Shunts, occluders, fenestration medical devices and related systems and methods

Abstract

An implantable medical device comprising: a first frame portion; a second frame portion disposed within the first frame portion; and a plurality of diverging elements connecting the first frame portion to the second frame portion.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 16 / 709,129, filed December 10, 2019, which claims the benefit of Provisional Application No. 62 / 777,931, filed December 11, 2018, both of which are incorporated herein by reference in their entirety for all purposes.

[0002] Field FIELD OF THE DISCLOSURE The present disclosure relates generally to implantable medical devices, and more particularly to implantable medical devices for diverting and / or occluding bodily fluids or structures and their associated systems and methods. [Background technology]

[0003] background Heart failure and heart diseases affect millions of people worldwide. Heart failure can include disorders of the left side of the heart, the right side of the heart, or both. Heart diseases that can lead to heart failure include high blood pressure, pulmonary arterial hypertension, and congenital heart defects. The constantly evolving nature of heart failure represents a significant challenge for treatment. Therefore, new and adaptable methods and devices for treating heart failure are needed. Summary of the Invention

[0004] Abstract In one example ("Example 1"), an implantable medical device includes a first frame portion having at least three lobes, a second frame portion disposed within the first frame portion, and a plurality of diverging elements disposed between the first frame portion and the second frame portion, the plurality of diverging elements diverging from the first frame portion and the second frame portion to form a central frame having at least six divergence points in an expanded configuration.

[0005] In another example ("Example 2"), in addition to the device of Example 1, the first frame portion and the second frame portion are adjacent to each other.

[0006] In another example ("Example 3"), further to the device of any one of Examples 1-2, when the device is in the deployed configuration, the opening is hexagonal in shape.

[0007] In another example ("Example 4"), in addition to the device of any one of Examples 1-3, the first frame portion is disposed on a first side of a partition wall, the second frame portion is disposed on a second side of the partition wall, and the plurality of diverging elements form a fluid flow path therethrough.

[0008] In another example ("Example 5"), in addition to the device of Example 4, the first and second frame portions are sufficiently flexible to conform to the anatomy of the septum.

[0009] In another example ("Example 6"), in addition to the device of any one of Examples 1-5, the second frame portion includes at least three lobes.

[0010] In another example ("Example 7"), in addition to the device of any one of Examples 1 to 6, the first frame portion has a first geometric shape and the second frame portion has a second geometric shape different from the first geometric shape.

[0011] In another example ("Example 8"), in addition to the device of any one of Examples 1-7, the first frame portion includes six lobes.

[0012] In another example ("Example 9"), further to the device of any one of Examples 1-8, each lobe of the second frame portion includes an eyelet configured to aid in delivery of the device.

[0013] In another example ("Example 10"), in addition to the device of any one of Examples 1-9, the device also includes a coating material disposed over at least a portion of the device.

[0014] In another example ("Example 11"), in addition to the device of Example 10, the first frame portion includes a coating material and the second frame portion does not include a coating material.

[0015] In another example ("Example 12"), in addition to the device of Example 11, the coating material comprises expanded polytetrafluoroethylene (ePTFE).

[0016] In another example ("Example 13"), in addition to the device of any one of Examples 1-12, the first frame portion and the second frame portion are integral such that the device is formed from a single wire.

[0017] In another example ("Example 14"), in addition to the device of any one of Examples 1-13, the device also includes a sensor disposed with the conduit portion or frame component and configured to sense at least one of a physiological characteristic, hemodynamics, a biomarker, sound, pressure, and electrolytes.

[0018] In another example ("Example 15"), in addition to the device of any one of Examples 1-14, the device also includes at least one of a coating of heparin to promote thrombosis resistance and patency of the device and a coating of paclitaxel to modulate tissue / cellular response.

[0019] In one example ("Example 16"), an implantable medical device for regulating blood pressure between the left and right atria of the heart, the device having a delivery configuration and a deployed configuration, includes a first frame portion, a second frame portion disposed within the first frame portion, and a plurality of diverging elements connecting the first frame portion to the second frame portion, the plurality of diverging elements forming a central portion having an opening, the opening being substantially hexagonal in shape when the device is in the deployed configuration.

[0020] In another example ("Example 17"), further to the device of Example 16, each of the plurality of diverging elements overlaps one another to form a diverging point, and the diverging point expands outward to form a hexagonal shape when the device is in the deployed configuration.

[0021] In another example ("Example 18"), in addition to the device of Example 16, the first frame portion and the second frame portion are flush with each other when the device is in the deployed configuration and non-flush with each other when the device is in the delivery configuration.

[0022] In one example ("Example 19"), a method of making the implantable medical device of any one of Examples 1-18 includes cutting a two-dimensional pattern from a nitinol sheet.

[0023] In one example ("Example 20"), a method for regulating blood pressure between the left and right atria of the heart includes delivering an implantable medical device to a desired treatment location within a patient's body while the device is in a delivery configuration, positioning a first frame portion of the device on a first side of a septum, positioning a second frame portion of the device on a second side of the septum, and releasing the device from the delivery configuration to a deployed configuration such that a central portion of the device forms a substantially hexagonal-shaped opening.

[0024] In another example ("Example 21"), in addition to the method of Example 20, the method also includes expanding the central portion to adjust the rate of fluid flow therethrough.

[0025] In one example ("Example 22"), an implantable medical device includes a first frame portion having at least two lobes, a second frame portion having at least two lobes, and a plurality of diverging elements disposed between the first frame portion and the second frame portion, the plurality of diverging elements diverging from the first frame portion and the second frame portion to form a central frame configured to be generally circular in shape in an expanded configuration.

[0026] In another example ("Example 23"), further to the medical device of Example 22, the central frame includes a polygonal structure configured to assume a generally circular shape in the deployed configuration.

[0027] In another example ("Example 24"), in addition to the medical device of Example 22, the two lobes of the first frame portion are configured to conform to a first tissue surface, and the two lobes of the second frame portion are configured to conform to a second tissue surface.

[0028] In another example ("Example 25"), in addition to the medical device of Example 22, the first frame portion and the second frame portion are sufficiently flexible to conform to the anatomy of a septum.

[0029] The foregoing examples are exemplary only and should not be read to limit or otherwise narrow the scope of any inventive concepts provided by the present disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. [Brief explanation of the drawings]

[0030] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated into and constitute a part of this specification, illustrate embodiments, and together with the description, serve to explain the principles of the disclosure.

[0031] [Figure 1] FIG. 1 is an exemplary implantable medical device for regulating blood pressure, according to one embodiment.

[0032] [Figure 2] FIG. 2 is a perspective view of an implantable medical device according to one embodiment.

[0033] [Figure 3] FIG. 3 is a top view of a first side of an implantable medical device according to one embodiment.

[0034] [Figure 4] FIG. 4 is a top view of another implantable medical device, according to one embodiment.

[0035] [Figure 5] FIG. 5 is a top view of another implantable medical device, according to one embodiment.

[0036] [Figure 6] FIG. 6 is a top view of a first side of another implantable medical device, according to one embodiment.

[0037] [Figure 7] FIG. 7 is a perspective view of another implantable medical device, according to one embodiment.

[0038] [Figure 8A] FIG. 8A is an image of a first side of an implantable medical device according to one embodiment.

[0039] [Figure 8B] FIG. 8B is an image of a second side of the implantable medical device of FIG. 7A, according to one embodiment.

[0040] [Figure 9A] FIG. 9A is an image of an implantable medical device according to one embodiment.

[0041] [Figure 9B] FIG. 9B is an image of a first side of the implantable medical device of FIG. 9A with a membrane, according to one embodiment.

[0042] [Figure 9C] FIG. 9C is an image of a second side of the implantable medical device of FIGS. 9A-B, according to one embodiment.

[0043] [Figure 10A] FIG. 10A is an image of an implantable medical device according to one embodiment.

[0044] [Figure 10B] FIG. 10B is an image of the implantable medical device of FIG. 10A having an open central portion, according to one embodiment.

[0045] [Figure 11] FIG. 11 is an image of another implantable medical device according to one embodiment.

[0046] [Figure 12] FIG. 12 is an image of another implantable medical device according to one embodiment.

[0047] [Figure 13] FIG. 13 is an image of an implantable medical device and deployment apparatus, according to one embodiment.

[0048] [Figure 14A] FIG. 14A is an image of an implantable medical device and deployment apparatus, according to one embodiment.

[0049] [Figure 14B] FIG. 14B is an image of an implantable medical device with a first side deployed from the delivery apparatus shown in FIG. 14A, according to one embodiment.

[0050] [Figure 15A] FIG. 15A is an image of the implantable medical device shown in FIG. 5, according to one embodiment.

[0051] [Figure 15B] FIG. 15B is an image of the implantable medical device shown in FIG. 15A including a coating material, according to one embodiment.

[0052] [Figure 15C] FIG. 15C is an image of a first side of the implantable medical device shown in FIG. 15A with a membrane, according to one embodiment.

[0053] [Figure 15D] FIG. 15D is an image of a second side of the implantable medical device shown in FIGS. 15B-C, according to one embodiment.

[0054] [Figure 16A] FIG. 16A is an image of an implantable medical device according to one embodiment.

[0055] [Figure 16B] FIG. 16B is an image of a second configuration of the implantable medical device shown in FIG. 16A, according to one embodiment.

[0056] [Figure 16C] FIG. 16C is an image of the implantable medical device shown in FIG. 16A in a deployed configuration, according to one embodiment.

[0057] [Figure 17A] FIG. 17A is an image of an implantable medical device according to one embodiment.

[0058] [Figure 17B] FIG. 17B is an image of the implantable medical device shown in FIG. 17A in a deployed configuration, according to one embodiment.

[0059] [Figure 18] FIG. 18 is a diagram of an implantable medical device, according to one embodiment.

[0060] [Figure 19] FIG. 19 is a diagram of an implantable medical device, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0061] Detailed Description Definitions and Terminology This disclosure is not intended to be read in a limiting manner. For example, the terms used in this application should be read broadly in the context of the meanings ascribed to such terms by terms of the art.

[0062] With respect to the term imprecision, the terms "about" and "approximately" are used interchangeably and can refer to a measurement that includes the stated measurement and any measurement that is reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount, as understood and readily ascertained by one of ordinary skill in the relevant art. Such deviations can result from, for example, measurement error, differences in calibration of measuring and / or manufacturing equipment, human error in reading and / or setting measurements, small adjustments made to optimize performance and / or structural parameters to account for differences in measurements associated with other components, specific implementation scenarios, imprecise adjustment and / or manipulation of the object by a person or machine, etc. If it is determined that such a reasonably small difference would not be readily ascertainable by one of ordinary skill in the relevant art, the terms "about" and "approximately" can be understood to mean ±10% of the stated value.

[0063] Description of Various Embodiments Those skilled in the art will readily appreciate that the 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 accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard the drawings should not be construed as limiting.

[0064] Various aspects of the present disclosure are directed to implantable medical devices, such as devices for diverting and / or occluding bodily fluids or structures. In certain instances, various aspects of the present disclosure relate to methods and devices for treating heart failure by reducing high blood pressure within a heart chamber by creating a pressure-relief shunt. Additionally, some embodiments relate to methods and devices for customizing, regulating, or manipulating blood flow through the shunt to enhance the therapeutic effect of the pressure-relief shunt. In some instances, the devices disclosed herein maintain patency within a patient's body by reducing shear forces around the heart.

[0065] FIG. 1 illustrates an exemplary implantable medical device for regulating blood pressure implanted within a patient's body, according to one embodiment. Device 100 is shown implanted within the patient's heart H. Device 100 is shown positioned between the patient's left atrium LA and right atrium RA. In a particular example, device 100 can be used to regulate blood flow within heart H, for example, between the left atrium LA and the right atrium RA. As shown, device 100 generally includes a first frame portion 110 positioned on a first side of the septum (e.g., in the left atrium LA), a second frame portion 120 positioned on a second side of the septum (e.g., in the right atrium RA), and a central portion 130 extending through the septum. A needle can be used to create an opening in the septum.

[0066] Sheath 140 and constraint and / or release lines (not shown) can be used to facilitate deployment of device 100. For example, a first side of device 100, including first frame portion 110, can be released after sheath 190 is advanced through the septum to the LA, and a second side of device 100, including second frame portion 120, can be released second on the RA side of the septum. Central portion 130 (e.g., shown in FIG. 2) is positioned within the opening. First and second frame portions 110, 120, and central portion 130 can be compressed within sheath 190 into a delivery configuration such that first and second frame portions 110, 120 are non-coplanar with one another during delivery of device 100 to a desired treatment area within a patient. The first frame portion 110 and the second frame portion 120 can then be expanded to a deployed configuration upon deployment of the device 100 such that the first frame portion 110 and the second frame portion 120 are flush with each other.

[0067] FIG. 2 is a perspective view of an implantable medical device 200 in a deployed configuration, according to one embodiment. As described herein, the device includes a first frame portion 210 and a second frame portion 220. The first frame portion 210 and the second frame portion 220 are sufficiently flexible to conform to a patient's anatomy at a desired treatment location. For example, as shown in FIG. 1 , the first frame portion 210 can conform to a first side of the patient's septum (e.g., in the left atrium), and the second frame portion 220 can conform to a second side of the patient's septum (e.g., in the right atrium). In some examples, the first frame portion 210 and the second frame portion 220 include a first plurality of lobes 212 and a second plurality of lobes 222, respectively. In some examples, the first frame portion 210 and the second frame portion 220 can include the same number of lobes or different numbers of lobes, as desired. For example, both the first frame portion 210 and the second frame portion 220 can include two lobes, three lobes, or four or more lobes, as desired. For example, as shown in FIGS. 6 and 9A-C, the frame portions each include two lobes. In another example, the first frame portion 210 includes two lobes, while the second frame portion 220 includes three or more lobes, etc. The first frame portion 210 and the second frame portion 220 can have any number of lobes, as desired. In general, the number of lobes on the first frame portion 210 and the second frame portion 220 can depend, among other factors, on the patient's anatomy and the desired treatment location within the patient's body.

[0068] The first frame portion 210 and the second frame portion 220 can have various geometries (e.g., shapes, sizes, lobe configurations, etc.). For example, in some instances, the first plurality of lobes 212 of the first frame portion 210 can have a first geometric shape, while the second plurality of lobes 222 of the second frame portion 220 can have a second geometric shape that is different from the first geometric shape. For example, the first plurality of lobes 212 can be rhomboid-shaped, while the second plurality of lobes 222 can be rounded or petal-like. In another example, the first plurality of lobes 212 can be larger than the second plurality of lobes 222, or vice versa. In other instances, the first frame portion 210 and the second frame portion 220 can have the same or substantially similar geometric shapes. For example, the first frame portion 210 and the second frame portion 220 can be substantially symmetrical.

[0069] As shown in FIG. 2 , the diverging element 240 is disposed between the first frame portion 210 and the second frame portion 220. In certain examples, the diverging element 240 and the first and second frame portions 210, 220 are adjacent portions of a frame. In some examples, the diverging element 240 is integral with the first and second frame portions 210, 220. The diverging element 240 is generally an elongate member configured to span a patient's septum and form the central portion 230 of the device 200 and a fluid flow path therethrough in the deployed configuration. For example, the first and second frame portions 210, 220 and the diverging element 240 can be formed from a single wire. In other words, the first and second frame portions 210, 220 are adjacent to one another.

[0070] In some instances, the diverging elements 240 intersect with one another at specific locations within the central portion 230 to form diverging points 242. For example, in certain instances, the diverging elements 240 form at least six diverging points 242, which help define the openings 250 through the device 200 or tissue. As described in more detail below, the device 200 can include a covering material 270. In instances where the device 200 does not have a covering material 270, the frame 200 can create and retain the openings 250 in the tissue. In instances where the frame 200 includes a covering material 270, the openings 250 can be considered to be part of the device 200 with the covering material 270 forming the openings 250 or fluid pathways. The diverging points 242 also provide support and rigidity to the central portion 230 when the device 200 is in the deployed configuration. The divergence points 242 generally define an opening 250 that is hexagonal in shape (e.g., each divergence point 242 forms a corner of the hexagon), for example, when there are six divergence points 242. However, the shape of the opening 250 (e.g., the opening in the tissue or the device 200) depends on the number of divergence points 242 in the central portion 230. For example, a device 200 with four divergence points 242 can have an opening 250 that is substantially rectangular in shape, or a device 200 with eight divergence points 242 can have an opening 250 that is octagonal in shape.

[0071] In some examples, device 200 can be formed from a single wire. For example, first frame portion 210, second frame portion 220, and diverging element 240 can be formed by winding a single wire (e.g., nitinol or stainless steel wire) in a desired shape or pattern. In some examples, device 200 can be formed from a single sheet of flexible, biocompatible material. For example, a two-dimensional pattern can be cut from a flat sheet of nitinol, stainless steel, or a non-metallic material. In some examples, when using a non-metallic material, device 200 can be absorbable or biodegradable.

[0072] In some examples, device 200 also includes a covering material 270. Covering material 270 can be, for example, a membrane material that can promote tissue ingrowth. In some examples, the membrane can also be configured to reduce erosion of first frame portion 210 and / or second frame portion 220. For example, covering material 270 can be polytetrafluoroethylene (ePTFE) or any other suitable biocompatible material (e.g., a polymeric or synthetic material or a woven material).

[0073] In some examples, covering material 270 covers at least a portion of first frame portion 210 and / or at least a portion of second frame portion 220. In some examples, both first frame portion 210 and second frame portion 220 are completely covered by covering material 270. In these examples, covering material 270 can span central portion 230. In some examples, first frame portion 210 can include a first membrane material, and second frame portion 220 can include a second membrane material that is different from the first membrane material. In these examples, the first membrane material and the second membrane material can be bonded together at central portion 230.

[0074] In some instances, the covering material 270 may be perforated to facilitate filtration and / or fluid flow through the device 200, for example, to reduce the risk of stroke in certain patients. However, in other instances where less fluid flow is desired, the covering material 270 may reduce or prevent fluid flow therethrough.

[0075] In certain examples, a portion of coating material 270 can be configured to inhibit tissue ingrowth (e.g., within openings 250 through device 200). Additionally, a portion of coating material 270 disposed on first plurality of lobes 212 and / or second plurality of lobes 222 can be configured to promote tissue ingrowth to enhance fixation of device 200 within tissue. Additionally, first plurality of lobes 212 and / or second plurality of lobes 222 can conform to the first tissue surface and the second tissue surface, respectively, resulting in reduced tissue erosion and first plurality of lobes 212 and / or second plurality of lobes 222 moving in response to forces that alter the tissue topography.

[0076] In certain examples, and as shown, opening 250 through device 200 includes a perimeter that is approximately circular in shape. Diverging elements 240 intersect each other at specific locations within central portion 230 such that the boundary or perimeter of opening 250 is approximately circular in shape. Diverging elements 240 can form a polygonal structure, perimeter, or boundary that is approximately circular. For example, diverging elements 240 can include 8, 10, 12, 14, 16, 18, 20, 22, 24, or more sides that form a polygonal structure, perimeter, or boundary that is approximately circular in the deployed configuration. Openings 250 that generally have a perimeter or boundary that is approximately circular in shape can facilitate folding of the device into a delivery configuration while maintaining hoop strength and reducing collapse of opening 250 in the deployed configuration. In the deployed configuration, the first frame portion 210 can be deployed on one side of the tissue structure and the second frame portion 220 can be deployed on another side of the tissue structure (e.g., as shown in Figures 9B-C).

[0077] 3 is a top view of a first side of an implantable medical device 300, according to one embodiment. As shown, the first frame portion 310 includes three lobes (e.g., a first lobe 312a, a second lobe 312b, and a third lobe 312c). The lobes can be spaced equidistant from one another, as shown, such that each of the lobes is separated from one another. For example, each of the first, second, and third lobes 312a, 312b, 312c can move independently of one another to conform to a patient's anatomy when the device 300 is in the deployed configuration.

[0078] 3, the second frame portion 320 can have the same or a different number of lobes as the first frame portion 310. For example, in some examples, the first frame portion 310 and the second frame portion 320 each have three lobes. In other examples, the first frame portion 310 can include three lobes, while the second frame portion 320 includes two, four, five, or more lobes. In some examples, the first frame portion 310 can have lobes that are larger, smaller, and / or differently shaped than the lobes of the second frame portion 320.

[0079] 4 is a top view of a first side of another implantable medical device 400, according to one embodiment. As shown, a first frame portion 410 includes three lobes (e.g., a first lobe 412a, a second lobe 412b, and a third lobe 412c) and an inner frame portion 414. Each of the lobes 412a, 412b, and 412c can be attached to the inner frame portion 414 such that the lobes are evenly spaced around the inner frame portion 414. In some examples, the lobes can be attached to the inner frame portion 414 and / or to adjacent lobes at attachment points 416a, 416b, and 416c. For example, in some instances, the first lobe 412a is attached to the second lobe 412b at attachment point 416a, the second lobe 412b is attached to the third lobe 412c at attachment point 416b, and the third lobe 412c is attached to the first lobe 412a at attachment point 416c. While FIG. 4 is described with reference to three lobes and three attachment points, the first frame portion 410 can have any number of lobes and respective attachment points as desired. The first frame portion 410 and the second frame portion 420 are formed by diverging elements of consecutive or adjacent frames. The first frame portion 410 and the second frame portion 420 can be formed from cut tubing, wound wire, or other similar structures.

[0080] 4, the second frame portion 420 can have the same or a different number of lobes as the first frame portion 410. For example, in some examples, the first frame portion 410 and the second frame portion 420 each have three lobes. In other examples, the first frame portion 410 can include two or three lobes, while the second frame portion 420 includes two, four, five, or more lobes. In some examples, the first frame portion 410 can have lobes that are larger, smaller, and / or differently shaped than the lobes of the second frame portion 420.

[0081] In certain examples, certain portions of device 400 may include a coating material, such as described in detail above with reference to Figure 2. As discussed with reference to Figure 2, the coating material may be configured to inhibit tissue ingrowth (e.g., within inner frame portion 414 through device 400). Additionally, first frame portion 410 and / or second frame portion 420 may conform to the first tissue surface and the second tissue surface, respectively, such that tissue erosion is reduced and first frame portion 410 and / or second frame portion react and move with forces that alter the tissue topography.

[0082] In certain examples, and as shown, the inner frame portion 414 through the device 400 includes a perimeter that is approximately circular in shape. The inner frame portion 414 can form a polygonal structure, perimeter, or boundary that is approximately circular. For example, the inner frame portion 414 can include 8, 10, 12, 14, 16, 18, 20, 22, 24, or more sides that form a polygonal perimeter or boundary that is approximately circular in the deployed configuration. An inner frame portion 414 having a perimeter or boundary that is approximately circular in shape can facilitate folding of the device into a delivery configuration while maintaining hoop strength and reducing collapse of the inner frame portion 414 in the deployed configuration. In the deployed configuration, one or more of the lobes 412a, 412b, 412c can be deployed on one side of the tissue structure, and others of the lobes 412a, 412b, 412c can be deployed on another side of the tissue structure (e.g., as shown in FIGS. 9B-C). The inner frame portion 414 can provide a lumen through which fluid can flow and can also hold tissue open.

[0083] 5 is a top view of a first side of another implantable medical device 500, according to one embodiment. As shown, a first frame portion 510 includes three lobes (e.g., a first lobe 512a, a second lobe 512b, and a third lobe 512c) and an inner frame portion 514. Each of the lobes 512a, 512b, and 512c can be attached to the inner frame portion 514 such that the lobes are evenly spaced around the inner frame portion 514. In some examples, the lobes can be attached to the inner frame portion 514 and / or to adjacent lobes at attachment points 516a, 516b, and 516c. For example, in some instances, first lobe 512a is attached to second lobe 512b at attachment point 516a, second lobe 512b is attached to third lobe 512c at attachment point 516b, and third lobe 512c is attached to first lobe 512a at attachment point 516c. Although Figure 5 is described with respect to three lobes and three attachment points, first frame portion 510 of device 500 can have any number of lobes and respective attachment points, as desired.

[0084] The inner frame portion 514 can be any shape as desired. For example, in some instances, the inner frame portion 514 is substantially circular (e.g., as shown in FIG. 4) or substantially triangular ( FIG. 5). In some instances, the inner frame portion 514 can define inner lobes 514a, 514b, and 514c, which can extend into first, second, and third lobes 512a, 512b, 512c to define the shape of the inner frame portion 514.

[0085] 5, the second frame portion 520 can have the same or a different number of lobes as the first frame portion 510. For example, in some examples, the first frame portion 510 and the second frame portion 520 each have three lobes. In other examples, the first frame portion 510 can include three lobes, while the second frame portion 520 includes two, four, five, or more lobes. In some examples, the first frame portion 510 can have lobes that are larger, smaller, and / or differently shaped than the lobes of the second frame portion 520.

[0086] In certain examples, device 500 can include reinforcements 518a, 518b, 518c. Reinforcements 518a, 518b, 518c are disposed inside inner lobes 514a, 514b, and 514c (and can be included in any of the lobes of the devices discussed herein). Reinforcements 518a, 518b, 518c form diamond-shaped cells in inner lobes 514a, 514b, and 514c, which fold and unfold during loading and deployment of device 500 within a catheter. Reinforcements 518a, 518b, 518c can provide increased radial strength during deployment and facilitate placement of device 500 in its intended deployed shape.

[0087] In certain examples, and as shown, the opening 550 through the device 500 includes a perimeter that is approximately circular in shape. The boundary or perimeter of the opening 550 is approximately circular in shape. When deployed, the first frame portion 510 and / or the second frame portion 520 can form a polygonal structure, perimeter, or boundary for the approximately circular opening 550. For example, the opening 550 can include 8, 10, 12, 14, 16, 18, 20, 22, 24, or more sides that form a polygonal structure, perimeter, or boundary that is approximately circular in the deployed configuration. An opening 550 having a perimeter or boundary that is approximately circular in shape can facilitate folding of the device into a delivery configuration while maintaining hoop strength and reducing collapse of the opening 550 in the deployed configuration. In the deployed configuration, the first frame portion 510 can be deployed on one side of a tissue structure and the second frame portion 520 can be deployed on another side of the tissue structure (e.g., as shown in FIGS. 9B-C). The first frame portion 510 and the second frame portion 520 are formed by continuous or adjacent frame diverging elements. The first frame portion 510 and the second frame portion 520 may be formed from cut tubing, wound wire, or other similar structures.

[0088] FIG. 6 is a top view of a first side of another implantable medical device 600, according to one embodiment. As shown, a first frame portion 610 includes two lobes (e.g., a first lobe 612a and a second lobe 612b). A first inner frame portion 614a of the first lobe 612a and a second inner frame portion 614b of the second lobe 614b define an opening 650. The opening 650 can be any shape as desired. However, the shape of the opening 650 generally depends on the shapes of the first lobe 612a and the second lobe 612b. For example, in some instances, the opening 650 can be substantially oval, rectangular, or elliptical, while in other instances, the opening 650 can be more circular in shape. The first frame portion 610 and the second frame portion 620 can be formed by diverging elements of continuous or adjacent frames. First frame portion 610 and second frame portion 620 may be formed from cut tubing, wound wire, or other similar structures.

[0089] The first lobe 612a and the second lobe 612b can be integral with one another. For example, the first lobe 612a and the second lobe 612b can be integral such that the lobes are formed from a single wire. In some examples, the first lobe 612a and the second lobe 612b can be formed separately from one another. For example, the first lobe 612a can be formed from a first wire and the second lobe 612b can be formed from a second wire, and the lobes can be attached at first attachment point 616a and second attachment point 616b, as shown in FIG. 6.

[0090] 6, the second frame portion 620 can have the same or a different number of lobes as the first frame portion 610. For example, in some examples, the first frame portion 610 and the second frame portion 620 each have three lobes. In other examples, the first frame portion 610 can include three lobes, while the second frame portion 620 includes two, four, five, or more lobes. In some examples, the first frame portion 610 can have lobes that are larger, smaller, and / or differently shaped than the lobes of the second frame portion 620.

[0091] In certain examples, a portion of the first frame portion 610 and / or the second frame portion 620 can include a covering material. The covering material can be configured to inhibit tissue ingrowth (e.g., within the openings 650 through the device 600). Additionally, a portion of the covering material disposed on the first frame portion 610 and / or the second frame portion 620 can be configured to promote tissue ingrowth, enhancing fixation of the device 600 within the tissue. Furthermore, the lobes of the first frame portion 610 and the second frame portion 620 can conform to the first tissue surface and the second tissue surface, respectively, such that tissue erosion is reduced and the lobes respond and move with forces that alter the tissue topography. In the deployed configuration, the first frame portion 610 can be deployed on one side of a tissue structure and the second frame portion 620 can be deployed on the other side of the tissue structure (e.g., as shown in FIGS. 9B-C ).

[0092] 7 is a perspective view of another implantable medical device 700, according to one embodiment. The device 700 is shown in a delivery configuration in which a first frame portion 710 and a second frame portion 720 are folded upon themselves to facilitate compression of the device 700 for delivery to a desired treatment location. As shown, each side of the device 700 includes two lobes. For example, the first frame portion 710 includes a first lobe 712a and a second lobe 712b, and the second frame portion 720 includes a first lobe 722a and a second lobe 722b. The first frame portion 710 and the second frame portion 720 are connected to each other at divergence points 742a and 742b to form a central portion 730 that defines an opening 750.

[0093] One or more frame portions of device 700 can include eyelets 790 to help facilitate delivery of the device. For example, each lobe of first frame portion 710 and / or second frame portion 720 can include one or more eyelets 790. During delivery of device 700, a delivery line can be threaded, for example, through eyelets 790 and tensioned to collapse and / or compress first frame portion 710 and second frame portion 720 into a delivery configuration. Eyelets 790 can interact with a tether, wire, or other similar structure to allow loading into a delivery catheter. Device 700 can be pulled into the catheter by eyelets 790 and collapsed, for example, into the shape shown. In certain examples, device 700 can include posts, balls, or encapsulating frame elements in place of eyelets 790.

[0094] Once device 700 is positioned at the desired treatment location, first frame portion 710 and second frame portion 720 can be unfolded (e.g., tension applied to device 700 can be released) to release the lobes toward the patient's septum (e.g., first lobe 712a and second lobe 712b of first frame portion 710 release against a first side of the septum, and first lobe 722a and second lobe 722b of second frame portion 720 release against a second side of the septum).

[0095] FIG. 8A is an image of a first side of an implantable medical device 800 deployed at a desired treatment location, according to one embodiment. FIG. 8B is an image of a second side of the implantable medical device 800 of FIG. 8A deployed at a desired treatment location, according to one embodiment. As shown in FIG. 8A, a first frame portion 810 includes a first lobe 812a and a second lobe 812b. A second frame portion 820 (FIG. 8B) also includes a first lobe 822a and a second lobe 822b. In some examples, the first lobe 812a of the first frame portion 810 and the first lobe 822a of the second frame portion 820 are adjacent to one another. For example, the first lobes 812a, 822a are formed from a single, integral wire that spans the septum and forms at least a portion of a central portion 830 of the device 800. Second lobe 812b of first frame portion 810 and second lobe 822b of second frame portion 820 are also adjacent to one another. For example, second lobes 812a, 822a are formed from a single, integral wire that spans the septum and forms at least a portion of central portion 830 of device 800. As shown, second frame portion 820 can have a different shape and size than first frame portion 810. For example, in certain instances, lobes 822a, 822b of second frame portion 820 can have a different shape and / or size than lobes 812a, 812b of first frame portion 810.

[0096] Each of the first lobes 812 a, 822 a and second lobes 812 b, 822 b is connected to one another at divergence points 842 a, 842 b to form a central portion 830 that defines an opening 850. As shown, the opening 850 is generally oval or elliptical in shape. However, the opening 850 can be any shape, as desired, depending on the shape and / or orientation of the first frame portion 810 and the second frame portion 820 and the number of divergence points 842 in the central portion 830.

[0097] 9A is an image of an implantable medical device 900 according to one embodiment. As shown, the device 900 is formed in a flat, two-dimensional configuration. A first frame portion 910 includes two lobes (e.g., a first lobe 912a and a second lobe 912b). A second frame portion 920 is in the same plane as the first frame portion 910. As shown, the second frame portion 920 also includes two lobes (e.g., a first lobe 922a and a second lobe 922b). In some examples, the first lobe 912a of the first frame portion 910 and the first lobe 922a of the second frame portion 920 are adjacent to one another. For example, the first lobes 912a, 922a are formed from a single, integral wire. The second lobe 912b of the first frame portion 910 and the second lobe 922b of the second frame portion 920 are also adjacent to one another. For example, the second lobes 912a, 922a are formed from a single, integral wire. As shown, the second frame portion 920 can have a different shape and / or size than the first frame portion 910. For example, the lobes 912a, 912b of the first frame portion can be larger and more elongated than the smaller lobes 922a, 922b of the second frame portion 920. The larger lobes 912a, 912b on one side (e.g., the left side) of the device 900 can prevent migration or dislodgement due to the greater pressure on the left side of the heart. The larger lobes 912a, 912b on the left side can absorb the greater pressure on the left side of the heart. The first frame portion 910 and the second frame portion 920 can be formed by continuous or adjacent frame diverging elements. The first frame portion 910 and the second frame portion 920 can be formed from cut tubing, wound wire, or other similar structures.

[0098] 9B is an image of a first side of the implantable medical device 900 of FIG. 9A including a covering material 970, according to one embodiment. In some examples, the first frame portion 910 includes a covering material 970 disposed on each lobe (e.g., first lobe 912a and second lobe 912b). The covering material 970 can be, for example, a membrane configured to promote tissue ingrowth and cover at least a portion of the first frame portion 910. The second frame portion 920 may or may not include the covering material 970.

[0099] Figure 9C is an image of a second side of the implantable medical device 900 of Figure 9A in an expanded configuration, according to one embodiment. As shown in Figure 9A, the first frame portion 910 includes a first lobe 912a and a second lobe 912b. The second frame portion 920 (Figure 9B) also includes a first lobe 922a and a second lobe 922b. The first lobes 912a, 922a and the second lobes 912b, 922b, respectively, are connected to each other at divergence points 942a, 942b, 942c, 942d to form a central portion 930 that defines an opening 950. As shown, the opening 950 is generally oval or elliptical in shape. However, the opening 950 can be any shape as desired, depending on the shape and / or orientation of the first frame portion 910 and the second frame portion 920, and the number of divergence points 942 in the central portion 930.

[0100] In certain examples, a portion of the covering material 970 can be configured to inhibit tissue ingrowth (e.g., within the openings 950 through the device 200). Additionally, a portion of the covering material 970 disposed on the first frame portion 910 and / or the second frame portion 920 can be configured to promote tissue ingrowth to enhance fixation of the device 900 within the tissue. Additionally, each lobe of the first frame portion 910 and / or the second frame portion 920 can conform to the first tissue surface and the second tissue surface, respectively, such that tissue erosion is reduced and the lobes of the first frame portion 910 and / or the second frame portion 920 move responsively with forces that alter the tissue topography.

[0101] In certain examples, and as shown, opening 950 through device 900 includes a perimeter that is approximately circular in shape. The boundary or perimeter of opening 950 is approximately circular in shape. When deployed, first frame portion 910 and / or second frame portion 920 can form a polygonal structure, perimeter, or boundary for opening 950 that is approximately circular. For example, opening 950 can include 8, 10, 12, 14, 16, 18, 20, 22, 24, or more sides that form a polygonal structure, perimeter, or boundary that is approximately circular in the deployed configuration. Opening 950 generally having a perimeter or boundary that is approximately circular in shape can facilitate folding of the device into a delivery configuration while maintaining hoop strength and reducing collapse of opening 950 in the deployed configuration.

[0102] 10A is an image of an implantable medical device 1000, according to one embodiment. As shown, in some examples, both the first frame portion 1010 and the second frame portion 1020 can include a covering material 1070. In particular examples, the covering material 1070 can be disposed over at least a portion of the first frame portion 1010 and / or the second frame portion 1020 and can span the central portion 1030. When covered with the covering material 1070, the first frame portion 1010 and the second frame portion 1020 can form first and second petals, respectively. As shown in FIG. 10A , the first frame portion 1010 and the second frame portion 1020 can be configured to flatten or longitudinally shorten when covered with the covering material 1070 to form petals. For example, the central portion 1030 of the device (FIG. 10B) can be configured to longitudinally shorten and compress so that the first frame portion 1010 and the second frame portion 1020 are substantially flush with one another (e.g., with minimal separation between the first frame portion 1010 and the second frame portion 1020).

[0103] 10B, first frame portion 1010 and second frame portion 1020, when covered with covering material 1070, can expand outward from central portion 1030 to form a cup-like structure. In certain instances, and as shown in FIG. 10B, central portion 1030 can be configured to expand and stretch longitudinally to enable device 1000 to span a patient's septum.

[0104] 11 is an image of another implantable medical device 1100, according to one embodiment. As shown, a first frame portion 1110 includes a first plurality of lobes 1112 arranged in an overlapping configuration. For example, each lobe of the first plurality of lobes 1112 at least partially overlaps an adjacent lobe. A second frame portion 1120 also includes a second plurality of lobes 1122 arranged in an overlapping configuration (e.g., each lobe of the second plurality of lobes 1122 at least partially overlaps an adjacent lobe).

[0105] 12 is an image of another implantable medical device 1200, according to one embodiment. As shown, the device 1200 includes a first frame portion 1210 including a first plurality of lobes 1212. The first frame portion 1210 is connected to a second frame portion 1220 by a diverging element 1240 to form a central portion 1230. The second frame portion 1220 includes a conduit portion 1280 extending from the second frame portion 1220 in a direction opposite the first frame portion 1210. In some examples, the conduit portion 1280 can be positioned in a side branch of a blood vessel within a patient's body. In some examples, the conduit portion 1280 can form a lumen configured to facilitate fluid flow therethrough. In some examples, the conduit portion 1280 can also include a valve configured to control fluid flow through the lumen.

[0106] 13 is an image of a system for delivering an implantable medical device 1300 to a patient's body, according to one embodiment. As shown, the system can include a delivery device 1350 and a deployment mechanism 1360. In some examples, the deployment mechanism includes a deployment line configured to collapse the device 1300 into a delivery configuration.

[0107] In certain examples, device 1300 can be loaded into delivery device 1350 such that delivery device 1350 extends through opening 1350 in device 1300. A deployment line can then be threaded through a lobe portion of at least one of first frame portion 1310 and second frame portion 1320. In some examples, the deployment line can be threaded through an eyelet formed in the lobe. Advancement of delivery device 1350 causes first frame portion 1310 and second frame portion 1320 to collapse into a low-profile delivery configuration.

[0108] While in the delivery configuration, device 1300 can be delivered to a desired treatment location. A first frame portion 1310 is then positioned on a first side of the septum and a second frame portion is positioned on a second side of the septum. Release 1320 of the second frame portion is controlled by advancement and retraction of the delivery catheter.

[0109] In some instances, when deployed, the central portion 1330 of the device 1300 can be radially expanded or compressed as desired to adjust the rate of fluid flow through the openings.

[0110] Figure 14A is an image of an implantable medical device 1400 and a deployment apparatus 1450, according to one embodiment. Figure 14B is an image of the implantable medical device 1400 deployed on a first side from the deployment apparatus 1450 shown in Figure 14A, according to one embodiment. As shown, the device 1400 is compressed into a delivery configuration, loaded into the deployment apparatus 1450, and delivered to a desired treatment location within a patient's body.

[0111] In certain instances, the device 1400 is loaded into the deployment apparatus 1450 such that the device 1400 is completely enclosed within the deployment apparatus 1450, as shown in FIG. 14A.

[0112] While in the delivery configuration, the device 1400 can be delivered to a desired treatment location. The first frame portion 1410 is then positioned on a first side of the septum, and the second frame portion is positioned on a second side of the septum. In some examples, when deployed, the central portion 1430 of the device 1400 can be radially expanded or compressed, as desired, to adjust the rate of fluid flow through the opening. As described in detail above, the central portion 1430 can include a perimeter that is approximately circular in shape. The central portion 1430 can form a polygonal structure, perimeter, or boundary that is approximately circular. For example, the central portion 1430 can include 8, 10, 12, 14, 16, 18, 20, 22, 24, or more sides that form the perimeter or boundary of the polygonal structure that is approximately circular in the deployed configuration. A central portion 1430 having a perimeter or boundary that is approximately circular in shape can facilitate folding of the device into a delivery configuration while maintaining hoop strength and reducing collapse of the central frame portion 1430 in the deployed configuration.

[0113] 15A is an image of an implantable medical device 1500 (shown in FIG. 5), according to one embodiment. As shown, a first frame portion 1510 includes three lobes (e.g., a first lobe 1512a, a second lobe 1512b, and a third lobe 1512c) and an inner frame portion 1514. Each of the lobes 1512a, 1512b, and 1512c can be attached to the inner frame portion 1514 such that the lobes are evenly spaced around the inner frame portion 1514. In some examples, the inner frame portion 1514 functions as a second frame portion 1520, as shown and described with reference to FIG. 15D.

[0114] 15B is an image of the implantable medical device 1500 of FIG. 15A including a covering material 1570, according to one embodiment. As shown, the covering material 1570 can be disposed on the first frame portion 1510. In some examples, the covering material 1570 can be attached to one or more of the first lobe 1512a, the second lobe 1512b, and the third lobe 1512c, as shown.

[0115] 15C is an image of a first side of implantable medical device 1500 shown in FIG. 15A including a covering material 1570, according to one embodiment. As shown, in some instances, covering material 1570 can be disposed over opening 1530. Thus, covering material 1530 can act to slow or occlude flow through device 1500, as desired.

[0116] 15D is an image of a second side of the implantable medical device 1500 shown in FIG. 15C, according to one embodiment. As shown, a covering material 1570 is disposed over the opening 1530. In various examples, the first lobe 1522a, the second lobe 1522b, and the third lobe 1522c of the second frame portion 1520 may or may not include the covering material 1570. For example, as shown in FIG. 15D, the covering material 1570 is disposed over the opening 1530 but not over the second frame portion 1520, while in other examples, the covering material 1570 may be disposed over both the opening 1530 and the second frame portion 1520.

[0117] 16A is an image of an implantable medical device 1600, according to one embodiment. As shown, device 1600 includes a first frame portion 1610 and a second frame portion 1620. Second frame portion 1620 includes first and second spokes 1622a and 1622b. In various examples, a covering material 1670 can be disposed over all or a portion of first frame portion 1610 of device 1600, as shown.

[0118] FIG. 16B is an image of a second configuration of the implantable medical device 1600 shown in FIG. 16A, according to one embodiment. As shown, the device 1600 is sufficiently flexible so that it is compressible into a delivery configuration. Once positioned at a desired treatment location within a patient's body, the first frame portion 1610 of the device 1600 can be bent toward itself to force the spokes 1622a and 1622b radially outward, as shown in FIG. 16C. The first frame portion 1610 can be positioned on a first side of the septum, while the second frame portion 1620 can be positioned on a second side of the septum. When the first frame portion 1610 is released and returns to its original configuration, the spokes 1622a, 1622b can hold the device 1600 in place within the patient's body.

[0119] 17A is an image of an implantable medical device 1700, according to one embodiment. As shown, a first frame portion 1710 of the device 1700 may have no lobes, while a second frame portion 1720 has two or more lobes. For example, the second frame portion 1720 can have a first lobe 1722a and a second lobe 1722b. In some examples, the first frame portion 1710 and / or the second frame portion 1720 can include a covering material 1770. For example, the first frame portion 1710 can include a covering material 1770, as shown in FIG. 17B. However, in other examples, one or more lobes 1722a, 1722b of the second frame portion 1720 can include a covering material 1770, as desired.

[0120] 18 is a diagram of an implantable medical device 1800, according to one embodiment. The implantable medical device 1800, including a first frame portion 1810 and a second frame portion 1820, is formed by continuous or adjacent frame diverging elements. The first frame portion 1810 and the second frame portion 1820 may be formed from cut tubing, wound wire, or other similar structures. As discussed in detail above, the first frame portion 1810 and the second frame portion 1820 may include multiple lobes, which may be interconnected to one another.

[0121] In a particular example, first frame portion 1810 and second frame portion 1820 are formed by a plurality of diverging elements that diverge from first frame portion 1810 and second frame portion 1820 to form a central frame 1850 that is configured in an approximately circular shape 1880 in the expanded configuration. As shown in FIG. 18 , the diverging frame elements form a polygonal structure that is central frame 1850. The number of sides of the polygonal structure that is central frame 1850 results in the approximately circular shape 1880 in the expanded configuration.

[0122] In certain instances, the central frame 1850 is an opening through the device 1900 for fluid flow. The central frame 1850 forms a boundary or perimeter that is approximately circular in shape. The first frame portion 1810 and / or the second frame portion 1820 can form the central frame 1850 with a polygonal structure, perimeter, or boundary that results in the approximately circular shape 1880 when deployed. For example, the central frame 1850 can include 8, 10, 12, 14, 16, 18, 20, 22, 24, or more sides that form the polygonal structure, perimeter, or boundary that results in the approximately circular shape 1880 in the deployed configuration. A central frame 1850 with a perimeter or boundary that is approximately circular in shape can facilitate folding of the device into a delivery configuration while maintaining hoop strength and reducing collapse of the central frame 1850 in the deployed configuration. In the deployed configuration, the first frame portion 1810 can be deployed on one side of the tissue structure and the second frame portion 1820 can be deployed on another side of the tissue structure (e.g., as shown in Figures 9B-C).

[0123] 19 is a diagram of an implantable medical device 1900, according to one embodiment. As shown, a first frame portion 1910 includes three lobes (e.g., first lobe 1912a, second lobe 1912b, and third lobe 1912c) and a second frame portion 1920. Each of the lobes 1912a, 1912b, and 1912c can be attached to the second frame portion 1920 such that the lobes are evenly spaced around the second frame portion 1920, which can also include a set of lobes 1914a, 1914b, and 1914c.

[0124] Although not shown in FIG. 19 , the first frame portion 1910 and the second frame portion 1920 can have the same or different numbers of lobes. For example, in some examples, the first frame portion 1910 and the second frame portion 1920 each have three lobes. In other examples, the first frame portion 1910 can include two or three lobes, while the second frame portion 1920 can include two, four, five, or more lobes. In some examples, the first frame portion 1910 can have lobes that are larger, smaller, and / or differently shaped than the lobes of the second frame portion 1920. The first frame portion 1910 and the second frame portion 1920 can be formed by diverging elements of consecutive or adjacent frames. The first frame portion 1910 and the second frame portion 1920 can be formed from cut tubing, wound wire, or other similar structures.

[0125] In certain examples, and as shown, the opening 1950 through the device 1900 includes a perimeter that is approximately circular in shape. The boundary or perimeter of the opening 1950 is approximately circular in shape. The first frame portion 1910 and / or the second frame portion 1920 may form a polygonal structure, perimeter, or boundary of the approximately circular opening 1950 when deployed. For example, the opening 1950 may include 8, 10, 12, 14, 16, 18, 20, 22, 24, or more sides that form a polygonal structure, perimeter, or boundary that is approximately circular in the deployed configuration. An opening 1950 that generally has a perimeter or boundary that is approximately circular in shape can facilitate folding of the device into a delivery configuration while maintaining hoop strength and reducing collapse of the opening 1950 in the deployed configuration. In the deployed configuration, the first frame portion 1910 can be deployed on one side of the tissue structure and the second frame portion 1920 can be deployed on another side of the tissue structure (e.g., as shown in Figures 9B-C).

[0126] In certain examples, a portion of first frame portion 1910 and / or second frame portion 1920 can include covering material 1970. Covering material 1970 can be configured to inhibit tissue ingrowth (e.g., into openings 1950 through device 600). Additionally, a portion of covering material 1970 can be disposed on first frame portion 1910 and / or second frame portion 1920 between the lobes, as shown. Additionally, covering material 1970 between the lobes can be configured to promote tissue ingrowth to enhance fixation of device 600 within tissue. In the deployed configuration, first frame portion 1910 can be deployed on one side of a tissue structure and second frame portion 1920 can be deployed on another side of the tissue structure (e.g., as shown in FIGS. 9B-C ).

[0127] The devices discussed herein can include sensors integrated into each frame component for continuously monitoring various hemodynamic parameters, such as pressure, among other parameters within the patient's body. For example, an antenna or inductor can be wrapped around one of the first frame component 110 and the second frame component 120, and a sensor can be attached to the inductor. The sensors can be configured to sense physiological characteristics, such as 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 conditions.

[0128] In certain instances, the devices discussed herein may be capable of delivering drugs to a desired treatment location within a patient's body. For example, the devices may be capable of eluting drugs configured to modulate tissue response. In certain instances, the devices may be coated with a therapeutic coating, drug-eluting material, or other therapeutic material. In one particular example, the devices may be coated with heparin to promote the thrombosis resistance and patency of the device. Alternatively or additionally, the devices may include paclitaxel (to modulate tissue / cellular response).

[0129] In a particular example, the heparin coating is a heparin coating. The heparin coating is utilized to bind heparin molecules to a membrane or coating material. For further reference regarding heparin-coated membranes or coating materials, see U.S. Pat. No. 6,461,665 ("Scholander"), which is incorporated herein by reference for its specific teachings of the antithrombogenic activity of surface-immobilized heparin. In a particular example, the heparin coating can be CARMEDA® BioActive Surface (CBAS® Heparin Surface).

[0130] In certain instances, the heparin coating may be applied to the membrane or covering material in one or more layers. The chemical composition of the coating material in each layer may be the same or different. In some instances, the coating material is cross-linked to itself or to other coating materials in other layers. The cross-linking may be covalent or ionic. The heparin coating may form at least one layer on at least a portion of the membrane or covering material and may be cross-linked to itself or to other layers of the coating. The cross-linking may be covalent, ionic, or both. For references regarding the application of layers of heparin to membranes or covering materials, see U.S. Pat. No. 9,399,085 (Cleek et al.), which is incorporated herein by reference.

[0131] Suitable membrane or covering materials include, but are not limited to, polymers such as olefins, PEEK, polyamides, polyurethanes, polyesters, e.g., polyethylene terephthalate (PET), polyethylene, polypropylene, polyurethane, silicones, fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), and fluoroelastomers, e.g., tetrafluoroethylene / polymethylvinylether (TFE / PMVE) copolymers. In certain examples, the membrane or covering material can be or include an elastomeric material (e.g., TFE / PMVE).

[0132] In some embodiments, the bioresorbable or bioabsorbable material can be, for example, a bioresorbable or bioabsorbable polymer. In some embodiments, the membrane can include a fluoropolymer, such as those described in one or more of U.S. Patent Nos. 7,049,380, 7,462,675, and 8,048,440, the contents of which are each incorporated herein by reference. In some embodiments, the membrane can include Dacron, polyolefin, carboxymethyl cellulose fabric, polyurethane, or other woven or film elastomers. In some embodiments, the membrane or covering material can include knit or fiber. The membrane or covering material can be a woven or nonwoven fabric, in various embodiments, including, for example, wire. In some embodiments, the membrane or covering material can be formed from a combination and / or copolymer of fluoropolymers or a blend thereof.

[0133] Examples of synthetic polymers that may be used as membrane components include, but are not limited to, nylon, polyacrylamide, polycarbonate, polyformaldehyde, polymethyl methacrylate, polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicone polymers, polyethylene, polypropylene, polyurethane, polyglycolic acid, polyester, polyamide, mixtures, blends and copolymers thereof, which are suitable as membrane materials.

[0134] In some embodiments, the membrane is configured to inhibit, filter, regulate, or substantially regulate the passage of fluids and / or materials (such as blood and / or clots) therethrough. In some embodiments, the membrane is configured to induce rapid tissue ingrowth therethrough. In one embodiment, the membrane provides a blood or fluid impermeable membrane that occludes blood or fluid flow through the membrane but promotes ingrowth and endothelialization. The membrane can have a microporous structure that provides a tissue ingrowth scaffold for durable occlusion and supplemental fixation strength of the frame. In some embodiments, the membrane can be a porous member. The pores of the membrane can be sized to help substantially, or in some instances completely, prevent the passage of blood, other fluids, and emboli. In some embodiments, the membrane prevents or substantially prevents blood, other fluids, clots, emboli, or other bodily materials from passing through the membrane.

[0135] Nitinol (NiTi) can be used as the frame material discussed herein. In other examples, the frame can be formed from other materials, such as stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or other suitable biocompatible materials and combinations thereof, which can be used as the frame material. NiTi's superelastic properties and flexibility can enhance the conformability of the frame. Furthermore, NiTi can be shape-set into a desired shape. That is, NiTi can be shape-set so that when the frame is unconstrained, such as when it is deployed from a delivery system, the frame tends to self-expand into a desired shape. More specifically, the frame (made of NiTi) can have spring properties that allow the frame to elastically collapse or "collapse" into a low-profile delivery configuration for loading into a delivery system, and then reconfigure to an expanded configuration upon exiting the delivery system. The frames discussed herein can be generally compliant, fatigue-resistant, and resilient so that the frame can conform to the topography of the surrounding tissue when the occlusion device is deployed within a patient. In certain embodiments, bioresorbable or bioabsorbable materials can be used in the frame or portions thereof, including, for example, bioresorbable or bioabsorbable polymers.

[0136] As discussed herein, the membrane component can be attached to the self-expandable frame component by using a connecting member that is a generally flat ribbon or tape having at least one generally flat surface. In a specific example, the tape member is made from expanded PTFE (ePTFE) coated with an adhesive. The adhesive can be a thermoplastic adhesive. In a specific example, the thermoplastic adhesive can be fluorinated ethylene propylene (FEP). More specifically, the FEP-coated side of the ePTFE faces and contacts the outer surfaces of the self-expandable frame component and the membrane component, thus attaching the self-expandable frame component to the membrane component. Materials and methods for attaching the frame component to the membrane are described in U.S. Pat. No. 6,042,605 to Martin, which is incorporated herein by reference for all purposes.

[0137] Additionally, Nitinol (NiTi) can be used as the frame or stent (and any of the frames discussed herein) material, and other materials, such as, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or other suitable biocompatible materials and combinations thereof, can be used as the frame material. The superelastic properties and flexibility of NiTi can enhance the conformability of the stent. Furthermore, NiTi can be shape-set into a desired shape, i.e., the frame tends to self-expand into a desired shape when unconstrained, such as when the frame is deployed from a delivery system.

[0138] A variety of materials, including various metallic superelastic alloys such as Nitinol, are suitable for use in these frame components. The primary requirement for the material is that it be adequately elastic, even when processed into very thin sheets or small diameter wires. Various stainless steels that have been physically, chemically, or otherwise processed to produce high elasticity are suitable, as are other metal alloys such as cobalt-chromium alloys (e.g., ELGILOY®), platinum / tungsten alloys, and especially nickel-titanium alloys (e.g., Nitinol).

[0139] The invention of this application has been described above with reference to both general and specific embodiments. It will be apparent to those skilled in the art that various changes and modifications can be made in the embodiments without departing from the scope of the present disclosure. Therefore, it is intended that the embodiments cover the modifications and variations of the present invention provided they come within the scope of the appended claims and their equivalents. (Aspect) (Aspect 1) a first frame portion having at least three lobes; a second frame portion disposed within the first frame portion; and a plurality of diverging elements disposed between the first frame portion and the second frame portion, the plurality of diverging elements diverging from the first frame portion and the second frame portion to form a central frame having at least six divergence points in a deployed configuration; 1. An implantable medical device, including (Aspect 2) 2. The device of embodiment 1, wherein the first frame portion and the second frame portion are adjacent to one another. (Aspect 3) The device of any one of embodiments 1-2, wherein the opening is hexagonal in shape when the device is in the deployed configuration. (Aspect 4)

[0023] Embodiment 4. The device of any one of embodiments 1-3, wherein the first frame portion is disposed on a first side of a septum, the second frame portion is disposed on a second side of the septum, and the plurality of diverging elements form a fluid flow path therethrough. (Aspect 5) 5. The device of embodiment 4, wherein the first and second frame portions are sufficiently flexible to conform to the anatomy of the septum. (Aspect 6) The device of any one of embodiments 1 to 5, wherein the second frame portion comprises at least three lobes. (Aspect 7) 7. The device of any one of embodiments 1 to 6, wherein the first frame portion has a first geometric shape and the second frame portion has a second geometric shape that is different from the first geometric shape. (Aspect 8) The device of any one of embodiments 1 to 7, wherein the first frame portion comprises six lobes. (Aspect 9) The device of any one of embodiments 1-8, wherein each lobe of the second frame portion includes an eyelet configured to aid in delivery of the device. (Aspect 10) The device of any one of embodiments 1-9, further comprising a coating material disposed over at least a portion of the device. (Aspect 11) 11. The device of embodiment 10, wherein the first frame portion comprises a coating material and the second frame portion does not comprise a coating material. (Aspect 12) 12. The device of embodiment 11, wherein the coating material comprises expanded polytetrafluoroethylene (ePTFE). (Aspect 13) 13. The device of any one of embodiments 1-12, wherein the first frame portion and the second frame portion are unitary such that the device is formed from a single wire. (Aspect 14) 14. The device of any one of aspects 1-13, further comprising a sensor disposed with the conduit portion or frame component and configured to sense at least one of a physiological characteristic, hemodynamics, a biomarker, sound, pressure, and electrolytes. (Aspect 15) 15. The device of any one of embodiments 1-14, further comprising at least one of a coating of heparin to promote thrombosis resistance and patency of the device and a coating of paclitaxel to modulate tissue / cellular response. (Aspect 16) 1. An implantable medical device for regulating blood pressure between the left and right atria of the heart, the device having a delivery configuration and a deployed configuration, the device comprising: a first frame portion; a second frame portion disposed within the first frame portion; and a plurality of diverging elements connecting the first frame portion to the second frame portion; Including, A device wherein the plurality of diverging elements intersect one another to form a central portion having an opening, the opening being substantially hexagonal in shape when the device is in a deployed configuration. (Aspect 17) 17. The device of embodiment 16, wherein each of the plurality of diverging elements overlaps one another to form a diverging point, and the diverging point expands outward to form a hexagonal shape when the device is in the deployed configuration. (Aspect 18) 17. The device of embodiment 16, wherein the first frame portion and the second frame portion are coplanar with each other when the device is in the deployed configuration and non-coplanar with each other when the device is in the delivery configuration. (Aspect 19) A method of making the implantable medical device of any one of embodiments 1-18, comprising cutting a two-dimensional pattern from a nitinol sheet or wound wire. (Aspect 20) 1. A method for regulating blood pressure between the left and right atria of a heart, comprising: delivering an implantable medical device to a desired treatment location within a patient's body while said device is in a delivery configuration; positioning a first frame portion of the device on a first side of a septum; positioning a second frame portion of the device on a second side of the septum; and releasing the device from a delivery configuration to a deployed configuration such that a central portion of the device forms a substantially hexagonal shaped opening; A method comprising: (Aspect 21) 21. The method of embodiment 20, further comprising expanding or contracting the central portion to adjust the rate of fluid flow therethrough. (Aspect 22) a first frame portion having at least two lobes; a second frame portion having at least two lobes; and a plurality of diverging elements disposed between the first frame portion and the second frame portion; Including, The implantable medical device, wherein the plurality of diverging elements diverge from the first frame portion and the second frame portion to form a central frame configured to assume a generally circular shape in an expanded configuration. (Aspect 23) 23. The medical device of embodiment 22, wherein the central frame comprises a polygonal structure configured to assume a generally circular shape in the deployed configuration. (Aspect 24) 23. The medical device of embodiment 22, wherein the two lobes of the first frame portion are configured to conform to a first tissue surface and the two lobes of the second frame portion are configured to conform to a second tissue surface. (Aspect 25) 23. The medical device of embodiment 22, wherein the first frame portion and the second frame portion are sufficiently flexible to conform to the anatomy of the septum.

Claims

1. a first frame portion having an annular shape and at least three lobes; a second annular frame portion disposed within the first frame portion; and a plurality of divergence points disposed between the first frame portion and the second frame portion; 1. An implantable medical device comprising: An implantable medical device, wherein the first frame portion and the second frame portion are coplanar with each other when the device is in a deployed configuration and non-coplanar with each other when the device is in a delivery configuration.

2. The device of claim 1 , wherein the first frame portion and the second frame portion are adjacent to one another.

3. The device of any one of claims 1 to 2, wherein the first frame portion is positioned on a first side of a cardiac septum and the second frame portion is positioned on a second side of the septum.

4. The device of claim 3 , wherein the first and second frame portions are flexible to conform to the anatomy of the septum.

5. The device of any one of claims 1 to 4, wherein the second frame portion includes at least three lobes.

6. The device of any one of claims 1 to 5, wherein the first frame portion has a first geometric shape and the second frame portion has a second geometric shape that is different from the first geometric shape.

7. The device of any one of claims 1 to 6, wherein the first frame portion includes six lobes.

8. The device of any one of claims 1 to 7, wherein each lobe of the second frame portion includes an eyelet configured to aid in delivery of the device.

9. The device of any one of claims 1 to 8, further comprising a coating material disposed over at least a portion of the device.

10. The device of claim 9 , wherein the first frame portion includes a coating material and the second frame portion does not include a coating material.

11. The device of claim 10 , wherein the coating material comprises expanded polytetrafluoroethylene (ePTFE).

12. The device of any preceding claim, wherein the first frame portion and the second frame portion are integral such that the device is formed from a single wire.

13. 13. The device of any one of claims 1 to 12, further comprising a sensor disposed with the conduit portion or frame component and configured to sense at least one of a physiological characteristic, hemodynamics, a biomarker, sound, pressure, and electrolytes.

14. The device of any one of claims 1 to 13, further comprising at least one of a coating of heparin to promote thrombosis resistance and patency of the device and a coating of paclitaxel to modulate tissue / cellular response.

15. 1. An implantable medical device for regulating blood pressure between the left and right atria of the heart, the device having a delivery configuration and a deployed configuration, the device comprising: a first annular frame portion; a second annular frame portion disposed within the first frame portion; and a plurality of divergence points connecting the first frame portion to the second frame portion; Including, A device wherein the first frame portion and the second frame portion are coplanar with one another when the device is in a deployed configuration and non-coplanar with one another when the device is in a delivery configuration.

16. 16. A method of making the implantable medical device of any one of claims 1 to 15, comprising cutting a two-dimensional pattern from a nitinol sheet or wound wire.

17. a first frame portion having an annular shape and at least two lobes; a second annular frame portion disposed within the first frame portion and having at least two lobes; and a plurality of divergence points disposed between the first frame portion and the second frame portion; 1. An implantable medical device comprising: An implantable medical device, wherein the first frame portion and the second frame portion are coplanar with each other when the device is in a deployed configuration and non-coplanar with each other when the device is in a delivery configuration.

18. 18. The medical device of claim 17, wherein the two lobes of the first frame portion are configured to conform to a first tissue surface and the two lobes of the second frame portion are configured to conform to a second tissue surface.

19. 18. The medical device of claim 17, wherein the first frame portion and the second frame portion are flexible to conform to the anatomy of the cardiac septum.

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