Left atrial appendage shunting system

Abstract

A shunt device is configured to be implanted at a site of an elongated shunt opening in a tissue wall between a left atrial appendage (LAA) and a great cardiac vein (GCV) of a human heart. The shunt device includes a body portion through which a flow path extends, one or more anchoring portions connected to the body portion, and an elongated flow path opening configured to align with the elongated shunt opening in the tissue wall to permit blood to flow from the LAA into the GCV through the shunt device along the flow path.

Description

Docket: ADV-23767WO01LEFT ATRIAL APPENDAGE SHUNTING SYSTEMCROSS-REFERENCE TO RELATED APPLICATION^ )

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 689,026, filed August 30, 2024, the disclosure of which is hereby incorporated by reference herein in its entirety for all purposes.BACKGROUND

[0002] The present disclosure relates generally to cardiovascular shunts and, more specifically, to devices, systems, and methods for shunting from the left atrial appendage.

[0003] Atrial fibrillation (also known as AFib or A-fib) is an abnormal heart rhythm (or arrhythmia) characterized by irregular — often very rapid — beating of the atrial chambers of the heart. AFib is one of the most common types of arrhythmias. During AFib, the atria beat chaotically (posing a risk of blood stasis and thrombosis or clotting) and out of sync with the ventricles, such that the ventricles are unable to fill completely or pump enough blood to the lungs and body. Untreated, AFib can lead to life-threatening complications including stroke, heart failure, and other heart-related complications.

[0004] Heart failure (also known as congestive heart failure) is a common condition affecting humans, whereby suboptimal heart pump performance results in symptoms, morbidity, and / or mortality, sometimes even despite maximal medical treatment. In particular, diastolic heart failure (also known as heart failure with preserved ejection fraction, or HFpEF) refers to the clinical syndrome of heart failure occurring in the context of preserved left ventricular systolic function (ejection fraction) and in the absence of major valvular disease. Approximately one half of patients with heart failure have diastolic heart failure and there are very few, if any, proven effective treatments. Diastolic heart failure is characterized by a stiff left ventricle with decreased compliance and impaired relaxation, which leads to increased end-diastolic pressure, which in turn causes an elevation in pressure in the left atrium. Symptoms of diastolic heart failure are due, at least in a large part, to this elevation in pressure in the left atrium. Both diastolic heart failure and heart failure with reduced ejection fraction (HFrEF) can exhibit elevated left atrial pressure (LAP). Elevated LAP is also present in several other abnormal heart or other medical conditions in addition to heart failure, including systolic dysfunction of the left ventricle and certain forms of congenital heart and valve disease.

[0005] The left atrial appendage is a muscular pouch-like structure that is continuous with the left atrium of the heart. The left atrial appendage serves as a decompression chamber during left ventricular systole and / or other periods when LAP is elevated and houses relative blood stasis due to its variable shape and extensive trabeculations. Because of this, the left atrial appendage, particularly during AFib, can be a substrate for formation of a blood clot (or thrombus), which places the patient at risk for embolic stroke.

[0006] Left atrial appendage occlusion (LAAO) may be offered to patients with AFib who desire stroke prophylaxis without the use of oral anticoagulation, e.g., due to prohibitive bleeding risk or lifestyle preference. One example of LAAO involves an externally applied clip to isolate the left atrial appendage from the left atrium. Another example of LAAO involves endocardial plugging of the left atrial appendage to isolate it from the left atrium. Current approaches to LAAO ultimately achieve the same effect of eliminating the left atrial appendage from the effective left atrial volume.SUMMARY

[0007] In one example, a shunt device is sized for implantation within an opening in a tissue wall between a left atrial appendage (LAA) and a great cardiac vein (GCV) of a human heart. The shunt device includes a body portion through which a flow path extends, one or more anchoring portions connected to the body portion, and an elongated flow path opening configured to align with the elongated shunt opening in the tissue wall to permit blood to flow from the LAA into the GCV through the shunt device along the flow path. Allowing blood to flow from the LAA into the GCV provides numerous benefits, such as enhancing compliance of the left atrium, which can alleviate symptoms of heart failure. Allowing blood to flow from the LAA into the GCV may also assist with washout of the LAA, thereby reducing the likelihood of clot formation.

[0008] In another example, a method of forming a shunt through a tissue wall between a left atrial appendage (LAA) and a great cardiac vein (GCV) of a human heart includes advancing a catheter-based shunting system to a site along the tissue wall between the LAA and the GCV, and forming one or more openings in the tissue wall at the site using the catheter-based shunting system to create one or more shunt openings that permit blood to flow from the LAA into the GCV through the one or more shunt openings.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] ANATOMY OF HEART H AND VASCULATURE V

[0010] FIG. 1 is a schematic diagram of a heart and vasculature.

[0011] FIG. 2 is a schematic cross-sectional view of the heart.

[0012] FIG. 3A is a schematic elevation view of the heart and vasculature showing a left atrial appendage and a great cardiac vein.

[0013] FIG. 3B is an enlarged partial view of the schematic view of FIG. 3A showing details of the left atrial appendage and the great cardiac vein.

[0014] SHUNT S

[0015] FIG. 4A is a schematic cross-sectional side view of a shunt formed between the left atrial appendage and the great cardiac vein.

[0016] FIG. 4B is a schematic top view of the shunt of FIG. 4A.

[0017] FIG. 4C is a schematic cross-sectional end view of the shunt of FIG. 4A and further showing trabeculations of the left atrial appendage.

[0018] FIGS. 5A-5D are schematic top views of various alternative shunt shapes.

[0019] FIG. 6 is a schematic cross-sectional side view of multiple shunts formed between the left atrial appendage and the great cardiac vein.

[0020] SYSTEM 50

[0021] FIG. 7 is a schematic side view of a shunting system positioned in the left atrial appendage and the great cardiac vein.

[0022] DEVICE 100

[0023] FIG. 8A is a schematic front perspective view of a first example of a shunt device.

[0024] FIG. 8B is a schematic cross-sectional view of the first example of the shunt device implanted in the left atrial appendage and the great cardiac vein.

[0025] DEVICE 200

[0026] FIG. 9 is a schematic side view of a second example of a shunt device implanted in the left atrial appendage and the great cardiac vein.

[0027] DEVICE 300

[0028] FIG. 10A is a schematic cross-sectional side view of a third example of a shunt device implanted in the left atrial appendage and the great cardiac vein.

[0029] FIG. 10B is a schematic front perspective view of the third example of the shunt device.

[0030] DEVICE 400

[0031] FIG. 11 is a schematic front perspective view of a fourth example of a shunt device.

[0032] DEVICE 500

[0033] FIG. 12 is a schematic side view of a fifth example of a shunt device implanted in the great cardiac vein.DETAILED DESCRIPTION

[0034] According to techniques of this disclosure, shunting blood from the left atrial appendage to the great cardiac vein — with or without placement of a shunt device — has the twofold purpose of decompressing the left atrium and providing left atrial appendage washout to mitigate stasis. That is, moving blood out of the left atrial appendage into the great cardiac vein can reduce LAP and also provide stroke prophylaxis. This would be beneficial in patients with heart failure and / or AFib.

[0035] In patients with otherwise normal heart structure and function (e.g., without enlarged chambers), the loss of effective left atrial volume due to LAAO may have no clinical consequence. However, for patients with cardiomyopathy substrates, such as an enlarged left atrium, a weakened left ventricle, and / or a filling-compromised left ventricle, the loss of effective left atrial volume registers as a loss of left atrial compliance when there is elevated LAP. Elevated LAP can only be transmitted a few places: into the left atrial appendage (i.e., the left atrial appendage can serve as a pressure pop-off chamber), forward through the mitral valve to the left ventricle, or oftentimes backwards to the lungs, especially if the left atrial appendage is eliminated.

[0036] It has been hypothesized that both subgroups of heart failure (HFpEF and HFrEF) might benefit from a reduction in LAP, which in turn reduces the systolic preload on the left ventricle (preload is also referred to as left ventricular end diastolic pressure (LVEDP). Reducing LAP could also relieve back-pressure on the pulmonary circulation, reducing the risk of pulmonary edema, improving respiration, and improving patient comfort. Reduction of back-pressure on the pulmonary circulation also reduces pulmonary artery pressures, which can injure the small arteries leading to the lungs resulting in pulmonary hypertension. Increased pulmonary artery pressures can also lead to pressure overload of the right ventricle, injuring the right ventricle and potentially leading to right sided heart failure. For patients who also experience AFib, the loss of atrial kick combined with pressure transmission retrograde to the pulmonary veins due to elevated LAP can further compromise the ability of the left atrium to empty in the appropriate anterograde direction.

[0037] Existing attempts to restore left atrial compliance tend to assume left atrial compliance behaves like vascular compliance. However, unlike a blood vessel, the leftatrial appendage is a terminal structure with no outlet. Spring-like mechanisms for attempting to restore compliance may face challenges in recoil timing. One theory is that the core problem to solve in this clinical scenario may not be compliance per se, but rather the effect of lost compliance, which is increased LAP and subsequent pulmonary congestion. Rather than focusing on compliance, another physiologically acceptable solution may be instead to shunt blood out of the left atrium and / or left atrial appendage to some other system.

[0038] Moreover, shunting blood out of the left atrial appendage can provide washout of the left atrial appendage to counter blood stasis occurring therein. Existing techniques for washing out the left atrial appendage, such as tubes connecting the left atrial appendage to another anatomical structure, may be limited in that stasis can still occur within a tube. Thus, directly shunting blood out of the left atrial appendage, as described herein, may be more effective for stroke prophylaxis.

[0039] Left atrial decompression in combination with a stroke prophylaxis solution could be effective for patients with heart failure and / or AFib who desire symptomatic improvement of AFib, stroke prophylaxis without anticoagulation, and / or no worsening of heart failure hospitalizations (e.g., as an alternative to LAAO). The present disclosure provides devices, systems, and methods that allow for stroke prophylaxis and for reducing LAP by shunting blood from the left atrial appendage to the great cardiac vein.

[0040] ANATOMY OF HEART H AND VASCULATURE V (FIGS. 1-3B)

[0041] FIG. 1 is a schematic diagram of heart H and vasculature V. FIG. 2 is a schematic cross-sectional view of heart H. FIG. 3 A is a schematic elevation view of heart H and vasculature V showing left atrial appendage LAA and great cardiac vein GCV. FIG. 3B is an enlarged partial view of the schematic view of FIG. 3 A showing details of left atrial appendage LAA and great cardiac vein GCV. FIGS. 1-3B will be discussed together. FIGS. 1-3A show heart H, vasculature V, left atrium LA, left ventricle LV, and pulmonary veins PVS. FIGS. 1-2 further show right atrium RA, right ventricle RV, superior vena cava SVC, inferior vena cava IVC, and mitral valve MV. FIG. 1 further shows tricuspid valve TV, pulmonary valve PV, pulmonary artery PA, and aortic valve AV. FIGS. 1 and 3A further show aorta AT. FIG. 2 further shows thebesian valve BV and inter-atrial septum IS. FIGS. 2-3B further show left atrial appendage LAA and great cardiac vein GCV. FIGS. 2 and 3A further show coronary sinus CS. FIG. 3A further shows oblique vein of left atrium OVLA. FIG. 3B further shows region R.

[0042] Heart H is a human heart that receives blood from and delivers blood to vasculature V. Heart H includes four chambers: right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV. As shown in FIG. 2, inter-atrial septum IS is the wall that separates right atrium RA from left atrium LA. The right side of heart H, including right atrium RA and right ventricle RV, receives deoxygenated blood from vasculature V and pumps the blood to the lungs. Blood flows into right atrium RA from superior vena cava SVC, inferior vena cava IVC, and coronary sinus CS. Blood flows and is pumped from right atrium RA through tricuspid valve TV into right ventricle RV. Contraction of right ventricle RV pumps blood through pulmonary valve PV into pulmonary artery PA. The blood flows from pulmonary artery PA into smaller arteries that deliver the deoxygenated blood to the lungs via the pulmonary circulatory system. The lungs can then oxygenate the blood.

[0043] The left side of heart H, including left atrium LA and left ventricle LV, receives oxygenated blood from the lungs and provides blood flow to the body. Blood flows into left atrium LA from pulmonary veins PVS. Direct flow and the pumping action of left atrium LA propels the blood through mitral valve MV into left ventricle LV. Blood is pumped by left ventricle LV through aortic valve AV into aorta AT. The blood flows from aorta AT into arteries that deliver the oxygenated blood to the body via the systemic circulatory system.

[0044] Blood is additionally received in right atrium RA from coronary sinus CS. Coronary sinus CS collects deoxygenated blood from the heart muscle and delivers it to right atrium RA. Thebesian valve BV (a pseudo-valve) is a semicircular fold of tissue at the opening of coronary sinus CS in right atrium RA. Thebesian valve BV is not always present, but some studies show it is present in greater than sixty percent (60%) of hearts.

[0045] Coronary sinus CS is wrapped around heart H and runs in part along and beneath the floor of left atrium LA just above mitral valve MV, as shown in FIG. 2. Coronary sinus CS also wraps around a portion of right atrium RA posteriorly before it enters right atrium RA via the ostium of coronary sinus CS lateral and posterior to an orifice of tricuspid valve TV and medial to an inferior vena cava IVC entry point. Coronary sinus CS begins at the junction of great cardiac vein GC V (also known as the left coronary vein) and oblique vein of left atrium OVLA (also known as the oblique vein of Marshall). Great cardiac vein GCV begins at the apex of heart H and ascends along the anterior interventricular sulcus (not labeled). Great cardiac vein GCV generally has an increasing diameter as it ascends to merge with oblique vein of left atrium OVLA and becomecoronary sinus CS. That is, great cardiac vein GCV is tapered along its length away from coronary sinus CS. Coronary sinus CS also has an increasing diameter as it approaches right atrium RA.

[0046] As shown in FIGS. 2-3B, left atrial appendage LAA is a muscular finger- or ear- like pouch or extension that originates from left atrium LA. Left atrial appendage LAA can vary in size and shape. Shapes of left atrial appendage LAA have been classified into four morphological types, including “chicken wing,” “cactus,” “windsock,” and “cauliflower” types. Left atrial appendage LAA serves as a decompression chamber for left atrium LA. Due to its shape and interior trabeculations, left atrial appendage LAA tends to be a location where blood can accumulate and become static, which can lead to the formation of clots in left atrial appendage LAA.

[0047] As is most easily seen in FIGS. 3A-3B, at least a portion of left atrial appendage LAA generally overlaps with great cardiac vein GCV. Region R (outlined schematically in FIG. 3B with dashed lines) indicates a region along the tissue wall (or walls) between left atrial appendage LAA and great cardiac vein GCV where left atrial appendage LAA overlays and is in close approximation to great cardiac vein GCV. For example, region R might be slightly inward from a tip or crease of left atrial appendage LAA toward a flatter portion that directly overlays great cardiac vein GCV. In some examples, left atrial appendage LAA may need to be shifted slightly (e.g., during a surgical procedure) to bring left atrial appendage LAA into closer approximation with great cardiac vein GCV. As will be described in greater detail below, region R can include one or more sites for forming a shunt between the left atrial appendage LAA and the great cardiac vein GCV.

[0048] Shunting from left atrial appendage LAA has the dual effects of preventing static blood from forming in left atrial appendage LAA and decompressing the left atrium LA by moving blood out of left atrial appendage LAA. Anatomically, the great cardiac vein GCV is a good option for shunting from the left atrial appendage LAA due to its position in close approximation to the left atrial appendage LAA, as illustrated in FIG. 3B. Further, if a clot did form in left atrial appendage LAA, rather than crossing the mitral valve MV into the left ventricle LV, the clot is more likely to go through the shunt from left atrial appendage LAA into great cardiac vein GCV, move through great cardiac vein GCV to the coronary sinus CS, pass into right atrium RA from coronary sinus CS, and then pass to the pulmonary system, where the deleterious effects may be reduced. A clot is likely to followthis path because there is a significant pressure gradient between right atrium RA and the coronary vasculature (i.e., coronary sinus CS and great cardiac vein GCV).

[0049] Other anatomical considerations or landmarks relating to left atrial appendage LAA include the left circumflex coronary artery (not shown), which generally runs parallel and adjacent to great cardiac vein GCV with variable positioning between the two, and the phrenic nerve (not shown), which is embedded within the pericardium in this region. Depending on the relative positioning of great cardiac vein GCV and the left circumflex coronary artery, shunt procedures impacting great cardiac vein GCV may also require attention to potential compression or possible iatrogenic damage to the left circumflex coronary artery. There also might be significant epicardial fat in this region, which may help contain blood flow through an implantable shunt or opening formed in the tissue.

[0050] SHUNT S (FIGS. 4A-6)

[0051] FIG. 4A is a schematic cross-sectional side view of shunt S formed between left atrial appendage LAA and great cardiac vein GCV. FIG. 4B is a schematic top view of shunt S. FIG. 4C is a schematic cross-sectional end view of shunt S and further showing trabeculations TR of left atrial appendage LAA. FIGS. 4A-4C will be discussed together. FIGS. 4A-4C show shunt S. FIG. 4A further shows tissue wall TW (including first side TW1, which is also shown in FIG. 4B, and second side TW2). FIGS. 4A-4B further show length L. FIGS. 4A and 4C further show flow path F, left atrial appendage LAA, and great cardiac vein GCV. FIGS. 4B-4C further show width W. FIG. 4C further shows trabeculations TR.

[0052] Shunt S is a shunt opening formed between left atrial appendage LAA and great cardiac vein GCV, such as at region R (shown in FIG. 3B). More specifically, shunt S is a shunt opening that extends through tissue wall TW from first side TW1 to second side TW2. First side TW1 is a first side of tissue wall TW, and second side TW2 is a second side of tissue wall TW. First side TW1 and second side TW2 can either represent independent tissue wall portions of adjacent anatomical structures (e.g., first side TW1 can be the tissue wall of left atrial appendage LAA, and second side TW2 can be the tissue wall of great cardiac vein GCV) or opposite sides of a continuous tissue wall region between adj cent anatomical structures (e.g., first side TW1 can be a first side and second side TW2 can be a second side of a continuous tissue wall region between left atrial appendage LAA and great cardiac vein GCV).

[0053] Shunt S can be formed by any suitable system for forming a shunt (e.g., system 50, as described below with reference to FIG. 7). In some examples, as will be described in greater detail below, the edges of shunt S can be sealed. Sealed edges of shunt S are shown schematically in FIG. 4A with rounded ends of tissue wall TW. FIG. 4C illustrates an example location of shunt S between left atrial appendage LAA and great cardiac vein GCV where left atrial appendage LAA and great cardiac vein GCV are held in direct apposition by the sealed edges of shunt S. In some examples, shunt S may also be formed through the trabeculations TR in the left atrial appendage LAA.

[0054] Shunt S has a length L and a width W. Length L is measured in a longitudinal direction along the great cardiac vein GCV. In some examples, shunt S is an elongated shunt opening. That is, as is most easily viewed in FIG. 4B, length L can be greater than width W. In such examples, the elongated shunt opening of shunt S can effectively “unroof’ great cardiac vein GCV in the region where left atrial appendage LAA overlaps great cardiac vein, i.e., in region R (shown in FIG. 3B). As further illustrated by the example shown in FIG. 4B, shunt S can be generally oval shaped; however, other shapes and dimensions of shunt S are possible, as will be described in greater detail below with reference to FIGS. 5A-6.

[0055] As shown in FIGS. 4 A and 4C, shunt S permits blood to flow from the left atrial appendage LAA to the great cardiac vein GCV along a flow path F. After entering the great cardiac vein GCV, blood continues along flow path F toward the coronary sinus CS (shown in FIGS. 2-3A) and then the right atrium RA (shown in FIGS. 1-2). Shunt S creates the following new physiologic scenarios: (a) in patients who are eu volemic with normal LAP and normal sinus rhythm (NSR), there may be little to no flow through shunt S; and (b) in patients with elevated LAP (e.g., due to AFib, heart failure, or other conditions), there will be activated flow through shunt S. In the first scenario with little or no flow through shunt S, direct apposition of left atrial appendage LAA and great cardiac vein GCV prevents static blood from forming, whereas this risk may not be mitigated in existing treatments where tubes connect between non-directly apposed structures. In some examples, shunt S being an elongated shunt opening allows for adequate flow along flow path F when shunting to a relatively small target blood vessel, such as great cardiac vein GCV. The elongated shunt opening of shunt S can have a greater cross-sectional area (e.g., compared to a circular shunt opening) while also having a narrow enough width to fit within the tissue wall of great cardiac vein GCV.

[0056] Blood flow through the shunt S along the flow path F moves blood out of the left atrium LA (shown in FIGS. 1-3A) via the left atrial appendage LAA and the great cardiac vein GCV. Shunt S can provide a highly effective decompression mechanism for the left atrium LA. More specifically, the great cardiac vein GCV effectively adds unlimited capacity to the left atrium LA because blood is continuously existing the left atrium LA via the great cardiac vein GCV. This benefit is achieved without reducing the volume of left atrial appendage LAA, such as occurs with occlusion (LAAO). Rather, the effective left atrial volume is actually increased due to preservation of the original left atrial appendage volume plus the shunted volume that exits via the great cardiac vein GCV. Accordingly, shunt S can reduce LAP, which may be beneficial for patients experiencing elevated LAP, such as patients with AFib and / or heart failure. Movement of blood through shunt S along flow path F can also wash out left atrial appendage LAA to prevent static blood or formation of clots in left atrial appendage LAA, which in turn can prevent strokes. Reduced LAP and stroke prophylaxis due to the formation of shunt S can improve patient outcomes, such as in patients with AFib and / or patients experiencing heart failure.

[0057] FIGS. 5A-5D are schematic top views of various alternative shunt shapes. FIG. 5A shows tapered shunt S'. FIG. 5B shows slit shunt S". FIG. 5C shows rounded shunt S'". FIG. 5D shows rectangular shunt S"". FIGS. 5A-5D further show a portion of first side TW1 (of tissue wall TW, as shown in FIG. 4A). FIGS. 5A-5D will be discussed together.

[0058] Tapered shunt S', slit shunt S", rounded shunt S'", and rectangular shunt S"" are examples of shunt S (shown in FIGS. 4A-4C). As shown in FIG. 5A, tapered shunt S' is tapered along its length. That is, one lengthwise end of tapered shunt S' is wider than the opposite lengthwise end of tapered shunt S'. For example, tapered shunt S' can be wider towards coronary sinus CS (shown in FIG. 2-3 A) and narrower away from coronary sinus CS, such that the taper of tapered shunt S' accommodates the natural tapering of great cardiac vein GCV. Tapered shunt S' can also have rounded or angled edges.

[0059] As shown in FIG. 5B, slit shunt S" is a slit shaped shunt opening. The width of slit shunt S" can be minimal. Tapered shunt S' and slit shunt S" are examples of elongated shunt openings. As shown in FIG. 5C, rounded shunt S'” is a generally circular shaped shunt opening. As shown in FIG. 5D, rectangular shunt S"" is a generally rectangular or square shaped shunt opening. Rounded shunt S'" and rectangular shunt S"" are examples of shunts openings that are not elongated. It should be understood that shuntopenings can also be combinations of the shapes shown in FIGS. 5A-5D and / or other regular or irregular shapes.

[0060] The shape of a shunt opening — such as one of tapered shunt S', slit shunt S", rounded shunt S'", and rectangular shunt S"" — can be selected, for example, to accommodate the anatomy of left atrial appendage LAA and great cardiac vein GCV. For example, the relatively small size of great cardiac vein GCV may necessitate a small or narrow shunt opening. The shape of a shunt opening can also be selected based on a desired amount of flow from left atrial appendage LAA to great cardiac vein GCV. For example, a longer, larger, or wider shunt opening could be selected for relatively more flow, and a shorter, smaller, or narrower shunt opening could be selected for relatively less flow.

[0061] FIG. 6 is a schematic cross-sectional side view of multiple shunts formed between left atrial appendage LAA and great cardiac vein GCV. FIG. 6 shows first shunt SI having first length LI, second shunt S2 having second length L2, and third shunt S3 having third length L3. FIG. 6 further shows left atrial appendage LAA, great cardiac vein GCV, flow path F, and tissue wall TW (including first side TW1 and second side TW2).

[0062] Each of first shunt SI, second shunt S2, and third shunt S3 is an example of shunt S (shown in FIGS. 4A-4C). Moreover, any one or more of first shunt SI, second shunt S2, and third shunt S3 can include features of tapered shunt S' (shown in FIG. 5A), slit shunt S" (shown in FIG. 5B), rounded shunt S'" (shown in FIG. 5C), and / or rectangular shunt S"" (shown in FIG. 5D). That is, in some examples, first shunt SI, second shunt S2, and third shunt S3 can be the same shape, and, in other examples, first shunt SI, second shunt S2, and third shunt S3 can be different shapes.

[0063] FIG. 6 illustrates an example where multiple shunt openings, including first shunt SI, second shunt S2, and third shunt S3, are spaced along the tissue wall TW (i.e., along a portion of the great cardiac vein GCV) within region R, as shown in FIG. 3B. Although three shunts (first shunt SI, second shunt S2, and third shunt S3) are shown in FIG. 6, it should be understood that any suitable number of shunts are possible, including more or fewer than three shunts. In some examples, the number of shunt openings can depend on the size of region R and / or the size (e.g., the length) of the shunt openings. In some examples, the number of shunt openings can depend on a desired rate of flow from left atrial appendage LAA to great cardiac vein GCV.

[0064] In the example shown in FIG. 6, first shunt SI is a most distal one of the shunts along the great cardiac vein GCV with respect to the coronary sinus CS (shown in FIGS. 2-3A), and third shunt S3 is a most proximal one of the shunts along great cardiacvein GCV with respect to coronary sinus CS. Second shunt S2 is located between first shunt SI and third shunt S3. As illustrated in FIG. 6, first shunt SI has first length LI, second shunt S2 has second length L2, and third shunt S3 has third length L3. First length LI, second length L2, and third length L3 can be the same or different. In some examples, first length LI can be greater than second length L2 and third length L3 (i.e., first shunt SI is a longest one of the shunts). In one example, first length LI is greater than second length L2, which in turn is greater than third length L3 (i.e., third shunt S3 is the shortest). That is, the lengths of first shunt SI , second shunt S2, and third shunt S3 can decrease moving proximally along great cardiac vein GCV toward coronary sinus CS.

[0065] Multiple shunts spaced along the length of great cardiac vein GCV (e.g., first shunt SI, second shunt S2, and third shunt S3) can be used additionally or alternatively to elongated shunt openings to allow for adequate flow along flow path F, given the relatively small size of great cardiac vein GCV. By including longer shunt openings (e.g., first shunt SI) more distally along great cardiac vein GCV and shorter shunt openings (e.g., third shunt S3) more proximally along great cardiac vein GCV, shunts can be sized to match the natural tapering of great cardiac vein GCV as it extends away from coronary sinus CS. Multiple shunts with different shapes and sizes can also accommodate different anatomical features along the length of great cardiac vein GCV.

[0066] SYSTEM 50 (FIG. 7)

[0067] FIG. 7 is a schematic side view of shunting system 50 positioned in left atrial appendage LAA and great cardiac vein GCV. As illustrated in FIG. 7, shunting system 50 (also referred to herein as “system 50”) includes first catheter 52 and second catheter 54, which are connected to electrical source 55 via electrical connection 57. First catheter 52 includes first magnets 56, and second catheter 54 includes second magnets 58. Second catheter 54 further includes cutter 60 and opening 62. First catheter 52 further includes recess 64. FIG. 7 further shows left atrial appendage LAA, great cardiac vein GCV, tissue wall TW (including first side TW1 and second side TW2), and direction EX.

[0068] System 50 is one example of a catheter-based shunting system for forming a shunt opening or aperture between anatomically adjacent chambers or vessels of the cardiovascular system of a patient. For example, as shown in FIG. 7, system 50 can be used to form a shunt through tissue wall TW between left atrial appendage LAA and great cardiac vein GCV. That is, system 50 can be used to form any of shunt S (shown in FIGS. 4A-4C), tapered shunt S' (shown in FIG. 5A), slit shunt S" (shown in FIG. 5B), rounded shunt S'" (shown in FIG. 5C), rectangular shunt S"" (shown in FIG. 5D), first shunt SI(shown in FIG. 6), second shunt S2 (shown in FIG. 6), and third shunt S3 (shown in FIG. 6).

[0069] It should be understood that system 50 is merely one example of a system for forming a shunt opening, and other suitable systems are possible, including singlecatheter approaches. In the example shown in FIG. 7, system 50 includes multiple catheters. Specifically, system 50 includes first catheter 52 and second catheter 54. First catheter 52 is in left atrial appendage LAA, and second catheter 54 is in great cardiac vein GCV.

[0070] Each of first catheter 52 and second catheter 54 comprises a flexible shaft or tube that can be moved through a patient’ s heart and / or vasculature. Each of first catheter 52 and second catheter 54 can include a handle or other similar component at a distal end to be grasped by a physician or other user to control movement of the catheter, which can further include a number of ports through which guidewires, tubes, fluids, or other components or elements may be passed. In some examples, the overall size of first catheter 52 can be minimized. This can allow an opening in inter-atrial septum IS (shown in FIG. 2) for accessing left atrium LA (shown in FIGS. 1-3A) to be likewise minimized, such that the opening may close spontaneously. In some such examples, the main operating components of system 50 can be contained in second catheter 54 to reduce the number of components contained in first catheter 52 and minimize the size of first catheter 52.

[0071] First catheter 52 and second catheter 54 are connected to electrical source 55 via electrical connection 57, as indicated with dashed lines in FIG. 7. Electrical source 55 is any suitable electrical source for supplying electrical current to first catheter 52 and second catheter 54. For example, electrical source 55 can be positioned externally to a patient’s body during a shunt formation procedure. Electrical connection 57 can be a wired connection between electrical source 55 and first catheter 52 and / or second catheter 54.

[0072] First catheter 52 includes first magnets 56, and second catheter 54 includes second magnets 58. FIG. 7 shows two first magnets 56 and two second magnets 58; however, first catheter 52 can include any suitable number of first magnets 56, such as more or fewer than two first magnets 56, and second catheter 54 can include any suitable number of second magnets 58, such as more or fewer than two second magnets 58. In some examples, at least one of first magnets 56 and second magnets 58 are electromagnets that are selectively magnetized. In such examples, first magnets 56 and / or second magnets 58 can be selectively magnetized to align with the opposing magnets (i.e., the other of first magnets 56 and second magnets 58) across tissue wall TW once first catheter 52 and secondcatheter 54 are moved to a desired location along tissue wall TW. First magnets 56 and second magnets 58 function together to maintain the alignment of first catheter 52 and second catheter 54 in a desired position for forming a shunt opening.

[0073] Second catheter 54 includes cutter 60. Cutter 60 is configured as a cutting implement for creating an opening or aperture through tissue wall TW, such as between left atrial appendage LAA and great cardiac vein GCV. For example, cutter 60 can utilize electrocautery, radio frequency (RF), ultrasound, or other cutting or ablation technologies. For example, cutter 60 can be connected via electrical connection 57 to electrical source 55 to receive electrical current. Cutter 60 can be at least partially contained within an internal lumen of second catheter 54. In some examples, cutter 60 can be a thin piece of wire. In some examples, cutter 60 is an electrode.

[0074] Second catheter 54 also includes opening 62. Opening 62 is an opening in the side of second catheter 54. Opening 62 is configured to allow cutter 60 to protrude or extend out of second catheter 54. Accordingly, opening 62 can be continuous with an internal lumen of second catheter 54 in which cutter 60 is contained. As illustrated in FIG. 7, at least a portion of cutter 60 can protrude or extend through opening 62. In some examples, cutter 60 can be pushed or actuated to cause a portion of cutter 60 to protrude or extend through opening 62. In other examples, cutter 60 can be self-expandable or mechanically expandable to cause a portion of cutter 60 to protrude or extend through opening 62. First catheter 52 includes recess 64. Recess 64 is a trough or depression in the side of first catheter 52 that is configured to receive the portion of cutter 60 that protrudes or extends through opening 62 of second catheter 54. That is, recess 64 can be sized and shaped to correspond to a size and shape of the protruded portion of cutter 60. As shown in FIG. 7, recess 64 is between first magnets 56 and opening 62 is between second magnets 58.

[0075] In operation, first catheter 52 and second catheter 54 are inserted and advanced to region R (shown in FIG. 3B) along left atrial appendage LAA and great cardiac vein GCV. In one example, first catheter 52 can be inserted through aorta AT (shown in FIG. 1) into left ventricle LV (shown in FIGS. 1-2), through mitral valve MV (shown in FIGS. 1-2) into left atrium LA (shown in FIGS. 1-3A), and into left atrial appendage LAA. In another example, first catheter 52 can be inserted from inferior vena cava IVC (shown in FIGS. 1-2), through right atrium RA (shown in FIGS. 1-2), across inter-atrial septum IS (shown in FIG. 2), into left atrium LA, and advanced from left atrium LA into left atrial appendage LAA. In some examples, first catheter 52 can be inserted through a pre-existingopening in inter-atrial septum IS. In one example, second catheter 54 can be inserted from superior vena cava SVC (shown in FIG. 2), through right atrium RA, into coronary sinus CS (shown in FIG. 2) via the ostium of the coronary sinus, and extended through coronary sinus CS to great cardiac vein GCV.

[0076] Once within region R, first catheter 52 is positioned along first side TW1 of tissue wall TW, and second catheter 54 is positioned along second side TW2 of tissue wall TW. As shown in FIG. 7, first catheter 52 and second catheter 54 are aligned across tissue wall TW between left atrial appendage LAA and great cardiac vein GCV, with first catheter 52 in left atrial appendage LAA and second catheter 54 in great cardiac vein GCV. Accordingly, in the example illustrated in FIG. 7, first side TW 1 is on a left atrial appendage side of tissue wall TW, and second side TW2 is on a great cardiac vein side of tissue wall TW. In other examples, first catheter 52 can be in great cardiac vein GCV and second catheter 54 can be in left atrial appendage LAA. First catheter 52 and second catheter 54 can be aligned, for example, using fluoroscopic visualization or other visualization techniques.

[0077] First magnets 56 are configured to face first side TW 1 when first catheter 52 is inserted along first side TW1 of tissue wall TW. Similarly, second magnets 58 are configured to face second side TW2 when second catheter 54 is inserted along second side TW2 of tissue wall TW. First magnets 56 and / or second magnets 58 are magnetized to maintain alignment of first catheter 52 and second catheter 54. First magnets 56 and second magnets 58 are attracted together with tissue wall TW sandwiched therebetween.

[0078] Aligning first catheter 52 and second catheter 54 also aligns opening 62 and recess 64. Cutter 60 is pushed or expanded through opening 62 in direction EX, as indicated by the arrows in FIG. 7. As it is pushed or expanded out of second catheter 54, cutter 60 pushes against and cuts through, or ablates, tissue wall TW from second side TW2 to first side TW 1 in the region bounded by first magnets 56 and second magnets 58. For example, cutter 60 can be energized using electrocautery, RF, or ultrasound technology to cut through tissue wall TW. The alignment of first magnets 56 and second magnets 58 ensures that only the desired portion of tissue wall TW is cut or ablated, which minimizes or prevents damage to other parts of the tissue. Recess 64 can serve as a backstop as cutter 60 cuts or ablates through tissue wall TW.

[0079] Cutting or ablating through tissue wall TW with cutter 60 forms a shunt opening through tissue wall TW, such as any of shunt S (shown in FIGS. 4A-4C), tapered shunt S' (shown in FIG. 5A), slit shunt S" (shown in FIG. 5B), rounded shunt S'" (shownin FIG. 5C), rectangular shunt S"" (shown in FIG. 5D), first shunt SI (shown in FIG. 6), second shunt S2 (shown in FIG. 6), and third shunt S3 (shown in FIG. 6). In some examples, such as examples where cutter 60 is an electrocautery wire, the edges of the resulting shunt opening are immediately sealed upon contact with cutter 60. Cauterizing the edge of the shunt opening can function to hold great cardiac vein GCV and left atrial appendage LAA in direct apposition. Alternatively, the pressure gradient alone may also maintain blood flow in the proper direction (i.e., from left atrial appendage LAA to great cardiac vein GCV) without extravasation. After formation of the shunt, cutter 60 can be retracted into second catheter 54, and both first catheter 52 and second catheter 54 can be removed from the body. In alternate embodiments, first catheter 52 can include cutter 60 and second catheter 54 can include recess 64.

[0080] The shunt formed using system 50 can be an “implantless” or “deviceless” shunt, meaning that the shunt opening does not require an implantable stent device or other implantable device to maintain patency of the shunt. An implantless shunt formation procedure carried out using system 50 can be a relatively short intervention, thereby reducing patient risk posed by more complex or extensive procedures. Moreover, an implantless shunt may be effective for shunting between left atrial appendage LAA and great cardiac vein GCV because the relatively small size of great cardiac vein GCV may be prohibitive or limiting for certain treatment options that would require more space.

[0081] System 50 may further improve patient outcomes in examples that include cautery or similar techniques for sealing the tissue because the shunt opening can have a higher likelihood of remaining patent (i.e., being permanent) compared to traditional shunts, which have some potential to reclose. That is, tissue ingrowth that could cause a shunt to reclose can be minimized or prevented by using system 50 to create a shunt opening with a sealed or cauterized edge. In turn, the higher likelihood of creating a permanent shunt by using system 50 can correspond to decreased frequency of further interventions, such as to reopen a closed shunt.

[0082] Using system 50 to form a shunt between left atrial appendage LAA and great cardiac vein GCV may also be more effective for preventing clots from forming in left atrial appendage LAA compared to other treatments like wash-out tubes between left atrial appendage LAA and another structure because blood can become static inside a tube. System 50, on the other hand, can form a shunt opening that directly connects left atrial appendage LAA to great cardiac vein GCV, such as with cautery or similar techniques forsealing the tissue or with the pressure gradient between left atrial appendage LAA and great cardiac vein GCV self-maintaining flow therebetween.

[0083] Several examples of shunt devices that can be implanted within or adjacent to a shunt opening, e.g., between left atrial appendage LAA and great cardiac vein GCV, will be described with reference to FIGS. 8A-12. Each shunt device example shown in FIGS. 8A-12 includes several generally similar components, which share the same name and which are identified by shared reference numbers that are increased incrementally between each of FIGS. 8A-12 (e.g., FIGS. 8A-8B include shunt device 100; FIG. 9 includes shunt device 200; FIGS. 10A-10B include shunt device 300; FIG. 11 includes shunt device 400; and FIG. 12 includes shunt device 500). For ease of discussion, details of some components of the shunt device examples shown in FIGS. 8A-12 may not be repeated in each of the following sections. Additionally, although depicted in FIGS. 8A-12 as separate examples, a shunt device according to techniques of this disclosure can generally include all or any combination of the components and features described herein, except where differences are explicitly indicated.

[0084] The shunt devices described herein (shunt devices 100, 200, 300, 400, 500) can be formed in a variety of ways, e.g., connecting individual wires together to form a mesh or lattice, braiding, cutting from a sheet and then rolling or otherwise forming into the shape of the shunt device, molding, cutting from a cylindrical tube (e.g., cutting from a nitinol tube), other ways, or a combination of these. All or a portion of shunt devices 100, 200, 300, 400, 500 can be made from a flexible metal, metal alloy, polymer, biocompatible material, bioresorbable material, or other suitable material. Examples of metals and metal alloys that can be used include, but are not limited to, nitinol (a nickel titanium alloy) and other shape-memory materials, elgiloy, and stainless steel, but other metals and resilient or compliant non-metal materials can be used to make shunt devices 100, 200, 300, 400, 500 or their constituent components. All or a portion of shunt devices 100, 200, 300, 400, 500 can be monolithically formed of any of these materials. These materials can allow shunt devices 100, 200, 300, 400, 500 to be compressed to a small size, and then — when the compression force is released — shunt devices 100, 200, 300, 400, 500 can self-expand back to the pre-compressed shape. Shunt devices 100, 200, 300, 400, 500 can expand back to the pre-compressed shape due to the material properties of shunt devices 100, 200, 300, 400, 500 and / or shunt devices 100, 200, 300, 400, 500 can be expanded by inflation or expansion of another device, e.g., positioned inside the respective shunt device. For example, shunt devices 100, 200, 300, 400, 500 can be compressed such that shunt devices100, 200, 300, 400, 500 can fit into a delivery catheter. Shunt devices 100, 200, 300, 400, 500 can also be made of other materials and can be expandable and collapsible in different ways, e.g., mechanically expandable, balloon-expandable, self-expandable, or a combination of these. In yet other examples, ones of shunt devices 100, 200, 300, 400, 500 are not expandable.

[0085] Devices 100, 200, 300, 400, 500 are examples of implantable devices that are configured to be implanted in blood vessels or chambers of heart H. Generally, devices 100, 200, 300, 400, 500 are configured to be implanted at the site of any of shunt S (shown in FIGS. 4A-4C), tapered shunt S' (shown in FIG. 5A), slit shunt S" (shown in FIG. 5B), rounded shunt S'" (shown in FIG. 5C), rectangular shunt S"" (shown in FIG. 5D), first shunt SI (shown in FIG. 6), second shunt S2 (shown in FIG. 6), and third shunt S3 (shown in FIG. 6). However, for ease of discussion, devices 100, 200, 300, 400, 500 will be described in the following sections with reference to shunt S. Moreover, multiple devices 100, 200, 300, 400, 500 can be implanted at multiple shunt sites, such as one of devices 100, 200, 300, 400, 500 for each of first shunt SI, second shunt S2, and third shunt S3. Devices 100, 200, 300, 400, 500 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or can be surgically placed using transcatheter or surgical procedures known in the art. In some examples, transcatheter delivery of devices 100, 200, 300, 400, 500 can follow similar routes as described previously with reference to first catheter 52 and second catheter 54 of system 50, as shown in FIG. 7.

[0086] DEVICE 100 (FIGS. 8A-8B)

[0087] FIG. 8A is a schematic front perspective view of shunt device 100. FIG. 8B is a schematic cross-sectional view of shunt device 100 implanted in left atrial appendage LAA and great cardiac vein GCV. FIGS. 8A-8B will be discussed together. As illustrated in FIGS. 8A-8B, shunt device 100 (also referred to herein as “device 100”) includes body portion 110 and anchoring portions 112 (including first curled end 112 A and second curled end 112B). As illustrated in FIG. 8A, shunt device 100 further includes proximal end 114, distal end 116, first surface 118, second surface 119, and opening 120, which has length LA, first end width WAA, and second end width WAB. FIG. 8B further shows left atrial appendage LAA (including trabeculations TR), great cardiac vein GCV, shunt S, tissue wall TW (including first side TW 1 and second side TW2) and flow path F.

[0088] Device 100 is an example of an implantable device that is configured to be implanted in blood vessels or chambers of heart H. Specifically, as shown in FIG. 8B, device 100 is configured to be positioned in left atrial appendage LAA and great cardiacvein GCV at the site of shunt S. Device 100 has a three-dimensional scroll-like shape that is formed of body portion 110 and anchoring portions 112. Body portion 110 is a main portion of device 100. Body portion 110 is cylindrical or about cylindrical and tubular in cross-section to permit blood flow therethrough, except body portion 110 is separated along its length to form opening 120. Body portion 110 is a portion of device 100 that is configured to be positioned within great cardiac vein GCV. Accordingly, body portion 110 is sized and shaped (or expandable) to fit within or conform to an interior of great cardiac vein GCV. In some examples, body portion 1 10 can be formed of a lattice or mesh. In some examples, body portion 110 can include a frame supporting a graft material. In other examples, body portion 110 can be solidly formed.

[0089] Device 100 extends from proximal end 114 to distal end 116 in a lengthwise direction. Proximal end 114 and distal end 116 are opposite ends of device 100. Proximal end 114 and distal end 116 also form respective first and second ends of body portion 110. Proximal end 114 is a proximal end of device 100 with respect to coronary sinus CS (shown in FIG. 2) when device 100 is implanted at the site of shunt S. Proximal end 114 can be a relatively downstream end of device 100 with respect to blood flow through device 100 along flow path F when body portion 110 of device 100 is implanted in great cardiac vein GCV. Distal end 116 is a distal end of device 100 with respect to coronary sinus CS when device 100 is implanted at the site of shunt S. Distal end 116 can be a relatively upstream end of device 100 with respect to blood flow through device 100 along flow path F when body portion 110 of device 100 is implanted in great cardiac vein GCV.

[0090] Device 100 further includes first surface 118 and second surface 119. First surface 118 is an exterior surface of device 100 at body portion 110. Second surface 119 is an interior surface of device 100 at body portion 110. Due to this arrangement, second surface 119 is generally a flow contacting surface of device 100. First surface 118 and second surface 119 also make up opposing sides of anchoring portions 112.

[0091] Anchoring portions 112 are connected to body portion 110. Anchoring portions 112 are configured to secure device 100 in position at the site of shunt S. Additionally, as shown in FIG. 8B, anchoring portions 112 are configured to cinch tissue wall TW together, including cinching first side TW1 and second side TW2 of tissue wall TW together. Anchoring portions 112 can cinch first side TW1 and second side TW2 sufficient to prevent blood from escaping around device 100 between left atrial appendage LAA and great cardiac vein GCV without causing tissue necrosis or ischemia. Accordingly, anchoring portions 112 can hold left atrial appendage LAA and great cardiacvein GCV in direct apposition. Anchoring portions 112 are also configured to hold tissue wall TW open at shunt S, as shown in FIG. 8B, so that blood can flow along flow path F from left atrial appendage LAA through device 100 into great cardiac vein GCV.

[0092] Anchoring portions 112 curl outward from body portion 110. Specifically, anchoring portions 112 include first curled end 112A and second curled end 112B. First curled end 112A and second curled end 112B are each continuous with a curvature of body portion 110 on respective first and second sides of the longitudinal separation in body portion 1 10 to form the scroll-like shape of device 100. First curled end 1 12A and second curled end 112B are shaped such that they are configured to curl from inside great cardiac vein GCV, around an edge of shunt S, and into left atrial appendage LAA when body portion 110 is positioned within great cardiac vein GCV. The curled shapes of first curled end 112A and second curled end 112B expose a portion of second surface 119 to the interior of left atrial appendage LAA, whereas first surface 118 contacts both first side TW 1 and second side TW2 of tissue wall TW.

[0093] First curled end 112A and second curled end 112B are configured to press down trabeculations TR in left atrial appendage LAA to secure device 100 within shunt S. First curled end 112A and second curled end 112B are sized to extend a sufficient distance along first side TW1 of tissue wall TW within left atrial appendage LAA to anchor device 100 and prevent slippage of device 100 through shunt S (first curled end 112A and second curled end 112B are shown schematically in FIGS. 8A-8B and may be longer or shorter than illustrated). The curled shapes of first curled end 112A and second curled end 112B also facilitate cinching first side TW1 and second side TW2 of tissue wall TW together to hold great cardiac vein GCV and left atrial appendage LAA in direct apposition and prevent extravasation.

[0094] Opening 120 is the opening formed by the lengthwise separation or split in body portion 110. Accordingly, opening 120 is a space between first curled end 112A and second curled end 112B. Opening 120 is a flow path opening of device 100 that is configured to align with shunt S to permit blood to flow along flow path F from left atrial appendage LAA, through device 100, and into great cardiac vein GCV. Opening 120 can be sized and shaped to correspond to (i.e., fit within) a size and shape of shunt S. Opening 120 has length LA, first end width WAA, and second end width WAB- First end width WAA is a width of opening 120 as measured at proximal end 114 of device 100. Second end width WAB is a width of opening 120 as measured at distal end 116 of device 100. In some examples, opening 120 has a uniform width (e.g., first end width WAA is the same as secondend width WAB). First end width WAA and second end width WAB of opening 120 can correspond to width W of shunt S, as shown in FIGS. 4B-4C. In other examples, opening 120 is tapered (e.g., first end width WAA is different from second end width WAB). For example, the tapering of opening 120 can correspond to the tapering of tapered shunt S' (shown in FIG. 5A). In one such example, first end width WAA is greater than second end width WAB- Length LA of opening 120 can correspond to length L of shunt S, as shown in FIGS. 4A-4B. In some examples, length LA is greater than first end width WAA and second end width WAB- In such examples, opening 120 is an elongated opening, which can correspond to an elongated shunt opening.

[0095] Once device 100 is implanted at the site of shunt S in left atrial appendage LAA and great cardiac vein GCV, circulating blood flows along flow path F from left atrial appendage LAA, through opening 120 of device 100, through body portion 110 of device 100, and exits device 100 at proximal end 114 into great cardiac vein GCV. Blood continues in great cardiac vein GCV to coronary sinus CS (shown in FIGS. 2-3 A) and right atrium RA (shown in FIGS. 1-2). Additionally, blood flowing in great cardiac vein GCV from more distal portions of great cardiac vein GCV beyond device 100 (i.e., towards the apex of heart H) can enter device 100 at distal end 116 and join blood flowing along flow path F.

[0096] As shown in FIG. 8A, device 100 has a relatively simple design that, in some examples, can be formed from a single piece of material that is curled into the illustrated scroll-like shape, including first curled end 112A and second curled end 112B. First curled end 112A and second curled end 112B anchor device 100 at the site of shunt S to encourage blood flow out of left atrial appendage LAA, through device 100, and into great cardiac vein GCV. First curled end 112A and second curled end 112B also hold left atrial appendage LAA and great cardiac vein GCV in direct apposition, which is beneficial for preventing extravasation and static blood formation, such as in conditions where there is not activated flow through device 100. Thus, device 100 helps maintain blood flow from left atrial appendage LAA into great cardiac vein GCV, thereby reducing LAP and providing stroke prophylaxis, which can improve patient outcomes, such as in patients with AFib and / or patients experiencing heart failure.

[0097] DEVICE 200 (FIG. 9)

[0098] FIG. 9 is a schematic side view of shunt device 200 implanted in left atrial appendage LAA and great cardiac vein GCV. As illustrated in FIG. 9, shunt device 200 (also referred to herein as “device 200”) includes body portion 210, anchoring portions 212(including first arms 212A and second arms 212B), first end 215, second end 217, and opening 220, which has length LB. FIG. 9 further shows left atrial appendage LAA, great cardiac vein GCV, shunt S, flow path F, and tissue wall TW (including first side TW1 and second side TW2).

[0099] Device 200 is another example of an implantable device that is configured to be implanted in blood vessels or chambers of heart H. Specifically, as shown in FIG. 9, device 200 is configured to be positioned in left atrial appendage LAA and great cardiac vein GCV at the site of shunt S. Device 200 is formed of body portion 210 and anchoring portions 212. Body portion 210 is a main portion of device 200. Body portion 210 is cylindrical or about cylindrical and tubular in cross-section to permit blood flow therethrough. Body portion 210 is a portion of device 200 that is configured to be positioned within shunt S between left atrial appendage LAA and great cardiac vein GCV. Accordingly, body portion 210 is sized and shaped (or expandable) to fit within or conform to a size and shape of shunt S. Body portion 210 can have a height that approximates the thickness of tissue wall TW. In some examples, body portion 210 can be formed of a lattice or mesh. For example, body portion 210 can be formed of struts and openings. In some examples, body portion 210 can include a frame supporting a graft material. In other examples, body portion 210 can be solidly formed.

[0100] Device 200 extends from first end 215 to second end 217 in a height-wise direction. First end 215 and second end 217 are opposite ends of device 200. First end 215 and second end 217 also form respective first and second ends of body portion 210. First end 215 can be a relatively upstream end of device 200 with respect to blood flow through device 200 along flow path F when body portion 210 of device 200 is implanted in shunt S. Second end 217 can be a relatively downstream end of device 200 with respect to blood flow through device 200 along flow path F when body portion 210 of device 200 is implanted in shunt S.

[0101] Anchoring portions 212 are connected to body portion 210. Anchoring portions 212 are configured to secure device 200 to tissue wall TW and within shunt S. Additionally, as shown in FIG. 9, anchoring portions 212 are configured to cinch tissue wall TW, including cinching first side TW1 and second side TW2 of tissue wall TW together. Anchoring portions 212 can cinch first side TW1 and second side TW2 sufficient to prevent blood from escaping around device 200 between left atrial appendage LAA and great cardiac vein GCV without causing tissue necrosis or ischemia. Accordingly, anchoring portions 212 can hold left atrial appendage LAA and great cardiac vein GCV indirect apposition. Anchoring portions 212 are also configured to hold tissue wall TW open at shunt S, as shown in FIG. 9, so that blood can flow along flow path F from left atrial appendage LAA through device 200 into great cardiac vein GCV.

[0102] Anchoring portions 212 extend radially outward from body portion 210. Specifically, anchoring portions 212 include first arms 212A and second arms 212B. First arms 212A are connected to body portion 210 at first end 215. Second arms 212B are connected to body portion 210 at second end 217. In the example shown in FIG. 9, device 200 includes two first arms 212A and two second arms 212B. However, it should be understood that other examples can include any suitable number of first and second arms, including more or fewer than two of each. First arms 212A and second arms 212B are positioned in clasping arrangements with one another. That is, one of first arms 212A is positioned opposite a corresponding one of second arms 212B to form a clasp around tissue wall TW at the edge of shunt S. As shown in FIG. 9, first arms 212A are configured to press against first side TW1 and second arms 212B are configured to press against opposed second side TW2 when device 200 is positioned within shunt S, such that the clasping arrangement of first arms 212A and second arms 212B can hold great cardiac vein GCV and left atrial appendage LAA in direct apposition and prevent extravasation.

[0103] Moreover, first arms 212A and second arms 212B are configured to press down trabeculations TR (shown in FIGS. 4C and 8B) in left atrial appendage LAA to secure device 200 within shunt S. First arms 212A and second arms 212B are sized to extend a sufficient distance along respective first side TW1 and second side TW2 of tissue wall TW to anchor device 200 and prevent slippage of device 200 through shunt S (first arms 212A and second arms 212B are shown schematically in FIG. 9 and may be longer or shorter than illustrated). First arms 212A and second arms 212B can be curved or straight, or can include both curved and straight portions, such that first arms 212A and second arms 212B are configured to curve toward tissue wall TW or press flat against tissue wall TW when device 200 is implanted in shunt S. The curved shapes of first arms 212A and second arms 212B also facilitate cinching first side TW1 and second side TW2 of tissue wall TW together to hold great cardiac vein GCV and left atrial appendage LAA in direct apposition and prevent extravasation.

[0104] Opening 220 is an open passageway through body portion 210. Opening 220 is a flow path opening of device 200 that is configured to align with shunt S to permit blood to flow along flow path F from left atrial appendage LAA, through device 200, and into great cardiac vein GCV. Opening 220 can be sized and shaped to correspond to (i.e.,fit within) a size and shape of shunt S. Opening 220 has length LB. Length LB of opening 220 can correspond to length L of shunt S, as shown in FIGS. 4A-4B. In some examples, length LB is greater than a width of opening 220. In such examples, opening 220 is an elongated opening, which can correspond to an elongated shunt opening. In some examples, opening 220 is tapered, and the tapering of opening 220 can correspond to the tapering of tapered shunt S' (shown in FIG. 5A).

[0105] Once device 200 is implanted at the site of shunt S in left atrial appendage LAA and great cardiac vein GCV, circulating hlood flows along flow path F from left atrial appendage LAA at first end 215, through opening 220 of device 200, and exits device 200 at second end 217 into great cardiac vein GCV. Blood continues in great cardiac vein GCV to coronary sinus CS (shown in FIGS. 2-3A) and right atrium RA (shown in FIGS. 1-2). Additionally, blood flowing in great cardiac vein GCV from more distal portions of great cardiac vein GCV beyond device 200 (i.e., towards the apex of heart H) may not enter device 200 but can join blood flowing along flow path F.

[0106] First arms 212A and second arms 212B anchor device 200 within shunt S to encourage blood flow out of left atrial appendage LAA, through device 200, and into great cardiac vein GCV. First arms 212A and second arms 212B also hold left atrial appendage LAA and great cardiac vein GCV in direct apposition, which is beneficial for preventing extravasation and static blood formation, such as in conditions where there is not activated flow through device 200. Thus, device 200 helps maintain blood flow from left atrial appendage LAA into great cardiac vein GCV, thereby reducing LAP and providing stroke prophylaxis, which can improve patient outcomes, such as in patients with AFib and / or patients experiencing heart failure.

[0107] DEVICE 300 (FIGS. 10A-10B)

[0108] FIG. 10A is a schematic cross-sectional side view of shunt device 300 implanted in left atrial appendage LAA and great cardiac vein GCV. FIG. 10B is a schematic front perspective view of shunt device 300. FIGS. 10A-10B will be discussed together. As illustrated in FIGS. 10A-10B, shunt device 300 (also referred to herein as “device 300”) includes body portion 310, anchoring portions 312 (including first collar 312A and second collar 312B), first end 315, second end 317, and opening 320, which has length Lc. FIG. 10A further shows left atrial appendage LAA, great cardiac vein GCV, shunt S, flow path F, and tissue wall TW (including first side TW1 and second side TW2).

[0109] Device 300 is another example of an implantable device that is configured to be implanted in blood vessels or chambers of heart H. Specifically, as shown in FIG.10A, device 300 is configured to be positioned in left atrial appendage LAA and great cardiac vein GCV at the site of shunt S. Device 300 has a double-disk shape, as is most easily viewed in FIG. 10B. Device 300 is formed of body portion 310 and anchoring portions 312. Body portion 310 is a main portion of device 300. Body portion 310 is cylindrical or about cylindrical and tubular in cross-section to permit blood flow therethrough. Body portion 310 is a portion of device 300 that is configured to be positioned within shunt S between left atrial appendage LAA and great cardiac vein GCV. Accordingly, body portion 310 is sized and shaped (or expandable) to fit within or conform to a size and shape of shunt S. Body portion 310 can have a height that approximates the thickness of tissue wall TW. In some examples, body portion 310 can be formed of a lattice or mesh. In some examples, body portion 310 can include a frame supporting a graft material. In other examples, body portion 310 can be solidly formed.

[0110] Device 300 extends from first end 315 to second end 317 in a height- wise direction. First end 315 and second end 317 are opposite ends of device 300. First end 315 and second end 317 also form respective first and second ends of body portion 310. First end 315 can be a relatively upstream end of device 300 with respect to blood flow through device 300 along flow path F when body portion 310 of device 300 is implanted in shunt S. Second end 317 can be a relatively downstream end of device 300 with respect to blood flow through device 300 along flow path F when body portion 310 of device 300 is implanted in shunt S.

[0111] Anchoring portions 312 are connected to body portion 310. Anchoring portions 312 are configured to secure device 300 to tissue wall TW and within shunt S. Additionally, anchoring portions 312 are configured to cinch tissue wall TW, including cinching first side TW1 and second side TW2 of tissue wall TW together. Anchoring portions 312 can cinch first side TW1 and second side TW2 sufficient to prevent blood from escaping around device 300 between left atrial appendage LAA and great cardiac vein GCV without causing tissue necrosis or ischemia. Accordingly, anchoring portions 312 can hold left atrial appendage LAA and great cardiac vein GCV in direct apposition. Anchoring portions 312 are also configured to hold tissue wall TW open at shunt S, as shown in FIG. 10 A, so that blood can flow along flow path F from left atrial appendage LAA through device 300 into great cardiac vein GCV.

[0112] Anchoring portions 312 extend radially outward from body portion 310. Specifically, anchoring portions 312 include first collar 312A and second collar 312B. First collar 312A and second collar 312B are flanges or annular projections from the ends ofbody portion 310. First collar 312A is connected to body portion 310 at first end 315. Second collar 312B is connected to body portion 310 at second end 317. As illustrated in FIG. 10B, each of first collar 312A and second collar 312B is a substantially solid and continuous piece that extends circumferentially around an entirety of first end 315 and second end 317, respectively, such that first collar 312A and second collar 312B can form acontinuous seal around the edges of shunt S. As illustrated in FIG. 10A, first collar 312A is configured to press against first side TW1 and second collar 312B is configured to press against opposed second side TW2 when device 300 is positioned within shunt S, such that first collar 312A and second collar 312B can hold great cardiac vein GCV and left atrial appendage LAA in direct apposition and prevent extravasation.

[0113] Moreover, first collar 312A and second collar 312B are configured to press down trabeculations TR (shown in FIGS. 4C and 8B) in left atrial appendage LAA to secure device 300 within shunt S. First collar 312A and second collar 312B are sized to extend a sufficient distance along respective first side TW 1 and second side TW2 of tissue wall TW to anchor device 300 and prevent slippage of device 300 through shunt S (first collar 312A and second collar 312B are shown schematically in FIGS. 10A-10B and may have a larger or smaller diameter than illustrated). That is, first collar 312A and second collar 312B have larger diameters than a diameter of shunt S to prevent device 300 from slipping through shunt S or becoming dislodged. First collar 312A and second collar 312B can be curved or straight, or can include both curved and straight portions, such that first collar 312A and second collar 312B are configured to curve toward tissue wall TW or press flat against tissue wall TW when device 300 is implanted in shunt S. Curved shapes of first collar 312A and second collar 312B also facilitate cinching first side TW1 and second side TW2 of tissue wall TW together to hold great cardiac vein GCV and left atrial appendage LAA in direct apposition and prevent extravasation.

[0114] Opening 320 is an open passageway through body portion 310. Opening 320 is a flow path opening of device 300 that is configured to align with shunt S to permit blood to flow along flow path F from left atrial appendage LAA, through device 300, and into great cardiac vein GCV. Opening 320 can be sized and shaped to correspond to (i.e., fit within) a size and shape of shunt S. Opening 320 has length Lc. Length Lc of opening 320 can correspond to length L of shunt S, as shown in FIGS. 4A-4B. In some examples, length Lc is greater than a width of opening 320. In such examples, opening 320 is an elongated opening, which can correspond to an elongated shunt opening. In someexamples, opening 320 is tapered, and the tapering of opening 320 can correspond to the tapering of tapered shunt S' (shown in FIG. 5A).

[0115] Once device 300 is implanted at the site of shunt S in left atrial appendage LAA and great cardiac vein GCV, circulating blood flows along flow path F from left atrial appendage LAA at first end 315, through opening 320 of device 300, and exits device 300 at second end 317 into great cardiac vein GCV. Blood continues in great cardiac vein GCV to coronary sinus CS (shown in FIGS. 2-3A) and right atrium RA (shown in FIGS. 1-2). Additionally, blood flowing in great cardiac vein GCV from more distal portions of great cardiac vein GCV beyond device 300 (i.e., towards the apex of heart H) may not enter device 300 but can join blood flowing along flow path F.

[0116] First collar 312A and second collar 312B anchor device 300 within shunt S to encourage blood flow out of left atrial appendage LAA, through device 300, and into great cardiac vein GCV. First collar 312A and second collar 312B also hold left atrial appendage LAA and great cardiac vein GCV in direct apposition, which is beneficial for preventing extravasation and static blood formation, such as in conditions where there is not activated flow through device 300. Moreover, first collar 312A and second collar 312B seal circumferentially around an entirety of shunt S to prevent extravasation more effectively. Thus, device 300 helps maintain blood flow from left atrial appendage LAA into great cardiac vein GCV, thereby reducing LAP and providing stroke prophylaxis, which can improve patient outcomes, such as in patients with AFib and / or patients experiencing heart failure.

[0117] DEVICE 400 (FIG. 11)

[0118] FIG. 11 is a schematic front perspective view of shunt device 400. As illustrated in FIG. 11, shunt device 400 (also referred to herein as “device 400”) includes body portion 410, anchoring portions 412 (including first collar 412A and second collar 412B) formed of arms 413 (including first arms 413A and second arms 413B), first end 415, second end 417, and opening 420, which has length LD.

[0119] Device 400 has a similar structure and design to device 300 described above in reference to FIGS. 10A-10B, except device 400 includes anchoring portions 412 formed of arms 413. More specifically, anchoring portions 412 of device 400 include first collar 412A and second collar 412B, which are similar to first collar 312A and second collar 312B of device 300, except first collar 412A and second collar 412B are not in the form of flanges but rather are formed of first arms 413A and second arms 413B, respectively.

[0120] Each of arms 413 is an individual projection that makes up anchoring portions 412, including first collar 412A and second collar 412B. As illustrated in FIG. 11, first collar 412A is formed of first arms 413A. First arms 413A are ones of arms 413 that are connected to body portion 410 at first end 415 of device 400 and extend radially therefrom. First collar 412A can include any suitable number of first arms 413A arranged circumferentially around first end 415. In some examples, first arms 413A are arranged circumferentially around an entirety of first end 415. Second collar 412B is formed of second arms 413B. Second arms 413B are ones of arms 413 that are connected to body portion 410 at second end 417 of device 400 and extend radially therefrom. Second collar 412B can include any suitable number of second arms 413B arranged circumferentially around second end 417. In some examples, second arms 413B are arranged circumferentially around an entirety of second end 417. Moreover, first arms 413A and second arms 413B are positioned in clasping arrangements with one another. That is, each one of first arms 413A is positioned opposite a corresponding one of second arms 413B to form a clasp around a tissue wall at the edge of a shunt opening in which device 400 is implanted.

[0121] Device 400, including first collar 412 A formed of first arms 413 A and second collar 412B formed of second arms 413B, combines features of device 200 (shown in FIG. 9) and device 300 (shown in FIGS. 10A-10B). First collar 412A and second collar 412B anchor device 400 within shunt S (shown in FIGS. 4A-4C) to encourage blood flow out of left atrial appendage LAA (shown in FIGS. 2-3B), through device 400, and into great cardiac vein GCV (shown in FIGS. 2-3B). First collar 412A and second collar 412B also hold left atrial appendage LAA and great cardiac vein GCV in direct apposition, which is beneficial for preventing extravasation and static blood formation, such as in conditions where there is not activated flow through device 400. Moreover, the circumferential arrangement of arms 413 allows first collar 412A and second collar 412B to seal around shunt S to prevent extravasation more effectively. Thus, device 400 helps maintain blood flow from left atrial appendage LAA into great cardiac vein GCV, thereby reducing LAP and providing stroke prophylaxis, which can improve patient outcomes, such as in patients with AFib and / or patients experiencing heart failure.

[0122] DEVICE 500 (FIG. 12)

[0123] FIG. 12 is a schematic side view of shunt device 500 implanted in great cardiac vein GCV. As illustrated in FIG. 12, shunt device 500 (also referred to herein as “device 500”) includes body portion 510, anchoring portions 512 (including first stentportion 512A and second stent portion 512B), proximal end 514, distal end 516, and opening 520, which has length LE. FIG. 12 further shows left atrial appendage LAA, great cardiac vein GCV, shunt S, flow path F, and tissue wall TW (including first side TW1 and second side TW2).

[0124] Device 500 is another example of an implantable device that is configured to be implanted in blood vessels or chambers of heart H. Specifically, as shown in FIG. 12, device 500 is configured to be positioned in great cardiac vein GCV at the site of shunt S. Device 500 is formed of body portion 510 and anchoring portions 512. Body portion 510 is a main portion of device 500. Body portion 510 is cylindrical or about cylindrical and tubular in cross-section to permit blood flow therethrough. Body portion 510 is a portion of device 500 that is configured to be positioned within great cardiac vein GCV. Accordingly, body portion 510 is sized and shaped (or expandable) to fit within or conform to an interior of great cardiac vein GCV. In some examples, body portion 510 can be formed of a lattice or mesh. In some examples, body portion 510 can include a frame supporting a graft material. In other examples, body portion 510 can be solidly formed.

[0125] Device 500 extends from proximal end 514 to distal end 516 in a lengthwise direction. Proximal end 514 and distal end 516 are opposite ends of device 500. Proximal end 514 is a proximal end of device 500 with respect to coronary sinus CS (shown in FIG. 2) when device 500 is implanted at the site of shunt S. Proximal end 514 can be a relatively downstream end of device 500 with respect to blood flow through device 500 along flow path F when body portion 510 of device 500 is implanted in great cardiac vein GCV. Distal end 516 is a distal end of device 500 with respect to coronary sinus CS when device 500 is implanted at the site of shunt S. Distal end 516 can be a relatively upstream end of device 500 with respect to blood flow through device 500 along flow path F when body portion 510 of device 500 is implanted in great cardiac vein GCV.

[0126] Anchoring portions 512 are connected to body portion 510. Anchoring portions 512 are configured to secure device 500 in position at the site of shunt S. Specifically, anchoring portions 512 include first stent portion 512A and second stent portion 512B. First stent portion 512A and second stent portion 512B are generally cylindrical stents extending axially from opposite ends of body portion 510 within great cardiac vein GCV. First stent portion 512A is connected to body portion 510 at a first end of body portion 510 such that first stent portion 512A has proximal end 514. Second stent portion 512B is connected to body portion 510 at a second end of body portion 510 such that second stent portion 512B has distal end 516. First stent portion 512A and secondstent portion 512B press against an interior wall of great cardiac vein GCV to hold device 500 in place adjacent shunt S and prevent slippage of device 500 within great cardiac vein GCV. For example, each of first stent portion 512A and second stent portion 512B can be expandable to anchor device 500.

[0127] Opening 520 is a lengthwise opening in the side of body portion 510. Opening 520 is a flow path opening of device 500 that is configured to align with shunt S to permit blood to flow along flow path F from left atrial appendage LAA, through device 500, and into great cardiac vein GCV. Opening 520 can be sized and shaped to correspond to (i.e., fit within) a size and shape of shunt S. Device 500 can be positioned within great cardiac vein GCV such that opening 520 faces shunt S. Opening 520 has length LE. Length LE of opening 520 can correspond to length L of shunt S, as shown in FIGS. 4A-4B. In some examples, length LE is greater than a width of opening 520. In such examples, opening 520 is an elongated opening, which can correspond to an elongated shunt opening. In some examples, opening 520 is tapered, and the tapering of opening 520 can correspond to the tapering of tapered shunt S' (shown in FIG. 5A).

[0128] Once device 500 is implanted at the site of shunt S in left atrial appendage LAA and great cardiac vein GCV, circulating blood flows along flow path F from left atrial appendage LAA, through opening 520 of device 500, through body portion 510 of device 500, and exits device 500 at proximal end 514 into great cardiac vein GCV. The pressure gradient between left atrial appendage LAA and great cardiac vein GCV can maintain flow in this direction. Blood continues in great cardiac vein GCV to coronary sinus CS (shown in FIGS. 2-3A) and right atrium RA (shown in FIGS. 1-2). Additionally, blood flowing in great cardiac vein GCV from more distal portions of great cardiac vein GCV beyond device 500 (i.e., towards the apex of heart H) can enter device 500 at distal end 516 and join blood flowing along flow path F.

[0129] As shown in FIG. 12, device 500 has a relatively simple design that does not require delivery across or through tissue wall TW (i.e., when implanted, device 500 is within great cardiac vein GCV and does not require device portions to be in left atrial appendage LAA). First stent portion 512A and second stent portion 512B anchor device 500 within great cardiac vein GCV at the site of shunt S to keep opening 520 aligned with shunt S and encourage blood flow out of left atrial appendage LAA, through device 500, and into great cardiac vein GCV. Additionally, first stent portion 512A and second stent portion 512B may also help support a shape of great cardiac vein GCV at the site of shunt S to further encourage blood flow therethrough. Thus, device 500 helps maintain bloodflow from left atrial appendage LAA into great cardiac vein GCV, thereby reducing LAP and providing stroke prophylaxis, which can improve patient outcomes, such as in patients with AFib and / or patients experiencing heart failure.

[0130] Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0131] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.

[0132] DISCUSSION OF DETAILED EMBODIMENTS

[0133] The following are non-exclusive descriptions of possible embodiments of the present invention.

[0134] A shunt device configured to be implanted at a site of an elongated shunt opening in a tissue wall between a left atrial appendage (LAA) and a great cardiac vein (GCV) of a human heart includes a body portion through which a flow path extends; one or more anchoring portions connected to the body portion; and an elongated flow path opening configured to align with the elongated shunt opening in the tissue wall to permit blood to flow from the LAA into the GCV through the shunt device along the flow path.

[0135] The shunt device of the preceding paragraph can optionally include, additionally and / or alternatively, any one or more of the following features, configurations and / or additional components:

[0136] The body portion is cylindrical or about cylindrical.

[0137] The body portion is configured to be positioned within the elongated shunt opening.

[0138] The one or more anchoring portions include one or more arms extending outward from the body portion and configured to secure the shunt device to the tissue wall and within the elongated shunt opening.

[0139] The one or more arms include: a first arm connected to the body portion at a first end of the body portion; and a second arm connected to the body portion at a second end of the body portion that is opposite the first end.

[0140] The first arm and the second arm are positioned in a clasping arrangement.

[0141] The first arm is configured to press against a first side of the tissue wall and the second arm is configured to press against an opposed second side of the tissue wall when the shunt device is positioned within the elongated shunt opening such that the clasping arrangement of the first and second arms is configured to hold the GCV and the LAA in direct apposition.

[0142] The one or more arms include: a plurality of first arms connected to the body portion at a first end of the body portion; and a plurality of second arms connected to the body portion at a second end of the body portion that is opposite the first end.

[0143] The plurality of first arms is arranged circumferentially about the first end of the body portion and the plurality of second arms is arranged circumferentially about the second end of the body portion.

[0144] Each first arm of the plurality of first arms is positioned in a clasping arrangement with a corresponding second arm of the plurality of second arms.

[0145] The one or more anchoring portions include one or more collars connected to the body portion and configured to secure the shunt device to the tissue wall and within the elongated shunt opening.

[0146] The one or more collars include: a first collar connected to the body portion at a first end of the body portion; and a second collar connected to the body portion at a second end of the body portion that is opposite the first end.

[0147] The first collar is configured to press against a first side of the tissue wall and the second collar is configured to press against an opposed second side of the tissue wall when the shunt device is positioned within the elongated shunt opening such that the first and second collars are configured to hold the GCV and the LAA in direct apposition.

[0148] The one or more collars extend circumferentially around an entirety of the body portion such that the one or more collars are configured to form a seal around the elongated shunt opening.

[0149] The body portion is configured to be positioned within the GCV.

[0150] The elongated flow path opening of the shunt device forms a longitudinal separation in the body portion, and wherein the one or more anchoring portions include a first curled end and a second curled end that are each continuous with a curvature of the body portion on respective first and second sides of the longitudinal separation such that the shunt device is scroll-like and configured to secure the shunt device to the tissue wall and within the elongated shunt opening.

[0151] The first and second curled ends are shaped such that the first and second curled ends are configured to curl from inside the GCV around an edge of the elongated shunt opening into the LAA when the body portion is positioned within the GCV.

[0152] The first and second curled ends are configured to press down trabeculations in the LAA.

[0153] The first and second curled ends are configured to hold the GCV and the LAA in direct apposition.

[0154] The one or more anchoring portions include one or more stent portions configured to be positioned in the GCV to secure the shunt device within the GCV.

[0155] The one or more stent portions include: a first stent portion connected to the body portion at a first end of the body portion; and a second stent portion connected to the body portion at a second end of the body portion that is opposite the first end.

[0156] The one or more stent portions are cylindrical.

[0157] A length of the elongated flow path opening of the shunt device is greater than a width of the elongated flow path opening of the shunt device.

[0158] The elongated flow path opening of the shunt device is tapered.

[0159] The one or more anchoring portions of the shunt device are configured to hold the GCV and the LAA in direct apposition.

[0160] The shunt device is formed at least partially of a shape-memory material.

[0161] The shape-memory material is nitinol.

[0162] The shunt device is sterilized.

[0163] The shunt device is configured to wash out the LAA to prevent blood stasis in the LAA.

[0164] The shunt device is configured to reduce left atrial pressure of a left atrium of the human heart.

[0165] A method of forming a shunt through a tissue wall between a left atrial appendage (LAA) and a great cardiac vein (GCV) of a human heart includes advancing a catheter-based shunting system to a site along the tissue wall between the LAA and the GCV; and forming one or more openings in the tissue wall at the site using the catheterbased shunting system to create one or more shunt openings that permit blood to flow from the LAA into the GCV through the one or more shunt openings.

[0166] The method of the preceding paragraph can optionally include, additionally and / or alternatively, any one or more of the following features, configurations and / or additional components:

[0167] The one or more shunt openings include an elongated shunt opening, and wherein a length of the elongated shunt opening in a longitudinal direction along the GCV is greater than a width of the elongated shunt opening.

[0168] The elongated shunt opening is tapered in a direction of tapering of the GCV.

[0169] The elongated shunt opening is an oval.

[0170] The elongated shunt opening is a slit.

[0171] The one or more shunt openings include a rounded shunt opening.

[0172] The one or more shunt openings include a rectangular shunt opening.

[0173] The one or more shunt openings include multiple shunt openings spaced along the tissue wall.

[0174] The multiple shunt openings have different lengths.

[0175] A longest shunt opening of the multiple shunt openings is located relatively distally along the GCV with respect to a coronary sinus (CS) of the human heart; and a shortest shunt opening of the multiple shunt openings is located relatively proximally along the GCV with respect to the CS.

[0176] The site along the tissue wall between the LAA and the GCV is a region where the LAA and the GCV are in close approximation.

[0177] Cauterizing an edge of each of the one or more shunt openings.

[0178] Cauterizing the edge of each of the one or more shunt openings holds the GCV and the LAA in direct apposition.

[0179] Forming the one or more openings in the tissue wall further includes cutting through the tissue wall.

[0180] Cauterizing an edge of each of the one or more shunt openings.

[0181] Cauterizing the edge of each of the one or more shunt openings holds the GCV and the LAA in direct apposition.

[0182] Delivering a shunt device to a first shunt opening of the one or more shunt openings, the shunt device including: a body portion through which a flow path extends; one or more anchoring portions connected to the body portion; and a flow path opening configured to align with the first shunt opening to permit blood to flow from the LAA into the GCV through the shunt device along the flow path.

[0183] Delivering the shunt device to the first shunt opening further includes positioning the body portion within the first shunt opening.

[0184] Delivering the shunt device to the first shunt opening further includes positioning the body portion within the GCV.

[0185] The first shunt opening is an elongated shunt opening and the flow path opening of the shunt device is an elongated flow path opening.

[0186] Advancing the catheter-based shunting system to the site along the tissue wall between the LAA and the GCV further includes: advancing a first catheter into the LAA; advancing a second catheter into the GCV; and aligning the first catheter and the second catheter across the tissue wall.

[0187] The first catheter includes a first magnet; the second catheter includes a second magnet; and aligning the first catheter and the second catheter across the tissue wall further includes: magnetizing at least one of the first magnet and the second magnet such that the first magnet and the second magnet are attracted together; and sandwiching the tissue wall between the first magnet and the second magnet.

[0188] The second catheter includes a cutting implement, the cutting implement being an electrocautery wire.

[0189] Forming one or more openings in the tissue wall at the site using the catheter-based shunting system further includes: pushing or expanding the cutting implement out of an opening in the second catheter; energizing the cutting implement; and cutting through the tissue wall at the site.

[0190] Cauterizing an edge of each of the one or more shunt openings with the electrocautery wire, wherein cauterizing the edge of each of the one or more shunt openings holds the GCV and the LAA in direct apposition.

[0191] One skilled in the art would appreciate that any of the medical devices described herein can be delivered via a medical device (e.g., a shunt) delivery system(s) (e.g., via catheter), which can be delivered from a variety of different entry points on the body based on where the shunt is being delivered. One example delivery system is described below.

[0192] A delivery system comprises a medical device delivery system (e.g., a shunt delivery system) configured to form a shunt through a tissue wall between a left atrial appendage (LAA) and a great cardiac vein (GCV) of a human heart includes advancing a catheter-based shunting system to a site along the tissue wall between the LAA and the GCV; and the delivery system is configured to create one or more openings in the tissue wall at the site using the catheter-based shunting system to create one or more shuntopenings that permit blood to flow from the LAA into the GCV through the one or more shunt openings.

[0193] The delivery system of the preceding paragraph can optionally be configured to include, additionally and / or alternatively, any one or more of the following functions, operations, features, configurations and / or additional components:

[0194] The one or more shunt openings include an elongated shunt opening, and wherein a length of the elongated shunt opening in a longitudinal direction along the GCV is greater than a width of the elongated shunt opening.

[0195] The elongated shunt opening is tapered in a direction of tapering of the GCV.

[0196] The elongated shunt opening is an oval.

[0197] The elongated shunt opening is a slit.

[0198] The one or more shunt openings include a rounded shunt opening.

[0199] The one or more shunt openings include a rectangular shunt opening.

[0200] The one or more shunt openings include multiple shunt openings spaced along the tissue wall.

[0201] The multiple shunt openings have different lengths.

[0202] A longest shunt opening of the multiple shunt openings is located relatively distally along the GCV with respect to a coronary sinus (CS) of the human heart; and a shortest shunt opening of the multiple shunt openings is located relatively proximally along the GCV with respect to the CS.

[0203] The site along the tissue wall between the LAA and the GCV is a region where the LAA and the GCV are in close approximation.

[0204] Cauterizing an edge of each of the one or more shunt openings.

[0205] Cauterizing the edge of each of the one or more shunt openings holds the GCV and the LAA in direct apposition.

[0206] Forming the one or more openings in the tissue wall further includes cutting through the tissue wall.

[0207] Cauterizing an edge of each of the one or more shunt openings.

[0208] Cauterizing the edge of each of the one or more shunt openings holds the GCV and the LAA in direct apposition.

[0209] Delivering a shunt device to a first shunt opening of the one or more shunt openings, the shunt device including: a body portion through which a flow path extends; one or more anchoring portions connected to the body portion; and a flow path openingconfigured to align with the first shunt opening to permit blood to flow from the LAA into the GCV through the shunt device along the flow path.

[0210] Delivering the shunt device to the first shunt opening further includes positioning the body portion within the first shunt opening.

[0211] Delivering the shunt device to the first shunt opening further includes positioning the body portion within the GCV.

[0212] The first shunt opening is an elongated shunt opening and the flow path opening of the shunt device is an elongated flow path opening.

[0213] Advancing the catheter-based shunting system to the site along the tissue wall between the LAA and the GCV further includes: advancing a first catheter into the LAA; advancing a second catheter into the GCV; and aligning the first catheter and the second catheter across the tissue wall.

[0214] The first catheter includes a first magnet; the second catheter includes a second magnet; and aligning the first catheter and the second catheter across the tissue wall further includes: magnetizing at least one of the first magnet and the second magnet such that the first magnet and the second magnet are attracted together; and sandwiching the tissue wall between the first magnet and the second magnet.

[0215] The second catheter includes a cutting implement, the cutting implement being an electrocautery wire.

[0216] Forming one or more openings in the tissue wall at the site using the catheter-based shunting system further includes: pushing or expanding the cutting implement out of an opening in the second catheter; energizing the cutting implement; and cutting through the tissue wall at the site.

[0217] Cauterizing an edge of each of the one or more shunt openings with the electrocautery wire, wherein cauterizing the edge of each of the one or more shunt openings holds the GCV and the LAA in direct apposition.

[0218] A shunt delivery system for placing a shunt through a tissue wall between a left atrial appendage (LAA) and a great cardiac vein (GCV) of a human heart includes a first catheter that is configured for advancing to a site along the tissue wall between the LAA and the GCV and forming one or more openings in the tissue wall between the LAA and the GVC at the site using the first catheter to create one or more shunt openings that permit blood to flow from the LAA into the GCV through the one or more shunt openings.

[0219] The shunt delivery system of the preceding paragraph can optionally include, additionally and / or alternatively, any one or more of the following features, configurations and / or additional components:

[0220] The one or more shunt openings include an elongated shunt opening, and wherein a length of the elongated shunt opening in a longitudinal direction along the GCV is greater than a width of the elongated shunt opening.

[0221] The elongated shunt opening is tapered along the length of the elongated shunt opening in a direction of tapering of the GCV.

[0222] The elongated shunt opening is an oval or a slit.

[0223] The one or more shunt openings include multiple shunt openings spaced along the tissue wall, wherein the multiple shunt openings have different lengths.

[0224] A longest shunt opening of the multiple shunt openings is located relatively distally along the GCV with respect to a coronary sinus (CS) of the human heart; and a shortest shunt opening of the multiple shunt openings is located relatively proximally along the GCV with respect to the CS.

[0225] The first catheter is configured for cauterizing an edge of each of the one or more shunt openings, wherein cauterizing the edge of each of the one or more shunt openings holds the GCV and the LAA in direct apposition.

[0226] Forming the one or more openings in the tissue wall comprises cutting through the tissue wall.

[0227] The first catheter is configured for cauterizing an edge of each of the one or more shunt openings, wherein cauterizing the edge of each of the one or more shunt openings holds the GCV and the LAA in direct apposition.

[0228] The first catheter is configured for delivering a shunt device to a first shunt opening of the one or more shunt openings, the shunt device including: a body portion through which a flow path extends; one or more anchoring portions connected to the body portion; and a flow path opening configured to align with the first shunt opening to permit blood to flow from the LAA into the GCV through the shunt device along the flow path.

[0229] Delivering the shunt device to the first shunt opening comprises positioning the body portion within the first shunt opening.

[0230] Delivering the shunt device to the first shunt opening comprises positioning the body portion within the GCV.

[0231] The first shunt opening is an elongated shunt opening and the flow path opening of the shunt device is an elongated flow path opening.

[0232] Advancing the first catheter to the site along the tissue wall between the LAA and the GC V comprises advancing the first catheter into the LAA or the GCV ; the shunt delivery system further comprises a second catheter that is configured for advancing into the GCV or the LAA; and the first catheter and the second catheter are configured to be aligned across the tissue wall between the LAA and the GCV.

[0233] The first catheter includes a first magnet; the second catheter includes a second magnet; and aligning the first catheter and the second catheter across the tissue wall between the LAA and the GCV comprises: magnetizing at least one of the first magnet and the second magnet such that the first magnet and the second magnet are attracted together; and sandwiching the tissue wall between the first magnet and the second magnet.

[0234] The first catheter or the second catheter includes a cutting implement, the cutting implement being an electrocautery wire; and forming one or more openings in the tissue wall between the LAA and the GCV at the site comprises: pushing or expanding the cutting implement out of an opening in the first catheter or the second catheter; energizing the cutting implement; cutting through the tissue wall between the LAA and the GCV at the site; and cauterizing an edge of each of the one or more shunt openings with the electrocautery wire, wherein cauterizing the edge of each of the one or more shunt openings holds the GCV and the LAA in direct apposition.

[0001]

[0235] A shunt delivery system for forming a blood flow pathway between a left atrial appendage and a great cardiac vein includes an elongate cutting catheter having a cutting implement disposed along a distal end thereof; an elongate delivery catheter; and a collapsible and expandable metallic shunt sized for placement within an opening between the left atrial appendage and the great cardiac vein, the shunt having a body portion formed by a plurality of cells and anchoring portions for placement in the left atrial appendage and the great cardiac vein; wherein the shunt is collapsible for advancement through a patient’s vasculature via the elongate delivery catheter, and wherein the shunt is expandable for placement in the opening, thereby providing a flow path for permitting blood to flow from the left atrial appendage into the great cardiac vein.

[0236] The shunt delivery system of the preceding paragraph can optionally include, additionally and / or alternatively, any one or more of the following features, configurations and / or additional components:

[0237] The cutting implement includes an electrocautery device.

[0238] The cutting implement includes a radio-frequency emitter.

[0239] The cutting implement includes a blade.

[0240] The shunt is made from a shape memory metal.

[0241] The shape memory metal is Nitinol.

[0242] The elongate cutting catheter includes a first magnet, and the elongate delivery catheter includes a second magnet, the first magnet and the second magnet being magnetizable for maintaining alignment of the elongate cutting catheter and the elongate delivery catheter.

[0243] The elongate delivery catheter comprises a recess for receiving a portion of the cutting implement.

[0244] The shunt further comprises an elongated flow path opening configured to align with the opening between the left atrial appendage and the great cardiac vein.

[0245] The shunt further comprises: a first collar connected to the body portion of the shunt at a first end of the body portion; and a second collar connected to the body portion of the shunt at a second end of the body portion that is opposite the first end.

[0246] The elongated flow path opening of the shunt device forms a longitudinal separation in the body portion.

[0247] A length of the elongated flow path opening of the shunt device is greater than a width of the elongated flow path opening of the shunt device.

[0248] The elongated flow path opening is tapered.

[0249] The anchoring portions of the shunt comprise: a first stent portion connected to the body portion of the shunt at a first end of the body portion and configured to be positioned in the great cardiac vein; and a second stent portion connected to the body portion at a second end of the body portion that is opposite the first end and configured to be positioned in the great cardiac vein.

[0250] The elongate delivery catheter is smaller than the elongate cutting catheter.

[0251] While the invention has been described with reference to an exemplary embodiment(s), it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment(s) disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims

CLAIMS:

1. A shunt delivery system for forming a blood flow pathway between a left atrial appendage and a great cardiac vein, comprising: an elongate cutting catheter having a cutting implement disposed along a distal end portion thereof; an elongate delivery catheter; and a collapsible and expandable metallic shunt sized for placement within an opening between the left atrial appendage and the great cardiac vein, the shunt having a body portion formed by a plurality of cells and anchoring portions for placement in the left atrial appendage and great cardiac vein; wherein the shunt is collapsible for advancement through a patient’s vasculature via the elongate delivery catheter, and wherein the shunt is expandable for placement in the opening, thereby providing a flow path for permitting blood to flow from the left atrial appendage into the great cardiac vein.The shunt delivery system of claim 1, wherein the cutting implement includes an electrocautery device.

3. The shunt delivery system of claim 1, wherein the cutting implement includes a radiofrequency (RF) emitter.The shunt delivery system of claim 1, wherein the cutting implement includes a cutting blade.

5. The shunt delivery system of claim 1, wherein the shunt is made from a shape memory metal.

6. The shunt delivery system of claim 5, wherein the shape memory metal is Nitinol.

7. The shunt delivery system of claim 1, wherein the elongate cutting catheter includes a first magnet, and the elongate delivery catheter includes a second magnet, the first magnet and the second magnet being magnetizable for maintaining alignment of the elongate cutting catheter and the elongate delivery catheter.

8. The shunt delivery system of claim 1, wherein the elongate delivery catheter comprises a recess for receiving a portion of the cutting implement.

9. The shunt delivery system of claim 1, wherein the shunt further comprises an elongated flow path opening configured to align with the opening between the left atrial appendage and the great cardiac vein.

10. The shunt delivery system of claim 9, wherein the anchoring portions comprise first and second collars extending from opposing end regions of the body portion.

11. The shunt delivery system of claim 9, wherein the elongated flow path opening of the shunt device forms a longitudinal separation in the body portion.

12. The shunt delivery system of claim 9, wherein a length of the elongated flow path opening of the shunt device is greater than a width of the elongated flow path opening of the shunt device.

13. The shunt delivery system of claim 12, wherein the elongated flow path opening is tapered.

14. The shunt delivery system of claim 1, wherein the anchoring portions comprise first and second stent portions coupled to the body portion.

15. The shunt delivery system of claim 1 , wherein the elongate delivery catheter is smaller in diameter than the elongate cutting catheter.

16. A shunt delivery system for forming a blood flow pathway between a left atrial appendage and a great cardiac vein, comprising:an elongate cutting catheter having an electrocautery tool disposed along a distal end thereof; a steerable elongate delivery catheter; and a collapsible and expandable shunt formed from a shape memory material, the shunt sized for placement within an opening between the left atrial appendage and the great cardiac vein, the shunt having a body portion formed by a plurality of cells and anchoring portions for placement in the left atrial appendage and great cardiac vein; wherein the shunt is collapsible for advancement through a patient’s vasculature via the elongate delivery catheter, and wherein the shunt is expandable for placement in the opening, thereby providing a flow path for permitting blood to flow from the left atrial appendage into the great cardiac vein.

17. A shunt device sized for implantation at a site of an elongated shunt opening in a tissue wall between a left atrial appendage (LAA) and a great cardiac vein (GCV) of a human heart, the shunt device comprising: a body portion through which a flow path extends; one or more anchoring portions connected to the body portion; and an elongated flow path opening configured to align with the elongated shunt opening in the tissue wall to permit blood to flow from the LAA into the GCV through the shunt device along the flow path.

18. The shunt device of claim 17, wherein the body portion is cylindrical or about cylindrical.

19. The shunt device of claim 17, wherein the body portion is configured to be positioned within the elongated shunt opening.

20. The shunt device of claim 19, wherein the one or more anchoring portions include one or more arms extending outwardly from the body portion and shaped to secure the shunt device to the tissue wall between the LAA and the GCV and within the elongated shunt opening.

21. The shunt device of claim 20, wherein the one or more arms include a first arm connected to the body portion at a first end and a second arm connected to the body portion at a second end.

22. The shunt device of claim 21, wherein the first arm and the second arm are positioned in a clasping arrangement, and wherein the first arm is configured to press against a first side of the tissue wall between the LAA and the GCV and the second arm is configured to press against an opposed second side of the tissue wall between the LAA and the GCV when the shunt device is positioned within the elongated shunt opening such that the clasping arrangement of the first arm and the second arm is configured to hold the GCV and the LAA in direct apposition.

23. The shunt device of claim 20, wherein the one or more arms include: a plurality of first arms connected to the body portion at a first end of the body portion; and a plurality of second arms connected to the body portion at a second end of the body portion that is opposite the first end; wherein the plurality of first arms is arranged circumferentially about the first end of the body portion and the plurality of second arms is arranged circumferentially about the second end of the body portion; and wherein each first arm of the plurality of first arms is positioned in a clasping arrangement with a corresponding second arm of the plurality of second arms.

24. The shunt device of claim 19, wherein the one or more anchoring portions include one or more collars connected to the body portion and configured to secure the shunt device to the tissue wall between the LAA and the GCV and within the elongated shunt opening.

25. The shunt device of claim 24, wherein the one or more collars include: a first collar connected to the body portion at a first end of the body portion; anda second collar connected to the body portion at a second end of the body portion that is opposite the first end; wherein the first collar is configured to press against a first side of the tissue wall between the LAA and the GCV and the second collar is configured to press against an opposed second side of the tissue wall between the LAA and the GCV when the shunt device is positioned within the elongated shunt opening such that the first collar and the second collar are configured to hold the GCV and the LAA in direct apposition.

26. The shunt device of claim 24, wherein the one or more collars extend circumferentially around an entirety of the body portion such that the one or more collars are configured to form a seal around the elongated shunt opening.

27. The shunt device of claim 17, wherein the elongated flow path opening of the shunt device forms a longitudinal separation in the body portion, wherein the one or more anchoring portions include a first curled end and a second curled end that are each continuous with a curvature of the body portion on respective first and second sides of the longitudinal separation such that the shunt device is scroll-like and configured to secure the shunt device to the tissue wall and within the elongated shunt opening, and, wherein the first curled end and the second curled end are shaped such that the first curled end and the second curled end are configured to curl from inside the GCV around an edge of the elongated shunt opening into the LAA when the body portion is positioned within the GCV.

28. The shunt device of claim 17, wherein the one or more anchoring portions include one or more stent portions configured to be positioned in the GCV to secure the shunt device within the GCV, and wherein the one or more stent portions include: a first stent portion connected to the body portion at a first end of the body portion; and a second stent portion connected to the body portion at a second end of the body portion that is opposite the first end.

29. The shunt device of claim 17, wherein a length of the elongated flow path opening of the shunt device is greater than a width of the elongated flow path opening ofthe shunt device, and wherein the elongated flow path opening of the shunt device is tapered.

30. The shunt device of claim 17, wherein the shunt device is sterilized.

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