Impedance-based tissue capture confirmation system for shunt devices

Abstract

Impedance-based tissue capture confirmation system for shunt devices A device for determining tissue capture by a shunt device includes a delivery catheter and a shunt device positioned on the delivery catheter. The shunt device is configured to be inserted into a tissue wall puncture and includes a central flow tube extending from a first axial end to a second axial end, a first distal arm attached to the first axial end of the central flow tube, and a first proximal arm attached to the second axial end of the central flow tube. The first distal arm and the first proximal arm are configured to capture the tissue wall between them, and the delivery catheter includes a first conductive wire and a second conductive wire. The first conductive wire is electrically connected to the shunt device, and the second conductive wire is disconnected from the shunt device.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 502,913, filed on May 17, 2023, entitled "IMPEDANCE TISSUE CONFIRMATION SYSTEM", the disclosure of which is hereby incorporated by reference in its entirety.

[0002] The present disclosure generally relates to implantable devices, and more specifically to confirming the placement of cardiovascular shunt devices.

Background Art

[0003] For example, a shunt device can be positioned in the heart to shunt blood between the left atrium and the right atrium to reduce the pressure in the left atrium. The pressure in the left atrium can increase due to abnormal heart conditions caused by age and / or disease. For example, a shunt device can be used to treat patients with heart failure (also known as congestive heart failure). The shunt device can be positioned in the atrial septum between the left atrium and the right atrium to shunt blood from the left atrium into the right atrium, and thus can reduce the pressure in the left atrium.

Summary of the Invention

[0004] In one embodiment, a device for determining tissue capture by a shunt device includes a delivery catheter and a shunt device positioned on the delivery catheter. The shunt device is configured to be inserted into a tissue wall puncture and includes a central flow tube extending from a first axial end to a second axial end, a first distal arm attached to the first axial end of the central flow tube, and a first proximal arm attached to the second axial end of the central flow tube. The first distal arm and the first proximal arm are configured to capture the tissue wall between them. The delivery catheter includes a first conductive wire and a second conductive wire. The first conductive wire is electrically connected to the shunt device, and the second conductive wire is disconnected from the shunt device.

[0005] In another embodiment, a method for determining tissue capture of a shunt device includes deploying a first distal arm of the shunt device to puncture a tissue wall, moving a first proximal arm toward the first distal arm, positioning the first proximal arm in an deployed position relative to the first distal arm, providing an AC signal to a first electrode, determining the electrical impedance between the first electrode and a second electrode, and determining, based on the electrical impedance, whether tissue has been captured between the first distal arm and the first proximal arm. The shunt device includes a central drainage tube, the first distal arm is positioned at the first axial end of the central drainage tube, and the first proximal arm is positioned at the second axial end of the central drainage tube. The first distal arm and the first proximal arm are configured to capture a tissue wall between them. The first distal arm is free to engage with a tissue wall when deployed. The deployed position of the first proximal arm is configured to capture the tissue wall between the first distal arm and the first proximal arm when a tissue wall is present. One of the first electrode and the second electrode is positioned adjacent to the first proximal arm, and the other of the first electrode and the second electrode is located on the first distal arm.

[0006] This summary is provided as an example only and is not limiting. Other aspects of this disclosure will be understood in light of the entire disclosure, including the full text, claims, and accompanying drawings. [Brief explanation of the drawing]

[0007] Anatomical structure of the heart (H) and vascular structure (V) [Figure 1] Figure 1 is a schematic diagram of the heart and vascular structure. [Figure 2] Figure 2 is a schematic cross-sectional view of the heart. Shunt device 100, and 100' [Figure 3A] Figure 3A is a perspective view of the shunt device. [Figure 3B] Figure 3B is a side view of the shunt device. [Figure 4] Figure 4 is a perspective view of the configured shunt device. [Figure 5] Figure 5 is a perspective view of the shunt device, including the sensor. Delivery catheter 200 [Figure 6] Figure 6 is a side view of the delivery catheter. [Figure 7A] Figure 7A is a side view of the distal portion of the delivery catheter in its sheathed state. [Figure 7B] Figure 7B is a side view of the distal portion of the delivery catheter in its non-sheathed state. Delivery method 300 [Figure 8A] Figure 8A is a flowchart illustrating the steps for creating a puncture in the tissue wall between the coronary sinus and the left atrium. [Figure 8B] Figure 8B is a flowchart illustrating the steps for implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9A] Figure 9A is a schematic diagram illustrating the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9B] Figure 9B is a schematic diagram illustrating the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9C]Figure 9C is a schematic diagram illustrating the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9D] Figure 9D is a schematic diagram illustrating the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9E] Figure 9E is a schematic diagram illustrating the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9F] Figure 9F is a schematic diagram illustrating the steps involved in implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9G] Figure 9G is a schematic diagram illustrating the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9H] Figure 9H is a schematic diagram illustrating the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9I] Figure 9I is a schematic diagram illustrating the steps of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9J] Figure 9J is a schematic diagram illustrating the steps of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9K] Figure 9K is a schematic diagram illustrating the steps of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9L] Figure 9L is a schematic diagram illustrating the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9M] Figure 9M is a schematic diagram illustrating the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9N] Figure 9N is a schematic diagram illustrating the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9O] Figure 9O is a schematic diagram illustrating the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9P]FIG. 9P is a schematic diagram showing the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 9Q] FIG. 9Q is a schematic diagram showing the step of implanting a shunt device into the tissue wall between the coronary sinus and the left atrium. [Figure 10A] FIG. 10A is a simplified perspective view of a shunt device properly seated between the left atrium and the coronary sinus. [Figure 10B] FIG. 10B is a simplified perspective view of a shunt device improperly seated between the left atrium and the coronary sinus. [Figure 10C] FIG. 10C is a simplified perspective view of a shunt device embodied in the left atrium. Devices and methods for confirming tissue capture (FIGS. 11 - 15) [Figure 11] FIG. 11 is a simplified view of a device for determining tissue capture of a shunt device during the process of determining tissue capture, and tissue capture is confirmed. [Figure 12] FIG. 12 is a simplified view of the device of FIG. 11 during the process of determining tissue capture, and tissue capture is not confirmed. [Figure 13] FIG. 13 is a simplified view of the handle of the device of FIG. 11. [Figure 14A] FIG. 14A is an enlarged view of a portion 14A of FIG. 11. [Figure 14B] FIG. 14B is an enlarged view of a portion 14B of FIG. 11. [Figure 15] FIG. 15 is a simplified view of a device for determining tissue capture of a shunt device during deployment. [Figure 16] FIG. 16 is an enlarged view of a portion of FIG. 15.

[0008] The drawings specified above, which are described in embodiments of the present invention, also describe other embodiments as described in the detailed description. In all cases, this disclosure presents the invention by representation, not limitation. Numerous other modifications and embodiments, which are within the scope and spirit of the principles of the embodiments of the present invention, can be devised by those skilled in the art. The drawings do not have to be drawn to scale, and the uses and embodiments of the present invention may include features, steps, and / or components not specifically shown in the drawings. [Modes for carrying out the invention]

[0009] Anatomical structure of the heart (H) and vascular structure (V) (Figures 1-2) Figure 1 is a schematic diagram of the heart H and vascular structure V. Figure 2 is a cross-sectional view of the heart H. Figures 1 and 2 will be examined together. Figures 1 and 2 show the heart H, vascular structure V, right atrium RA, right ventricle RV, left atrium LA, left ventricle LV, superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV (shown in Figure 1), pulmonary valve PV (shown in Figure 1), pulmonary artery PA (shown in Figure 1), pulmonary vein PVS, mitral valve MV, aortic valve AV (shown in Figure 1), aorta AT (shown in Figure 1), coronary sinus CS (shown in Figure 2), Thebesius valve BV (shown in Figure 2), atrial septum IS (shown in Figure 2), and fossa ovale FO (shown in Figure 2).

[0010] The heart H is the human heart, which receives blood from the vascular system V and delivers blood to the vascular structure V. The heart H includes four chambers, namely the right atrium RA, the right ventricle RV, the left atrium LA, and the left ventricle LV.

[0011] The right side of the heart (H), including the right atrium (RA) and right ventricle (RV), receives deoxygenated blood from the vascular structure (V) and pumps it to the lungs. Blood flows into the right atrium (RA) from the inferior vena cava (IVC) and the superior vena cava (SVC). The right atrium (RA) pumps the blood through the tricuspid valve (TV) to the right ventricle (RV). The blood is then pumped by the right ventricle (RV) through the pulmonary valve (PV) to the pulmonary artery (PA). From the pulmonary artery (PA), the blood flows into the smaller arteries, delivering deoxygenated blood to the lungs via the pulmonary circulation system. The lungs can then supply oxygen to the blood.

[0012] The left side of the heart, including the left atrium (LA) and left ventricle (LV), receives oxygenated blood from the lungs and pumps it to the body. Blood flows into the left atrium (LA) from the pulmonary veins (PVS). The left atrium (LA) pumps the blood through the mitral valve (MV) to the left ventricle (LV). The blood is then pumped by the left ventricle (LV) through the aortic valve (AV) to the aorta (AT). From the aorta (AT), the blood flows into the arteries, where it is oxygenated and delivered to the body via the systemic circulatory system.

[0013] Blood is further received in the right atrium (RA) from the coronary sinus (CS). The coronary sinus (CS) collects deoxygenated blood from the myocardium and delivers it to the right atrium (RA). The Thebesius valve (BV) is a semicircular fold of tissue in the right atrium (RA) at the opening of the coronary sinus (CS). The coronary sinus (CS) wraps around the heart (H), as shown in Figure 2, and a portion extends below it along the bed of the left atrium (LA) and to the right of the mitral valve (MV). The diameter of the coronary sinus (CS) increases as it connects to the right atrium (RA).

[0014] The atrial septum (IS) and fossa ovale (FS) are also shown in Figure 2. The atrial septum (IS) is the wall separating the right atrium (RA) from the left atrium (LA). The fossa ovale (FS) is a recess in the atrial septum (IS) within the right atrium (RA). At birth, a congenital structure called the foramen ovale is located within the atrial septum (IS). The foramen ovale is an opening in the atrial septum (IS) that closes immediately after birth, forming the fossa ovale (FS). The foramen ovale functions as a functional shunt within the uterus, primarily allowing blood from the right atrium (RA) to move to the left atrium (LA) and then circulate throughout the body. This is necessary within the uterus because the lungs are in a fluid sac and do not oxygenate the blood. Rather, oxygenated blood is received from the mother. Oxygenated blood from the mother flows from the placenta, through the umbilical vein and ductus venosus, into the inferior vena cava (IVC). The oxygenated blood then moves through the inferior vena cava (IVC) to the right atrium (RA). The opening of the inferior vena cava (IVC) in the right atrium (RA) is positioned to direct oxygenated blood through the right atrium (RA) and the foramen ovale (LA) to the left atrium (LA). The left atrium (LA) can then pump the oxygenated blood to the left ventricle (LV), which pumps the oxygenated blood to the aorta (AT) and the systemic circulatory system. This allows the pulmonary circulatory system to be bypassed within the womb. At birth, respiration expands the lungs, blood begins circulating through the lungs for oxygenation, the foramen ovale closes, and the fovea ovale (FS) forms.

[0015] A shunt device is positioned within the heart (H) and can shunt blood between the left atrium (LA) and the right atrium (RA). The left atrium (LA) may experience elevated pressure due to abnormal cardiac conditions. It is hypothesized that patients with elevated pressure in the left atrium (LA) may benefit from a reduction in left atrium (LA) pressure. In these patients, a shunt device can be used to shunt blood from the left atrium (LA) to the right atrium (RA), thereby reducing the blood pressure in the left atrium (LA) and consequently decreasing the systolic preload of the left ventricle (LV). Reducing left atrium (LA) pressure further reduces back pressure in the pulmonary circulation and lowers the risk of pulmonary edema.

[0016] For example, a shunt device can be used to treat patients with heart failure (also known as congestive heart failure). In patients with heart failure, the heart is unable to pump blood sufficiently to the extent it should. Heart failure can affect the right and / or left sides of the heart. Diastolic heart failure (also known as heart failure with preserved ejection fraction) refers to heart failure that occurs when the left ventricle is rigid (has reduced compliance) and has difficulty relaxing properly and filling with blood. This leads to elevated end-diastolic pressure, which causes increased pressure in the left atrial LA. There are very few effective treatments available for diastolic heart failure, if any. Other examples of abnormal cardiac conditions that cause elevated pressure in the left atrial LA include left ventricular systolic dysfunction and valvular disease.

[0017] A septal shunt device (also called an atrial septal shunt device) is positioned within the atrial septum (IS) to shunt blood directly from the left atrium (LA) to the right atrium (RA). Typically, the septal shunt device is positioned in the fovea ovale (FS), as the fovea ovale (FS) is a thinner area of ​​tissue within the atrial septum (IS) where the two atria share a common wall. If the pressure in the right atrium (RA) exceeds the pressure in the left atrium (LA), the septal shunt device may allow blood to flow from the right atrium (RA) to the left atrium (LA). This carries a risk of paradoxical stroke (also known as paradoxical embolism) because an embolus can travel from the right atrium (RA) to the left atrium (LA), and then to the aorta (AT) and systemic circulation.

[0018] A shunt device can also be a left atrium-to-coronary sinus shunt device positioned in the tissue wall between the left atrium (LA) and the coronary sinus (CS), where these two structures are in close proximity. A left atrium-to-coronary sinus shunt device moves blood from the left atrium (LA) into the coronary sinus (CS), and then delivers the blood to the right atrium (RA) via the Thebesius valve (BV) and the natural orifice of the coronary sinus (CS). The coronary sinus (CS) can act as an additional compliance chamber when using a left atrium-to-coronary sinus shunt device. A left atrium-to-coronary sinus shunt device provides further increased protection against paradoxical stroke because the blood must travel retrogradely from the right atrium (RA) through the coronary sinus (CS) before entering the left atrium (LA). Furthermore, a left atrium-to-coronary sinus shunt device also provides significant protection against the right atrium (RA) compared to a left atrium-LA shunt. This is because, even in this case, the blood needs to flow retrogradely from the right atrium (RA) through the coronary sinus (CS) before entering the left atrium (LA).

[0019] Shunt devices 100 and 100' (Figures 3A-5) Figure 3A is a perspective view of the shunt device 100. Figure 3B is a side view of the shunt device 100. Figure 4 is a perspective view of the shunt device 100 in a folded configuration. Figures 3A, 3B, and 4 will be described together. The shunt device 100 includes a body 102 formed from a support column 104 and an opening 106. The body 102 includes a central flow tube 110, a flow channel 112, and an arm 114. The shunt device 100 also includes a tissue capture feature 116. The central flow tube 110 has a side section 120 (including side sections 120A and 120B), an end section 122 (including end sections 122A and 122B), a first axial end section 124, and a second axial end section 126. Arm 114 includes a distal arm 130 (including distal arm 130A and distal arm 130B) and a proximal arm 132 (including proximal arm 132A and proximal arm 132B). The distal arm 130 has an end portion 134 (including end portions 134A and end portions 134B). The proximal arm 132 has an end portion 136 (including end portions 136A and end portions 136B). Figure 3B further shows the gap G, the horizontal reference plane HP, the vertical reference axis RA, the central axis CA, the inclination angle θ, the first angle α, and the second angle β.

[0020] Shunt device 100 is a cardiovascular shunt. Shunt device 100 is shown in its expanded configuration in Figures 3A-3B. Shunt device 100 is made of a superelastic material that can be compressed within a catheter for delivery into the body, and then retains its relaxed or expanded shape when released from the catheter. For example, shunt device 100 may be made of a shape memory material such as Nitinol (nickel-titanium alloy). Shunt device 100 is shown in its compressed configuration in Figure 4. Upon delivery into the body, shunt device 100 returns to its relaxed or expanded shape. Shunt device 100 may be sterilized before delivery into the body. Shunt device 100 has a body 102 formed from interconnected struts 104. The opening 106 of the body 102 is defined by the struts 104. The main body 102 of the shunt device 100 is formed from a support column 104 to increase the flexibility of the shunt device 100, allowing it to be compressed and expanded.

[0021] The main body 102 includes a central drainage tube 110 that forms the central portion of the shunt device 100. The central drainage tube 110 has a tubular cross-section but is formed by a support column 104 and an opening 106. The central drainage tube 110 can be positioned within a tissue wall puncture or opening and can hold the puncture open. The flow path 112 is an opening that extends through the central drainage tube 110. The flow path 112 is the pathway through which blood flows when the shunt device 100 is implanted in the body. The arm 114 extends from the central drainage tube 110. The arm 114 extends outward from the central drainage tube 110 when the shunt device 100 is in an expanded configuration. The arm 114 holds the shunt device 100 in place within the tissue wall when the shunt device 100 is implanted in the body.

[0022] When the shunt device 100 is implanted in the tissue wall between the left atrium and the coronary sinus of the heart, the central drainage vessel 110 holds the puncture open, thereby allowing blood to flow from the left atrium to the coronary sinus through the channel 112. The struts 104 of the central drainage vessel 110 form various grids or cages around the central drainage vessel 110 that are sufficient to hold the puncture in the tissue wall open. The central drainage vessel 110 extends from a first axial end 124 to a second axial end 126. The central drainage vessel 110 is designed to have an axial length measured from the first axial end 124 to the second axial end 126, which approximates the thickness of the tissue wall between the left atrium and the coronary sinus. When the shunt device 100 is implanted in the tissue wall between the left atrium and the coronary sinus, the first axial end 124 may face the left atrium (i.e., the left atrial side of the shunt device 100), and the second axial end 126 may face the coronary sinus (i.e., the coronary sinus side of the shunt device 100). In other embodiments, the orientation of the first axial end 124 and the second axial end 126 can be reversed.

[0023] The central flow pipe 110 has sides 120 and ends 122. Sides 120A and 120B form opposing sides of the central flow pipe 110. Ends 122A and 122B form opposing ends of the central flow pipe 110. Ends 122A and 122B each extend between side 120A and side 120B, connecting to them to form a substantially circular or elliptical opening that defines the flow path 112. Sides 120 and 122 form a tubular grid for the central flow pipe 110. The support columns 104 of the central flow pipe 110 define an opening 106 in the central flow pipe 110. In some embodiments, the opening 106 may be substantially parallelogram-shaped. In other embodiments, the opening 106 may be any regular or irregular shape as desired. For example, the support columns 104 of the side portion 120 can form an array of parallelogram-shaped openings 106 on the side portion 120. The support columns 104 of the end portion 122 can form an opening 106 on the end portion 122. The support columns 104 of the arm 114 can form an opening 106 on the arm 114.

[0024] As shown in Figure 3B, the central flow tube 110 is angled with respect to a horizontal reference plane HP, which extends through the shunt device 100. The horizontal reference plane HP is generally in the plane of the tissue wall immediately adjacent to the shunt device 100 when the shunt device 100 is implanted in the tissue wall. The end 122 is similarly angled with respect to the horizontal reference plane HP. As shown in Figure 3B, the vertical reference axis RA is perpendicular to the horizontal reference plane HP. As shown in Figure 3B, the central axis CA is the axis passing through the center of the central flow tube 110 and the flow channels 112. The central axis CA extends through the central flow tube 110 at an angle θ with respect to the vertical reference axis RA. Thus, the central axis CA defines the angle, or inclination, of the central flow tube 110 with respect to the vertical reference axis RA (and the horizontal reference plane HP). The end 122 of the central flow tube 110 extends parallel to the central axis CA.

[0025] The arms 114 of the shunt device 100 include two distal arms 130 and two proximal arms 132. In some embodiments, the individual arms of the distal arms 130 and / or proximal arms 132 may be formed from a plurality of segmented arm portions. The arms 114 extend outward from the end 122 of the central flow tube 110 when the shunt device 100 is in an extended configuration. The distal arm 130A is connected to the end 122A and extends away from the end 122A, and the distal arm 130B is connected to the end 122B and extends away from the end 122B. The proximal arm 132A is connected to the end 122A and extends away from the end 122A, and the proximal arm 132B is connected to the end 122B and extends away from the end 122B. When the shunt device 100 is implanted in the tissue wall between the left atrium and the coronary sinus, the distal arm 130 is positioned in the left atrium and the proximal arm 132 is positioned in the coronary sinus. Each distal arm 130 has a terminal portion 134. Specifically, distal arm 130A has a terminal portion 134A, and distal arm 130B has a terminal portion 134B. Each proximal arm 132 has a terminal portion 136. Specifically, proximal arm 132A has a terminal portion 136A, and proximal arm 132B has a terminal portion 136B.

[0026] The distal arm 130 and the proximal arm 132 curve outward from the end wall 122. As shown in Figure 3B, each of the distal arm 130 and the proximal arm 132 has a proximal portion adjacent to the central flow pipe 110 that forms a shallow curve or arc in the direction away from the end wall 122 of the central flow pipe 110. Each of the distal arm 130 and the proximal arm 132 flattens toward their respective terminals 134 and 136, and as a result, each portion of the distal arm 130 and the proximal arm 132 at or adjacent to their respective terminals 134 or 136 is generally parallel to the horizontal reference plane HP. Thus, as outlined in Figure 3B, the axis drawn through terminal 134A and the axis drawn through terminal 136B can, for simplification, form a first angle α with the central axis CA through the central flow pipe 110, respectively, as axes in the plane of the horizontal reference plane HP. Similarly, as outlined in Figure 3B, the axes drawn through terminal 134B and terminal 136A, for simplification, can be, respectively, through the central flow tube 110 as axes in the plane of the horizontal reference plane HP, forming a second angle β with the central axis CA. Alternatively, the distal arm 130 and the proximal arm 132 are not flattened and are parallel to the horizontal reference plane HP, but instead have terminals 134 and 136 that approach the horizontal reference plane HP at an angle away from the horizontal reference plane HP and / or at an angle away from the horizontal reference plane HP. In such embodiments, the first angle α and the second angle β are approximations of the arc center angle from the end wall 122 to the tissue wall, which each arm encompasses when the shunt device 100 is implanted in the tissue wall. More simply, the first angle α is the angle between the central axis CA and the horizontal reference plane HP, and the second angle β is a supplementary angle to the first angle α. In some embodiments, the first angle α may be less than 90 degrees (<90°), and the second angle β may be greater than 90 degrees (>90°). In other embodiments, the first angle α and the second angle β may be any preferred combination of angles that add up to 180 degrees (180°). The difference between the first angle α and the second angle β (as well as the corresponding curvature of either the distal arm 130 or the proximal arm 132) corresponds to the inclination of the central flow tube 110.

[0027] As shown in Figure 3B, distal arms 130A and 130B extend outward from the central flow pipe 110 in opposite directions, parallel to the horizontal reference plane HP. Distal arms 130A and 130B can be aligned with each other (i.e., oriented 180° to each other across the central flow pipe 110). In some embodiments, distal arm 130A is longer than distal arm 130B. In other embodiments, distal arm 130A is shorter than distal arm 130B. In yet another embodiment, distal arms 130 can be of similar length. Proximal arms 132A and 132B extend outward from the central flow pipe 110, extending in opposite directions parallel to the horizontal reference plane HP. Proximal arms 132A and 132B can be aligned with each other (i.e., oriented 180° to each other across the central flow pipe 110). In some embodiments, the proximal arm 132A is shorter in length than the proximal arm 132B. In other embodiments, the proximal arm 132A is longer in length than the proximal arm 132B. In yet another embodiment, the proximal arm 132 may have a similar length. In some embodiments, the distal arm 130A is generally the same length and shape as the proximal arm 132B, and the distal arm 130B is generally the same length and shape as the proximal arm 132A. In other embodiments, the distal arm 130 and the proximal arm 132 may each have different lengths and shapes, but the overall shape of each arm is similar. Thus, the shunt device 100 has some degree of inverse symmetry with respect to the horizontal reference plane HP, as shown in Figure 3B.

[0028] The shunt device 100 is generally elongated longitudinally but relatively narrow laterally. In other words, the distal arm 130 and the proximal arm 132 are not annular or circular, but rather generally extend outward in only one plane. As shown in Figure 3B, the shunt device 100 has a roughly H-shape when viewed from the side. The elongated shape of the shunt device 100 means that when compressed, as shown in Figure 4, it stretches along the line to better conform within the catheter.

[0029] The distal end 134 of the distal arm 130 and the distal end 136 of the proximal arm 132 converge toward each other. The distal arm 130 and the proximal arm 132 form two pairs of arms; that is, each of the distal arms 130 forms a clamping pair with the corresponding one of the proximal arms 132. The distal arm 130A and the proximal arm 132A form a first pair of arms extending outward from the first side of the central flow pipe 110, with the distal end 134A of the distal arm 130A converging toward the distal end 136A of the proximal arm 132A. The distal arm 130B and the proximal arm 132B form a second pair of arms extending outward from the second side of the central flow pipe 110, with the distal end 134B of the distal arm 130B converging toward the distal end 136B of the proximal arm 132B. The gap G between the distal end 134 and the distal end 136 is slightly smaller than the approximate thickness of the tissue wall between the left atrium and the coronary sinus, or another tissue wall in the subject. This allows the distal arm 130 and the proximal arm 132 to bend outward and grasp the tissue wall when implanted to help hold the shunt device 100 in place. Thus, the distance corresponding to the gap G, as measured when the shunt device 100 is implanted, may vary slightly between different clamping pairs of the distal arm 130 and the proximal arm 132, depending on anatomical variations along the particular tissue wall. The distal end 134 of the distal arm 130 and the distal end 136 of the proximal arm 132 may also have openings or recesses configured to engage with a delivery tool, such as the working rod of a delivery tool, to facilitate the implantation of the shunt device 100. Furthermore, the distal end 134 of the distal arm 130 and the distal end of the proximal arm 132 may include the positions of radiopaque markers to enable visualization of the positioning of the shunt device 100.

[0030] When implanted in the tissue wall, the distal arm 130 and the proximal arm 132 are designed to minimize their respective protrusions into the left atrium and coronary sinus, respectively. This minimizes disruption of the natural flow pattern in the left atrium and coronary sinus. The shunt device 100 may also be designed so that the profile of the proximal arm 132 protruding into the coronary sinus is lower than the profile of the distal arm 130 protruding into the left atrium, minimizing disruption of natural blood flow through the coronary sinus and reducing the possibility of the proximal arm 132 obstructing narrower passages in the coronary sinus.

[0031] The tissue capture feature 116 can take several different forms. For example, a tissue capture feature 116 connected to the central flow tube 110 at a first axial end 124 and / or a second axial end 126 may be a tab extending outward from the side 120. A tissue capture feature 116 connected to an arm 114 may be a deflectable projection extending between each of the arms 114 and the tissue wall being compressed toward each arm 114 when the shunt device 100 is implanted in the tissue wall. A tissue capture feature 116 connected to an end 122 of the central flow tube 110 may be a secondary arm associated with one of the arms 114. A tissue capture feature 116 that is part of the arm 114 itself may be, for example, an extended portion of one of the arms 114, a separate segmented arm portion of one of the arms 114, and / or an interlaced arm 114. Any one or more of the tissue-grabbing features 116 can be incorporated individually or in combination on the shunt device 100 to help anchor the shunt device 100 to the tissue wall and prevent displacement of the shunt device 100.

[0032] Figure 5 is a perspective view of the shunt device 100', including the sensor 150'. The shunt device 100' includes a body 102' formed by a support column 104' and an opening 106'. The body 102' includes a central flow tube 110', a flow channel 112', and an arm 114'. The shunt device 100' also includes a tissue capture feature 116'. The central flow tube 110' has a side section 120' (including side sections 120A' and 120B'), an end section 122' (including end sections 122A' and 122B'), a first axial end section 124', and a second axial end section 126'. Arm 114' includes a distal arm 130' (including distal arm 130A' and distal arm 130B') and a proximal arm 132' (including proximal arm 132A' and proximal arm 132B'). The distal arm 130' has a terminal portion 134' (including terminal portions 134A' and terminal portion 134B'). The proximal arm 132' has a terminal portion 136' (including terminal portions 136A' and terminal portion 136B'). The shunt device 100' further includes a sensor 150' and a sensor mounting portion 152'.

[0033] Shunt device 100' includes a structure and design similar to that of the shunt device 100 described above, except that shunt device 100' further includes a sensor 150' connected to a sensor mounting portion 152'.

[0034] As shown in Figure 5, the sensor 150' can be attached to the shunt device 100' such that the sensor 150' is positioned within the left atrium when the shunt device 100' is implanted in the tissue wall between the left atrium and the coronary sinus. Thus, the sensor 150' can be attached to one of the distal arms 130'. Alternatively, the sensor 150' can be attached to the shunt device 100' such that the sensor 150' is positioned within the coronary sinus when the shunt device 100' is implanted in the tissue wall. In such embodiments, the sensor 150' can be attached to one of the proximal arms 132'. In further embodiments, additional sensors can be included on the shunt device 100' to position sensors in both the left atrium and the coronary sinus.

[0035] Sensor 150' is attached to the shunt device 100' at sensor mounting portion 152'. Sensor 150' can be connected to sensor mounting portion 152' using any preferred mounting mechanism. For example, sensor 150' and sensor mounting portion 152' may include complementary mating features. Sensor mounting portion 152' may be an extension of one of the arms 114' of the shunt device 100'. In some embodiments, sensor mounting portion 152' is an extension of the distal arm 130A'. In other embodiments, sensor mounting portion 152' is an extension of the distal arm 130B' or an extension of the proximal arm 132'. Alternatively, as shown in Figure 5, sensor mounting portion 152' may be a separate segmented arm portion of one of the arms 114'. The sensor mounting portion 152' can be angled away from a horizontal reference plane (not shown) that lies within the plane of the tissue wall adjacent to the shunt device 100' when the shunt device 100' is implanted in the tissue wall. In other words, the sensor mounting portion 152' can be angled away from the tissue wall.

[0036] Sensor 150' may be a pressure sensor for sensing the pressure in the left atrium. In other embodiments, sensor 150' may be any sensor for measuring parameters in the left atrium. In yet another embodiment, sensor 150' may be any sensor for measuring parameters in the coronary sinus. In one embodiment, sensor 150' may include a transducer, a control circuit, and an antenna. The transducer, for example, a pressure transducer, is configured to sense a signal from the left atrium. The transducer may communicate the signal to the control circuit. The control circuit may process the signal from the transducer or communicate the signal from the transducer to a remote device outside the main body using the antenna. In other embodiments, sensor 150' may include alternative or additional components. Furthermore, the components of sensor 150' may be held within a hermetically sealed sensor housing.

[0037] Delivery catheter 200 (Figures 6-7B) Figure 6 is a side view of the delivery catheter 200. Figure 7A is a side view of the distal portion 214 of the delivery catheter 200 in the sheathed state. Figure 7B is a side view of the distal portion 214 of the delivery catheter 200 in the unsheathed state. Figures 6, 7A, and 7B will be examined together. Figures 6-7B show the delivery catheter 200. Figure 7B shows the shunt device 202. The delivery catheter 200 includes a proximal end 200A, a distal end 200B, a proximal portion 210, an intermediate portion 212, a distal portion 214, a handle 216, an outer sheath 218, an inner sheath 220, a bridge 222, a nose cone 224, an operating rod 226, a side opening 228, and a notch 229.

[0038] The delivery catheter 200 is an embodiment of a delivery catheter that can be used to implant a shunt device in a patient. As shown in Figures 6-7B, the delivery catheter 200 is used to implant a shunt device 202 (shown in Figure 7B). The delivery catheter 200 may take other forms in alternative embodiments. The shunt device 202 may have any suitable shunt device structure and design, e.g., shunt device 100, or 100', as shown in Figures 3A-5. In the embodiments shown in Figures 6-7B, the delivery catheter 200 is shown as configured to implant the shunt device 202 without a sensor. In alternative embodiments, the delivery catheter 200 may be used to implant a shunt device with a sensor, including any modifications necessary to accommodate the sensor.

[0039] The delivery catheter 200 includes a proximal portion 210 adjacent to the proximal end 200A of the delivery catheter 200, an intermediate portion 212 extending from the proximal portion 210, and a distal portion 214 extending from the intermediate portion 212 to the distal end 200B of the delivery catheter 200. The proximal portion 210 includes a handle 216 that can be grasped by a physician to control the movement of the delivery catheter 200. The handle 216 includes several ports through which a guidewire, tube, fluid, or other component or element may pass.

[0040] The intermediate section 212 is the length of the catheter that extends outward from the handle 216 and can move through the patient. The outer sheath 218 and inner sheath 220 extend outward from the handle 216 and form part of the intermediate section 212. The outer sheath 218 covers the inner sheath 220.

[0041] The distal portion 214 extends from the intermediate portion 212. The distal portion 214 includes a bridge 222 and a nose cone 224. The bridge 222 extends from the inner sheath 220 toward the nose cone 224. The nose cone 224 extends from the bridge 222 of the delivery catheter 200 toward the distal end 200B. The bridge 222 is configured to hold the shunt device 202. When the delivery catheter 200 is in a sheathed state, as shown in Figure 7A, the outer sheath 218 extends over and covers the shunt device 202 on the bridge 222. When the delivery catheter 200 is in an unsheathed state, as shown in Figure 7B, the outer sheath 218 is retracted, exposing the bridge 222 and the shunt device 202 on the bridge 222. The nose cone 224 extends outward from the bridge 222 and helps guide the delivery catheter 200 through the patient's vascular structure. The actuation rod 226, also called the actuation arm, extends through the inner sheath 220 and the lumen of the bridge 222. The actuation rod 226 emerges from a lateral opening 228 of the bridge 222 and connects to the first proximal arm of the shunt device 202. The lateral opening 228 extends into the body of the bridge 222. The notch 229 extends into the body of the bridge 222 on the opposite side of the lateral opening 228. The notch 229 is configured to seat the second proximal arm of the shunt device 202. The second proximal arm may be held on the bridge 222 before being deployed by a release wire (not shown) which extends through the lumen of the bridge 222 and through the notch 229.

[0042] The delivery catheter 200 is described in more detail below with respect to Figures 8A-9Q.

[0043] Delivery method 300 (Figures 8A-10C) Figure 8A is a flowchart showing the steps for creating a puncture in the tissue wall TW between the coronary sinus CS and the left atrium LA. Figure 8B is a flowchart showing the steps for implanting the shunt device 202 in the tissue wall TW between the coronary sinus CS and the left atrium LA. Figures 9A-9Q are schematic diagrams showing the steps for implanting the shunt device 202 in the tissue wall TW between the coronary sinus CS and the left atrium LA. Figures 8A-9Q will be examined together. Figures 8A-8B show method 300. Figure 8A shows steps 302-316 of method 300. Figure 8B shows steps 318-334 of method 300.

[0044] Step 302 involves advancing the guidewire 230 into the coronary sinus CS, as shown in Figure 9A. The guidewire 230 may be inserted using a conventional method. The guidewire 230 is inserted into the right atrium RA, through the opening of the coronary sinus CS, and then into the coronary sinus CS. Optionally, a catheter with a radiopaque marker may be inserted onto the guidewire 230 and imaging may be performed to confirm the placement of the guidewire 230 in the coronary sinus CS. Furthermore, contrast agent may be injected into the coronary sinus CS through the catheter to further confirm the placement of the guidewire 230 in the coronary sinus CS. Once the placement of the guidewire 230 in the coronary sinus CS is confirmed, the catheter may be removed.

[0045] Step 304 involves advancing the puncture catheter 232 onto the guidewire 230 into the coronary sinus CS, as shown in Figure 9B. The puncture catheter 232 is used to puncture the tissue wall TW between the coronary sinus CS and the left atrium LA. The puncture catheter 232 includes a catheter body 234 having an opening 236 on a first side and a balloon 238 on a second side opposite the opening 236. The puncture catheter 232 may also include radiopaque markers 239 proximal and distal to the opening 236 to confirm the placement of the puncture catheter 232 in the coronary sinus CS. The puncture catheter 232 advances into the coronary sinus CS such that the opening 236 faces the tissue wall TW between the coronary sinus CS and the left atrium LA. The puncture catheter 232 shown in Figure 9B is one embodiment of the puncture catheter. In alternative embodiments, the tissue wall TW may be punctured using other puncture catheters or other suitable mechanisms.

[0046] Step 306 includes inflating the balloon 238 of the puncture catheter 232, as shown in Figure 9C. As the balloon 238 inflates, it is pressed against the coronary sinus CS opposite the tissue wall TW. The inflation of the balloon 238 presses the puncture catheter 232 against the tissue wall TW. Specifically, the opening 236 is pressed against the tissue wall TW. The balloon 238 anchors the puncture catheter 232 in place within the coronary sinus CS while the tissue wall TW is being punctured. In alternative embodiments, any other suitable anchoring mechanism may be used instead of the balloon 238. In further embodiments, step 306 is not necessary.

[0047] Step 308 involves puncturing the tissue wall TW between the coronary sinus CS and the left atrium LA, as shown in Figure 9D. The puncture catheter 232 includes a puncture arm 240 extending through the lumen of the puncture catheter 232. The puncture arm 240 includes a sheath 242 and a needle 244, positioned within the sheath 242 so as to extend from the distal end of the puncture sheath 242. The puncture arm 240 can advance through the puncture catheter 232, exit through the opening 236, and puncture the tissue wall TW between the coronary sinus CS and the left atrium LA.

[0048] The puncture catheter 232 should be positioned within the coronary sinus CS such that its opening 236 is located 2-4 centimeters from the opening of the coronary sinus CS. This positions the puncture through the tissue wall TW in the same location. The puncture, and ultimately the placement of the shunt device 202 within the puncture, is positioned above the posterior leaflet of the mitral valve MV.

[0049] Step 310 includes removing the needle 244 from the puncture catheter 232, as shown in Figure 9E. The needle 244 can be removed by pulling it out proximal through the lumen extending through the needle sheath 242 of the puncture arm 240. The needle 244 is completely removed from the puncture catheter 232, leaving a lumen extending from the proximal end of the puncture catheter 232 through the distal end of the needle sheath 242.

[0050] Step 312 involves advancing the guidewire 246 into the left atrium LA through the puncture catheter 232, as shown in Figure 9F. Specifically, the guidewire 246 advances through the lumen, extending through the proximal end of the puncture catheter 232 and the needle sheath 242 of the puncture arm 240. The guidewire 246 may advance into the left atrium LA until it is wrapped around the left atrium LA, as shown in Figure 9F. Once the guidewire 246 is fully positioned in the left atrium LA, the puncture catheter 232 and the guidewire 230 may be removed from the left atrium LA and the coronary sinus CS.

[0051] Step 314 includes advancing the balloon catheter 248 over the guidewire 246 through the puncture of the tissue wall TW, as shown in Figure 9G. The balloon catheter 248 advances through the puncture of the tissue wall TW so that the balloon 250 of the balloon catheter 248 is positioned within the puncture of the tissue wall TW. In the embodiment shown in Figure 9G, the balloon catheter 248 is shown as a separate device from the puncture catheter 232. However, in alternative embodiments, the balloon catheter 248 may be inserted through the puncture catheter 232 and through the puncture of the tissue wall TW.

[0052] Step 316 includes inflating the balloon 250 of the balloon catheter 248, which extends through the puncture in the tissue wall TW, as shown in Figure 9H. The balloon 250 extends along the distal portion of the balloon catheter 248. As the balloon 250 is inflated, it expands and pushes open the tissue surrounding the puncture in the tissue wall TW. The inflation of the balloon 250 causes the puncture in the tissue wall TW to become a wider opening into which the shunt device can be positioned. The balloon 250 may then be deflated, and the balloon catheter 248 can be removed from the left atrium LA and coronary sinus CS.

[0053] Step 318 involves advancing the delivery catheter 200 over the guidewire 246, as shown in Figure 9I. The delivery catheter 200 has a general structure and design, as discussed with reference to Figures 6-7B above. The delivery catheter 200 is inserted into the left atrium LA through the coronary sinus CS and the opening in the tissue wall TW. Once the delivery catheter 200 is properly positioned within the tissue wall TW, the nose cone 224 is positioned within the left atrium LA, and the bridge 222 extends through the tissue wall TW between the left atrium LA and the coronary sinus CS. The nose cone 224 is tapered from a smaller diameter at the distal end to a larger diameter at the proximal end. The tapering of the nose cone 224 helps to advance the nose cone 224 through the opening in the tissue wall TW and widen the opening as needed. The bridge 222 holds the shunt device 202 (not shown in Figure 9I) in a folded position on the bridge 222. The bridge 222 is positioned within the tissue wall TW so that the shunt device 202 is generally positioned within the opening of the tissue wall TW for deployment into the opening.

[0054] Step 320 includes withdrawing the outer sheath 218 of the delivery catheter 200 and releasing the distal arm 252 of the shunt device 202, as shown in Figure 9J. Withdrawing the outer sheath 218 may expose a portion of the shunt device 202 that is held on the bridge 222 of the delivery catheter 200. When the outer sheath 218 is withdrawn, the distal arm 252 of the shunt device 202 is released and takes its pre-set shape. The delivery catheter 200 should be positioned in the left atrium LA so that when the outer sheath 218 is withdrawn and the distal arm 252 of the shunt device 202 is released, the distal arm 252 of the shunt device 202 is positioned in the left atrium LA.

[0055] Step 322 includes withdrawing the delivery catheter 200 proximal to seat the distal arm 252 of the shunt device 202 on the tissue wall TW, as shown in Figure 9K. The delivery catheter 200 may be gently withdrawn proximal to seat the distal arm 252 of the shunt device 202 on the tissue wall TW of the left atrium LA. The physician should gently stop withdrawing the delivery catheter 200 when resistance is felt, indicating that the distal arm 252 has made contact with the tissue wall TW. This also positions the central flow duct of the shunt device 202 within the opening of the tissue wall TW.

[0056] Step 324 includes withdrawing the outer sheath 218 of the delivery catheter 200, as shown in Figure 9L, to expose the proximal arm 254 of the shunt device 202. The outer sheath 218 is withdrawn by a set distance to fully expose the shunt device 202, including the proximal arm 254 of the shunt device 202. The delivery catheter 200 should be positioned within the left atrium LA, tissue wall TW, and coronary sinus CS so that the proximal arm 254 is positioned within the coronary sinus CS when the outer sheath 218 is withdrawn. The proximal arm 254 is constrained to the bridge 222 of the delivery catheter 200 and does not automatically assume their pre-set shape when the outer sheath 218 is withdrawn.

[0057] Step 326 includes moving the first proximal arm 254A of the shunt device 202 toward the tissue wall TW using the actuating rod 226 of the delivery catheter 200, as shown in Figure 9M. The actuating rod 226 extends through the lumen of the delivery catheter 200 and acts forward to move the first proximal arm 254A toward the tissue wall TW.

[0058] Step 328 involves seating the first proximal arm 254A on the tissue wall TW, as shown in Figure 9N. The actuation rod 226 of the delivery catheter 200 is actuated fully laterally to seat the first proximal arm 254A on the tissue wall TW. Once the first proximal arm 256A is seated on the tissue wall TW, it is positioned within the coronary sinus CS.

[0059] Step 330 includes confirming the placement of the shunt device 202 in the tissue wall TW. Figure 9O shows a known method for confirming tissue confirmation, which includes injecting a contrast agent through the lumen extending through the delivery catheter 200. The contrast agent may travel through the coronary sinus CS and the left atrium LA. The contrast agent highlights the shunt device 202 under fluoroscopy to confirm the proper placement of the distal arm 252 and the first proximal arm 254A of the shunt device 202 on the tissue wall TW. Alternative methods for confirming tissue capture are described below.

[0060] Step 332 includes removing the actuarial rod 226 from the first proximal arm 254A of the shunt device 202, as shown in Figure 9P. The actuarial rod 226 may be held on and removed from the first proximal arm 254A using any preferred mechanism. In the embodiment shown in Figure 9P, a release wire holds the actuarial rod 226 on the first proximal arm 254A. The release wire may be pulled out proximal to sever the release wire from the first proximal arm 254A. The actuarial rod 226 may then be pulled proximal through the lumen of the delivery catheter 200 to remove the actuarial rod 226 from the coronary sinus CS.

[0061] Step 334 includes withdrawing the delivery catheter 200 from the coronary sinus CS and left atrium LA, as shown in Figure 9Q, and releasing the second proximal arm 254B of the shunt device 202. The second proximal arm 254B is held in place on the bridge 222 within a notch 229 formed within the bridge 222. As the delivery catheter 200 is withdrawn, the second proximal arm 254B is released from the notch 229 in the bridge 222 and takes its pre-set shape. Specifically, as the second proximal arm 254B takes its pre-set shape, it is seated on the tissue wall TW. The second proximal arm 245B is positioned within the coronary sinus CS. After the second proximal arm 254B is seated on the tissue wall TW, the shunt device 202 is fully deployed on the tissue wall TW, as shown in Figure 10A (below). Next, the delivery catheter 200 and guidewire 246 can be removed from the left atrium (LA) and coronary sinus (CS).

[0062] Method 300 is an embodiment of a method that may be used to implant a shunt device 202 into the tissue wall TW between the left atrium LA and the coronary sinus CS. Method 300 may include fewer, more, or different steps in alternative embodiments. Furthermore, the puncture catheter 232 and the delivery catheter 200 are shown as separate catheters in the embodiments shown in Figures 9A–9Q, but may be a single catheter in alternative embodiments.

[0063] The shunt device must be anchored in place to avoid displacement during a normal cardiac rhythm. Techniques are needed to ensure proper placement of the shunt device during implantation.

[0064] Figure 10A is a simplified perspective view of the shunt device 202 properly seated between the left atrium (LA) and the coronary sinus (CS). Figure 10B is a simplified perspective view of the shunt device 202 improperly seated between the left atrium (LA) and the coronary sinus (CS). Figure 10C is a simplified perspective view of the shunt device 202 embodied in the left atrium (LA). Figures 10A-10C will be examined together. Figures 10A-10C show the shunt device 202, including the distal arm 252 and the proximal arm 254. Figures 10A-10C further show the left atrium (LA), the coronary sinus (CS), and the tissue wall (TW).

[0065] Figure 10A shows the shunt device 202 properly seated on the tissue wall TW between the left atrium (LA) and the coronary sinus (CS). As shown, the distal arm 252 engages with the tissue wall TW and is positioned within the left atrium (LA), and the proximal arm 254 engages with the tissue wall TW and is positioned within the coronary sinus (CS). During deployment, one or more of the distal arms 252 or the proximal arm 254 may be improperly seated. In one embodiment, as shown in Figure 10B, the shunt device 202 may be improperly seated such that one or more of the distal arms 252 are positioned within the coronary sinus (CS) rather than the left atrium (LA). For example, during the implantation procedure (e.g., in step 322 of method 300, as shown in Figure 8B), the physician may excessively pull back the delivery catheter 200 after the distal arms 252 have been released, drawing all or part of the shunt device 202 into the coronary sinus (CS). In another embodiment, as shown in Figure 10C, the shunt device 202 may be improperly seated so that the entire shunt device 202 is positioned within the left atrium LA. For example, during the implantation procedure (e.g., in step 322 of method 300, as shown in Figure 8B), the physician may not be able to pull back the delivery catheter 200 sufficiently after the distal arm 252 has been released, causing one or more of the proximal arms 254 to be released into or pushed through the left atrium LA, thereby embolizing the shunt device 202. Confirming tissue capture between the arms of the shunt device helps the physician determine when it is safe to release the shunt device. Thus, confirming proper seating of the shunt device during and / or after delivery helps reduce the risk of embolization and / or the need for redeployment. This disclosure relates to an apparatus for determining tissue capture of the shunt device. The disclosed device can be used to confirm the presence of tissue wall twitch (TW) between the distal and proximal arms of a shunt device without injecting contrast agent into the patient. Thus, the disclosed device is particularly important for procedures involving patients for whom exposure to contrast agents is contraindicated.

[0066] Devices and methods for confirming tissue capture (Figures 11-16) The occurrence of mis-imposition of a shunt device can be reduced by accurate determination of tissue capture during shunt device delivery. In this disclosure, a small alternating current (AC) signal may be used to measure the electrical impedance between a reference electrode and an electrode positioned adjacent to at least one arm of the shunt device. The electrical impedance differs when measured through blood pairs, compared to tissue. Thus, the measurement of electrical impedance can be used to determine whether tissue is captured between adjacent arms of the shunt device, or whether adjacent arms are seated on the same side of the tissue wall and separated by blood. In some embodiments, one or more existing wires of a previously disclosed delivery catheter, which may be connected to or positioned adjacent to the shunt device, may function as electrodes or be used to supply the AC signal.

[0067] Figure 11 is a simplified diagram of device 400 for determining tissue capture of shunt device 402 during deployment. Figure 11 shows device 400, shunt device 402, distal arms 404A and 404B with terminals 406A and 406B, proximal arms 408A and 408B with terminals 410A and 410B, central drainage duct 412, delivery catheter 414, bridge 416, first wire 418, second wire 420, working arm 422, distal tip 424, ground 426, AC signal 428, tissue wall TW, coronary sinus CS, and left atrial LA. A circuit may be formed between shunt device 402, first wire 418, second wire 420, distal tip 424, and tissue wall TW. Using electrical impedance measurements, it can be determined whether the circuit is contained by a tissue wall TW, as shown in Figure 11, or by blood (as shown in Figure 12).

[0068] Shunt device 402 may have any preferred shunt device structure and design. Shunt device 402 may be substantially the same as, or similar to, shunt devices 100, 100', and 202 shown and described therein in Figures 3A, 3B, 4, 5, 7B, 9J-9Q, and 10A-10C. The distal arms 404A and 404B are positioned on the opposing sides of the central drainage canal 412. The proximal arms 408A and 408B are positioned on the opposing sides of the central drainage canal 412. The distal arms 404A and proximal arms 408A are positioned on the opposing axial ends of the central drainage canal 412 and are configured to capture the tissue wall TW of the left atrial LA and the coronary sinus CS between them. The distal arm 404B and the proximal arm 408B are positioned at opposing axial ends of the central drainage duct 412 and are configured to capture the tissue wall TW of the left atrium LA and the coronary sinus CS between them (e.g., Figure 10A). The shunt device 402 may be deployed according to method 300, with modifications of step 330 relating to tissue capture confirmation, as further described herein. The proximal arm 408A corresponds to the first proximal arm 254A of the shunt device 202, which, for example, in Figure 9M, was moved toward the tissue wall using the working rod 226. The proximal arm 408B corresponds to the second proximal arm 245B, as shown, for example in Figure 9Q, which seats on the tissue wall TW of the coronary sinus CS, for example, as the delivery catheter 200 is withdrawn.

[0069] The shunt device 402 is formed from a conductive material. As mentioned above, the shunt device 402 can be formed from a shape memory material such as Nitinol (nickel-titanium alloy).

[0070] Device 400 includes a delivery catheter 414. The delivery catheter 414 is an embodiment of a delivery catheter that can be used to implant the shunt device 402 into a patient. The delivery catheter 414 may be substantially similar to the delivery catheter 200 shown in Figure 7B and described with respect to it. In alternative embodiments, the delivery catheter 414 may take other forms. A bridge 416, a first wire 418, a second wire 420, and an actuating arm 422 are shown. The outer sheath is retracted to release the shunt device 402. As described with respect to the delivery catheter 200 shown in Figure 7B, the outer sheath holds the shunt device 402 in a folded position on the bridge 416, with distal arms 404A and 404B extending spaced apart from proximal arms 408A and 408B. When the outer sheath is retracted, the distal arms 404A and 404B return to their pre-set shapes and curve toward the proximal arms 408A and 408B, respectively, as shown in Figure 11. The proximal arm 408B is fixed to the bridge 416. The proximal arm 408A is fixed to the actuarial arm 422.

[0071] The first wire 418 may be a stationary wire configured to temporarily hold the proximal arm 408B of the shunt device 402 on the bridge 416. The first wire 418 extends through the lumen (not shown) of the delivery catheter 414. The first wire 418 is made of a conductive material and is positioned in contact with the proximal arm 408B, providing an electrical connection between the first wire 418 and the shunt device 402. Specifically, the first wire 418 may be positioned in contact with the terminal portion 410B when the terminal portion 410B is seated on the bridge 416. The first wire 418 may remain in contact with the proximal arm 408B until the proximal arm 408B is released from the delivery catheter 414. The proximal arm 408B may be released from the delivery catheter 414 when the delivery catheter is withdrawn from the coronary sinus CS, as described with respect to it as shown in Figure 9Q. The first wire 418 may be formed from, for example, nitinol, or other biocompatible conductive materials including, but not limited to, platinum-iridium, silver, gold, and stainless steel. As shown in Figure 11, the first wire 418 may be connected to ground 426. As further described herein, the first wire 418 and the shunt device 402 form part of a circuit used to determine tissue capture between the distal arm 404A and the proximal arm 408A.

[0072] A second wire 420 may be provided within the actuarial arm 422. The actuarial arm 422 is an embodiment of the actuarial arm that may be used to position the proximal arm 408A on the tissue wall TW of the coronary sinus CS. The actuarial arm 422 may be substantially similar to the actuarial rod, or arm 226, shown and described in relation thereto in Figures 7B, 9M, and 9N. The actuarial arm 422 extends through the lumen (not shown) of the delivery catheter 414 and can exit through a lateral opening of the bridge 416. The actuarial arm 422 may actuarially to move the proximal arm 408A toward the tissue wall TW of the coronary sinus CS. The proximal arm 408A of the shunt device 402 may be connected to the actuarial arm 422 adjacent to the distal tip 424 of the actuarial arm 422.

[0073] The second wire 420 may be a stationary wire formed of a conductive material and configured to deliver an AC signal to the circuit. The second wire 420 may be connected to the AC signal 428 and extend through the working arm 422 to the distal tip 424. The distal tip 424 may also be formed of a conductive material and may function as an electrode. The second wire 420 may be positioned in contact with the distal tip 424 to provide an electrical connection between the second wire 420 and the distal tip 424. The distal tip 424 is configured to engage with the tissue wall TW during deployment of the proximal arm 408A within the coronary sinus CS. The AC signal may be transmitted through the tissue wall TW via the distal tip 424 when the distal tip 424 is positioned in contact with the tissue wall TW of the coronary sinus CS.

[0074] When the shunt device 402 is properly positioned between the left atrium (LA) and the coronary sinus (CS), the distal arm 404A of the shunt device 402 is positioned on the tissue wall TW of the left atrium (LA). The distal arm 404A, in particular, its distal portion 406A, can function as a reference electrode or ground electrode. The actuating arm 422 can act forward to position the proximal arm 408A on the tissue wall TW of the coronary sinus (CS). When the actuating arm 422 acts forward, the distal tip 424 can come into contact with the tissue wall TW of the coronary sinus (CS). A small AC current can be applied to the second wire 420, thereby to the distal tip 424, as schematically shown in Figure 11. The coronary sinus (CS) and the tissue wall TW of the left atrium (LA) complete the circuit between the distal tip 424 of the shunt device 402 and the distal arm 404A. Using an electrical impedance sensor known in the art, the electrical impedance of the shunt device 402 can be determined based on the voltage measured between the distal tip 424 and the terminal portion 406A. For a given current applied to tissue (e.g., blood, or tissue wall TW), low voltage corresponds to low impedance, and high voltage corresponds to high impedance.

[0075] In some embodiments (as shown in Figure 15), the second wire 420 extends from the working arm 422 to the terminal portion 410A of the proximal arm 408A, positioning an electrode on the proximal arm 408A, thereby improving the accuracy of tissue capture determination. The electrode or terminal portion of the second wire 420 may be separated from the terminal portion 410A of the proximal arm 408A by an insulating material (not shown) to avoid direct electrical connection between the proximal arm 408A and the second wire 420. For example, a biocompatible insulating film or pad (e.g., Kapton® polyamide) may be placed between the proximal arm 408A and the second wire 420. The insulating material may be provided locally on the proximal arm 408A or may extend from the working arm 422 to the proximal arm 408A together with the second wire 420. The second wire 420 may be configured to be released from or withdrawn from the proximal arm 408A when the actuating arm 422 is retracted.

[0076] The electrical impedance through the tissue wall TW is substantially different from the electrical impedance through the blood in the coronary sinus CS and left atrium LA, allowing the physician to confirm when the distal arm 404A of the shunt device 402 and the distal tip 424 of the actuating arm 422 are seated against the tissue wall TW, respectively. Once tissue capture is confirmed, the proximal arm 408A, as described therein as shown in Figure 9P, can be released. The actuating arm 422 can then be withdrawn proximally through the lumen of the delivery catheter 414 to remove it from the coronary sinus CS.

[0077] Figure 12 is a simplified diagram of device 400 during the process of determining tissue capture, where tissue capture is not confirmed. As previously mentioned, during deployment, one or more distal arms 404A, 404B, or proximal arms 408A, 408B may be improperly seated. In one embodiment, as shown in Figure 12, the shunt device 402 may be improperly seated such that one or more of the distal arms 404A, 404B are positioned in the coronary sinus CS rather than the left atrium LA. For example, during the implantation procedure (e.g., in step 322 of method 300, as shown in Figure 8B), the physician may pull back the delivery catheter 414 too forcefully after the distal arms 404A, 404B have been released, causing all or part of the shunt device 402 to be pulled into the coronary sinus CS. In another embodiment, as shown in Figure 10C, the shunt device 402 may be improperly seated so that the entire shunt device 402 is positioned in the left atrium LA. For example, during the implantation procedure (e.g., in step 322 of method 300, as shown in Figure 8B), the physician may not be able to fully retract the delivery catheter 414 after the distal arms 404A, 404B have been released, resulting in one or more of the proximal arms 408A, 408B being released into or pushed into the left atrium LA, thereby embolizing the shunt device 202. In either scenario, the shunt device 402 fails to capture the tissue wall TW between the distal arm 404A and the proximal arm 408A, and the distal arm 404A of the shunt device 402 may be separated from the distal tip 424 of the working arm 422 by blood in the coronary sinus CS or the left atrium LA.

[0078] As schematically shown in Figure 12, a small AC current can be delivered to the distal tip 424. Blood in the coronary sinus CS completes the circuit between the distal tip 424 and the distal arm 404A. Using an impedance sensor (shown in Figure 13), the electrical impedance between the distal tip 424 and the terminal end 406A of the shunt device 402 can be determined, as described above.

[0079] In some embodiments, the AC signal may be applied during the deployment of the actuating arm 422, allowing the physician to monitor changes in electrical impedance as the distal tip 424 contacts the tissue wall TW. In other embodiments, the AC signal may be applied after the distal tip 424 has fully deployed. Based on the electrical impedance, or changes in electrical impedance, the physician may be able to distinguish the type of material separation electrode of the distal arm 404A of the shunt device 402 and the distal tip 424 of the actuating arm 422, thereby determining whether the shunt device 402 is properly seated. In some embodiments, an indicator light may be provided on the handle of the delivery catheter 414 to inform the physician whether the shunt device 402 is properly seated based on the determined electrical impedance.

[0080] Figure 13 is a simplified schematic diagram of the handle of the delivery catheter 414. Figure 13 shows the handle 430, the first wire 418, the second wire 420, the programmable microchip 432, the impedance sensor 433, and the indicator light 434. The handle 430 may be substantially similar to the handle 216 shown and described in relation to Figure 6. The impedance sensor 433 may be located within the handle 430 and electrically connected to the first wire 418 and the second wire 420. The impedance sensor 433 is configured to determine electrical impedance, as is known in the art. The programmable microchip 432 may be configured to receive and interpret the digital impedance signal. The programmable microchip 432 may be configured to analyze the electrical impedance signal using machine learning methods or standard signal processing and analysis methods. This may involve classifying media (e.g., blood and tissue wall TW) using features including, but not limited to, amplitude, frequency, waveform, capacitance / resistance / inductance, or real and virtual components derived from the impedance signal vector. A programmable microchip 432 may be electrically connected to one or more indicator lights 434. As previously mentioned, the electrical impedance across tissue wall TW is substantially different from the electrical impedance across blood. In some embodiments, the electrical impedance range can be predetermined for each substance (tissue wall TW and blood), and the programmable microchip 432 may be configured to distinguish the electrical impedance across tissue wall TW from the electrical impedance across blood based on a predetermined range. In some embodiments, when the shunt device 402 is in the blood and separated from the tissue wall TW, a baseline electrical impedance may be determined for the patient before the full deployment of the shunt device 402. Baseline measurements of the signal and calibration can be used to create a robust algorithm for providing accurate classification for all patients (e.g., patients with more adipose tissue, more muscle tissue, or thicker or thinner blood).The programmable microchip 432 may be configured to classify electrical impedance as indicating contact with blood or contact with a tissue wall TW, and to indicate via one or more indicator lights 434 which material is separating the electrodes on the distal arm 404A of the shunt device 402 and the distal tip 424 of the actuating arm 422, or which material the distal tip 424 is in contact with. For example, one or more indicator lights 434 of different colors may be provided on the handle 430 to indicate when the distal tip 424 is in contact with a tissue wall TW. For example, an RGB LED may be configured to light up red to indicate contact with blood and to light up green to indicate contact with a tissue wall TW. The indicator lights 434 may allow the physician to determine when the shunt device 402 is properly seated and when the shunt device 402 is incorrectly seated and requires adjustment or repositioning.

[0081] Figure 14A is an enlarged view of a portion 14A of Figure 11. Figure 13 shows a first wire 418 in contact with the proximal arm 408B of the shunt device 402 on the delivery catheter 414. In some embodiments, the first wire 418 may extend over or through the terminal opening 410B of the proximal arm 408B. The first wire 418 may be a release wire configured to hold the proximal arm 408A of the shunt device 402 on the delivery catheter 414. For example, the first wire 418 may be screwed in through one or more openings in the proximal arm 408B (e.g., around the support or through a hole in the terminal 410B). The first wire 418 may be withdrawn from the proximal arm 408A during deployment of the shunt device 402, allowing the proximal arm 408B to take a predetermined shape relative to the tissue wall TW. In some embodiments, an outer sheath (not shown) on the delivery catheter 414 can be used to fix the first wire 418 in a position that contacts the proximal arm 408B.

[0082] Figure 14B is an enlarged view of a portion 14B of Figure 11. It shows the actuating arm 422, distal tip 424, proximal arm 408A, terminal portion 410A, second wire 420, release wire 436, and connecting body 438. The actuating arm 422 includes the distal tip 424 at its distal end. The connecting body 438 may be positioned proximal to the distal tip 424. The second wire 420 may extend through the actuating arm 422 to the distal tip 424. The release wire 436 may extend through the actuating arm 422 and the connecting body 438. The release wire 436 may extend through the opening of the terminal portion 410A of the shunt device 402 to hold the proximal arm 408A on the actuating arm 422. The release wire 436 may extend through the lumen of the actuating arm 422, as described above. As shown in Figure 14B, the connecting body 438 may include an opening into the lumen through which a release wire 436 extends. The release wire 436 may be supplied through the opening of the terminal portion 410A during the assembly of the shunt device 402 on the delivery catheter 414 to capture the proximal arm 408A. The release wire 436 may hold the proximal arm 408A on the actuating arm 422 after the proximal arm 408A has been deployed until the release wire 436 is withdrawn from the actuating arm 422. Withdrawal of the release wire 436 releases the proximal arm 408A from the actuating arm 422. The proximal arm 408A may take a predetermined shape with respect to the tissue wall TW.

[0083] The proximal arm 408A is electrically isolated from the second wire 420 of the actuating arm 422. In some embodiments, the second wire 420 may be located in a separate lumen of the actuating arm 422, and the connecting body 438 may be formed of an electrically insulating material. In some embodiments, the portion of the proximal arm 408A that contacts the actuating arm 422 and the release wire 436 may be coated with an electrically insulating material.

[0084] In some embodiments, the first wire 418 can be connected to an AC signal 428, and the second wire 420 can be connected to ground 426. In some embodiments, the second wire 420 may be removed, and the release wire 436 may function as an electrode or provide an electrical connection to a distal tip 424 in the working arm 422 that may function as an electrode. For example, the release wire 436 may be formed of a conductive material, received within and connected to the distal tip 424. Alternatively, the release wire 436 may extend adjacent to the distal tip 424 and be positioned to contact the tissue wall TW when the working arm 422 is deployed. The proximal arm 408A may be electrically isolated from the release wire 436. For example, at least a portion of the release wire 436 configured to contact the terminal portion 410A of the proximal arm 408A may be sheathed in an electrically insulating material. In other embodiments, a biocompatible insulating film (e.g., Kapton® polyamide) may be provided on at least a portion of the proximal arm 408A, configured to contact the release wire 436.

[0085] In another embodiment, electrodes may be provided at one or more arbitrary locations on the shunt device while remaining electrically isolated from the shunt device. In some embodiments, electrodes may be positioned to determine when a pair of arms of the shunt device make contact with a tissue wall TW. Figure 15 is a simplified diagram of device 500 for determining tissue capture of shunt device 502 during deployment. Figure 16 is an enlarged view of a portion of Figure 15. Figure 15 shows the device 500, shunt device 502, distal arms 504A and 504B having terminals 506A and 506B, proximal arms 508A and 508B having terminals 510A and 510B, central drainage tube 512, delivery catheter 514, bridge 516, first wire 518, second wire 520, third wire 522, fourth wire 524, first electrode 526, second electrode 528, third electrode 530, fourth electrode 532, insulating pad 534, working arm 536, distal tip 538, tissue wall TW, coronary sinus CS, and left atrial LA. Figure 16 shows the terminal 506B, third electrode 530, insulating pad 534, and tissue wall TW.

[0086] The first, second, third, and fourth wires 518, 520, 522, and 524 each have the first, second, third, and fourth electrodes 526, 528, 530, and 532, respectively. The first, second, third, and fourth electrodes 526, 528, 530, and 532 may each be positioned on the terminal portions 506A, 510A, 506B, and 510B of the shunt device 502. The first, second, third, and fourth electrodes 526, 528, 530, and 532 may be electrically isolated from the shunt device 502 by insulating material positioned between the first, second, third, and fourth electrodes 526, 528, 530, and 532 and the terminal portions 506A, 510A, 506B, and 510B (for example, an insulating pad 534 on terminal portion 506B).

[0087] As shown in Figure 15, the circuit may be formed between electrodes 526 and 528, positioned, for example, on the distal arm 504A and the proximal arm 508A, and the tissue wall TW. Using electrical impedance measurements, it is determined whether the circuit is completed by the tissue wall TW or by blood (for example, as shown in Figure 12), as shown in Figure 15. Additional electrodes 530 and 532, positioned, respectively, on the distal arm 504B and the proximal arm 508B, may be used to determine when the distal and proximal arms 504B and 508B are in contact with the tissue wall TW. In some embodiments, the third and fourth wires 522 and 524, as well as electrodes 530 and 532, may be omitted.

[0088] Shunt device 502 may have any preferred shunt device structure and design. Shunt device 502 may be substantially the same as or similar to shunt device 402, which is shown and described in relation to Figure 11. In contrast to shunt device 402, shunt device 502 may include an insulating film or pad (e.g., Kapton® polyamide) disposed at any of the terminals 506A, 506B, 510A, 510B, having electrodes 526, 528, 530, 532, thereby electrically isolating shunt device 502 from electrodes 526, 528, 530, 532, even if shunt device 502 is formed of a conductive material. Shunt device 502 may be deployed in substantially the same or similar manner as shunt device 402.

[0089] Device 500 may be substantially similar to device 400 shown and described in relation to Figure 11. In contrast to device 400, the delivery catheter 514 of device 500 may include two or more wires 518, 520, 522, 524 extending from a handle (for example, similar to the handle 430 shown in Figure 13) to the terminal portions 506A, 506B, 510A, 510B of the shunt device 502.

[0090] As shown in Figure 15, the first, second, third, and fourth wires 518, 520, 522, and 524 may each extend outward through the delivery catheter 514 from the opening of the delivery catheter 514 to the terminal portions 506A, 510A, 506B, and 510B of the shunt device 502. Each of the first, second, third, and fourth wires 518, 520, 522, and 524 may be received within the lumen of the delivery catheter 414. The first, second, third, and fourth wires 518, 520, 522, and 524 are conductive. The first, second, third, and fourth wires 518, 520, 522, and 524 may be formed from other biocompatible conductive materials, including, but not limited to, nitinol, or platinum-iridium, silver, gold, and stainless steel. At least portions of the first, second, third, and fourth wires 518, 520, 522, and 524, positioned proximal to the shunt device 502, may be sheathed in an electrically insulating material. The unsheathed ends of the first, second, third, and fourth wires 518, 520, 522, and 524 may form electrodes 526, 528, 530, and 532, respectively. The electrodes 526, 528, 530, and 532 may be connected to the distal arm 504A, proximal arm 508A, distal arm 504B, and proximal arm 508B, respectively, by a biocompatible insulating material (e.g., Kapton® polyimide film or pad) so that the shunt device 502 is electrically isolated from the electrodes 526, 528, 530, and 532. The exposed sides of electrodes 526, 528, 530, and 532 on the opposite side of the connection to the shunt device 502 are positioned to face the tissue wall TW during the deployment of the shunt device 502. The first, second, third, and fourth wires 518, 520, 522, 524, and / or insulating material (insulating pad 534) may be configured to be released from the shunt device 502 during withdrawal of the delivery catheter 514 after the deployment of the shunt device 502.

[0091] In some embodiments, the second wire 420 may be routed to the proximal arm 508A of the shunt device 502 via the actuating arm 536, as described above. In some embodiments, a third wire 522 may be used to hold the proximal arm 508B on the delivery catheter 514, as described above. The routes of the first, second, third, and fourth wires 518, 520, 522, and 524 through the delivery catheter are not limited to the embodiments shown.

[0092] A small AC current may be applied to any one of the first, second, third, and fourth wires 518, 520, 522, and 524. An electrode positioned on the opposite side of the arm receiving the AC signal may serve as a reference electrode. For example, the first and third wires 518 and 522 may be connected to ground, and the AC signal may be supplied to the second and fourth wires 520 and 524. When the shunt device 502 is properly positioned between the left atrium LA and the coronary sinus CS, the distal arm 504A of the shunt device 502 and electrode 526 is positioned on the tissue wall TW of the left atrium LA. The actuating arm 536 may be actuated forward to position the proximal arm 508A and electrode 528 on the tissue wall TW of the coronary sinus CS. A small AC current may be applied to electrode 528 via the second wire 520, as schematically shown in Figure 15. The tissue wall TW between the coronary sinus CS and the left atrium LA completes the circuit between electrode 528 on the proximal arm 508A and electrode 526 on the distal arm 504A of the shunt device 502. An impedance sensor can be used to determine whether the distal arm 504A and the proximal arm 508A have captured the tissue wall TW between them, as previously described with respect to device 400. Similarly, tissue capture between the proximal arm 504B and the distal arm 508B can be confirmed by determining the electrical impedance between electrodes 530 and 532. The electrode arrangement is not limited to that shown. Other arrangements or combinations of electrodes on the shunt device 502 and / or delivery catheter 514 are intended.

[0093] A programmable microchip can be used to classify electrical impedance signals, as described above. In some embodiments, RGB LEDs on the handle of the delivery catheter 514 may be used to indicate each electrode on the shunt device 502 and the type of medium in contact with each electrode. For example, the LEDs may be configured to light up red to indicate contact with blood, or to light up green to indicate contact with tissue wall TW. The indicator lights may allow a physician to determine when the shunt device 502 is properly seated and when the shunt device 502 is incorrectly seated and requires adjustment or repositioning.

[0094] Any of the various systems, devices, apparatus, etc. of this disclosure can be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use with patients, and the methods herein may include sterilization of the relevant systems, devices, apparatus, etc. (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0095] Procedures, methods, steps, etc., described or suggested herein, or described or suggested in the literature referenced herein, may be performed on living animals or on non-living simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, or simulators (in which parts of the body, tissues, etc., are simulated).

[0096] Any relative terms or degree conditions used herein, such as “substantially,” “essentially,” “generally,” and “approximately,” should be interpreted in accordance with any applicable definitions or limitations expressly set forth herein. In all cases, any relative terms or degree conditions used herein should be interpreted to broadly encompass any relevant disclosed embodiments, as well as such scopes or variations, which would be understood by a person skilled in the art in light of the entirety of this disclosure, including incidental changes in alignment, thermally induced temporary alignments or shape changes, rotational or vibrating operating conditions, etc., to encompass variations in normal manufacturing tolerances. Furthermore, any relative terms or degree terms used herein should be interpreted to encompass a range including specified qualities, characteristics, parameters, or values ​​without variation, as if no qualified relative terms or degree terms had been used in a given disclosure or enumeration.

[0097] Detailed Examination of Embodiments The following is a non-exclusive description of possible embodiments of the present invention.

[0098] The device for determining tissue capture by the shunt device includes a delivery catheter and a shunt device positioned on the delivery catheter. The shunt device is configured to be inserted into a tissue wall puncture and includes a central flow tube extending from a first axial end to a second axial end, a first distal arm attached to the first axial end of the central flow tube, and a first proximal arm attached to the second axial end of the central flow tube. The first distal arm and the first proximal arm are configured to capture the tissue wall between them. The delivery catheter includes a first conductive wire and a second conductive wire. The first conductive wire is electrically connected to the shunt device, and the second conductive wire is disconnected from the shunt device.

[0099] The device described in the preceding paragraph may optionally, additionally, and / or alternatively, include one or more of the following features, configurations, and / or additional components:

[0100] In further embodiments of the preceding device, one of the first conductive wire and the second conductive wire can be connected to ground, and the other of the first conductive wire and the second conductive wire can be connected to an AC signal.

[0101] In any further embodiment of the devices described above, the shunt device includes a second distal arm formed of a conductive material and attached to a first axial end of a central flow tube, and a second proximal arm attached to a second axial end of the central flow tube, wherein the second distal arm and the second proximal arm are configured to capture a tissue wall between them, and a first conductive wire may be electrically connected to the second proximal arm.

[0102] In any further embodiment of the device described above, the delivery catheter may further include an actuation arm configured to position a first proximal arm, and a second conductive wire may be received within the actuation arm.

[0103] In any further embodiment of the aforementioned device, the second conductive wire may be positioned adjacent to the end of the first proximal arm.

[0104] In any further embodiment of the device described above, the actuating arm may include a conductive tip at its distal end, and a second conductive wire may be electrically connected to the conductive tip.

[0105] In any further embodiment of the device described above, the first proximal arm may be held on the actuating arm, and an electrically insulating material may separate the first proximal arm from the second conductive wire.

[0106] In any further embodiment of the device described above, the first proximal arm may be held on an actuating arm, and an electrically insulating material may separate the second conductive wire from the first proximal arm.

[0107] In any further embodiment of the aforementioned device, the first conductive wire may be connected to ground, and the second conductive wire may be connected to an AC signal.

[0108] Any further embodiment of the aforementioned device may further include an electrical impedance sensor located within the handle of the delivery catheter, the electrical impedance sensor being connected to a first conductive wire and a second conductive wire and configured to determine the electrical impedance between the second conductive wire and the first distal arm.

[0109] Any further embodiment of the aforementioned device may include a programmable microchip that communicates with an impedance sensor and may be located within a handle, and may be configured to classify electrical impedance as one of electrical impedance through blood and electrical impedance through tissue walls.

[0110] Any further embodiment of the aforementioned device may further include an indicator light positioned on the handle of the delivery catheter, the indicator light being configured to communicate with a programmable microchip and transmit a signal when tissue capture occurs, based on the classification of electrical impedance.

[0111] A method for determining tissue capture of a shunt device includes deploying the first distal arm of the shunt device to puncture a tissue wall, moving the first proximal arm toward the first distal arm, positioning the first proximal arm in an deployed position relative to the first distal arm, providing an AC signal to the first electrode, determining the electrical impedance between the first electrode and the second electrode, and determining, based on the electrical impedance, whether tissue is captured between the first distal arm and the first proximal arm. The shunt device includes a central drainage tube, the first distal arm is positioned at the first axial end of the central drainage tube, and the first proximal arm is positioned at the second axial end of the central drainage tube. The first distal arm and the first proximal arm are configured to capture a tissue wall between them. The first distal arm engages freely with a tissue wall when deployed. The deployed position of the first proximal arm is configured to capture the tissue wall between the first distal arm and the first proximal arm when a tissue wall is present. One of the first electrode and the second electrode is positioned adjacent to the first proximal arm, and the other of the first electrode and the second electrode is located on the first distal arm.

[0112] The method of the preceding paragraph may optionally, additionally, and / or alternatively, include one or more of the following features, structures, additional components, and / or steps:

[0113] In a further embodiment of the method described above, the shunt device can be connected to a first conductive wire, and the second electrode can be connected to a second conductive wire.

[0114] In any further embodiment of the method described above, one of the first conductive wire and the second conductive wire is connected to ground, and the other of the first conductive wire and the second conductive wire is connected to an AC signal.

[0115] In any further embodiment of the above-described method, the shunt device further includes a second distal arm formed of a conductive material and attached to a first axial end of a central flow tube, and a second proximal arm attached to a second axial end of a central flow tube, wherein the second distal arm and the second proximal arm are configured to capture a tissue wall between them, and a first conductive wire may be electrically connected to the second proximal arm.

[0116] In any further embodiment of the method described above, the delivery catheter may further include an action arm configured to position a first proximal arm, and a second conductive wire may be received within the action arm.

[0117] In any further embodiment of the method described above, moving the first proximal arm to the deployed position may include moving the second electrode toward the first distal arm.

[0118] In any further embodiment of the method described above, an AC signal may be applied when the first proximal arm is in the deployed position.

[0119] In any further embodiment of the method described above, the second electrode may be located at the end of the first proximal arm and separated from the end by an insulating material.

[0120] In any further embodiment of the method described above, the second electrode may be a conductive tip located at the distal end of the working arm, and the second conductive wire is electrically connected to the conductive tip.

[0121] In any further embodiment of the method described above, the first proximal arm may be held on the actuating arm, and an electrically insulating material may separate the first proximal arm from the second conductive wire and conductive tip.

[0122] In any further embodiment of the method described above, the first conductive wire may be connected to earth, and the second conductive wire may be connected to an AC signal.

[0123] In any further embodiment of the method described above, the electrical impedance may be determined by an electrical impedance sensor located within the handle of the delivery catheter and connected to a first conductive wire and a second conductive wire.

[0124] A further embodiment of any of the methods described above may further include classifying the electrical impedance as one of the electrical impedances through blood and electrical impedances through tissue walls, via a programmable microchip located within the handle of the delivery catheter.

[0125] A further embodiment of any of the methods described above may include transmitting a signal via an indicator light, located on a handle and connected to a programmable microchip, when tissue capture occurs, based on electrical impedance.

[0126] One or more of the above methods can be carried out on living animals, or on simulations such as corpses, corpse hearts, anthropomorphic ghosts, or simulators (where body parts, hearts, tissues, etc., are simulated).

[0127] A device for determining tissue capture of a shunt device configured to be inserted into a tissue wall includes a delivery catheter and a shunt device positioned on the delivery catheter. The delivery catheter includes a first conductive wire having a first electrode and a second conductive wire having a second electrode. The shunt device includes a central flow tube extending from a first axial end to a second axial end, a first distal arm attached to the first axial end of the central flow tube, and a first proximal arm attached to the second axial end of the central flow tube, wherein the first distal arm and the first proximal arm are configured to capture the tissue wall between them. The first electrode is positioned on the first distal arm and separated from the shunt device by insulating material. The second electrode is positioned adjacent to the first proximal arm and separated from the first proximal arm by spatial separation and / or insulating material.

[0128] The device described in the preceding paragraph may optionally, additionally, and / or alternatively, include one or more of the following features, configurations, and / or additional components:

[0129] In one embodiment of the preceding device, one of the first conductive wire and the second conductive wire can be connected to ground, and the other of the first conductive wire and the second conductive wire can be connected to an AC signal.

[0130] In any further embodiment of the device described above, the delivery catheter may further include an actuation arm configured to position a first proximal arm. A second conductive wire may be received within the actuation arm.

[0131] In any further embodiment of the device described above, the actuating arm may include a conductive tip at its distal end, and a second conductive wire may be electrically connected to the conductive tip.

[0132] In any further embodiment of the device described above, the first proximal arm may be held on the actuating arm, and an electrically insulating material may separate the first proximal arm from the second conductive wire.

[0133] In any further embodiment of the aforementioned device, a second electrode may be positioned on the first proximal arm and separated from the first proximal arm by an insulating material.

[0134] In any further embodiment of the devices described above, the shunt device further includes a second distal arm attached to a first axial end of the central flow tube and a second proximal arm attached to a second axial end of the central flow tube, wherein the second distal arm and the second proximal arm are configured to capture a tissue wall between them, and the device may further include a third conductive wire having a third electrode. The third electrode is positioned on one of the second distal arm and the second proximal arm and may be separated from the second distal arm and the second proximal arm by an insulating material.

[0135] A further embodiment of any of the aforementioned devices may include a fourth conductive wire having a fourth electrode positioned on the other of the second distal arm and the second proximal arm. The fourth electrode may be separated from the second distal arm and the other of the second proximal arm by an insulating material.

[0136] A further embodiment of any of the aforementioned devices may include an electrical impedance sensor located within the handle of a delivery catheter and connected to a first conductive wire and a second conductive wire. The electrical impedance sensor is configured to determine the electrical impedance between the first electrode and the second electrode.

[0137] A further embodiment of any of the aforementioned devices may include a programmable microchip that communicates with an electrical impedance sensor and is located within the handle of a delivery catheter. The programmable microchip may be configured to classify electrical impedance as one of the following: electrical impedance through blood and electrical impedance through tissue walls.

[0138] Any further embodiment of the aforementioned device may include an indicator light positioned on the handle of the delivery catheter, the indicator light being configured to communicate with a programmable microchip and transmit a signal when tissue capture occurs, based on a calculated electrical impedance.

[0139] While the present invention has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various modifications may be made, and equivalents may be substituted for their elements without departing from the scope of the invention. Furthermore, many modifications may be made to adapt specific circumstances or materials to the teachings of the invention without departing from their essential scope. Thus, the present invention is not limited to the specific embodiments disclosed, and is intended to encompass all embodiments included in the appended claims.

Claims

1. A device for determining tissue capture of a shunt device, configured to be inserted into a tissue wall puncture, wherein the device is A delivery catheter, The first conductive wire, A delivery catheter comprising a second conductive wire, A shunt device disposed on the delivery catheter, wherein the shunt device is A central flow pipe extending from the first axial end to the second axial end, A first distal arm attached to the first axial end of the central flow tube, A shunt device comprising: a first proximal arm attached to the second axial end of the central flow tube, the first proximal arm configured to capture the tissue wall between the first distal arm and the first proximal arm; The first conductive wire is electrically connected to the shunt device. A device in which the second conductive wire is separated from the shunt device.

2. The device according to claim 1, wherein one of the first conductive wire and the second conductive wire is connected to ground, and the other of the first conductive wire and the second conductive wire is connected to an AC signal.

3. The aforementioned shunt device, A second distal arm is attached to the first axial end of the central flow tube, A second proximal arm attached to the second axial end of the central flow tube, further comprising a second proximal arm configured to capture the tissue wall between the second distal arm and the second proximal arm, The first conductive wire is electrically connected to the second proximal arm. The device according to claim 2, wherein the shunt device is formed of a conductive material.

4. The device according to claim 2, wherein the delivery catheter further comprises an actuation arm configured to position the first proximal arm, and the second conductive wire is received within the actuation arm.

5. The device according to claim 4, wherein the operating arm has a conductive tip at its distal end, and the second conductive wire is electrically connected to the conductive tip.

6. The device according to claim 4, wherein the first proximal arm is held on the actuating arm, the second conductive wire is positioned adjacent to the end portion of the proximal arm, and an electrically insulating material separates the first proximal arm from the second conductive wire.

7. An electrical impedance sensor is disposed within the handle of the delivery catheter, wherein the electrical impedance sensor is connected to the first conductive wire and the second conductive wire, and is configured to determine the electrical impedance between the second conductive wire and the first distal arm. The device according to claim 4, further comprising: a programmable microchip that communicates with the impedance sensor and is located within the handle of the delivery catheter, wherein the programmable microchip is configured to classify the electrical impedance as one of electrical impedances through blood and electrical impedances through tissue walls.

8. The device according to claim 7, further comprising an indicator light positioned on the handle of the delivery catheter, wherein the indicator light is configured to communicate with the programmable microchip and transmit a signal when tissue capture occurs based on the classification of the electrical impedance.

9. A method for determining tissue capture of a shunt device, wherein the shunt device comprises a central flow tube, a first distal arm positioned at a first axial end of the central flow tube, and a first proximal arm positioned at a second axial end of the central flow tube, wherein the first distal arm and the first proximal arm are configured to capture the tissue wall between them, and the method is Deploying the first distal arm to puncture the tissue wall via a delivery catheter, wherein the first distal arm is deployed so as to freely engage with the tissue wall. Moving the first proximal arm toward the first distal arm via the delivery catheter, and positioning the first proximal arm in an deployed position relative to the first distal arm, wherein the deployed position is configured to capture the tissue wall between the first distal arm and the first proximal arm if such a tissue wall exists. To provide an AC signal to the first electrode, The electrical impedance between the first electrode and the second electrode is determined such that one of the first electrode and the second electrode is positioned adjacent to the first proximal arm but electrically isolated from the first proximal arm, and the other of the first electrode and the second electrode is located on the first distal arm. A method comprising determining, based on the electrical impedance, whether tissue is trapped between the first distal arm and the first proximal arm.

10. The method according to claim 9, wherein the shunt device is connected to a first conductive wire, the second electrode is connected to a second conductive wire, one of the first conductive wire and the second conductive wire is connected to ground, and the other of the first conductive wire and the second conductive wire is connected to the AC signal.

11. The aforementioned shunt device, A second distal arm is attached to the first axial end of the central flow tube, A second proximal arm attached to the second axial end of the central flow tube, further comprising a second proximal arm configured to capture the tissue wall between the second distal arm and the second proximal arm, The first conductive wire is electrically connected to the second proximal arm. The method according to claim 10, wherein the shunt device is formed of a conductive material.

12. The method according to claim 10, wherein the delivery catheter further comprises an actuating arm configured to position the first proximal arm, the second conductive wire being received within the actuating arm, and moving the first proximal arm to the deployed position includes moving the second electrode toward the first distal arm, and the alternating current signal is applied when the first proximal arm is in the deployed position.

13. The method according to claim 12, wherein the second electrode is positioned at the end of the first proximal arm, and the second electrode is separated from the end by an insulating material.

14. The method according to claim 12, wherein the second electrode is a conductive tip located at the distal end of the operating arm, and the second conductive wire is electrically connected to the conductive tip.

15. The electrical impedance is classified as either the electrical impedance through the blood or the electrical impedance through the tissue wall via a programmable microchip located within the handle of the delivery catheter. The method according to claim 12, further comprising transmitting a signal when tissue capture occurs, based on the classification of electrical impedance, via an indicator light located on the handle and connected to the programmable microchip.

16. A device for determining tissue capture of a shunt device, configured to be inserted into a tissue wall puncture, wherein the device is A delivery catheter, A first conductive wire having a first electrode, A catheter comprising a second conductive wire having a second electrode, A shunt device disposed on the delivery catheter, wherein the shunt device is A central flow pipe extending from the first axial end to the second axial end, A first distal arm attached to the first axial end of the central flow tube, A shunt device comprising: a first proximal arm attached to the second axial end of the central flow tube, the first proximal arm configured to capture the tissue wall between the first distal arm and the first proximal arm; The first electrode is positioned on the first distal arm, and the first electrode is separated from the shunt device by an insulating material. A device in which the second electrode is positioned adjacent to the first proximal arm, and the second electrode is separated from the first proximal arm by spatial isolation and / or insulating material.

17. The device according to claim 16, wherein the delivery catheter further comprises an actuation arm configured to position the first proximal arm, the second conductive wire being received within the actuation arm and electrically isolated from the first proximal arm, the second conductive wire being electrically connected to a conductive tip at the distal end of the actuation arm, or being positioned on the first proximal arm and isolated from the first proximal arm by an insulating material.

18. A second distal arm attached to the first axial end of the central flow tube, A second proximal arm attached to the second axial end of the central flow tube, wherein the second distal arm and the second proximal arm are configured to capture the tissue wall between them, The present invention further comprises a third conductive wire having a third electrode, The device according to claim 17, wherein the third electrode is positioned on one of the second distal arm and the second proximal arm, and the third electrode is separated from the second distal arm and the second proximal arm by an insulating material.

19. The present invention further comprises a fourth conductive wire having a fourth electrode, The device according to claim 18, wherein the fourth electrode is positioned on the other of the second distal arm and the second proximal arm, and the fourth electrode is separated from the other of the second distal arm and the second proximal arm by an insulating material.

20. An electrical impedance sensor is disposed within the handle of the delivery catheter, and is connected to the first conductive wire and the second conductive wire, and is configured to determine the electrical impedance between the first electrode and the second electrode. A programmable microchip, which communicates with the electrical impedance sensor and is located within the handle of the delivery catheter, is configured to classify the electrical impedance as one of the following: electrical impedance through blood and electrical impedance through tissue wall. The delivery catheter further comprises an indicator light positioned on the handle, which is configured to communicate with the programmable microchip and transmit a signal when tissue capture occurs based on the classification of the electrical impedance, The device according to claim 16, wherein one of the first conductive wire and the second conductive wire is configured to be connected to ground, and the other of the first conductive wire and the second conductive wire is configured to be connected to an alternating current.

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