Implantable medical device with adjustable blood flow

Abstract

An implantable medical device is disclosed, wherein the implantable medical device includes a fluid shunt extending through a wall separating a first cavity and a second cavity in the heart. The fluid shunt includes a first portion adapted to extend into a first cavity in the heart, a second portion adapted to extend into a second cavity in the heart, and an intermediate portion interconnecting the first portion and the second portion. The fluid shunt has a lumen extending between the first portion and the second portion, the lumen being adapted to fluidically couple the first cavity and the second cavity in the heart. The implantable medical device also includes a blocking assembly associated with the fluid shunt and adapted to selectively block flow through the lumen of the fluid shunt, the blocking assembly being activated to adjust flow through the lumen of the fluid shunt. The implantable medical device further includes at least one sensor assembly, the at least one sensor assembly being associated with the first portion of the fluid shunt, such that the at least one sensor assembly senses one or more physiological parameters in the first cavity.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of Provisional Application Nos. 62 / 783,902, filed December 21, 2018, 62 / 783,935, filed December 21, 2018, 62 / 845,386, filed May 9, 2019, 62 / 894,260, filed August 30, 2019, and 62 / 901,105, filed September 16, 2019, all of which are incorporated herein by reference in their entirety for all purposes. Background Art

[0003] Over the past decade, due to advances in medicine and treatment, the number of deaths from coronary heart disease in the United States has steadily decreased, but the number of deaths from heart failure has increased relatively, indicating that more people than ever before are living at high risk of heart failure. Typically, heart failure occurs when the heart cannot supply enough blood to the body. Therefore, lower volume output results in a higher filling pressure in the left heart to help compensate for insufficient output. Lower volume output also results in lower organ perfusion, including a reduction in kidney or renal perfusion. Reduced renal perfusion may lead to excessive fluid retention. An acute decompensation episode refers to a period during which fluid levels rise and / or vascular blood distribution decreases to the point where the patient experiences fatigue and dyspnea (difficult breathing). If not treated, this may lead to serious complications and death.

[0004] It has been observed that heart failure is mainly caused by problems with the left side of the heart. In a normal healthy heart, oxygenated blood is first transported from the pulmonary veins through the left atrium to the left ventricle, and then into the aorta, after which the blood is pumped to the whole body. Thereafter, deoxygenated blood is transported from the two vena cava to the right atrium, through the right ventricle, and into the pulmonary artery, which then transports the blood to the lungs for oxygenation. The pumping performance of the left ventricle may be affected by thickening / thinning of the left ventricle wall or damage to the aortic / mitral valve, resulting in less blood being pumped to the rest of the body.

[0005] Progress in effectively treating patients with heart failure, including both diagnosis and proactive avoidance of heart failure, remains to be achieved. Summary of the invention

[0006] According to one example ("Example 1"), an implantable medical device includes: a fluid shunt, the fluid shunt being adapted to extend through a wall separating a first cavity and a second cavity within a heart, the fluid shunt including a first portion adapted to extend into the first cavity within the heart, a second portion adapted to extend into the second cavity within the heart, and an intermediate portion interconnecting the first portion and the second portion, the fluid shunt having a lumen extending between the first portion and the second portion, the lumen being adapted to fluidically couple the first cavity and the second cavity within the heart; an occlusion assembly associated with the fluid shunt and adapted to selectively occlude flow through the lumen of the fluid shunt, the occlusion assembly being configured to be activated to adjust flow through the lumen of the fluid shunt; and at least one sensor assembly, the at least one sensor assembly being associated with the first portion of the fluid shunt, such that the at least one sensor assembly is adapted to sense one or more physiological parameters in the first cavity.

[0007] According to one example ("Example 2"), with respect to Example 1, at least one sensor assembly includes a first sensor assembly and a second sensor assembly associated with a second portion of the fluid diverter such that the second sensor assembly is adapted to sense one or more physiological parameters in the second cavity.

[0008] According to one example ("Example 3"), with respect to Example 1, an implantable medical device includes a control unit in communication with at least one sensor component. The control unit includes: a receiver coupled to the at least one sensor component, the receiver being configured to receive physiological parameter information from the at least one sensor component; and a processing unit coupled to the receiver to analyze the physiological parameter information received by the receiver.

[0009] According to one example ("Example 4"), with respect to any of the preceding examples, the implantable medical device includes an actuation mechanism associated with the occlusion assembly, the control unit being operatively coupled to the actuation mechanism and configured to send a control signal to activate the actuation mechanism in response to the performed analysis.

[0010] According to one example ("Example 5"), with respect to Example 4, at least one sensor assembly is operably coupled to an actuation mechanism of the occlusion assembly such that when the at least one sensor assembly senses a predetermined physiological measurement, the actuation mechanism is adapted to increase flow through the lumen of the fluid diverter.

[0011] According to one example ("Example 6"), with respect to Example 1, at least one of the first portion and the second portion includes a flange member for engaging a wall of the heart.

[0012] According to one example ("Example 7"), with respect to Example 1, the fluid diverter includes a support.

[0013] According to one example ("Example 8"), with respect to Example 7, the support comprises a resilient frame.

[0014] According to one example ("Example 9"), with respect to any of the preceding examples, the fluid diverter includes a cover that is impermeable to blood under physiological conditions.

[0015] According to one example ("Example 10"), in relation to Example 9, the cover includes a composite film material.

[0016] According to one example ("Example 11"), with respect to any of the preceding examples, the first chamber is a left atrium of the heart and the second chamber is a right atrium of the heart.

[0017] According to one example ("Example 12"), with respect to any of the preceding examples, the occlusion assembly is configured in a closed configuration such that the lumen of the fluid diverter is initially sealed.

[0018] According to one example ("Example 13"), with respect to any of the preceding examples, the occlusion assembly includes a thermally actuated mechanism configured to be activated by heating to adjust flow through the lumen of the fluid diverter.

[0019] According to one example ("Example 14"), with respect to any of the foregoing Examples 9-12, the cover is configured to be activated by mechanically opening to adjust flow through the lumen of the fluid diverter.

[0020] According to one example ("Example 15"), with respect to any of the foregoing Examples 9-12, the cover is configured to be activated by thermal opening to adjust flow through the lumen of the fluid diverter.

[0021] According to one example ("Example 16"), with respect to any of the foregoing Examples 9-12, the cover is configured to selectively absorb ultrasound waves such that the membrane is configured to be thermally opened using an ultrasound source to adjust flow through the lumen of the fluid diverter.

[0022] According to one example ("Example 17"), with respect to any of the foregoing Examples 9-12, the cover is configured to selectively absorb laser energy such that the membrane is configured to be thermally opened using the laser source.

[0023] According to one example ("Example 18"), with respect to any of the foregoing Examples 9-12, the cover is configured to selectively absorb RF energy such that the cover is configured to be thermally opened using the RF energy source.

[0024] According to one example ("Example 19"), with respect to any of the foregoing Examples 9-12, the cover is configured to be selectively electrolytically degradable using an electrical energy source.

[0025] According to one example ("Example 20"), with respect to Example 19, the closure assembly further includes at least one element operatively securing the cover in the closed configuration.

[0026] According to one example ("Example 21"), with respect to Example 20, at least one element operatively securing the cover in the closed configuration is configured to selectively electrolytically degrade using an electrical energy source.

[0027] According to one example ("Example 22"), with respect to Example 21, electrical energy is provided via magnetic induction.

[0028] According to one example ("Example 23"), with respect to any of the foregoing Examples 13-22, the occlusion component includes a thermoplastic polymer film.

[0029] According to one example ("Example 24"), with respect to any of the foregoing Examples 14-23, the cover is under radial tension to assist in opening of the membrane.

[0030] According to one example ("Example 25"), with respect to any of the preceding Examples 14-24, it is characterized in that the cover exhibits a residual stress distribution to assist opening of the membrane.

[0031] According to one example ("Example 26"), with respect to any of the foregoing Examples 14-25, the cover is selectively openable between a plurality of opening sizes to alter flow through the lumen of the fluid diverter.

[0032] According to one example ("Example 27"), with respect to any of the foregoing Examples 9-26, the cover is configured to cover a first portion of the fluid shunt, the first portion being adapted to extend into a first chamber within the heart.

[0033] According to one example ("Example 28"), with respect to any of the foregoing Examples 9-27, the cover is configured to cover a first portion of the fluid shunt, the first portion extending into a first chamber within the heart.

[0034] According to one example ("Example 29"), with respect to any of the foregoing Examples 1-8, the fluid diverter includes a membrane disposed in the lumen between the first portion and the second portion, the membrane being impermeable to blood under physiological conditions.

[0035] According to one example (“Example 30”), with respect to any of the foregoing Examples 13-24, the device is part of a system comprising at least one of: an in vitro inductive energy source, an internal inductive energy receiver, an ultrasound energy source, a laser energy source, a radiofrequency energy source, or another type of energy source for activating the occlusion component.

[0036] According to one example ("Example 31"), with respect to any of the preceding examples, the device is configured to exhibit different resonant frequencies based on a flow rate through a lumen of the fluid diverter.

[0037] According to one embodiment ("Example 32"), a method for treating heart disease is disclosed, comprising: sensing one or more physiological parameters in a first chamber within the heart through a first sensor assembly associated with a fluid shunt, the fluid shunt being adapted to extend through a wall separating the first chamber within the heart and a second chamber within the heart; and adjusting the flow through the fluid shunt by actuating a blocking assembly associated with the fluid shunt.

[0038] According to one example ("Example 33"), with respect to Example 32, the method includes sensing, via a second sensor assembly associated with the fluid shunt, one or more physiological parameters in a second chamber within the heart.

[0039] According to one example ("Example 34"), with respect to Example 32 or 33, the method includes: receiving a physiological parameter sensed by at least a first sensor component by a receiver coupled to at least a first sensor component; performing analysis on the physiological parameter received by the receiver to generate an actuation signal by a processing unit coupled to the receiver; and actuating the occlusion component according to the actuation signal.

[0040] According to one example ("Example 35"), with respect to any of the foregoing Examples 32-34, the method includes sending, by the controller, an actuation signal to the blocking assembly.

[0041] According to one example ("Example 36"), with respect to any of the aforementioned Examples 32-35, the controller is configured such that when at least the first sensor assembly senses a predetermined physiological measurement, the controller sends an actuation signal to the occlusion assembly such that the occlusion assembly increases flow through the lumen of the fluid diverter.

[0042] According to one example ("Example 37"), with respect to Example 32, a method includes passing a fluid shunt through a wall of a heart, including engaging flange portions of a first portion and a second portion of the fluid shunt with the wall of the heart.

[0043] According to one example ("Example 38"), with respect to Example 32, the method includes: passing a fluid shunt through a wall of the heart separating a first chamber within the heart from a second chamber within the heart; and includes engaging a support of the fluid shunt with the wall of the heart.

[0044] According to one example ("Example 39"), with respect to Example 38, the support member includes a resilient frame.

[0045] According to one example ("Example 40"), with respect to any of the foregoing Examples 32-39, the fluid diverter includes a cover that is impermeable to blood under physiological conditions.

[0046] According to one example ("Example 41"), with respect to Example 40, the cover includes a composite film material.

[0047] According to one example ("Example 42"), with respect to any of the foregoing Examples 32-41, the first chamber is the left atrium of the heart and the second chamber is the right atrium of the heart.

[0048] According to one example ("Example 43"), a medical system includes an implantable medical device and a deployment catheter. The implantable medical device includes: a fluid shunt, the fluid shunt is suitable for extending through a wall separating a first cavity and a second cavity in the heart, the fluid shunt includes a first portion suitable for extending into the first cavity in the heart, a second portion suitable for extending into the second cavity in the heart, and an intermediate portion interconnecting the first portion and the second portion, the fluid shunt having a lumen extending between the first portion and the second portion, the lumen being suitable for fluidically coupling the first cavity and the second cavity in the heart; an occlusion assembly, the occlusion assembly is associated with the fluid shunt and is suitable for selectively occluding flow through the lumen of the fluid shunt, the occlusion assembly being configured to be activated to adjust flow through the lumen of the fluid shunt; and at least one sensor assembly, the at least one sensor assembly being associated with the first portion of the fluid shunt, such that the at least one sensor assembly is suitable for sensing one or more physiological parameters in the first cavity. The deployment catheter is configured to compress the implantable medical device and maintain the implantable medical device in a compressed configuration until the implantable medical device is deployed at a desired treatment location in the heart.

[0049] The above examples are limited thereto and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by the present invention. Although multiple examples are disclosed, other embodiments will be apparent to those skilled in the art from the following detailed description, which shows and describes exemplary examples. Therefore, the drawings and detailed description are to be regarded as illustrative rather than restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] The accompanying drawings, which are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments and together with the description serve to explain the principles of the disclosure.

[0051] Figure 1 is a schematic diagram of an implantable medical device according to an embodiment disclosed herein;

[0052] Figure 2 An occlusion assembly of an implantable medical device according to an embodiment disclosed herein is shown;

[0053] Figure 3 An occlusion assembly of an implantable medical device according to an embodiment disclosed herein is shown;

[0054] Figure 4 An occlusion assembly of an implantable medical device having a membrane according to embodiments disclosed herein is shown;

[0055] Figure 5 The membrane according to the embodiments disclosed herein is shown as it is opened. Figure 4 The blocking component;

[0056] Figure 6 An occlusion assembly of an implantable medical device according to an embodiment disclosed herein is shown;

[0057] Figure 7 The membrane according to the embodiments disclosed herein is shown as it is opened. Figure 6 The blocking component;

[0058] Figure 8 Components of an actuated blocking assembly according to embodiments disclosed herein are shown;

[0059] Fig. 9 shows a sensor system implanted in an implantable medical device according to embodiments disclosed herein;

[0060] Fig.10 A method of operating an implantable medical device according to embodiments disclosed herein is shown;

[0061] Fig.11 A method of operating an implantable medical device according to an embodiment disclosed herein is shown.

[0062] Fig.12 shows an implantable medical device according to embodiments disclosed herein viewed from one side of the device;

[0063] Fig.13 shows the device viewed from the other side Fig.12 implantable medical devices;

[0064] Fig.14 is a schematic diagram of an implantable medical device according to an embodiment disclosed herein;

[0065] Fig.15 is a schematic diagram of an implantable medical device according to an embodiment disclosed herein;

[0066] Fig.16 A delivery system for an implantable medical device according to an embodiment disclosed herein is shown;

[0067] Fig.17 shows a deployment apparatus of an implantable medical device according to embodiments disclosed herein as the implantable medical device is delivered to a heart;

[0068] Fig.18 shows an implantable medical device according to embodiments disclosed herein viewed from one side of the device;

[0069] Fig.19 shows an implantable medical device according to embodiments disclosed herein viewed from one side of the device;

[0070] Fig. 20 shows an implantable medical device according to embodiments disclosed herein viewed from one side of the device;

[0071] Fig.21 shows a power-on unit of an implantable medical device viewed from one side of the device according to embodiments disclosed herein;

[0072] Fig. 22 is a schematic diagram of an implantable medical device according to an embodiment disclosed herein.

[0073] Those skilled in the art will readily appreciate that various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the drawings referred to in the present disclosure are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be interpreted as limiting. DETAILED DESCRIPTION

[0074] Definitions and terminology

[0075] This disclosure is not meant to be read in a limiting manner. For example, the terms used in the application should be read broadly in the context of the meaning that persons in the art attribute to such terms.

[0076] With respect to imprecision terms, the terms "about" and "approximately" may be used interchangeably to refer to measurements that include the stated measurement, as well as any measurement that is reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement have fairly small deviations from the stated measurement, as understood and readily determined by one of ordinary skill in the relevant art. For example, such deviations may be due to measurement error or minor adjustments made to optimize performance. If it is determined that such a reasonably small difference would not be readily determined by one of ordinary skill in the relevant art, the terms "about" and "approximately" may be understood to be plus or minus 20% of the stated value.

[0077] Certain terms are used herein for convenience only. For example, words such as "top," "bottom," "up," "down," "left," "right," "horizontal," "vertical," "upward," and "downward" describe only the orientation of the configuration or part in the installed position shown in the figure. In fact, the referenced components can be oriented in any direction. Similarly, throughout this disclosure, where a process or method is shown or described, the method can be performed in any order or simultaneously unless the context clearly indicates that the method depends on certain actions being performed first.

[0078] Description of various embodiments

[0079] Various examples are related to non-invasive methods of monitoring heart pressure (e.g., left atrial pressure or "LAP") in patients with heart failure. Such monitoring can help with early warning of acute decompensation events, improved options for controlling heart pressure (e.g., LAP), and other potential advantages. Some examples relate to heart failure management devices that provide titratable device-based therapy and hemodynamic monitoring. In some embodiments, the heart failure management device includes a controllable cardiac shunt (e.g., an intra-atrial shunt) and a sensor system for continuous non-invasive cardiac pressure measurement (e.g., LAP measurement), wherein flow through the shunt is controlled based on cardiac pressure measurements from the sensor system. In some examples, the heart failure management device initially operates in a monitoring mode, and if symptoms worsen, the controllable cardiac shunt is operable to change the heart pressure.

[0080] Figure 1 An implantable medical device 100 according to some embodiments is shown. As shown, the implantable medical device 100 has a control unit 102 and an occlusion assembly 104 controlled and maintained by the control unit 102. The occlusion assembly 104 is configured to be implanted in an organ wall (e.g., the septum of the heart) and includes one or more sensor assemblies 106 and an actuation mechanism 108. The control unit 102 includes a receiver 110 and a processing unit 112 coupled to the receiver 110, the receiver 110 receiving physiological parameter information data measured by the sensor assembly 106 from the sensor assembly 106, and the processing unit 112 is optionally configured to analyze the physiological parameter information received by the receiver 110.

[0081] The processing unit 112 can be a central processing unit (CPU), a system on a chip (SoC), or any suitable processor. In some examples, the processing unit 112 performs analysis of the physiological parameter information and determines to send a control signal to the actuator 108 associated with the occlusion assembly 104 to control the physiological parameter in the heart.

[0082] The purpose of the actuation mechanism 108 is to open the occlusion assembly 104 to allow fluid to flow therethrough. In some embodiments, the actuation mechanism 108 is configured to be activated when the sensor assembly 106 detects certain conditions within the heart. In one example, the occlusion assembly 104 can be placed in a wall (such as an atrial wall) separating two chambers of the heart. When the sensor assembly 106 detects that the difference between the blood pressure measurement within the left atrium (also referred to as "left atrial pressure" or LAP) and the blood pressure measurement within the right atrium (also referred to as "right atrial pressure" or RAP) exceeds a threshold, the actuation mechanism 108 can be activated in response to the increased blood pressure difference to reduce the difference between the left atrial blood pressure and the right atrial blood pressure. In some examples, the sensor assembly 106 detects a single physiological measurement. In some examples, the sensor assembly 106 detects a relative measurement or an absolute measurement.

[0083] In one example, the pressure measurement made by the sensor assembly 106 can be converted into a ratio of LAP to RAP. In common practice, an ideal LAP to RAP ratio of 2:1 is desired. Therefore, any ratio that is significantly less than or greater than the desired ratio will pose a threat to cardiac health, so the actuator 108 is activated to cause some of the blood flow to flow from one atrium to the other atrium (as the case may be), thereby bringing the ratio closer to the desired ratio. In another example, the threshold value can be determined by a physician, who then decides under what conditions to activate the actuator 108. In another example, data from a single sensor assembly can be reported and used by a physician (or algorithm) to determine whether the actuator should be activated. It should be noted that other physiological data can be used to make this decision, as explained below.

[0084] In some embodiments, the control unit 102 is configured to be located outside the body, such as Figure 8 As shown. For example, receiver 110 is optionally configured to receive information wirelessly, and processing unit 112 is optionally configured to send control signals wirelessly. Actuation mechanism 108 can be activated in response to receiving a control signal (such as an actuation signal transmitted by processing unit 112). In this example, actuation mechanism 108 can also be coupled to a receiver capable of receiving such a signal from an external source.

[0085] Figure 2 An implantable medical device 200 according to some embodiments is shown. The implantable medical device 200 includes a fluid shunt 202 adapted to extend through an organ wall 204 (e.g., a septum) separating a first cavity 206 (e.g., a first heart chamber) and a second cavity 208 (e.g., a second heart chamber) within a patient's body. In some examples, the cavities are, for example, the left and right atria, or the left and right ventricles. In another example, one or more of the cavities are the aorta, vena cava, or other vascular structures.

[0086] In some examples, the fluid splitter 202 includes a first portion 210 adapted to extend into the first cavity 206, a second portion 212 adapted to extend into the second cavity 208, and an intermediate portion 214 interconnecting the first portion 210 and the second portion 212. The fluid splitter 202 also has a lumen 216 extending through the intermediate portion 214 between the first portion 210 and the second portion 212. The lumen 216 is adapted to provide a fluid path between the first cavity 206 and the second cavity 208, or to fluidly couple the first cavity 206 and the second cavity 208 together.

[0087] In some embodiments, the first portion 210 includes a first flange 224. The first flange 224 can be an annular shape having a first aperture 225 and includes a first flange support 221 and a first flange cover 223. The first flange support 221 can be an elastic frame including one or more frame elements, which can be wound, woven, knitted, cut or otherwise formed. In various examples, the first flange support 221 is made of a shape memory material such as a shape memory alloy (e.g., nickel titanium alloy). The first flange cover 223 optionally includes a membrane material (e.g., an ePTFE membrane) or other biocompatible material as needed. In other examples, the first flange cover 223 is configured to promote or inhibit tissue ingrowth and / or be biodegradable over time under physiological conditions.

[0088] Figure 3-Figure 5 Different embodiments and examples of the flanges described above are shown. Figure 3 A first flange 224 according to an embodiment is shown, wherein the first flange 224 engages with the organ wall 204 and is attached to the antenna 300. The sensor assembly 220 is attached to the antenna 300, and the antenna 300 is operable to send physiological measurement information provided by the sensor assembly 220. In some embodiments, as explained below, the occlusion assembly 218 is also attached to the antenna 300. The antenna 300 is operable to receive a control signal sent to the occlusion assembly 218, or more specifically to the actuation mechanism 108 of the occlusion assembly 218. In one example, the implantable medical device 200 has a second flange 226 at the second portion 210, and the second flange 226 has a second flange cover 231 to prevent fluid from flowing between the lumen 216 and the second cavity 208. In some embodiments, the first flange cover 223 and / or the second flange cover 231 include a composite membrane material, such as a polymer membrane. In one example, the polymer is expanded polytetrafluoroethylene (ePTFE). In another example, the membrane can be any other suitable fluoropolymer, thermoplastic polymer, elastomer, biopolymer, fabric, textile, etc. In some examples, the second flange 226 has a similar, but not identical, configuration as the first flange 224 .

[0089] Figure 4 and Figure 5 A first frame portion 400 is shown according to an embodiment. In some examples, the first frame portion 400 forms part of the first flange 224 of the implantable medical device 200. The first frame portion 400 can be covered by or otherwise supported by a flange cover 223, which can be configured to be impermeable to body fluids (such as blood) under physiological conditions to act as a separator to help prevent fluid from flowing between the lumen 216 and the first cavity 206. As shown, the first frame portion 400 can include one or more outer lobes (e.g., a first outer lobe 406a, a second outer lobe 406b, and a third outer lobe 406c) and an inner frame portion 402 (which defines three inner lobes 402a, 402b, and 402c in this example). Each of the lobes 406a, 406b, and 406c can be attached to the inner frame portion 402 so that the lobes are equally spaced apart around the inner frame portion 402. In some examples, the lobes can be attached to the inner frame portion 402 and / or adjacent lobes at attachment points 408a, 408b, and 408c. For example, in some examples, the first lobe 406a is attached to the second lobe 406b at attachment point 408a, the second lobe 406b is attached to the third lobe 406c at attachment point 408b, and the third lobe 406c is attached to the first lobe 406a at attachment point 408c. Although Figure 4 and Figure 5 While described with reference to three lobes and three attachment points, the first frame portion 400 may have any number of lobes and corresponding attachment points as desired.

[0090] When present, the inner frame portion 402 can be any desired shape. For example, in some examples, the inner frame portion 402 is substantially circular or substantially triangular (e.g., Figure 4 and Figure 5 In some examples, the inner lobes 402a, 402b, and 402c can extend into the first lobe 406a, the second lobe 406b, and the third lobe 406c to define the shape of the inner frame portion 402. In some examples, the first frame portion 400 includes the sensor assembly 220 attached thereto. In some examples, the sensor assembly is operatively coupled to Figure 3 The antenna 300 is shown in FIG.

[0091] although Figure 4 and Figure 5Not shown, and similar to first flange 224, second flange 226 of implantable medical device 200 may include a second frame portion having the same or a different number of lobes as first frame portion 400. For example, in some instances, the first frame portion and the second frame portion each have three lobes. In some instances, first frame portion 400 may include three lobes, while the second frame portion includes two, four, five, or more lobes. In some instances, first frame portion 400 may have lobes that are larger, smaller, and / or differently shaped than the lobes of the second frame portion. Additionally, in some examples, first frame portion 400 may include one or more sensor components (e.g., 220 and 222) and antenna 300, such as Figure 3 shown.

[0092] In addition, although not Figure 4 and Figure 5 224 and / or the second flange 226. The pattern of structural frame elements can be arranged within the inner lobes 402a, 402b, and 402c (e.g., projected from within the inner lobes 402a, 402b, and 402c) and can be included in any lobe of the device discussed herein. If desired, the pattern of structural frame elements can be arranged to form an open cell pattern. For example, the pattern of structural frame elements can form a diamond cell pattern in the inner lobes 402a, 402b, and 402c that folds and unfolds during loading and deployment of the implantable medical device 200 in the catheter. The pattern of structural frame elements can enhance radial strength during deployment and help arrange the implantable medical device 200 into a deployed or other operable shape.

[0093] Figure 5 The first flange cover 223 is shown after the actuation mechanism 108 creates a first aperture 225 in the cover 223 to allow fluid to flow through the lumen 216. In some embodiments, the first aperture 225 is formed by a mechanical or interventional procedure. In some embodiments, the first aperture 225 is formed by a non-invasive procedure.

[0094] Return to reference Figure 2In some embodiments, the second portion 212 includes a second flange 226. The second flange 226 can be annular in shape with a second aperture 227 and include a second flange support 229 and a second flange cover 231. The second flange support 229 can also be an elastic frame including one or more frame elements, which can be wound, woven, knitted, cut or otherwise formed. In various examples, the first flange support 229 is made of a shape memory material such as a shape memory alloy (e.g., nickel titanium alloy). The second flange cover 231 can optionally include a membrane material (e.g., an ePTFE membrane) or other biocompatible material. In other examples, the second flange cover 226 is configured to promote or inhibit tissue ingrowth and / or be biodegradable over time under physiological conditions.

[0095] In some embodiments, the middle portion 214 of the fluid diverter 202 includes a tubular member 215 and an intermediate support 213, which is configured to help maintain the shape of the tubular member 215 to resist the compression and / or deformation forces applied by the patient's anatomical structure (e.g., wall 204) and / or physiological process (e.g., blood pressure). The intermediate support 213 can also be an elastic frame including one or more frame elements, which can be wound, woven, knitted, cut or otherwise formed. In various examples, the intermediate support 213 is made of a shape memory material (such as a shape memory alloy (e.g., nickel-titanium alloy)). The tubular member 215 optionally includes a membrane material (e.g., an ePTFE membrane) or other biocompatible material as needed. In other examples, the tubular member 215 is configured to promote or inhibit tissue ingrowth and / or be biodegradable over time under physiological conditions.

[0096] like Figure 2 , the implantable medical device 200 further includes an occlusion assembly 218 associated with the fluid diverter 202 as mentioned above. In some examples, the occlusion assembly 218 is adapted to selectively occlude flow through the lumen 216 of the fluid diverter 202. For example, the occlusion assembly 218 can be configured to be activated (via physical, manual intervention or via remote or automated means) to adjust flow through the lumen 216 of the fluid diverter 202.

[0097] In some examples, the actuation mechanism 108 is configured to be actuated to allow fluid to flow through the lumen 216, or to increase or decrease the amount of fluid flowing through the lumen 216. In some examples, the actuation mechanism 108 is selectively activated to increase and decrease flow, for example, by being in an actuable state to open or narrow the lumen 216. The actuation mechanism 108 is optionally positioned at the first portion 210, the second portion 212, and / or the middle portion 214. The actuation mechanism 108 can be "one-way" actuable, in that the actuation mechanism 108 starts in a no-flow or low-flow condition and can then be opened (e.g., fully opened or opened in stages) to increase flow. In other embodiments, the actuation mechanism 108 can increase and decrease flow through the fluid diverter 202.

[0098] In one example, the actuation mechanism 108 includes a needle or other suitable piercing member to mechanically penetrate one or both of the flange covers 223 and 231. In one example of an interventional procedure, the needle is guided to the location of the implantable medical device 200 through a catheter, and the needle is used to form a first aperture 225 by piercing the first flange cover 223 and a second aperture 227 by piercing the second flange cover 231. Other interventional procedures include mechanical, thermal, laser, ultrasonic, and inductive methods.

[0099] exist Figure 6 In one example shown, the actuator 218 is attached to the antenna 300. The membrane defining the first flange cover 223 is composed of three flap elements 600, 602, and 604 under radial tension, wherein a wire 606 secures the three flap elements together at a stitch 608 to prevent the radial tension from causing the flap elements to move toward the outer edge of the first flange 224. The sensor assembly 220 is located on the antenna 300. Upon receiving an actuation signal from the control unit 102, the actuator 218 pulls the wire 606 to pull the flap elements 600, 602, and 604 back toward the outer edge, thereby forming a sensor assembly 220. Figure 7 The first aperture 225 shown. Wire 606 can be made of any suitable material. In some examples, wire 606 can be a thread made of a polymer (such as nylon or PTFE). In some examples, wire 606 is made of a conductive material (such as stainless steel or nickel titanium alloy, etc.). In one example, the same actuation mechanism can also be attached to the second flange cover 231, wherein the second flange cover 231 is also made of similar flap elements. In one example, the number of flap elements can be 2. In other examples, the number of flap elements can be 4 or more.

[0100] Various additional or alternative actuation mechanisms are contemplated. In some examples, wire 606 is electrically conductive, and upon receiving an actuation signal from control unit 102, occlusion assembly 218 applies a voltage to wire 606 to cause wire 606 to undergo electrolytic degradation. After undergoing electrolytic degradation, wire 606 breaks or dissolves and no longer holds flap elements 600, 602, and 604 together. As a result, flap elements 600, 602, and 604 are no longer attached. Figure 6 The initial position shown is retracted or opened, thereby forming a Figure 7 A first aperture 225 is shown.

[0101] In some examples, actuation mechanism 108 is outside the body, such as an external energization unit 800 . Figure 8 An implantable medical device 100 or 200 is shown. In a treatment system according to an embodiment, an in vitro energizing unit 800 is used to inductively energize the implantable medical device. The energizing unit 800 may include an in vitro inductive energy source that powers the implantable medical device so that the electrical energy can electrolytically degrade the element 606, thereby forming a first aperture 225 to convert the device into an open configuration. In some examples, the control unit 102 is configured to be located outside the body and control the in vitro energizing unit 800. In some embodiments, the treatment system operates one or more of the following to control the first aperture 225 in the implantable medical device 200, including: an internal inductive energy receiver, an ultrasonic energy source, a laser energy source, a radio frequency (RF) energy source, and / or another type of energy source for activating the occlusion component 104. In addition, in some embodiments, when the first aperture 225 is formed and the fluid is allowed to flow within the lumen 216, the implantable medical device 200 exhibits different resonant frequencies based on the flow rate through the lumen 216. The resonant frequency can be measured using one or both of the sensor assemblies 220 and 222 coupled to the implantable medical device 200. In one example, the resonant frequency measured by the receiver 110 is converted by the processing unit 112 into a physiological parameter, such as the flow rate of the fluid. In one example, both the sensor assemblies 220 and 222 are pressure sensors, and thus the flow rate of the fluid through the lumen 216 is estimated based on the size of the lumen, the pressure differential, and the known fluid dynamic properties of the fluid (which may be blood). Additional or alternative sensing features are contemplated. In some examples, the shift in the resonant frequency measured by the sensor assembly 220 or 222 provides verification that the lumen 216 is successfully opened to allow fluid to flow through.

[0102] In some embodiments, wireless extracorporeal energization includes inductive energy transfer or ultrasonic energy transfer, which are non-limiting examples of non-invasive procedures. In one embodiment, after the flange cover 223 is exposed to heat or ultrasonic energy, the film of the flange cover 223 can be melted to form the aperture 225 to produce a thermal activation mechanism. In some examples, the size of the aperture 225 can be adjusted by changing the amount of thermal activation. For reference, if desired, any of the methods / mechanisms that are the same as any of the methods / mechanisms described in conjunction with the flange cover 223 can be used, or the aperture 227 in the flange cover 231 can be formed by a different method as needed.

[0103] In another embodiment, the flange cover 223 is composed of at least one flap element, which is mechanically controlled by the actuator 108, and the actuator 108 is wirelessly controlled by the control unit 102. In one example, the mechanical control is achieved by the actuator 108 pulling the flap element to change the state of the flap element from a closed state to a more open state. The size of the aperture 225 can be adjusted by changing the displacement of the flap element from the closed position. In some embodiments, the actuator 108 can also control the flap element to reduce the size of the aperture 225 by making the position of the flap element closer to the closed position. In one example, a voltage is applied by the actuator 108 of the occluding assembly 218 to cause a line (e.g., Figure 6 The at least one flap element is controlled by electrolytic degradation of the line 606) shown, thereby causing the at least one flap element to change from a closed state to a more open state.

[0104] In some embodiments configured to be actuated using a non-invasive procedure, one or both of the covers 223 and 231 are made of a membrane that selectively absorbs ultrasound waves, such that the membrane is configured to be thermally opened using an ultrasound source to adjust the flow through the lumen 216 of the fluid diverter 214. In some embodiments configured to be actuated using a non-invasive procedure, one or both of the covers 223 and 231 are made of a membrane that selectively absorbs RF energy, such that the membrane is configured to be thermally opened using an RF ablation source to adjust the flow through the lumen 216 of the fluid diverter 214. In some embodiments, the membrane selectively absorbs laser energy, such that the membrane is configured to be thermally opened using a laser source. In some embodiments, the membrane or element (e.g., a wire) that holds the membrane in place can be selectively and electrolytically degraded using electrical energy provided by an inductive energy source. In some examples, the electrical energy can be provided by any suitable means, such as a battery, a piezoelectric receiver exposed to an ultrasonic energy source, magnetic induction, a radio frequency (RF) energy source, and / or another type of energy source for activating the occlusion assembly. In some embodiments, both covers 223 and 231 can be actuated using similar methods. For example, covers 223 and 231 can both be configured to open simultaneously in response to receiving energy (e.g., RF energy, laser energy, induction energy, etc.) from an external source.

[0105] In some embodiments, one or both of the covers 223 and 231 are under radial tension to assist in forming one or both of the apertures 225 and 227. For example, when the (multiple) covers 223 and 231 are stretched, even a small opening in the cover can be enlarged as the radial tension applied from the outer edge of the cover pulls the cover material surrounding the opening away from the position of the opening in multiple directions. In some embodiments, the (multiple) covers present a residual stress distribution to assist in forming one or both of the apertures 225 and 227 in the cover. In some embodiments, for one or both of the apertures 225 and 227, the cover can be selectively opened between multiple sizes to change the flow through the lumen 216.

[0106] Fig. 9A sensor system 900 implemented in one embodiment of an implantable medical device 100 is shown. In some examples, the sensor system 900 includes one or more sensor components 106 and a sensor control unit 902 that communicates with the one or more sensor components 106. In one example, the one or more sensor components 106 are active sensors, including a transmitter that sends a signal and records an environmental response to the signal. In another example, the one or more sensor components 106 are passive sensors that require an external energy source (e.g., when receiving input from the physical environment) to perform physiological measurements. The sensor control unit 902 includes a battery 904, a receiver 906, and a transmitter 908. The battery 904 powers the sensor component 106 to continue to perform physiological measurements, and powers the sensor control unit 902 to receive and transmit the measured data. The receiver 906 receives the measurement data from the sensor component 106, and the transmitter 908 sends the data (e.g., wirelessly) to the external control unit 102.

[0107] In some examples, one or more sensor assemblies 106 include a first sensor assembly 220 associated with a first portion 210 of the fluid diverter 202 and a second sensor 222 associated with a second portion 212 of the fluid diverter 202, the first sensor assembly 220 being adapted to sense one or more physiological parameters in the first cavity 206, and the second sensor 222 being adapted to sense one or more physiological parameters in the second cavity 208 within the heart. Although two sensor assemblies are shown and described, more (e.g., three or more) or fewer (e.g., a single sensor) sensor assemblies are contemplated. In one example, one or all of the sensor assemblies 106 are configured to sense physiological parameters, including blood pressure levels in various chambers. In some examples, one or more sensor assemblies are configured to sense the flow rate of blood flow in a specified cavity within the heart. In yet further examples, one or more sensors are configured to sense the temperature of the blood. In yet other examples, one or more sensors are configured to sense blood oxygen saturation.

[0108] Examples of suitable sensors capable of measuring fluid flow or pressure within an organ include piezoelectric sensors, pressure switches, optical pressure sensors, Venturi meters, impedance monitors, and ultrasonic pressure sensors, as well as other types of electrophysiological and hemodynamic sensors.

[0109] Fig.10A method 1000 of operating an implantable medical device 200 according to embodiments disclosed herein is shown. In a first step 1002, a lumen 216 extends through a wall 204 separating a first cavity 206 within a heart and a second cavity 208 within a heart. In one example, a fluid diverter 214 is passed through the wall 204 of the heart, including engaging flange portions or anchors 224 and 226 of a first portion 210 and a second portion 212 of the fluid diverter 214 with the wall 204 of the heart. In step 1004, a first sensor assembly 220 senses one or more physiological parameters in the first cavity 206. In a next step 1006, flow through the fluid diverter 214 is adjusted by actuating an occlusion assembly 218 associated with the fluid diverter 214.

[0110] Fig.11 Another method 1100 of operating an implantable medical device 200 according to some embodiments is shown. In step 1102, following the aforementioned step 1004, the second sensor 222 senses one or more physiological parameters in the second chamber 208 within the heart. In step 1104, the receiver receives the physiological parameters sensed by the first sensor assembly 220 and the second sensor 222. In a following step 1106, the processing unit 112 performs an analysis on the physiological parameters received by the receiver 110 to generate an actuation signal. In step 1108, the control unit 102 sends the actuation signal to the occlusion assembly 218. Finally, in step 1006, the flow through the fluid diverter 214 is adjusted by actuating the occlusion assembly 218 associated with the fluid diverter 214 according to the actuation signal provided by the processing unit 112 of the control unit 102.

[0111] In some embodiments, when the first sensor assembly 220 and the second sensor 222 sense a predetermined differential physiological parameter, the control unit 102 sends an actuation signal to the occlusion assembly 218, causing the occlusion assembly 218 to increase flow through the lumen 216 by performing one or more of the procedures as explained above.

[0112] Fig.12 is an image of a first side of an implantable medical device 200 according to an embodiment, wherein Figure 4 and Figure 5The first frame portion 400 is shown with a first flange 224 of a covering material including a flange cover 223 being visible. As shown, in some instances, the covering material 223 can be disposed over the opening or aperture 225. Thus, the covering material 223 can slow or block flow through the first frame portion 400 as desired. In some instances, the covering material 223 can be disposed over the first frame portion 400. In some instances, the covering material 223 can be attached to one or more of the first lobe 406a, the second lobe 406b, and the third lobe 406c. In some instances, the inner frame portion 402 serves as the second frame portion 1300, as shown in reference Fig.13 As shown and discussed. In some examples, sensor assembly 220 is located on one or more of first lobe 406a, second lobe 406b, and third lobe 406c.

[0113] Fig.13 2 is an image of a second side of an implantable medical device 200 according to an embodiment. As shown, a covering material 231 is disposed over the opening 227. In various examples, the first lobe 1302a, the second lobe 1302b, and the third lobe 1302c of the second frame portion 1300 may or may not include the covering material 231. For example, as shown, the covering material 231 may be disposed over the opening 227 but not over the second frame portion 1300, but in other examples, for example, the covering material 231 may be disposed over the opening 227 and the second frame portion 1300. In some examples, the sensor assembly 224 is located on one or more of the first lobe 1302a, the second lobe 1302b, and the third lobe 1302c.

[0114] Fig.14 An implantable medical device 1400 is shown having two flanges 224 and 226 attached to a surface of an organ wall 204, wherein the first flange and the second flange are located on opposite sides of the organ wall, and a catheter extends through the organ wall, according to an embodiment. In one example, the organ wall 204 is an atrial wall between the left atrium and the right atrium of the heart, such that the first flange 224 is located on the surface of the atrial wall 204 in the right atrium and the second flange is located on the surface of the atrial wall 204 in the left atrium, wherein the catheter 1402 extends between the two flanges 224 and 226, such that the catheter 1402 forms a lumen 216 that fluidly connects the two atria of the heart.

[0115] In one example, the catheter 1402 includes a covering material, such as a membrane having high rigidity and stiffness, for example, a covering material made of a polymer material (such as fluoroelastomer, high-density polyethylene, polyethylene terephthalate (PTE), polyvinyl chloride (PVC), polyamide, polycarbonate, polymethylpentene, polypropylene, polystyrene, polysulfone, etc.), so that the membrane applies a radial force to the wall 204 to prevent the lumen 216 from collapsing.

[0116] In some examples, the catheter 1402 includes one or more structural elements (e.g., stent elements) made of suitable materials, such as shape memory alloys (e.g., nickel-titanium alloys) or stainless steel. As shown, the medical device 1400 includes a cover 1404, such as a flexible membrane of any suitable polymer material (including but not limited to ePTFE). As shown, the cover 1404 is located or otherwise configured to reside between the first flange 224 and the wall 204. Additionally, the medical device 1400 includes one or more (e.g., three) positions for placing one or more sensors to perform physiological measurements in the body. In the first position 1406, a sensor (e.g., a pressure sensor) can be placed at the first flange 224 so that the sensor can perform measurements in the right atrium. At the second position 1408, a sensor (e.g., a flow sensor) can be placed in the catheter 1402 to measure the flow of fluid in the lumen 216. In the third position 1410, a sensor (e.g., a pressure sensor) can be placed at the second flange 226 to perform measurements in the left atrium. In some examples, a single sensor performing a single sensing function is placed at each location, while in other examples, multiple sensors or sensors performing multiple sensing functions may be placed at each location.

[0117] Fig.15 15. The embodiment shown has an additional, secondary cover 1500 (eg, such as the flexible film material previously described). Fig.14 The implantable medical device 1400 is shown. In this embodiment and Fig.14 In the embodiment shown in , the covers 1404 and 1500 selectively absorb RF energy so that the covers are thermally opened using an RF ablation source to adjust flow through the lumen 216. In some embodiments, the covers 1404 and 1500 selectively absorb laser energy so that each cover is configured to be thermally opened using a laser source. In some embodiments, the covers 1404 and 1500 selectively absorb ultrasound energy so that each cover (1404 and / or 1500) is configured to be thermally opened using an ultrasound source. In some embodiments, the covers 1404 and 1500 or an element (e.g., a wire) holding the covers in place can be selectively and electrolytically degraded using electrical energy provided by an inductive energy source.

[0118] Fig.16An implantable medical device 1400 is shown in a compressed configuration within a deployment apparatus 1600 according to an embodiment. As shown, the device 1400 is compressed into a delivery configuration and loaded into the deployment apparatus 1600 for delivery to a desired treatment location within a patient's body. In some instances, such as Fig.16 As shown, the device 1400 is loaded into the deployment device 1600 so that the device 1400 is completely contained within the deployment device 1600. The device 1400 can be delivered to the desired treatment location in the delivery configuration. Then, the first flange 224 is positioned on the first side of the wall 204, and the flange 226 is positioned on the second side of the wall 204. In some instances, once deployed, the central portion or conduit 1402 of the device 1400 can be radially expanded or compressed / restricted to adjust the flow rate of the fluid through the opening as needed. In one example, the deployment device 1600 includes a cannula or sheath.

[0119] Fig.17 An example of using an implantable medical device 1400 for regulating blood pressure according to an embodiment is shown. The implantable medical device 1400 is shown to be implanted in a patient's heart H. The device 1400 is shown to be arranged between the patient's left atrium LA and the right atrium RA. In some instances, the device 1400 can be used to regulate blood flow in the heart H (e.g., between the left atrium LA and the right atrium RA). As shown, the device 1400 generally includes a first flange 224 arranged on a first side of the septum (e.g., in the right atrium RA), a second flange 226 arranged on a second side of the septum (e.g., in the left atrium LA), and a catheter 1402 extending therethrough. In some examples, a needle can be used to create or open a trans-septal opening in the septum.

[0120] The deployment device 1600 and the restraint and / or release line (not shown) can be used to facilitate the deployment of the device 1400. For example, after the deployment device 1600 is advanced through the organ wall (e.g., the septum) and into the desired internal cavity (e.g., LA), the second flange 226 of the device 1400 can be released first, and then the first flange 224 can be released on the opposite side of the organ wall (e.g., the RA side of the atrial septum). The catheter 1402 can be arranged in the opening of the organ wall (e.g., the trans-septal opening). The flanges 224 and 226 and the catheter 1402 can be compressed in the deployment device 1600 during the delivery of the device 1400 to the desired treatment area in the patient's body, and then expand during the deployment of the device 1400. After deployment, the device 1400 can then be used to perform one or more treatment procedures on the patient. In one example, the device 1400 detects and treats pulmonary congestion and pulmonary hypertension by using sensors at one or more locations in the heart for physiological measurements. For example, if the pressure measurement within the left atrium is increased relative to the right atrium in a patient at risk for heart failure, a sensor of medical device 1400 detects the condition and opens conduit 1402 (e.g., allowing blood to flow through lumen 216) by activating occlusion component 218, thereby reducing the pressure within the left atrium to a safe level.

[0121] Fig.18 An example of an implantable medical device 1800 for regulating blood pressure according to an embodiment is shown. As shown, the implantable medical device 1800 includes a first frame member 1802 and a second frame member 1804. The first frame member 1802 can be configured to conform to the patient's anatomy (i.e., for example, a first side of a diaphragm). The second frame member 1804 can be configured to conform to the patient's anatomy (i.e., a second side of a diaphragm). In some examples, the sensor assembly 220 is located on one or both of the first frame member 1802 and the second frame member 1804.

[0122] In some examples, the first frame member 1802 includes a first set of elongated elements 1806, and the second frame member 1804 includes a second set of elongated elements 1808. The frame members 1802, 1804 including and, for example, the elongated elements 1806, 1808 can be discrete and separate from each other. For example, the first frame member 1802 forms a first side 1810 of the device 1800, and the second frame member 1804 forms a second side 1812 of the device 1800. The first frame member 1802 is discrete and separate from the second frame member 1804 and does not enter the second side 1812 of the device, and the second frame member 1804 is discrete and separate from the first frame member 1802 and does not enter the first side 1810 of the device.

[0123] In some instances, the first frame member 1802 and the second frame member 1804 are discontinuous with each other. The first frame member 1802 and the second frame member 1804 being discontinuous with each other allow the first frame member 1802 and the second frame member 1804 to be different and separate from each other. In addition, in response to the movement of the patient's anatomical structure, the first frame member 1802 and the second frame member 1804 are free to move separately from each other. In this way, a force acting on one of the first frame member 1802 and the second frame member 1804 is maintained within the other of the first frame member 1802 and the second frame member 1804. A force acting on one of the first frame member 1802 and the second frame member 1804 can be isolated from the frame member on which the force is applied.

[0124] As shown, the conduit portion 1814 is disposed between the first frame portion and the second frame portion. At least a portion of the conduit portion 1814 is generally radially or circumferentially supported by the first frame member 1802 and the second frame member 1804 within the conduit portion 1814. Fig.18 As shown, the catheter portion 1814 transitions to the first side 1810 and the second side 1812 at an approximately 90 degree angle (other angles are contemplated). The boundary of the catheter portion 1814 can be considered to be the location where the catheter portion 1814 transitions to the first side 1810 and the second side 1812. The first frame member 1802 and the second frame member 1804 extend laterally relative to the catheter portion 1814. In addition, the first frame member 1802 and the second frame member 1804 support the catheter portion 1814 without substantially entering the boundary of the catheter portion 1814. In some instances, the first frame member 1802 and the second frame member 1804 laterally support the catheter portion 1814 from the outside of the catheter portion 1814. Therefore, the first frame member 1802 and the second frame member 1804 can maintain a lumen through the catheter portion 1814 and facilitate deployment of the catheter portion 1814 by laterally forcing the catheter portion 1814 to open.

[0125] In some instances, the first frame member 1802 and the second frame member 1804 can apply tension to the catheter portion 1814 to deploy and maintain the catheter portion 1814, wherein the lumen passes through the catheter portion 1814. The catheter portion 1814 can be deployed within the septum between the tissue surfaces through an opening (e.g., a needle stick through the septum) having a diameter that is smaller than the fully deployed diameter of the catheter portion 1814. The tension applied in the catheter portion 1814 by the expansion of the first frame member 1802 and the second frame member 1804 can also expand the septum between the tissue surfaces to a desired shunt size.

[0126] In some instances, the catheter portion 1814 can be substantially free of frame components. For example, as described above, because the first frame component 1802 and the second frame component 1804 are discontinuous with each other and are arranged outside the boundary of the catheter portion 1814. The catheter portion 1814 can include, for example, a membrane 1816 connecting the first frame component 1802 and the second frame component 1804, such as an expanded polytetrafluoroethylene (ePTFE) membrane. The membrane 1816 generally separates the first frame component 1802 and the second frame component 1804 by a suitable distance compatible with the patient's body. For example, the membrane 1816 can separate the first frame component 1802 and the second frame component 1804 by a gap of 0 to 15 mm, depending on the desired treatment position in the patient's body. In addition, the catheter portion can be formed only by the membrane 1816. The catheter portion 1814 configured to be deployed in the diaphragm between the tissue surfaces does not have the first frame component 1802 and the second frame component 1804. The conduit portion 1814 can include a smooth interior that facilitates blood flow through the conduit portion 1814 without ridges from the stent elements interrupting or disrupting the blood flow. Thus, the conduit portion 1814 can reduce the chance of thrombosis.

[0127] In addition to forming the membrane 1816 of the conduit portion 1814, the membrane 1816 can also cover at least a portion of the first frame member 1802, at least a portion of the second frame member 1804, or at least a portion of the first frame member 1802 and the second frame member 1804. In some examples, the membrane 1816 disposed on at least a portion of the first frame member 1802 and / or the second frame member 1804 is a separate membrane (e.g., a first membrane disposed on the first frame member 1802 and a second membrane disposed on the second frame member 1804). In these examples, the membrane or film can be coupled to the membrane 1816 of the conduit portion 1814. The membrane 1816 can be elastic to allow the conduit portion 1814 to expand and allow a portion of the first frame member 1802 and / or the second frame member 1804 to move (e.g., movement of the first group of elongated elements 1806 and / or the second group of elongated elements 1808).

[0128] The membrane 1816 can span the gap between the first group of elongated elements 1806 and / or the second group of elongated elements 1808. In some cases, the membrane 1816 is disposed at least on the tissue engaging side of at least the first frame member 1802 and the tissue engaging side of the second frame member 1804. In these examples, the membrane 1816 is configured to reduce the potential for frame erosion of the first frame member 1802 and / or the second frame member 1804. The arrangement of the membrane 1816 and the first group of elongated elements 1806 and / or the second group of elongated elements 1808 can conform to the tissue surface surrounding the diaphragm. The first group of elongated elements 1806 and / or the second group of elongated elements 1808 can lie flat on the tissue surface.

[0129] In some examples, each of the elongated elements in the first set of elongated elements 1806 can be attached to each other via a film 1816 to form a first frame member 1802. In some examples, the first frame member 1802 can form a substantially flat or 2-dimensional disk-like shape, as shown. Additionally or alternatively, the second set of elongated elements 1808 can also be attached to each other via a film material 1816 to form a second frame member 1804. The second frame member 1804 can form a substantially flat or 2-dimensional disk-like shape, such that when the device 1800 is in the deployed configuration, the first frame member 1802 and the second frame member 1804 are substantially parallel to each other.

[0130] In some instances, the membrane 1816 can be configured to promote or inhibit tissue ingrowth at least a portion of the membrane 1816 or at least a portion of the membrane 1816. In some instances, the membrane 1816 is configured to promote or inhibit tissue ingrowth to cover at least a portion of the first frame portion 1802 and / or the second frame portion 1804, which can further promote the compatibility and stability of the device 1800 in the patient's body. The membrane 1816 of the catheter portion 1814 can be configured to not allow tissue ingrowth that increases patency. In some instances, the membrane 1816 is configured to promote endothelialization without hindering ingrowth in the catheter portion 1814. The membrane 1816 can promote endothelialization without hindering excessive growth of tissue into the catheter portion 1814.

[0131] In some instances, the device 1800 can deliver a drug to a desired treatment location in a patient's body. For example, the device 1800 can elute a drug configured to modulate a tissue response. In some instances, the device 1800 can be coated with a therapeutic coating, a drug eluting material, or other therapeutic material or a hydrophilic coating. In one specific example, the device 1800 can be coated with heparin to promote the anti-thrombotic and patency properties of the device 1800. Additionally or alternatively, the device 1800 can include paclitaxel (for modulating tissue / cellular responses).

[0132] Fig.191 is a perspective view of another example of an implantable medical device 1900 for regulating blood pressure according to an embodiment. As shown, each of the elongated elements in the first group of elongated elements 1806 can be discrete and separated from adjacent elongated elements. In other words, the membrane 1816 does not connect each of the elongated elements in the first group of elongated elements 1806 together. In this way, each of the elongated elements in the first group of elongated elements 1806 can move independently of each other and conform to the topography of the first side of the diaphragm individually, thereby providing a highly conforming first frame member 1802. Each of the elongated elements in the second group of elongated elements 1808 can also be discrete and separated from adjacent elongated elements. For example, each of the elongated elements in the second group of elongated elements 1808 can move independently of each other and conform to the second side of the diaphragm individually, much like the first group of elongated elements 1806 conform to the first side of the diaphragm. Therefore, both the first frame member 1802 and the second frame member 1804 are highly conforming and can conform to each other independently based on the patient's anatomical structure.

[0133] In some examples, one set of elongated elements in the first set of elongated elements 1806 and the second set of elongated elements 1808 can be attached to each other via the membrane 1816, while the other set of elongated elements are not attached (e.g., they are discrete and separated from adjacent elongated elements). In some examples, only some of the elongated elements in the first set of elongated elements 1806 and the second set of elongated elements 1808 can be attached to each other, while other elongated elements in the first set of elongated elements 1806 and the second set of elongated elements 1808 are not attached. Thus, depending on factors such as the desired treatment location in the patient's body and the size and / or shape of the lesion, the device 1900 can be highly customized for the patient. In some examples, the sensor assembly 220 is located on one or both of the first frame member 1802 and the second frame member 1804.

[0134] The device 1900 can be deployed or expanded from a delivery configuration to a deployed configuration. In some examples, when the device is in the delivery configuration, the first set of elongated elements 1806 and the second set of elongated elements 1808 can be nested with each other. This allows the device 1900 to be compressed to a smaller size, for example, for delivering the device 1900 to a wider range of treatment locations (e.g., through small, narrow or curly passages).

[0135] Fig. 20 is a side view of an implantable medical device 1900 for regulating blood pressure according to an embodiment. Fig.19 shown. Fig. 20The device 1900 is shown in a deployed configuration. As shown, when the device 1900 is in the deployed configuration, the first frame member 1802 including the first group of elongated elements 1806 and the second frame member 1804 including the second group of elongated elements 1808 are positioned radially outward relative to the longitudinal axis L of the catheter portion 1814. For example, the first frame member 1802 and the second frame member 1804 are positioned at a first angle 2000 and a second angle 2002, respectively. When the device is in the deployed configuration, the first angle 2000 and the second angle 2002 can form an angle of about 90° relative to the longitudinal axis L. This allows the first frame member 1802 and the second frame member 1804 to be parallel and adjacent to the first and second sides of the septum. In some instances, the first frame member 1802 and the second frame member 1804 can be positioned at any angle relative to the longitudinal axis L (e.g., from about 0° to greater than 90° relative to the longitudinal axis L), thereby allowing contact with the tissue surface of the first and second sides of the septum.

[0136] In some examples, when device 1900 is in the deployed configuration, first elongated member 1806 and second elongated member 1808 are configured to be separated from each other. Fig. 20 As shown, when device 1900 is in the deployed configuration, each elongated element in first group of elongated elements 1806 is discrete and separated from each other, so that each elongated element in first group of elongated elements 1806 can move independently of adjacent elongated elements. When device 1900 is in the deployed configuration, each elongated element in second group of elongated elements 1808 can also be discrete and separated from each other, so that each elongated element in second group of elongated elements 1808 can move independently of adjacent elongated elements. In some examples, sensor assembly 220 can be located on any one elongated element or multiple elongated elements of first group of elongated elements 1806, and another sensor assembly 222 can be located on any one elongated element or multiple elongated elements of second group of elongated elements 1808.

[0137] The first frame member 1802 and the second frame member 1804 can maintain a lumen through the catheter portion 1814 and facilitate deployment of the catheter portion 1814 by laterally forcing the catheter portion 1814 to open. In addition, the lumen can be free, or without the first frame member 1802 and the second frame member 1804. In this way, the catheter portion 1814 can facilitate re-passing of the septum for additional procedures (e.g., left atrial appendage occluder implantation). In addition, the first frame member 1802 and the second frame member 1804 can be configured differently. For example, one group of frame members in the first frame member 1802 and the second frame member 1804 can be expanded, while another group of frame members in the first frame member 1802 and the second frame member 1804 can be flat. In other instances, both the first frame member 1802 and the second frame member 1804 can be expanded. Additionally, one set of the frame members in the first frame member 1802 and the second frame member 1804 may be convex, while another set of the frame members in the first frame member 1802 and the second frame member 1804 may be flat or concave, or both the first frame member 1802 and the second frame member 1804 may be convex. Additionally, one set of the frame members in the first frame member 1802 and the second frame member 1804 may be concave, while another set of the frame members in the first frame member 1802 and the second frame member 1804 may be flat or convex, or both the first frame member 1802 and the second frame member 1804 may be concave. Additionally, the first frame member 1802 and the second frame member 1804 may be different sizes.

[0138] The first frame member 1802 and the second frame member 1804 may include sensors integrated into the respective frame members, for example, for continuously monitoring various hemodynamic parameters in a patient, such as pressure and other parameters. For example, an antenna or inductor may be wrapped around the perimeter of one of the first frame member 1802 and the second frame member 1804, and a sensor may be attached to the inductor. The sensor may be configured to sense physiological characteristics, such as temperature, cardiac electrical signals, blood chemistry, blood pH levels, hemodynamics, biomarkers, sound, pressure, and electrolytes, which may be important in diagnosing, monitoring, and / or treating heart disease, heart failure, and / or other cardiovascular disease states.

[0139] In some instances, after delivery, the catheter portion 1814 can be quite large. The membrane 1816 can be selectively adjustable by a balloon applied within the catheter portion 1814 to expand the membrane 1816. The device 1900 can be any size suitable for the patient's anatomical structure. In some instances, the diameter of the catheter portion is from 3mm to 12mm. For example, depending on the patient's anatomical structure and / or the desired treatment location, the diameter of the catheter portion can be from 4mm to 10mm, or from 5mm to 8mm. For example, the first frame member 1802 and the second frame member 1804 typically have a diameter larger than the diameter of the catheter portion 1814, so that the frame members can anchor the catheter portion 1814 of the device 1900 in the septum.

[0140] Device 1900 can be any shape suitable for the patient's anatomy. For example, first frame member 1802 and second frame member 1804 can be any of a variety of suitable shapes for anchoring device 1900 in the patient's body. For example, first frame member 1802 and second frame member 1804 can be substantially circular, ovule-shaped, diamond-shaped, star-shaped, flower-shaped, or any other desired suitable shape. In some instances, for example, at least one of first set of elongated elements 1806 and second set of elongated elements 1808 forms a star shape. In some instances, for example, first set of elongated elements 1806 and second set of elongated elements 1808 both form a star shape.

[0141] In some examples, first group of elongated elements 1806 forms a plurality of first lobes 2004, and second group of elongated elements 1808 forms a plurality of second lobes 2006. As desired, each of the plurality of first lobes 2004 and the plurality of second lobes 2006 may include, for example, 3 to 12 lobes, 4 to 10 lobes, or 6 to 8 lobes. In some examples, the number of lobes in the plurality of first lobes 2004 may be greater than the number of lobes in the plurality of second lobes 2006, while in other examples, the number of lobes in the plurality of first lobes 2004 may be equal to or less than the number of lobes in the plurality of second lobes 2006.

[0142] Fig.21An example of an implantable medical device 1400 being activated by an energy source (e.g., an energizing unit 2100) according to an embodiment is shown. The energizing unit 2100 operates in a manner similar to the in vitro energizing unit 800, in that the energizing unit 2100 can transmit energy to the implantable medical device via magnetic induction, and the energy can be converted into electrical energy to electrolytically degrade the components of the implantable medical device. Alternatively, the energizing unit 2100 can deliver energy via an ultrasonic energy source, a laser energy source, a radio frequency (RF) energy source, and / or another type of suitable energy source, which applies energy transmission 2102 to form an aperture in a membrane coupled to a flange (e.g., a membrane 2104 coupled to a first flange 224). Unlike the in vitro energizing unit 800, the energizing unit 2100 is delivered to a location within the heart H (e.g., in the right atrium RA) near the membrane 2104. In one embodiment, after exposing the membrane 2104 to thermal energy or ultrasonic energy, the membrane of the membrane 2104 can be melted to form an aperture to produce a thermal activation mechanism. In some examples, the size of the aperture can be adjusted by varying the amount of thermal activation.

[0143] In some embodiments, the medical device 1400 may include an additional, secondary membrane (not shown) coupled to the second flange 226. In these embodiments, one or both of the membranes selectively absorb ultrasound so that the membranes are configured to be thermally opened using an ultrasound source to adjust flow through the medical device 1400. In some embodiments, one or both of the membranes selectively absorb RF energy so that the membranes are thermally opened using an RF ablation source to adjust flow through the medical device 1400. In some embodiments, the membrane selectively absorbs laser energy so that the membranes are configured to be thermally opened using a laser source. In some embodiments, the membrane or element (e.g., wire) holding the membrane in place may be selectively and electrolytically degraded using electrical energy provided by induction or other energy sources. In some embodiments, both membranes may be actuated using similar methods. For example, the membranes may both be configured to open simultaneously in response to receiving energy (e.g., RF energy, laser energy, induction energy, etc.) from an external source.

[0144] In some embodiments, one or both of the membranes are under radial tension to assist in forming one or both of the apertures therethrough. For example, when the membrane(s) are stretched, even small openings in the membrane(s) can be enlarged as radial tension applied from the outer edges of the membrane(s) pulls the membrane(s) around the opening away from the position of the opening in multiple directions. In some embodiments, the membrane(s) exhibit a residual stress distribution to assist in forming one or both of the apertures in the membrane(s). In some embodiments, for one or both of the apertures, the membrane(s) can be selectively opened between multiple sizes to alter the flow through the medical device 1400.

[0145] Fig. 22 An example of an implantable medical device 2200 according to an embodiment is shown. The implantable medical device 2200 has two flanges 224 and 226 that engage with the surface of an organ wall 204 to secure the medical device 2200 in place, wherein the flanges 224 and 226 are located on opposite sides of the organ wall 204. In one example, the organ wall 204 is an atrial wall between the left atrium and the right atrium of the heart, such that the first flange 224 is located on the surface of the atrial wall 204 in the right atrium and the second flange is located on the surface of the atrial wall 204 in the left atrium, wherein the catheter 1402 extends between the two flanges 224 and 226, such that the catheter 1402 forms a lumen 216 that fluidly connects the two atria of the heart. In other examples, the medical device 2200 is secured to the ventricular wall or other tissue of the body as desired.

[0146] In some examples, the catheter 1402 includes a membrane 2202 made of a polymer material as described above, the membrane 2202 being impermeable to blood under physiological conditions, such that the membrane 2202 separates the lumen 216 into two segments: a first lumen segment 216A and a second lumen segment 216B. In some examples, the membrane 2202 is positioned in the middle of the lumen 216, although the membrane can be offset or located at either end of the lumen 216. In some examples, the membrane 2202 is positioned at any position in the lumen 216 such that the volume of the first lumen segment 216A is greater than the volume of the second lumen segment 216B, or the volume of the second lumen segment 216B is greater than the volume of the first lumen segment 216A.

[0147] The membrane 2202 helps prevent fluid from flowing through the lumen 26 (e.g., between the first lumen segment 216A and the second lumen segment 216B), and thus prevents fluid from flowing between two opposing sides of the organ wall 204. In some examples, as previously described, the membrane 2202 can selectively absorb ultrasound, RF energy, laser energy, or any suitable energy source, in which case the absorbed energy causes the membrane 2202 to degrade, melt, or open to allow fluid to flow between the first lumen segment 216A and the second lumen segment 216B. In some examples, the flow of fluid can be adjusted by changing the degree of degradation or the size of the opening in the membrane 2202.

[0148] Additionally, medical device 2200 includes one or more (e.g., three) locations where one or more sensors are placed to perform physiological measurements in the body. First location 1406 and third location 1410 are substantially similar to the locations mentioned above for medical device 1400. Second location 1408 can be located in catheter 1402 for a sensor (e.g., a flow sensor) to measure the flow of the fluid in lumen 216. In some examples, second location 1408 can be located in first lumen segment 216A or second lumen segment 216B. In some examples, second location 1408 can be adjacent to or close to membrane 2202 so that the sensor can also detect when membrane 2202 is opened or degraded to allow fluid to flow through lumen 216.

[0149] Although various examples have been provided in the context of a trans-septal approach, with the device located between the two atria, it should be understood that a variety of different applications and locations are contemplated (e.g., trans-septal between ventricles, between the aorta and a heart chamber, between two blood vessels, between two gastrointestinal organs, etc.). In other words, the invention of the present application has been described above generally and based on specific embodiments. It will be apparent to those skilled in the art that various modifications and variations may be made in the embodiments without departing from the scope of the present disclosure. Therefore, the present disclosure is intended to cover various modifications and variations of the present invention in the embodiments, as long as such modifications and variations are within the scope of the appended claims and their equivalents.

Claims

1. An implantable medical device comprising: a fluid shunt adapted to extend through a wall separating a first cavity and a second cavity within a heart, the fluid shunt comprising a first portion adapted to extend into the first cavity within the heart, a second portion adapted to extend into the second cavity within the heart, and an intermediate portion interconnecting the first portion and the second portion, the fluid shunt having a lumen extending between the first portion and the second portion, the lumen adapted to fluidly couple the first cavity and the second cavity within the heart; an occlusion assembly associated with the fluid diverter and adapted to selectively occlude flow through the lumen of the fluid diverter, the occlusion assembly being configured to be in a closed configuration such that the lumen of the fluid diverter is initially sealed, and being configured to be thermally activated to regulate flow through the lumen of the fluid diverter, wherein the occlusion assembly comprises a thermoplastic polymer film cover on at least one of the first portion of the fluid diverter or the second portion of the fluid diverter, and the thermoplastic polymer film cover is impermeable to blood under physiological conditions, and is configured to be activated by heating to regulate flow through the lumen of the fluid diverter; as well as At least one sensor assembly is associated with the first portion of the fluid diverter such that the at least one sensor assembly is adapted to sense one or more physiological parameters in the first cavity.

2. The implantable medical device according to claim 1, wherein: The at least one sensor assembly includes a first sensor assembly and a second sensor assembly associated with the second portion of the fluid diverter such that the second sensor assembly is adapted to sense one or more physiological parameters in the second cavity.

3. The implantable medical device of claim 1 , further comprising a control unit in communication with the at least one sensor assembly, the control unit comprising: a receiver coupled to the at least one sensor assembly, the receiver configured to receive physiological parameter information from the at least one sensor assembly; as well as A processing unit is coupled to the receiver to analyze the physiological parameter information received by the receiver.

4. The implantable medical device of claim 3, further comprising an actuation mechanism associated with the occlusion assembly, the control unit being operatively coupled to the actuation mechanism and configured to send a control signal to activate the actuation mechanism in response to the performed analysis.

5. The implantable medical device according to claim 4, wherein: The at least one sensor assembly is operably coupled to the actuation mechanism of the occlusion assembly such that the actuation mechanism is adapted to increase flow through the lumen of the fluid shunt when the at least one sensor assembly senses a predetermined physiological measurement.

6. The implantable medical device according to claim 1, wherein: At least one of the first and second portions of the fluid shunt includes a flange member for engaging the wall of the heart.

7. The implantable medical device according to claim 1, wherein: The fluid diverter includes a support member.

8. The implantable medical device according to claim 7, wherein: The support member includes a resilient frame.

9. The implantable medical device according to claim 1, wherein: The thermoplastic polymer film lid comprises a composite film material.

10. The implantable medical device according to any one of claims 1 to 9, characterized in that The first chamber is the left atrium of the heart and the second chamber is the right atrium of the heart.

11. The implantable medical device according to any one of claims 1 to 9, characterized in that: The thermoplastic polymer membrane cover is configured to selectively absorb ultrasound waves such that the thermoplastic polymer membrane cover is configured to be thermally opened using an ultrasound source to adjust flow through the lumen of the fluid diverter.

12. The implantable medical device according to any one of claims 1 to 9, characterized in that: The thermoplastic polymer film cover is configured to selectively absorb laser energy such that the thermoplastic polymer film cover is configured to be thermally opened using a laser source.

13. The implantable medical device according to any one of claims 1 to 9, characterized in that: The thermoplastic polymer film cover is configured to selectively absorb radio frequency energy such that the thermoplastic polymer film cover is configured to be thermally opened using a radio frequency energy source.

14. The implantable medical device according to any one of claims 1 to 9, characterized in that: The thermoplastic polymer film cover is under radial tension to assist in opening of the thermoplastic polymer film cover.

15. The implantable medical device according to any one of claims 1 to 9, characterized in that: The thermoplastic polymer film cover exhibits a residual stress distribution to assist in opening of the thermoplastic polymer film cover.

16. The implantable medical device according to any one of claims 1 to 9, characterized in that The thermoplastic polymer membrane cover is selectively openable between a plurality of opening sizes to alter flow through the lumen of the fluid diverter.

17. The implantable medical device according to any one of claims 1 to 9, characterized in that: The thermoplastic polymer film cover is configured to cover the first portion of the fluid shunt, the first portion being adapted to extend into the first chamber within the heart.

18. The implantable medical device of claim 17, further comprising a secondary cover, wherein the secondary cover is configured to cover the second portion of the fluid shunt, the second portion being adapted to extend into the second chamber within the heart.

19. The implantable medical device according to any one of claims 1 to 9 or 18, characterized in that The device is part of a system including at least one of an external inductive energy source, an internal inductive energy receiver, an ultrasound energy source, a laser energy source, a radiofrequency energy source, or another type of energy source for activating the occlusive component.

20. The implantable medical device according to any one of claims 1 to 9 or 18, wherein: The device is configured to exhibit different resonant frequencies based on a flow rate through the lumen of the fluid diverter.

21. An implantable medical device comprising: a first sensor assembly associated with a fluid shunt, the first sensor assembly configured to sense one or more physiological parameters in a first chamber within the heart, the fluid shunt being adapted to extend through a wall separating the first chamber within the heart and a second chamber within the heart, wherein the fluid shunt includes a first portion adapted to extend into the first chamber, a second portion adapted to extend into the second chamber, an intermediate portion interconnecting the first portion and the second portion, and a lumen extending between the first portion and the second portion to fluidly couple the first chamber and the second chamber within the heart; as well as An occlusion assembly associated with the fluid diverter, the occlusion assembly being configured to be actuated to adjust flow through the fluid diverter, wherein the occlusion assembly is suitable for selectively occluding flow through the lumen of the fluid diverter, and is configured to be in a closed configuration so that the lumen of the fluid diverter is initially in a sealed state, and is configured to be thermally activated to adjust flow through the lumen, and wherein the occlusion assembly includes a thermoplastic polymer film cover, the thermoplastic polymer film cover is on at least one of the first portion of the fluid diverter or the second portion of the fluid diverter, and the thermoplastic polymer film cover is impermeable to blood under physiological conditions, and the thermoplastic polymer film cover is activated by heating to adjust flow through the lumen of the fluid diverter.

22. The implantable medical device of claim 21, further comprising: A second sensor assembly is associated with the fluid shunt, the second sensor assembly being configured to sense one or more physiological parameters in the second chamber within the heart.

23. The implantable medical device of claim 21 or 22, further comprising: a receiver coupled to at least the first sensor assembly, the receiver configured to receive the physiological parameter sensed by at least the first sensor assembly; a processing unit coupled to the receiver, the processing unit configured to perform an analysis on the physiological parameter received by the receiver to generate an actuation signal; as well as Wherein, the blocking component is configured to be actuated according to the actuation signal.

24. The implantable medical device of claim 23, further comprising: A controller is configured to send the actuation signal to the blocking assembly.

25. The implantable medical device of claim 24, wherein: The controller is configured such that when at least the first sensor assembly senses a predetermined physiological measurement, the controller sends the actuation signal to the occlusion assembly such that the occlusion assembly increases flow through the lumen of the fluid diverter.

26. The implantable medical device of claim 21, wherein: The fluid shunt is configured to pass through the wall of the heart, wherein the flange portions of the first and second portions of the fluid shunt are configured to engage the wall of the heart.

27. The implantable medical device of claim 21, wherein: The fluid shunt is configured to pass through a wall of the heart separating the first chamber within the heart from the second chamber within the heart, wherein a support of the fluid shunt is configured to engage the wall of the heart.

28. The implantable medical device of claim 27, wherein: The support member includes a resilient frame.

29. The implantable medical device according to any one of claims 21-22, 24-28, characterized in that The thermoplastic polymer film lid comprises a composite film material.

30. The implantable medical device according to any one of claims 21-22, 24-28, characterized in that The first chamber is the left atrium of the heart and the second chamber is the right atrium of the heart.

31. A medical system comprising: An implantable medical device, the implantable medical device comprising: a fluid shunt adapted to extend through a wall separating a first cavity and a second cavity within a heart, the fluid shunt comprising a first portion adapted to extend into the first cavity within the heart, a second portion adapted to extend into the second cavity within the heart, and an intermediate portion interconnecting the first portion and the second portion, the fluid shunt having a lumen extending between the first portion and the second portion, the lumen adapted to fluidly couple the first cavity and the second cavity within the heart; an occlusion assembly associated with the fluid diverter and adapted to selectively occlude flow through the lumen of the fluid diverter, the occlusion assembly being configured to be in a closed configuration such that the lumen of the fluid diverter is initially sealed, and being configured to be thermally activated to regulate flow through the lumen of the fluid diverter, wherein the occlusion assembly comprises a thermoplastic polymer film cover on at least one of the first portion of the fluid diverter or the second portion of the fluid diverter, and the thermoplastic polymer film cover is impermeable to blood under physiological conditions, and is configured to be activated by heating to regulate flow through the lumen of the fluid diverter; and at least one sensor assembly associated with the first portion of the fluid diverter such that the at least one sensor assembly is adapted to sense one or more physiological parameters in the first cavity; and A deployment catheter is configured to compress the implantable medical device and maintain the implantable medical device in a compressed configuration until the implantable medical device is deployed at a desired treatment location within the heart.

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