Cardiac micro-perfusion devices, methods and systems

Abstract

Disclosed are cardiac micro-perfusion devices including integrated flow restrictor and flow diversion from the left atrium to modulate flow within the vessel, in particular within the coronary sinus. Related methods and systems are also disclosed.

Description

CARDIAC MICRO-PERFUSION DEVICES, METHODS AND SYSTEMSRELATED APPLICATION DATA

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application Serial No. 63 / 641,130, filed on May 1, 2024, and titled “Vascular Flow and Retro-Perfusion Method and System” which is incorporated by reference herein in its entirety.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates to vascular interventional devices and methods, and more specifically, to devices to facilitate cardiac micro-perfusion and related systems and methods.BACKGROUND

[0003] A flow / pressure modulator is a vascular restrictor used by physicians, typically interventional cardiologists, to modulate hemodynamic flows and pressures to induce an artificial physiological effect beneficial to the patient that the current physiological system cannot achieve. The vascular restrictor is variable and of a specific diameter personalized to the patient’s needs at the time of implantation. The application of such a device is broad to all types of vessels (arterial and venous), and more particularly for reducing flow and augmenting pressure in the coronary sinus to benefit refractory angina and microvascular dysfunction patients.

[0004] Partial occlusion of the coronary sinus (CS) to achieve diversion of myocardial blood flow from CS to ischemic territories of the myocardium, thereby alleviating ischemia-derived angina, was first described by Claude S. Beck (Beck and Leighninger, J.A.M.A., November 27, 1954, Vol. 156, No. 13, Operations for Coronary Artery Disease, pp. 1226-1233) in the early 1950s. Beck demonstrated that partially ligating the CS to a diameter of 3 mm could alleviate symptoms in human patients with ischemic heart disease by increasing absolute coronary blood flow and decreasing coronary microvascular resistance. Efficacy of partial coronary sinus occlusion for this purpose using Coronary Sinus Reducer (CSR) devices continues to be of interest. See, e.g., Giannini F., et al., Impact of the coronary sinus reducer on the coronary artery circulation cases report, European Heart Journal - Case Reports (2022); 6, pp 1-2;https: / / doi.org / 10.1093 / ehjcr / ytacl 59; Palmisano A., et al., Feature tracking and mapping analysis of myocardial response to improved perfusion reserve in patients with refractory angina treated by coronary sinus Reducer implantation: a CMR study, International Journal of Cardiovascular Imaging, Vol. 37, pp 291-303 (2021); doi: 10.1007 / sl 0554-020-01964-9.

[0005] Further clinical data has revealed that along with its symptom -relieving effect, the Coronary Sinus Reducer (CSR) procedure has also been shown to improve objective indices of ischemia (e.g., dobutamine echocardiography) and physical function (e.g., 6-min walk test, treadmill ergometry, cardiopulmonary exercise test), as well as provide health economic benefit, (Galione et al., Cost-effectiveness of the coronary sinus Reducer and its impact on the healthcare burden of refractory angina pectoris, European Heart Journal - Quality of Care and Clinical Outcomes, Vol. 6, Is. 1, Jan. 2020, pp 32-40, https: / / doi.org / 10.1093 / ehjqcco / qcz027 (initially pub. May 24, 2019)), making a strong argument for a favorable risk-benefit ratio for this approach. CSR procedures are being used as a treatment to alleviate symptoms of debilitating angina otherwise refractory to optimal medical and revascularization strategies.

[0006] Currently available techniques for CSR procedures focus primarily on balloon expanded (BE)-CSR. Studies investigating the use of BE-CSR report that the BE-CSR is safe, with no device migration, continuous device patency, and no MACE related to the BE-CSR. See, e.g., Giannini et al., First experience with the Coronary Sinus Reducer System for the Management of Refractory Angina in Patients Without Obstructive Coronary Artery Disease, JACC: Cardiovascular Interventions Vol. 10, No. 18, September 25, 2017, pp. 1899-903; Cheng et al., Implantation of the coronary sinus reducer for refractory angina due to coronary microvascular dysfunction in the context of apical hypertrophic cardiomyopathy - a case report, European Heart Journal - Case Reports (2022) 6, ppl-7; https: / / doi.org / 10.1093 / ehcr / ytac440. Additionally, these studies provide evidence that the BE-CSR is effective in this population. An increased myocardial perfusion reserve index (MPRI) has been reported as well as improvement in subjective measures such as angina symptoms (CCS and / or Seattle Angina Questionnaire (SAQ)) and quality-of-life. Although not specifically related to CSRs, Ullrich et al., Coronary Venous Pressure and Microvascular Hemodynamics in Patients with Microvascular Angina, JAMA Cardiology, Brief Report, Vol. 8, No. 10 (2023) pp 979-983, jamacardiology.com, doi: 10.1001 / jamacardio.2023.2566, report efficacy of CS lumen reduction to increase CardiacFlow Reserve (CFR). This provides mechanistic evidence that CS restriction can influence empirical metrics of coronary function.

[0007] The present Applicant has developed improved vascular flow modulation devices including Self-Expanding (SE) CSR as described in U.S. Patent No. 12,070,404 and International Publication No. WO 2024 / 238724 Al, each of which is incorporated by reference herein in its entirety. Systems described in these prior disclosures include various hourglassshaped geometries, while streamlining its usability and avoiding the design complications of a covered stent design. These vascular flow modulation devices offer improvements compared to prior devices, in particular in the treatment of angina with coronary sinus-placed devices, including advantages in delivery and reduced time to effectiveness after placement.

[0008] Patients in heart failure also often exhibit adverse symptoms due to elevated left atrial pressure. Atrial septal shunts were developed to offload high pressure in the left atrium to the right atrium in an attempt to rebalance cardiac pressure. Examples of disclosures describing atrial septal shunts to reduce high blood pressure from the left atrium to the right atrium include U.S. Patent No. 10,413,284 (McNamara), U.S. Patent No. 10,251,740 (Eigler), U.S. Patent Publication No. 2024 / 0065840 (Vettukattil), U.S. Patent Publication No. 2020 / 0289196 (Arevalos), U.S. Patent Publication No. 2020 / 0261704 (Wang), and U.S. Patent No. 10,993,736 (Vardi). Another method that has been explored to offload the high pressure from the left atrium is shunt placement between the left atrium and coronary sinus that is connected to the right atrium. U.S. Patent No. 10,039,905 and U.S. Patent Publication No. 2023 / 0218232 (Rowe), show this type of atrial shunt.

[0009] In spite of the various advances described above, there still remains a need for improvements in treatment of conditions such as ischemia-derived angina and excess left atrial pressure.SUMMARY

[0010] In some aspects, the present disclosure is directed to a vascular device that includes an expandable open-cell tubular body configured for placement in a patient’s coronary sinus in contact with a wall of the coronary sinus; a flow restriction portion at a proximal end of the open-cell tubular body, the flow restriction portion including a reduced diameter orifice; an opendistal end opposite the flow restriction portion; and a side port disposed between the flow restriction portion and the open distal end, the side port comprising a circumferential open-cell side port wall extending outward from the open-cell tubular body and configured to extend into an anastomosis joining the coronary sinus with the left atrium.

[0011] In one or more embodiments of the vascular device, the expandable open-cell tubular body is self-expanding.

[0012] In one or more embodiments of the vascular device, the expandable open-cell tubular body is balloon expandable.

[0013] In one or more embodiments of the vascular device, open-cell size in the flow restriction portion is smaller than open cell size in one or both of the side port and the expandable open-cell tubular body proximally with respect to the flow restriction portion.

[0014] In one or more embodiments of the vascular device, the side port wall has a tissue adhesion promoting covering.

[0015] In one or more embodiments of the vascular device, the side port wall is tapered from a larger diameter side port opening to a narrower diameter junction with the expandable open-cell tubular body.

[0016] In one or more embodiments of the vascular device, the side port wall has a length sufficient to position the larger diameter side port opening within the left atrium when the vascular device deployed in the coronary sinus and the side port wall taper is configured to anchor the side port in the anastomosis by engaging a wall of the anastomosis within the anastomosis and extending radially beyond the wall of the anastomosis within the left atrium.

[0017] In one or more embodiments of the vascular device, the vascular device further comprises fixation tabs disposed at an outward end of the side port wall around a side port opening defined by the side port wall.

[0018] In one or more embodiments of the vascular device, the fixation tabs are foldable to capture tissue surrounding the anastomosis between the fixation tabs and the expandable opencell tubular body.

[0019] In one or more embodiments of the vascular device, the fixation tabs are formed of a shape memory alloy and self-foldable upon deployment.

[0020] In one or more embodiments of the vascular device, the fixation tabs foldable in response to applied force.

[0021] In one or more embodiments of the vascular device, the side port wall is configured to expand into the anastomosis biased against tissue surrounding the anastomosis and terminating at a position substantially aligned with the inner wall of the left atrium.

[0022] In one or more embodiments of the vascular device, the side port wall is configured with a length sufficient to extend into beyond the anastomosis into the left atrium and with a diameter less than a diameter of the anastomosis.

[0023] In one or more embodiments of the vascular device, the side port wall forms a tube positioned at an acute angle with respect to the expandable open-cell tubular body.

[0024] In some aspects, the present disclosure is directed to a method of modulating cardiac pressure, the method including forming an anastomosis between the left atrium and the coronary sinus to allow blood to flow from the left atrium into the coronary sinus; and restricting flow from the coronary sinus into the right atrium to limit pressure increase in the right atrium in response to flow of blood from the left atrium into the coronary sinus.

[0025] In one or more embodiments of the method, the method further includes positioning a stenting device in the anastomosis to maintain the blood flow from the left atrium into the coronary sinus.

[0026] In one or more embodiments of the method, the method further includes placing a coronary sinus reducer (CSR) within the coronary sinus between the anastomosis and the ostium of the coronary sinus to restrict flow from the coronary sinus into the right atrium.

[0027] In one or more embodiments of the method, the method further includes accessing a patient’s vasculature at the jugular vein; delivering a guidewire from access into the coronary sinus; using the guidewire, delivering a puncture device into the coronary sinus; forming an initial opening between the coronary sinus and left atrium with the puncture device; using theguidewire, delivering a dilation device into the coronary sinus and positioning the dilation device within the initial opening; and enlarging the initial opening with the dilation device to form the anastomosis.

[0028] In one or more embodiments of the method, the dilation device comprises a balloon catheter and the enlarging the initial opening comprises expanding a balloon of the balloon catheter within the initial opening.

[0029] In one or more embodiments of the method, the restricting flow from the coronary sinus and the positioning a stenting device include delivering a vascular device into the coronary sinus, wherein the vascular device comprises an expandable open-cell tubular body with a flow restriction portion at a proximal end of the open-cell tubular body an open distal end opposite the flow restriction portion, and a side port disposed between the flow restriction portion and the open distal end, the side port comprising an extendable side port wall; extending the side port wall into the anastomosis; and expanding the expandable open-cell tubular body in the coronary sinus to anchor the vascular device in the coronary sinus with the side port wall extending into the anastomosis.

[0030] In one or more embodiments of the method, the method further includes deploying fixation members at an end of the extendable side port wall to engage a wall of the left atrium and capture tissue surrounding the anastomosis between the fixation members and the expandable open-cell tubular body.

[0031] In one or more embodiments of the method, the expandable open-cell tubular body is self-expanding and the expanding comprises releasing the expandable open-cell tubular body from a delivery device.

[0032] In one or more embodiments of the method, the open-cell tubular body is delivered to the coronary sinus over a balloon and the expanding comprises balloon expanding the expandable open-cell tubular device.BRIEF DESCRIPTION OF THE DRAWINGS

[0033] To illustrate the disclosure, the drawings show aspects of one or more embodiments of the disclosure. However, it should be understood that the present disclosure is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein:FIG. l is a schematic diagram of a heart showing placement of a cardiac micro-perfusion device according to an embodiment of the present disclosure.FIG. 2 is a schematic diagram showing systemic flow modulation in vessels of the heart according to the present disclosure.FIG. 3 is a schematic side view of a further alternative embodiment of a vascular flow modulator and a clip shunt combined according to the present disclosure.FIG. 3A is a schematic side view of a further variation of the alternative embodiment shown in FIG. 3.FIG. 4 is a schematic side view of a further alternative embodiment of a vascular flow modulator and a T shunt combined according to the present disclosure.FIG. 5 is a schematic side view of another alternative embodiment of a vascular flow modulator and shunt according to the present disclosure.FIG. 6 is a schematic of a heart showing the four chambers with a vascular flow modulator and a shunt according to the present disclosure.DESCRIPTION OF EMBODIMENTS

[0034] Devices described in the present disclosure generally comprise an expandable scaffold to modulate hemodynamic output via a flow restriction and a flow diverting side port to redirect blood from the left atrium to inside a vessel, for instance, the coronary sinus in order to increase cardiac micro-perfusion. Devices disclosed herein generally comprise three functional aspects: anchoring structure configured to fix the device in a vascular lumen and avoid device embolization, a flexible structure configured to create a flow / pressure reduction at an output without excessively restricting flow and a flow diversion that provides the ability to cross from the left atrium into an adjoining vascular lumen. Conical or straight configurations are used as different structural platforms in various disclosed embodiments. Conical structures perform both the anchoring of the device in addition to the flow diversion. Straight body sections sized toexpand against the vascular lumen wall provide further anchoring. The left atrial flow diversion component may be covered with material such as PTFE to provide a scaffold to anchor across and into the left atrium. The flow diversion component also may have clips that self-spring around the opening to secure around the walls of an anastomosis joining the left atrium and adjoining vessel, such as the coronary sinus. The flow diversion component of the device thus provides a permanent conduit of arterial pressure into the venous side, such as the coronary sinus. Disclosed embodiments are thus configured to provide a therapy customized to the patient’s hemodynamic environment, which are useful in a short time frame and / or adjustable instill.

[0035] In one embodiment, cardiac micro-perfusion device 100, as shown in FIG. 1, is formed as expandable mesh body 102 with flow restriction portion 103 and side port 104. Expandable mesh body 102 may be constructed as a braided wire construct or as a laser cut tube construct and may be configured as a self-expanding construct or a balloon expandable construct. Flow restriction portion 103 includes reduced diameter orifice 106, which transitions to an enlarged proximal opening 108. Side port 104 is configured to communicate with the left atrium through an anastomosis formed through the atrium and coronary sinus walls. Side port 104 defines opening 110 within the left atrium. In some embodiments, the wall 112 of side port 104 is slightly tapered from wider at opening 110 down to narrower at transition 113 into the main body portion of mesh body 102. The tapered wall of side port 104 can be configured to help to anchor the side port within the anastomosis leading to the left atrium after deployment of device 100. Distal opening 114 is positioned at the end of expandable mesh body 102 opposite flow restriction portion 103. In some embodiments, side port 104 may be configured as a bare wire section. Alternatively and optionally, tapered side port wall 112 may be covered to provide tissue adhesion and a scaffold for tissue in-growth.

[0036] In one non-limiting example, devices as described herein may be formed with a Nitinol wire having a diameter of about 140 um, overall device length may be about 30-55 mm with the length of the flow restriction portion being about 22 mm. Mesh body 102, proximal end opening 108 and distal end opening 114 may have an outer diameter of about 11.6 mm and an inner diameter of about 11 mm. The inner diameter of reduced diameter orifice 106 may beabout 3.5 mm, with an outer diameter of about 4.1 mm. The inner diameter of side port 104, a point where it crosses the anastomosis, may be about 7 mm.

[0037] Persons of ordinary skill also may derive a variety of techniques for constructing devices according to the present disclosure. For example, devices disclosed herein may be formed using techniques described in Applicant’s prior disclosure WO 2024 / 238724 Al, which is incorporated by reference. One such technique involves braiding the device onto a shaping mandrel having substantially the same outer dimensions as the desired inner dimensions of the device to be made. For example, the shaping mandrel may be fed directly into the braider (as a core) and the cell angle is set corresponding to the section of the device where the wire is laid down on the shaping mandrel as per the dimensions provided (such as, for example, in the examples listed above). The braid is cinched down onto the shaping mandrel using a cinching wire, for example, silver-plated copper wire. The completed braid on the shaping mandrel is heat set in an oven (following material-specific heat treating protocols, for example approx. 550C for 10 mins, followed by quench to cool for the Nitinol wire size described above). The cinching wire is thereafter removed and the braided device thus shaped is removed from the core (shaping mandrel). It should be appreciated that different techniques for removing the core may be devised, such as use of a core that splits in half in the middle of the throat to allow the braid to be removed from the core.

[0038] Laser-cut tube devices according to the present disclosure can be made by making a pattern of small slits around and along a metal tube and then stretching the tube by pulling the ends in opposite directions to create expanded, open diamond-shaped cells dispersed along the elongated tube. The hourglass shape of the flow restriction portion is then created by shape setting the expanded straight tube on an appropriately sized mandrel. For example, the tube section is cinched down onto the shaping mandrel using wraps of a cinching wire to form the desired final shape with the flow restriction portion and reduced diameter orifice. The tube thus secured on the shaping mandrel is heat set in an oven at an appropriate time and temperature for the selected braid material (e.g., approximately 550 C for 10 mins, followed by quench to cool). The cinching wire is removed and the formed device is removed from shaping mandrel. The shape and size of the cells formed in this process will depend on the shape and size of the initial slits made in the tube.

[0039] Placement of disclosed devices may be made using clinically accepted cardiology procedures by accessing the jugular or femoral vein, and traversing the superior vena cava (SVC), right atrium, and into the coronary sinus. The anastomosis may be formed by puncture from the coronary sinus into the left atrium. The puncture may be expanded to a desired diameter by a balloon or blunt dilation. With the anastomosis formed and the device positioned in the coronary sinus, the guidewire is positioned through the anastomosis into the left atrium and the flow diversion component of the device follows the guidewire from the coronary sinus into the left atrium. After confirmation of placement, anchoring components are deployed. With embodiments disclosed herein there is not a need for separate access to the left atrium (other than through the anastomosis).

[0040] FIG. 2 illustrates systemic circulation in vessels of the heart including flow from the coronary arteries to the arterioles and into the venules when modulated by devices disclosed herein. As shown therein, the CS flow restriction 202 in combination with the LA-CS flow path 204 may provide re-distribution of flow back through the capillary vessels to contribute to increased oxygenated blood supply in the coronary arteries in terms of one or both of additional flow and dwell time. For example, flow 206 into the coronary sinus may be slowed down due to the restriction and the capillary vessels dilate, while flow 208 may be increased to the capillary vessels and possibly other branches communicating through the venules. Depending on factors such as patient physiology and disease state, flow may be reversed in the capillary vessels.

[0041] Further alternative embodiments are hereinafter described. Unless specifically otherwise stated, features, configurations and functions of these alternative embodiments are substantially the same as for the embodiment described above in greater detail.

[0042] In one alternative embodiment, cardiac micro-perfusion device 300, shown in FIG. 3, has expandable mesh body 302 with side port 304 configured to communicate with the left atrium LA again through an appropriately sized anastomosis. Expandable mesh body is to be configured to expand against the vessel wall (VW) to anchor the device at the selected location within the coronary sinus (CS). Device 300 also includes flow restriction portion 305 with reduced diameter orifice 306 leading to proximal end opening 308. In this embodiment, side port 304 is formed as an expandable mesh structure defining side port opening 310, but side portwall 312 is formed with relatively larger cell size as compared to the body 302 and flow restriction portion 305. Petals or tabs 313 form a crimp mechanism to secure the side port to the inner wall of the left atrium LA. The folding or crimping of fixation features such as tabs 313 around the anastomosis can be accomplished with a mechanical tool or inflating a balloon to bend the tabs around the opening of the anastomosis. Alternatively, tabs 313 are formed from a shape memory that allow and self-deploy into the fixation position as shown in FIG. 3 when released from a delivery device. Expandable mesh body 302 terminates with distal end opening 314 opposite flow restriction portion 305.

[0043] In a further alternative embodiment, shown in FIG. 3A, cardiac micro-perfusion device 300A is substantially the same as device 300 except that expandable mesh body 302A is formed with a larger mesh cell size, which may be similar to the cell size of side port wall 312. In order to facilitate blood flow through reduced diameter orifice 306, flow restriction portion 305 is formed with a smaller cell size. For example, in a device having the illustrative dimensions above, cell size in the mesh body portion may be about 1 mm2- 1.8 mm2, while cell size in the flow restriction portion, at least in the area of the reduced diameter orifice, may be about 0.04 mm2to 0.3 mm2.

[0044] FIG. 4 shows another alternative embodiment. In this embodiment, cardiac microperfusion device 400 has expandable mesh body 402, side port 404, and flow restriction portion 405 with reduced diameter orifice 406, which cooperate to modulate blood flow in the coronary sinus in the same manner as described with respect to other disclosed embodiments. Proximal end opening 408 is adjacent flow restriction portion 405 and distal end opening 414 is at the opposite end of expandable mesh body 402. Side port wall 412 defines side port opening 410 in the left atrium LA and is formed with an expandable mesh that secures against the sides of the anastomosis to contribute to anchoring of the device at the placement position in the coronary sinus CS aligned with and extending into the anastomosis.

[0045] In yet another alternative embodiment, the side port may be formed as an extended tube-like structure. As shown in FIG. 5, cardiac micro-perfusion device 500 has expandable mesh body 502, side port 504, and flow restriction portion 505 with reduced diameter orifice 506, which cooperate to modulate blood flow in the coronary sinus in the same manner asdescribed with respect to other disclosed embodiments. Proximal end opening 508 is adjacent flow restriction portion 505 and distal end opening 514 is at the opposite end of expandable mesh body 502. In this embodiment, side port wall 512 is configured to form an expandable mesh tube terminating in side port opening 510. As will be noted by persons of ordinary skill, side port 504 does not require an additional tool to crimp around the anastomosis.

[0046] In a further aspect of the present disclosure, methods of modulating vascular flow are described. Embodiments of the described methods comprise preparing a vascular flow modulator for placement in a patient, delivering the vascular flow modulator through the patient’s vasculature to a treatment site as described above, placing the vascular flow modulator within a vascular lumen at the treatment site, and adjusting a narrowed flow reducing portion of the vascular flow modulator based on specific patient clinical need. In some embodiments, the adjusting of the narrowed flow reducing portion comprises configuring the vascular flow modulator during the preparing step. In other embodiments, the adjusting of the narrowed flow reducing portion comprises changing an internal diameter of the narrowed flow reducing portion after placing the vascular flow modulator in the vascular lumen.

[0047] Embodiments described in the present disclosure also may include procedures employing a combination of a coronary sinus flow modulator and a flow diversion from the left atrium to the coronary sinus using a separate shunt device to provide advantages and benefits of the cardiac micro-perfusion devices described herein, such increased micro-perfusion and in some cases retro-perfusion within the coronary sinus. This methodology is illustrated in FIG. 6 using a system comprising two separate components, the first component would be either a balloon expanded or self-expanded coronary sinus reducer (CSR) 602 that can be delivered into the coronary sinus by either the jugular vein or the femoral vein. The second component would be an expandable stenting device or stent-like device 603 to maintain the anastomosis and provide a permanent conduit to the coronary sinus from the left atrium. One example of a device suitable as stenting device 603 is a LA-CS shunt such as shown in U.S. Patent No. 10,039,905 mentioned above. Stenting device 603 may be delivered from inside the coronary sinus and puncture into the left atrium leaving the device to maintain the blood pathway across from the LA to the CS. The stenting device could also be placed from the left atrium side. The blood from the LA would enter the CS and the CSR would provide flow modulation to increaseone or more of dwell time of oxygenated blood in the coronary arteries, micro-perfusion and / or retro-perfusion, as well as provide pressure reduction in the LA while modulating resulting pressure increase in the RA. In some embodiments, the anastomosis may not require a stenting device since the anastomosis across from the CS to LA may remain open on its own as long as the healing between the left atrium and coronary sinus would continue to allow for blood from the LA to cross into and up the coronary sinus.

[0048] Devices, methods and systems disclosed herein present a new alternative integrated approach in heart failure management and treatment of angina and left atrial pressure conditions by integrating flow modulation and shunting in a single device or complimentary methodology not previously available. Disclosed embodiments thus may offer new advantages as compared to conventional treatments for symptomatic ischemic disease patients. Self-expanding device embodiments disclosed herein also may offer further advantages including delivery systems and methodologies designed to minimize the risk of device dislodgement, potentially allowing for partial deployment and repositioning of the device to help achieve desired placement regardless of variations in the underlying anatomy, and in some embodiments providing the densely weaved nitinol cell design that enables significant immediate flow diversion without the need for a covering in the flow restriction portion. These advantages are expected to further enhance the safety and efficacy of the treatment for symptomatic ischemic disease patients.

[0049] Embodiments disclosed herein address concerns identified with existing coronary sinus flow modulation solutions through the deployment of a personalized restriction to maintain a specific pressure gradient. Such gradient can also be attained through the size of the flow diversion anastomosis which provides blood flow from higher pressure region to the vessel.

[0050] While not wishing to be bound by any particular theory, the following explanation is provided to aid in understanding certain aspects of the present disclosure. It is believed that the combination of modulation of flow exiting the coronary sinus with augmentation of blood volume entering the coronary sinus via the left atrial anastomosis will improve the infarcted areas of the heart by increasing oxygenated blood in the microvasculature. The coronary sinus is one of many parallel venous or drainage paths for cardiac circulation. When the coronary sinus is restricted, flow is diverted to the other drainage paths. In certain instances, alternate paths canaccommodate due to vasodilation or neovascularization, there is no increase in pressure, but flow diversion to alternate drainage paths will occur. If the restriction leads to a diversion that overwhelms the ability for the alternate drainage paths to accommodate, pressure will increase leading to flow distribution at the arterioles and potential retro-perfusion of the coronary arteries. The left atrial anastomosis provides increased flow and pressure to the coronary sinus, potentially reversing the flow in the venous side across the arterioles and back into the coronary capillaries. The combination of the restriction with the left atrial anastomosis pathway increases the amount of blood in the arterioles and causes the microvascular vessels to dilate and provide additional oxygen to the heart muscle.

[0051] The device is also theorized to improve results for heart failure patients with hypertension. It has been shown that a shunt crossing from the left atrium to the right atrium can improve hypertension in patients. But in some patients, the increase in the right atrium can cause right heart failure. The combination of the coronary sinus flow restriction with the left atrial flow diversion provides synergistic advantages not previously appreciated because without the vascular restrictor component of the disclosed devices, the additional flow from the left atrium flows unimpeded into the right atrium. However, with the flow restriction portion of the disclosed devices positioned proximal to the anastomosis within the coronary sinus, blood flow from the left atrium can be controlled and reduced leading back into the right atrium and thus lessening pressure in the right atrium relative to a left atrial shunt alone.

[0052] The foregoing has been a detailed description of illustrative embodiments of the disclosure. It is noted that in the present specification and claims appended hereto, conjunctive language such as is used in the phrases “at least one of X, Y and Z” and “one or more of X, Y, and Z,” unless specifically stated or indicated otherwise, shall be taken to mean that each item in the conjunctive list can be present in any number exclusive of every other item in the list or in any number in combination with any or all other item(s) in the conjunctive list, each of which may also be present in any number. Applying this general rule, the conjunctive phrases in the foregoing examples in which the conjunctive list consists of X, Y, and Z shall each encompass: one or more of X; one or more of Y; one or more of Z; one or more of X and one or more of Y; one or more of Y and one or more of Z; one or more of X and one or more of Z; and one or more of X, one or more of Y and one or more of Z.

[0053] Various modifications and additions can be made without departing from the spirit and scope of this disclosure. Features of each of the various embodiments described above may be combined with features of other described embodiments as appropriate in order to provide a multiplicity of feature combinations in associated new embodiments. Furthermore, while the foregoing describes a number of separate embodiments, what has been described herein is merely illustrative of the application of the principles of the present disclosure. Additionally, although particular methods herein may be illustrated and / or described as being performed in a specific order, the ordering is highly variable within ordinary skill to achieve aspects of the present disclosure. Accordingly, this description is meant to be taken only by way of example, and not to otherwise limit the scope of this disclosure or of the inventions as set forth in following claims.

Claims

CLAIMS1. A vascular device, comprising: an expandable open-cell tubular body configured for placement in a patient’s coronary sinus in contact with a wall of the coronary sinus; a flow restriction portion at a proximal end of the open-cell tubular body, the flow restriction portion including a reduced diameter orifice; an open distal end opposite the flow restriction portion; and a side port disposed between the flow restriction portion and the open distal end, the side port comprising a circumferential open-cell side port wall extending outward from the open-cell tubular body and configured to extend into an anastomosis joining the coronary sinus with the left atrium.

2. The vascular device of claim 1, wherein the expandable open-cell tubular body is selfexpanding.

3. The vascular device of claim 1, wherein the expandable open-cell tubular body is balloon expandable.

4. The vascular device of claim 1, wherein open-cell size in the flow restriction portion is smaller than open cell size in one or both of the side port and the expandable open-cell tubular body proximally with respect to the flow restriction portion.

5. The vascular device of claim 1, wherein the side port wall has a tissue adhesion promoting covering.

6. The vascular device of any of claims 1-5, wherein the side port wall is tapered from a larger diameter side port opening to a narrower diameter junction with the expandable open-cell tubular body.

7. The vascular device of claim 6, wherein the side port wall has a length sufficient to position the larger diameter side port opening within the left atrium when the vascular device deployed in the coronary sinus and the side port wall taper is configured to anchor the side port in the anastomosis by engaging a wall of the anastomosis within the anastomosis and extending radially beyond the wall of the anastomosis within the left atrium.

8. The vascular device of any of claims 1-5, further comprising fixation tabs disposed at an outward end of the side port wall around a side port opening defined by the side port wall.

9. The vascular device of claim 8, wherein the fixation tabs are foldable to capture tissue surrounding the anastomosis between the fixation tabs and the expandable open-cell tubular body.

10. The vascular device of claim 9, wherein the fixation tabs are formed of a shape memory alloy and self-foldable upon deployment.

11. The vascular device of claim 10, wherein the fixation tabs are foldable in response to applied force.

12. The vascular device of any of claims 1-5, wherein the side port wall is configured to expand into the anastomosis biased against tissue surrounding the anastomosis and terminating at a position substantially aligned with the inner wall of the left atrium.

13. The vascular device of any of claims 1-5, wherein the side port wall is configured with a length sufficient to extend into beyond the anastomosis into the left atrium and with a diameter less than a diameter of the anastomosis.

14. The vascular device of claim 11, wherein the side port wall forms a tube positioned at an acute angle with respect to the expandable open-cell tubular body.

15. A method of modulating cardiac pressure, comprising: forming an anastomosis between the left atrium and the coronary sinus to allow blood to flow from the left atrium into the coronary sinus; and restricting flow from the coronary sinus into the right atrium to limit pressure increase in the right atrium in response to flow of blood from the left atrium into the coronary sinus.

16. The method of claim 15, further comprising positioning a stenting device in the anastomosis to maintain the blood flow from the left atrium into the coronary sinus.

17. The method of claim 15, further comprising placing a coronary sinus reducer (CSR) within the coronary sinus between the anastomosis and the ostium of the coronary sinus to restrict flow from the coronary sinus into the right atrium.

18. The method of any of claims 15, 16 or 17, further comprising:accessing a patient’s vasculature at the jugular vein; delivering a guidewire from access into the coronary sinus; using the guidewire, delivering a puncture device into the coronary sinus; forming an initial opening between the coronary sinus and left atrium with the puncture device; using the guidewire, delivering a dilation device into the coronary sinus and positioning the dilation device within the initial opening; and enlarging the initial opening with the dilation device to form said anastomosis.

19. The method of claim 18, wherein the dilation device comprises a balloon catheter and said enlarging the initial opening comprises expanding a balloon of the balloon catheter within the initial opening.

20. The method of claim 16, wherein said restricting flow from the coronary sinus and said positioning a stenting device comprise: delivering a vascular device into the coronary sinus, wherein the vascular device comprises an expandable open-cell tubular body with a flow restriction portion at a proximal end of the open-cell tubular body, an open distal end opposite the flow restriction portion, and a side port disposed between the flow restriction portion and the open distal end, the side port comprising an extendable side port wall; extending the side port wall into the anastomosis; and expanding the expandable open-cell tubular body in the coronary sinus to anchor the vascular device in the coronary sinus with the side port wall extending into the anastomosis.

21. The method of claim 20, further comprising deploying fixation members at an end of the extendable side port wall to engage a wall of the left atrium and capture tissue surrounding the anastomosis between the fixation members and the expandable open-cell tubular body.

22. The method of claim 20 or claim 21, wherein the expandable open-cell tubular body is selfexpanding and said expanding comprises releasing the expandable open-cell tubular body from a delivery device.

3. The method of claim 20 or claim 21, wherein the open-cell tubular body is delivered to the coronary sinus over a balloon and said expanding comprises balloon expanding the expandable open-cell tubular device.

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