DOUBLE DISC BASED ACCESS AND ANCHOR DEVICE WITH SHAPE MEMORY PROPERTIES TECHNICAL FIELD

[0001] Embodiments are generally related but not restricted to anchoring devices for cannulation of cardiac chambers and blood vessels. Embodiments are further related to an improved cannula insertion technique. Embodiments are also related method of constructing anchoring devices. Embodiments are particularly related to a double disc based anchoring device made of self- expanding, nitinol wire mesh with ‘shape- memory’ properties.

BACKGROUND OF THE INVENTION

[0002] Heart failure is a cardiovascular condition in which the heart fails to sufficiently supply the body with the oxygen rich blood that the body requires. For example, congestive heart failure (CHF) is heart failure accompanied by a build-up of fluid pressure in the circulation. Such critical medical conditions require immediate diagnostic and treatment procedures to handle an emergency. [0003] Mechanical blood pump devices such as for example, but not limited to, ECMO or ventricular assist devices are commonly used to support the function of the heart and/or lungs during the surgery. Blood is withdrawn from the patient via uptake cannula placed into the vena cavae and atria or ventricles of the heart and pumped back into the pulmonary artery and aorta via return cannula.

[0004] The conventional prior art of using cannula involve suturing a graft with sutures or inserting a cannula and securing it in place using sutures which needs surgical skill and the need for side biting exclusion clamps. Clamps are not always safe as they can slip, injure friable vessels and in atherosclerotic and calcified aorta leading to the risk of atheroembolism.

[0005] Based on the foregoing a need therefore exists for an improved cannula placement viz a double disc based anchoring device made of self- expanding, nitinol wire mesh with ‘shape- memory’ properties, as discussed in greater detail herein. This will avoid using side biting clamps and incisions and can be inserted with a minimally invasive approach.

SUMMARY OF THE INVENTION

[0006] The following summary is provided to facilitate a clear understanding of the new features in the disclosed embodiment, and it is not intended to be a full, detailed description. A detailed description of all the aspects of the disclosed invention can be understood by reviewing the full specification, the drawing and the claims and the abstract, as a whole.

[0007] One objective of the present invention relates to provide an improved device and method for cannulation of cardiac chambers or blood vessels.

[0008] Another objective of the present invention is to provide an improved technique of cannula insertion which is fast, easy and secure.

[0009] Further objective of the present invention is to provide double disc based anchoring device made of self- expanding, nitinol wire mesh with ‘shapememory’ properties. [0010] The aforementioned aspects along with the objectives and the advantages can be achieved as described herein. A double disc based anchoring device (100) made of self- expanding, nitinol wire mesh with ‘shape- memory’ properties, is disclosed. The device (100) comprises two discs (110 and 120) [with a diameter of 9.5mm which goes through an 18F sheath] connected by a throat/collar. The inner disc (110) with a central lumen (130) is designed to be inside a cardiac chamber which contains blood and is connected to the outer disc (120) with a lumen (140) by a tubular collar (150) attached between the two discs (110 and 120) which engages the wall of the desired cardiac structures such as for example, the wall of the pulmonary artery or aorta or left and right atrium ventricle.

[0011] The tubular collar (150) is configured to allow blood to flow through its lumen. The tubular collar (150) is coated with e-PTFE membrane which may be collapsible to facilitate delivery of the device (100).

[0012] The outer disc (120) of the anchoring device (100) has a cylindrical elongation, the end of which is provided with a haemostatic valve made of Silicon. The anchoring device (100) can then be connected to a cannula of desired length and can carry blood from and to the heart. The outer to inner diameter ratio of the discs (110 and 120) will be 0.8 to ensure stability of the device (100) and not to slip out, obviating the need for a snugger. If bleeding is anticipated at the entry into the vessel, an appropriately designed sewing cuff is incorporated.

Thermal bonding of the PTFE membrane or other coatings in the interior of device (100) ensures that the device (100) is impermeable to blood. The device

(100) is intended to be implanted by direct puncture into the cardiac great vessels using hybrid catheterization techniques as well as direct anchoring into cardiac structures by surgical implantation.

BRIEF DESCRIPTION OF DRAWINGS

[0001] The drawings shown here are for illustration purpose and the actual system will not be limited by the size, shape, and arrangement of components or number of components represented in the drawings.

[0002] FIG. 1 illustrates a graphical representation of the double disc based anchoring device (100) made of self- expanding, nitinol wire mesh with ‘shapememory’ properties, in accordance with the disclosed embodiments;

[0003] FIG. 2 illustrates a graphical representation of a sheath and introducer system (200) wherein the distal end of the sheath is embedded with a radio opaque marker which retracts after deployment to give a ridge in the distal end which in turn acts as support for the retention cylinder of the device, in accordance with the disclosed embodiments;

[0004] FIG. 3 illustrates a graphical representation (300) illustrating the sheath in place after deployment with the distal radio-opaque end forming the retention ridge wherein the proximal end shows the deairing system and inflatable valves, in accordance with the disclosed embodiments; and

[0005] FIG. 4 illustrates a graphical representation of the anchoring device (100) in place anchored to the vessel/cardiac muscle with the retention cylinder firmly stabilizing the device (100) and the sheath, in accordance with the disclosed embodiments;

[0006] FIG. 5 illustrates a graphical representation (500) the anchoring device (100) configured on a myocardium (heart muscle) to illustrate the working of the invention, in accordance with the disclosed embodiments; and

[0007] FIG. 6 illustrates a front view (600) of the anchoring device (100), in accordance with the disclosed embodiments.

DETAILED DESCRIPTION

[0008] The principles of operation, design configurations and evaluation values in these non-limiting examples can be varied and are merely cited to illustrate at least one embodiment of the invention, without limiting the scope thereof.

[0013] The proposed invention teaches an improved double disc-based anchoring device (100) made of self- expanding, nitinol wire mesh with ‘shapememory’ properties, is disclosed. The device (100) comprises two discs (110 and 120) connected by a throat/collar. The inner disc (110) with a central lumen (130) is designed to be inside a cardiac chamber which contains blood and is connected to the outer disc (120) with a lumen (140) by a tubular collar (150) attached between the two discs (110 and 120) which engages the wall of the desired cardiac structures such as for example, the wall of the pulmonary artery or aorta.

[0014] The tubular collar (150) is configured to allow blood to flow through its lumen. The tubular collar (150) is coated with e-PTFE membrane which may be collapsible to facilitate delivery of the device (100). [0015] The outer disc (120) of the anchoring device (100) has a cylindrical elongation, the end of which is provided with a haemostatic valve made of Silicon. The anchoring device (100) can then be connected to a cannula of desired length and can carry blood from and to the heart. The outer to inner diameter ratio of the discs (110 and 120) will be 0.8 to ensure stability of the device (100) and not to slip out, obviating the need for a snugger. If bleeding is anticipated at the entry into the vessel, an appropriately designed sewing cuff is incorporated. Thermal bonding of the PTFE membranes in the interior of device (100) ensures that the device (100) is impermeable to blood. The device (100) is intended to be implanted by direct puncture into the cardiac great vessels using hybrid catheterization techniques as well as direct anchoring into cardiac structures by surgical implantation.

[0009] Technique of implantation: Using standard seidinger technique, access the target cardiac chamber or great vessel with a needle. Insert appropriate guide wire through the needle, remove the needle and leave the guide wire in situ. Advance the dilator/valved sheath combination over the guide wire. Remove the dilator, aspirate and flush the side arm attached with the sheath. Insert the selected anchoring device through the valved sheath.

[0010] The introducer system consists of a dilator and sheath, with a hemostasis valve and side port on the proximal end of the sheath assembly. The distal end of the valved sheath has nitinol tip to enable automatic retention of the anchoring device (100). [0011] Once the introducer is removed, the system will remain in place with stay sutures. Valved sheath has 3 mm inflexing ridge. Introducer sheath has radiopaque band/tip incorporated within sheath tip to identify location of sheaths distal tip. The introducer system also has optimal tapering design at the tip of the sheath and dilator for smooth penetration. Cross-cut haemostasis valve effectively avoids blood reflux and air aspiration. Snap-on/click-off dilator lock prevents dilator back-out during insertion and allows one-hand unlocking. The silicone-coated valve and smooth inner surface promote device passage. For delivery to the end user, anchoring device (100) needs standard pusher type delivery cable and sheath depending upon the size of device (100).

[0012] A flexible waist in the center of anchoring device (100) connects the two discs (110 and 120) and has a centrally located fenestration. A welded ball structure (ball-connector) located on the device’s proximal disc serves as an adapter for a pusher during deployment. The implanted anchoring device (100) conforms completely to the cardiac wall or large vessel, leaving the central connection with pre-fixed diameter.

[0016] In general, the anchoring devices are characterized by the ease of handling, the quality of self-centering following deployment in cardiac muscle, and retrievability prior to decoupling and placement. Also, the anchoring device should be available with different waist diameters, waist heights and disc diameters to maintain patency as well as for positioning cannula of different sizes.

The proposed invention address the above key characteristics of an efficient anchoring device with made of self- expanding, nitinol wire mesh with ‘shapememory’ properties.

[0013] It will be appreciated that variations of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Also, that various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the following claims.