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62/006,334 filed June 2, 2014, which is incorporated by reference herein, in its entirety.

FIELD OF THE INVENTION

[0002] The present invention relates generally to medical training. More particularly, the present invention relates to devices for training extracorporeal membrane oxygenation cardiopulmonary resuscitation and vascular cut down.

BACKGROUND OF THE INVENTION

[0003] In the event of a cardiac arrest, high quality cardio-pulmonary resuscitation (CPR) saves lives. However, in some cases even high quality CPR does not succeed in restarting circulation. In such a case where high-quality CPR does not succeed in restarting circulation, Extracorporeal Membrane Oxygenation (ECMO-CPR or ECPR) may be capable of re-establishing blood flow to vital organs. In the current state of the art, training for deploying ECMO during CPR and maintaining ECMO after CPR is provided through didactic, bedside clinical and hands-on training and simulation-based training. Recent advances in technology have been associated with development of high-fidelity mannequins. Unfortunately, the currently available high-fidelity mannequins do not allow cutting-edge training in ECPR.

[0004] Additionally, vascular access is a potentially life-saving procedure that allows for delivery of resuscitation medications, fluid, blood, blood products, and other therapeutics to an acutely ill or injured patient. Vascular access also allows a medical team to connect a critically ill patient to the artificial life-support called Extracorporeal Life-Support (ECLS) or Extracorporeal Membrane Oxygenator (ECMO) to support vital organ functions, described above. Vascular access can be gained using different methods. However, the two most commonly used techniques are the Seldinger technique using needle insertion and the vascular cut down technique. Generally, for placement of large-bore cannulas, vascular cut- down technique is superior to Seldinger technique, especially if performed by a trained practitioner.

[0005] Vascular cut-down procedure is a step-wise surgical procedure which involves the following steps:

• Placement of an incision on the skin at an anatomical landmark

• Dissection of the tissues to identify and isolate vein and artery

• Placement of loose ligatures around the vessel of interest

• Placement of a tiny incision on wall of the vessel to access lumen of the vessel

• Placement of a cannula through the lumen

• Placement of the ligature knots around the cannulas to secure them within the vessel

• Closure of the skin incision.

Unfortunately, there is no reusable, synthetic training device for a practitioner to use to practice and gain proficiency with the steps of and the entirety of vascular access technique.

[0006] Accordingly, there is a need in the art for a mannequin for training practitioners, first responders, and other healthcare professionals in ECPR and a need for a synthetic, reusable device for training practitioners in the vascular cut-down procedure. Given the interconnectedness of the two procedures the devices can be incorporated into one device or separate for the two purposes. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The accompanying drawings provide visual representations, which will be used to more fully describe the representative embodiments disclosed herein and can be used by those skilled in the art to better understand them and their inherent advantages. In these drawings, like reference numerals identify corresponding elements and:

[0008] FIG. 1 illustrates a schematic diagram of an ECPR mannequin, according to an embodiment of the present invention.

[0009] FIG. 2 illustrates a schematic diagram of a tissue block for practicing a cut down procedure, according to an embodiment of the present invention.

SUMMARY OF THE INVENTION

[0010] The foregoing needs are met, to a great extent, by the present invention which provides a device for simulating a vascular cut down procedure including an artificial tissue block. The device includes anatomical landmarks appropriate to a vascular cut down procedure, said anatomical landmarks being disposed on and within the artificial tissue block. The device also includes a vein disposed within the artificial tissue block and an artery disposed within the artificial tissue block. The artificial tissue block is configured to allow for incision, dissection, identification and isolation of the vein and artery within the artificial tissue block, performance of cut-down of the vein and artery to insert cannulas, lines, and monitoring devices in the vessels, and insertion of ligatures around the vessels after placement of cannulas, lines, or monitoring devices.

[0011] In accordance with an aspect of the present invention, the artificial tissue block is formed from a material configured to approximate the properties of tissue. The vein and artery are also formed from a material configured to approximate the properties of tissue. [0012] In accordance with another aspect of the present invention, a method for training a practitioner on a vascular cut down procedure includes providing an artificial tissue block having anatomical landmarks appropriate to a vascular cut down procedure, said anatomical landmarks being disposed on and within the artificial tissue block, a vein disposed within the artificial tissue block, and an artery disposed within the artificial tissue block. The method also includes teaching placement of an incision on the skin at a certain anatomical landmark of the anatomical landmarks of the tissue block and teaching dissection of the artificial tissue to identify and isolate the vein and the artery. The method includes teaching placement of loose ligatures around the vein or artery of interest and teaching placement of a tiny incision on a wall of the vein or artery of interest to access the lumen of the vein or artery.

Additionally, the method includes teaching placement of the cannula through the lumen, teaching placement of the ligature knots around the cannulas to secure them within the vessel, and teaching closure of the skin incision.

[0013] In accordance with another aspect of the present invention, the method includes forming the artificial tissue block from a self-healing material, such that the method for training can be repeated using the same tissue block.

[0014] In accordance with yet another aspect of the present invention a device for training Extracorporeal Membrane Oxygenation includes a high fidelity mannequin and an artificial tissue block. The device also includes anatomical landmarks appropriate to a vascular cut down procedure, said anatomical landmarks being disposed on and within the artificial tissue block. The device includes a vein disposed within the artificial tissue block and an artery disposed within the artificial tissue block. The artificial tissue block is configured to allow for incision, dissection, identification and isolation of the vein and artery within the artificial tissue block, performance of cut-down of the vein and artery to insert cannulas, lines, and monitoring devices in the vessels, and insertion of ligatures around the vessels after placement of cannulas, lines, or monitoring devices.

[0015] In accordance with still another aspect of the present invention, the device includes an artificial, heart-like thoracic pump and tube system within the high fidelity mannequin. The artificial tissue block includes a first artificial tissue block configured to provide vascular cut down training in a neck of the mannequin, and the mannequin is configured to receive the first artificial tissue block in the neck region. The artificial tissue block also includes a second artificial tissue block configured to provide vascular cut down training in a groin, and the mannequin is configured to receive the second artificial tissue block in the groin region. The device can also include a tube and pump system configured to mimic physiology of a patient. The tube and pump system is configured to mimic pathophysiologic states in a patient who is on ECMO. Additionally, these pathophysiologic states can take the form of at least one chosen from a group consisting of increased cardiac output, decreased cardiac output, hypovolemia, venous clots, arterial clots, and increase in afterload.

[0016] In accordance with yet another aspect of the present invention, the artificial tissue block is formed from a gelatin. A preferred amount of gelatin is 0.5 oz. of gelatin. The artery is formed from plastic tubing as is the vein. The artery is filled with a liquid configured to mimic oxygenated blood, and the vein is filled with a liquid configured to mimic deoxygenated blood.

DETAILED DESCRIPTION

[0017] The presently disclosed subject matter now will be described more fully hereinafter with reference to the accompanying Drawings, in which some, but not all embodiments of the inventions are shown. Like numbers refer to like elements throughout. The presently disclosed subject matter may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Indeed, many modifications and other embodiments of the presently disclosed subject matter set forth herein will come to mind to one skilled in the art to which the presently disclosed subject matter pertains having the benefit of the teachings presented in the foregoing descriptions and the associated Drawings. Therefore, it is to be understood that the presently disclosed subject matter is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims.

[0018] The present invention is directed to a device for training practitioners in

Extracorporeal Membrane Oxygenation CPR (ECMO-CPR or ECPR). The device takes the form of a high fidelity mannequin having a detachable and replaceable vascular cut-down neck and groin tissue blocks. The device also includes an artificial, heart-like thoracic pump and tube system within the chest to allow actual placement of ECMO cannulas through the neck or groin. The tube system in the chest is connected to vessels in the neck and groin tissue blocks. The device is configured to allow for simulated blood flow in and out of ECMO cannulas. It also allows for manipulation of blood flow within the thoracic pump and tube system to mimic certain pathophysiologic changes such as but not limited to

hypovolemia, low or increased cardiac output, and development of clot or air embolus in the system.

[0019] FIG. 1 illustrates a schematic diagram of an ECPR mannequin according to an embodiment of the present invention. The ECPR mannequin 1 can take the form of a high fidelity ECPR mannequin. The ECPR mannequin 1 includes a tissue block 2 positioned in a neck 4 of the ECPR mannequin 1. The ECPR mannequin 1 also includes an artery 6 and a vein 8. The artery 6 and the vein 8 extend from a body of the ECPR mannequin 1 into the tissue block 2. The artery 6 and the vein 8 can be filled with colored liquid in order to approximate the blood in the artery 6 and the vein 8. The ECPR mannequin 1 also includes a venous system occlusion systemlO and an arterial system occlusion system 12. These two systems are coupled to a pump 22 with venous system occlusion tube 18 and arterial system occlusion tube 20, respectively. A body-wall part of the arterial venous occlusion system sits at the body- wall of the ECPR mannequin 1. Additionally, there is a mechanical pump 16 coupled to a proximal end of both the artery 6 and the vein 8.

[0020] The built-in tube and pump system to approximate the artery and vein mimics physiology. This system also allows artificial creation of pathophysiology states which occur in a patient who is managed on ECMO. These pathophysiologic states include but are not limited to increased or decreased cardiac output, hypovolemia, venous or arterial clots, and increase in afterload.

[0021] FIG. 2 illustrates a schematic diagram of a tissue block for placement in an ECPR mannequin according to an embodiment of the present invention. As illustrated in FIG. 2, the tissue block 2 includes an artery 6 and a vein 8. The tissue block is formed from a material that is configured to approximate cutting through human tissue, which will be described herein in further detail. The artery 6 and the vein 8 can be formed from plastic, rubber, or any other suitable material configured to approximate arterial and venous walls. The artery 6 and the vein 8 are filled with colored liquid to approximate being filled with oxygenated and unoxygenated blood. The vein 8 is filled with blue colored liquid and the artery 6 is filled with red colored liquid. [0022] Further, the present invention is directed to a device for training practitioners in the vascular cut down procedure. The device is an artificial tissue block with appropriate anatomical landmarks, vein, and artery included in the block. The device allows a learning practitioner to make an incision on the artificial skin, dissect the artificial tissue, identify and isolate the vein and artery within the block, perform a cut-down of the vessels to insert cannulas, lines, and monitoring devices in the vessels and insert ligatures around the vessels after placement of cannulas, lines or monitoring devices. The device can also be formed from a material configured to approximate the properties of tissue. The vascular cut-down block can be incorporated into the ECMO training device, or can be offered as a separate device for training in vascular cut down technique.

[0023] Each vascular cut down training insert can be formed from a material that approximates the texture and density of tissue. It is possible that in some embodiments the material can be self-healing in order to allow for reuse. By way of example, the insert can be formed from a gelatin. To create a cut-down trainer, two packets of gelatin are used per tissue block insert, or approximately 0.5 oz. of gelatin. ¾ cup of water is poured slowly into a 2" x 4" container. While a 2" x 4" container is described herein, any suitable size for forming the tissue block insert can be used. The gelatin is stirred gently to eliminate bubbles and mix the ingredients uniformly. It is preferable to pour the water into the gelatin to avoid bubbles and create a more uniform consistency. The tissue insert block is refrigerated for 3-4 hours. Next, a sink is filled with hot water. The tissue block insert is placed into the water, such that it floats. After 15 minutes the mixture melts. A second container of equivalent dimension is greased and the melted gel mixture is poured into the second container gently, to avoid creating bubbles. The tissue block insert needs to be allowed to set for 12 hours. After that time, the gel will be ready to use and will slide out of the container for placement in the ECMO mannequin or for use as a separate vascular cut-down trainer. Tubing and other artificial landmarks, including nerves, can be positioned in the gel to approximate vasculature either during formation of the tissue block insert, or after the gel is formed. Liquid with coloring can be placed into the tubes to approximate blood, for training purposes. This way the trainee will have the most realistic training experience possible. The tubing can be formed from rubber, plastic, a self-healing material, or any other suitable material for approximating vasculature and other anatomical landmarks.

[0024] Residents can use the ECMO mannequin and tissue cut down blocks for practice. Attending physicians can use the devices to run code or other simulations with the attending inserting the ECMO cannula. Other persons essential for running a code can be present to practice where to stand and how to best assist in the code procedure. Other parties that may be present include techs, nurses, pharmacy personnel, and respiratory therapists. In some instances the mannequin can be created to approximate children that are approximately 5-8 years of age. [0025] The many features and advantages of the invention are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention.

Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.