Heart microperfusion device, method and system

Abstract

A cardiac microperfusion device is disclosed that includes an integrated flow restrictor and a diverter from the left atrium to modulate flow within the blood vessel, particularly flow within the coronary sinus. Related methods and systems are also disclosed.

Description

Relevant application data

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 641,130, filed May 1, 2024, entitled “Vascular Flow and Retro-Perfusion Method and System,” the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to vascular interventional devices and methods, and more specifically, to devices, systems and methods for promoting cardiac microperfusion. Background Technology

[0003] Flow / pressure modulators are vascular restrictors used by physicians (usually interventional cardiologists) to regulate hemodynamic flow and pressure to induce beneficial artificial physiological effects that are not achievable with current physiological systems. Vascular restrictors are variable and have a specific diameter personalized to the patient's needs at the time of implantation. These devices are widely applicable to all types of vessels (arteries and veins), particularly for reducing flow and increasing pressure in the coronary sinuses to benefit patients with refractory angina and microvascular dysfunction.

[0004] In the early 1950s, Claude S. Beck (Beck and Leighninger, JAMA, November 27, 1954, Vol. 156, No. 13, "Operations for Coronary Artery Disease", pp. 1226-1233) first proposed that partial occlusion of the coronary sinus (CS) could divert myocardial blood flow from the CS to the ischemic area, thereby relieving angina caused by ischemia. Beck demonstrated that partial ligation of the CS to a diameter of 3 mm could alleviate symptoms in patients with ischemic heart disease by increasing absolute coronary blood flow and reducing coronary microvascular resistance. The effectiveness of partial coronary sinus occlusion using a coronary sinus decompressor (CSR) device remains a subject of considerable interest. See, for example, Giannini F. et al., Impact of the coronary sinus reducer on the coronary arterycirculation cases report, European Heart Journal-Case Reports (2022), Vol. 6, pp. 1-2, https: / / doi.org / 10.1093 / ehjcr / ytac159; Palmisano A. et al., Feature tracking and mapping analysis of myocardial response to improved perfusion reserve inpatients with refractory angina treated by coronary sinus reducer implantation: a CMR study, International Journal of Cardiovascular Imaging (International Journal of Cardiovascular Imaging), Vol. 37, pp. 291-303 (2021), doi:10.1007 / s10554-020-01964-9.

[0005] Further clinical data have shown that, in addition to symptom relief, coronary sinus decompressor (CSR) surgery has also been shown to improve objective indicators of ischemia (such as dobutamine echocardiography) and physical function (such as the 6-minute walk test, treadmill ergometer test, and cardiopulmonary exercise test), and to bring health and economic benefits (Gallone 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, No. 1, January 2020, pp. 32-40, https: / / doi.org / 10.1093 / ehjqcco / qcz027 (originally published on May 24, 2019)). This provides strong evidence for the favorable risk-benefit ratio of this approach. CSR surgery is being used as a treatment to relieve symptoms of debilitating angina that are difficult to alleviate with optimal medication and revascularization strategies.

[0006] Currently available CSR surgical techniques mainly focus on balloon-expandable (BE)-CSR. Studies on BE-CSR have shown that it is safe, with no device displacement, continuous patency of the device, and no major adverse cardiovascular events (MACE) associated with BE-CSR. See, for example, 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: Interventional Cardiovascular Journal, Vol. 10, No. 18, September 25, 2017, pp. 1899-1903; 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 (European Heart Journal - Case Reports) (2022), Vol. 6, pp. 1-7, https: / / doi.org / 10.1093 / ehcr / ytac440. Furthermore, these studies provide evidence of the efficacy of BE-CSR in this population. Reports show increases in myocardial perfusion reserve index (MPRI), as well as improvements in subjective indicators such as angina symptoms (CCS and / or Seattle Angina Scale (SAQ)) and quality of life.Although not specifically for CSR, Ullrich et al. reported the efficacy of reducing the cerebral cortex (CS) lumen to increase cardiac flow reserve (CFR) in 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. This provides mechanistic evidence for the impact of CS flow restriction on empirical indicators of coronary function.

[0007] The applicant has developed improved vascular flow modulators, including the self-expanding (SE) CSR described in U.S. Patent No. 12,070,404 and International Publication No. WO 2024 / 238724 A1, the entire contents of which are incorporated herein by reference. The systems described in these previously published documents incorporate various hourglass-shaped geometries, simplifying their usability and avoiding the complexities of stent design. These vascular flow modulators offer improvements over prior art devices, particularly in the treatment of angina using coronary sinus implantation devices, including advantages such as reduced time to effectiveness after delivery and placement.

[0008] Patients with heart failure often experience adverse symptoms due to elevated left atrial pressure. Atrial septal shunts were developed to divert high pressure from the left atrium to the right atrium in an attempt to rebalance cardiac pressure. Publicated examples describing atrial septal shunts for reducing left atrial hypertension 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 explored method for shunting high left atrial pressure involves placing a shunt between the left atrium and the coronary sinus connected to the right atrium. This type of atrial shunt is illustrated in U.S. Patent No. 10,039,905 and U.S. Patent Publication No. 2023 / 0218232 (Rowe).

[0009] Despite the aforementioned advancements, improvements are still needed in treating conditions such as ischemic angina and high left atrial pressure. Summary of the Invention

[0010] In some aspects, this disclosure relates to a vascular device comprising: an expandable, perforated tubular body configured for placement in and contact with the wall of a patient's coronary sinus; a flow-limiting portion located at a proximal end of the perforated tubular body, the flow-limiting portion including an orifice with a reduced diameter; an open distal end opposite the flow-limiting portion; and a side hole disposed between the flow-limiting portion and the open distal end, the side hole including a side hole wall of an annular opening extending outwardly from the perforated tubular body, the side hole wall being configured to extend into an anastomosis connecting the coronary sinus to the left atrium.

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

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

[0013] In one or more embodiments of the vascular device, the opening size of the flow-limiting portion is smaller than the opening size of one or both of the side opening and the expandable opening tubular body relative to the proximal end of the flow-limiting portion.

[0014] In one or more embodiments of the vascular device, the sidehole walls have a covering that promotes tissue adhesion.

[0015] In one or more embodiments of the vascular device, the side hole wall tapers from the larger diameter side hole opening toward the smaller diameter connection with the expandable open tubular body.

[0016] In one or more embodiments of the vascular device, when the vascular device is deployed in the coronary sinus, the side hole wall has a length sufficient to position a larger diameter side hole opening within the left atrium, and the tapered configuration of the side hole wall is such that the side hole is anchored in the anastomosis by engaging with the anastomosis wall within the anastomosis and extending radially beyond the anastomosis wall within the left atrium.

[0017] In one or more embodiments of the vascular device, the vascular device further includes a fixing piece disposed at the outer end of the side hole wall and surrounding the side hole opening defined by the side hole wall.

[0018] In one or more embodiments of the vascular device, the fixation piece can be folded to hold tissue surrounding the anastomosis between the fixation piece and the expandable perforated tubular body.

[0019] In one or more embodiments of the vascular device, the fixation plate is made of shape memory alloy and is capable of folding itself upon deployment.

[0020] In one or more embodiments of the vascular device, the fixation plate is capable of folding in response to an applied force.

[0021] In one or more embodiments of the vascular device, the side hole wall is configured to expand into the anastomosis, bias onto the tissue surrounding the anastomosis, and terminate 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 hole wall is configured to have a length sufficient to extend into and beyond the anastomosis into the left atrium, and has a diameter smaller than the diameter of the anastomosis.

[0023] In one or more embodiments of the vascular device, the sidewalls are formed into a tube that is set at an acute angle relative to the expandable, perforated tubular body.

[0024] In some aspects, this disclosure relates to a method for regulating cardiac pressure, the method 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 the flow from the coronary sinus to the right atrium to limit the increase in right atrial pressure caused by the 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 stent device in the anastomosis to maintain blood flow from the left atrium to the coronary sinus.

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

[0027] In one or more embodiments of the method, the method further includes: accessing the patient's vascular system from the jugular vein; advancing a guidewire from the entry point into the coronary sinus; using the guidewire, advancing a puncture device into the coronary sinus; forming an initial opening between the coronary sinus and the left atrium using the puncture device; using the guidewire, advancing 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 an anastomosis.

[0028] In one or more embodiments of the method, the dilation device includes a balloon catheter, and the dilation of the initial opening includes a balloon that dilates the balloon catheter within the initial opening.

[0029] In one or more embodiments of the method, limiting flow from the coronary sinus and positioning the stent device include: delivering a vascular device into the coronary sinus, wherein the vascular device includes an expandable open-ended tubular body having a flow-limiting portion at its proximal end, an open distal end opposite the flow-limiting portion, and a side hole disposed between the flow-limiting portion and the open distal end, the side hole including an extendable side hole wall; extending the side hole wall into the anastomosis; and expanding the expandable open-ended tubular body in the coronary sinus to anchor the vascular device in the coronary sinus while allowing the side hole wall to extend into the anastomosis.

[0030] In one or more embodiments of the method, the method further includes deploying a fixation member at the end of an extendable side hole wall to engage with the wall of the left atrium and clamping tissue around the anastomosis between the fixation member and the expandable open-hole tubular body.

[0031] In one or more embodiments of the method, the expandable perforated tubular body is self-expanding, and the expansion includes releasing the expandable perforated tubular body from the conveying device.

[0032] In one or more embodiments of the method, the perforated tubular body is inserted into the coronary sinus via a balloon, and the dilation includes dilating the expandable perforated tubular device using a balloon. Attached Figure Description

[0033] To illustrate this disclosure, the accompanying drawings show aspects of one or more embodiments of the disclosure. However, it should be understood that this disclosure is not limited to the precise arrangements and apparatus shown in the drawings, wherein: Figure 1 A schematic diagram of a heart placed according to an embodiment of the present disclosure is shown; Figure 2 A schematic diagram of the regulation of systemic blood flow in the cardiac vessels according to the present disclosure is shown; Figure 3 This is a schematic side view of another alternative embodiment of the combination of the vascular flow regulator and the clip-on shunt according to the present disclosure; Figure 3A yes Figure 3 A schematic side view of a further variant of the alternative embodiment shown; Figure 4 This is a schematic side view of another alternative embodiment of the combination of the vascular flow regulator and the T-shunt according to the present disclosure; Figure 5 This is a schematic side view of another alternative embodiment of the vascular flow regulator and shunt according to the present disclosure; Figure 6A schematic diagram of a four-chamber heart with a vascular flow regulator and shunt according to the present disclosure is shown. Detailed Implementation

[0034] The devices described in this disclosure typically include an expandable stent for regulating hemodynamic output via flow restriction and flow shunt side orifices to redirect blood from the left atrium into the vessel (e.g., the coronary sinus), thereby increasing cardiac microperfusion. The devices disclosed herein typically include three functional aspects: an anchoring structure configured to secure the device within the vessel lumen and prevent device embolism; a flexible structure configured to create a flow / pressure reduction at the output end without excessively restricting flow; and a flow shunt structure for enabling access from the left atrium into the adjacent vessel lumen. In various disclosed embodiments, conical or straight configurations are used as different structural platforms. The conical structure serves both as a flow shunt and a device anchor. The straight body portion is dimensioned to counteract expansion of the vessel lumen wall, thereby providing further anchorage. The left atrial flow shunt assembly may be covered with a material such as PTFE to provide a stent that spans and anchors into the left atrium. The flow shunt assembly may also have a self-springing clip around the opening to secure it around the wall of the anastomosis connecting the left atrium and an adjacent vessel (such as the coronary sinus). Thus, the flow shunt assembly of the device provides a permanent catheter from the arterial pressure side to the venous side (such as the coronary sinus). Therefore, the disclosed embodiments are configured to provide treatments tailored to the patient's hemodynamic environment, which are effective for a short time and / or modulated in vivo.

[0035] In one embodiment, such as Figure 1 The illustrated cardiac microperfusion device 100 is formed as an expandable mesh body 102 having a flow-limiting portion 103 and a side orifice 104. The expandable mesh body 102 can be configured as a braided filament structure or a laser-cut tube structure, and can be configured as a self-expanding structure or a balloon-expandable structure. The flow-limiting portion 103 includes a reduced-diameter orifice 106 that transitions to an enlarged proximal opening 108. The side orifice 104 is configured to communicate with the left atrium via an anastomosis formed on the walls of the atrium and coronary sinus. The side orifice 104 defines an opening 110 within the left atrium. In some embodiments, the wall 112 of the side orifice 104 tapers slightly downward from its wider portion at the opening 110 to its narrower portion at a transition 113 within the main body portion of the mesh body 102. The tapered wall of the side orifice 104 can be configured to help anchor the side orifice within the anastomosis leading to the left atrium after the device 100 is deployed. The distal opening 114 is located at the end of the expandable mesh body 102 opposite the flow-limiting portion 103. In some embodiments, the side aperture 104 may be configured as a bare filament segment. Alternatively and optionally, the walls 112 of the tapered side aperture may be covered to provide a scaffold for tissue adhesion and inward tissue growth.

[0036] In a non-limiting example, the device described herein can be formed from a nitinol wire with a diameter of approximately 140 μm, and the total length of the device can be approximately 30-55 mm, wherein the length of the flow-limiting portion is approximately 22 mm. The mesh body 102, the proximal opening 108, and the distal opening 114 can have an outer diameter of approximately 11.6 mm and an inner diameter of approximately 11 mm. The orifice 106 with a reduced diameter can have an inner diameter of approximately 3.5 mm and an outer diameter of approximately 4.1 mm. The side hole 104 can have an inner diameter of approximately 7 mm at the point of penetration through the anastomosis.

[0037] Those skilled in the art can also deduce various techniques for constructing the apparatus of this disclosure. For example, the apparatus disclosed herein can be manufactured using the techniques described in the applicant's previously disclosed WO 2024 / 238724 A1, which is incorporated herein by reference. One such technique involves weaving the apparatus onto a shaped mandrel having external dimensions substantially the same as the required internal dimensions of the apparatus to be manufactured. For example, the shaped mandrel can be fed directly into a braiding machine (as a core), and the mesh angle is set to correspond to the portion of the apparatus on the shaped mandrel where the yarn is laid according to the provided dimensions (e.g., as listed in the examples above). The braid is tightened onto the shaped mandrel using a tightening wire (e.g., silver-plated copper wire). The braid completed on the shaped mandrel is heat-set in an oven (following a material-specific heat treatment scheme, e.g., heating at approximately 550°C for 10 minutes for the aforementioned nickel-titanium alloy yarn dimensions, followed by quenching and cooling). The tightening wire is then removed, and the braided apparatus thus formed is removed from the core (shaped mandrel). It should be understood that different techniques for removing the core can be designed, such as using a core that is split in half in the middle of the throat to allow the braid to be removed from the core.

[0038] The laser-cut tube apparatus according to this disclosure can be manufactured by creating a pattern of small slits around and along the length of a metal tube, and then stretching the tube by pulling the ends in opposite directions to create an expanding, open diamond-shaped grid distributed along the tube. The flow-restricting portion is then shaped into an hourglass shape by forming the expanded straight tube on a mandrel of appropriate size. For example, the tube segment is tightened onto the forming mandrel using a tightening wire to form the desired final shape with the flow-restricting portion and a reduced-diameter orifice. The tube thus fixed to the forming mandrel is then heat-set in an oven at an appropriate time and temperature suitable for the selected material (e.g., heating at approximately 550°C for 10 minutes, followed by quenching and cooling). The tightening wire is removed, and the formed apparatus is removed from the forming mandrel. The shape and size of the grid formed in this process will depend on the shape and size of the initial slits created on the tube.

[0039] The disclosed device can be placed using a clinically recognized cardiological procedure, involving access to the jugular or femoral vein, through the superior vena cava (SVC), right atrium, and into the coronary sinus. The anastomosis can be formed by puncture from the coronary sinus into the left atrium. The puncture can be enlarged to the desired diameter using a balloon or blunt dilation. After the anastomosis is formed and the device is positioned in the coronary sinus, a guidewire is positioned through the anastomosis into the left atrium, and the device's flow shunt assembly follows the guidewire from the coronary sinus into the left atrium. After confirmation of placement, the anchoring assembly is deployed. Using the embodiments disclosed herein, separate access to the left atrium (other than through the anastomosis) is not required.

[0040] Figure 2 The systemic circulation in the heart vessels, including flow from the coronary arteries to the arterioles and into the venules, is illustrated by the device disclosed herein. As shown, the combination of the CS flow limiter 202 and the LA-CS flow path 204 can provide a redistribution of return flow through the capillaries to contribute to increasing the supply of oxygenated blood in the coronary arteries in one or both of the additional flow and residence time. For example, the flow 206 into the coronary sinus may be slowed due to restriction and capillary dilation, while the flow 208 to the capillaries and other branches that may be connected via the venules may be increased. The flow in the capillaries may be reversed depending on factors such as the patient's physiology and disease state.

[0041] Further alternative embodiments will be described below. Unless otherwise specifically stated, these alternative embodiments are substantially the same in features, configuration, and function as the embodiments described in more detail above.

[0042] In an alternative embodiment, Figure 3 The illustrated cardiac microperfusion device 300 has an expandable mesh body 302 with side holes 304 configured to reconnect with the left atrium (LA) via an anastomosis of appropriate size. The expandable mesh body is configured to expand against a vessel wall (VW) to anchor the device at a selected location within the coronary sinus (CS). The device 300 also includes a flow-limiting portion 305 having a reduced-diameter orifice 306 leading to a proximal opening 308. In this embodiment, the side holes 304 are formed to define an expandable mesh structure defining a side hole opening 310, but the side hole wall 312 has a relatively large mesh size compared to the body 302 and the flow-limiting portion 305. A flap or fixation piece 313 forms a crimping mechanism to secure the side holes to the inner wall of the left atrium (LA). The fixation piece can be bent around the anastomosis opening using mechanical tools or by inflating a balloon, thereby achieving folding or crimping of fixation features such as the fixation piece 313 around the anastomosis. Optionally, the retaining plate 313 is made of shape memory material, which allows and self-deploys to such a position when released from the conveying device. Figure 3The fixed position is shown. The expandable mesh body 302 terminates at the distal opening 314 opposite to the flow restriction portion 305.

[0043] exist Figure 3A In another alternative embodiment shown, the cardiac microperfusion device 300A is substantially the same as device 300, except that the expandable mesh body 302A has a larger mesh size, possibly similar to the mesh size of the side orifice wall 312. To facilitate blood flow through the reduced-diameter orifice 306, the flow-limiting portion 305 has a smaller mesh size. For example, in a device with the aforementioned example dimensions, the mesh size of the mesh body portion could be approximately 1 mm. 2 Up to 1.8mm 2 The mesh size for the flow-limiting section, at least in the orifice region where the diameter decreases, can be approximately 0.04 mm. 2 up to 0.3mm 2 .

[0044] Figure 4 Another alternative embodiment is shown. In this embodiment, the cardiac microperfusion device 400 has an expandable mesh body 402, side holes 404, and a flow-limiting portion 405 with a reduced-diameter orifice 406, which cooperate to regulate blood flow in the coronary sinus in the same manner as in other disclosed embodiments. A proximal opening 408 is adjacent to the flow-limiting portion 405, and a distal opening 414 is located at the opposite end of the expandable mesh body 402. Side hole walls 412 define side hole openings 410 in the left atrium LA and are formed with expandable meshes that abut against the sides of the anastomosis to facilitate anchoring the device in a placement position aligned with and extending into the coronary sinus CS.

[0045] In another alternative embodiment, the side holes can be formed as extended tubular structures. For example... Figure 5 As shown, the cardiac microperfusion device 500 has an expandable mesh body 502, side holes 504, and a flow-limiting portion 505 with a reduced-diameter orifice 506, which cooperate to regulate blood flow in the coronary sinus in the same manner as in other disclosed embodiments. A proximal opening 508 is adjacent to the flow-limiting portion 505, and a distal opening 514 is located at the opposite end of the expandable mesh body 502. In this embodiment, the side hole wall 512 is configured to form an expandable mesh tube terminating at the side hole opening 510. Those skilled in the art will note that the side holes 504 do not require additional tools for crimping around the anastomosis.

[0046] In another aspect of this disclosure, a method for regulating vascular flow is described. Embodiments of the method include preparing a vascular flow regulator for placement within a patient, delivering the vascular flow regulator to a treatment site as described above via the patient's vascular system, placing the vascular flow regulator within the lumen of a blood vessel at the treatment site, and adjusting a narrowing flow reduction portion of the vascular flow regulator according to the clinical needs of a particular patient. In some embodiments, adjusting the narrowing flow reduction portion includes configuring the vascular flow regulator during a preparation step. In other embodiments, adjusting the narrowing flow reduction portion includes changing the inner diameter of the narrowing flow reduction portion after the vascular flow regulator has been placed within the lumen of the blood vessel.

[0047] The embodiments described in this disclosure may also include a procedure employing a combination of a coronary sinus flow regulator and a flow shunt from the left atrium to the coronary sinus via a separate shunt device to provide the advantages and benefits of the cardiac microperfusion device described herein, such as increased microperfusion, and in some cases, retrograde perfusion within the coronary sinus. The method is as follows: Figure 6 As shown, a system comprising two independent components is used. The first component can be a balloon-expandable or self-expanding coronary sinus decompression device (CSR) 602, which can be delivered to the coronary sinus via the jugular or femoral vein. The second component can be an expandable stent device or stent-like device 603, which maintains the anastomosis and provides a permanent catheter from the left atrium to the coronary sinus. An example of a suitable device as stent device 603 is the LA-CS shunt as shown in the aforementioned U.S. Patent No. 10,039,905. Stent device 603 can be delivered from within the coronary sinus and punctured into the left atrium, leaving the device in place to maintain the blood flow from the LA to the CS. The stent device can also be placed from the left atrial side. Blood from the LA will flow into the CS, and the CSR will provide flow regulation to increase one or more of oxygenated blood residence time, microperfusion, and / or retrograde perfusion in the coronary artery, and to reduce LA pressure while regulating the resulting increase in RA pressure. In some embodiments, the anastomosis may not require a stent device, and the anastomosis from CS to LA may remain open on its own during the healing process, as long as the healing between the left atrium and the coronary sinus continues to allow blood to pass through from LA into the coronary sinus and ascend along the coronary sinus.

[0048] The devices, methods, and systems disclosed herein offer a novel, comprehensive alternative for managing heart failure and treating angina and left atrial pressure conditions, integrating flow regulation and shunting into a single device or complementary approach that was previously unavailable. Therefore, the disclosed embodiments can offer new advantages compared to conventional treatments for patients with symptomatic ischemic disease. The self-expanding device embodiments disclosed herein may also offer further advantages, including delivery systems and methods designed to minimize the risk of device displacement, potentially allowing partial deployment and repositioning of the device to aid in achieving desired placement without being affected by changes in underlying anatomy, and in some embodiments, a densely woven nickel-titanium alloy mesh design that enables significant immediate flow shunting without requiring coverage of the flow-limiting portion. These advantages are expected to further improve the safety and effectiveness of treatment for patients with symptomatic ischemic disease.

[0049] The embodiments disclosed herein address problems present in existing coronary sinus flow regulation solutions by deploying personalized constraints to maintain a specific pressure gradient. This gradient can also be achieved through the size of a flow shunt anastomosis that provides blood flow from the high-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 this disclosure. It is believed that the combination of regulating outflow from the coronary sinus with increasing blood volume entering the coronary sinus via the left atrial anastomosis will improve the infarcted area of ​​the heart by increasing oxygenated blood in the microvessels. The coronary sinus is one of several parallel venous or drainage pathways in the cardiac circulation. When the coronary sinus is blocked, flow is diverted to other drainage pathways. In some cases, the alternative pathway can adapt through vasodilation or angiogenesis without increasing pressure, but a shift of flow to the alternative drainage pathway occurs. If the shunt caused by this restriction exceeds the adaptability of the available drainage pathway, pressure will increase, leading to flow distribution at the arterioles and potential retrograde perfusion in the coronary arteries. The left atrial anastomosis provides the coronary sinus with increased flow and pressure, potentially reversing the flow on the venous side through the arterioles and back into the coronary capillaries. The combination of restriction with the left atrial anastomosis pathway increases blood volume in the arterioles and leads to microvascular dilation, providing additional oxygen to the myocardium.

[0051] Theoretically, this device could also improve treatment outcomes in patients with hypertension and heart failure. It has been shown that shunting from the left atrium to the right atrium can improve hypertension in patients. However, in some patients, increased right atrial pressure can lead to right heart failure. The combination of coronary sinus flow restriction and left atrial flow shunting provides a previously unrecognized synergistic advantage, as additional blood flow from the left atrium would flow unimpeded into the right atrium without the vascular restrictor component of this disclosed device. However, by positioning the flow restriction portion of this disclosed device proximal to the coronary sinus anastomosis, the blood flow from the left atrium back to the right atrium can be controlled and reduced, thereby reducing right atrial pressure relative to left atrial shunting alone.

[0052] The foregoing is a detailed description of exemplary embodiments of this disclosure. It should be noted that, unless specifically stated or indicated, in this specification and the appended claims, the connective language used in phrases such as "at least one of X, Y, and Z" and "one or more of X, Y, and Z" should be understood to mean that each item in the connective list can exist independently of every other item in the list in any number, or in any combination with any or all other items in the connective list, which can also exist in any number. Applying this general rule, the connective phrases in the foregoing examples consisting of X, Y, and Z should each include: one or more X; one or more Y; one or more Z; one or more X and one or more Y; one or more Y and one or more Z; one or more X and one or more Z; and one or more X, one or more Y, and one or more Z.

[0053] Various modifications and additions can be made without departing from the spirit and scope of this disclosure. Features of the various embodiments described above can be appropriately combined with features of other described embodiments to provide multiple combinations of features in related new embodiments. Furthermore, while many independent embodiments have been described in the foregoing, the description is merely illustrative of the application of the principles of this disclosure. Additionally, although specific methods may be shown and / or described herein in a particular order, the ordering in implementing this disclosure is highly variable within the scope of ordinary art. Therefore, this description is by way of example only and should not otherwise limit the scope of this disclosure or the invention described in the following claims.

Claims

1. A vascular device comprising: An expandable, perforated tubular body, constructed for placement in the patient's coronary sinus and contact with the wall of the coronary sinus; A flow-limiting portion located at the proximal end of the perforated tubular body, the flow-limiting portion including an orifice with a reduced diameter; Open the remote end, which is in contrast to the traffic restriction portion; as well as A side hole, disposed between the flow-limiting portion and the open distal end, the side hole comprising a side hole wall of an annular opening extending outward from the open tubular body, the side hole wall being configured to extend into an anastomosis connecting the coronary sinus and the left atrium.

2. The vascular device according to claim 1, wherein, The expandable perforated tubular body is self-expanding.

3. The vascular device according to claim 1, wherein, The expandable perforated tubular body is balloon-expandable.

4. The vascular device according to claim 1, wherein, The opening size of the flow-limiting portion is smaller than the opening size of one or both of the side holes and the expandable opening tubular body relative to the proximal end of the flow-limiting portion.

5. The vascular device according to claim 1, wherein, The sidewalls have a covering that promotes tissue adhesion.

6. The vascular device according to any one of claims 1 to 5, wherein, The side hole wall tapers in a conical shape from the larger diameter side hole opening to the smaller diameter connection point with the expandable perforated tubular body.

7. The vascular device according to claim 6, wherein, When the vascular device is deployed in the coronary sinus, the side hole wall has a length sufficient to position a large-diameter side hole opening within the left atrium, and the tapered configuration of the side hole wall is such that the side hole is anchored in the anastomosis by engaging with the anastomosis wall within the anastomosis and extending radially beyond the anastomosis wall within the left atrium.

8. The vascular device according to any one of claims 1 to 5, further comprising a fixing piece disposed at the outer end of the side hole wall and surrounding a side hole opening defined by the side hole wall.

9. The vascular device according to claim 8, wherein, The fixation piece can be folded to clamp tissue surrounding the anastomosis between the fixation piece and the expandable perforated tubular body.

10. The vascular device according to claim 9, wherein, The fixing plate is made of shape memory alloy and can fold itself during deployment.

11. The vascular device according to claim 10, wherein, The retaining plate can fold in response to an applied force.

12. The vascular device according to any one of claims 1 to 5, wherein, The side hole wall is configured to expand into the anastomosis, bias onto the tissue surrounding the anastomosis, and terminate at a position substantially aligned with the inner wall of the left atrium.

13. The vascular device according to any one of claims 1 to 5, wherein, The side hole wall is configured to have a length sufficient to extend into and beyond the anastomosis into the left atrium, and has a diameter smaller than the diameter of the anastomosis.

14. The vascular device according to claim 11, wherein, The sidewalls form a tube that is set at an acute angle relative to the expandable perforated tubular body.

15. A method for regulating cardiac pressure, comprising: An anastomosis is formed between the left atrium and the coronary sinus to allow blood to flow from the left atrium into the coronary sinus; as well as Limit the flow of blood from the coronary sinus to the right atrium to limit the increase in right atrial pressure caused by blood flowing from the left atrium into the coronary sinus.

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

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

18. The method according to any one of claims 15, 16 or 17, further comprising: It enters the patient's vascular system through the jugular vein; The guidewire is inserted into the coronary sinus from the entry point; Using the guidewire, the puncture device is inserted into the coronary sinus; An initial opening is formed between the coronary sinus and the left atrium using the aforementioned puncture device; Using the guidewire, the dilator is inserted into the coronary sinus and positioned within the initial opening; as well as The expansion device is used to enlarge the initial opening to form the anastomosis.

19. The method according to claim 18, wherein, The dilation device includes a balloon catheter, and the dilation of the initial opening includes a balloon that dilates the balloon catheter within the initial opening.

20. The method of claim 16, wherein, Limiting flow from the coronary sinus and positioning the stent device include: A vascular device is inserted into the coronary sinus, wherein the vascular device includes an expandable open tubular body having a flow-limiting portion at its proximal end, an open distal end opposite the flow-limiting portion, and a side hole disposed between the flow-limiting portion and the open distal end, the side hole including an extendable side hole wall. Extending the sidewall into the anastomosis; and The expandable perforated tubular body is expanded within the coronary sinus to anchor the vascular device within the coronary sinus, while simultaneously allowing the side opening walls to extend into the anastomosis.

21. The method of claim 20, further comprising deploying a fixation member at the end of the extendable side hole wall to engage with the wall of the left atrium and clamping tissue surrounding the anastomosis between the fixation member and the expandable perforated tubular body.

22. The method according to claim 20 or 21, wherein, The expandable perforated tubular body is self-expanding, and the expansion includes releasing the expandable perforated tubular body from the conveying device.

23. The method according to claim 20 or 21, wherein, The perforated tubular body is inserted into the coronary sinus via a balloon, and the dilation includes dilating the expandable perforated tubular device using a balloon.

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