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

Abstract

An implantable medical device includes a first frame component. The first frame component includes a first set of elongated elements configured to conform to an anatomical structure of a patient. The implantable medical device also includes a second frame component including a second set of elongated elements configured to conform to the anatomical structure of the patient. The first frame component and the second frame component are discrete and separate from one another. The implantable medical device further includes a conduit portion disposed 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.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of provisional patent application No. 62 / 962541, filed on January 17, 2020, the full text of which is incorporated herein by reference for all purposes. Technical Field

[0003] This disclosure generally relates to implantable medical devices, and more specifically to implantable medical devices for shunting and / or occluding bodily fluids or body structures, and related systems and methods.

[0004] background

[0005] Heart failure and heart disease affect millions of people worldwide. Heart failure includes failure of the left, right, or both sides of the heart. Heart conditions that can lead to heart failure include high blood pressure, pulmonary hypertension, and congenital heart defects. The progressive nature of heart failure represents a significant challenge to treatment methods. Therefore, new and adaptable methods and devices are needed to treat heart failure. Summary of the Invention

[0006] According to one example (“Example 1”), an implantable medical device includes a first frame component configured to conform to the anatomy of a patient; a second frame component configured to conform to the anatomy of a patient, wherein the first frame component and the second frame component are discrete (separate) and separate from each other, and 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 apertures disposed together with 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, the conduit portion including a membrane connecting the first frame component and the second frame component.

[0007] According to a further example of the device relative to Example 1 (“Example 2”), at least a portion of the conduit portion is not radially supported within the conduit portion by the first frame member and the second frame member.

[0008] According to another further example of the device relative to Example 2 (“Example 3”), the first frame component and the second frame component are configured to facilitate the deployment of the catheter portion and maintain the lumen through the catheter portion.

[0009] In a further example (“Example 4”) of the device relative to any of Examples 1-3, the conduit portion has no frame component.

[0010] According to a further example of the device relative to any one of Examples 1-4 (“Example 5”), the first frame component includes a first set of elongated elements, and 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.

[0011] According to another further example of the device relative to Example 5 (“Example 6”), the first set of elongated elements includes a first plurality of support struts, and wherein the second set of elongated elements includes a second plurality of support struts, the first and second plurality of support struts forming a support structure within each elongated element.

[0012] According to another further example of the device relative to Example 6 (“Example 7”), the first set of elongated elements forms a plurality of first convex corners.

[0013] According to another further example of the device relative to Example 6 (“Example 8”), the first set of elongated elements forms a star shape.

[0014] According to a further example of the device relative to any one of Examples 1-8 (“Example 9”), 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.

[0015] According to another further example of the device relative to Example 9 (“Example 10”), one or more eyelets include a pair of eyelets disposed on either side of at least one inner vertex.

[0016] According to another further example of the device relative to any one of Examples 1-8 (“Example 11”), 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 element along one or both of the first surface and the second surface.

[0017] According to another further example (“Example 12”) of the device relative to Example 11, the eyelets extend around the frame element and are alternately disposed on the first and second surfaces.

[0018] According to another further example of the device relative to any of Examples 1-8 (“Example 13”), at least one of the inner vertex and the outer vertex includes one or more larger width portions and one or more smaller width portions disposed between the inner vertex and the outer vertex.

[0019] According to another further example of the device relative to Example 13 (“Example 14”), at least one of the first frame component and the second frame component includes two larger width portions and a smaller width portion located between two vertices of each vertex.

[0020] According to another further example of the device relative to Example 14 (“Example 15”), the eyelet is provided together with one or more larger width portions.

[0021] According to another further example (“Example 16”) of the device relative to any one of Examples 1-8, at least one of the first frame component and the second frame component includes a first surface and a second surface and an opening located between the first surface and the second surface.

[0022] According to another further example (“Example 17”) of the device relative to any of Examples 1-8, the device also includes one or more tethers coupled to the first frame component and the second frame component and configured to pass through the conduit portion.

[0023] According to another further example (“Example 18”) of the device relative to Example 17, one or more tethers are configured to structurally reinforce the conduit portion.

[0024] According to another further example (“Example 19”) of the device relative to any one of Examples 1-8, at least one of the first frame component and the second frame component includes a curved star shape.

[0025] According to another further example of the device relative to any of Examples 1-8 (“Example 20”), at least one of the first frame component and the second frame component includes a vertex, an eyelet disposed at the vertex, and a tether configured to pass through and connect the eyelet.

[0026] According to another further example (“Example 21”) of the device relative to any of Examples 1-8, the membrane includes a first layer and a second layer that clamp the first frame member and the second frame member.

[0027] According to another further example (“Example 22”) of the device relative to any one of Examples 1-8, at least one of the first frame component and the second frame component includes a sector.

[0028] According to another further example (“Example 23”) of the device relative to any one of Examples 1-8, at least one of the first frame component and the second frame component includes a partial star shape.

[0029] According to another further example (“Example 24”) of the device relative to any one of Examples 1-8, 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 rings, and the one or more rings form an eyelet.

[0030] According to another example (“Example 25”), a method for regulating blood pressure between the left and right atria of a heart includes: delivering an implantable medical device to a desired treatment site in a patient, the implantable medical device including a catheter portion configured to cross a diaphragm of the heart and configured to allow fluid to flow therethrough; a frame component including a first set of elongated elements disposed on a first side of the catheter portion and a second set of elongated elements disposed on a second side of the catheter portion, wherein the first and second sets of elongated elements are not adjacent to each other, and at least one of the first and second frame components includes an inner apex and an outer apex, and one or more apertures disposed together with at least one of the outer and inner apexes; positioning the device such that the catheter portion crosses a diaphragm between the left and right atria of the heart; and deploying the first and second frame components such that the catheter portion opens by a desired amount to provide a fluid flow path between the left and right atria.

[0031] According to another example (“Example 26”) that is a further step relative to the method of Example 25, the method further includes: adjusting the tension on the device to adjust the diameter of the conduit portion and the flow rate (flow rate) of the fluid passing through it.

[0032] According to one example (“Example 27”), an implantable medical device includes a first frame component configured to conform to the anatomy of a patient; a second frame component configured to conform to the anatomy 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 disposed together with at least one of the outer vertex and the inner vertex; and 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 (multiple pairs of eyelets), wherein one of the plurality of eyelet pairs (one pair of eyelets among multiple pairs of eyelets) is disposed on either side of each of at least one of the inner vertex and the outer vertex.

[0033] According to another further example (“Example 28”) of the implantable medical device relative to Example 27, multiple pairs of eyelets (multiple pairs of eyelets) are provided on the first side of the inner vertex.

[0034] According to another further example (“Example 29”) of the implantable medical device relative to Example 27, the plurality of eye pairs include a first plurality of eye pairs and a second plurality of eye pairs, the first plurality of eye pairs being configured to be adjacent to an inner vertex and the second plurality of eye pairs being configured to be adjacent to an outer vertex.

[0035] According to another further example of the implantable medical device relative to Example 29 (“Example 30”), a first plurality of eyelet pairs are disposed on a first side of at least one of the first frame member and the second frame member, adjacent to an inner vertex, and a second plurality of eyelet pairs are disposed on a second side of at least one of the first frame member and the second frame member, adjacent to an outer vertex.

[0036] According to another further example (“Example 31”) of the implantable medical device relative to Example 27, at least one of the first frame component and the second frame component includes a first surface and a second surface, and a plurality of eyelets extend around the frame element along one or both of the first surface and the second surface.

[0037] According to another further example (“Example 32”) of the implantable medical device relative to Example 31, a plurality of eyelets extend around the frame element and are alternately disposed on the first and second surfaces.

[0038] According to another further example (“Example 33”) of the implantable medical device relative to Example 27, at least one of the inner vertex and the outer vertex includes one or more larger width portions and one or more smaller width portions disposed between the inner vertex and the outer vertex.

[0039] According to another further example (“Example 34”) of the implantable medical device relative to Example 33, at least one of the first frame component and the second frame component includes two larger width portions and a smaller width portion located between two vertices of each vertex.

[0040] According to another further example (“Example 35”) of the implantable medical device relative to Example 34, multiple pairs of eyelets (multiple pairs of eyelets) are disposed together with one or more larger width portions.

[0041] According to another further example (“Example 36”) of the implantable medical device relative to any of Examples 27-35, the implantable medical device further includes a catheter portion disposed between the first frame component and the second frame component, and one or more tethers connected to the first frame component and the second frame component and configured to pass through the catheter portion.

[0042] According to another further example (“Example 37”) of the implantable medical device relative to Example 36, one or more tethers are configured to structurally reinforce the catheter portion.

[0043] According to another further example (“Example 38”) of the implantable medical device relative to any of Examples 27-37, the implantable medical device also includes a membrane comprising a first layer and a second layer that clamp (grip) the first frame component and the second frame component.

[0044] According to one example (“Example 39”), an implantable medical device includes: a first frame component configured to conform to the anatomy of a patient; a second frame component configured to conform to the anatomy 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 apertures disposed together with at least one of the outer vertex and the inner vertex; and 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.

[0045] According to another further example of the implantable medical device relative to Example 39 (“Example 40”), the implantable medical device also includes a catheter portion disposed between the first frame component and the second frame component, and one or more tethers connected to the first frame component and the second frame component and configured to pass through the catheter portion.

[0046] According to another further example (“Example 41”) of the implantable medical device relative to Example 40, one or more tethers are configured to structurally reinforce the catheter portion.

[0047] According to one example (“Example 42”), 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 disposed together with at least one of the outer vertex and the inner vertex; and wherein the first frame component and the second frame component include a vertex, an eyelet disposed at the vertex, and a tether disposed through and connecting the eyelet of the first frame component and the eyelet of the second frame component.

[0048] According to one example (“Example 43”), an implantable medical device includes: a first frame component configured to conform to the anatomy of a patient; a second frame component configured to conform to the anatomy 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 apertures disposed together with at least one of the outer vertex and the inner vertex; and a membrane including a first layer and a second layer sandwiching the first frame component and the second frame component.

[0049] According to one example (“Example 44”), 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 apertures disposed together with 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 fan shape.

[0050] According to one example (“Example 45”), 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 apertures disposed together with at least one of the outer vertex and the inner vertex; and wherein at least one of the first frame component and the second frame component includes a partial star shape.

[0051] According to one example (“Example 46”), an implantable medical device includes: a first frame component configured to conform to the anatomy of a patient; a second frame component configured to conform to the anatomy 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 disposed together with at least one of the outer vertex and the inner vertex; and 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, and the one or more loops form the eyelets.

[0052] The foregoing examples are merely illustrative and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by this disclosure. Although several examples have been disclosed, other examples will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples of the invention. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive in nature. Attached Figure Description

[0053] The accompanying drawings are included to provide a further understanding of the present disclosure, and the drawings are incorporated in and form part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the present disclosure.

[0054] Figure 1 This is an example implantable medical device for regulating blood pressure according to one embodiment.

[0055] Figure 2 This is an example implantable medical device for regulating blood pressure according to one embodiment.

[0056] Figure 3A This is a perspective view of another example implantable medical device for regulating blood pressure according to one embodiment.

[0057] Figure 3B According to one embodiment, Figure 3A The image shows a side view of an implantable medical device for regulating blood pressure.

[0058] Figure 4 An example frame component is shown that can be used in an implantable medical device for regulating blood pressure according to one embodiment.

[0059] Figure 5 Another example frame component is shown that can be used in an implantable medical device for regulating blood pressure, according to one embodiment.

[0060] Figure 6 An example frame component is shown that can be used in an implantable medical device for regulating blood pressure according to one embodiment.

[0061] Figure 7 An example frame component is shown that can be used in an implantable medical device for regulating blood pressure according to one embodiment.

[0062] Figure 8 An example frame component is shown that can be used in an implantable medical device for regulating blood pressure according to one embodiment.

[0063] Figure 9 An example implantable medical device for regulating blood pressure is shown according to one embodiment.

[0064] Figure 10A An end view of an example implantable medical device for regulating blood pressure is shown according to one embodiment.

[0065] Figure 10B An embodiment of the invention is shown that can be used with Figure 10A The example suture setup shown is for use with implantable medical devices.

[0066] Figure 11 Another example frame component is shown that can be used in an implantable medical device for regulating blood pressure, according to one embodiment.

[0067] Figure 12 Another example frame component is shown that can be used in an implantable medical device for regulating blood pressure, according to one embodiment.

[0068] Figure 13A An end view of an example implantable medical device for regulating blood pressure is shown according to one embodiment.

[0069] Figure 13BAn example of a [symbol / example] is shown. Figure 13A The example material setup shown is for use with implantable medical devices.

[0070] Figure 14 An end view of an example implantable medical device for regulating blood pressure is shown according to one embodiment.

[0071] Figure 15 An end view of an example implantable medical device for regulating blood pressure is shown according to one embodiment.

[0072] Figure 16 An end view of an example implantable medical device for regulating blood pressure is shown according to one embodiment.

[0073] Figure 17 An example implantable medical device and an example delivery system for regulating blood pressure are shown according to one embodiment.

[0074] Figure 18 Another example implantable medical device and example delivery system for regulating blood pressure are shown according to one embodiment.

[0075] Figure 19 An example implantable medical device and an example delivery system for regulating blood pressure are shown according to one embodiment.

[0076] Figure 20 An example implantable medical device and an example delivery system for regulating blood pressure are shown according to one embodiment.

[0077] Figure 21 An example implantable medical device and an example delivery system for regulating blood pressure are shown according to one embodiment.

[0078] Figure 22 An example implantable medical device and an example delivery system for regulating blood pressure in a delivery configuration are shown according to one embodiment. Detailed Implementation

[0079] Definitions and Terms

[0080] This disclosure is not intended to be read in a restrictive manner. For example, the terms used in this application should be read broadly in the context of their meanings to be attributed to those skilled in the art.

[0081] Regarding imprecise terminology, the terms "about" and "approximately" are used interchangeably to refer to a measurement that includes the stated measurement value as well as any measurement value that is reasonably (comparably) close to the stated measurement value. As understood and readily determined by one of ordinary skill in the art, a measurement value reasonably close to the stated measurement value deviates from the stated measurement value by a reasonably small amount. Such deviations can be attributed to, for example, measurement errors, differences in measurement values ​​and / or manufacturing equipment calibration, human errors in reading and / or setting the measurement value, fine-tuning to optimize performance and / or structural parameters taking into account differences in measurement values ​​related to other components, specific implementation scenarios, imprecise adjustments and / or manipulations of the object by humans or machines, and / or the like. Where it is determined that such a reasonably small difference value would not be readily determined by one of ordinary skill in the art, the terms "about" and "approximately" can be understood as the value plus or minus 10%.

[0082] Description of various embodiments

[0083] Those skilled in the art will readily understand that various aspects of this disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale, but may be enlarged to illustrate various aspects of this disclosure, and in this regard, the drawings should not be construed as limiting.

[0084] Various aspects of this disclosure relate to two types of implantable medical devices, such as devices for shunting and / or occluding bodily fluids or body structures. In some cases, various aspects of this disclosure relate to methods and devices for treating heart failure by reducing elevated blood pressure in the ventricles through the formation of a decompression shunt. Furthermore, some embodiments relate to methods and devices for customizing, adjusting, or manipulating blood flow (blood volume) through the shunt to enhance the therapeutic effect of the decompression shunt.

[0085] Figure 1 This is an example 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 some cases, 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 typically includes a first frame member 110 positioned on a first side of the diaphragm (e.g., within the right atrium RA), a second frame member 120 positioned on a second side of the diaphragm (e.g., within the left atrium LA), and a catheter portion 130 extending through the diaphragm. A needle can be used to create an opening in the diaphragm.

[0086] The sheath 140 and constraint lines and / or release lines (not shown) can be used to facilitate the deployment of the device 100. For example, a first side of the device 100, including a first frame member 110, can be released after the sheath 140 advances through the diaphragm and reaches the RA, and a second frame member 120, including a second frame member 120, can be released on the LA side of the diaphragm. The conduit portion 130 (e.g., Figure 2 (As shown in the figure) is disposed within the opening. The frame components 110, 120 and the catheter portion 130 can be compressed within the sheath 140 during delivery of the device 100 to the desired treatment area in the patient's body, and subsequently expand during deployment of the device 100.

[0087] Figure 2 This is an example 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. The first frame component 110 may be configured to conform to the patient's anatomy (i.e., a first side of a diaphragm). The second frame component 120 may be configured to conform to the patient's anatomy (i.e., a second side of a diaphragm).

[0088] In some cases, the first frame member 110 includes a first set of elongated elements 112, and the second frame member 120 includes a second set of elongated elements 122. The frame members 110 and 120, including, for example, elongated elements 112 and 122, can be discrete and separate from each other. For example, the first frame member 110 forms a first side 100a of the device 100, and the second frame member 120 forms a second side 100b of the device 100. The first frame member 110, discrete and separate from the second frame member 120, does not enter the second side 100b of the device, and the second frame member 120, discrete and separate from the first frame member 110, does not enter the first side 100a of the device.

[0089] In some cases, the first frame component 110 and the second frame component 120 are not adjacent to each other. This non-adjacent arrangement allows the first frame component 110 and the second frame component 120 to be distinct and separate from each other. Furthermore, the first frame component 110 and the second frame component 120 can move freely and separately in response to movement of the patient's anatomy. In this way, a force acting on one of the first frame component 110 and the second frame component 120 is maintained within the other. A force acting on one of the first frame component 110 and the second frame component 120 can be isolated from the frame component on which that force acts.

[0090] As shown in the figure, the conduit portion 130 is disposed between the first frame member and the second frame member. At least a portion of the conduit portion 130 is not supported by the first frame member 110 and the second frame member 120 in a generally radial or circumferential direction within the conduit portion 130. Figure 2 As shown, the catheter portion 130 transitions to the first side 100a and the second side 100b at approximately a 90-degree angle (other angles are also conceivable). The boundary of the catheter portion 130 can be considered as the position where the catheter portion 130 transitions to the first side 100a and the second side 100b. The first frame member 110 and the second frame member 120 extend laterally relative to the catheter portion 130. Furthermore, the first frame member 110 and the second frame member 120 can support the catheter portion 130 without substantially entering the boundary of the catheter portion 130. In some cases, the first frame member 110 and the second frame member 120 laterally support the catheter portion 130 from outside the boundary of the catheter portion 130. Therefore, the first frame member 110 and the second frame member 120 can maintain their position through the lumen of the catheter portion 130 and facilitate the deployment (deployment) of the catheter portion 130 by laterally forcing the catheter portion 130 open.

[0091] In certain circumstances, the first frame member 110 and the second frame member 120 may apply tension to the catheter portion 130 to deploy and maintain the catheter portion 130 having an inner lumen therethrough. The catheter portion 130 may be deployed within the septum between tissue surfaces through an opening (e.g., a needle puncture through a septum), the diameter of which is smaller than the fully deployed diameter of the catheter portion 130. The tension in the catheter portion 130 applied by the expansion of the first frame member 110 and the second frame member 120 may also cause the septum between tissue surfaces to expand to the desired shunt size.

[0092] In some cases, the catheter portion 130 may be substantially without frame components. For example, because the first frame component 110 and the second frame component 120 are not adjacent to each other as described above and are positioned outside the boundary of the catheter portion 130. The catheter portion 130 may include, for example, a membrane 132 connecting the first frame component 110 and the second frame component 120, such as an expanded polytetrafluoroethylene (ePTFE) membrane. The membrane 132 typically separates the first frame component 110 and the second frame component 120 at a suitable distance compatible with the patient's body. For example, depending on the desired treatment location within the patient's body, the membrane 132 may separate the first frame component 110 and the second frame component 120 by a gap of 0 to 15 mm. Furthermore, the catheter portion may be formed solely of the membrane 132. The catheter portion 130 configured to unfold within a septum between tissue surfaces lacks the first frame component 110 and the second frame component 120. The catheter portion 130 may include a smooth interior that facilitates blood flow without ridges from the support elements that interrupt or disrupt the flow. Therefore, catheter portion 130 can reduce the likelihood of thrombosis.

[0093] 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 member 110, at least a portion of the second frame member 120, or at least a portion of the first frame member 110 and the second frame member 120. In some cases, the membrane 132 disposed on at least a portion of the first frame member 110 and / or the second frame member 120 is a separate thin film (e.g., a first thin film disposed on the first frame member 110 and a second thin film disposed on the second frame member 120). In these cases, one or more thin films may be coupled to the membrane 132 in the conduit portion 130. The membrane 132 may be elastic to allow the conduit portion 130 to expand and to allow movement of portions of the first frame member 110 and / or the second frame member 12 (e.g., movement of the first set of elongated elements 112 and / or the second set of elongated elements 122).

[0094] Membrane 132 may span the gap between the first set of elongated elements 112 and / or the second set of elongated elements 122. In some cases, membrane 132 is disposed at least on the tissue-joining side of the first frame member 110 and the tissue-joining side of the second frame member 120. In these cases, membrane 132 is configured to reduce the likelihood of frame corrosion of the first frame member 110 and / or the second frame member 120. The structure (configuration) of membrane 132 and the first set of elongated elements 112 and / or the second set of elongated elements 122 may conform to the tissue surface surrounding the diaphragm. The first set of elongated elements 112 and / or the second set of elongated elements 122 may lie flat against the tissue surface.

[0095] In some cases, each of the first set of elongated elements 112 may be attached to each other via membrane 132 to form a first frame member 110. In some cases, the first frame member 110 may be formed into a substantially flat or two-dimensional disk shape, as shown. Additionally or alternatively, the second set of elongated elements 122 may also be attached to each other via membrane 132 to form a second frame member 120. The second frame member 120 may also be formed into a substantially flat or two-dimensional disk shape such that when the device 100 is in deployed configuration, the first frame member 110 and the second frame member 120 are substantially parallel to each other.

[0096] In some cases, membrane 132 may be configured to promote inward tissue growth on or at least a portion of membrane 132. In some cases, membrane 132 may be configured to promote inward tissue growth to cover at least a portion of the first frame component 110 and / or the second frame component 120, which may further promote the compatibility and stability of device 100 in the patient. Membrane 132 within catheter portion 130 may be configured to prevent inward tissue growth, thereby resulting in increased patency. In some cases, membrane 132 may be configured to promote endothelialization without obstructive inward growth within catheter portion 130. Membrane 132 may promote endothelialization without obstructive overgrowth of tissue within catheter portion 130.

[0097] In some cases, device 100 may be able to deliver a drug to a desired therapeutic site within a patient's body. For example, device 100 may be able to elute a drug configured to modulate a tissue response. In some cases, device 100 may be coated with a therapeutic coating, drug elution material, or other therapeutic material or hydrophilic coating. In a particular example, device 100 may be coated with heparin to enhance the antithrombotic and patency properties of device 100. Alternatively or additionally, device 100 may include paclitaxel (to modulate a tissue / cell response).

[0098] Figure 3AThis is a perspective view of another example implantable medical device 100 for regulating blood pressure according to one embodiment. As shown, each of the first set of elongated elements 112 may be discrete and separate 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 individually conform to the topology of a first side of the diaphragm, thus providing a highly compliant first frame member 110. Each of the second set of elongated elements 122 may also be discrete (separate) and separate from adjacent elongated elements. For example, each of the second set of elongated elements 122 can move independently of each other and individually conform to a second side of the diaphragm, much like the first set of elongated elements 112 conforms to the first side of the diaphragm. Therefore, both the first frame member 110 and the second frame member 120 are highly compliant and can independently conform to each other based on the patient's anatomy.

[0099] In some cases, one set of elongated elements in the first group of elongated elements 112 of the first frame component 110 or the second set of elongated elements 122 of the second frame component 120 may be attached to each other via the membrane 132, while the other set of elongated elements is not attached (e.g., they are discrete and separate from adjacent elongated elements). In other cases, only some of the elongated elements in the first group of elongated elements 112 or the second group of elongated elements 122 may be attached to each other, while the other elongated elements in the first group of elongated elements 112 and the second group of elongated elements 122 are not attached. Therefore, the device 100 can be customized according to the patient's height based on factors such as the desired treatment location within the patient's body and the size and / or shape of the defect.

[0100] The device 100 can generally be deployed from a delivery configuration or expanded to a deployment configuration. In some cases, when the device is in the delivery configuration, the first set of elongated elements 112 and the second set of elongated elements 122 can be nested together. This allows the device 100 to be compressed to a smaller size, for example, for delivery of the device 100 to a wider variety of treatment sites (e.g., through small, narrow, or spiral (coiled) pathways).

[0101] Figure 3B According to one embodiment Figure 3A The image shows a side view of an implantable medical device for regulating blood pressure. Figure 3BA device 100 in its deployed configuration is shown. As shown, when the device 100 is in its deployed configuration, a first frame member 110, including a first set of elongated elements 112, and a second frame member 120, including a second set of elongated elements 122, are positioned radially outward relative to the longitudinal axis L of the catheter portion 130. For example, the first frame member 110 and the second frame member 120 are positioned at a first angle 114 and a second angle 124, respectively. When the device is in its deployed configuration, the first angle 114 and the second angle 124 may form an angle of approximately 90° relative to the longitudinal axis L. This allows the first frame member 110 and the second frame member 120 to be positioned parallel to and adjacent to a first and a second side of the septum. In some cases, the first frame member 110 and the second frame member 120 may be positioned at any angle relative to the longitudinal axis L (e.g., from approximately 0° to greater than 90° relative to the longitudinal axis L), said angle allowing contact with the tissue surfaces of the first and second sides of the septum.

[0102] In some cases, the first elongated element 112 and the second elongated element 122 are configured to be separated from each other when the device 100 is in the deployed configuration. For example... Figure 3B As shown, when the device 100 is in the deployed configuration, each of the first set of elongated elements 112 is discrete and separate from each other, such that each of the first set of elongated elements 112 can move independently of its adjacent elongated elements. When the device 100 is in the deployed configuration, each of the second set of elongated elements 122 can also be discrete and separate from each other, such that each of the second set of elongated elements 122 can move independently of its adjacent elongated elements.

[0103] The first frame member 110 and the second frame member 120 can maintain the lumen through the catheter portion 130 and facilitate the deployment (deployment) of the catheter portion 130 by laterally forcing it open. Furthermore, the lumen can be free or without the first frame member 110 and the second frame member 120. In this way, the catheter portion 130 can facilitate the re-passage of the septum for additional surgical procedures (e.g., left atrial appendage occluder implantation). Additionally, the first frame member 110 and the second frame member 120 can be constructed differently. For example, one of the first frame member 110 and the second frame member 120 can be expanded, while the other is flat. In other cases, both the first frame member 110 and the second frame member 120 can be expanded. Furthermore, one of the first frame component 110 and the second frame component 120 may be convex, while the other may be flat or recessed, or both may be convex. Additionally, the first frame component 110 and the second frame component 120 may have different dimensions.

[0104] The first frame component 110 and the second frame component 120 may include sensors integrated into the respective frame components, for example, for continuously monitoring various hemodynamic parameters in a patient, such as primarily pressure. For example, an antenna or inductor may be wound around the perimeter of one of the first frame component 110 and the second frame component 120, and the sensor may be attached to the inductor. The sensor may be configured to sense, for example, physiological characteristics that may be important in the diagnosis, monitoring, and / or treatment of cardiac disease, heart failure, and / or other cardiovascular diseases, such as temperature, cardiac electrical signals, blood chemistry, blood pH, hemodynamics, biomarkers, sound, pressure, and electrolytes.

[0105] In some cases, the catheter portion 130 may be size-adjustable after delivery. The membrane 132 can be selectively adjusted to inflate by a sac applied within the catheter portion 130. The device 100 may be of any size suitable for conforming to the patient's anatomy. In some cases, the diameter of the catheter portion is from 3 to 12 mm. For example, depending on the patient's anatomy and / or the desired treatment location, the diameter of the catheter portion may be from 4 to 10 mm, or from 5 to 8 mm. For example, the diameters of the first frame component 110 and the second frame component 120 are typically larger than the diameter of the catheter portion 130, such that each frame component can anchor the catheter portion 130 of the device 100 within the septum.

[0106] The device 100 can have any shape suitable for matching the patient's anatomy. For example, the first frame portion 110 and the second frame portion 120 can have any of a variety of suitable shapes for anchoring the device 100 within the patient's body. For example, the first frame portion 110 and the second frame portion 120 can be generally circular, oval, rhomboid, star-shaped, flower-shaped, or any other suitable shape as needed. In some cases, for example, at least one set of elongated elements 112 and 122 forms a star shape. In some cases, both the first set of elongated elements 112 and 122 form a star shape.

[0107] In some cases, the first set of elongated elements 112 forms a plurality of first convex angles 116, while the second set of elongated elements 122 forms a plurality of second convex angles 126. Each of the plurality of first convex angles 116 and second convex angles 126 may, as desired, include, for example, 3 to 12 convex angles, 4 to 10 convex angles, or 6 to 8 convex angles. In some cases, the plurality of first convex angles 116 may have more convex angles than the plurality of second convex angles 126, while in other cases, the plurality of first convex angles 116 may have the same number of convex angles as the plurality of second convex angles 126 or fewer convex angles.

[0108] Figure 4 An example frame component 400 according to an embodiment is shown for use in an implantable medical device for regulating blood pressure. The frame component 400 can be used in place of the above reference. Figure 1-3 shows and discusses one or both of the frame components 110, 120. For example, frame component 400 may replace the first frame component 110 and / or the second frame component 120 to maintain the lumen through the conduit portion 130. Frame component 400 may include elongated elements 112 forming frame component 400. Elongated elements 112 may be formed, for example, from wire, cut tube, or cut sheet. In some cases, elongated elements 112 may be attached to each other via a membrane (not shown). Furthermore, and as discussed in detail above, membranes such as expanded polytetrafluoroethylene (ePTFE) membranes may connect frame component 400 and form conduit portion 130.

[0109] The membrane may span the gap between the elongated elements 112 and, in some cases, may be disposed on at least the tissue-joining side of the frame member 400. In these cases, the membrane is configured to reduce the likelihood of frame corrosion of the frame member 400. The elongated elements 112 may conform to the tissue surface surrounding the diaphragm. Furthermore, the elongated elements 112 may lie flat against the tissue surface.

[0110] In some cases, the elongated element 112 is formed as follows: Figure 4 The star shape is shown. The star-shaped frame component 400 includes an outer vertex 402 and an inner vertex 404. In some cases, the frame element 400 may include one or more eyelets 406 disposed with at least one of the outer vertex 402 and the inner vertex 404. One or more eyelets 406 may be disposed on either side of the inner vertex 404. In some cases, each inner vertex 404 includes a pair of eyelets 406, such as... Figure 4 As shown. In other cases, eyelet 406 may alternatively be disposed together with outer vertex 402. In still other cases, eyelet 406 may be disposed together with both outer vertex 402 and inner vertex 404. Eyelet 406 may be configured to interface with a delivery system to facilitate the deployment of frame elements.

[0111] Figure 5 Another example frame component according to one embodiment is shown for use in an implantable medical device for regulating blood pressure. Frame component 500 can be used in place of the above reference. Figure 1 -3 shows and discusses one or both of the frame components 110 and 120. For example, frame component 500 may replace the first frame component 110 and / or the second frame component 120 to maintain the lumen through the conduit portion 130. Frame component 500 may include elongated elements 112 forming frame component 500. Elongated elements 112 may be formed, for example, from wire, cut tube, or cut sheet. In some cases, elongated elements 112 may be attached to each other via a membrane (not shown). Furthermore, and as discussed in detail above, membranes such as expanded polytetrafluoroethylene (ePTFE) membranes may connect frame component 500 and form conduit portion 130.

[0112] The membrane may span the gap between the elongated elements 112 and, in some cases, may be disposed on at least the tissue-joining side of the frame member 500. In these cases, the membrane is configured to reduce the likelihood of frame corrosion of the frame member 400. The elongated elements 112 may conform to the tissue surface surrounding the diaphragm. Furthermore, the elongated elements 112 may lie flat against the tissue surface.

[0113] In some cases, the elongated element 112 is formed as follows: Figure 5 The star shape is shown. The star-shaped frame element 500 includes a first surface 512 and a second surface 514. In some cases, the frame member 500 may include an eyelet 406 extending around the frame member 500. The eyelet 406 may be arranged along one or both of the first surface 512 and the second surface 514. In some cases, the eyelet 406 extends around the frame member 500 and is alternately arranged on the first surface 512 and the second surface 514, such as... Figure 5 As shown. The eyelet 406 can be configured to interface with the delivery system to facilitate the deployment of the frame elements.

[0114] Figure 6 An example frame component 600 is shown that can be used in an implantable medical device for regulating blood pressure according to one embodiment. The frame component 600 can be used in place of the above reference. Figure 1 -3 shows and discusses one or both of the frame components 110 and 120. For example, frame component 600 may replace the first frame component 110 and / or the second frame component 120 to maintain the lumen through the conduit portion 130. Frame component 600 may include elongated elements 112 forming frame component 600. Elongated elements 112 may be formed, for example, from wire, cut tube, or cut sheet. In some cases, elongated elements 112 may be attached to each other via a membrane (not shown). Furthermore, and as discussed in detail above, membranes such as expanded polytetrafluoroethylene (ePTFE) membranes may connect frame component 600 and form conduit portion 130.

[0115] The membrane may span the gap between the elongated elements 112 and, in some cases, may be disposed on at least the tissue-joining side of the frame member 600. In these cases, the membrane is configured to reduce the likelihood of frame corrosion of the frame member 600. The elongated elements 112 may conform to the tissue surface surrounding the diaphragm. Furthermore, the elongated elements 112 may lie flat against the tissue surface.

[0116] In some cases, the elongated element 112 includes, for example: Figure 6The variable width portion is shown. Frame assembly 600 includes vertices 602 disposed around frame element 600. The width of elongated element 112 can vary between vertices 602. Frame element 600 may include a larger width portion 620 and a smaller width portion 622. In some cases, frame element 600 may include two larger width portions 620 and one smaller width portion 622 between two vertices 602. In some cases, the smaller width portion 622 is between two larger width portions 620. Furthermore, frame element 600 may also include an eyelet 406. In some cases, eyelet 406 is disposed together with the larger width portion 620 of frame element 600. Eyelet 406 may be configured to interface with a delivery system to facilitate the deployment of the frame element.

[0117] Figure 7 An example frame component 700 is shown 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 the above reference. Figure 1 -3 shows and discusses one or both of the frame components 110 and 120. For example, frame component 700 may replace the first frame component 110 and / or the second frame component 120 to maintain the lumen through the conduit portion 130. Frame component 700 may include elongated elements 112 forming frame component 700. Elongated elements 112 may be formed, for example, from wire, cut tube, or cut sheet. In some cases, elongated elements 112 may be attached to each other via a membrane (not shown). Furthermore, and as discussed in detail above, membranes such as expanded polytetrafluoroethylene (ePTFE) membranes may connect frame component 700 and form conduit portion 130.

[0118] The membrane may span the gap between the elongated elements 112 and, in some cases, may be disposed on at least the tissue-joining side of the frame member 700. In these cases, the membrane is configured to reduce the likelihood of frame corrosion of the frame member 700. The elongated elements 112 may conform to the tissue surface surrounding the diaphragm. Furthermore, the elongated elements 112 may lie flat against the tissue surface.

[0119] In some cases, the elongated element 112 is formed as follows: Figure 7 The star shape is shown. The star-shaped frame element 700 includes a first surface 512 and a second surface 514. In some cases, 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 some cases, 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 Another example frame component 800 with an opening 740 between the first surface 512 and the second surface 514 is shown.

[0120] Figure 9 An example implantable medical device 900 for regulating blood pressure is shown according to one embodiment. Device 900 includes, as described above... Figure 7-8 The two frame components 800 discussed, and the membrane 132 connecting the components 800. For example... Figure 9 As shown, device 900 includes conduit portion 130 as discussed in detail above. Frame component 800 can be any type of frame component discussed herein.

[0121] As shown in the figure, device 900 includes one or more tethers 952 that connect to frame member 800 and are configured to pass through conduit portion 130. In some cases, the one or more tethers 952 are configured to pass through opening 740 in frame member 800. Tethers 952 may be configured to structurally reinforce conduit portion 130. Figure 10A Another example implantable medical device 1000 for blood pressure regulation is shown in an end view, having tethers 952 arranged to pass through openings 740 spaced apart around the inner periphery of the frame component 1010. The tethers 952 may be fibers, threads, polymer (e.g., ePTFE) strips, braided fibers or threads, interwoven fibers or threads, or other similar structural components. Figure 10B An embodiment of the invention is shown that can be used with Figure 10A The example tether 952 setup shown is for use with implantable medical devices.

[0122] Figure 11 Another example frame component according to one embodiment is shown for use in an implantable medical device for regulating blood pressure. Frame component 1100 can be used in place of the above reference. Figure 1 -3 shows and discusses one or both of the frame components 110 and 120. For example, frame component 1100 may replace the first frame component 110 and / or the second frame component 120 to maintain the lumen through the conduit portion 130. Frame component 1100 may include elongated elements 112 forming frame component 1100. Elongated elements 112 may be formed, for example, from wire, cut tube, or cut sheet. In some cases, elongated elements 112 may be attached to each other via a membrane (not shown). Furthermore, and as discussed in detail above, membranes such as expanded polytetrafluoroethylene (ePTFE) membranes may connect frame component 1100 and form conduit portion 130.

[0123] The membrane may span the gap between the elongated elements 112 and, in some cases, may be disposed on at least the tissue-joining side of the frame member 1100. In these cases, the membrane is configured to reduce the likelihood of frame corrosion of the frame member 1100. The elongated elements 112 may conform to the tissue surface surrounding the diaphragm. Furthermore, the elongated elements 112 may lie flat against the tissue surface.

[0124] In some cases, the elongated element 112 is formed as follows: Figure 11 The curved star shape is shown. The star-shaped frame element 1100 includes elongated elements 112, which include curvature between vertices 402. In some cases, the frame element 1100 also includes eyelets 406 disposed with each vertex 402. The eyelets 406 may be configured to interface with a delivery system to facilitate the deployment of the frame element.

[0125] Figure 12 Another example frame component according to one embodiment is shown for use in an implantable medical device for regulating blood pressure. Frame component 1200 can be used in place of the above reference. Figure 1 -3 shows and discusses one or both of the frame components 110, 120. For example, frame component 1200 may replace the first frame component 110 and / or the second frame component 120 to maintain the lumen through the conduit portion 130. Frame component 1200 may include elongated elements 112 forming frame component 1200. Elongated elements 112 may be formed, for example, from wire, cut tube, or cut sheet. In some cases, elongated elements 112 may be attached to each other via a membrane (not shown). Furthermore, and as discussed in detail above, membranes such as expanded polytetrafluoroethylene (ePTFE) membranes may connect frame component 1200 and form conduit portion 130.

[0126] The membrane may span the gap between the elongated elements 112 and, in some cases, may be disposed on at least the tissue-joining side of the frame member 1200. In these cases, the membrane is configured to reduce the likelihood of frame corrosion of the frame member 1200. The elongated elements 112 may conform to the tissue surface surrounding the diaphragm. Furthermore, the elongated elements 112 may lie flat against the tissue surface.

[0127] In some cases, the elongated element 112 is formed as follows: Figure 12 The star shape is shown. The star-shaped frame element 1200 includes an outer vertex 402 and an inner vertex 404. In some cases, the frame element 1200 may include eyelets 406 disposed with at least one of the outer vertex 402 and the inner vertex 404. Eyelets 406 may be disposed on the inner vertex 404. In some cases, a tether 1250 is configured to pass through and connect to each eyelet 406. The tether 1250 may structurally reinforce the frame element 1200.

[0128] Figure 13A An end view of an example implantable medical device 1300 for regulating blood pressure according to an embodiment is shown. Figure 13B An example of a [symbol / example] is shown. Figure 13A The example material setup shown is used in conjunction with the implantable medical device 1300. (Example material setup shown) Figure 13AAs shown in -B, the implantable medical device 1300 includes frame components 1302, 1304 and a membrane 132. (As indicated...) Figure 13B As shown, membrane 132 may include two layers 132a and 132b. In some cases, the two layers 132a and 132b of membrane 132 sandwich frame members 1302 and 1304 in between. The two layers 132a and 132b of membrane 132 may have different material properties and may promote flexibility along different parts of device 1300.

[0129] Figure 14 An end view of an example implantable medical device 1400 for regulating blood pressure according to one embodiment is shown. Device 1400 includes one or more frame components 1402 as discussed in detail above. As shown, frame component 1402 includes a fan-shaped or starfish-shaped form with curved elongated elements 112. Frame component 1402 is retractable and twistable for deployment (unfolding). The device includes a membrane 132, as discussed in detail above, coupled to or attached to frame component 1602.

[0130] Figure 15 An end view of an example implantable medical device 1500 for regulating blood pressure according to an embodiment is shown. Device 1500 includes one or more frame components 1502 as discussed in detail above. As shown, frame component 1502 includes a partial star shape formed by elongated elements 112. In some cases, frame component 1502 may include fewer star-shaped branches formed by elongated elements 112 than shown. The device includes a membrane 132, as discussed in detail above, coupled to or attached to frame component 1502.

[0131] Figure 16 An end view of an example implantable medical device 1600 for regulating blood pressure according to one embodiment is shown. Device 1600 includes one or more frame members 1602 as discussed in detail above. The device includes a membrane 132 coupled to or attached to the frame member 1602, also as discussed in detail above. In some cases, the frame member 1602 is formed of an elongated element 112 comprising a plurality of rings 1604. As shown, the elongated element 112 extends outward and overlaps itself to form the rings 1604.

[0132] Figure 17 An example implantable medical device 1700 and an example delivery system 1750 for regulating blood pressure are shown according to one embodiment. As discussed in detail above, the medical device 1700 includes a first frame member 1702, a second frame member 1704, and a catheter portion 130. The medical device 1700 also includes a membrane 132, as discussed in detail above, coupled to the frame members 1702 and 1704 and forming the catheter portion 130.

[0133] Delivery system 1750 may include a delivery sheath 1752 configured to contain a medical device 1700 in a collapsed or delivery configuration. Delivery system 1750 may also include an inner catheter 1754 and a tether 1756, the tether engaging a portion of one or both of frame members 1702, 1704 (e.g., via eyelets as described above). Tether 1756 may collapse the frame members 1702, 1704 toward the inner catheter 1754 in response to tension. Medical device 1700 may collapse into a delivery configuration (e.g., as described above). Figure 22 (As shown). Figure 18-21 Other examples of implantable medical devices for regulating blood pressure and having a delivery system are shown, and Figure 22 The collapsed structure of the device is shown.

[0134] The invention of this application has been described above generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and alterations can be made to the embodiments without departing from the scope of this disclosure. Therefore, the embodiments are intended to cover modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.

Claims

1. An implantable medical device, comprising: A first frame component, the first frame component being configured to conform to the patient's anatomy; A second frame component, configured to conform to the patient's anatomy, wherein at least one of the first and second frame components includes an inner vertex and an outer vertex, and one or more eyelets disposed together with at least one of the outer vertex and the inner vertex; and Wherein, at least one of the first frame component and the second frame component includes a star shape having the inner vertex and the outer vertex, and the one or more eyelets include a plurality of eyelet pairs, wherein one of the plurality of eyelet pairs is disposed inside one of the first frame component and the second frame component at the inner vertex, and one of the plurality of eyelet pairs is disposed outside one of the first frame component and the second frame component at the outer vertex.

2. The implantable medical device as described in claim 1, characterized in that, The plurality of eyelets are arranged on the first side of the inner vertex.

3. The implantable medical device as described in claim 1, characterized in that, The plurality of eyelet pairs includes a first plurality of eyelet pairs and a second plurality of eyelet pairs, wherein the first plurality of eyelet pairs are all configured to be adjacent to the inner vertex, and the second plurality of eyelet pairs are all configured to be adjacent to the outer vertex.

4. The implantable medical device as described in claim 3, characterized in that, The first plurality of eyelet pairs are all disposed on the first side of at least one of the first frame component and the second frame component, adjacent to the inner vertex, and the second plurality of eyelet pairs are all disposed on the second side of at least one of the first frame component and the second frame component, adjacent to the outer vertex.

5. The implantable medical device as described in claim 4, characterized in that, 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 eyelets extend around the first frame component or the second frame component along one or both of the first surface and the second surface.

6. The implantable medical device as described in claim 5, characterized in that, The plurality of eyelets extend around the first frame member or the second frame member and are alternately disposed on the first surface and the second surface.

7. The implantable medical device as described in claim 1, characterized in that, At least one of the inner vertex and the outer vertex includes one or more larger width portions and one or more smaller width portions disposed between the inner vertex and the outer vertex.

8. The implantable medical device as described in claim 7, characterized in that, At least one of the first frame component and the second frame component includes two larger width portions and one smaller width portion located between two vertices in each vertex.

9. The implantable medical device as described in claim 8, characterized in that, The plurality of eyelets are arranged together with the one or more larger width portions.

10. The implantable medical device as described in claim 1, characterized in that, It also includes a conduit portion disposed between the first frame component and the second frame component, and one or more tethers connected to the first frame component and the second frame component and configured to pass through the conduit portion.

11. The implantable medical device as described in claim 10, characterized in that, The one or more tethers are configured to structurally reinforce the conduit portion.

12. The implantable medical device as claimed in claim 1, characterized in that, It also includes a membrane comprising a first layer and a second layer that clamp the first frame member and the second frame member together.

13. An implantable medical device, comprising: A first frame component, the first frame component being configured to conform to the patient's anatomy; A second frame component, configured to conform to the patient's anatomy, wherein at least one of the first and second frame components includes an inner vertex and an outer vertex, and one or more eyelets disposed together with at least one of the outer vertex and the inner vertex; and 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. The one or more eyelets include multiple eyelet pairs, wherein one of the multiple eyelet pairs is disposed on the inner side of one of the first frame component and the second frame component at the inner vertex, and one of the multiple eyelet pairs is disposed on the outer side of one of the first frame component and the second frame component at the outer vertex.

14. The implantable medical device as described in claim 13, characterized in that, It also includes a conduit portion disposed between the first frame component and the second frame component, and one or more tethers connected to the first frame component and the second frame component and configured to pass through the conduit portion.

15. The implantable medical device as described in claim 14, characterized in that, The one or more tethers are configured to structurally reinforce the conduit portion.

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