Medical implant including two frame components and a pair of eyelets

Abstract

An implantable medical device includes a first frame component. The first frame component includes a first set of elongate elements configured to fit the patient's anatomy. The implantable medical device also includes a second frame component including a second set of elongate elements configured to fit the patient's anatomy. The first and second frame components are distinct and separate from one another. The implantable medical device also includes a conduit portion disposed between the first and second frame components. The conduit portion includes a membrane connecting the first and second frame components.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of Provisional Application No. 62 / 962,541, filed on January 17, 2020, and incorporates it herein by reference in its entirety for all purposes.

[0002] The present disclosure generally relates to implantable medical devices, more specifically, implantable medical devices for shunting and / or occluding bodily fluids or structures, and related systems and methods therefor.

Background Art

[0003] Heart failure and heart diseases affect millions of people worldwide. Heart failure includes disorders of either the left side, the right side or both sides of the heart. Heart diseases that can lead to heart failure include hypertension, pulmonary hypertension and congenital heart defects. The ever - evolving nature of heart failure represents an important challenge for treatment methods. Therefore, new and adaptable methods and devices for treating heart failure are needed.

Summary of the Invention

[0004] According to one example ( "Example 1"), an implantable medical device includes a first frame component configured to conform to a patient's anatomical structure, a second frame component configured to conform to the patient's anatomical structure, wherein the first frame component and the second frame component are distinct and separated from each other, at least one of the first frame component and the second frame component includes an inner vertex and an outer vertex, and one or more eyelets disposed at at least one of the outer vertex and the inner vertex, and a conduit portion disposed between the first frame component and the second frame component, wherein the conduit portion includes 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 portion is not radially supported by the first and second frame components within the conduit portion.

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

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

[0008] In another example ("Example 5"), in addition to any one of the devices in Examples 1-4, the first frame component includes a first set of elongated elements, the second frame component includes a second set of elongated elements, and the first set of elongated elements and the second set of elongated 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 elongated elements includes a first plurality of support struts, the second set of elongated 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 elongated elements.

[0010] In another example ("Example 7"), in addition to the device of Example 6, the first set of elongated elements forms 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 forms a star shape.

[0012] In another example ("Example 9"), in addition to any one of the devices in Examples 1 to 8, at least one of the first frame component and the second frame component includes a star shape having the inner vertices and the outer vertices.

[0013] In another example ("Example 10"), in addition to the device of Example 9, the one or more eyelets include a pair of eyelets positioned on one side of at least one of the inner vertices.

[0014] In another example ("Example 11"), in addition to any one of the devices in Examples 1 to 8, at least one of the first frame component and the second frame component includes a star shape having a first surface and a second surface, and an eyelet extending around the frame component along one or both of the first surface and the second surface.

[0015] In another example ("Example 12"), in addition to the device of Example 11, the eyelets extend around the frame element and are alternately arranged on the first surface and the second surface.

[0016] According to another example ("Example 13"), in addition to any one of the devices in Examples 1 to 8, at least one of the inner vertices and the outer vertices includes one or more wider width portions and one or more smaller width portions located between at least one of the inner vertices and the outer vertex.

[0017] In another example ("Example 14"), in addition to the device of Example 13, at least one of the first frame component and the second frame component includes two wider width portions and one narrower width portion between two of the vertices.

[0018] In another example ("Example 15"), in addition to the device of Example 14, the eyelets are arranged in one or more wider sections.

[0019] In another example ("Example 16"), in addition to any one of the devices in Examples 1 to 8, at least one of the first frame component and the second frame component includes a first surface and a second surface, as well as an opening between the first surface and the second surface.

[0020] In another example ("Example 17"), in addition to any one of the devices in Examples 1 to 8, the device also includes one or more tethers coupled to the first frame component and the second frame component and arranged through the conduit portion.

[0021] In another example ("Example 18"), in addition to the device of Example 17, the one or more tethers are configured to structurally reinforce the conduit portion.

[0022] In another example ("Example 19"), in addition to any one of the devices in Examples 1 to 8, at least one of the first frame component and the second frame component includes a curved star shape.

[0023] In another example ("Example 20"), in addition to any one of the devices in Examples 1 to 8, at least one of the first frame component and the second frame component includes a vertex, an eyelet positioned at the vertex, and a tether positioned and connected through the eyelet.

[0024] In another example ("Example 21"), in addition to any one of the devices in Examples 1 to 8, the film includes a first layer and a second layer sandwiching the first and second frame components.

[0025] In another example ("Example 22"), in addition to any one of the devices in Examples 1 to 8, at least one of the first frame component and the second frame component includes a sector.

[0026] According to another example ("Example 23"), in addition to any one of the devices of Examples 1-8, at least one of the first frame component and the second frame component includes a partial star.

[0027] According to another example ("Example 24"), in addition to any one of the devices of Examples 1-8, at least one of the first frame component and the second frame component includes at least one elongate element that overlaps itself to form one or more loops, and the one or more loops form eyelets.

[0028] According to another example ("Example 25"), a method for regulating blood pressure between the left atrium and the right atrium of the heart includes delivering an implantable medical device to a desired treatment location within a patient's body, where the implantable medical device includes a catheter portion configured to span across the heart septum and configured to permit fluid flow therethrough, a first set of elongate elements disposed on a first side of the catheter portion, and a second set of elongate elements disposed on a second side of the catheter portion, where the first set of elongate elements and the second set of elongate elements are not adjacent to each other, and at least one of the first frame component and the second frame component includes an inner apex and an outer apex, and one or more eyelets disposed at least at one of the outer apex and the inner apex, disposing the device such that the catheter portion spans across the septum between the left atrium and the right atrium of the heart, and deploying the first frame component and the second frame component such that the catheter portion opens to a desired amount to provide a fluid flow path between the left atrium and the right atrium.

[0029] According to another example ("Example 26"), in addition to the method of Example 25, the method also includes adjusting the tension on the device to adjust the diameter of the catheter portion and the fluid flow rate therethrough.

[0030] According to one example ("Example 27"), an implantable medical device includes a first frame component configured to conform to a patient's anatomical structure, a second frame component configured to conform to a patient's anatomical structure, wherein at least one of the first frame component and the second frame component includes an inner vertex and an outer vertex, and one or more eyelets disposed at at least one of the outer vertex and the inner vertex, at least one of the first frame component and the second frame component includes a star having the inner vertex and the outer vertex, the one or more eyelets include a plurality of eyelet pairs, and one of the plurality of eyelet pairs is disposed on either side of at least one of the inner vertex and the outer vertex.

[0031] According to another example ("Example 28"), in addition to the implantable medical device of Example 27, the plurality of eyelet pairs are disposed on a first side of the inner vertex.

[0032] According to another example ("Example 29"), in addition to the implantable medical device of Example 27, the plurality of eyelet pairs include a first plurality of eyelet pairs each disposed adjacent to the inner vertex and a second plurality of eyelet pairs each disposed adjacent to the outer vertex.

[0033] According to another example ("Example 30"), in addition to the implantable medical device of Example 29, the first plurality of eyelet pairs respectively disposed on a first side of at least one of the first frame component and the second frame component are adjacent to the inner vertex, and the second plurality of eyelet pairs respectively disposed on a second side of at least one of the first frame component and the second frame component are adjacent to the outer vertex.

[0034] In another example ("Example 31"), in addition to the implantable medical device of Example 27, at least one of the first frame component and the second frame component includes a first surface and a second surface, and the plurality of eyelet pairs extend around the frame component along one or both of the first surface and the second surface.

[0035] In another example ("Example 32"), in addition to the implantable medical device of Example 31, the plurality of eyelet pairs extend around a frame element and are arranged alternately on the first surface and the second surface.

[0036] In another example ("Example 33"), in addition to the implantable medical device of Example 27, at least one of the inner vertex and the outer vertex includes one or more wider width portions and one or more narrower width portions located between at least one of the inner vertex and the outer vertex.

[0037] In another example ("Example 34"), in addition to the implantable medical device of Example 33, at least one of the first frame component and the second frame component includes two wider width portions and one narrower width portion between two of the vertices.

[0038] In another example ("Example 35"), in addition to the implantable medical device of Example 34, the multiple pairs of eyelets are arranged in one or more wider width portions.

[0039] In another example ("Example 36"), in addition to any one of the implantable medical devices in Examples 27-35, the implantable medical device also includes a conduit portion positioned between the first frame component and the second frame component, and one or more tethers coupled to the first frame component and the second frame component and positioned through the conduit portion.

[0040] In another example ("Example 37"), in addition to the implantable medical device of Example 36, the one or more tethers are configured to structurally reinforce the conduit portion.

[0041] In another example ("Example 38"), in addition to any one of the implantable medical devices in Examples 27-37, the implantable medical device also includes a membrane comprising a first layer and a second layer sandwiching the first and second frame components.

[0042] According to one example ("Example 39"), an implantable medical device includes a first frame component configured to conform to the patient's anatomical structure, a second frame component configured to conform to the patient's anatomical structure, wherein at least one of the first frame component and the second frame component includes an inner vertex and an outer vertex, and one or more eyelets positioned at at least one of the outer vertex and the inner vertex, wherein at least one of the first frame component and the second frame component includes a first surface and a second surface, and an opening between the first surface and the second surface.

[0043] In another example ("Example 40"), in addition to the implantable medical device of Example 39, the implantable medical device also includes a conduit portion positioned between the first frame component and the second frame component, and one or more tethers coupled to the first frame component and the second frame component and positioned through the conduit portion.

[0044] In another example ("Example 41"), in addition to the implantable medical device of Example 40, the one or more tethers are configured to structurally reinforce the conduit portion.

[0045] According to one example ("Example 42"), an implantable medical device includes a first frame component configured to conform to the patient's anatomical structure, a second frame component configured to conform to the patient's anatomical structure, wherein at least one of the first frame component and the second frame component includes an inner vertex and an outer vertex, and one or more eyelets positioned at at least one of the outer vertex and the inner vertex, wherein the first frame component and the second frame component include tethers positioned and connected through the vertices, the eyelets positioned at the vertices, the eyelets of the first frame component and the eyelets of the second frame component.

[0046] According to one example ("Example 43"), an implantable medical device comprises a first frame component configured to conform to the anatomical structure of a patient, a second frame component configured to conform to the anatomical structure of a patient, wherein at least one of the first frame component and the second frame component includes an inner vertex and an outer vertex, and one or more eyelets positioned at at least one of the outer vertex and the inner vertex, and a membrane, the membrane comprising a first layer and a second layer sandwiching the first frame component and the second frame component.

[0047] According to one example ("Example 44"), an implantable medical device includes a first frame component configured to conform to the patient's anatomical structure, a second frame component configured to conform to the patient's anatomical structure, wherein at least one of the first frame component and the second frame component includes an inner vertex and an outer vertex, and one or more eyelets positioned at at least one of the outer vertex and the inner vertex, and at least one of the first frame component and the second frame component includes a sector.

[0048] According to one example ("Example 45"), an implantable medical device includes a first frame component configured to conform to the patient's anatomical structure, a second frame component configured to conform to the patient's anatomical structure, wherein at least one of the first frame component and the second frame component includes an inner vertex and an outer vertex, and one or more eyelets positioned at at least one of the outer vertex and the inner vertex, wherein at least one of the first frame component and the second frame component includes a partial star shape.

[0049] According to one example ("Example 46"), an implantable medical device includes a first frame component configured to conform to the anatomical structure of a patient, a second frame component configured to conform to the anatomical structure of a patient, wherein at least one of the first frame component and the second frame component includes an inner vertex and an outer vertex, and one or more eyelets positioned at at least one of the outer vertex and the inner vertex, wherein at least one of the first frame component and the second frame component includes at least one elongated element that overlaps itself to form one or more loops, the one or more loops forming eyelets.

[0050] The examples described above are merely embodiments and should not be read to limit or otherwise narrow the scope of any concept of the Invention provided otherwise by this disclosure. Although several examples are disclosed, further embodiments will become apparent to those skilled in the art from the following detailed description, which illustrates exemplary examples. Accordingly, the drawings and detailed description should be considered illustrative, not restrictive, in nature. [Brief explanation of the drawing]

[0051] The accompanying drawings are included to provide a further understanding of this disclosure, are incorporated herein, constitute part thereof, illustrate embodiments, and, together with the description, help to illustrate the principles of this disclosure.

[0052] [Figure 1] Figure 1 shows an exemplary implantable medical device for regulating blood pressure according to one embodiment.

[0053] [Figure 2] Figure 2 shows an exemplary implantable medical device for regulating blood pressure according to one embodiment.

[0054] [Figure 3A] Figure 3A is a perspective view of another exemplary implantable medical device for regulating blood pressure, according to one embodiment.

[0055] [Figure 3B] Figure 3B is a side view of an implantable medical device for regulating blood pressure, as shown in Figure 3A, according to one embodiment.

[0056] [Figure 4] Figure 4 shows an exemplary frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment.

[0057] [Figure 5] Figure 5 shows another exemplary frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment.

[0058] [Figure 6] Figure 6 shows an exemplary frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment.

[0059] [Figure 7] Figure 7 shows an exemplary frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment.

[0060] [Figure 8] Figure 8 shows an exemplary frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment.

[0061] [Figure 9] Figure 9 shows an exemplary implantable medical device for regulating blood pressure according to one embodiment.

[0062] [Figure 10A] Figure 10A shows an end view of an exemplary implantable medical device for regulating blood pressure according to one embodiment.

[0063] [Figure 10B] Figure 10B shows an exemplary suture arrangement that can be used with the implantable medical device shown in Figure 10A, according to one embodiment.

[0064] [Figure 11] Figure 11 shows another exemplary frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment.

[0065] [Figure 12] Figure 12 shows another exemplary frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment.

[0066] [Figure 13A] Figure 13A shows an end view of an exemplary implantable medical device for regulating blood pressure according to one embodiment.

[0067] [Figure 13B] Figure 13B shows an exemplary material arrangement that can be used in the implantable medical device shown in Figure 13A, according to one embodiment.

[0068] [Figure 14] Figure 14 shows an end view of an exemplary implantable medical device for regulating blood pressure according to one embodiment.

[0069] [Figure 15] Figure 15 shows an end view of an exemplary implantable medical device for regulating blood pressure according to one embodiment.

[0070] [Figure 16] Figure 16 shows an end view of an exemplary implantable medical device for regulating blood pressure according to one embodiment.

[0071] [Figure 17] Figure 17 shows an exemplary implantable medical device and exemplary delivery system for regulating blood pressure according to one embodiment.

[0072] [Figure 18] Figure 18 shows another exemplary implantable medical device and exemplary delivery system for regulating blood pressure according to one embodiment.

[0073] [Figure 19] Figure 19 shows an exemplary implantable medical device and exemplary delivery system for regulating blood pressure according to one embodiment.

[0074] [Figure 20]Figure 20 shows an exemplary implantable medical device and exemplary delivery system for regulating blood pressure according to one embodiment.

[0075] [Figure 21] Figure 21 shows an exemplary implantable medical device and exemplary delivery system for regulating blood pressure according to one embodiment.

[0076] [Figure 22] Figure 22 shows an exemplary implantable medical device and exemplary delivery system for regulating blood pressure in a delivery configuration according to one embodiment. [Modes for carrying out the invention]

[0077] Definitions and Terms This disclosure is not intended to be read in a limited manner. For example, the terms used in this application should be read broadly in relation to the semantic relationships to which the terms in the art belong.

[0078] With regard to the terminology of inaccuracy, the terms “approximately” and “nearly” may be used interchangeably to refer to measurements that include the stated measurement and measurements that are reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates by only a reasonably small amount from the stated measurement, as understood and readily verifiable by a person skilled in the art. Such deviations may result from measurement errors, differences in the calibration of measurement and / or manufacturing equipment, human error in reading and / or setting of measurements, fine-tuning made to optimize performance and / or structural parameters to account for differences in measurements related to other components, specific implementation scenarios, improper adjustment and / or manipulation of the object by person or machine, etc. If a person skilled in the art determines that the value of such a reasonably small difference is not readily verifiable, the terms “approximately” and “nearly” may be understood to mean ±10% of the stated value.

[0079] Those skilled in the art will readily understand that various aspects of this disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to a fixed scale and may be exaggerated to illustrate various aspects of this disclosure; in this respect, the drawings should not be construed as limiting.

[0080] Various aspects of this disclosure relate to two implantable medical devices, such as devices for shunting and / or occluding bodily fluids or structures. In certain examples, various aspects of this disclosure relate to methods and devices for treating heart failure by reducing intracardiac hypertension by creating a pressure-relieving shunt. Furthermore, some embodiments relate to methods and devices for customizing, regulating, or manipulating blood flow through a shunt to enhance the therapeutic effect of the pressure-relieving shunt.

[0081] Figure 1 shows an exemplary implantable medical device for regulating blood pressure according to one embodiment. The implantable medical device 100 is shown to be implanted within the 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 atrium LA and the right atrium RA. As shown, the device 100 generally includes a first frame component 110 positioned on the first side of the septum (e.g., within the right atrium RA), a second frame component 120 positioned on the second side of the septum (e.g., within the left atrium LA), and a conduit portion 130 extending through the septum. A needle can be used to create an opening in the septum.

[0082] The deployment of the device 100 can be facilitated using a sheath 140 and restraint and / or release lines (not shown). For example, the first side of the device 100, including the first frame component 110, can be released after the sheath 140 has advanced through the septum to the RA, and the second frame component 120, including the second frame component 120, can be released on the LA side of the septum. A conduit portion 130 (e.g., shown in Figure 2) is positioned within the opening. The frame components 110, 120 and the conduit portion 130 can be compressed within the sheath 140 during the delivery of the device 100 to the desired therapeutic area in the patient and subsequently expanded during the deployment of the device 100.

[0083] Figure 2 shows an exemplary implantable medical device for regulating blood pressure according to one embodiment. As shown, the device 100 includes a first frame component 110 and a second frame component 120. The first frame component 110 may be configured to conform to the patient's anatomical structure (i.e., the first side of the septum). The second frame component 120 may be configured to conform to the patient's anatomical structure (i.e., the second side of the septum).

[0084] In a particular example, the first frame component 110 includes a first set 112 of elongated elements, and the second frame component 120 includes a second set 122 of elongated elements. For example, frame components 110 and 120, which include the elongated elements 112 and 122, can be distinct and separated from each other. For example, the first frame component 110 forms the first side 100a of the device 100, and the second frame component 120 forms the second side 100b of the device 100. The first frame component 110, which is distinct and separated from the second frame component 120, does not enter the second side 100b of the device, and the second frame component 120, which is distinct and separated from the first frame component 110, does not enter the first side 100a of the device.

[0085] In a particular example, the first and second frame components 110, 120 are not adjacent to each other. Because the first and second frame components 110, 120 are not adjacent to each other, they can be distinguished and separated from one another. Furthermore, the first and second frame components 110, 120 can move independently and freely in response to the movement of the patient's anatomical structure. In this way, a force acting on one of the first and second frame components 110, 120 is maintained within the other. A force acting on one of the first and second frame components 110, 120 can be separated from the frame component on which the force acts.

[0086] As shown, the conduit section 130 is positioned between the first frame component and the second frame component. At least a portion of the conduit section 130 is not generally supported radially or circumferentially by the first and second frame components 110, 120 within the conduit section 130. As shown in Figure 2, the conduit section 130 transitions to the first side 100a and the second side 100b at an angle of about 90 degrees (other angles are possible). The boundary of the conduit section 130 can be considered to be where the conduit section 130 transitions to the first side 100a and the second side 100b. The first and second frame components 110, 120 extend transversely to the conduit section 130. Furthermore, the first and second frame components 110, 120 can support the conduit section 130 without substantially encroaching on the boundary of the conduit section 130. In a particular example, the first and second frame components 110 and 120 support the conduit portion 130 transversely from outside its boundary. Thus, the first and second frame components 110 and 120 maintain the lumen through the conduit portion 130 and facilitate the deployment of the conduit portion 130 by forcing it to open transversely.

[0087] In certain examples, the first and second frame components 110, 120 can apply tension to the conduit portion 130, causing it to expand and be maintained within the lumen through which it passes. The conduit portion 130 can be expanded into the septum between tissue surfaces through an opening (e.g., a needle puncture across the septum) having a diameter smaller than the fully expanded diameter of the conduit portion 130. The tension in the conduit portion 130 provided 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.

[0088] In certain examples, the conduit portion 130 may not substantially include frame components. For example, the first and second frame components 110 and 120 are not adjacent to each other as described above, and are located outside the boundary of the conduit portion 130. The conduit portion 130 includes a membrane 132, such as an stretched polytetrafluoroethylene (ePTFE) membrane, which can connect the first frame component 110 and the second frame component 120. The membrane 132 generally separates the first frame component 110 and the second frame component 120 at an appropriate distance that fits within the patient's body. For example, the membrane 132 can separate the first frame component 110 and the second frame component 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 by the membrane 132 alone. A conduit portion 130 configured to unfold within a septum between tissue surfaces does not include the first frame component 110 and the second frame component 120. The conduit portion 130 may include a smooth interior that facilitates blood flow through it without any protrusions from the stent element interrupting or obstructing the flow. Thus, the conduit portion 130 can reduce the chance of thrombosis.

[0089] In addition to the membrane 132 forming the conduit portion 130, the membrane 132 may 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 both the first and second frame components 110. In certain examples, the membrane 132 positioned 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 positioned on the first frame component 110 and a second membrane film positioned on the second frame component 120). In these examples, one or more membrane films may be bonded to the membrane 132 in the conduit portion 130. The membrane 132 may be elastic to allow 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 a first set of elongated elements 112 and / or a second set of elongated elements 122).

[0090] The membrane 132 can span the gap between the first set 112 and / or the second set 122 of the elongated elements. In certain examples, the membrane 132 is positioned at least on the tissue engagement side of the first frame component 110 and on the tissue engagement side of the second frame component 120. In these examples, the membrane 132 is configured to reduce the possibility of frame erosion of the first frame component 110 and / or the second frame component 120. The arrangement of the membrane 132 and the first set 112 and / or the second set 122 of the elongated elements can be adapted to the tissue surface surrounding the partition. The first set 112 and / or the second set 122 of the elongated elements can be placed flat against the tissue surface.

[0091] In a particular example, each of the first set 112 of elongated elements can be attached to one another via a film 132 to form a first frame component 110. In a particular example, the first frame component 110 can form a substantially flat or two-dimensional disk shape, as shown. Additionally or alternatively, a second set 122 of elongated elements can also be attached to one another via a film 132 to form a second frame component 120. The second frame component 120 can also form a substantially flat or two-dimensional disk shape, such that the first frame components and the second frame components 110, 120 are substantially parallel to each other when the device 100 is in a deployed configuration.

[0092] In certain examples, the membrane 132 may be configured to promote tissue endothelial growth in at least a portion of the membrane 132, or over at least a portion of the membrane 132. In certain examples, the membrane 132 may be configured to promote tissue endothelial growth so as to cover at least a portion of the first frame component and / or the second frame component 110, 120, which can further promote the fit and stability of the device 100 in the patient's body. The membrane 132 within the conduit portion 130 may be configured not to allow tissue endothelial growth, leading to increased patency. In certain examples, the membrane 132 may be configured to promote endothelialization without occlusive endothelial growth within the conduit portion 130. The membrane 132 may promote endothelialization without occlusive overgrowth of tissue into the conduit portion 130.

[0093] In certain cases, device 100 may be able to deliver a drug to a desired therapeutic site in the patient's body. For example, device 100 may be able to elute a drug configured to modulate a tissue response. In certain cases, device 100 may be coated with a therapeutic coating, a drug-eluting material, or other therapeutic material or hydrophilic coating. In one particular case, device 100 may be coated with heparin to enhance the thrombotic resistance and patency of device 100. Alternatively or additionally, device 100 may contain paclitaxel (to modulate a tissue / cellular response).

[0094] Figure 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 first set of elongated elements 112 can be distinguished and separated from adjacent elongated elements. In other words, the membrane 132 does not connect each of the first set of elongated elements 112 together. In this way, each of the first set of elongated elements 112 can move independently of each other and fit individually to the topography of the first side of the partition, thus providing a highly adaptable first frame component 110. Each of the second set of elongated elements 122 can also be distinguished and separated from adjacent elongated elements. For example, each of the second set of elongated elements 122 can move independently of each other and fit individually to the second side of the partition, very similarly to how the first set of elongated elements 112 fit to the first side of the partition. Therefore, both the first frame component and the second frame components 110 and 120 are highly compatible and can be fitted independently of each other based on the patient's anatomical structure.

[0095] In certain examples, one of the first set or the second set 112, 122 of the elongated elements of the first and second frame components 110, 120 is attached to one another via the membrane 132, while the other set of elongated elements is not attached (for example, they are distinguished and separated from adjacent elongated elements). In other examples, only a portion of the first set or the second set 112, 122 of elongated elements can be attached to one another, while the other elongated elements of the first set and the second set 112, 122 are not attached. Thus, the device 100 can be highly customizable to the patient, depending, among other factors, on the desired treatment location within the patient and the size and / or shape of the defect.

[0096] The device 100 is generally deployable or expandable from a delivery configuration to a deployment configuration. In some examples, a first set of elongated elements 112 and a second set of elongated elements 122 can be nested within each other when the device is in a delivery configuration. This allows the device 100 to be compressed to a smaller size, enabling it to be delivered to a wider variety of treatment locations (e.g., through small, narrow, or complex passages).

[0097] Figure 3B is a side view of an implantable medical device for blood pressure regulation shown in Figure 3A, according to one embodiment. Figure 3B shows the device 100 in a deployed configuration. As shown, the first frame component 110, which includes a first set of elongated elements 112, and the second frame component 120, which includes a second set of elongated elements 122, are arranged radially outward with respect to the longitudinal axis L of the conduit portion 130 when the device 100 is in a deployed configuration. For example, the first and second frame components 110, 120 are arranged at a first angle and a second angle 114, 124, respectively. The first and second angles 114, 124 can form an angle of about 90° with respect to the longitudinal axis L when the device is in a deployed configuration. This allows the first and second frame components 110, 120 to be arranged adjacent to the first and second sides of the partition wall, parallel to each other. In certain examples, the first and second frame components 110 and 120 can be positioned at any angle with respect to the longitudinal axis L (for example, from approximately 0° to greater than 90° with respect to the longitudinal axis L), thereby allowing them to contact the tissue surfaces on the first and second sides of the partition.

[0098] In a particular example, the first and second long elements 112, 122 are configured to separate from each other when the device 100 is in a deployed configuration. As shown in Figure 3B, each of the first set of long elements 112 is distinguished and separated from each other when the device 100 is in a deployed configuration so that each of the first set of long elements 112 can move independently from adjacent long elements. Each of the second set of long elements 122 can also be distinguished and separated from each other when the device 100 is in a deployed configuration so that each of the second set of long elements 122 can move independently from adjacent long elements.

[0099] The first and second frame components 110, 120 maintain the lumen passing through the conduit portion 130 and facilitate the deployment of the conduit portion 130 by forcing it to open transversely. Furthermore, the lumen may be free or may not have the first and second frame components 110, 120. In this way, the conduit portion 130 can facilitate the re-crossing of the septum for additional procedures (e.g., left atrial appendage occlusion 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 may be flared, while the other is flat. In other examples, both the first and second frame components 110, 120 may be flared. Furthermore, one of the first frame component and the second frame component 110, 120 may be convex, while the other of the first frame component and the second frame component 110, 120 may be flat or concave, or both of the first frame component and the second frame component 110, 120 may be convex. Furthermore, one of the first frame component and the second frame component 110, 120 may be concave, while the other of the first frame component and the second frame component 110, 120 may be flat or convex, or both of the first frame component and the second frame component 110, 120 may be concave. Furthermore, the first frame component and the second frame component 110, 120 may be of different sizes.

[0100] The first and second frame components 110, 120 may include sensors integrated into each frame component to continuously monitor 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 detect physiological properties such as temperature, electrical signals of the heart, blood chemistry, blood pH levels, hemodynamics, biomarkers, sound, pressure, and electrolytes, which may be important for the diagnosis, monitoring, and / or treatment of heart disease, heart failure, and / or other cardiovascular conditions.

[0101] In certain cases, the conduit portion 130 can become considerably 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 of any size suitable to fit the patient's anatomical structure. In certain cases, the diameter of the conduit portion is 3 to 12 mm. For example, the diameter of the conduit portion can be 4 to 10 mm or 5 to 8 mm, depending on the patient's anatomical structure and / or the desired treatment location. The first and second frame components 110, 120 generally have a larger diameter than, for example, the diameter of the conduit portion 130, so that the frame components can fix the conduit portion 130 of the device 100 within the septum.

[0102] The device 100 can be any shape suitable for conforming to the patient's anatomical structure. For example, the first frame portion and the second frame portion 110, 120 can be any of a variety of suitable shapes for fixing the device 100 inside the patient's body. For example, the first frame portion and the second frame portion 110, 120 can be substantially circular, oval, diamond-shaped, star-shaped, floral-shaped, or any other suitable shape as desired. In a particular example, for example, at least one of the first set and the second set 112, 122 of the elongated elements forms a star shape. In a particular example, both the first set and the second set 112, 122 of the elongated elements form a star shape.

[0103] In a particular example, a first set 112 of elongated elements forms a plurality of first lobes 116, and a second set 122 of elongated elements forms a plurality of second lobes 126. Each of the plurality of first lobes and plurality of second lobes 116, 126 may, as desired, contain, for example, 3 to 12 lobes, 4 to 10 lobes, or 6 to 8 lobes. In a particular example, the plurality of first lobes 116 may have more lobes than the plurality of second lobes 126, and in other examples, the plurality of first lobes 116 may have the same number of lobes as the plurality of second lobes 126 or fewer lobes.

[0104] Figure 4 shows an exemplary frame component 400 that can be used in an implantable medical device for regulating blood pressure according to one embodiment. Frame component 400 can be used in place of one or both of the frame components 110, 120 shown and discussed above with reference to Figures 1-3. For example, frame component 400 replaces the first frame component and / or the second frame components 110, 120 to maintain the lumen through the conduit portion 130. Frame component 400 may include elongated elements 112 that form the frame component 400. The elongated elements 112 may be formed from, for example, wire, cut tubing, or cut sheet. In certain examples, the elongated elements 112 can be attached to each other via a membrane (not shown). Furthermore, as discussed in detail above, a membrane such as an stretched polytetrafluoroethylene (ePTFE) membrane can connect the frame components 400 and form the conduit portion 130.

[0105] The membrane can span the gaps between the elongated elements 112 and, in certain examples, can be positioned at least on the tissue engagement side of the frame component 400. In these examples, the membrane is configured to reduce the possibility of frame erosion of the frame component 400. The elongated elements 112 can conform to the tissue surface surrounding the septum. Furthermore, the elongated elements 112 can be placed flat against the tissue surface.

[0106] In a particular example, the elongated element 112 forms a star shape as shown in Figure 4. The star-shaped frame component 400 includes an outer vertex 402 and an inner vertex 404. In a particular example, the frame element 400 may include one or more eyelets 406 located at at least one of the outer vertices 402 and the inner vertices 404. One or more eyelets 406 may be located on either side of the inner vertex 404. In a particular example, each of the inner vertices 404 includes a pair of eyelets 406 as shown in Figure 4. In another example, the eyelets 406 may instead be located at the outer vertex 402. In yet another example, the eyelets 406 may be located at both the outer vertex 402 and the inner vertex 404. The eyelets 406 may be configured to interface with a delivery system to facilitate the unfolding of the frame element.

[0107] Figure 5 shows another exemplary frame component that can be used in an implantable medical device for regulating blood pressure according to one embodiment. Frame component 500 can be used in place of one or both of the frame components 110, 120 shown and discussed above with reference to Figures 1-3. For example, frame component 500 can replace the first frame component and / or the second frame components 110, 120 and maintain the lumen through the conduit portion 130. Frame component 500 may include elongated elements 112 that form the frame component 500. The elongated elements 112 may be formed from, for example, wire, cut tubing or cut sheet. In certain examples, the elongated elements 112 can be attached to each other via a membrane (not shown). Furthermore, as discussed in detail above, a membrane such as an stretched polytetrafluoroethylene (ePTFE) membrane can connect the frame components 500 and form the conduit portion 130.

[0108] The membrane can span the gaps between the elongated elements 112 and, in certain examples, can be positioned at least on the tissue engagement side of the frame component 500. In these examples, the membrane is configured to reduce the possibility of frame erosion of the frame component 400. The elongated elements 112 can conform to the tissue surface surrounding the septum. Furthermore, the elongated elements 112 can be placed flat against the tissue surface.

[0109] In a particular example, the elongated element 112 forms a star shape as shown in Figure 5. The star-shaped frame element 500 includes a first surface 512 and a second surface 514. In a particular example, the frame element 500 may include eyelets 406 extending around the frame element 500. The eyelets 406 may be positioned along one or both of the first surface 512 and the second surface 514. In a particular example, the eyelets 406 extend around the frame element 500 and are positioned alternately on the first surface 512 and the second surface 514 as shown in Figure 5. The eyelets 406 may be configured to interface with a delivery system to facilitate the deployment of the frame element.

[0110] Figure 6 shows an exemplary frame component that can be used in an implantable medical device for regulating blood pressure according to one embodiment. Frame component 600 can be used in place of one or both of the frame components 110, 120 shown and discussed above with reference to Figures 1-3. For example, frame component 600 can replace the first frame component and / or the second frame components 110, 120 and maintain a lumen through the conduit portion 130. Frame component 600 may include elongated elements 112 that form the frame component 600. The elongated elements 112 can be formed from, for example, wire, cut tubing, or cut sheet. In certain examples, the elongated elements 112 can be attached to each other via a membrane (not shown). Furthermore, as discussed in detail above, a membrane such as an stretched polytetrafluoroethylene (ePTFE) membrane can connect the frame components 600 and form the conduit portion 130.

[0111] The membrane can span the gaps between the elongated elements 112 and, in certain examples, can be positioned at least on the tissue engagement side of the frame component 600. In these examples, the membrane is configured to reduce the possibility of frame erosion of the frame component 600. The elongated elements 112 can conform to the tissue surface surrounding the septum. Furthermore, the elongated elements 112 can be placed flat against the tissue surface.

[0112] In a particular example, the elongated element 112 includes a variable-width portion as shown in Figure 6. The frame element 600 includes vertices 602 arranged around the frame element 600. Between the vertices 602, the width of the elongated element 112 can vary. The frame element 600 may include wider width portions 620 and narrower width portions 622. In a particular example, the frame element 600 may include two wider width portions 620 and one narrower width portion 622 between two vertices 602. In a particular example, the narrower width portion 622 is located between two wider width portions 620. Furthermore, the frame element 600 may also include an eyelet 406. In a particular example, the eyelet 406 is located in the wider width portion 620 of the frame element 600. The eyelet 406 may be configured to interface with a delivery system to facilitate the unfolding of the frame element.

[0113] Figure 7 shows an exemplary frame component that can be used in an implantable medical device for regulating blood pressure according to one embodiment. The frame component 700 can be used in place of one or both of the frame components 110, 120 shown and discussed above with reference to Figures 1-3. For example, the frame component 700 can replace the first frame component and / or the second frame components 110, 120 and maintain a lumen through the conduit portion 130. The frame component 700 may include elongated elements 112 that form the frame component 700. The elongated elements 112 can be formed from, for example, wire, cut tubing, or cut sheet. In certain examples, the elongated elements 112 can be attached to each other via a membrane (not shown). Furthermore, as discussed in detail above, a membrane such as an stretched polytetrafluoroethylene (ePTFE) membrane can connect the frame components 700 and form the conduit portion 130.

[0114] The membrane can span the gaps between the elongated elements 112 and, in certain examples, can be positioned at least on the tissue engagement side of the frame component 700. In these examples, the membrane is configured to reduce the possibility of frame erosion of the frame component 700. The elongated elements 112 can conform to the tissue surface surrounding the septum. Furthermore, the elongated elements 112 can be placed flat against the tissue surface.

[0115] In a particular example, the elongated element 112 forms a star shape as shown in Figure 7. The star-shaped frame element 700 includes a first surface 512 and a second surface 514. In a particular example, the frame element 700 may include an opening 740 extending around the frame element 700 between the first surface 512 and the second surface 514. In a particular example, the opening 740 may be rectangular in shape. The opening 740 may be configured to interface with a delivery system to facilitate the deployment of the frame element. Figure 8 shows another exemplary frame component 800 having an opening 740 between the first surface 512 and the second surface 514.

[0116] Figure 9 shows an exemplary implantable medical device 900 for regulating blood pressure according to one embodiment. The device 900 includes two frame components 800 and a membrane 132 connecting the components 800, as discussed above in relation to Figures 7-8. As shown in Figure 9, the device 900 includes a conduit portion 130, as discussed in detail above. The frame components 800 may be any of the frame components discussed herein.

[0117] As shown, the device 900 includes one or more tethers 952 that connect the frame components 800 and are positioned through the conduit portion 130. In a particular example, one or more tethers 952 are positioned through openings 740 in the frame component 800. The tethers 952 may be configured to structurally reinforce the conduit portion 130. Figure 10A shows an end view of another exemplary implantable medical device 1000 and frame component 1010 for regulating blood pressure, having tethers 952 positioned through spaced openings 740 around the inner circumference of the frame component 1010. The tethers 952 can be fibers, wires, polymer (e.g., ePTFE) strips, braided fibers or wires, woven fibers or wires, or other similar structural elements. Figure 10B shows an exemplary tether 952 arrangement that can be used in the implantable medical device shown in Figure 10A, according to one embodiment.

[0118] Figure 11 shows another exemplary frame component that can be used in an implantable medical device for regulating blood pressure according to one embodiment. Frame component 1100 can be used in place of one or both of the frame components 110, 120 shown and discussed above with reference to Figures 1-3. For example, frame component 1100 can replace the first frame component and / or the second frame components 110, 120 and can maintain the lumen through the conduit portion 130. Frame component 1100 may include elongated elements 112 that form the frame component 1100. The elongated elements 112 may be formed from, for example, wire, cut tube or cut sheet. In certain examples, the elongated elements 112 can be attached to each other via a membrane (not shown). Furthermore, as discussed in detail above, a membrane such as an stretched polytetrafluoroethylene (ePTFE) membrane can connect the frame components 1100 and form the conduit portion 130.

[0119] The membrane can span the gaps between the elongated elements 112 and, in certain examples, can be positioned at least on the tissue engagement side of the frame component 1100. In these examples, the membrane is configured to reduce the possibility of frame erosion of the frame component 1100. The elongated elements 112 can conform to the tissue surface surrounding the septum. Furthermore, the elongated elements 112 can be placed flat against the tissue surface.

[0120] In a particular example, the elongated element 112 forms a curved star shape, as shown in Figure 11. The star-shaped frame element 1100 includes the elongated element 112, which includes a curve between the vertices 402. In a particular example, the frame component 1100 also includes eyelets 406 positioned at each vertex 402. The eyelets 406 may be configured to interface with a delivery system to facilitate the unfolding of the frame element.

[0121] Figure 12 shows another exemplary frame component that can be used in an implantable medical device for regulating blood pressure according to one embodiment. Frame component 1200 can be used in place of one or both of the frame components 110, 120 shown and discussed above with reference to Figures 1-3. For example, frame component 1200 can replace the first frame component and / or the second frame components 110, 120 and maintain the lumen through the conduit portion 130. Frame component 1200 may include elongated elements 112 that form the frame component 1200. The elongated elements 112 can be formed from, for example, wire, cut tubing, or cut sheet. In certain examples, the elongated elements 112 can be attached to each other via a membrane (not shown). Furthermore, as discussed in detail above, a membrane such as an stretched polytetrafluoroethylene (ePTFE) membrane can connect the frame components 1200 and form the conduit portion 130.

[0122] The membrane can span the gaps between the elongated elements 112 and, in certain examples, can be positioned at least on the tissue engagement side of the frame component 1200. In these examples, the membrane is configured to reduce the possibility of frame erosion of the frame component 1200. The elongated elements 112 can conform to the tissue surface surrounding the septum. Furthermore, the elongated elements 112 can be placed flat against the tissue surface.

[0123] In a particular example, the elongated element 112 forms a star shape as shown in Figure 12. The star-shaped frame element 1200 includes outer vertices 402 and inner vertices 404. In a particular example, the frame element 1200 may include an eyelet 406 positioned at at least one of the outer vertices 402 and inner vertices 404. In a particular example, a tether 1250 is positioned and connected through each of the eyelets 406. The tether 1250 can structurally reinforce the frame element 1200.

[0124] Figure 13A shows an end view of an exemplary implantable medical device 1300 for regulating blood pressure according to one embodiment. Figure 13B shows an exemplary material arrangement that can be used in the implantable medical device 1300 shown in Figure 13A, according to one embodiment. As shown in Figures 13A-B, the implantable medical device 1300 includes frame components 1302, 1304 and a membrane 132. The membrane 132 may include two layers 132a, 132b, as shown in Figure 13B. In a particular example, the two layers 132a, 132b of the membrane 132 sandwich the frame components 1302, 1304. The two layers 132a, 132b of the membrane 132 may have different material properties and may promote flexibility along different parts of the device 1300.

[0125] Figure 14 shows an end view of an exemplary implantable medical device 1400 for regulating blood pressure according to one embodiment. The device 1400 includes one or more frame components 1402, as discussed in detail above. As shown, the frame components 1402 include a fan-shaped or starfish-like shape with a curved elongated element 112. The frame components 1402 can contract and twist to unfold. The device includes a membrane 132 coupled to or attached to the frame component 1602, as discussed in detail above.

[0126] Figure 15 shows an end view of an exemplary implantable medical device 1500 for regulating blood pressure according to one embodiment. The device 1500 includes one or more frame components 1502, as discussed in detail above. As shown, the frame component 1502 includes a partial star shape formed by elongated elements 112. In certain examples, the frame component 1502 may include fewer star-shaped branches formed by the elongated elements 112 than shown. The device includes a membrane 132 bonded to or attached to the frame component 1502, as discussed in detail above.

[0127] Figure 16 shows an end view of an exemplary implantable medical device 1600 for regulating blood pressure according to one embodiment. The device 1600 includes one or more frame components 1602, as discussed in detail above. The device also includes a membrane 132 coupled to or attached to the frame components 1602, as discussed in detail above. In a particular example, the frame component 1602 is formed by a long element 112 including a plurality of loops 1604. The long element 112 extends outward and overlaps itself to form the loops 1604 as shown.

[0128] Figure 17 shows an exemplary implantable medical device 1700 and an exemplary delivery system 1750 for regulating blood pressure according to one embodiment. As discussed in detail above, the medical device 1700 includes a first frame component 1702, a second frame component 1704, and a conduit portion 130. The medical device 1700 also includes a membrane 132 coupled to the frame components 1702, 1704, which forms the conduit portion 130, as discussed in detail above.

[0129] The delivery system 1750 may include a delivery sheath 1752 configured to enclose the medical device 1700 in a collapsed configuration or a delivery sheath configuration. The delivery system 1750 may also include an internal catheter 1754 and a tether 1756 that engage with a portion of one or both of the frame components 1702, 1704 (e.g., via an eyelet as described above). The tether 1756 can collapse the frame components 1702, 1704 toward the internal catheter 1754 in response to tension. The medical device 1700 can collapse into a delivery configuration (e.g., as shown in Figure 22). Figures 18–21 show other exemplary implantable medical devices with a delivery system for regulating blood pressure, and Figure 22 shows the collapsed configuration of the device.

[0130] The invention of this application has been described both generally and with respect to specific embodiments above. It will be apparent to those skilled in the art that various changes and modifications can be made in embodiments without departing from the scope of this disclosure. Accordingly, the embodiments are intended to cover changes and modifications of the invention, insofar as they fall within the scope of the appended claims and equivalent forms thereof. The following are aspects of the present invention. [Aspect 1] A first frame component configured to conform to the patient's anatomical structure, A second frame component configured to conform to the anatomical structure of a patient, wherein at least one of the first frame component and the second frame component includes an inner vertex and an outer vertex, and one or more eyelets positioned at at least one of the outer vertex and the inner vertex. Includes, An implantable medical device wherein at least one of the first frame component and the second frame component includes a star shape having an inner vertex and an outer vertex, and the one or more eyelets include a plurality of eyelet pairs, one of the plurality of eyelet pairs being located on either side of at least one of the inner vertex and the outer vertex. [Aspect 2] The implantable medical device according to embodiment 1, wherein the plurality of eyelet pairs are located on the first side of the inner vertex. [Aspect 3] The implantable medical device according to embodiment 1, wherein the plurality of eyelet pairs include a first plurality of eyelet pairs, each positioned adjacent to the inner vertex, and a second plurality of eyelet pairs, each positioned adjacent to the outer vertex. [Aspect 4] The implantable medical device according to embodiment 3, wherein each of the first eyelet pairs is positioned adjacent to the inner vertex on the first side of at least one of the first frame component and the second frame component, and each of the second eyelet pairs is positioned adjacent to the outer vertex on the second side of at least one of the first frame component and the second frame component. [Aspect 5] The implantable medical device according to Embodiment 1, wherein at least one of the first frame component and the second frame includes a first surface and a second surface, and the plurality of eyelet pairs extend around the frame component along one or both of the first surface and the second surface. [Aspect 6] The implantable medical device according to embodiment 5, wherein the plurality of eyelet pairs extend around the frame element and are alternately arranged on the first surface and the second surface. [Aspect 7] The implantable medical device according to embodiment 1, wherein at least one of the inner vertex and the outer vertex includes one or more wider width portions and one or more narrower width portions disposed between at least one of the inner vertex and the outer vertex. [Aspect 8] The implantable medical device according to embodiment 7, wherein at least one of the first frame component and the second frame component includes two wider width portions and one narrower width portion between two of the vertices. [Aspect 9] The implantable medical device according to embodiment 8, wherein the plurality of eyelet pairs are arranged in one or more wider width portions. [Aspect 10] An implantable medical device according to any one of embodiments 1 to 9, further comprising a conduit portion disposed between the first frame component and the second frame component, and one or more tethers coupled to the first frame component and the second frame component and disposed through the conduit portion. [Aspect 11] The implantable medical device according to embodiment 10, wherein one or more tethers are configured to structurally reinforce the conduit portion. [Aspect 12] An implantable medical device according to any one of embodiments 1 to 11, further comprising a membrane including a first layer and a second layer sandwiching the first frame component and the second frame component. [Aspect 13] A first frame component configured to conform to the patient's anatomical structure, A second frame component configured to conform to the anatomical structure of a patient, wherein at least one of the first frame component and the second frame component includes an inner vertex and an outer vertex, and one or more eyelets positioned at at least one of the outer vertex and the inner vertex. Includes, An implantable medical device wherein at least one of the first frame component and the second frame component includes a first surface and a second surface, and an opening between the first surface and the second surface. [Aspect 14] An implantable medical device according to embodiment 13, further comprising a conduit portion disposed between the first frame component and the second frame component, and one or more tethers coupled to the first frame component and the second frame component and disposed through the conduit portion. [Aspect 15] The implantable medical device according to embodiment 14, wherein one or more tethers are configured to structurally reinforce the conduit portion.

Claims

1. A first frame component configured to conform to the patient's anatomical structure, and A second frame component configured to conform to the patient's anatomical structure. Includes, An implantable medical device wherein at least one of the first frame component and the second frame component includes a star shape having an inner vertex and an outer vertex, and one or more eyelets including a plurality of eyelet pairs, the plurality of eyelet pairs each including a first plurality of eyelet pairs arranged on either side of the inner vertex, and a second plurality of eyelet pairs arranged on either side of the outer vertex.

2. The implantable medical device according to claim 1, wherein each of the first plurality of eyelet pairs is positioned on the first side of at least one of the first frame component and the second frame component, straddling the inner vertex, and each of the second plurality of eyelet pairs is positioned on the second side of at least one of the first frame component and the second frame component, straddling the outer vertex.

3. The implantable medical device according to claim 1, wherein at least one of the first frame component and the second frame component includes a first surface and a second surface, and the plurality of eyelet pairs extend around the frame component along one or both of the first surface and the second surface.

4. The implantable medical device according to claim 3, wherein the plurality of eyelet pairs extend around the frame component and are alternately arranged on the first surface and the second surface.

5. The implantable medical device according to claim 1, wherein at least one of the inner vertex and the outer vertex includes one or more wider portions and one or more narrower portions disposed between at least one of the inner vertex and the outer vertex.

6. The implantable medical device according to claim 5, wherein at least one of the first frame component and the second frame component includes two wider width portions and one narrower width portion between two of the vertices.

7. The implantable medical device according to claim 6, wherein the plurality of eyelet pairs are arranged in one or more wider width portions.

8. An implantable medical device according to any one of claims 1 to 7, further comprising a conduit portion disposed between the first frame component and the second frame component, and one or more tethers coupled to the first frame component and the second frame component and disposed through the conduit portion.

9. The implantable medical device according to claim 8, wherein one or more tethers are configured to structurally reinforce the conduit portion.

10. An implantable medical device according to any one of claims 1 to 9, further comprising a membrane including a first layer and a second layer sandwiching the first frame component and the second frame component.

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