Hybrid devices having sizes adjustable in vivo and methods of

Abstract

Devices having internal dimensions that can be increased and decreased in vivo are provided. In one example, a ventricular shunt for placement at an atrial septum of a patient's heart includes a body. The body includes a first region and a second region coupled in fluid communication through a neck region. The body includes a shape memory material. The body defines a passage through the neck region for blood flow between the first atrium and the second atrium. The first and second regions are superelastic at body temperature and the neck region is malleable at body temperature. The flow area of the channel through the neck region may be adjusted in vivo.

Description

[0001] Cross-reference to related applications This application claims priority to U.S. Provisional Application No. 63 / 591,428, filed October 18, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This technology generally relates to devices used within the human body (such as percutaneous implantation devices) and methods for regulating the flow of fluids (such as blood) within the human body. Background Technology

[0003] For many medical conditions, such as regulating fluid flow within the body through a channel between two body cavities, it is beneficial. Such channels are commonly used in catheterization procedures where a catheter is delivered through the patient's vascular system. In some catheterization procedures, it is advantageous to move from one cavity to another by creating a channel. For example, such a channel can be formed between the right and left sides of the heart, for instance, between the right atrium and the left atrium, where clinical procedures are performed on the left side of the heart using an inlet from the right side. Such clinical procedures include, for example, arrhythmia ablation procedures in the left atrium and mitral valve repair procedures.

[0004] Furthermore, channels can be created and maintained in the heart wall between the two chambers to accommodate shunts, allowing blood to be redistributed from one chamber to the other to address pathologies such as heart failure (HF), myocardial infarction (MI), and pulmonary hypertension (PAH). HF is a physiological state in which cardiac output is insufficient to meet the body's needs or can only meet the body's needs at higher filling pressures. HF has many potential causes, including MI, coronary artery disease, valvular disease, hypertension (e.g., PAH), and myocarditis. Chronic heart failure is associated with alterations in neurohormonal activation and autonomic control. While these compensatory neurohormonal mechanisms provide valuable support to the heart under normal physiological conditions, they also play a fundamental role in the development and subsequent progression of HF.

[0005] Heart failure (HF) is typically classified as either systolic heart failure (“SHF”) or diastolic heart failure (“DHF”). In SHF, the heart’s pumping action is reduced or weakened. A common clinical measure is ejection fraction, which is a function of the amount of blood ejected from the left ventricle (stroke volume) divided by the maximum volume of the left ventricle at the end of diastole or relaxation. A normal ejection fraction is greater than 50%. Systolic heart failure typically results in a reduced ejection fraction of less than 40%. Such patients have heart failure with a reduced ejection fraction (“HFrEF”). Patients with HFrEF often have a larger left ventricle due to a phenomenon called “cardiac remodeling” that occurs after higher ventricular pressure.

[0006] In DHF, the heart typically contracts well with a normal ejection fraction, but is stiffer or less compliant than a healthy heart when relaxed and filled with blood. Such patients are considered to have heart failure with preserved ejection fraction (“HFpEF”). This stiffness can prevent blood from filling the heart and create obstruction in the lungs, potentially leading to pulmonary venous hypertension and pulmonary edema. HFpEF is more common in patients over 75 years of age, particularly in women with hypertension.

[0007] Two variants of HF have been treated using pharmacological approaches, typically involving vasodilators to reduce the workload on the heart by lowering systemic vascular resistance, and diuretics to inhibit fluid accumulation and edema formation and lower cardiac filling pressure. Pharmacological treatments have not been shown to improve morbidity or mortality in HFpEF, while several classes of drugs have a significant impact on the management of patients with HFrEF, including renin-angiotensin antagonists, neprilysin inhibitors, beta-blockers, mineralocorticoid antagonists, and sodium-glucose cotransporter-2 (SGLT2) inhibitors. However, in general, HF remains a progressive disease, and cardiac function and symptoms worsen over time in most patients. In the United States, more than one million people are hospitalized annually due to the rapid deterioration of HF, and its mortality rate is higher than that of most forms of cancer.

[0008] In more severe cases of HFrEF, mechanical circulatory support (MCS) devices, such as mechanical pumps, are used to reduce the workload on the heart by performing all or part of the pumping function normally performed by the heart. Chronic left ventricular assist devices (“LVADs”), total artificial hearts, and heart transplantation are used as last resort measures. However, such assist devices are generally designed to improve the heart’s pumping capacity, increase cardiac output to a level appropriate for normal life, and sustain the patient until a donor heart for transplantation becomes available. This use of MCS is also known as “transplant transition” therapy. More often, because the supply of donor hearts for transplantation is insufficient to meet demand, MCS is the only treatment option—also known as “targeted therapy.” Such mechanical devices enable the propulsion of large amounts of blood (liters / minute) but are limited by power requirements, relatively large pumps, and the risk of hemolysis, thrombosis, and infection. Temporary assist devices, intra-aortic balloons, and pacing devices have also been used.

[0009] Various devices have been developed that use stents to alter blood pressure and flow within a given blood vessel or between heart chambers. For example, U.S. Patent No. 6,120,534, granted to Ruiz, relates to an endovascular stent for regulating the flow of fluid through blood vessels or organs in the body (e.g., for regulating blood flow through the pulmonary artery to treat congenital heart defects). The stent may include an expandable mesh having a balloon-expandable leaf-shaped or conical portion combined with a shape-memory contractile region that restricts flow through the stent. The contractile region can be adjusted in vivo and can additionally be heated to restore maximum contractility. Ruiz avoids mentioning treatment of HF or reduction of left atrial pressure.

[0010] U.S. Patent Publication No. 2013 / 0178784, granted to McNamara, describes an adjustable decompression shunt that can be expanded, for example, via an inflatable balloon. The tubular body of the shunt can be plastically deformed in vivo, allowing the shunt's dimensions to be repeatedly adjusted in response to measurements of the patient's physiological parameters via various mechanisms, such as elastically wound springs or a series of pawls and one-way mechanical ramps. A key drawback of the method described in this patent is the hysteresis effect, i.e., the irreversible change in the underlying crystalline structure that occurs when the shunt is permanently deformed. Importantly, such plastic deformation can lead to stress- and fatigue-related fractures of the device.

[0011] U.S. Patent No. 6,468,303, granted to Amplatz et al., describes a collapsible medical device and related methods for shunting selected organs and vessels. Amplatz describes the device as being adaptable for shunting septal defects in a patient's heart, for example, by creating a shunt in the atrial septum of a newborn with hypoplastic left heart syndrome (“HLHS”). The patent also describes improved oxygen saturation due to increased mixing of pulmonary and systemic venous blood, and the shunt can subsequently be closed with an occlusion device. Amplatz avoids mentioning the treatment of HF or the reduction of left atrial pressure, or the means of regulating blood flow rate through the device.

[0012] Implantable atrial shunt devices have been successfully used in patients with severe symptomatic heart failure. By diverting or shunting blood from the left atrium (“LA”) to the right atrium (“RA”), the pressure in the left atrium is reduced or prevented from rising to its original level (left atrial decompression). Such achievements hold promise for preventing, alleviating, or limiting symptoms, signs, and syndromes associated with pulmonary congestion. These include severe shortness of breath, pulmonary edema, hypoxia, the need for acute hospitalization, mechanical ventilation, and death.

[0013] Shunt flow is typically controlled by the pressure gradient between the atria and the hydromechanical properties of the shunt device. The latter is generally influenced by the geometry and material composition of the shunt device. For example, the general flow properties of similar shunt designs have been shown to be related to the average intra-atrial pressure gradient and the effective orifice diameter.

[0014] Percutaneous implantation of an atrial shunt typically requires immediate transseptal catheter insertion prior to shunt device placement. The transseptal catheter insertion system is usually placed from the inlet site in the femoral vein, traversing the atrial septum in the fossa ovalis (“FO”) region, which is the central and thinnest area of ​​the atrial septum. The axial dimension of the FO in adults is typically 15–20 mm, and the thickness is <3 mm, but in some cases it can reach 10 mm. Access to the atrial septum can be achieved using a number of different techniques familiar to those skilled in the art, including, but not limited to, needle puncture, probe puncture, spiral needle puncture, and radiofrequency ablation. The passage between the two atria is dilated to facilitate the passage of a shunt device with the desired orifice size. Dilation is typically accomplished by advancing a conical sheath / dilate catheter system or by inflating an angioplasty-type balloon across the FO. This is the same location where a congenital atrial septal defect (“ASD”) is located.

[0015] U.S. Patent Publication No. 2005 / 0165344, granted to Dobak, III, describes a device for treating heart failure comprising a tubular catheter having an embolic filter or valve, the device being configured to be positioned in an opening in the interatrial septum of the heart to allow blood flow from the left atrium to the right atrium. Dobak discloses that the shunting of blood can reduce left atrial pressure, thereby preventing pulmonary edema and progressive left ventricular dysfunction, and reducing LVEDP. Dobak describes the device as including deployable retaining struts, such as metal arms that apply slight forces on both sides of the interatrial septum and clamp or hold the device to the septum.

[0016] In addition, after a shunt device is implanted in the heart wall, tissue, including the endothelial layer or neointimal layer, typically grows inward onto the device, thereby inhibiting thrombus formation in the shunt device and narrowing the size of the passage through the device. Summary of the Invention

[0017] This disclosure overcomes the shortcomings of previously known systems and methods by providing a device that can not only increase in size but also decrease in size within the body, as well as a method for fabricating and using the device. In particular, this disclosure overcomes the limitations of previously known devices and methods by providing an implantable device having a composite structure exhibiting both hyperelasticity and shape memory properties at body temperature. Dimensions that can affect blood flow or other intended interactions between the implanted device and its biological host can be repeatedly changed in either direction by mechanical deformation of a crystalline phase of the shape memory component in one direction and by temperature induction of a crystalline phase transition of the shape memory component material to its original size, thereby greatly simplifying catheter-related manipulation.

[0018] According to one aspect, a hybrid shunt comprising a shape memory material is provided for placement in the interatrial septum of a patient's heart. The hybrid shunt may include: a neck region configured to be stretchable at body temperature; a first end region configured to be hyperelastic at body temperature, the distal end of the first end region being permanently fixed to the proximal end of the neck region at a first connection; a second end region configured to be hyperelastic at body temperature, the proximal end of the second end region being permanently fixed to the distal end of the neck region at a second connection; and a channel extending through the first end region, the neck region, and the second end region to allow blood flow across the interatrial septum. The flow area of ​​the channel through the neck region may be configured to be adjustable in vivo. Preferably, the first end region and the second end region are not integrally formed with the neck region.

[0019] The proximal and distal ends of the neck region may include shapes configured to interlock with complementary shapes of the distal ends of the first end region and the proximal ends of the second end region, respectively. For example, the complementary shapes of the proximal and distal ends of the neck region to the distal ends of the first end region and the proximal ends of the second end region may include a tabelement and a socket element. The tabelement may be configured to be heat-shrinkable or the socket element may be configured to be heat-expandable, such that the tabelement fits within the socket element, and when the tabelement and the socket element are brought to the same temperature and the tabelement is received within the socket element, the tabelement and the socket element can form a rigid connection. For example, the tabelement may be configured to heat-shrink from a first size to a second size, such that the second size can be configured to fit within the socket element, and when the tabelement and the socket element are brought to the same temperature and the tabelement is fitted within the socket element, the tabelement and the socket element can form a rigid connection. Alternatively, the socket element can be configured to thermally expand from a first size to a second size, such that the second size can be configured to receive the tongue element therein, and the tongue element and the socket element can form a rigid connection when the tongue element and the socket element are brought to the same temperature while the tongue element is received within the socket element.

[0020] The hybrid shunt may further include a retaining ring configured to be disposed on the tongue element and the socket element when the tongue element is adapted within the socket element to maintain a rigid connection between the tongue element and the socket element. Furthermore, the outer surface of the socket element may include one or more protrusions such that the retaining ring maintains the rigid connection between the tongue element and the socket element via an interference fit between the one or more protrusions and the inner surface of the retaining ring. Additionally, the hybrid shunt may further include a physiological sensor disposed on the tongue element such that the physiological sensor is enclosed within the retaining ring when the retaining ring is disposed on the tongue element and the socket element. In some embodiments, the shape of the proximal and distal ends of the neck region may include the tongue element, and the shape of the distal end of the first end region and the proximal end of the second end region may include the socket element. Alternatively, the shape of the proximal and distal ends of the neck region may include the socket element, and the shape of the distal end of the first end region and the proximal end of the second end region may include the tongue element.

[0021] The first end region and the second end region can be configured to expand from a collapsed delivery state to an expanded deployment state at body temperature. Therefore, in the expanded deployment state, the proximal end of the first end region can open outward from the distal end of the first end region at the first connection, and the distal end of the second end region can open outward from the proximal end of the second end region at the second connection. Additionally, in the expanded deployment state, the first connection may include a smooth, continuous transition from the neck region to the first end region, and the second connection may include a smooth, continuous transition from the neck region to the second end region.

[0022] In some embodiments, the distal end of the first end region may include a plurality of circumferentially spaced connectors configured to permanently attach at the first connection to a corresponding plurality of circumferentially spaced connectors at the proximal end of the neck region, and the proximal end of the second end region may include a plurality of circumferentially spaced connectors configured to permanently attach at the second connection to a corresponding plurality of circumferentially spaced connectors at the distal end of the neck region. For example, the plurality of circumferentially spaced connectors at the distal end of the first end region and the proximal end of the neck region may be permanently attached at the first connection along a single plane, or alternatively, the plurality of circumferentially spaced connectors at the distal end of the first end region and the proximal end of the neck region may be permanently attached at the first connection in an alternating manner, such that the connections are not all located in a single plane. Additionally, the plurality of circumferentially spaced connectors at the proximal end of the second end region and the distal end of the neck region may be permanently fixed at the second connection along a single plane, or alternatively, the plurality of circumferentially spaced connectors at the proximal end of the second end region and the distal end of the neck region may be permanently fixed at the second connection in an alternating manner, such that the connection is not all located in a single plane.

[0023] The neck region may include nitinol with an austenite finish temperature (Af) between 45-60°C. Additionally, the neck region may be configured to be mechanically expandable in vivo, such that the channel expands from a first cross-sectional area to a second cross-sectional area larger than the first cross-sectional area. Furthermore, the neck region may be configured to be thermally shrinkable in vivo. Furthermore, the first and second end regions may also include nitinol with an austenite finish temperature (Af) between 5-20°C. Additionally, the first and second end regions and the neck region may also include a diabolo-shaped shunt. The first and second end regions and the neck region may be at least partially encapsulated with a biocompatible material. Furthermore, the hybrid shunt may further include one or more physiological sensors disposed at the first connection and / or the second connection. For example, the one or more physiological sensors may be configured to measure at least one of pressure, flow rate, velocity, temperature, or pH.

[0024] The hybrid shunt may further include a bridging element extending from a first outer surface of the first end region to a second outer surface of the second end region. The bridging element may be formed of a biocompatible material and may be configured to engage the patient's atrial compartment. For example, the first end region, the second end region, and the neck region may be at least partially encapsulated with a biocompatible material integrally formed with the bridging element. Alternatively, the first end region, the second end region, and the neck region may be at least partially encapsulated with a biocompatible material different from that of the bridging element. For example, the biocompatible material of the bridging element may be configured to allow inward tissue growth, while the encapsulating biocompatible material may be configured to inhibit inward tissue growth. Furthermore, the internodal distance of the biocompatible material of the bridging element may be greater than the internodal distance of the encapsulating biocompatible material. For example, the internodal distance of the bridging element material may be selected to allow inward tissue growth, while the internodal distance of the encapsulating material may be selected to inhibit inward tissue growth. The biocompatible material of the bridging element and the encapsulating biocompatible material can be expanded polytetrafluoroethylene (ePTFE). Furthermore, the biocompatible material of the bridging element may also include porosity selected to allow tissue inward growth. Additionally, the bridging element can be configured to still engage with the patient's atrial septum when the neck region is contracted. Attached Figure Description

[0025] Figures 1A-1E An example device with internal dimensions that can be reduced and increased within the body is schematically illustrated.

[0026] Figures 2A-2E Another example device with internal dimensions that can be reduced and increased within the body is illustrated schematically.

[0027] Figures 3A-3D An example device with multiple internal dimensions that can be reduced and increased within the body is schematically illustrated.

[0028] Figures 4A-4B An example encapsulation is schematically illustrated that can be provided in a device having internal dimensions that can be reduced and increased within the body.

[0029] Figures 5A-5B An example arrangement of components in a device having internal dimensions that can be reduced and increased within the body is illustrated schematically.

[0030] Figure 6 Another example device with internal dimensions that can be reduced and increased within the body is illustrated schematically.

[0031] Figure 7 Another example device with internal dimensions that can be reduced and increased within the body is illustrated schematically.

[0032] Figures 8A-8D This schematic diagram illustrates the use of [the product / service] in the human body. Figure 7 Example steps of the apparatus.

[0033] Figures 9A-9B schematically illustrated Figure 7 Example construction of the device.

[0034] Figures 10A-10C The schematic diagram illustrates the preparation Figure 7 Examples of tools used in the device.

[0035] Figure 11 The operational flow of an example method for reducing and increasing the internal dimensions of a device within a body is shown.

[0036] Figure 12 The operation flow of an example method for securing a device in a body cavity is shown.

[0037] Figures 13A-13D An example expander device with external dimensions that can be reduced and increased within the body is schematically illustrated.

[0038] Figures 14A-14I schematically illustrated Figures 13A-13D The use of delivery devices inside the human body.

[0039] Figures 15A-15E Another example device with internal dimensions that can be reduced and increased within the body is schematically illustrated, as well as an example of its temporary use within the human body.

[0040] Figures 16A-16H These are images of the apparatus prepared and used according to the examples provided in this article.

[0041] Figure 17A It has a bridging component constructed according to the principles of this disclosure. Figure 7 A side view of the device.

[0042] Figures 17B-17E yes Figure 17A Side view, cross-sectional view and perspective view of the device.

[0043] Figure 18A and Figure 18B yes Figure 17A A cross-sectional side view of the device.

[0044] Figures 19A-19E The illustration shows its use in the human body. Figure 17A Example steps of the apparatus.

[0045] Figure 20A and Figure 20B Another example device with internal dimensions that can be reduced and increased within the body is illustrated, which has interlocking components in an unassembled configuration.

[0046] Figure 20C and Figure 20D The diagram illustrates the assembled structure in a collapsed delivery state. Figure 20A and Figure 20B The device.

[0047] Figure 20E and Figure 20F The diagram illustrates the assembly structure in the extended deployment state. Figure 20A and Figure 20B The device.

[0048] Figure 21A and Figure 21B Another example device with internal dimensions that can be reduced and increased within the body is illustrated, which has interlocking components and retaining rings in an assembled configuration.

[0049] Figure 21C and Figure 21D The diagram illustrates the unassembled structure. Figure 21A and Figure 21B The device.

[0050] Figures 22A-22I The diagram illustrates the assembly process. Figure 21A and Figure 21B Example methods of the device.

[0051] Figures 23A-23E The illustration shows an alternative exemplary interlock component for a hybrid shunt constructed in accordance with the principles of this disclosure. Detailed Implementation

[0052] This disclosure provides a device having a size that can be reduced and increased in size within the body, as well as methods for manufacturing and using the device. This document describes devices and methods for manufacturing and using improved atrial shunts to improve the treatment and outcomes of patients with cardiovascular and cardiopulmonary conditions such as pulmonary hypertension (PAH) or heart failure (HF). In some aspects, the device has a size that can be reduced and increased in size within the body.

[0053] For example, this device can be implanted permanently or temporarily in the human body and includes one or more components that can be adjusted in size (larger or smaller) after implantation. For instance, a need for such an adjustable device may arise in the treatment of pulmonary arterial hypertension (PAH) or heart failure (HF). In PAH, placing a shunt in the interatrial septum allows relief of excessively high blood pressure in the right atrium by allowing some blood to flow from the right atrium to the left atrium through an orifice. In HF, placing a shunt in the interatrial septum allows relief of excessively high blood pressure in the left atrium by allowing some blood to flow from the left atrium to the right atrium through an orifice. In both PAH and HF, atrial shunting has been shown to effectively reduce symptoms and increase exercise tolerance. Atrial shunting can also reduce the need for hospitalization and even improve life expectancy.

[0054] However, if the orifice of an atrial shunt is too small, it may deliver too little blood, and the shunt may be relatively ineffective, providing little or no clinical benefit. In contrast, shunting too much blood through an oversized orifice (“over-shunting”) can lead to serious or even fatal complications over time. For example, in patients with PAH, over-shunting can lead to decreased systemic oxygen saturation and its sequelae, including cyanosis, polycythemia vera with increased blood viscosity, peripheral organ ischemia, and potential death. In patients with HF, over-shunting can lead to pulmonary hypertension, right ventricular failure, and potential death.

[0055] Currently, there is no known method to predict a given patient's response to a specific shunt orifice size. As previously known, the shunt orifice can be increased in vivo, for example, by expanding a properly designed shunt through an inflatable balloon catheter or other similar mechanical expansion device within the shunt. However, this assumes the shunt is made of a malleable material and will remain expanded due to plastic deformation or some other physical property, so that when the balloon or other expansion device is removed, the amount of elastic rebound or retraction will be low enough that the desired increment in orifice size is achieved. One drawback of this approach is that the orifice size can only be increased. If the shunt starts to be too large, or if the shunt becomes too large by balloon expansion but the patient requires a smaller shunt, there is no return to a smaller orifice size except by providing another smaller shunt or placing a smaller shunt within the lumen of the original shunt. This technique is known as a "shunt within a shunt." Therefore, finding the appropriate shunt orifice size for a given patient is a trial-and-error process, where the orifice size is selected based on the patient's response, which may be observed over a period ranging from minutes to months, and the orifice size is increased (e.g., by balloon dilation) or decreased (by providing a new, smaller shunt) based on the patient's response. Thus, the opportunities to increase or decrease the shunt size are very limited and may not be repeatable. Furthermore, the extent to which an inflatable balloon catheter can expand the shunt orifice may be limited by the maximum size of the balloon. Therefore, there is a need for a device that allows for repeated and non-invasive adjustment of the orifice size (larger or smaller) of shunts and other implantable devices in vivo and in both directions.

[0056] This document provides a device having a cross-sectional area that can be easily reduced and expanded in vivo in any order as needed for clinical purposes. In some examples, the device provided herein can be incorporated with a technique employing an adjustable cross-sectional flow area that can be easily reduced and / or expanded in vivo in any order as needed for clinical purposes. Examples of atrial shunts with adjustable cross-sectional flow areas are described in U.S. Patent No. 9,724,499 to Rottenberg, U.S. Patent No. 10,898,698 to Eigler, WO 2021 / 224736, and U.S. Patent No. 11,744,589 to Ben-David, each of which is assigned to the assignee of this application, the entire contents of which are incorporated herein by reference. In particular, some examples of this device include self-expanding hyperelastic (austenitic) materials and malleable shape memory (martensitic) materials. When a device is implanted into the human body, for example by delivering a compressed device to a desired location within a sheath and then removing the sheath, the self-expanding hyperelastic material can automatically deploy to its desired size, while the stretchable shape memory material can initially remain in a reduced-size state. The cross-sectional area of ​​the stretchable shape memory material can then be expanded and reduced within the body as needed to obtain a cross-sectional area suitable for the patient being treated, for example by providing a suitable fluid flow rate through it, or to properly secure the device within the patient while allowing repositioning to improve therapeutic effectiveness. A wide variety of devices, such as those illustrated herein, can be fabricated using components comprising both a self-expanding hyperelastic material and a stretchable shape memory material.

[0057] In some examples, the device may be or include an hourglass-shaped or "diabolo"-shaped shunt, optionally encapsulated in a biocompatible material, and the shunt may be used to treat patients with conditions where regulating fluid flow can be helpful, such as CHF or PAH. In some examples, the hourglass-shaped shunt may be specifically configured to be securely housed within the interatrial septum, for example in an opening through the fossa ovalis, to allow blood flow from the left atrium to the right side when blood pressure in the left atrium exceeds that in the right atrium, or to allow blood flow from the right atrium to the left side when blood pressure in the right atrium exceeds that in the left atrium. As provided herein and described in more detail in PCT application WO 2021 / 224736, which is incorporated above, the internal dimensions of the hourglass-shaped shunt may be suitably adjusted in vivo, for example, to adjust fluid flow through it, for example, to adjust fluid flow through the interatrial septum between the left and right atria.

[0058] Figures 1A-1E An example device with internal dimensions that can be reduced and increased within the body is schematically illustrated. Figures 1A-1EThe illustrated device 100 includes a first component 110 and a second component 120 coupled (e.g., fluidly coupled) to the first component 110. The first component 110 may include a self-expanding hyperelastic material, and the second component 120 may include a stretchable shape memory material. The stretchable shape memory material of the second component 120 may have a first cross-sectional area allowing a first fluid flow rate to pass through the second component, may expand to a second cross-sectional area allowing a second fluid flow rate to pass through the second component, and may contract to a third cross-sectional area allowing a third fluid flow rate to pass through the second component. Note that the total fluid flow rate through the device 100 may also depend on the cross-sectional area of ​​the first component 110.

[0059] For example, Figure 1A The diagram schematically illustrates a device 100 in a compressed or coiled state, loaded into a sheath 130 for percutaneous implantation in the human body. In the coiled state, both the first component 110 and the second component 120 may have a dimension D1 (corresponding to a first cross-sectional area). Once the device 100 is delivered to the desired location, the sheath 130 can retract to allow for percutaneous implantation of the device. Figure 1B As shown, after the sheath 130 is removed, the self-expanding hyperelastic material of the first component 110 can automatically expand to its heat-set hyperelastic structure, in this example having dimension Ds, while the stretchable shape memory material of the second component 120 can remain in a curled state (e.g., at a first dimension D1 corresponding to the first cross-sectional area) until it is further adjusted. The second component 120 can be in any suitable amount (e.g., as...) Figure 1C The second component 120 can be reduced by any suitable amount (e.g., as shown) to dimension D2 (corresponding to the second cross-sectional area). Figure 1D and Figure 1E As shown, by first shrinking component 120 to its annealed configuration size D0 using shape memory properties, and then (e.g., by balloon expansion) expanding it to size D3 (corresponding to a third cross-sectional area), different fluid flow rates can be allowed through the component based on the specific size (and cross-sectional area) to which the second component 120 is adjusted by expanding or shrinking, thereby providing an adjustable orifice for controlling fluid flow within the human body location where the control device 100 is deployed.

[0060] In some examples, reducing the size of the shape memory material-based component in this paper always returns the component to its heat-set (annealed) size D0, which was determined by heat setting within a fixture during manufacturing. Once the size is thus reduced, it can be expanded to an intermediate size, for example, by balloon expansion. Additionally, note that while D0 and D1 may be approximately the same in some examples, D0 may be smaller than D1 in others, and larger than D1 in still others. Although Figures 1A-1EOnly four exemplary dimensions D0, D1, D2, and D3 of the second component 120 are illustrated; however, it should be understood that any suitable dimension higher than the minimum value D0 set by the annealed construction can be obtained as needed by balloon expansion. For example, D2 can be smaller than D3. Alternatively, D2 can be larger than D3, and D3 can be achieved by reducing the second component 120 to, for example... Figure 1D The heat-setting dimension D0 is shown, and then the second part 120 is extended as shown. Figure 1E The size D3 shown is used to achieve this. In some examples, the second component can be heated using a thermal balloon, and then the balloon is compressed to the desired size before the second component is cooled. Because heating causes a crystalline phase transition, the size of the second component will never plastically deform due to balloon expansion, so the shunt can be repeatedly cycled from one size to another (larger or smaller) as many times as the patient needs to optimize the shunt size.

[0061] Note that, as used herein, "internal dimension" refers to, for example, along... Figures 1A-1E The line AA indicated in the text represents the lateral dimension between the inner walls of the device components. As used herein, "external dimension" refers to, for example, along... Figures 1A-1E The line AA indicated in the diagram represents the lateral dimension between the outer walls of the device components. As used herein, "cross-sectional area" refers to the area in a plane passing through that dimension (e.g., in a plane parallel to...). Figures 1A-1E The area of ​​the cross-sectional plane within the wall of the device (indicated by line AA and passing through the plane of the second component 120). Dimensional expansion or contraction can be referenced to a specific location within the device component (e.g., along...). Figures 1A-1E The distance between the walls of the component (indicated by line AA in the diagram). The expansion or contraction of the cross-sectional area can be referenced to a specific location within the component (e.g., along...). Figures 1A-1E The line AA (indicated in the middle) travels through the area within the wall of the device in a plane of the corresponding size of the device component. The device may have any suitable cross-sectional shape and may include, but is not limited to, a circular or uniform cross-section.

[0062] exist Figure 1B and Figure 1D In the non-limiting embodiment shown, the interface between the curled state of the second component 120 and the expanded first component 110 can apply a force that inhibits the full expansion of the first component 110; it should be understood that such an interface can alternatively apply a force that causes the second component 120 to partially expand. As described in more detail below, the specific manner in which the first component 110 and the second component 120 are coupled to each other can be selected to control the forces applied to these components(s), and thereby control the shape and size of these components.

[0063] In some examples, the self-expanding superelastic material of the first component 110 and the stretchable shape memory material of the second component 120 may comprise materials different from each other, or may comprise materials that are the same as each other but have different phases. For example, the first component 110 and the second component 120 may independently comprise one or more materials selected from the group consisting of nickel-titanium (NiTi) (also known as nitinol), other shape memory alloys, self-expanding materials, superelastic materials, polymers, and the like. For example, the first component 110 may comprise a nitinol alloy having an austenitic finish temperature (Af) sufficiently below body temperature such that the material is in the austenitic superelastic phase in the human body. In a non-limiting example, the self-expanding superelastic material of the first component 110 comprises a nitinol having an Af of less than 37°C. For example, the Af of the nitinol of the self-expanding superelastic material may be between 5 and 20°C. The first component 110 and the second component 120 may optionally be integrally formed with each other from a common frame. The first component 110 and the second component 120 may initially be cut and machined into individual units from the same tubular, sheet, or other suitably constructed frame. The parts of this common framework can be heat-treated differently from each other, so as to, for example, with reference to Figures 10A-10C The first component 110 and the second component 120 are defined in a similar manner as described.

[0064] The second component 120 may comprise a nitinol alloy having an austenitic phase transformation temperature Af slightly above body temperature, such that the material remains in its martensitic shape memory phase while in bulk, unless and until it is heated to or above its Af, for example by injecting warm or hot brine (or other fluid) into or through the fluid flowing through the second component 120, or by applying heat via electrical energy (e.g., using an RF energy source). In a non-limiting example, the malleable shape memory material of the second component 120 comprises nitinol having an austenitic completion temperature (Af) greater than 37°C. For example, the Af of the nitinol of the malleable shape memory material of the second component 120 may be between 40 and 60°C, for example, from 45 to 60°C or from 50 to 55°C. In some examples, warm or hot brine (or other fluid) may be injected sufficiently close to the second component 120 to heat the component to or above its Af using a conduit positioned through a side hole in device 100. In other examples, a pair of RF electrodes may, for example, come into contact with device 100 via a conduit and be actuated with sufficient voltage and frequency to heat component 120 to or above its Af. In other examples, any other suitable means of locally applying heat to device 100 may be used, such as laser, magnetic induction, resistance, or the like. Using resistance heating device 100 may include, for example, bringing the device into contact with a pair of electrodes via a conduit and passing a current that causes the device to heat through the device. Using laser heating device 100 may include irradiating the device with light from a laser that can be introduced via a conduit. Using magnetic induction heating device 100 may include passing an alternating magnetic field through the device, which induces eddy currents within the device that heat the device. Note that in blood vessels with particularly high blood flow rates (e.g., 2-5 L / min), such as the aorta or internal iliac artery, it may be useful to use direct heating methods (such as using RF energy, laser, magnetic induction, or resistance) to heat device 100, rather than saline that may be flushed away by the high blood flow rate before the device is adequately heated.

[0065] Alternatively, device 100 may comprise a single nitinol alloy (common frame) that has been heat-treated to produce a lower Af in the region corresponding to the first component 110 and a higher Af in the region corresponding to the second component 120, such that the first component 110 and the second component 120 are integrally formed together. The stretchable shape memory material of the second component 120 can be expanded and contracted using any suitable technique. For example, the stretchable shape memory material of the second component 120 can be mechanically expanded, for example, using balloon expansion as known in the art. Additionally or alternatively, the stretchable shape memory material of the second component 120 can be thermally contracted, for example using saline solution at a temperature equal to or higher than the Af of the material, or otherwise using methods such as those described above, such as utilizing RF energy or using laser, magnetic induction, resistance, or the like for heating.

[0066] Optionally, the first component 110 may be configured to engage a lumen within the body, for example, in a manner described in U.S. Patent No. 10,898,698 to Eigler entitled “Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same” (the entire contents of which are incorporated herein by reference). For example, the lumen may include a blood vessel, and the first component may be configured to engage a blood vessel.

[0067] It should be understood that this device may include any suitable number of components comprising self-expanding hyperelastic materials, and any suitable number of components comprising stretchable shape memory materials. For example, Figures 2A-2E Another example device with internal dimensions that can be reduced and increased within the body is illustrated schematically. Figures 2A-2E The illustrated device 200 includes a first component 210, a second component 220, and a third component 211, the third component 211 being coupled (e.g., fluidly coupled) to the first component 210 and the second component 220. The first component 210 may include a first self-expanding hyperelastic material, the second component 220 may include a stretchable shape memory material, and the third component 211 may include a second self-expanding hyperelastic material. The stretchable shape memory material of the second component 220 may have a first cross-sectional area allowing a first fluid flow rate to pass through the second component, may expand to a second cross-sectional area allowing a second fluid flow rate to pass through the second component, and may contract to a third cross-sectional area allowing a third fluid flow rate to pass through the second component.

[0068] For example, Figure 2A The diagram schematically illustrates a device 200 in a coiled state and loaded into a sheath 230 for percutaneous implantation in the human body. In the coiled state, the first component 210, the second component 220, and the third component 211 may have a dimension D1 (corresponding to a first cross-sectional area). Once the device 200 is delivered to the desired location, the sheath 230 can retract to allow for percutaneous implantation of the device. Figure 2B As shown, after the sheath 230 is removed, the corresponding self-expanding hyperelastic materials of the first component 210 and the third component 211 can automatically expand to the heat-set size Ds, while the stretchable shape memory material of the second component 220 can remain in a curled state (e.g., in the first cross-sectional area) until it is further adjusted. The second component 220 can be in any suitable amount (e.g., as...) Figure 2CThe second component 220 can be extended to dimension D2 (corresponding to the second cross-sectional area) in the same manner as described above with respect to Figure 1 by any suitable amount (e.g., as shown). Figure 2E (As shown) reduced to dimension D3 (corresponding to the third cross-sectional area), by first heating the shape memory component 220 above its Af temperature, causing it to return to its original state. Figure 2D The annealed structure D0 shown is then (e.g., by balloon expansion) expanded to a third size D3 (corresponding to a third cross-sectional area). Based on the specific size (and cross-sectional area) to which the second component 220 is adjusted by expansion or contraction, different fluid flow rates can be allowed through the component, thus providing an adjustable orifice for controlling fluid flow within the human body location where the device 200 is deployed. Note that the total fluid flow rate through the device 200 can also depend on the cross-sectional areas of the first component 210 and the second component 211.

[0069] although Figures 2A-2E Only three exemplary dimensions D1, D2, and D3 of the second component 220 are illustrated; however, it should be understood that any suitable dimension can be obtained by expanding or shrinking the second component as needed. Note that while D0 and D1 may be approximately the same in some examples, D0 may be smaller than D1 in other examples, and D0 may be larger than D1 in still others. Furthermore, it should be understood that shape memory components can be formed and thermo-shaped into other geometries besides the cylindrical shape illustrated herein, and the shape of a shape memory element can be changed in other ways besides the radial expansion illustrated herein, and a shape memory element can return to its original thermo-shaped geometry by heating it above its Af temperature. Additionally, with respect to each example described herein, it should be understood that the component does not necessarily have to have a circular cross-section, but can have any suitable cross-sectional shape.

[0070] exist Figure 2B and Figure 2D In the non-limiting example shown, the corresponding interfaces between the curled state of the second component 220 and the extended first component 210 and extended third component 211 can apply forces that inhibit the full extension of the first component 210 and third component 211; it should be understood that such interfaces(s) can, in turn, apply forces that cause the second component 220 to partially extend. As described in more detail below, the specific manner in which the first component 210, the second component 220, and the third component 211 are respectively coupled to each other can be selected to control the forces(s) applied to these components(s) and thus control the shape and size of these components. The first component 210 and the third component 211 can be, but are not necessarily, the same in size, shape, and dimensions as each other.

[0071] In some examples, the first self-expanding superelastic material of the first component 210, the stretchable shape memory material of the second component 220, and the second self-expanding superelastic material of the third component 211 may comprise materials different from each other, or may comprise materials that are the same as each other but have different phases. For example, the first component 210, the second component 220, and the third component 211 may independently comprise one or more materials selected from the group consisting of nickel-titanium (NiTi) (also known as nitinol), other shape memory alloys, self-expanding materials, superelastic materials, polymers, and the like. In a non-limiting example, both the first component 210 and the third component 211 may comprise a nitinol alloy having an Af sufficiently below body temperature, such that the material, when in the human body, exhibits a phase such as a reference phase. Figures 1A-1E The described manner is in the austenitic superelastic phase. The second component 220 may include a nickel-titanium alloy having an austenitic phase transformation temperature Af slightly above bulk temperature, such that the material remains in its martensitic shape memory phase in bulk unless and until it is heated to its Af, for example by means of a reference... Figures 1A-1E The described method involves injecting warm or hot brine into or through a fluid flowing through the second component 220, applying RF energy, or using lasers, magnetic induction, resistance, or similar methods. Alternatively, the device 200 may comprise a single nickel-titanium alloy that has been heat-treated to produce lower Af in regions corresponding to the first component 210 and the third component 211, and has been heat-treated to produce higher Af in the region corresponding to the second component 220. The malleable shape memory material of the second component 220 may use, for example, reference materials. Figures 1A-1E Any suitable technical extensions and contractions described. First component 210, second component 220, and third component 211 may optionally be referenced. Figures 1A-1E The ways of describing them are formed by a common framework that integrates them together.

[0072] With references Figures 7-10C In a more detailed manner, a first component 210 may provide an inlet, a second component 220 may provide a neck, and a third component 211 may provide an outlet coupled (e.g., fluidly coupled) to the inlet via the neck. As used herein, "inlet" means a component with blood flow entering, and "outlet" means a component with blood flow exiting (going out). The specific components that can be used to provide blood flow entering and exiting (going out) may be selected based on the condition being treated. For example, in HF, the inlet may be on the left atrium (LA) side, where blood flow from LA to the right atrium (RA) and LA decompression are desired. In contrast, in PAH, the interatrial pressure gradient is reversed, causing R to L flow and RA decompression, and the inlet is on the RA side. The cross-sectional area of ​​the neck may be smaller than the cross-sectional area of ​​at least one of the inlet and outlet, for example, as referenced. Figures 7-10CA more detailed description is provided. The third component 211 can be configured as shown in reference to... Figures 7-10C The described manner engages openings within the human body. As described in U.S. Patent No. 10,898,698 to Eigler, the cross-sectional area of ​​the neck may be greater than the respective cross-sectional area of ​​at least one of the inlet and outlet, and the first component 210 and / or the third component 211 may be configured to engage lumens within the body, such as blood vessels, and / or the neck (if present) may optionally be configured to be adjacent to a blood vessel opening.

[0073] Figures 3A-3D An example device with multiple internal dimensions that can be reduced and increased within the body is schematically illustrated. Figures 3A-3D The illustrated device 300 includes a first component 310, a second component 320, and a third component 321, the third component 321 being coupled (e.g., fluidly coupled) to the first component 310 and the second component 320. The first component 310 may include a self-expanding hyperelastic material, the second component 320 may include a first stretchable shape memory material, and the third component 321 may include a second stretchable shape memory material. The respective stretchable shape memory materials of the second component 320 and the third component 321 may have a first cross-sectional area allowing a first fluid flow rate to pass through the second component, may expand to a second cross-sectional area allowing a second fluid flow rate to pass through the second component, and may contract to a third cross-sectional area allowing a third fluid flow rate to pass through the second component. Note that the cross-sectional area, size, and shape of the second component 320 and the third component 321 may, but do not necessarily have to, be the same as each other. Note that the total fluid flow rate through the device 200 may also depend on the cross-sectional areas of the first component 210 and the second component 211. Illustrated, in an example where the cross-sectional area of ​​the second component 320 is smaller than the cross-sectional area of ​​the third component 321 or the cross-sectional area of ​​the second component 320 is larger than the cross-sectional area of ​​the third component 321, the smaller of the cross-sectional areas may limit the fluid flow rate through the device 300.

[0074] In addition to limiting the fluid flow rate through device 300, such as reference Figures 3A-3D The described example allows for controlled adjustment of the juxtaposition to expand, for example, via the balloon of the juxtaposition components 320, 321, to a position such as reference. Figures 14A-14C The described method anchors or secures the device to the body cavity wall while allowing these juxtaposed components to retract, enabling the device to be repositioned after deployment. Alternatively or alternatively, for example, compared to extending the first, second, and third components 310, 320, 321 together with each other, as described in reference... Figures 3A-3DThe described examples provide a relatively safe implantation method. For instance, in embodiments such as those described in U.S. Patent No. 10,898,698 to Eigler, extending the first, second, and third components 310, 320, 321 together with each other could cause blockage of the branch artery. Allowing selective extension of specific segments in a more progressive manner could be safer.

[0075] Figure 3A The diagram schematically illustrates a device 300 in a coiled state and loaded into a sheath 330 for percutaneous implantation in the human body. In the coiled state, the first component 310, the second component 320, and the third component 321 may have a dimension D1 (corresponding to a first cross-sectional area). Once the device 300 is delivered to the desired location, the sheath 330 can retract to allow for percutaneous implantation of the device. Figure 3B As shown, after the sheath 330 is removed, the self-expanding hyperelastic material of the first component 310 can automatically expand, while the first stretchable shape memory material of the second component 320 and the second stretchable shape memory material of the third component 321 can remain in a curled state (e.g., in the first cross-sectional area) until they are further adjusted. The second component 320 and the third component 321 can independently expand by any suitable amount (e.g., Figure 3C As shown, the second component 320 and the third component 321 can be independently reduced to their respective heat-set dimensions, and then expanded by any suitable amount (e.g., ...). Figure 3D (As shown) is extended to the corresponding dimensions D4 (corresponding to the third cross-sectional area) and D5.

[0076] Based on the specific dimensions (and cross-sectional area) of the second component 320 and the third component 321, which are independently adjusted by expansion or contraction, different fluid flow rates can be allowed through these components, thereby providing adjustable orifices for controlling fluid flow within the human body location where the control device 300 is deployed. Although Figures 3A-3D The illustration shows exemplary dimensions D1, D2, D3, D4, and D5 to which the second component 320 and the third component 321 can be independently set; however, it should be understood that any suitable size(s) can be obtained as needed by independently expanding or shrinking the second and third components. For example, the second component 320 and the third component 321 may have corresponding heat-set dimensions D0 that may be the same as or different from each other, and may be rolled up to a size D1 smaller than D0. The second component 320 and the third component 321 may each be expanded to any suitable size(s), reset to D0, and subsequently expanded back to any suitable size(s) any suitable number of times.

[0077] exist Figure 3B and Figure 3DIn the non-limiting example shown, the corresponding interface between the curled state of the second component 320 and the third component 321 and the extended first component 310 can apply a force that inhibits the full extension of the first component 310; it should be understood that such an interface can instead apply a corresponding force that causes partial extension of the second component 320 or the third component 321. As described in more detail below, the specific manner in which the first component 310, the second component 320, and the third component 321 are respectively coupled to each other can be selected to control the forces(one or more) applied to these components and thus control the shape and size of these components.

[0078] In some examples, the self-expanding superelastic material of the first component 310, the first malleable shape memory material of the second component 320, and the second malleable shape memory material of the third component 321 may comprise materials different from each other, or may comprise materials that are the same as each other but have different phases. For example, the first component 310, the second component 320, and the third component 321 may independently comprise one or more materials selected from the group consisting of nickel-titanium (NiTi) (also known as nitinol), other shape memory alloys, self-expanding materials, superelastic materials, polymers, and the like. In a non-limiting example, the first component 310 may comprise a nitinol alloy having an Af sufficiently below body temperature, such that the material, when in the human body, exhibits a phase such as a reference phase. Figures 1A-1E The described manner is in the austenitic superelastic phase. Both the second component 320 and the third component 321 may comprise a nickel-titanium alloy having an austenitic phase transformation temperature Af slightly above bulk temperature, such that the material remains in its martensitic shape memory phase in bulk unless and until it is heated to its Af, for example by means of a reference... Figures 1A-1E The described method involves injecting warm or hot brine into or through a fluid flowing through the second component 320 or the third component 321, applying RF energy, or using laser, magnetic induction, resistance, or the like. Alternatively, the device 300 may comprise a single nickel-titanium alloy that has been heat-treated to produce a lower Af in the region corresponding to the first component 310 and to produce a higher Af in the regions corresponding to the second and third components 320 and 321, respectively. The second component 120 and the third component 321 may, but do not necessarily, have the same material or the same Af as each other. The respective malleable shape memory materials of the second component 120 and the third component 321 may use, for example, reference materials. Figures 1A-1E Any suitable technique described can be extended independently of each other, reset to its corresponding heat-setting dimensions, and then independently re-extended to the corresponding dimensions. The first component 310, the second component 320, and the third component 321 can optionally be referenced... Figures 1A-1E The ways of describing them are formed by a common framework that integrates them together.

[0079] As described in, for example, U.S. Patent No. 10,898,698 to Eigler, the cross-sectional areas of the second component 320 and the third component 321 can be expanded independently of each other to secure the device within the lumen while allowing for repositioning. Furthermore, the second component 320 can be configured as an inlet, and the third component 321 can be configured to be fluidly coupled to an outlet of the inlet via the first component 310. Additionally, the inlet 320 can be configured to engage a blood vessel within the body, and the outlet 321 can be configured to extend into the orifice of the blood vessel. A fourth component can be fluidly coupled to the first component 310 and is configured to extend into another blood vessel orifice. In some examples, the first component 310 can be configured to provide a fluid path for blood flow, for example, to guide blood flow through a weak segment of an aneurysm (such as an aortic aneurysm). To effectively protect the aneurysm from the stress of aortic pressure, the inlet 320, outlet 321, and fourth component can be expanded to form a sufficiently tight seal with their respective blood vessels(s).

[0080] In such as by referring separately Figures 1A-1E , Figures 2A-2E and Figures 3A-3D In the devices 100, 200, and 300 described herein, the first, second, and (if present) third components can be coupled (e.g., fluidly coupled) to each other using any suitable coupling method (one or more). For example, any stretchable shape memory material (such as in components 120, 220, 320, or 321) can optionally and independently be bonded to any self-expanding hyperelastic material (such as in components 110, 210, 211, or 310) by welding. Alternatively or additionally, any stretchable shape memory material (such as in components 120, 220, 320, or 321) can optionally and independently be bonded to any self-expanding hyperelastic material (such as in components 110, 210, 211, or 310) using an encapsulation that can cover at least a portion of at least one component and that can bond these components to each other. Alternatively or additionally, any shape memory material and any self-expanding hyperelastic material can be integrally formed together by a common frame.

[0081] For example, Figures 4A-4B An exemplary encapsulation is schematically illustrated that can be provided in a device having internal dimensions that can be reduced and increased within the body. Figure 4A In the example device 400 shown, the example device 400 may include any suitable number of components (only two components are illustrated for simplicity), and the encapsulation 440 covers a portion of each of the first component 410 and the second component 420, which may be as described in the reference. Figures 1A-1E , Figures 2A-2E or Figures 3A-3D They are configured similarly as described. Encapsulation 440 can fluidly bond (e.g., of component 420) a stretchable shape memory material to (e.g., of component 410) a self-expanding hyperelastic material. Alternatively, encapsulation 440 can indirectly and elastically bond the stretchable shape memory material to the self-expanding hyperelastic material. Figure 4B In the illustrated example device 401, which may include any suitable number of components (only two components are illustrated for simplicity), the encapsulation 441 covers the entirety of each of the first component 410 and the second component 420, and these components may be as shown in the reference. Figures 1A-1E , Figures 2A-2E or Figures 3A-3D As described, they are configured similarly. Encapsulations 440 or 441 can fluidly bond (e.g., of component 420) a stretchable shape memory material to (e.g., of component 410) a self-expanding hyperelastic material. It should be understood that in other examples (not specifically illustrated), encapsulations may completely cover one or more components and may only partially cover one or more other components. Encapsulations can indirectly couple one or more components to each other. A combination of sealing and mechanical engagement (e.g., welding or mechanical interference) can be used to couple these components directly and indirectly to each other.

[0082] Encapsulation elements 440 and 441 may comprise any suitable biocompatible material, such as polymers or natural materials. Examples of polymers suitable for use as encapsulation elements include expanded polytetrafluoroethylene (ePTFE), silicone resins, polycarbonate polyurethanes, polyester (DACRON) (polyethylene terephthalate), ultra-high molecular weight polyethylene (UHMWPE), and polyurethane. Examples of natural materials suitable for use as encapsulation elements include, for example, pericardial tissue from horse, cattle, or pig sources, or human tissues (such as human placenta or other human tissues). The biocompatible material is preferably smooth to inhibit thrombus formation and may optionally be carbon-filled to promote tissue inward growth. Alternatively, to promote tissue inward growth and endothelialization, the biocompatible material may form a mesh structure. This device can be encapsulated with a biocompatible material in a manner similar to that described in U.S. Patent Nos. 11,304,831 and 10,835,394 to Nae, U.S. Patent No. 11,109,988 to Rosen, U.S. Patent Nos. 9,034,034 and 9,980,815 to Nitzan, and U.S. Patent No. 10,076,403 to Eigler (the entire contents of each of these patents are incorporated herein by reference). For example, an inner surface of one of the devices may be covered with a first graft layer, and an outer surface of the device may be covered with a second graft layer. The graft layers may be firmly bonded together to form a single layer of biocompatible material, for example, they may be sintered together to form a robust, smooth, substantially continuous coating covering the inner and outer surfaces of the device. A portion of the coating can then be removed from selected portions of the device as needed, for example, using laser cutting or mechanical cutting.

[0083] In one example, the device is encapsulated with ePTFE. Those skilled in the art will understand that ePTFE material has a characteristic microstructure consisting of nodes and fibrils, wherein the fibrils are oriented substantially parallel to the longitudinally extending axis. Expanded PTFE material can be prepared by extruding a compressed preform of granular PTFE and extrusion lubricant through an extrusion die to form a sheet or tubular extrudate. The extrudate is then longitudinally expanded to form the node-fibril microstructure and heated to a temperature equal to or above the crystalline melting point of PTFE (i.e., 327°C) for a sufficient time to sinter the ePTFE material. Heating can be performed in a vacuum chamber to prevent or inhibit oxidation of the device. Alternatively, heating can be performed in a nitrogen-rich environment. A furnace can be used to heat the encapsulated device. Alternatively or additionally, a mandrel on which the encapsulated device rests can be used to heat the encapsulated device.

[0084] In addition to any other method of joining components of this device to each other, or as a substitute, one or more components may be inserted completely or partially into another one or more components. For example, Figures 5A-5BAn example arrangement of components in a device having internal dimensions that can be reduced and increased within the body is schematically illustrated. Figure 5A In the example device 500 shown, the example device 500 may include any suitable number of components (only two components are illustrated for simplicity), the second component 520 being at least partially located inside the first component 510, and these components may be as described in reference. Figures 1A-1E , Figures 2A-2E or Figures 3A-3D The components are configured similarly as described. The overlapping region 550 between the first component 510 and the second component 520 (which may optionally extend the entire length of one or both of the first and second components 510 and 520) can incorporate (e.g., of component 520) a stretchable shape memory material to (e.g., of component 510) a self-expanding hyperelastic material. For example, the outer surface of the second component 520 can engage with the inner surface of the first component 510 in such a way as to inhibit lateral movement of the two components relative to each other (e.g., mechanical interference). Additionally, the size of the first component 510 can limit the expansion of the second component 520 within the overlapping region 550 beyond that size; for example, a force can be applied to inhibit the full expansion of the second component 520. Therefore, even if the second component 520 expands (e.g., mechanically), the size of the first component 510 can prevent the second component from fully expanding to a larger size.

[0085] exist Figure 5B In the example device 501 shown, the example device 501 may include any suitable number of components (for simplicity, only two components are illustrated), with the first component 511 at least partially located inside the second component 521, and these components may be as described in reference. Figures 1A-1E , Figures 2A-2E or Figures 3A-3D The components are configured similarly as described. The overlapping region 551 between the first component 511 and the second component 521 (which may optionally extend the entire length of one or both of the first and second components 511) can incorporate (e.g., of component 521) a stretchable shape memory material to (e.g., of component 511) a self-expanding hyperelastic material. For example, the inner surface of the second component 521 can engage with the outer surface of the first component 511 in such a way that it inhibits lateral movement of the two components relative to each other (e.g., mechanical interference). Additionally, the size of the second component 521 can limit the expansion of the first component 511 within the overlapping region 551 beyond that size; for example, a force can be applied to inhibit the full expansion of the first component 511. Therefore, even if the first component 511 expands (e.g., self-expands), the size of the second component 521 can prevent the first component from fully expanding to a larger size.

[0086] For example, refer to Figures 5A-5BMechanical interference between components can suppress the retraction of shape memory components. For example, a known problem with martensitic nitinol stents is retraction, where approximately 10-15% diameter shrinkage can make juxtaposition with the vessel wall challenging. Mechanical interference between device components (e.g., such as...) Figures 5A-5B The concentric coupling shown can reduce or suppress such retraction. For example, in the reference... Figure 5B In the described configuration, the first component 511 can physically suppress the retraction of the second component 521. In some configurations, the corresponding circumferential strengths of the first and second components can be approximately balanced with each other, optionally wherein the shape memory martensitic component is slightly stronger in order to reduce or minimize retraction.

[0087] It should be understood that, for example, reference Figures 1A-1E , Figures 2A-2E , Figures 3A-3D The described apparatus and such as reference Figures 4A-4B and Figures 5A-5B The options described can have any suitable construction. For example, Figure 6 Another example device 600 with internal dimensions that can be reduced and increased within the body is schematically illustrated. Device 600 includes a first component 610 (also designated "A"), a second component 620 (also designated "B"), and a third component 630 (also designated "C"). Device 600 may optionally include a material tube that is laser-cut to define a plurality of struts and connecting members, such as a plurality of sinusoidal rings connected by longitudinally extending struts (struts not specifically illustrated). Figure 6 The sinusoidal ring shown can be laser-cut to form a monolithic component, and different regions of this component can be heat-treated differently to produce components with different Af values ​​as described elsewhere herein. Alternatively, the sinusoidal rings of the first component 610, the second component 620, and the third component 611 can be individually defined to form different material components with suitable Af values, which are then coupled together to form device 600. Device 600 can also be electropolished to reduce thrombus formation.

[0088] Optionally, the Af of the first component 610 and the Af of the third component 611 can both be greater than the Af of the second component 620. For example, the first component 610 can correspond to a reference. Figures 2A-2EThe first component 210 is described and may include a first self-expanding hyperelastic material, the second component 620 may correspond to the second component 220 and may include a stretchable shape memory material, and the third component 611 may correspond to the third component 211 and may include a second self-expanding hyperelastic material. Alternatively, the Af of the first component 610 and the Af of the third component 611 may be smaller than the Af of the second component 620. For example, the first component 610 may correspond to a reference... Figures 3A-3D The first component 310 is described and may include a self-expanding superelastic material; the second component 620 may correspond to the second component 320 and may include a first stretchable shape memory material; and the third component 611 may correspond to the third component 321 and may include a second stretchable shape memory material. Optionally, the Af of the first component 610 and the Af of the third component 611 may be the same as each other.

[0089] It should be understood that this device can be percutaneously implanted in any suitable part of the human body, such as a body cavity (e.g., a blood vessel) or the heart. Similarly, it should be understood that this device can be appropriately modulated within the body after implantation to adjust fluid flow, treat or improve any suitable condition (such as HF, PAH, aneurysm, aortic stenosis, mitral stenosis), or improve outcomes following heart valve repair (e.g., mitral valve repair) or cardiac ablation (e.g., for the treatment of atrial fibrillation). Reference Figures 7-10C Some non-limiting examples of devices for implantation at selected locations are described.

[0090] In some examples, the device may be or include an hourglass-shaped or "diabolo"-shaped shunt, optionally encapsulated in a biocompatible material, and the shunt may be used to treat patients with conditions where regulating fluid flow can be helpful (e.g., CHF or PAH). In some examples, the hourglass-shaped shunt may be specifically configured to be securely housed in the interatrial septum, for example in an opening through the fossa ovalis, to allow blood flow from the left atrium to the right side when blood pressure in the left atrium exceeds that in the right atrium, or to allow blood flow from the right atrium to the left side when blood pressure in the right atrium exceeds that in the left atrium. As provided herein and referenced Figures 7-10C In more detail, the internal dimensions of the hourglass shunt can be appropriately adjusted within the body, for example, to adjust the flow of fluid through it, for example, to adjust the flow of fluid through the interatrial septum between the left and right atria.

[0091] Now for reference Figure 7 The illustration shows a diverter 700 with internal dimensions that can be reduced and increased within the body. The diverter 700 is hourglass or "diabolo" shaped and may include a first component 710, a second component 720, and a third component 730 fluidly coupled to each other. (See reference...) Figures 2A-2E In a similar manner, the first component 710 may include a first self-expanding hyperelastic material, the second component 720 may include a stretchable shape memory material, and the third component 730 may include a second self-expanding hyperelastic material. The first component 710 may include any suitable number of rings, such as rings 712 and 713, formed of or comprising the first self-expanding material, and optionally, they may be sinusoidal. The second component 720 may include any suitable number of rings, such as ring 714, formed of or comprising a stretchable shape memory material, and optionally, they may be sinusoidal. The third component 730 may include any suitable number of rings, such as rings 715 and 716, formed of or comprising a third self-expanding material, and optionally, they may be sinusoidal. Supports 711 and 708 may connect the rings of the first component 710, the second component 720, and the third component 730 to each other.

[0092] The first component 710 can provide a first flared end region 702, the third component 730 can provide a second flared end region 706, and the second component 720 can provide a neck region 704 disposed between the first and second flared end regions. The inlet and outlet of the device 700 can include flanges 702 and 706, and the neck 704 can include flexible longitudinal struts 711 and 708 and a sinusoidal ring 714. The flexible longitudinal struts 711 and 708 can allow the flanges to fully expand upon deployment; and the sinusoidal ring can have sufficient strength to maintain its diameter during balloon expansion or thermal contraction.

[0093] exist Figure 7 In the non-limiting example shown, the first flared end region 702 has a first end region size D1, the second flared end region 706 has a second end region size D2, and the neck region 704 has a neck size D3, which can be in the form of, for example, reference numerals. Figures 2A-2E The second component 220 shown is increased or decreased in the manner described. For example... Figure 7 As shown, the neck region 704 of the shunt 700 can be significantly smaller than the flared end regions 702 and 706; for example, it can have a smaller cross-sectional area and smaller dimensions than the flared end regions 702 and 706. Similarly, as... Figure 7As shown, the shunt 700 can be asymmetrical. For example, the shunt 700 can be asymmetrical to utilize the natural features of the atrial septum of the heart and the left and right atrial chambers. Alternatively, the hourglass-shaped shunt 700 can be symmetrical, wherein the first end region dimension D1 is equal to the second end region dimension D2. The first flared end region 702 and the second flared end region 706 can also have straight or curved profiles or both. For example, the strut 711 has a straight profile, and the strut 708 has a curved profile. Furthermore, the first flared end region 702 and the second flared end region 706 can present any angular position consistent with the hourglass construction.

[0094] The shunt 700 can be suitably formed in a manner as described elsewhere herein. For example, in some configurations, the shunt 700 is formed in a manner as described in reference [reference] Figure 6 The illustrated device 600 is described as being laser-cut from a single tube of nitinol, and different regions of the nitinol are heat-treated differently to define, respectively, one or more self-expanding hyperelastic materials and stretchable shape memory materials. Therefore, the first, second, and third components 710, 720, 730 of device 700 may optionally be integral with each other. The first and third self-expanding materials may optionally be the same material. In other configurations, the first, second, and third components 710, 720, 730 of device 700 may be, for example, in the form of a reference numeral. Figures 5A-5B Describe and refer to the following: Figures 20A-22I The further examples illustrate how they are formed and assembled independently of each other.

[0095] Figures 8A-8D This schematic diagram illustrates the use of [the product / service] in the human body. Figure 7 Example steps of the device. The shunt 700 can be coiled into a cylindrical shape, for example, by pushing it through a conical loading device. In a non-limiting example, the shunt 700 can be coiled to an external dimension of approximately 4.6 mm and an internal dimension of a 14F Cook sheath. The sheath can be percutaneously placed into the desired location within the body via a blood vessel, and the coiled shunt can be used with... Figure 2A A similar arrangement is used within the sheath. When the coiled shunt is extended from the sheath, it springs open from the expanding, superelastic flared end region to its designated configuration, while the extendable shape memory central neck region, for example, with... Figure 8AThe constraint is maintained at or near its curled dimension as shown, wherein the neck region (designated "B" and corresponding to the second component 220) engages an opening within the human body. Depending on the desired direction of blood flow through the device 700, one of the flared ends (designated "A" or "C" and corresponding to the first component 210 or the third component 211) provides an inlet, and the other of the flared ends (designated "C" or "A" and corresponding to the third component 211 or the first component 210) provides an outlet. For example, the neck region may engage an opening in the fossa ovalis created through the interatrial septum between the right and left atria, with one flared end extending into the right atrium and the other flared end extending into the left atrium. In some configurations, the flared end in the right atrium is the inlet and the flared end in the left atrium is the outlet, while in other configurations, the flared end in the left atrium is the inlet and the flared end in the right atrium is the outlet.

[0096] The cross-sectional area (and size) of the orifice provided by the stretchable shape memory center neck region can be increased or decreased to adjust the fluid flow through the distributor 700. For example, in the form of... Figure 8B As shown, the neck region can be expanded by balloon inflation using balloon 801, which can be fed through a hole using wire 802. Additionally, in ways such as... Figure 8C As shown, the neck region can be treated by injecting a hot saline solution with a temperature higher than the Af of the stretchable shape memory material (e.g., 40-60°C) via conduit 803 (this can cause the neck region to exhibit conditions such as...). Figure 8D The way shown is to return to its heat-set size (which may be different from its curl size) and be shrunk.

[0097] For example, heat from brine can cause a stretchable shape memory material to transform into an austenitic phase, compressing the neck region back to its coiled (or otherwise heat-set) dimensions, after which the neck region cools to body temperature and transforms back to its martensitic phase. The brine can be delivered in any suitable manner, such as through a flexible conduit having one or more orifices (e.g., one or more side orifices), through which the hot brine can flow, and can be placed within the neck region, for example, on a guidewire passing through the neck region. In a non-limiting example, the neck region can be positioned at the first moment (e.g., when...) Figure 8AThe neck region (initially deployed as shown) has its coiled internal dimensions, typically 1-2 mm. It can then be expanded at a second time using balloon dilation to any desired larger size between the coiled size and 7 mm. The neck region can then be contracted at a third time using hot saline to its heat-set size D0. Size D0 is determined by the dimensions of the clamp used in the heat-setting step during manufacturing. D0 can be larger than the size of the catheter used to deliver the hot saline and larger than the contracted size of the dilation balloon, but smaller than or equal to the minimum expected final shunt size, such as 4 mm. The neck region can then be expanded again at a second time using balloon dilation to any desired larger size between 4 mm and 7 mm. Any appropriate amount of expansion and contraction can be applied to the neck region at any desired time or at intervals to provide a suitable and customized fluid flow through the device for each given patient. It should be understood that what constitutes a suitable fluid flow for a given patient can change over time, and the device can be appropriately adjusted—to provide that fluid flow where appropriate, or to properly secure the device within the lumen. It should also be understood that the self-expanding hyperelastic component is unaffected by the injection of hot brine and therefore will retain its initial fully expanded dimensions while the shape memory component (the neck region in this example) is being adjusted. Furthermore, in addition to hot brine or other methods, references can be used... Figures 1A-1E The described method uses any suitable method for heating shape memory materials, such as RF heating or using lasers, magnetic induction, resistance, or the like.

[0098] The specific configuration of the splitter 700 can be selected to provide the desired flow dynamics through it. For example, Figures 9A-9B schematically illustrated Figure 7 Example construction of the device. In Figures 9A-9B In this design, the geometry of the internal dimensions of the inlet and outlet (e.g., inlet and outlet angles α and β) is selected to adjust the flow dynamics through the shunt 700. In addition to adjusting the flow dynamics to treat specific clinical conditions, the ability to narrow the inlet or outlet, or both, can also reduce the risk of thrombi entering or passing through the device lumen.

[0099] The shunt 700 (or any other device provided herein) can be manufactured using any suitable combination of technologies. Figures 10A-10C The schematic diagram illustrates the preparation Figure 7 Examples of tools used in the device. For example... Figures 10A-10C As shown, the shunt 700 (or any other device provided herein) can be heat-treated within the tool 1000, which allows components (one or more) that are substantially self-expanding hyperelastic materials to be held at a level higher than components (one or more) that are substantially stretchable shape memory materials (e.g., which may be exposed to...). Figure 10C The area shown (1003) is at a cooler temperature (e.g., individually insulated or dissipated by molds 1001, 1002 within the tooling system). Therefore, the exposed component(s) can receive a greater heat flux during heat treatment, which can result in a predetermined higher Af temperature compared to components(s) that are insulated from a radiator or kept cooler by contact. The temperature gradient between the heated and cooled areas can result in a transition zone between a region that is substantially martensitic at body temperature (37°C) and a region that is substantially austenitic at body temperature. Additionally, during the expansion or contraction of the neck region, the transition zone can provide a smooth, continuous transition between the neck region and the flared end region. Heat treatment can be carried out by a furnace, induction heating, electric current, or any suitable and controllable energy source. Differences in heat flux (which can result in a higher Af for components(s) that are substantially of malleable shape memory material) can also be achieved by providing a different (lower) wall thickness for the component, for example, by removing material from the nitinol tube prior to laser cutting or by manufacturing the device using an additive manufacturing process.

[0100] It should be understood that tool 1000 is optional, and any device herein (illustrated, see reference) Figures 2A-2E The described device 200; Reference Figure 7 , Figures 8A-8D , Figures 9A-9B and Figures 10A-10C The described device 700; or referenced Figures 15A-15E The described apparatus 28) can be suitably formed using localized heat treatment of one or more portions of each such apparatus to produce an Af different from that of the unheated portions(one or more) of the apparatus. This localized heating of the portions(one or more) of the apparatus can be performed, for example, using induction heating, optionally with active cooling of adjacent regions. Alternatively or concurrently, this localized heating of the portions(one or more) of the apparatus can be performed using localized laser heating, optionally with active cooling of adjacent regions. Furthermore, it is known that the effect of heat treatment on NiTiNOA Af is cumulative, such that multiple short-duration heat treatments to a given temperature can produce the same effect as a single longer-duration treatment at that temperature. Therefore, it is envisioned that a series of short, dense localized laser heating pulses (each pulse's intensity and duration selected to raise a region in the laser beam to the desired heat treatment temperature) combined with active cooling, such as by a flow of cold argon or other suitable gas, could allow for a highly localized increase in Af while maintaining a lower Af in adjacent regions.

[0101] It should also be understood that the device can be fabricated using wires with different Af temperatures. For example, the device can be fabricated using wires with different Af temperatures from one another and / or wires with different Af temperatures along their length, as described in U.S. Patent No. 10,898,698 to Eigler. Such wires can be used to fabricate devices having multiple Af temperatures (e.g., multiphase nitinol) using wire winding techniques, wire mesh techniques, or any suitable combination thereof, illustratedly.

[0102] It should also be understood that any suitable combination of hyperelastic and shape memory Nitinol components can be used within this device.

[0103] Alternatively or concurrently, the splitter 700 (or any other device described herein) can be manufactured using a multi-material additive manufacturing process. For example, a higher Af (Aspect F) part, which will be a malleable shape memory material, can be provided by using a selective laser melting or electron beam melting powder bed machine with two or more powder chambers, which can switch between the two or more powder chambers during the printing process. The Af of a given part can be manipulated by the chemical composition of the powder (e.g., different fractions of nickel, titanium, or (one or more) other elements that may be present). For example, a higher percentage of nickel results in a higher Af. The Af of a given part can also be manipulated, or alternatively, by the physical composition of the powder (e.g., particle size). For example, a smaller powder size results in a lower Af. Further details on manipulating the Af of materials during a multi-material additive manufacturing process can be found in Horvay and Schade's "Development of nitinol alloys for additive manufacturing," the entire contents of which are incorporated herein by reference. As another option, multiple materials can be achieved using a liquid dispersion method (material jetting). For example, a 3D printer may include two or more ink cartridges, each containing a different powder-liquid composition, in a manner similar to that described for the powder-based example.

[0104] It should be understood that any apparatus provided herein (not necessarily limited to the examples illustrated) can be used in methods for adjustably regulating fluid flow. For example, Figure 11 The operational flow of an example method 1100 for reducing and increasing the size of a device within a body is illustrated. Method 1100 may include inserting a first and a second component, coupled to each other, into a fluid path (1101). The first component may include a self-expanding hyperelastic material, and the second component may include a stretchable shape memory material having a first cross-sectional area. Reference Figures 1A-1E , Figures 2A-2E , Figures 3A-3D , Figures 4A-4B , Figures 5A-5B , Figure 6 , Figure 7 , Figures 8A-8D , Figures 9A-9B , Figures 15A-15E , Figures 17A-17E , Figures 20A-20F ,as well as Figures 21A-22I Non-limiting examples of such first and second components and their alternative constructions are described.

[0105] Figure 11 The method 1100 shown may also include expanding the stretchable shape memory material to a second cross-sectional area (operation 1102). For example, as described elsewhere herein, the stretchable shape memory material can be expanded using balloon expansion.

[0106] Figure 11 The method 1100 shown shrinks the stretchable shape memory material to a third cross-sectional area (operation 1103). For example, as described elsewhere herein, the stretchable shape memory material can be shrunk using heat applied, such as by using brine heated to above the Af of the shape memory material, or by using another suitable energy source, such as radio frequency current (RF)

[0107] Therefore, in the examples provided herein, the fluid flow path through the implantable device can be increased and decreased after implantation, allowing for device repositioning or tailored fluid flow to the specific needs of a particular patient. In contrast, for previously known devices, repositioning may be impossible, and the dimensions of the fluid flow path are selected prior to implantation or can be increased using balloon expansion, providing limited options for achieving the desired hemodynamic outcomes in the patient. In examples such as those provided herein, components comprising one or more self-expanding hyperelastic materials can immediately take on their shape upon implantation, which can inhibit device displacement and ensure accurate positioning. Components comprising one or more stretchable shape memory materials can plastically deform (e.g., expand) at body temperature and can return to their heat-set dimensions upon application of heat. The heat-set dimensions of the stretchable shape memory component can optionally be larger than the component's curled dimensions. Thus, in some examples, the stretchable shape memory component can be expanded by appropriate application of heat, for example, as an alternative to initial balloon expansion after delivery of the curled device. One or more stretchable shape memory components can be repeatedly expanded and contracted, which may allow adjustment of fluid flow through the device, or allow repositioning of the device, or a combination of these features.

[0108] For example, some of the devices provided herein can be repositioned for fixation within a body cavity. As described above, the devices can be positioned such as reference... Figures 1A-1E , Figures 2A-2E , Figures 3A-3D , Figures 4A-4B , Figures 5A-5B , Figure 6 , Figure 7 , Figures 8A-8D , Figures 9A-9B , Figure 11 A- Figure 11 B. Figures 15A-15E , Figures 17A-17E , Figures 20A-20F ,as well as Figures 21A-22I The described manner includes a first component and a second component, the first component comprising a self-expanding superelastic material, and the second component coupled to the first component and comprising a stretchable shape memory material. The self-expanding superelastic material may have a predetermined fully expanded size (e.g., it may be thermo-shaped during manufacturing). The second component may have a first size suitable for deployment via a catheter (e.g., it may be rolled up to this size). The stretchable shape memory material may expand to a second size for fixation within a body cavity (e.g., via balloon expansion) and may thermally transform to a third size (e.g., via applying heat within the body as described elsewhere herein). The stretchable shape memory material may mechanically expand to a fourth size (e.g., via balloon expansion).

[0109] Therefore, it should be understood that some of the devices provided herein (not necessarily limited to the specific examples shown) can be used in methods for adjustingly securing a device within a body cavity. For example, Figure 12 The illustration depicts the operational flow of an example method 1200 for repositioning a device. Method 1200 includes inserting a device comprising a first component and a second component coupled to each other into a body cavity (operation 1201). (See references...) Figures 1A-1E , Figures 2A-2E , Figures 3A-3D , Figures 4A-4B , Figures 5A-5B , Figure 6 , Figure 7 , Figures 8A-8D , Figures 9A-9B , Figure 11 A- Figure 11 B. Figures 15A-15E , Figures 17A-17E , Figures 20A-20F ,as well as Figures 21A-22I In the manner described, the first component may include a self-expanding superelastic material, and the second component may include a stretchable shape memory material having a first dimension.

[0110] Method 1200 further includes, for example, expanding the stretchable shape memory material to a second size via balloon dilation to secure the device within a body cavity (operation 1202). Method 1200 also includes, for example, thermally shrinking the stretchable shape memory material by applying heat (operation 1203). Method 1200 further includes, during the thermal shrinkage of the stretchable shape memory material, repositioning the device within the body cavity, for example, by moving the device along a guidewire (operation 1204). Method 1200 further includes, for example, mechanically re-expanding the stretchable shape memory material to a third size via balloon dilation to secure the device within a body cavity (operation 1205).

[0111] While some examples provided herein relate to permanently implantable devices for use in the human body, it should be understood that other examples relate to devices for temporary use only. Furthermore, while some examples in this document primarily involve altering the internal dimensions of the device, it should be understood that other examples primarily involve altering the external dimensions of the device. For example, Figures 13A-13D An example expander device 1300 having external dimensions that can be reduced and increased within the body is schematically illustrated. This can be used, for example, in a "sheathless" method for delivering a permanently implantable device to a suitable location within the human body using an over-the-knee (OTW) method, as shown in reference . Figures 14A-14I The method described uses device 1300.

[0112] exist Figure 13A In the example shown, device 1300 may include an expander 1310 disposed at the distal end of sheath 1320. For example... Figure 13B As shown in more detail, the expander 1310 may include a tip 1311, an enlarging region 1312, and a reducing region 1313. The reducing region 1313 may be sized to securely engage with the distal end of the sheath 1320, and the enlarging region 1312 may be sized to provide a smooth profile for the device 1300 between the sheath 1320 and the tip 1311. The tip 1310 may have external dimensions. d The apex 1311 intersects with the expanded region 1312, and its distal end can be approximately taper to a point. Figure 13B In the example configuration shown, expander 1310 includes a martensitic shape memory material defining an enlargement region 1312 and a reduction region 1313 (collectively referred to as region B), and a self-expanding hyperelastic material defining a apex 1311 (referred to as region A). The austenitic completion temperature (Af) of the self-expanding hyperelastic material can be below body temperature (approximately 37°C), for example, in the range of 5-20°C or 5-15°C. The Af of the martensitic shape memory material can be substantially above 37°C, for example, approximately 40-60°C, such as 45-60°C or approximately 50°C. Apex 1310, reduction region 1313, and enlargement region 1312 are optionally integrally formed with each other by a common framework.

[0113] like Figure 13C As shown, when heat is applied (e.g., using hot salt water or RF energy or using laser, magnetic induction, resistance or the like), the shape memory material in region B (corresponding to the expanded region 1312 and the reduced region 1313) can return to a state that can optionally be approximately equal to d The smaller heat-set external dimensions allow the expander 1310 to have a substantially smooth, reduced-size profile. Figure 13D In the alternative configuration shown, the expander 1310' includes a martensitic shape memory material defining a top 1311, an enlarged region 1312, and a reduced region 1313, which can be configured to return to an area that can optionally be approximately equal to... d The smaller heat-set dimensions allow the expander 1310 to have a substantially smooth, reduced-size profile.

[0114] Figures 14A-14I schematically illustrated Figures 13A-13D The delivery device 1300 is used inside the human body. Figure 14A In the non-limiting example shown, guidewire 1420 is percutaneously placed through the body region to be dilated (e.g., the fossa ovoid of the interatrial septum 1400), creating a small opening approximately the size of guidewire 1420. Device 1300 then... Figure 14B The guidewire 1420 is advanced to a position adjacent to the fossa 1410 as shown. Figure 14C As shown, pushing the proximal end of the sheath 1320 forces the dilator 1310 through the fossa 1410, enlarging the opening to approximately the outer dimension of the enlarged region 1312. Figure 14D As shown, the sheath 1320 can be retracted relative to the dilator 1310, leaving the dilator 1310 in a suitable position distal to the fossa 1410. To suppress damage to tissue of the interatrial septum 1400 upon retraction of the dilator 1310, for example by capturing tissue with the enlarged region 1312 upon retraction of the dilator 1310, and to prevent the dilator 1310 from becoming stuck or entangled with an expandable device that can be delivered through the septum in a manner as described below, heat can be applied to the dilator 1310 distal to the fossa 1410, such as... Figure 14E As shown, this can be achieved, for example, by applying hot salt water or RF energy, or using lasers, magnetic induction, resistance, or the like, at a temperature above the Af of the shape memory material of the expander. Such heat causes the outer dimensions of the expanded region 1312 to return to its thermally shaped dimensions. Figure 14G and its insertion Figure 14H As shown, the reduced-size expander 1310 can be safely retracted through the enlarged opening, and can then be positioned as follows: Figure 14IThe device is retracted inside the sheath 1320 as shown and subsequently withdrawn from the body. Note that delivery device 1300 can be used to deliver any suitable adjustable device described elsewhere herein, such as device 700, 1100, 1300, or 2100. For example, the adjustable device can be disposed within the sheath 1320 and, in a manner such as... Figure 14C The method shown is used to advance the device along with the delivery unit 1300 to partially penetrate the interatrial septum. (In a manner such as...) Figure 14D The method illustrated involves retracting the sheath 1320 to deploy the distal shunt flange of the adjustable device in the left atrium, then pulling the sheath back to the septal wall, releasing the retaining hook, and further retracting the sheath such that the septum pulls the remainder of the shunt out of the sheath, allowing the proximal flange of the shunt to self-expand in the right atrium. The dilator 1310 can then be adjusted in vivo and retracted via the adjustable device, thus providing a “sheathless” implantation procedure with a relatively low cross-sectional profile and a relatively short procedure time.

[0115] As described above, this device can be implanted permanently or temporarily. In temporary implantation, the device can be configured for easy removal and can have an adjustable size as described elsewhere herein, or can be permanently attached to the end of a catheter. For example, Figures 15A-15E An example device having internal dimensions that can be reduced and increased within the body is schematically illustrated, as well as an example of its temporary use within the human body. More specifically... Figure 15A This is a schematic diagram of temporary equipment 28 inside object 20. Figure 15B This is a schematic illustration of a temporary device 28 based on some examples provided in this document, and Figures 15C-15E Together, these illustrate techniques for removing temporary devices 28 from objects, based on some examples provided in this article.

[0116] Device 28 includes a means 21, which can be connected to a reference. Figures 2A-2B The described device 200 or reference Figure 7 The described device 700 is similarly configured, and device 21 can be placed between two chambers of the heart 22 of object 20, such as within the interatrial septum 24 of heart 22, between the right atrium 30 and the left atrium 32. Alternatively, device 21 can be placed between the two ventricles of the heart, or between any other two body cavities. Figure 15B In the example shown, device 21 includes a distal flared portion 40, a proximal flared portion 44, and an intermediate portion 42 disposed between the distal portion 40 and the proximal portion 44. The distal portion 40 and the proximal portion 44 anchor device 21 to the spacer 24 (i.e., prevent the device from shifting out of the spacer), while the intermediate portion 42 provides a channel through the spacer through which blood can flow. (See reference...) Figures 2A-2B and Figure 7In a similar manner, the distal flared portion 40 (first component) may include a first self-expanding material, the intermediate portion 42 (second component) may include a stretchable shape memory material, and the proximal portion 44 (third component) may include a second self-expanding material. The proximal portion 44, distal portion 40, and intermediate portion 42 may optionally be integrally formed with each other by a common frame. The distal and proximal flared portions 40 and 44 (first and third components) of the device 21 expand to their natural shape upon release from the delivery sheath 46. Figures 15A-15B The shape shown), while the intermediate portion 42 (second component) provides a cross-sectional area that can be increased and decreased within the body in a manner as further described below. It should be noted that, for clarity, in Figure 15A In this arrangement, device 28 is disproportionately enlarged relative to heart 22. The proximal portion 40 and distal portion 44 of device 21 may be "flared" because these portions extend radially outward at an acute angle from the axis of the central portion of the stent. In some examples, as shown, each of the proximal and distal portions 40, 44 of the device includes a plurality of blades 25, such as, for example, six blades 25, as shown. In other examples, the proximal and / or distal portions do not include multiple blades but are shaped to define a flared ring, or have some other suitable form.

[0117] For ease of reference, such as the following Figures 15C-15E Further described methods for removing the device 21 from the object include, for example, extending from the proximal portion 44 to the exterior of the object as one or more device-collapsed flexible longitudinal elements 36. For example, as... Figures 15A-15B As shown, the collapsible flexible longitudinal element of the device may include a control wire 36. In some examples, when inside the object, the wire 36 is contained within a control wire lumen 37 of a delivery conduit 31 that passes between the proximal portion 44 and the exterior of the object. For example, the delivery conduit 31 may exit the object via the femoral vein of the object. Figure 15A As shown, the proximal end of control cable 36 can be coupled to control handle 34, via which cable 36 can be pulled (or alternatively, cable 36 can be released to allow proximal extension of the device). Cable 36 can remain coupled to device 21 throughout the entire time device 21 is in place within the object. Because cable 36 remains coupled to device 21, upon receiving an indication that further shunting through the device is no longer necessary, it can be released at any desired time (e.g., immediately), for example, by reference to... Figures 15C-15E The described method allows for easy removal of the device. Figure 15BA specific example is shown in which the proximal portion 44 is shaped to define a plurality of orifices 48 and each control wire 36 passes through at least two of the orifices 48. For example, as shown, the end of each blade 25 can be shaped to define an orifice 48, and each wire can pass through the corresponding orifices of two adjacent blades, such that the wire forms a loop through the orifices. (Thus, in the illustrated example, a device with six proximal blades is coupled to three wires 36, each wire controlling the collapse of a corresponding pair of adjacent blades.) To cause the proximal portion of the device 21 to collapse, the two proximal ends of each wire can be pulled.

[0118] As an alternative to the example shown, a single wire 36 can form a loop passing through all the orifices 48, controlling the collapse of the entire proximal portion 44. In other words, the entire proximal portion can collapse by pulling both ends of this single wire. In other examples, the wire 36 does not form a loop; instead, individual wires are coupled to each blade. For example, each blade can be coupled to the distal end of a corresponding wire. Thus, for example, a device with six proximal blades is coupled to six wires, one wire per blade. Similarly, the wire 36 can be formed as an extension of the blades, such that each blade has a wire extension extending outside the object. In such an example, the proximal portion of the device can collapse by pulling a single proximal end of each wire.

[0119] In some cases, it may be advantageous to increase or decrease the cross-sectional area of ​​the intermediate portion 42, for example, in a manner as described elsewhere herein, when the device 21 is within the body of the patient. To allow for an increase in the cross-sectional area of ​​the intermediate portion 42, the delivery catheter 31 may include an enlarged central multipurpose lumen 39, through which an angioplasty balloon or other suitable balloon may be passed over a guidewire and inflated in a manner as described elsewhere herein. To decrease the cross-sectional area of ​​the intermediate portion 42, a catheter with one or more orifices may be used to inject hot saline into the device 21 in a manner as described elsewhere herein to heat the intermediate portion 42. In some examples, a catheter with one or more orifices passes over a guidewire within the delivery catheter 31. In other examples, a catheter with one or more orifices is not passed over a guidewire but is introduced separately from the guidewire into the device 21 through the multipurpose lumen 39 of the delivery catheter 31. It should be understood that the balloon expansion and heating process may be repeated any suitable number of times to increase or decrease the cross-sectional area of ​​the intermediate portion 42, for example, to provide an appropriate flow rate through the device 21 or to reposition the device 21.

[0120] In some examples, the adjustment of the cross-sectional area of ​​the middle portion 42 of device 21 is based on pressure monitoring; for example, a pressure sensor mounted on device 21 can be used to acquire intraatrial pressure measurements. The signal indicating such a pressure measurement can be transmitted to the outside of the body via conductor 38 (also called a signal wire), such as... Figure 15A As shown schematically, the cross-sectional area of ​​the intermediate portion 42 can be adjusted in response to such measurement. Alternatively or additionally, the cross-sectional area of ​​the intermediate portion 42 can be adjusted in response to hemodynamic monitoring, such as by applying flow imaging techniques, such as pulse wave (PW) or continuous wave (CW) Doppler echocardiography.

[0121] In some examples, to place the device 21 within the septum, the device is first collapsed and placed inside a delivery sheath 46, which has been percutaneously inserted into the subject's vascular system, such as via the femoral vein, and then, for example, through the inferior vena cava into the right atrium 30. (Alternatively, the sheath 46 may enter the right atrium via the jugular and superior vena cava.) Subsequently, the distal end of the sheath passes through the septum and enters the left atrium 32. Before the distal end of the sheath passes through the septum, an opening can be created in the septum using a puncture element, and optionally, a dilator can be used to enlarge the opening so that the distal end of the sheath can easily pass through the septum; in some examples, the dilator is positioned such as a reference Figures 13A-14I The configuration and use are described. Once the sheath has passed through the septum, the dilator is removed, and the device 21, connected to catheter 31, collapses and is placed proximally into the delivery sheath 46. Catheter 31 is used to push the device 21 through the delivery sheath until the distal flared portion 40 of the device is pushed from the distal end of the sheath and allowed to expand into its deployment shape. The sheath 46 is then slowly withdrawn from the septum until the distal flared portion of the device 21 engages the left atrial side of the septum. Continued withdrawal of the sheath causes the device 21 to be pulled out of the sheath by the septum until the proximal flared portion 44 is released, allowing it to expand into its deployment shape on the right atrial side of the septum, as... Figure 15A As shown. Therefore, the extended distal flare portion 40 and proximal flare portion 44 securely anchor the device 21 across the interatrial septum. The intermediate portion 42 (the second component) can initially be held in its coiled or compressed configuration having a first cross-sectional area and can be suitably expanded to a second cross-sectional area using a balloon passing over the lumen 39 of the catheter 31 over the guidewire. The cross-sectional area of ​​the intermediate portion 42 can then be increased and decreased within the body in a manner as described elsewhere herein.

[0122] After device 21 is deployed, when device 21 is in place, the sheath 46 and catheter 31 can remain within the body. For example, the sheath 46 and catheter 31 can remain within the body such that the distal end of the catheter is close to the proximal portion of the device. Therefore, the catheter can be used to deliver medication to the device site, a pressure sensor within the catheter can be used to monitor intraatrial pressure, a balloon can be introduced into device 21 to increase the cross-sectional area of ​​the intermediate portion 42, or a catheter with one or more orifices can be introduced into device 21 to decrease the cross-sectional area of ​​the intermediate portion 42. By way of example, Figure 15A A catheter 31 coupled to a control handle 34 is shown, such that the control handle 34 can be used to advance and retract the catheter through the sheath 46.

[0123] Device 21 helps relieve excessive intraatrial pressure by allowing blood to flow from high-pressure atria to low-pressure atria, where the flow rate can be increased or decreased based on the specific needs of the patient. Therefore, device 21 can be used as temporary acute treatment for any related condition (e.g., pulmonary hypertension or congestive heart failure) for which relief of excessive pressure is beneficial, or, for example, to help prevent left ventricular dilation and remodeling following acute myocardial injury. When device 21 is used for acute treatment, the subject remains hospitalized until the subject's physician determines that sufficient treatment has been provided, at which point reference... Figures 15C-15E The described method removes the device 21 from the object and, where appropriate, releases the object from the hospital. In some examples, the device 28 includes one or more pressure sensors, for example, disposed on the device 21, on any longitudinal element, or in the catheter 31. Such pressure sensors can be used (e.g., continuously) to measure pressure in the right and / or left atrium of the object to monitor the progress of treatment, determine whether and by how much the cross-sectional area of ​​the intermediate portion 42 should be adjusted, and to determine the point in time when the device can be removed from the object. For example, one pressure sensor may be disposed on the proximal portion 40 of the device 21, and another pressure sensor may be disposed on the distal portion 44 of the device, such that pressure in both the left and right atria is measured.

[0124] In another embodiment, device 21 serves as a temporary measuring device to determine the optimal size for a subsequently implanted permanent shunt. In this embodiment, the cross-sectional area of ​​the intermediate portion 42 of device 21 is adjusted while monitoring pressure and / or other physiological parameters as described for the acute treatment embodiment above. Once the optimal cross-sectional area has been determined, it is measured using a reference... Figures 15C-15E The described method involves removing the device 21 from the object and implanting a permanent shunt of indicated size.

[0125] Now for reference Figures 15C-15E , Figures 15C-15ETogether, techniques for removing device 21 from object 20 are illustrated according to some examples provided herein. Note that... Figures 15C-15E Many details shown are provided by way of example only, and many variations of the techniques shown are included within the scope of this disclosure. Figure 15C In the middle, the sheath 46 is advanced until the distal end of the sheath approaches the proximal portion 44 of the device 21. Then, as... Figure 15C As indicated by arrow 54, pulling the control wire 36 attached to device 21 causes an inward radial force to be applied to the proximal portion 44. This inward radial force causes the proximal portion 44 to at least partially collapse, as... Figure 15D As shown. After the proximal portion of device 21 collapses, as... Figure 15E As shown, the sheath 46 is advanced distally on device 21, while catheter 31 remains in place, pulling the proximal portion of device 21 into the distal end of the sheath. (The sheath may at least partially traverse the interatrial septum while passing over device 21). As sheath 46 continues to pass over device 21 from... Figure 15E When passing the indicated position, the catheter can be pulled proximally while holding the sheath in place, further pulling the device 21 into the sheath until the distal portion 40 of the device 21 collapses, causing the device 21 to completely collapse within the sheath. The sheath containing the catheter 31 and the device 21 can then be removed from the object.

[0126] In some examples, the sheath 46 is advanced as the proximal portion 44 collapses, such that as the proximal portion 44 continues to collapse, the catheter passes over the device 21 until the distal end of the catheter crosses the septum and reaches the distal portion of the device 21. (In such examples, Figure 15D The illustrated state may not actually occur because the sheath 46 covers the proximal portion 44 of device 21 before it completely collapses. Then, as the pulling of device 21 via the catheter 31 continues while the sheath 46 is held in place or pushed forward, the distal end of the catheter applies force to the distal portion 40 of device 21, causing the distal portion of device 21 to collapse and device 21 to be pulled into the catheter. In such an example, because the sheath is advanced on device 21 while the catheter 36 is pulled, it is relatively unlikely that device 21 will be pulled into the right atrium before collapsing into the sheath.

[0127] Figures 15C-15EA non-limiting example is shown in which conduit 31 extends into a stop 52 contained within a control handle 34, through which the wire 36 passes. When the wire is pulled, the stop 52 inhibits or prevents proximal movement of the conduit 31, such that most of the pulling force acts on the proximal portion 44 rather than on the conduit 31. Although the conduit 31 is flexible, it is resistant to buckling, allowing the pulling force to be effectively transmitted to the proximal portion 44. In some examples, two separate tubes travel through a single lumen or two separate lumens of the conduit 31, one of which holds the control wire 36, and the other of which holds the signal wire 38. In another embodiment, the control wire 36 and the signal wire 38 (when present) travel through separate individual lumens disposed in the wall of the conduit 31, leaving an enlarged central multipurpose lumen 39, such as Figure 15A As shown. These tubes can provide additional resistance to buckling, allowing the tensile force applied to the wire to be effectively transmitted to the device 21. In such an embodiment, the stop 52 can be used to suppress or prevent the wire holding tube from moving proximally when the wire is pulled.

[0128] In some embodiments, the proximal portion 44 may be provided as a stretchable shape memory phase at body temperature, thermally shaped to conform to... Figure 15D The collapsed structure shown is similar to the collapsed structure in that it is in line with the reference. Figures 15A-15B The deployment is similar to that described. However, instead of self-expansion, the proximal portion 44 can be deployed by positioning an hourglass-shaped balloon through device 21 and inflating the balloon to expand the proximal portion. This balloon expansion of the proximal portion 44 can be performed after the self-expansion of the distal portion 40.

[0129] It should be noted that, for example, references Figures 15A-15E The described apparatus and method can also be used in applications involving the permanent implantation of device 21. In such applications, during the implantation procedure, if the device is not properly positioned, wire 36 can be used to facilitate the retrieval or repositioning of device 21. Subsequently, after confirming that device 21 is properly positioned, wire 36 can be detached from device 21 and removed from the object.

[0130] Work Example The following examples are intended to be purely illustrative and do not limit this disclosure.

[0131] Figures 16A-16H These are sequential images of the apparatus prepared and used according to the examples provided herein. More specifically, refer to... Figure 7 The described diabolo-shaped shunt frame device 700 is formed from nitinol with an initial austenitic completion temperature below 20°C, allowing it to remain in the austenitic superelastic phase at a body temperature of 37°C. The superelastic device 700 is heat-set within a fixture forming a neck diameter of 4 mm. Figure 7The shape shown. Subsequently, by reheating the device in an oven to above 500°C for a suitable duration, the shunt was transformed from a purely self-expanding superelastic austenitic phase to a structure in which at least some elements of the framework exhibit malleable shape memory martensitic phase physical properties (where all dimensions, including the neck diameter, remain identical). Figure 16A During this time, in a tank of water at 37°C, a transparent membrane 1601 is suspended in a tool system 1602 to simulate a compartmental septum, and a shunt frame assembly 700 is deployed via a sheath 1600 from behind an opening in the membrane 1601 in a manner as described elsewhere herein. It should be noted that, according to Figure 8A In the example illustrated, the distal flange 702 (facing the observer) has self-expanded from its coiled structure within the delivery sheath 1600, indicating that the component is at least partially in the austenitic hyperelastic phase at a water bath temperature of 37°C. Figure 16B At the time of deployment across the transparent film, the neck 720 of the device 700 has an initial cross-sectional area corresponding to its minimum thermally shaped diameter of approximately 4 mm. Figure 16C At that time, a commercially available angioplasty balloon 1603 was inserted into the neck through device 700. Figure 16D During the time it takes for the balloon 1603 to inflate to a diameter of approximately 7 mm under pressure and duration sufficient to deform the neck of the device 700. Figure 16E During that time, balloon 1603 was compressed. Figure 16F From the time, it can be seen that, according to Figure 8B In the example described, after the balloon 1603 is withdrawn, the neck 720 of the device 700 remains at a diameter of approximately 7 mm. Figure 16G The time, according to Figure 8C In the example described, neck 720 is immersed in heated saline solution via rapid injection through catheter 1604. Figure 16H The time, in Figure 16G After the heating shown, the neck 720 has returned to its heat-set diameter of approximately 4 mm, according to Figure 8D The example described demonstrates that the neck region 720 of the device exhibits the desired martensitic shape memory properties. (See references...) Figures 16C-16G The described operation can be repeated any suitable number of times to increase and decrease the size of the neck 720 as needed, while the first and third portions 710, 730 securely hold the device 700 within the opening of the membrane 1601 through the simulated interatrial septum. Similar operations can be performed on other devices provided herein, for example, to adjust the flow rate of such devices or to allow for repositioning of the devices. Therefore, it can be understood that one or more dimensions of this device can be appropriately increased and decreased within the body.

[0132] Over time, one complication that can arise when adjusting the size of a shunt is to cause tissue trauma to the atrial septum. Encapsulated shunts may be designed to promote inward tissue growth and endothelialization; therefore, over time, expanding or shrinking the encapsulated shunt after tissue attachment can lead to trauma to the atrial septum. This document provides a device for adjusting the size of a shunt without disturbing the septal tissue surrounding the device. In particular, the device may include a bridging element as described in U.S. Patent No. 11,813,386 to Nae (the entire contents of which are incorporated herein by reference). For example, the bridging element may be formed of a biocompatible material extending between the outer surfaces of the first and second flared end regions, creating a gap between the bridging element and the neck region of the encapsulated shunt. The bridging element may be configured to engage the patient's atrial septum rather than the encapsulated shunt itself, such that when the device is adjusted in vivo, the bridging element can be configured to maintain the same outer diameter while only the inner diameter of the shunt is modified. Thus, the bridging element prevents cracking that may occur when adjusting the device in vivo. Furthermore, by reducing the diameter of the neck region within the body, the bridging element can slow down any bypass flow that might flow around the outside of the device. Additionally, the bridging element can be made of a material with properties selected to stimulate inward tissue growth, thereby promoting anchorage of the bridging element and, consequently, the shunt to the surrounding tissue.

[0133] The aforementioned bridging element can also be used in conjunction with non-adjustable encapsulated shunts within the body and encapsulated shunts located in other parts of the body, such as body cavities (e.g., blood vessels). Patients who may benefit from an atrial septal shunt may also require or will require a prior transseptal procedure to create an opening in the septal wall. Alternatively, patients may have a septal defect that is pre-expanded beyond the delivery system required for implantation of the device described herein. Incorporating a biocompatible bridging element into the encapsulated shunt increases the outer diameter of the device, thereby allowing implantation of the device into the enlarged septal opening without affecting the inner diameter of the device or the fluid flow rate through the device.

[0134] For example, now refer to Figure 17A and Figure 17E A shunt with a bridging element, such as shunt 700, is provided. As described above, the first flared end region 702 has a first end region dimension D1, the second flared end region 706 has a second end region dimension D2, and the neck region 704 has a neck dimension D3, which can be in the form of a reference dimension. Figures 19A-19D The second component 720 shown is increased or decreased in the manner described. For example... Figure 17AAs shown, the shunt 700 can be modified to add a bridging element 1740 at the neck region 704, the bridging element 1740 being configured to engage the patient's atrial septum. As described above, the shunt 700 is preferably encapsulated with graft material to create a shunt-graft assembly and a channel allowing blood flow; this graft material has been sourced from... Figure 17A The location of bridging element 1740 is omitted for better illustration. Bridging element 1740 may be made of a biocompatible material (such as polymers or natural materials as described above) and may be the same material as the material used for the encapsulation frame or may be a different material. Preferably, the biocompatible material of the bridging element is a biocompatible material that encourages tissue adhesion, such that contact with the septum wall is maintained if the inner diameter of the shunt decreases. Maintaining contact with the septum wall helps prevent any fluid from bypassing the device. The biocompatible material may be configured to promote inward tissue growth over the entire bridging element or only a portion of the bridging element. For example, holes may be placed at locations of bridging element 1740 configured to engage the interatrial septum, while the remainder of bridging element 1740 remains integral, such that inward tissue growth is not encouraged in the flared end region. Such hole addition or other treatments to promote inward tissue growth or encourage adhesion may be performed on the biocompatible material before or after shunt assembly.

[0135] Alternatively, the bridging element 1740 can be made of a different biocompatible material than the biocompatible material used to encapsulate the shunt. For example, the shunt can be encapsulated with a biocompatible material (such as ePTFE) with sufficiently small pores to slow tissue inward growth, while the bridging element can be made of a larger pore biocompatible material designed to stimulate tissue inward growth. Generally, the larger the pore size of the biocompatible material, the greater the tissue adhesion to the biocompatible material. In addition to stimulating tissue growth, greater porosity allows fluid to exchange between the outer surface of the neck region 704 and the gap between the bridging element 1740 and the fluid. For example, the bridging element 1740 can be made of ePTFE with a larger internode distance (e.g., approximately 60-200 μm) than the ePTFE encapsulating the shunt.

[0136] Alternatively, the bridging element 1740 can be made of braided polyester to further stimulate tissue inward growth. Stitches can be used to securely attach the polyester to the encapsulated shunt. Because polyester is thicker than ePTFE, the cross-section of the device may increase in a collapsed or crimped configuration, which could mean that the delivery device may require a larger diameter sheath. Other materials that can be used to promote tissue inward growth include the use of mesh structures, electrotextiles, or silicone.

[0137] In some embodiments, the shunt can be encapsulated with ePTFE of a thickness of .002” and an internode spacing of <= 30 micrometers. (Clowes et al.) Rapid Transmural Capillary Ingrowth Provides a Source of Intimal Endothelium and Smooth Muscle in Porous PTFE Prostheses The journal *Arterial Graft Failure*, Vol. 123, No. 2, pp. 220-230 (May 1986), describes how ePTFE with an IND of <= 30 micrometers exhibits low porosity, and the applicant's research indicates that inward tissue growth is inhibited within a shunt encapsulated with ePTFE of IND = 30 micrometers. On the other hand, the bridging element 1740 can have a thickness of .002” or .005” and a pore size to increase transwall permeation of cells and collagen into the potential space between the bridging element 1740 and other ePTFE layers. This can be achieved using ePTFE with larger pore sizes (e.g., ePTFE materials with an IND range of 60 to 200 micrometers). Alternatively, transwall permeation can be stimulated by creating patterned or multiple perforations of similar size into the bridging element 1740 made of conventional low-porosity (IND <= 30 micrometers)—before or after its application to the shunt. This specialized perforation process can be performed using, for example, an energy source (such as a laser, RF, etc.) or a mechanical source (such as a perforator) or any other technique known to those skilled in the art of thin material processing.

[0138] In some embodiments, the frame encapsulation material is designed to block inward tissue growth, while the bridging encapsulation material is more flexible to support significant expansion / contraction of the diameter without damaging the fossa or the frame encapsulation material. In some embodiments, the gap 1743 between the bridging element 1740 and the neck region 704 increases as the shunt neck region 704 contracts. The bridging element 1740 can be configured to still engage with the patient's atrial septum when the neck region contracts. In some embodiments, the porosity of the biocompatible material of the bridging element 1740 (measured, for example, by its intersegmental distance) is greater than the porosity of the shunt frame encapsulation biocompatible material. Thus, the intersegmental distance of the bridging element material can be selected to allow inward tissue growth, while the intersegmental distance of the encapsulation material can be selected to inhibit inward tissue growth. In some embodiments, the intersegmental distance of the bridging element is greater than 30 micrometers (e.g., in the range of 45-200 micrometers), while the intersegmental distance of the encapsulation material is less than or equal to 30 micrometers. In one embodiment, the intersegmental distance of the bridging element is 60 micrometers, while the intersegmental distance of the encapsulation material is 30 micrometers. The biocompatible material for the bridging component and the encapsulating biocompatible material can be expanded polytetrafluoroethylene (ePTFE).

[0139] The bridging member 1740 may be shorter than the shunt-graft assembly 1710, but have a diameter greater than the neck region 704. The bridging member 1740 may have a first end 1741 and a second end 1742, and may be shaped and sized such that the first end 1741 is positioned approximately halfway along the first flared end region 702, and the second end 1742 is positioned approximately halfway along the second flared end region 706. Alternatively, the first end 1741 and the second end 1742 may extend further along the first flared end region 702 and the second flared end region 706, or may be attached closer to the neck region 704. The bridging member 1740 may be stretched to create a gap between the outer surface of the neck region 704 and the inner surface of the bridging member 1740. The gap may be widest at the narrowest point of the outer surface of the neck region 704.

[0140] As described above, the encapsulated shunt can be adjusted in vivo to increase or decrease the neck size, thereby adjusting the fluid flow rate through the shunt. Since the encapsulated shunt can be designed to promote inward tissue growth and endothelialization, tissue may adhere to the shunt over time. Therefore, adjusting the encapsulated shunt to increase or decrease its size can cause trauma to the interatrial septum. The bridging member 1740 is designed to prevent dehiscence and mitigate tissue trauma that may result from such adjustment. The bridging member 1740 is configured to engage with the interatrial septum and define an outer diameter D4. Preferably, the outer diameter D4 is larger than the neck size D3. In one embodiment, the outer diameter D4 may be 7-9 mm, while the neck size D3 may be 4.5-5.5 mm. When adjusting the device in vivo, the bridging member 1740 can be configured to keep the outer diameter D4 constant, while only the neck size D3 of the shunt and the size of the gap are modified. Because a gap is created between the neck region 704 and the bridging member 1740, the neck dimension D3 can be reduced or increased up to the outer diameter D4, thereby causing an increase or decrease in the gap size without interfering with the contact of the spacer tissue with and surrounding the bridging member 1740, and at the same time maintaining contact with the spacer tissue so that leakage or bypass flow around the outer surface of the shunt is minimized.

[0141] The bridging element 1740 can also be used in conjunction with an encapsulated shunt that is not adjustable in vivo. In particular, incorporating the bridging element 1740 into an encapsulated shunt can be beneficial for patients whose septal defects have been enlarged prior to device implantation, such as due to a previous transseptal procedure, or for patients with septal defects that have been pre-expanded to a size larger than required for implantation of the device described herein. For example, in patients with severe mitral regurgitation and impaired left ventricular function, it may be clinically desirable to first perform a mitral valve repair procedure, such as MitraClip® mitral annulusop via a percutaneous transseptal approach, followed by atrial shunt placement. These mitral valve procedures currently use a 23Fr ID (approximately 8 mm outer diameter) guide catheter to traverse the fossa ovalis. After mitral valve repair, a shunt with a minimum outer diameter matching the larger foramen defect caused by the previous procedure can be implanted, wherein the catheter has a smaller diameter (e.g., 5.0 to 6.5 mm) desired for shunt placement. Similarly, this shunt can be advantageously used in cases where the fossa of the ovum is torn during the interval procedure, thus creating a larger opening defect than required.

[0142] A biocompatible bridging element is incorporated into the encapsulated shunt to increase the outer diameter of the device, thereby allowing the device to be implanted into the enlarged septum orifice without affecting the inner diameter and fluid flow rate through the device. Furthermore, the bridging element 1740 also allows for a temporary increase in the inner diameter of the encapsulated shunt—for example, during a separate septal procedure after device implantation—without interfering with the outer diameter of the neck region, thereby minimizing the risk of septal tissue tearing. As will be understood by those skilled in the art, references herein are made, for example, to... Figures 1A-1E , Figures 2A-2E , Figures 3A-3D , Figures 4A-4B , Figures 5A-5B , Figure 6 , Figure 7 , Figures 8A-8D , Figures 9A-9B , Figures 15A-15E , Figures 20A-20F and Figures 21A-22I The device described herein can be similarly incorporated into a bridging component.

[0143] Now for reference Figures 17B to 17E Additional side views, front views, side cross-sectional views, and perspective views are shown respectively. Figure 17B This illustrates encapsulating a shunt 700 with a biocompatible material 717 to create a shunt-graft assembly 1710 and define the flow path through the shunt-graft assembly 1710. (See diagram.) Figure 17D As shown, the neck region 704 defines the inner diameter of the channel through which blood flows, i.e., neck dimension D3. The bridging member 1740 surrounds the entire neck region 704 to define the outer diameter D4.

[0144] Now for reference Figure 18A and Figure 18B , Figure 17A A cross-sectional side view of the device shows the unfilled and filled gaps between the bridging member and the encapsulated shunt. The bridging member 1740 is attached at a first end 1741 to a first flared end region 702 and at a second end 1742 to a second flared end region 706. Preferably, the bridging member 1740 is stretched such that a gap is created between the neck region 704 and the bridging member 1740. The gap 1743 may be filled with a flexible biocompatible material or a liquid biocompatible material, such as hydrogel. Alternatively, the gap 1743 may be filled with bodily fluid after delivery and implantation of the shunt-graft 1710. This embodiment is advantageous when the shunt size is configured to be adjusted in vivo. Specifically, the gap 1743 can be increased or decreased during such adjustment while the outer diameter of the neck region (e.g., the bridging member) contacting the interatrial septum remains constant, thereby minimizing any tissue trauma. For example, the bridging element 1740 may be made of ePTFE with holes such that when the shunt-graft assembly 1710 expands, the biocompatible material disposed within the gap 1743 is configured to permeate through the bridging element 1740.

[0145] like Figure 18B As shown, the gap between the bridging element 1740 and the encapsulated shunt can be filled with a biocompatible material, such as a polymer or a non-flexible natural material, so that the gap remains the same size even if the size of the shunt-graft assembly 1710 is adjusted. This embodiment can be advantageous when the device is designed to be implanted into an enlarged septum and is not configured to be adjusted in vivo. In particular, since the inner diameter of the device may not be adjusted, the size of the gap 1744 does not need to be adjustable. Therefore, the gap 1744 can be filled with a solid material or a low-hardness material (such as hydrogel), which can improve the stability of the device and make the bridging element more robust.

[0146] Figures 19A-19E The illustration schematically depicts its use in the human body. Figure 17A Example steps of the device. The shunt-graft assembly 1710 can be rolled into a cylindrical shape, for example, by pushing it through a conical loading device. In a non-limiting example, the shunt-graft assembly 1710 can be rolled to an external dimension of approximately 4.6 mm, which is the internal dimension of a 14F Cook sheath. For example, Figure 19AThe illustration shows a shunt-graft assembly 1710 disposed within a sheath 1900. As those skilled in the art will understand, the shunt-graft assembly 1710 can be coiled to smaller or larger external dimensions if different sizes of Cook sheaths are used. Additionally, a hydrogel layer can be placed within the gap 1744 between the bridging member 1740 and the shunt-graft assembly 1710, which can affect the coiling size. The delivery catheter and sheath 1900 can be designed as described in U.S. Patent No. 9,713,696 to Yacoby, U.S. Patent No. 11,612,385 to Nae entitled “Systems and Methods for Delivering Implantable Devices across an Atrial Septum,” U.S. Patent Application Publication No. 2022 / 0184356 to Nae, and / or WO 2023 / 079498, each of which is assigned to the assignee of this application, the entire contents of which are incorporated herein by reference. The sheath can be percutaneously placed into the desired location within the body via a blood vessel. When the coiled shunt is pushed out of the sheath 1900, it springs open from the expanding, hyperelastic flared end region to its designated configuration, while the shape-memory center neck region can extend, for example, with... Figure 19B The manner shown—where a bridging member 1740 located on the neck region 704 (labeled “B” and corresponding to the second component 720) engages an opening within the body—retains the restraint at or near its curled size.

[0147] Depending on the desired direction of blood flow through the shunt-graft assembly 1710, a first flared end region 702 and a second flared end region 706 (labeled "A" or "C" and corresponding to the first component 710 or the third component 730) provide an inlet, while the other of the flared ends (labeled "C" or "A" and corresponding to the third component 730 or the first component 710) provides an outlet. For example, a bridging member 1740 may engage an opening created through the fossa ovalis between the right and left atria, with one flared end extending into the right atrium and the other extending into the left atrium. In some configurations, the flared end in the right atrium is the inlet and the flared end in the left atrium is the outlet, while in other configurations, the flared end in the left atrium is the inlet and the flared end in the right atrium is the outlet. As used herein, "inlet" means the component into which blood flows, and "outlet" means the component into which blood flows out (out). The specific components that can be used to provide blood flow in and out can be selected based on the condition being treated. For example, in HF, the inlet can be on the left atrium (LA) side, where blood flows from LA to the right atrium (RA), and LA decompression is desired. Conversely, in PAH, the interventricular pressure gradient is reversed, resulting in flow from R to L and RA decompression, with the inlet on the RA side.

[0148] The cross-sectional area (and size) of the orifice provided by the stretchable shape memory center neck region can be increased or decreased to adjust the fluid flow through the shunt-graft assembly 1710. For example, in the form of... Figure 19C As shown, the neck region can be expanded by balloon inflation using balloon 1901 (e.g., a 12 mm diameter balloon), which can be fed through an orifice using filament 1902. Preferably, balloon 1901 expands the neck region only to a threshold outer diameter defined by bridging member 1740 such that the expansion of the neck region does not affect the outer diameter of the device or interfere with the septal tissue around bridging member 1740. For example, bridging member 1740 can be sized and shaped to define an outer diameter of 7-14 mm, and balloon 1901 can be configured to expand the neck region up to 9 mm.

[0149] In addition, with such as Figure 19D As shown and described above, the neck region can be contracted by injecting a bolus of hot saline solution at a temperature above the Af of the stretchable shape memory material (e.g., at 40-65°C or 45-65°C) via the distal end of the conduit 1903. This allows the neck region to recover its heat-set size, which may differ from its curled size and is preferably 4.5-5.5 mm. Figure 19DOne method of heating the neck region is illustrated, but other methods may also be used. For example, saline may be injected via a side port in catheter 1903. Additionally, a second balloon catheter may be inserted through shunt-graft assembly 1710 such that the balloon is distal to the saline delivery location and the balloon can be expanded to block blood flow through shunt-graft assembly 1710 during saline delivery. In other examples, a pair of electrodes may be positioned, for example via catheter 1903, to contact the shunt-graft assembly and actuated at an appropriate voltage and frequency to heat the neck region to its Af or above. In yet another example, other suitable means (such as laser, magnetic induction, resistive, or similar means) may be used to locally apply heat to shunt 700. Preferably, the restoration of the neck region to its thermally sized state does not affect the outer diameter of bridging member 1740, as... Figure 19E As shown.

[0150] For example, heat from the brine can cause a stretchable shape memory material to transform into an austenitic phase, thereby shrinking the neck region back to its coiled (or otherwise heat-set) dimensions, after which the neck region cools to body temperature and transforms back to its martensitic phase. The brine can be delivered in any suitable manner, for example, through a flexible conduit having one or more orifices (e.g., an end orifice, a side orifice, or multiple side orifices) through which the hot brine can flow, and the flexible conduit can be placed within the neck region, for example, on a guidewire passing through the neck region. In a non-limiting example, initially, the neck region may have its coiled internal dimensions, typically 1-2 mm, such as when initially... Figure 19B When deployed as shown. Then, in a second step, the neck region can be expanded using balloon dilation to any desired larger size between the curled size and the outer diameter of the bridging member 1740. Then, in a third step, the neck can be contracted to its heat-set size using hot saline. The heat-set size is determined by the size of the clamp used in the heat-set step of the manufacturing process and can be approximately the same as, smaller than, or larger than the size of the neck region in the curled state. The heat-set size can be larger than the size of the catheter used to deliver the hot saline and larger than the collapsed size of the dilation balloon, but smaller than or equal to the minimum expected final shunt size, for example, 4 mm. Then, the neck region can be expanded again using balloon dilation to any desired larger size between 4 mm and the outer diameter of the bridging member 1740. Any suitable number of expansions and contractions can be applied to the neck region at any desired time or at intervals to provide a suitable and customized fluid flow through the device for each given patient.

[0151] It will be understood that the appropriate fluid flow configuration for a given patient can also change over time, and the device can be appropriately adjusted to provide fluid flow or to properly secure the device within the lumen. It will also be understood that the self-expanding hyperelastic component is unaffected by the hot saline injection and will therefore retain its initial fully expanded dimensions when the shape memory component (in this example, the neck region) is adjusted. Furthermore, in addition to or besides hot saline, any suitable method for heating the shape memory material can be used, such as RF heating or using laser, magnetic induction, resistance, or similar methods.

[0152] As described above, this device can include separately formed and assembled components. For example, first and second expandable end regions can be formed and heat-treated to achieve the hyperelastic properties described herein, separate from the neck region, which can be formed and heat-treated to achieve the martensitic shape memory properties described herein. By processing the shape memory components separately from the hyperelastic components, these components can be processed in large quantities without complex processing equipment, which is required for manufacturing hybrid shunts from a one-piece nitinol frame, thereby significantly reducing manufacturing time. See below regarding... Figures 20A to 22I As described in further detail, the components of the various devices described herein can be assembled together via interlocking shapes. These interlocking shapes maintain the advantages of a monolithic structure, particularly across the entire device size (e.g., neck diameter), where transitions between components are smooth and continuous. This is because discontinuous variations in lumen diameter can introduce undesirable eddies and / or turbulence during flow. Such flow disturbances can reduce the discharge coefficient, even leading to platelet activation and thrombosis, and may even damage red blood cells (hemolysis).

[0153] Now for reference Figures 20A-20F It provides a hybrid flow divider with interlocking components having different shape memory properties, which are processed separately and then assembled together. Figure 20A and Figure 20B The illustration shows a hybrid shunt 2000 in an unassembled configuration, for example, after individual components have been treated to achieve desired material properties. For example, the shunt 2000 may be formed from a first end region 2002, a neck region 2004, and a second end region 2006. As described above, the neck region 2004 may be treated such that it is malleable at body temperature (e.g., having an Af temperature between about 40-60°C), and the first end region 2002 and the second end region 2006 may be treated such that they are hyperelastic at body temperature (e.g., having an Af temperature between about 5-20°C).

[0154] like Figure 20AAs shown, the first end region 2002 may include a proximal end 2008 and a distal end 2010 having a plurality of first end region connectors 2011; the neck region 2004 may include a proximal end 2012 having a plurality of proximal neck region connectors 2013 and a distal end 2014 having a plurality of distal neck region connectors 2015; and the second end region 2006 may include a proximal end 2016 and a distal end 2018 having a plurality of second end region connectors 2017. Similar to... Figure 7 In the device 700, each of the first end region 2002, the neck region 2004, and the second end region 2006 may be formed by a plurality of longitudinally extending struts interconnected via one or more circumferentially extending sinusoidal rings. For example, as Figure 20A As shown, the first end region 2002 may include a plurality of longitudinal struts 2020a interconnected via a sinusoidal ring 2022a, such that the plurality of first end region connectors 2011 are disposed at the distal end 2010 of each longitudinal strut 2020a. The neck region 2004 may include a plurality of longitudinal struts 2020b interconnected via a sinusoidal ring 2022b, such that the plurality of proximal neck region connectors 2013 are disposed at the proximal end 2012 of each longitudinal strut 2020b and the plurality of distal neck region connectors 2015 are disposed at the distal end 2014 of each longitudinal strut 2020b. The second end region 2006 may include a plurality of longitudinal struts 2020c interconnected via a sinusoidal ring 2022c, such that the plurality of second end region connectors 2017 are disposed at the proximal end 2016 of each longitudinal strut 2020c. As will be understood by those skilled in the art, although Figure 20A The illustration shows a first end region 2002 and a second end region 2006 having a single sinusoidal loop, but the first end region 2002 and the second end region 2006 may each include more than one sinusoidal loop interconnecting multiple longitudinal struts 2020a, 2020c. Similarly, although Figure 20A The diagram illustrates a neck region 2004 with two sinusoidal loops, but the neck region 2004 may have fewer or more sinusoidal loops interconnecting multiple longitudinal struts 2020b. Furthermore, the shunt 2000 may also include more than... Figure 20A The diagram shows fewer or more longitudinal pillars.

[0155] Each of the plurality of first end region connectors 2011 in the first end region 2002 may have a shape configured to interlock with a complementary shape of each of the plurality of proximal neck region connectors 2013 in the neck region 2004, and each of the plurality of second end region connectors 2017 in the second end region 2006 may have a shape configured to interlock with a complementary shape of each of the plurality of distal neck region connectors 2015 in the neck region 2004. For example, the complementary shapes of the first end region connectors 2011 and proximal neck region connectors 2013, and the second end region connectors 2017 and distal neck region connectors 2015 may include tabs and recessed elements. As will be understood by those skilled in the art, other complementary shapes providing an interlocking puzzle-like connection may be used.

[0156] For example, such as Figure 20B As shown, the first end region connector 2011 may include a socket element, while the proximal neck region connector 2013 may include a tongue element. Similarly, the distal neck region connector 2015 may include a tongue element, while the second end region connector 2017 may include a socket element. As those skilled in the art will understand, the first end region connector 2011 and the second end region connector 2017 may alternatively include tongue elements, while the proximal neck region connector 2013 and the distal neck region connector 2015 include socket elements. In some embodiments, the distal end 2010 of the first end region 2002 (and similarly the proximal end 2016 of the second end region 2006) may include an eyelet 2009 adjacent to the socket element 2011 to improve the structural integrity of the socket element 2011, while also providing flexibility to the first end region 2002 when the first end region 2002 transitions between a collapsed delivery state and an expanded deployment state, and during adjustment of the lumen diameter of the neck region 2004. In addition, a non-transmissive marker can be placed within the aperture 2009 to facilitate visualization of the shunt 2000, for example, under fluorescence inspection.

[0157] like Figure 20BAs shown, the socket element 2011 includes an opening sized and shaped to securely receive the tab element 2013. Preferably, when the socket element 2011 and the tab element 2013 are at the same temperature, the tab element 2013 is slightly larger than the opening of the socket element 2011, such that when the tab element 2013 is disposed within the opening of the socket element 2011, the tab element 2013 can be permanently fixed to the socket element 2011. Therefore, the tab element 2013 can be heat-shrinkable (e.g., via cooling) so that the tab element 2013 changes from a first size to a second size smaller than the first size and smaller than the opening of the socket element 2011. When in a heat-shrinkable state with a second dimension, the tongue element 2013 can be fitted into the opening of the socket element 2013, such that when the tongue element 2013 and the socket element 2011 are brought to the same temperature, and the tongue element 2013 is positioned within the opening of the socket element 2011, the tongue element 2013 can be permanently fixed to the socket element 2011. For example, the tongue element 2013 can be thermally expanded to its first dimension, such that the tongue element 2013 is fixed within the opening of the socket element 2011 (e.g., via an interference fit). When the tongue element 2013 is fixed within the opening of the socket element 2011, the tongue element 2013 and the socket element 2011 form a rigid connection that provides a smooth, continuous transition between the first end region 2002 and the neck region 2004, such that the first end region 2002 can be uniformly bent relative to the neck region 2004, like a single element. The tongue element 2015 at the distal end 2014 of the neck region 2004 can be fixed to the socket element 2017 at the proximal end 2016 of the second end region 2006 in the same manner as the tongue element 2013 and the socket element 2011 described herein.

[0158] Alternatively or concurrently, the socket element 2011 may be thermally expandable (e.g., via heating) such that the opening of the socket element 2011 changes from a first size to a second size larger than the first size and larger than the tab element 2013. When in a thermally expanded state with the second size, the tab element 2013 can fit within the opening of the socket element 2011 such that when the tab element 2013 and the socket element 2011 are brought to the same temperature, and the tab element 2013 is disposed within the opening of the socket element 2011, the tab element 2013 can be permanently fixed to the socket element 2011. For example, the socket element 2011 may be thermally contracted to its first size, such that the tab element 2013 is fixed within the opening of the socket element 2011 (e.g., via an interference fit). Therefore, the tongue element 2013 and the socket element 2011 can form a rigid connection between the first end region 2002 and the neck region 2004, providing a smooth, continuous transition, such that the first end region 2002 can be uniformly bent relative to the neck region 2004, like a single element. In some embodiments, the tongue element 2013 and the socket element 2011 can be welded together to permanently secure the first end region 2002 to the neck region 2004, and similarly, the tongue element 2015 and the socket element 2017 can be welded together to permanently secure the second end region 2006 to the neck region 2004. Furthermore, in some embodiments, the plurality of first end region connectors 2011 can also be configured to interlock with the plurality of distal neck region connectors 2015, and the plurality of second end region connectors 2017 can also be configured to interlock with the plurality of proximal neck region connectors 2013.

[0159] Figure 20C and Figure 20D The diagram illustrates components of a shunt 2000 permanently fixed together in an assembly configuration, wherein a first end region 2002 is permanently fixed to a neck region 2004 at a first connection 2003 via a first end region connector 2011 and a proximal neck region connector 2013, and a second end region 2006 is permanently fixed to a neck region 2004 at a second connection 2005 via a second end region connector 2017 and a distal neck region connector 2015. Figure 20C As shown, each first end region connector 2011 can be permanently fixed to the proximal neck region connector 2013 along a single plane at the first connection 2003, and each second end region connector 2017 can be permanently fixed to each distal neck region connector 2015 along a single plane at the second connection 2005. For example, these planes can be parallel to each other and can be perpendicular to the longitudinal axis of the neck region 2004.

[0160] Alternatively, each first end region connector 2011 may be permanently fixed to each proximal neck region connector 2013 in an alternating manner along the circumference of the splitter 2000, such that stress is distributed to the alternating sides of the connection, thereby distributing strain and creating a smoother transition between components. For example, the connection between every other first end region connector 2011 and proximal neck region connector 2013 may be offset from the adjacent connection between the first end region connector 2011 and proximal neck region connector 2013. Thus, every other longitudinal strut of the first end region 2002 may be longer than (or shorter than) the adjacent longitudinal strut of the first end region 2002, and for each longer (or shorter) longitudinal strut of the first end region 2002, the corresponding longitudinal strut of the neck region 2004 may be shorter than (or longer than) the adjacent longitudinal strut of the neck region 2004. Each second end region connector 2017 can be permanently attached to each distal neck region connector 2015 in an alternating manner along the circumference of the shunt 2000.

[0161] Figure 20E and Figure 20F The diagram illustrates the assembled splitter 2000, with the first end region 2002 and the second end region 2006 in their expanded deployment state. Figure 20E As shown, in the extended state, the proximal end 2008 of the first end region 2002 flares radially outward from the distal end 2010 at the first connection 2003, while the distal end 2018 of the second end region 2006 flares radially outward from the proximal end 2016 at the second connection 2005. Furthermore, as described above, the components of the shunt 2000 are also configured such that the first connection 2003 provides a smooth, continuous transition from the neck region 2004 to the first end region 2002, such as... Figure 20F As shown, the second connection 2005 provides a smooth, continuous transition from the neck region 2004 to the second end region 2006 across the entire lumen diameter of the neck region 2004. Therefore, for any given lumen diameter of the neck region 2004, the first connection 2003 and the second connection 2005 provide a smooth, continuous transition between the corresponding components as the first end region 2002 and the second end region 2006 transition between their collapsed delivery state and expanded deployment state.

[0162] In some embodiments, the neck region 2004 may be processed in a non-uniform manner. For example, the central portion of the neck region 2004 may be processed to produce a martensitic phase at body temperature and an Af temperature, such as about 40-50°C or 42°C, while the end portions of the neck region 2004 to be fixedly coupled to the superelastic first and second end regions 2002, 2006 may be processed to produce an intermediate phase, such as the R phase, between martensite and austenite at body temperature. In this embodiment, more gradual variations may exist in response to manipulation of the device (such as mechanical expansion or thermal contraction of the shape memory neck region), thereby creating a smooth, continuous transition between the connected components.

[0163] Now for reference Figures 21A-21D This provides another hybrid shunt device with interlocking components having different shape memory properties, which are processed separately and then assembled together. Figure 21A and Figure 21B The illustration shows a hybrid splitter 2100 in its assembled configuration, while Figure 21C and Figure 21D The illustration shows a hybrid shunt 2100 in an unassembled configuration, for example, after individual components have been treated to achieve desired material properties. For example, the shunt 2100 may be formed from a first end region 2102, a neck region 2104, and a second end region 2106. As described above, the neck region 2104 may be treated such that it is malleable at body temperature, for example, having an Af temperature between about 40-60°C, and the first end region 2102 and the second end region 2106 may be treated such that they are hyperelastic at body temperature, for example, having an Af temperature between about 5-20°C. In some embodiments, similar to the neck region 2104, the neck region 2104 may be treated in a non-uniform manner.

[0164] like Figure 21C As shown, the first end region 2102 may include a proximal end 2108 and a distal end 2110 having a plurality of first end region connectors 2111; the neck region 2104 may include a proximal end 2112 having a plurality of proximal neck region connectors 2113 and a distal end 2114 having a plurality of distal neck region connectors 2115; and the second end region 2106 may include a proximal end 2116 and a distal end 2118 having a plurality of second end region connectors 2117. Similar to... Figures 20A-20F In the device 2000, each of the first end region 2102, the neck region 2104, and the second end region 2106 may be formed by a plurality of longitudinally extending struts interconnected via one or more circumferentially extending sinusoidal loops. For example, as Figure 21A and Figure 21CAs shown, the first end region 2102 may include a plurality of longitudinal struts 2120a interconnected via a sinusoidal ring 2122a, such that the plurality of first end region connectors 2111 are disposed at the distal end 2110 of each longitudinal strut 2120a.

[0165] The neck region 2104 may include a plurality of longitudinal struts 2120b interconnected via a sinusoidal ring 2122b, such that a plurality of proximal neck region connectors 2113 are disposed at the proximal end 2112 of each longitudinal strut 2120b, and a plurality of distal neck region connectors 2115 are disposed at the distal end 2114 of each longitudinal strut 2120b. The second end region 2106 may include a plurality of longitudinal struts 2120c interconnected via a sinusoidal ring 2122c, such that a plurality of second end region connectors 2117 are disposed at the proximal end 2116 of each longitudinal strut 2120c. As will be understood by those skilled in the art, although Figure 21A and Figure 21B The illustration shows a first end region 2102 with two sinusoidal loops and a second end region 2106 with three sinusoidal loops. However, the first end region 2102 may include fewer or more than two sinusoidal loops interconnected with a plurality of longitudinal supports 2120a, and the second end region 2106 may each include fewer or more than three sinusoidal loops interconnected with a plurality of longitudinal supports 2120c. Similarly, although Figure 21A and Figure 21B The diagram illustrates a neck region 2104 with two sinusoidal loops, but the neck region 2104 may have fewer or more sinusoidal loops interconnecting multiple longitudinal struts 2120b. Furthermore, the shunt 2100 may also include more than... Figure 21A and Figure 21C Showing fewer or more longitudinal struts.

[0166] Similar to the connector of the shunt 2000, each of the plurality of first end region connectors 2111 in the first end region 2102 may have a shape configured to interlock with a complementary shape of each of the plurality of proximal neck region connectors 2113 in the neck region 2104, and each of the plurality of second end region connectors 2117 in the second end region 2106 may have a shape configured to interlock with a complementary shape of each of the plurality of distal neck region connectors 2115 in the neck region 2104. For example, the complementary shapes of the first end region connectors 2111 and proximal neck region connectors 2113, and the second end region connectors 2117 and distal neck region connectors 2115 may include tabs and socket elements. Figure 21DAs shown, the second end region connector 2117 may include a socket element, while the distal neck region connector 2115 may include a tab element. Similarly, the proximal neck region connector 2113 may include a tab element, and the first end region connector 2111 may include a socket element. As those skilled in the art will understand, the first end region connector 2111 and the second end region connector 2117 may alternatively include tab elements, while the proximal neck region connector 2113 and the distal neck region connector 2115 include socket elements.

[0167] like Figure 21D As shown, the socket element 2117 includes an opening sized and shaped to receive the tongue element 2115. Unlike the tongue and socket elements of the distributor 2000, the tongue element 2115 can be fitted into the opening of the socket element 2117 without thermally shrinking the tongue element 2115 or thermally expanding the socket element 2117. Instead, when the tongue element 2115 is disposed within the opening of the socket element 2117, a retaining ring 2124 can be disposed on both the tongue element 2115 and the socket element 2117 to maintain a rigid connection between the neck region 2104 and the second end region 2106 at the second connection 2105, as shown. Figure 21B As shown, a smooth, continuous transition from the neck region 2104 to the second end region 2106 is provided throughout the entire lumen diameter of the neck region 2104. Similarly, when the tongue element 2113 at the proximal end 2112 of the neck region 2104 is disposed within the opening of the recess element 2111 at the distal end 2110 of the first end region 2102, a retaining ring 2124 can be disposed on both the tongue element 2113 and the recess element 2111, thereby maintaining a rigid connection between the neck region 2104 and the first end region 2102 at the first connection 2103, while providing a smooth, continuous transition from the neck region 2104 to the first end region 2102 throughout the entire lumen diameter of the neck region 2104. Therefore, the first end region 2102 and the second end region 2106 can be uniformly curved relative to the neck region 2104, like a single element. In some embodiments, the retaining ring 2124 can be made of a radiopaque material, making it visible under fluorescence inspection.

[0168] Furthermore, the shunt device described herein may also include one or more physiological sensors, such as pressure sensors configured to acquire intraatrial pressure measurements. For example, the shunt 2100 may include one or more pressure sensors (e.g., for measuring pressure in the first atrium of the patient's heart) disposed at the first connection 2103 and / or one or more pressure sensors (e.g., for measuring pressure in the second atrium of the patient's heart) disposed at the second connection 2105, enabling continuous monitoring of treatment progress. Figure 21D As shown, sensor 2126 (e.g., pressure sensor) can be disposed on (e.g., embedded therein) one or more of the tab elements 2115, such that when retaining ring 2124 is disposed on the tab elements 2115 and the socket elements 2117 at the second connection 2105 (as described above), sensor 2126 is encapsulated within retaining ring 2124. Therefore, retaining ring 2124 can form a sealed, biocompatible package that prevents corrosive bodily fluids from entering the electronic components of sensor 2126 while minimizing residual internal stress on sensor 2126.

[0169] Similarly, sensor 2126 can be disposed on one or more of the tab elements 2113 such that when retaining ring 2124 is disposed on the tab element 2113 and the socket element 2111 at the first connection 2103, sensor 2126 can be encapsulated within retaining ring 2124. Therefore, pressure measurements obtained by the sensor at the first connection 2103 (e.g., atrial pressure in the first atrium of the patient's heart) and pressure measurements obtained by the sensor at the second connection 2105 (e.g., atrial pressure in the second atrium of the patient's heart) can be used to calculate the pressure gradient across shunt 2100 between the first and second atria. For example, the sensor can be configured for telemetry and includes circuitry for transmitting data between each other and / or transmitting data to a receiver outside the patient for processing. Sensor 2126 can be configured to acquire other physiological measurements within one or both atria, including, for example, flow rate, velocity, temperature, pH, or concentration of certain chemicals, for example, for comparing measurements across the shunt, as described above. For example, sensor 2126 may be constructed as a sensor similar to that described in Eigler's U.S. Patent Application Publication No. 2022 / 0151784, which has been assigned to the assignee of this application, the entire contents of which are incorporated herein by reference. Alternatively or additionally, sensor 2126 may be disposed on (e.g., embedded therein) the retaining ring 2124 itself.

[0170] Similar to the splitter 2000, each first end region connector 2111 can be permanently fixed to each proximal neck region connector 2113 along a single plane at the first connection 2103, and each second end region connector 2117 can be permanently fixed to each distal neck region connector 2115 along a single plane at the second connection 2105. Alternatively, each first end region connector 2111 and each second end region connector 2117 can be permanently fixed to each proximal neck region connector 2113 and each distal neck region connector 2115 respectively in an alternating manner along the circumference of the splitter 2100, such that stress is distributed to the alternating sides of the connection, thereby distributing strain and creating a smoother transition between components.

[0171] Now for reference Figures 22A-22I An exemplary method for assembling components of a shunt 2100 is provided. First, a retaining ring 2124 may be disposed on and beyond each connector (e.g., first end region connector 2111 and second end region connector 2117) of the first end region 2102 and the second end region 2106, such that each retaining ring 2124 is temporarily disposed on the longitudinal strut 2120a of the first end region 2102 and the longitudinal strut 2120c of the second end region 2106, exposing the opening of the corresponding retaining element. For example, as... Figure 22A and Figure 22B As shown, the retaining ring alignment tool 2202 can be used to slide each retaining ring 2124 onto each second end region connector 2117. One end of the retaining ring alignment tool 2202 may include one or more fingers 2204, each finger having an extension extending therefrom, the extension being sized and shaped to receive the retaining ring 2124 thereon and configured to align with the connectors of the plurality of second end region connectors 2117, such that when aligned, the retaining ring 2124 can be easily transferred from the fingers 2204 to the connectors 2117 and to the longitudinal struts 2120c, as shown. Figure 22D As shown.

[0172] In some embodiments, the retaining ring alignment tool 2202 may have a plurality of fingers 2204 corresponding to the number of connectors of the plurality of second end region connectors 2117, such as Figure 22A As shown, this allows each retaining ring 2124 to be placed in a group simultaneously or individually on each connector of the second end region 2106. The retaining ring alignment tool 2202 can be similarly used to slide each retaining ring 2124 onto each first end region connector 2111. Additionally, as... Figure 22BAs shown, the outer surface of each socket element 2117 (e.g., the lateral side of the fingers of the socket element 2117 defining the opening of the socket element 2117) may include one or more protrusions 2119 extending outward therefrom to facilitate securing the retaining ring 2124 to the tongue element 2115 and the socket element 2117 when the tongue element 2115 is disposed within the opening of the socket element 2117 (e.g., via an interference fit). When the tongue element 2115 is not disposed within the socket element 2117, for example, as the retaining ring 2124 is moved on the socket element 2117, the fingers of the socket element 2117 may be pushed inward toward each other via the engagement between the protrusions 2119 and the inner surfaces of the retaining ring 2124.

[0173] like Figure 22C and Figure 22D As shown, the components of the splitter 2100 can then be assembled together on the alignment pin 2206. The alignment pin 2206 may include a plurality of ridges 2208 extending longitudinally along the outer surface of the alignment pin 2206, each ridge 2208 being circumferentially spaced around the outer surface of the alignment pin 2206 and separated by a plurality of grooves 2210. The positions of the ridges 2208 on the alignment pin 2206 may correspond to the longitudinal supports of the splitter 2100, such as... Figure 22C As shown, this provides support for the connection points between the components of the splitter 2100. Figure 22C As shown, when the retaining ring 2124 is disposed on the longitudinal support of the first end region 2102, the tongue element 2113 of the neck region 2104 can be adapted to the opening of the socket element 2111 of the first end region 2102, and when the retaining ring 2124 is disposed on the longitudinal support of the second end region 2106, the tongue element 2115 of the neck region 2104 can be adapted to the opening of the socket element 2117 of the second end region 2106. Figure 22D The diagram shows a tongue element 2113 in the neck region 2104, which is disposed within the opening of a socket element 2111 having a protrusion 2121, while a retaining ring 2124 is disposed on a longitudinal support 2120a in the first end region 2102.

[0174] Next, each retaining ring 2124 can be moved such that they are positioned on the socket / tongue connection. For example... Figure 22E , Figure 22F and Figure 22H As shown, the support ring 2216—having a lumen extending therethrough—can slide across the alignment pin 2206 on the splitter 2100 until the support ring 2216 is positioned on the middle portion of the neck region 2104. The inner surface of the support ring 2216 may have multiple ridges and grooves, such that the positions of the ridges correspond to the longitudinal supports of the splitter 2100, as... Figure 22EAs shown, the ridge 2208 of the alignment pin 2206 provides additional support for the connection point between the components of the splitter 2100 and prevents the frame of the splitter 2100 from wavy deformation when the retaining ring 2124 is moved to its final position on the socket / tongue connection.

[0175] In addition, such as Figure 22E , Figure 22F and Figure 22H As shown, one or more retaining rings 2212a, 2212b can be used to allow each retaining ring 2124 to slide on each socket / tongue connection between the neck region 2104 and the first and second end regions 2102, 2106. Therefore, the retaining rings 2212a, 2212b can have lumens extending through them and are sized and shaped such that the retaining rings 2212a, 2212b can be advanced onto the first and second end regions 2102, 2106 on the alignment pin 2206. The ends of each retaining ring 2212a, 2212b can each include one or more fingers 2214a, 2214b, each sized and shaped to align and engage with the retaining ring 2124 when the retaining rings 2212a, 2212b are moved onto the first and second end regions 2102, 2106 on the alignment pin 2206 toward the neck region 2104.

[0176] For example, such as Figure 22G and Figure 22I As shown, the seat ring 2212b can be moved proximally along the arrow direction on the alignment pin 2206 onto the second end region 2106 until the finger 2214b contacts and engages with the retaining ring 2124. Further proximal movement of the seat ring 2212b causes the finger 2214b to push the retaining ring 2124 onto the socket element 2217 and the tab element 2115. When the tab element 2115 is fitted into the opening of the socket element 2117, the finger of the socket element 2217, which defines the opening, cannot move inward. Therefore, when the retaining ring 2124 is positioned thereon, the protrusion 2119 applies force to the inner surface of the retaining ring 2124 to facilitate securing the retaining ring 2124 to the socket / tab connection. Figure 22I As shown, the retaining ring 2124 can have a very thin wall thickness, thereby providing a smooth, continuous transition from the neck region 2104 to the second end region 2106 as described above.

[0177] In some embodiments, the seat ring 2212b may have a plurality of fingers 2214b corresponding to the number of connectors of the plurality of second end region connectors 2117, such as Figure 22EAs shown, each retaining ring 2124 can be moved simultaneously or individually, either in groups, to its final position on the socket / tongue connection. A seat ring 2212a can be similarly used to slide each retaining ring 2124 to its final position on each socket / tongue connection between the neck region 2104 and the first end region 2102. Preferably, both seat rings 2212a and 2212b are simultaneously pushed to move the retaining rings to their final positions on the corresponding socket / tongue connections between the neck region 2104 and the first region 2102, and between the neck region 2104 and the second end region 2106. Alternatively, a single seat ring can be used to push the retaining ring onto a first set of socket / tongue connections, for example, at the first connection 2103, and then the remaining retaining rings can be pushed onto a second set of socket / tongue connections, for example, at the second connection 2105, and vice versa. As described above, for example, when the retaining ring 2124 is in its final position on the corresponding socket / tongue connection, a sealant can be applied to the distributor 2100 to further secure the retaining ring to the distributor 2100. As will be understood by those skilled in the art, the hybrid distributors 2000, 2100 can be used in conjunction with other features described herein, for example, for use with respect to the above-described features. Figures 15A-15E and / or Figures 17A-17E The bridging component 1740 describes the acute treatment.

[0178] Now for reference Figures 23A to 23E This provides an alternative exemplary interlocking component for the separately processed areas of a permanently coupled hybrid shunt. For example... Figure 23A As shown, the first interlocking component 2302 (e.g., a first end region connector of the first end region of a hybrid shunt) may include a first geometry (e.g., one or more tongue elements 2306), while the second interlocking component 2304 (e.g., a proximal neck region connector of the neck region of a hybrid shunt) may include a second geometry (e.g., one or more socket elements 2308, which are sized and shaped to complementaryly receive one or more tongues 2306), such as Figure 23B As shown. Figure 23A As shown, the tongue element 2306 can be disposed in a circular manner at the distal ends of a pair of fingers extending from the distal region of the first interlocking member 2302, such that the pair of fingers define a circular opening therebetween. For example, the pair of fingers may initially extend away from each other and then extend toward each other, thereby forming a circular opening. When the tongue element 2306 is disposed within the recess element 2308, the inner surface of the circular opening defined by the pair of fingers of the first interlocking member 2302 can form at least a portion of the eyelet 2310, such as... Figure 23BAs shown. Therefore, when the tongue element 2306 is disposed within the socket element 2308, the inner surface of the proximal end of the second interlocking member 2304 (e.g., the end facing the first interlocking member 2302 when the first interlocking member 2302 is coupled to the second interlocking member 2304) can form the remainder of the eyelet 2310, as shown. Figure 23B As shown.

[0179] Figure 23C The illustration shows a plunger-like component, such as a radiopaque marker 2312, sized and shaped to fit snugly within an eyelet 2310 defined by a first interlocking member 2302 and a second interlocking member 2304 when the tongue element 2306 is positioned within the socket element 2308. The radiopaque marker 2312 can be formed of, for example, tantalum, platinum, iridium, etc., thereby facilitating visualization under fluorescence inspection. Furthermore, the radiopaque marker 2312 can have a geometry slightly larger than that of the eyelet 2310, such that when the radiopaque marker 2312 is positioned within the eyelet 2310, it applies mechanical force to the first interlocking member 2302 and the second interlocking member 2304, thereby securing the tongue element 2306 within the socket element 2308 and permanently fixing the first interlocking member 2302 to the second interlocking member 2304, as shown. Figure 23D As shown. Figure 23E This is a side view of the first interlocking member 2302 and the second interlocking member 2304 when the radiopaque marker 2312 is disposed within the orifice 2310. Therefore, when the radiopaque marker 2312 is disposed within the orifice 2310, the tongue element 2306 and the socket element 2308 form a rigid connection that provides a smooth, continuous transition between the first end region and the neck region of the hybrid shunt, allowing the first end region to bend uniformly relative to the neck region, like a single element. As will be understood by those skilled in the art, the orifice 2310 can have a geometry other than circular, allowing the radiopaque marker 2312 to have a corresponding shape configured to be tightly disposed within the orifice. Alternatively, instead of the radiopaque marker, one or more of the orifices 2310 can have one or more physiological sensors disposed therein. For example, as described above, the physiological sensors can be configured to acquire measurements, including, for example, intraatrial pressure measurements, flow rate, velocity, temperature, pH, or concentration of certain chemical species.

[0180] As will be understood by those skilled in the art, the first interlocking component 2302 may be a proximal neck region connector of the neck region of the hybrid shunt, and therefore the second interlocking component 2304 may be a first end region connector of the first end region of the hybrid shunt, such that the first end region and the neck region of the hybrid shunt can be permanently fixed together to form a rigid connection. Furthermore, when the distal neck region connector of the neck region of the hybrid shunt may have a geometry similar to that of the second interlocking component 2304, the second end region connector of the second end region of the hybrid shunt may have a geometry similar to that of the first interlocking component 2302; or alternatively, when the distal neck region connector of the neck region of the hybrid shunt may have a geometry similar to that of the first interlocking component 2302, the second end region connector of the second end region of the hybrid shunt may have a geometry similar to that of the second interlocking component 2304.

[0181] Therefore, this paper provides an atrial shunt for placement in the atrial septum of a patient's heart, for adjustable regulation of fluid flow therethrough. The atrial shunt can be similarly configured as referenced. Figures 2A-2E The described device 200; Reference Figure 7 , Figures 8A-8D , Figures 9A-9B and Figures 10A-10C The described device 700; Reference Figures 15A-15E The described device 28; Figures 20A-20F Device 2000; or Figures 21A-21D One or more of the devices 2100. For example, an atrial shunt may include a body comprising first and second expandable end regions fluidly coupled through a neck region. The first expandable end region may be configured to be placed in a first atrium of the heart, the second expandable end region may be configured to be placed in a second atrium of the heart, and the neck region may be configured to be placed at the interatrial septum.

[0182] For example, the body may include shape memory material, as described elsewhere in this document. For example, as in reference materials... Figure 7 , Figures 8A-8D , Figures 9A-9B and Figures 10A-10C The described device 700; Reference Figures 15A-15E The described device 28; Figures 20A-20F Device 2000; or Figures 21A-21DIn the manner of device 2100, the body can define a channel through the neck region for blood to flow between the first and second atria. For example, in a manner as described elsewhere herein, the first and second regions can be hyperelastic at body temperature, and the neck region can be extensible at body temperature. For example, in a manner as described elsewhere herein, the flow area of ​​the channel through the neck region can be adjusted within the body.

[0183] The neck region can be heat-treated to exhibit shape memory properties different from the first and second expandable end regions, such that the cross-sectional area of ​​the channel is adjustable in bulk. For example, in a manner as described elsewhere herein, the superelastic first and second expandable end regions may comprise nitinol with an austenite finish temperature (Af) between 5 and 20 °C. For example, in a manner as described elsewhere herein, the stretchable neck region may comprise nitinol with an austenite finish temperature (Af) between 40 and 60 °C. For example, in a manner as described elsewhere herein, the neck region may be mechanically expandable. For example, in a manner as described elsewhere herein, the neck region may be thermally shrinkable.

[0184] For example, in a manner as described elsewhere herein, the stretchable shape memory material can be configured to expand in bulk such that the channel expands from a cross-sectional area to a second cross-sectional area larger than the cross-sectional area. For example, in a manner as described elsewhere herein, the stretchable shape memory material can be configured to contract in bulk such that the channel shrinks from a second cross-sectional area to a third cross-sectional area smaller than the second cross-sectional area. The cross-sectional area can range from 4.9 to 28.3 mm. 2 The areas of the second and third cross-sections can range from 15.9 to 78.6 mm. 2 between.

[0185] For example, as described elsewhere herein, a stretchable shape memory material may include nitinol with an austenitic finish temperature (Af) between 40 and 60 °C. For example, as described elsewhere herein, a self-expanding superelastic material may include nitinol with an austenitic finish temperature (Af) between 5 and 20 °C. For example, as described elsewhere herein, a stretchable shape memory material may be mechanically expandable. For example, as described elsewhere herein, a stretchable shape memory material may be thermally shrinkable. The cross-sectional area of ​​the neck region may be smaller than the corresponding cross-sectional area of ​​at least one of the first and second expandable end regions. The first and second expandable end regions may extend into the first and second atria, respectively, such that the corresponding ends of the first and second expandable end regions do not contact the interatrial septum. As described above, the first and second expandable end regions and the neck region may include a cane-shaped shunt. For example, as described elsewhere herein, the first and second expandable end regions and the neck region may be integrally formed from a common frame. Alternatively, for example, as described elsewhere herein, the first and second expandable end regions and the neck region may be formed separately and assembled together. For example, the first and second expandable end regions and the neck region may be encapsulated at least partially with a biocompatible material, in a manner as described elsewhere in this document.

[0186] It will be understood that in any of these examples, the device construction can be reversibly modified within the body. In many examples, construction changes include increasing or decreasing the size of the device, such as the internal or external dimensions of the device. However, other construction changes can be suitably implemented, such as those described in U.S. Patent No. 6,964,680 to Shanley entitled “Expandable medical device with tapered hinge” (the entire contents of which are incorporated herein by reference).

[0187] While various illustrative embodiments of the invention have been described above, it will be apparent to those skilled in the art that various changes and modifications can be made herein without departing from the invention. For example, although examples of the device are described as having two or three components, it should be understood that the device may include any suitable number of components, which may comprise self-expanding hyperelastic materials or stretchable shape memory materials. The appended claims are intended to cover all such variations and modifications that fall within the true spirit and scope of the invention.

Claims

1. A hybrid shunt comprising shape memory material for placement in the atrial septum of a patient's heart, the hybrid shunt comprising: The neck area is configured to be stretchable at body temperature; A first end region is configured to be superelastic at body temperature, and the distal end of the first end region is configured to be permanently fixed to the proximal end of the neck region at a first connection. The second end region is configured to be superelastic at body temperature, and the proximal end of the second end region is configured to be permanently fixed to the distal end of the neck region at the second connection; and A channel extending through the first end region, the neck region, and the second end region to allow blood to flow across the interatrial septum. The flow area of ​​the channel through the neck region is configured to be adjustable within the body.

2. The hybrid splitter according to claim 1, wherein the first end region and the second end region are not integrally formed with the neck region.

3. The hybrid shunt according to claim 1 or 2, wherein the proximal and distal ends of the neck region include shapes configured to interlock with complementary shapes of the distal end of the first end region and the proximal end of the second end region, respectively.

4. The hybrid shunt according to claim 3, wherein the complementary shapes of the proximal and distal ends of the neck region and the distal end of the first end region and the proximal end of the second end region include a tongue element and a socket element.

5. The hybrid splitter of claim 4, wherein the tongue element is configured to heat-shrink from a first size to a second size, the second size being configured to fit within the socket element, and wherein, When the tongue element and the socket element are brought to the same temperature, and the tongue element is fitted into the socket element, the tongue element and the socket element form a rigid connection.

6. The hybrid splitter of claim 4, wherein the socket element is configured to thermally expand from a first dimension to a second dimension, the second dimension being configured to receive the tongue element therein. And among them, When the tongue element and the socket element are brought to the same temperature, and the tongue element is received in the socket element, the tongue element and the socket element form a rigid connection.

7. The hybrid splitter of claim 4, further comprising a retaining ring configured to be disposed on the tongue element and the socket element when the tongue element is adapted into the socket element to maintain a rigid connection between the tongue element and the socket element.

8. The hybrid splitter of claim 7, wherein the outer surface of the retaining element includes one or more protrusions such that the retaining ring maintains a rigid connection between the tongue element and the retaining element via an interference fit between the one or more protrusions and the inner surface of the retaining ring.

9. The hybrid shunt according to claim 7, further comprising a physiological sensor disposed on the tongue element such that the physiological sensor is encapsulated within the retaining ring when the retaining ring is disposed on the tongue element and the socket element.

10. The hybrid splitter of claim 4, wherein the proximal and distal shapes of the neck region include the tongue element, and wherein the distal shape of the first end region and the proximal shape of the second end region include the socket element.

11. The hybrid splitter of claim 4, wherein the proximal and distal shapes of the neck region include the socket element, and wherein the distal shape of the first end region and the proximal shape of the second end region include the tongue element.

12. The hybrid shunt according to any one of the preceding claims, wherein the first end region and the second end region are configured to expand from a collapsed delivery state to an expanded deployment state at body temperature.

13. The hybrid splitter according to claim 12, wherein, In the extended deployment state, the proximal end of the first end region opens outward from the distal end of the first end region at the first connection portion, and the distal end of the second end region opens outward from the proximal end of the second end region at the second connection portion.

14. The hybrid splitter according to claim 12 or 13, wherein, In the extended deployment state, the first connection portion includes a smooth, continuous transition from the neck region to the first end region, and the second connection portion includes a smooth, continuous transition from the neck region to the second end region.

15. The hybrid shunt according to any one of the preceding claims, wherein the distal end of the first end region includes a plurality of circumferentially spaced connectors configured to permanently fix at the first connection to a corresponding plurality of circumferentially spaced connectors at the proximal end of the neck region, and wherein the proximal end of the second end region includes a plurality of circumferentially spaced connectors configured to permanently fix at the second connection to a corresponding plurality of circumferentially spaced connectors at the distal end of the neck region.

16. The hybrid splitter of claim 15, wherein the plurality of circumferentially spaced connectors at the distal end of the first end region and the proximal end of the neck region are permanently fixed at the first connection along a single plane.

17. The hybrid splitter of claim 15, wherein the plurality of circumferentially spaced connectors at the distal end of the first end region and the proximal end of the neck region are permanently fixed at the first connection in an alternating manner, such that the connection is not all located in a single plane.

18. The hybrid splitter of claim 15, wherein the plurality of circumferentially spaced connectors at the proximal end of the second end region and the distal end of the neck region are permanently fixed at the second connection along a single plane.

19. The hybrid splitter of claim 15, wherein the plurality of circumferentially spaced connectors at the proximal end of the second end region and the distal end of the neck region are permanently fixed at the second connection in an alternating manner, such that the connection is not all located in a single plane.

20. The hybrid shunt according to any one of the preceding claims, wherein the neck region comprises nitinol with an austenite finish temperature (Af) between 45 and 60°C.

21. The hybrid shunt according to any one of the preceding claims, wherein the neck region is configured to be mechanically expandable within the body, such that the channel expands from a first cross-sectional area to a second cross-sectional area larger than the first cross-sectional area.

22. The hybrid shunt according to any one of the preceding claims, wherein the neck region is configured to be heat-shrinkable in vivo.

23. The hybrid shunt according to any one of the preceding claims, wherein the first end region and the second end region comprise nitinol with an austenite finish temperature (Af) between 5 and 20 °C.

24. The hybrid splitter according to any one of the preceding claims, wherein the first end region, the second end region, and the neck region comprise a diabolo-shaped splitter.

25. The hybrid shunt according to any one of the preceding claims, wherein the first end region, the second end region, and the neck region are at least partially encapsulated with a biocompatible material.

26. The hybrid shunt according to any one of the preceding claims, further comprising a bridging member extending from a first outer surface of the first end region to a second outer surface of the second end region, the bridging member being formed of a biocompatible material and configured to engage the patient's room partition.

27. The hybrid shunt of claim 26, wherein the first end region, the second end region, and the neck region are at least partially encapsulated with a biocompatible material integrally formed with the bridging member.

28. The hybrid shunt of claim 26, wherein the first end region, the second end region, and the neck region are at least partially encapsulated with a biocompatible material different from that of the bridging member.

29. The hybrid shunt of claim 28, wherein the biocompatible material of the bridging element is configured to allow tissue inward growth, and the encapsulated biocompatible material is configured to inhibit tissue inward growth.

30. The hybrid shunt according to claim 28, wherein the internode spacing of the biocompatible material of the bridging member is greater than the internode spacing of the encapsulated biocompatible material.

31. The hybrid shunt of claim 30, wherein the internode spacing of the bridging material is selected to allow tissue inward growth, and the internode spacing of the encapsulating material is selected to inhibit tissue inward growth.

32. The hybrid shunt according to claim 30, wherein the biocompatible material of the bridging element and the encapsulating biocompatible material are expanded polytetrafluoroethylene (ePTFE).

33. The hybrid shunt of claim 26, wherein the biocompatible material of the bridging member comprises porosity selected to allow tissue inward growth.

34. The hybrid shunt of claim 26, wherein the bridging member is configured to remain engaged with the patient's atrial septum even when the neck region is constricted.

35. The hybrid shunt according to any one of the preceding claims, further comprising one or more physiological sensors disposed at the first connection portion and / or the second connection portion.

36. The hybrid shunt of claim 35, wherein the one or more physiological sensors are configured to measure at least one of pressure, flow rate, velocity, temperature, or pH.

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