Medical devices for shunts, occluders and fenestrations, and related systems and methods

Abstract

To provide favorable implantable medical devices.SOLUTION: An implantable medical device comprises a first frame component. The first frame component includes a first set of elongate elements configured to conform to an anatomy of a patient. The implantable medical device also comprises a second frame component including a second set of elongate elements configured to conform to an anatomy of a patient. The first frame component and the second frame component are discrete and separate from one another. The implantable medical device also comprises a conduit portion arranged between the first frame component and the second frame component. The conduit portion includes a membrane connecting the first frame component and the second frame component.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Application No. 62 / 699,815, filed July 18, 2018, which is incorporated herein by reference in its 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 shunting 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 dysfunction 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 cardiac defects. The ever-evolving nature of heart failure poses significant challenges 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 component configured to conform to a patient's anatomy, a second frame component configured to conform to a patient's anatomy, wherein the first frame component and the second frame component are distinct and separate from one another, and a conduit portion disposed between the first frame component and the second frame component, the conduit portion including a membrane connecting the first frame component and the second frame component.

[0005] In another example ("Example 2"), in addition to the device of Example 1, at least a portion of the conduit segment is not radially supported by the first frame component and the second frame component within the conduit segment.

[0006] In another example ("Example 3"), in addition to the device of Example 2, the first frame component and the second frame component are configured to facilitate deployment of the conduit portion and maintain a lumen through the conduit portion.

[0007] In another example ("Example 4"), in addition to the device of any one of Examples 1-3, the conduit portion does not include a frame component.

[0008] In another example ("Example 5"), in addition to the device of any one of Examples 1 to 4, the first frame component includes a first set of elongate elements, the second frame component includes a second set of elongate elements, and the first set of elongate elements and the second set of elongate elements are not adjacent to each other.

[0009] In another example ("Example 6"), in addition to the device of Example 5, the first set of elongate elements includes a first plurality of support struts, the second set of elongate elements includes a second plurality of support struts, and the first plurality of support struts and the second plurality of support struts form a support structure within each of the elongate elements.

[0010] In another example ("Example 7"), further to the device of Example 6, the first set of elongate elements form a plurality of first lobes.

[0011] In another example ("Example 8"), in addition to the device of Example 6, the first set of elongated elements form a star shape.

[0012] In another example ("Example 9"), in addition to the device of any one of Examples 5 to 8, the first frame component forms a first side, the second frame component forms a second side, and at least one of the first set of elongated elements are disposed within the first frame component without crossing the second side, and the second set of elongated elements are disposed within the second frame component without crossing the first side.

[0013] In another example ("Example 10"), in addition to the device of Example 9, at least one of the first set of elongate elements and the second set of elongate elements extends within the conduit portion.

[0014] In another example ("Example 11"), in addition to the device of any one of Examples 1 to 10, the membrane extends to at least partially cover a portion of one or both of the first frame component and the second frame component.

[0015] In another example ("Example 12"), in addition to the device of Example 11, the membrane is configured to promote tissue ingrowth and cover at least a portion of one or both of the first frame component and the second frame component.

[0016] In another example ("Example 13"), in addition to the device of any one of Examples 1 to 12, the device also includes a first membrane film disposed on the first frame component and a second membrane film disposed on the second frame component.

[0017] In another example ("Example 14"), in addition to the device of any one of Examples 1-3, the membrane separates the first frame component and the second frame component by a gap of 0-15 mm.

[0018] In one example ("Example 15"), an implantable medical device for regulating blood pressure between the left and right atria of the heart includes a conduit portion configured to span the septum of the heart and allow fluid flow therethrough, and a first set of elongate elements disposed on a first side of the conduit portion and a second set of elongate elements disposed on a second side of the conduit portion, wherein the first set of elongate elements and the second set of elongate elements include frame components that are not adjacent to one another.

[0019] In another example ("Example 16"), in addition to the device of Example 15, the frame component forms a first side including a first set of elongate elements and a second side including a second set of elongate elements, the first set of elongate elements being disposed within the first side and the conduit portion, and the second set of elongate elements being disposed within the first side and the conduit portion.

[0020] In another example ("Example 17"), in addition to the device of any one of Examples 15-16, the first set of elongate members and the second set of elongate members extend radially outward from the conduit portion and form a first angle and a second angle, the first angle and the second angle being approximately 90° relative to the conduit portion.

[0021] In another example ("Example 18"), in addition to the device of any one of Examples 15-17, the device also includes a sensor disposed with the conduit portion or the frame component and configured to sense at least one of a physiological characteristic, hemodynamics, a biomarker, sound, pressure, and electrolytes.

[0022] In another example ("Example 19"), in addition to the device of any one of Examples 15-18, 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.

[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, the implantable medical device including a conduit portion configured to span the septum of the heart and allow fluid flow therethrough, and a first set of elongate elements disposed on a first side of the conduit portion and a second set of elongate elements disposed on a second side of the conduit portion, the first set of elongate elements and the second set of elongate elements including frame components that are not adjacent to one another; positioning the device so that the conduit portion spans the septum between the left and right atria of the heart; and deploying the first and second frame components so that the conduit portion opens a desired amount to provide a fluid flow path between the left and right atria.

[0024] In another example ("Example 21"), in addition to the method of Example 20, the method also includes adjusting tension on the device to adjust the diameter of the conduit portion and the fluid flow rate therethrough.

[0025] According to one example ("Example 22"), an implantable medical device includes a first frame component and a second frame component, wherein the first frame component and the second frame component are distinct and separate from one another, and a conduit portion disposed between the first frame component and the second frame component, the conduit portion including a membrane connecting the first frame component and the second frame component configured to expand in response to tension in the conduit portion imparted by expansion of the first frame component and the second frame component.

[0026] In another example ("Example 23"), in addition to the device of Example 22, the conduit portion is configured to span the septum between the left and right atria of the patient, and the conduit portion is configured to expand the septum in response to tension in the conduit portion imparted by expansion of the first frame component and the second frame component.

[0027] In another example ("Example 24"), in addition to the device of Example 23, the conduit portion is configured to maintain an expanded diameter of the septum.

[0028] In another example ("Example 25"), in addition to the device of Example 22, the first frame component forms a first side, the second frame component forms a second side, and at least one of the first set of elongated elements is disposed within the first frame component without crossing the second side, and the second set of elongated elements is disposed within the second frame component without crossing the first side.

[0029] In another example ("Example 26"), in addition to the device of Example 25, at least one of the first set of elongate elements and the second set of elongate elements extends within the conduit portion.

[0030] The foregoing examples are exemplary only and should not be read to limit or otherwise narrow the scope of any of the 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]

[0031] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings 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.

[0032] [Figure 1] FIG. 1 is an exemplary implantable medical device for regulating blood pressure, according to one embodiment.

[0033] [Figure 2] FIG. 2 is an exemplary implantable medical device for regulating blood pressure, according to one embodiment.

[0034] [Figure 3A] FIG. 3A is a perspective view of another exemplary implantable medical device for regulating blood pressure, according to one embodiment.

[0035] [Figure 3B] FIG. 3B is a side view of the implantable medical device for regulating blood pressure shown in FIG. 3A, according to one embodiment.

[0036] [Figure 4] FIG. 4 is an exemplary implantable medical device according to one embodiment.

[0037] [Figure 5A] FIG. 5A is a first perspective view of another exemplary implantable medical device for regulating blood pressure, according to one embodiment.

[0038] [Figure 5B] FIG. 5B is a second perspective view of the implantable medical device for regulating blood pressure shown in FIG. 5A, according to one embodiment.

[0039] [Figure 5C] FIG. 5C is a third perspective view of an implantable medical device for regulating blood pressure, according to one embodiment.

[0040] [Figure 6] FIG. 6 is an exemplary stent pattern for an implantable medical device and deployment system for regulating blood pressure, according to one embodiment.

[0041] [Figure 7] FIG. 7 is another exemplary stent pattern for an implantable medical device and deployment system for regulating blood pressure, according to one embodiment.

[0042] [Figure 8A] FIG. 8A shows an exemplary implantable medical device positioned on a mandrel, according to one embodiment. [Figure 8B] FIG. 8B shows an exemplary implantable medical device positioned on a mandrel, according to one embodiment.

[0043] [Figure 8C] FIG. 8C illustrates the exemplary implantable medical device of FIGS. 8A and 8B implanted within a patient's body, according to one embodiment. [Figure 8D] FIG. 88D shows the exemplary implantable medical device of FIGS. 8A and 8B implanted within a patient's body, according to one embodiment.

[0044] [Figure 9] FIG. 9 is another exemplary implantable medical device, according to one embodiment.

[0045] [Figure 10] FIG. 10 is another exemplary implantable medical device, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0046] 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 with the meaning ascribed to such terms by terms of the art.

[0047] With respect to the term imprecision, the terms "about" and "approximately" can be used interchangeably and 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 measurement errors, 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 objects by humans or machines, and / or the like. If it is determined that the value of 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.

[0048] Certain terminology is used herein merely for convenience. For example, words such as "top," "bottom," "upper," "lower," "left," "right," "horizontal," "vertical," "upward," "downward," etc., merely describe the configuration shown in the figures or describe the orientation of parts in an installed position. In fact, referenced components may be oriented in any direction. Similarly, throughout this disclosure where processes or methods are shown or described, the methods may be performed in any order or simultaneously, unless it is clear from the context that the method is dependent on a particular operation being performed first.

[0049] 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 apparatus 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.

[0050] 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 apparatus for treating heart failure by reducing elevated blood pressure within a heart chamber by creating a pressure relief shunt. Additionally, some embodiments relate to methods and apparatus for customizing, regulating, or manipulating blood flow through the pressure relief shunt to enhance the therapeutic effect of the shunt.

[0051] FIG. 1 illustrates an exemplary implantable medical device for regulating blood pressure, according to one embodiment. The implantable medical device 100 is shown implanted within a patient's heart H. The device 100 is shown positioned between the patient's left and right atria. In a particular example, the device 100 can be used to regulate blood flow within the heart H, for example, between the left and right atria LA, RA. As shown, the device 100 generally includes a first frame component 110 positioned on a first side of the septum (e.g., in the right atrium RA), a second frame component 120 positioned on a second side of the septum (e.g., in the left atrium LA), and a conduit portion 130 extending through the septum. An opening can be created in the septum using a needle.

[0052] A sheath 140 and restraint 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 component 110 can be released after sheath 140 is advanced through the septum to the RA, and a second side 120 including second frame component 120 can be released on the LA side of the septum. A conduit portion 130 (e.g., shown in FIG. 2) is positioned within the opening. Frame components 110, 120 and conduit portion 130 can be compressed within sheath 140 during delivery of device 100 to a desired treatment area within a patient and subsequently expanded during deployment of device 100.

[0053] 2 is an exemplary implantable medical device for regulating blood pressure, according to one embodiment. As shown, device 100 includes a first frame component 110 and a second frame component 120. First frame component 110 can be configured to conform to a patient's anatomy (i.e., for example, a first side of the septum). Second frame component 120 can be configured to conform to a patient's anatomy (i.e., a second side of the septum).

[0054] In a particular example, the first frame component 110 includes a first set of elongate elements 112, and the second frame component 120 includes a second set of elongate elements 122. For example, the frame components 110, 120, including the elongate elements 112, 122, can be distinct and separate from one another. For example, the first frame component 110 forms a first side 100a of the device 100, and the second frame component 120 forms a second side 100b of the device 100. The first frame component 110, being distinct and separate from the second frame component 120, does not fit into the second side 100b of the device, and the second frame component 120, being distinct and separate from the first frame component 110, does not fit into the first side 100a of the device.

[0055] In certain examples, the first and second frame components 110, 120 are not adjacent to one another. Because the first and second frame components 110, 120 are not adjacent to one another, the first and second frame components 110, 120 are distinct and can be separated from one another. Furthermore, the first and second frame components 110, 120 are free to move independently of one another in response to movement of the patient's anatomy. In this manner, a force acting on one of the first and second frame components 110, 120 is maintained within the other of the first and second frame components 110, 120. A force acting on one of the first and second frame components 110, 120 can be isolated to the frame component on which the force acts.

[0056] As shown, the conduit portion 130 is disposed between the first and second frame components. At least a portion of the conduit portion 130 is generally not supported radially or circumferentially by the first and second frame components 110, 120 within the conduit portion 130. As shown in FIG. 2 , the conduit portion 130 transitions to the first and second sides 100a, 100b at approximately a 90-degree angle (other angles are contemplated). The boundary of the conduit portion 130 can be considered to be the location where the conduit portion 130 transitions to the first and second sides 100a, 100b. The first and second frame components 110, 120 extend transversely relative to the conduit portion 130. Furthermore, the first and second frame components 110, 120 may support the conduit portion 130 without substantially entering the boundary of the conduit portion 130. In certain examples, the first and second frame components 110, 120 support the conduit portion 130 laterally from outside the boundary of the conduit portion 130. Thus, the first and second frame components 110, 120 can maintain a lumen through the conduit portion 130 and facilitate deployment of the conduit portion 130 by forcing the conduit portion 130 open laterally.

[0057] In certain instances, the first and second frame components 110, 120 can apply tension to the conduit portion 130 to deploy and maintain the conduit portion 130 with a lumen therethrough. The conduit portion 130 can be deployed within the septum between tissue surfaces through an opening (e.g., a needle puncture across the septum) having a diameter smaller than the fully deployed diameter of the conduit portion 130. The tension in the conduit portion 130 applied by the expansion of the first and second frame components 110, 120 can also expand the septum between tissue surfaces to a desired shunt size.

[0058] In certain examples, the conduit portion 130 can be substantially free of frame components. For example, the first and second frame components 110, 120 are not adjacent to each other as described above and are therefore positioned outside the boundaries of the conduit portion 130. The conduit portion 130 can include a membrane 132, such as an expanded polytetrafluoroethylene (ePTFE) membrane, connecting the first and second frame components 110, 120. For example, the membrane 132 generally separates the first and second frame components by an appropriate distance to fit within the patient's body. For example, the membrane 132 can separate the first and second frame components 110, 120 by a gap of 0 to 15 mm, depending on the desired treatment location within the patient's body. Furthermore, the conduit portion can be formed solely from the membrane 132. A conduit portion 130 configured to deploy within a septum between tissue surfaces does not include the first and second frame components 110, 120. The conduit portion 130 may include a smooth interior that facilitates blood flow therethrough without bulges from the stent elements interrupting or obstructing the flow, and thus the conduit portion 130 may reduce the chance of thrombosis.

[0059] In addition to the membrane 132 forming the conduit portion 130, the membrane 132 can also cover at least a portion of the first frame component 110, at least a portion of the second frame component 120, or at least a portion of the first frame component 110 and the second frame component 120. In certain examples, the membrane 132 disposed on at least a portion of the first frame component 110 and / or the second frame component 120 is a separate membrane film (e.g., a first membrane film disposed on the first frame component 110 and a second membrane film disposed on the second frame component 120). In these examples, the membrane film(s) can be coupled to the membrane 132 within the conduit portion 130. The membrane 132 can be elastic, allowing for expansion of the conduit portion 130 and movement of portions of the first frame component 110 and / or the second frame component 120 (e.g., movement of the first set of elongate elements 112 and / or the second set of elongate elements 122).

[0060] The membrane 132 can span the gap between the first set of elongate elements 112 and / or the second set of elongate elements 122. In certain examples, the membrane 132 is positioned on at least the tissue-engaging side of the first frame component 110 and the tissue-engaging side of the second frame component 120. In these examples, the membrane 132 is configured to reduce the likelihood of frame erosion of the first frame component 110 and / or the second frame component 120. The positioning of the membrane 132 and the first set of elongate elements 112 and / or the second set of elongate elements 122 can conform to the tissue surface surrounding the septum. The first set of elongate elements 112 and / or the second set of elongate elements 122 can lie flat against the tissue surface.

[0061] In certain examples, each of the first set of elongate elements 112 can be attached to one another via a membrane 132 to form the first frame component 110. In certain examples, the first frame component 110 can form a substantially flat or two-dimensional disk shape, as shown. Additionally or alternatively, the second set of elongate elements 122 can also be attached to one another via a membrane material 132 to form the second frame component 120. The second frame component 120 can also form a substantially flat or two-dimensional disk shape such that the first and second frame components 110, 120 are substantially parallel to one another when the device 100 is in the deployed configuration.

[0062] In certain examples, the membrane 132 can be configured to promote tissue ingrowth over at least a portion of the membrane 132 or over at least a portion of the membrane 132. In certain examples, the membrane 132 is configured to promote tissue ingrowth to cover at least a portion of the first frame component and / or the second frame component 110, 120, which may further promote fit and stability of the device 100 within the patient's body. The membrane 132 within the conduit portion 130 can be configured to not allow tissue ingrowth, leading to increased patency. In certain examples, the membrane 132 is configured to promote endothelialization without occlusive ingrowth within the conduit portion 130. The membrane 132 can promote endothelialization without occlusive tissue overgrowth into the conduit portion 130.

[0063] In certain examples, device 100 may be capable of delivering drugs to a desired treatment location within a patient's body. For example, device 100 may be capable of eluting a drug configured to modulate a tissue response. In certain examples, device 100 may be coated with a therapeutic coating, a drug-eluting material, or other therapeutic material or a hydrophilic coating. In one particular example, device 100 may be coated with heparin to promote thrombosis resistance and patency of device 100. Alternatively or additionally, device 100 may include paclitaxel (to modulate tissue / cellular response).

[0064] FIG. 3A is a perspective view of another exemplary implantable medical device 100 for regulating blood pressure, according to one embodiment. As shown, each of the elongate elements 112 of the first set can be distinct and separated from adjacent elongate elements. In other words, the membrane 132 does not connect each of the elongate elements 112 of the first set together. In this manner, each of the elongate elements 112 of the first set can move independently of one another to individually conform to the topography of the first side of the septum, thus providing a highly adaptable first frame component 110. Each of the elongate elements 122 of the second set can also be distinct and separated from adjacent elongate elements. For example, each of the elongate elements 122 of the second set can move independently of one another to individually conform to the second side of the septum, much like the elongate elements 112 of the first set conform to the first side of the septum. Thus, both the first and second frame components 110, 120 are highly adaptable and can be adapted independently of each other based on the patient's anatomy.

[0065] In certain examples, one of the elongate elements 112, 122 of the first set or the second set of the first and second frame components 110, 120 may be attached to one another via the membrane 132, while the elongate elements of the other set may not be attached (e.g., they are distinct and separated from adjacent elongate elements). In other examples, only some of the elongate elements 112, 122 of the first set or the second set may be attached to one another, while the other elongate elements of the first and second sets 112, 122 are not attached. Thus, the device 100 can be highly customizable to the patient, depending on the desired treatment location within the patient and the size and / or shape of the defect, among other factors.

[0066] Device 100 is generally deployable or expandable from a delivery configuration to a deployed configuration. In some instances, first set of elongate elements 112 and second set of elongate elements 122 can nest within one another when the device is in the delivery configuration. This allows device 100 to be compressed to a smaller size, for example, allowing device 100 to be delivered to a wider variety of treatment locations (e.g., through small, narrow, or complex passages).

[0067] FIG. 3B is a side view of the implantable medical device for regulating blood pressure shown in FIG. 3A , according to one embodiment. FIG. 3B shows the device 100 in a deployed configuration. As shown, a first frame component 110 including a first set of elongate elements 112 and a second frame component 120 including a second set of elongate elements 122 are disposed radially outward relative to the longitudinal axis L of the conduit portion 130 when the device 100 is in the deployed configuration. For example, the first and second frame components 110, 120 are disposed at first and second angles 114, 124, respectively. The first and second angles 114, 124 can form an angle of approximately 90° with respect to the longitudinal axis L when the device is in the deployed configuration. This allows the first and second frame components 110, 120 to be disposed parallel to and adjacent to first and second sides of the septum. In certain instances, the first and second frame components 110, 120 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), which allows contact between tissue surfaces on the first and second sides of the septum.

[0068] In certain examples, the first elongate element and the second elongate element 112, 122 are configured to be separated from one another when the device 100 is in the deployed configuration. As shown in FIG. 3B , each of the first set of elongate elements 112 is distinct and separated from one another when the device 100 is in the deployed configuration, allowing each of the first set of elongate elements 112 to move independently of adjacent elongate elements. Each of the second set of elongate elements 122 can also be distinct and separated from one another when the device 100 is in the deployed configuration, allowing each of the second set of elongate elements 122 to move independently of adjacent elongate elements.

[0069] The first and second frame components 110, 120 maintain a lumen through the conduit portion 130 and can facilitate deployment of the conduit portion 130 by forcing the conduit portion 130 open laterally. Furthermore, the lumen can be free or free of the first and second frame components 110, 120. In this manner, the conduit portion 130 can facilitate re-crossing of the septum for additional procedures (e.g., left atrial appendage occluder implantation). Furthermore, the first and second frame components 110, 120 can be configured differently. For example, one of the first and second frame components 110, 120 can be flared, while the other of the first and second frame components 110, 120 is flat. In another example, both the first and second frame components 110, 120 can be flared. Furthermore, one of the first and second frame components 110, 120 can be convex and the other of the first and second frame components 110, 120 can be flat or concave, or both the first and second frame components 110, 120 can be convex. Furthermore, one of the first and second frame components 110, 120 can be concave and the other of the first and second frame components 110, 120 can be flat or convex, or both the first and second frame components 110, 120 can be concave. Furthermore, the first and second frame components 110, 120 can be different sizes.

[0070] The first and second frame components 110, 120 may include sensors integrated into the respective frame components for continuously monitoring various hemodynamic parameters, such as pressure, among other parameters within the patient's body. For example, an antenna or inductor may be wrapped around one of the first and second frame components 110, 120, and a sensor may be attached to the inductor. The sensors 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 conditions.

[0071] In certain instances, the conduit portion 130 can be significantly larger after delivery. The membrane 132 can be selectively adjustable by a balloon applied within the conduit portion 130 to inflate the membrane 132. The device 100 can be any size suitable to fit the patient's anatomy. In certain instances, the diameter of the conduit portion is 3-12 mm. For example, the diameter of the conduit portion can be 4-10 mm or 5-8 mm, depending on the patient's anatomy and / or the desired treatment location. The first and second frame components 110, 120 generally have a diameter larger than, for example, the diameter of the conduit portion 130, such that the frame components can secure the conduit portion 130 of the device 100 within the septum.

[0072] The device 100 can be any shape suitable for fitting to a patient's anatomy. For example, the first frame component and the second frame portion 110, 120 can be any of a variety of suitable shapes for securing the device 100 within a patient's body. For example, the first frame component and the second frame portion 110, 120 can be substantially circular, oval, diamond-shaped, star-shaped, flower-shaped, or any other suitable shape as desired. In certain examples, for example, at least one of the first and second sets of elongate elements 112, 122 forms a star shape. In certain examples, both the first and second sets of elongate elements 112, 122 form a star shape.

[0073] In certain examples, the first set of elongate elements 112 form a plurality of first lobes 116, and the second set of elongate elements 122 form a plurality of second lobes 126. Each of the plurality of first and second lobes 116, 126 can include, for example, 3 to 12 lobes, 4 to 10 lobes, or 6 to 8 lobes, as desired. In certain examples, the plurality of first lobes 116 can have more lobes than the plurality of second lobes 126, and in other examples, the plurality of first lobes 116 can have the same number of lobes as the plurality of second lobes 126 or fewer lobes.

[0074] FIG. 4 is another exemplary implantable medical device 100, according to one embodiment. In certain instances, the device 100 can include a cover 160 disposed over at least a portion of the conduit portion 130. The cover 160 can be formed, for example, from a graft material, such as the material used for the membrane 132. The cover 160 is configured to reduce the amount of fluid passing through the conduit portion 130, or, in certain instances, to prevent fluid from passing through the conduit portion 130 entirely. Thus, the cover 160 can partially or completely occlude the septum, as desired. In these cases, the device 100 can be an occluder. When used as an occluder, the expanded conduit portion 130 can be centered at the target location (e.g., within a defect).

[0075] 5A-5C show perspective views of another exemplary implantable medical device for regulating blood pressure, according to various embodiments. As shown, the plurality of first and second lobes 116, 126 of the first and second sets of elongate elements 112, 122 can have a variety of shapes. For example, each lobe of the first and second sets of elongate elements 112, 122 can be generally elongated, triangular, diamond-shaped, or petal-like.

[0076] 5A is a first perspective view of another exemplary implantable medical device for regulating blood pressure, according to one embodiment. As shown, first and second sets of elongate elements 112, 122 form first and second frame portions 110, 120 of device 100, and each of the first and second sets of elongate elements 112, 122 includes three lobes. As shown, the plurality of first lobes 116 and / or the plurality of second lobes 126 can be somewhat elongate in shape.

[0077] Device 100 is generally deployable or expandable from a delivery configuration to a deployed configuration. In some examples, first set of elongate elements 112 and second set of elongate elements 122 nest within one another when the device is in the delivery configuration. This allows device 100 to be compressed to a smaller size, for example, allowing device 100 to be delivered to a wider variety of treatment locations (e.g., through small, narrow, or complex passages).

[0078] As shown in FIG. 5B , the first set of elongate elements 112 can have a generally different shape than the second set of elongate elements 122. For example, the first plurality of lobes 116 are elongate in shape, and the second plurality of lobes 126 are triangular in shape. As shown, the first set of elongate elements 112 are attached to the first frame component 110, and the second set of elongate elements 122 are attached to the second frame component 120. Both the first and second frame components 110, 120 can extend into the conduit portion 130. However, neither the first nor second frame component 110, 120 extends into the opposing frame component (e.g., the first frame component 110 does not extend to the second side 100b, and the second frame component 120 does not extend to the first side 100a). In certain examples, a stent or frame element disposed within the conduit segment 130 can be formed from a third frame component, as described in further detail with reference to FIG. 10 . The first and second frame components 110, 120 can maintain a lumen through the conduit segment 130 and facilitate deployment of the conduit segment 130 by forcing the conduit segment 130 laterally open. FIG. 5C is a third perspective view of an implantable medical device for regulating blood pressure, according to one embodiment. As shown, in certain examples, the first set of elongate elements 112 can include a first plurality of support struts 118, and the second set of elongate elements 122 can include a second plurality of support struts 128. The first and second plurality of support struts 118, 128 generally form a support structure within each elongate element, thereby enhancing the strength and / or stability of each elongate element. In certain examples, the support struts 118, 128 can also aid in delivery of the device 100. For example, the support structure may provide a location where a delivery device can be easily attached to the device 100 when the device 100 is in the delivery configuration.

[0079] 6 is an exemplary stent pattern for an implantable medical device for regulating blood pressure, according to one embodiment. In certain instances, stent pattern 300 can be used in a method of making device 100. For example, in certain instances, device 100 is made from a tube or sheet of material, such as Nitinol (NiTi) or stainless steel, which is cut according to stent pattern 300 and then expanded into the configuration of device 100, as shown in FIGS.

[0080] 7 is another exemplary stent pattern for an implantable medical device for regulating blood pressure, according to one embodiment. As noted above, stent pattern 400 can be used in a method of making device 100. For example, in certain instances, device 100 is made from a tube or sheet of material, such as Nitinol (NiTi) or stainless steel, which is cut according to stent pattern 300 and then expanded into the configuration of device 100, as shown in FIGS. 2-5. In other instances, the stent component can be formed by wire wound on a jig and then heat set.

[0081] 6 and 7 are generally deployable or expandable from a delivery configuration to a deployed configuration. In some instances, the first set of elongate elements 112 (not shown) and the second set of elongate elements 122 (not shown) can nest within one another when the device is in the delivery configuration. This allows the device 100 to be compressed to a smaller size, for example, allowing the device 100 to be delivered to a wider variety of treatment locations (e.g., through small, narrow, or complex passages).

[0082] In certain examples, device 100 as discussed herein can include multiple frame components. The frame components can be formed from separate tubes or sheets of material or from a single tube or sheet of material. In other examples, each of the frame components can be individually formed from one or more wires, or the frame components can be formed together from one or more wires. As discussed herein, the elongate elements can be struts, wires, or portions of the tube or sheet of material that form part of the frame components.

[0083] 8A-8D illustrate an implantable medical device 100 according to one embodiment. FIGS. 8A and 8B show the device 100 positioned on a mandrel. As shown, the device 100 includes opposing first and second frame portions 110, 120 having first and second series of elongate elements 112, 122 disposed radially outward from a conduit portion 130, as shown in FIGS. 2, 3A, and 3B. Each of the first and second series of elongate elements 112, 122 can include eyelets configured to aid in delivery of the device 100. For example, the first series of elongate elements 112 includes a first plurality of eyelets 190, and the second series of elongate elements 122 includes a second plurality of eyelets 192. FIGS. 8C and 8D show the device 100 of FIGS. 8A and 8B implanted at a desired treatment location within a patient's body. The eyelets 190, 192 may interface with wires or suture-like elements on a delivery system to restrain portions of the implantable medical device 100 and, in certain instances, for recaptureability of the device 100.

[0084] 9 is another exemplary implantable medical device 100 according to one embodiment. As shown, the first frame portion 110 can include a first protruding portion 196 extending outward along the longitudinal axis from a surface of the first frame portion 110. The second frame portion 120 can also include a second protruding portion 198 extending outward along the longitudinal axis from a surface of the second frame portion 120. The first and second protruding portions 196, 198 can be formed, for example, from a stent frame. The first and second protruding portions 196, 198 can be separate from the first and second frame portions 110, 120. The protruding portions 196, 198 can intersect the first and second frame portions 110, 120 at 90° (e.g., as shown) or at an angle greater than or less than 90°, such as 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, or any angle therebetween. The first and second protruding portions 196, 198 can become significantly larger after the device 100 is delivered to the body or patient.

[0085] In certain examples, a method for regulating blood pressure includes delivering device 100 to a desired treatment location within a patient's body while device 100 is in a delivery configuration. Device 100 can then be positioned so that conduit portion 130 spans, for example, the septum between the left and right atria of the heart, or other defects within the patient's body as desired. Device 100 is then expanded from the delivery configuration to a deployed configuration such that first and second frame components 110, 120 extend radially outward from conduit portion 130, thereby opening a desired amount to provide a fluid flow path through device 100 (e.g., between the left and right atria in certain examples). In certain examples, the tension on device 100 can be adjusted to further adjust the diameter of conduit portion 130 of device 100. This allows, for example, for adjusting the fluid flow rate through the device 100, forcing more or less fluid through the conduit portion 130 of the device 100 as desired.

[0086] FIG. 10 is another exemplary implantable medical device according to one embodiment. Device 100, according to one embodiment, can be used to regulate blood pressure. As shown, device 100 can include a first frame portion 110 and a second frame portion 112. As described in further detail below, device 100 includes a third frame component 150 that can be configured to prop open conduit portion 130 by self-expansion or balloon expansion. As shown in FIG. 10 , in device 100, first frame component 110 can be positioned on a first side of the septum, and second frame component 120 can be positioned on a second side of the septum. Each of frame components 110, 120, and conduit portion 130 can include a membrane 132. Membrane 132 can cover at least a portion of first frame component 110, at least a portion of second frame component 120, or at least a portion of first frame component 110 and second frame component 120. The membrane 132 can be elastic, allowing expansion of the conduit portion 130 and allowing movement of portions of the first frame component 110 and / or second frame component 120 .

[0087] In certain examples, the first and second sets of elongate elements 112, 122 (e.g., struts, wires, frame elements, stent elements) form first and second frame portions 110, 120 of the device 100. As shown in FIG. 10 , the first set of elongate elements 112 form the first frame component 110, and the second set of elongate elements 122 form the second frame component 120. Both the first and second frame components 110, 120 can extend into the conduit portion 130. In certain examples, neither the first nor second frame component 110, 120 extends to the opposite frame component (e.g., the first frame component 110 does not extend to the second side 100b, and the second frame component 120 does not extend to the first side 100a).

[0088] Additionally, a third frame component 150 (e.g., a stent or frame element) may be disposed within the conduit portion 130. The third frame component 150 may be in addition to the first and / or second frame components 110, 120 extending within the conduit portion 130, or the third frame component 150 may be the only frame or stent component within the conduit portion 130. The third frame component 150 may not be coupled or connected to either or both of the first and second frame components 110, 120.

[0089] In certain instances, the conduit portion 130 can grow significantly after delivery. In certain instances, the third frame component 150 is balloon expandable. After implantation, the conduit portion 130 can be adjustable in size by the third frame component 150 being configured to expand. The conduit portion 130 can be adjusted in size to a desired diameter by a balloon. In certain instances, the third frame component 150 can be configured to self-expand. Additionally, the third frame component 150 can be configured to prop open the conduit portion 130, and in certain instances, to prop open the surrounding tissue.

[0090] In certain examples, the first and second frame components 110, 120 are self-expanding. The first and second frame components 110, 120 can be configured to conform to tissue on either side of the septum. In certain examples, the first set of elongate elements 112 can move independently of one another to individually conform to the topography of a first side of the septum, and the second set of elongate elements 122 can move independently of one another to individually conform to a second side of the septum. Thus, both the first and second frame components 110, 120 can be highly adaptable and can adapt independently of one another based on the patient's anatomy.

[0091] The device 100 discussed herein can be removable. In certain instances, the device 100 can be replaced or removed if treatment is no longer effective or needed. As described above, the device 100 can be coated with a drug, such as paclitaxel, to deliver the drug to a targeted anatomical location. In certain instances, the use of certain medications can prevent healing of a dilated septal puncture, resulting in the formation of an atrial shunt. The device 10 can function as a pressure relief valve, allowing blood to flow from the left atrium to the right atrium, reducing the strain on the heart.

[0092] Examples of synthetic polymers that can be used as membrane components include, but are not limited to, nylon, polyacrylamide, polycarbonate, polyformaldehyde, polymethyl methacrylate, polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organic silicone polymers, polyethylene, polypropylene, polyurethane, polyglycolic acid, polyester, polyamide, and mixtures, blends, and copolymers thereof, which are suitable as membrane materials. In one embodiment, the membrane is made from a class of polyesters such as polyethylene terephthalate, including DACRON® and MYLAR®, and polyaramids such as KEVLAR®, polyfluorocarbons such as polytetrafluoroethylene (PTFE) with or without copolymerized hexafluoropropylene (TEFLON® or GORE-TEX), and porous or non-porous polyurethanes. In a specific example, the membrane comprises an expanded fluorocarbon polymer (particularly PTFE) material as described in British Patent Nos. 1,355,373 or 1,506,432 or 1,506,432 or U.S. Patent Nos. 3,953,566, 4,187,390 or 5,276,276, the entire contents of which are incorporated by reference. Preferred classes of fluoropolymers include polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), copolymers of tetrafluoroethylene (TFE) and perfluoro(propyl vinyl ether) (PFA), homopolymers of polychlorotrifluoroethylene (PCTFE) and its copolymers with TFE, ethylene-chlorotrifluoroethylene (ECTFE), copolymers of ethylene-tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF), and polyvinyl fluoride (PVF). Particularly preferred is ePTFE due to its widespread use in vascular prostheses. In certain instances, the membrane comprises a combination of the materials listed above. In certain instances, the membrane is substantially impermeable to body fluids.The substantially impermeable membrane can be made from a material that is substantially impermeable to bodily fluids, or can be constructed from permeable materials that have been treated or manufactured to be substantially impermeable to bodily fluids (e.g., by layering different types of materials as described above or known in the art).

[0093] Additional examples of membrane materials include, but are not limited to, vinylidine fluoride / hexafluoropropylene, hexafluoropropylene (HFP), tetrafluoroethylene (TFE), vinylidene fluoride, 1-hydropentafluoropropylene, perfluoro(methyl vinyl ether), chlorotrifluoroethylene (CTFE), pentafluoropropene, trifluoroethylene, hexafluoroacetone, hexafluoroisobutylene, fluorinated poly(ethylene-co-propylene (FPEP), poly(hexafluoropropene) (PHFP), poly(chlorotrifluoroethylene) (PCTFE), poly(vinylidene fluoride), ) (PVDF), poly(vinylidene fluoride-co-tetrafluoroethylene) (PVDF-TFE), poly(vinylidene fluoride-co-hexafluoropropene) (PVDF-HFP), poly(tetrafluoroethylene-co-hexafluoropropene) (PTFE-HFP), poly(tetrafluoroethylene-co-vinyl alcohol) (PTFE-VAL), poly(tetrafluoroethylene-co-vinyl acetate) (PTFE-VAC), poly(tetrafluoroethylene-co-propene) (PTFEP), poly(hexafluoropropene-co-vinyl alcohol) (PHFP-VAL), poly(ethylene-co-tetrafluoroethylene) ( Examples of suitable polyfluoropolymers include tetrafluoroethylene (TFE), poly(ethylene-co-hexafluoropropene) (PEHFP), poly(vinylidene fluoride-co-chlorotrifluoroethylene) (PVDF-CTFE), and combinations thereof, as well as additional polymers and copolymers described in U.S. Publication No. 2004 / 0063805, which are incorporated herein by reference in their entireties for all purposes. Additional polyfluoro copolymers include tetrafluoroethylene (TFE) / perfluoroalkyl vinyl ether (PAVE). The PAVE can be perfluoromethyl vinyl ether (PMVE), perfluoroethyl vinyl ether (PEVE), or perfluoropropyl vinyl ether (PPVE), essentially as described in U.S. Publication No. 2006 / 019866 and U.S. Patent No. 7,049,380, both of which are incorporated herein by reference in their entireties for all purposes.Other polymers and copolymers include polylactides, polycaprolactone-glycolides, polyorthoesters, polyanhydrides, polyamino acids, polysaccharides, polyphosphazenes, poly(ether-ester) copolymers such as PEO-PLLA or blends thereof, polydimethyl-siloxanes, poly(ethylene-vinyl acetate), acrylate-based polymers or copolymers such as poly(hydroxyethylmethylmethacrylate), polyvinylpyrrolidinone, fluorinated polymers such as polytetrafluoroethylene, cellulose esters, and any of the polymers and copolymers described in U.S. Application Publication No. 2004 / 0063805, which is incorporated herein by reference in its entirety.

[0094] As discussed herein, the membrane component can be attached to the self-expanding frame component by using a connecting member, which is generally a flat ribbon or tape having at least one generally flat surface. In a particular example, the tape member is formed from expanded PTFE (ePTFE) coated with an adhesive. The adhesive can be a thermoplastic adhesive. In a particular 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-expanding frame component and the membrane component, thus attaching the self-expanding frame component to the membrane component. Materials and methods for attaching the frame component to the membrane are described in U.S. Pat. No. 6,042,602 to Martin, which is incorporated herein by reference for all purposes.

[0095] The frame components discussed herein can be fabricated from a variety of biocompatible materials. These materials can include 316L stainless steel, cobalt-chromium-nickel-molybdenum-iron alloys ("cobalt-chromium"), other cobalt alloys such as L605, tantalum, nickel-titanium alloys (such as Nitinol), or other biocompatible metals. In certain instances, as discussed in detail above, the frame components (and membranes) can be self-expanding. The prosthesis can be balloon-expandable. In other instances, the frame components can be formed from polymers (e.g., polyetheretherketone (PEEK)) and / or bioabsorbable materials (e.g., polylactic-co-glycolic acid (PLGA), polyglycolic acid:trimethylene carbonate (PGA-TMC)).

[0096] 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 treated 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).

[0097] The invention of this application has been described above both generically and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the present disclosure. Thus, the embodiments are intended to cover the modifications and variations of the present invention provided they come within the scope of the appended claims and their equivalents.

Claims

1. a first frame component configured to conform to the patient's anatomy; a second frame component configured to conform to the patient's anatomy; and a conduit portion disposed between the first frame component and the second frame component; 1. An implantable medical device comprising: the first frame component and the second frame component are distinct and separate from one another; An implantable medical device, wherein the conduit portion includes a membrane connecting the first frame component and the second frame component.

2. The device of claim 1 , wherein at least a portion of the conduit portion is not radially supported by the first frame component and the second frame component within the conduit portion.

3. The device of claim 2 , wherein the first frame component and the second frame component are configured to facilitate deployment of the conduit portion and maintain a lumen therethrough.

4. The device of any one of claims 1 to 3, wherein the conduit portion does not include a frame component.

5. 5. The device of claim 1, wherein the first frame component comprises a first set of elongate elements, the second frame component comprises a second set of elongate elements, and the first set of elongate elements and the second set of elongate elements are not adjacent to each other.

6. 6. The device of claim 5, wherein the first set of elongate elements includes a first plurality of support struts and the second set of elongate elements includes a second plurality of support struts, the first plurality of support struts and the second plurality of support struts forming a support structure within each of the elongate elements.

7. The device of claim 6 , wherein the first set of elongated elements form a plurality of first lobes.

8. The device of claim 6 , wherein the first set of elongated elements form a star shape.

9. 9. The device of claim 5, wherein the first frame component forms a first side, the second frame component forms a second side, and at least one of the first set of elongated elements is disposed within the first frame component without crossing the second side, and the second set of elongated elements is disposed within the second frame component without crossing the first side.

10. The device of claim 9 , wherein at least one of the first set of elongate elements and the second set of elongate elements extends within the conduit portion.

11. The device of any preceding claim, wherein the membrane extends to at least partially cover portions of one or both of the first and second frame components.

12. The device of claim 11 , wherein the membrane is configured to promote tissue ingrowth to cover at least a portion of one or both of the first frame component and the second frame component.

13. The device of any one of claims 1 to 12, further comprising a first membrane film disposed on the first frame component and a second membrane film disposed on the second frame component.

14. The device of any one of claims 1 to 13, wherein the membrane separates the first and second frame components by a gap of 0 to 15 mm.

15. 1. An implantable medical device for regulating blood pressure between the left and right atria of the heart, comprising: a conduit portion configured to span the septum of the heart and allow fluid flow therethrough; and a frame component including a first set of elongate elements disposed on a first side of the conduit portion and a second set of elongate elements disposed on a second side of the conduit portion, the first set of elongate elements and the second set of elongate elements not adjacent to one another; Including, the device.

16. 16. The device of claim 15, wherein the frame component defines a first side including a first set of elongate elements and a second side including a second set of elongate elements, the first set of elongate elements being disposed within the first side and the conduit portion, and the second set of elongate elements being disposed within the second side and the conduit portion.

17. 17. The device of any one of claims 15-16, wherein the first set of elongate members and the second set of elongate members diverge radially outward from the conduit portion and form a first angle and a second angle, the first angle and the second angle being approximately 90 degrees relative to the conduit portion.

18. 18. The device of any one of claims 14 to 17, further comprising a sensor disposed with the conduit portion or the frame component and configured to sense at least one of a physiological characteristic, a hemodynamic characteristic, a biomarker, sound, pressure, and an electrolyte.

19. The device of any one of claims 14 to 18, 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.

20. 1. A method for regulating blood pressure between the left and right atria of the heart, comprising: a conduit portion configured to span the septum of the heart and allow fluid flow therethrough; and a frame component including a first set of elongate elements disposed on a first side of the conduit portion and a second set of elongate elements disposed on a second side of the conduit portion, the first set of elongate elements and the second set of elongate elements not adjacent to one another; delivering an implantable medical device to a desired treatment location within a patient's body, positioning the device so that the conduit portion spans the septum between the left and right atria of the heart; and deploying the first frame component and the second frame component so that the conduit portion opens a desired amount to provide a fluid flow path between the left atrium and the right atrium; A method comprising:

21. 21. The method of claim 20, further comprising adjusting tension on the device to adjust the diameter of the conduit portion and fluid flow rate therethrough.

22. a first frame component; a second frame component; and a conduit portion disposed between the first frame component and the second frame component, the conduit portion including a membrane connecting the first frame component and the second frame component configured to expand in response to tension in the conduit portion imparted by expansion of the first frame component and the second frame component; wherein said first frame component and said second frame component are distinct and separate from one another.

23. 23. The device of claim 22, wherein the conduit portion is configured to span a septum between a patient's left atrium and a right atrium, and the conduit portion is configured to expand the septum in response to tension in the conduit portion imparted by expansion of the first frame component and the second frame component.

24. 24. The device of claim 23, wherein the conduit portion is configured to maintain an expanded diameter of the septum.

25. 23. The device of claim 22, wherein the first frame component forms a first side, the second frame component forms a second side, and at least one of a first set of elongated elements disposed within the first frame component without crossing the second side, and a second set of elongated elements disposed within the second frame component without crossing the first side.

26. 26. The device of claim 25, wherein at least one of the first set of elongate elements and the second set of elongate elements extends within the conduit portion.

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