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-reference to related applications

[0002] This application claims the benefit of provisional patent application No. 62 / 962540, 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. Background Technology

[0004] 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

[0005] 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 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.

[0006] According to a further example (“Example 2”) of the device relative to Example 1, 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.

[0007] According to a 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.

[0008] According to a further example (“Example 4”) of the device relative to any of Examples 1-3, the conduit portion has no frame component.

[0009] According to a further example (“Example 5”) of the device relative to any of Examples 1-4, the first frame component includes a first set of elongated elements, and the second frame component includes a second set of elongated elements, wherein the first set of elongated elements and the second set of elongated elements are not adjacent to each other.

[0010] According to a further example (“Example 6”) of the device relative to Example 5, 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.

[0011] According to a further example (“Example 7”) of the device relative to Example 6, the first set of elongated elements forms a plurality of first convex corners (protrusions).

[0012] According to a further example (“Example 8”) of the device relative to Example 6, the first set of elongated elements forms a star shape.

[0013] According to a further example (“Example 9”) 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 star shape having an inner vertex and an outer vertex.

[0014] According to a further example of the device relative to Example 9 (“Example 10”), at least one of the first frame component and the second frame component includes an outer side and an inner side, and one or more eyelets are provided on either side of at least one of the inner vertex and the outer vertex.

[0015] According to a further example of the device relative to Example 10 (“Example 11”), each inner vertex includes an eyelet disposed on the outer side of at least one of the first frame member and the second frame member, and each outer vertex includes an eyelet disposed on the inner side of at least one of the first frame member and the second frame member.

[0016] According to a further example of the device relative to Example 9 (“Example 12”), an eyelet disposed with the inner vertex opens to the outside of at least one of the first frame member and the second frame member, and an eyelet disposed with the outer vertex opens to the inside of at least one of the first frame member and the second frame member.

[0017] According to a further example (“Example 13”) of the device relative to Example 9, at least one of the first frame component and the second frame component includes a curved star shape.

[0018] According to a further example of the device relative to Example 13 (“Example 14”), the eyelet opens into the inside of at least one of the first frame component and the second frame component.

[0019] According to another further example of the device relative to Example 9 (“Example 15”), at least one of the first frame component and the second frame component includes a straight section disposed between the eyelet and the outer vertex.

[0020] According to a further example (“Example 16”) of the device relative to Example 9, the eyelet is elliptical.

[0021] According to a further example (“Example 17”) of the device relative to Example 9, the eyelet is disposed together with the outer vertex and opens into the inside of at least one of the first frame component and the second frame component.

[0022] According to a further example of the device relative to Example 1 (“Example 18”), 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 an elongated element having a variable width or one or more curvatures (bends) between the outer vertex and the inner vertex.

[0023] According to a further example (“Example 19”) of the device relative to Example 1, 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 an elongated element connected by interconnecting struts near the inner vertex.

[0024] According to one example (“Example 20”), a delivery system for deploying a device of any one of Examples 1-19 includes one or more engagement elements and one or more release lines configured to pass through the engagement elements and constructed to pass through one or more eyelets to engage at least one of a first frame component and a second frame component to the delivery system.

[0025] According to a further example of the device relative to Example 21 (“Example 21”), one or more engagement elements are configured to cause at least one of the first frame component and the second frame component to collapse toward the conduit.

[0026] According to a further example (“Example 22”) of the system relative to any of Examples 20-21, the release line is configured to retract from one or more orifices to release the frame component from the delivery system.

[0027] According to another example (“Example 23”), 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 the 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.

[0028] According to another example (“Example 24”) that is a further step relative to the method of Example 23, the method also includes adjusting the tension on the device to adjust the diameter of the conduit portion and the flow rate (flow rate) of the fluid through it.

[0029] According to another example (“Example 25”), 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, and at least one of the first frame component and the second frame component includes an inner vertex and an outer 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 at least one of the first frame component and the second frame component includes an outer side and an inner side, and one or more eyelets are provided on either side of at least one of the inner vertex and the outer vertex.

[0030] According to another further example of the device relative to Example 25 (“Example 26”), each inner vertex includes one of the holes disposed on the outer side of at least one of the first frame member and the second frame member, and each outer vertex includes one of the holes disposed on the inner side of at least one of the first frame member and the second frame member.

[0031] According to another further example of the device relative to Example 25 (“Example 27”), at least one of the first frame component and the second frame component includes an outer side and an inner side, and an eye disposed with an inner vertex opens to the outer side of at least one of the first frame component and the second frame component, and an eye disposed with an outer vertex opens to the inner side of at least one of the first frame component and the second frame component.

[0032] According to another example (“Example 28”) that goes further than the device in Example 25, the star is a curved star.

[0033] According to another further example of the device relative to Example 28 (“Example 29”), the eyelet opens into the inside of at least one of the first frame component and the second frame component.

[0034] According to another further example of the device relative to Example 25 (“Example 30”), one or more eyelets are disposed on either side of at least one of the inner vertex and the outer vertex, and at least one of the first frame component and the second frame component includes a straight line portion disposed between the eyelet and the outer vertex.

[0035] According to another further example (“Example 31”) of the device relative to any of Examples 25-30, the eyelet is elliptical.

[0036] According to another further example of the device relative to Example 25 (“Example 32”), one or more eyelets are disposed together with the outer vertex and open into the inside of at least one of the first frame component and the second frame component.

[0037] According to another further example of the device relative to Example 25 (“Example 33”), at least one of the first frame component and the second frame component includes a star shape having an elongated element having a variable width or one or more curvatures (bends) between the outer vertex and the inner vertex.

[0038] According to another further example of the device relative to Example 25 (“Example 34”), at least one of the first frame component and the second frame component includes a star shape with elongated elements, wherein the elongated elements are connected by interconnecting struts near the inner apex.

[0039] According to another example (“Example 35”), a delivery system for deploying an implantable medical device for regulating blood pressure between the left and right atria of the heart, the implantable medical device comprising: 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, and at least one of the first frame component and the second frame component, includes an inner vertex and an outer vertex; and wherein at least one of the first frame component and the second frame component comprises a star shape having an inner vertex and an outer vertex, and at least one of the first frame component and the second frame component includes an outer side and an inner side, and one or more eyelets are provided on either side of at least one of the inner vertex and the outer vertex, the system comprising: one or more engagement elements; one or more release lines configured to pass through the engagement elements and configured to pass through the one or more eyelets to connect at least one of the first frame component and the second frame component to the delivery system.

[0040] According to another further example (“Example 35”) of the device relative to Example 36, one or more coupling elements are configured to cause at least one of the first frame component and the second frame component to collapse toward the conduit.

[0041] According to another example (“Example 37”) of the system relative to any of Examples 35-36, the release line is configured to retract from one or more orifices to release the frame component from the delivery system.

[0042] According to another further example of the system relative to Example 35 (“Example 38”), each inner vertex includes one of the holes disposed on the outer side of at least one of the first frame member and the second frame member, and each outer vertex includes one of the holes disposed on the inner side of at least one of the first frame member and the second frame member.

[0043] According to another further example of the system relative to Example 35 (“Example 39”), at least one of the first frame component and the second frame component includes an outer side and an inner side, and an eye disposed with the inner vertex opens to the outer side of at least one of the first frame component and the second frame component, and an eye disposed with the outer vertex opens to the inner side of at least one of the first frame component and the second frame component.

[0044] According to another example (“Example 40”), a method for regulating blood pressure between the left and right atria of the heart includes: delivering an implantable medical device to a desired treatment site within a patient, said implantable medical device comprising: a catheter portion configured to cross a septum of the heart and configured to allow fluid to flow therethrough; and 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 set of elongated elements and the second set of elongated elements are not adjacent to each other, and the first frame component and the second set of elongated elements are not contiguous to each other. At least one of the two frame components includes an inner vertex and an outer vertex, and 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 at least one of the first frame component and the second frame component includes an outer side and an inner side, and one or more orifices are provided on either side of the inner vertex and the outer vertex; positioning the device such that the catheter portion crosses the septum between the left and right atria of the heart; and deploying the first frame component and the second frame component such that the catheter portion opens by a desired amount to provide a fluid flow path between the left and right atria.

[0045] According to another example (“Example 41”) that is a further step relative to the method of Example 40, the method also includes adjusting the tension on the device to adjust the diameter of the conduit portion and the flow rate (flow rate) of the fluid through it.

[0046] According to another example (“Example 42”) further relative to the method of Example 40, positioning the device includes: engaging one or more eyelets with one or more engagement elements; and setting one or more release lines passing through the engagement elements and configured to pass through one or more eyelets to connect at least one of the first frame component and the second frame component to the delivery system.

[0047] According to another further example (“Example 43”) of the system relative to Example 42, one or more coupling elements are configured to cause at least one of the first frame component and the second frame component to collapse toward the conduit.

[0048] According to another example (“Example 44”) that is a further system relative to Example 42, the release line is configured to retract from one or more orifices to release the frame component from the delivery system.

[0049] 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

[0050] 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.

[0051] Figure 1 This is an example implantable medical device for regulating blood pressure according to one embodiment.

[0052] Figure 2 This is an example implantable medical device for regulating blood pressure according to one embodiment.

[0053] Figure 3A This is a perspective view of another example implantable medical device for regulating blood pressure according to one embodiment.

[0054] Figure 3B According to one embodiment Figure 3A The image shows a side view of an implantable medical device for regulating blood pressure.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] Figure 9 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 10A A top view of an example frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment, is shown.

[0062] Figure 10B An embodiment is shown. Figure 10A The side view of the frame component shown.

[0063] Figure 11 An example frame component is shown that can be used in an implantable medical device for regulating blood pressure according to one embodiment.

[0064] Figure 12 An example frame component is shown that can be used in an implantable medical device for regulating blood pressure according to one embodiment.

[0065] Figure 13A A top view of an example frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment, is shown.

[0066] Figure 13B An embodiment is shown. Figure 13A The side view of the frame component shown.

[0067] Figure 14A A top view of an example frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment, is shown.

[0068] Figure 14B An embodiment is shown. Figure 14A The side view of the frame component shown.

[0069] Figure 14C An embodiment is shown. Figure 14A -B is a perspective view of the frame components shown.

[0070] Figure 15A A top view of an example frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment, is shown.

[0071] Figure 15B An embodiment is shown. Figure 15A The side view of the frame component shown.

[0072] Figure 15C An embodiment is shown. Figures 15A-15B A perspective view of the frame components shown.

[0073] Figure 16A A cut pattern of an example frame component that can be used in an implantable medical device for regulating blood pressure, according to one embodiment, is shown.

[0074] Figure 16B An embodiment is shown. Figure 16A The side view of the frame component shown.

[0075] Figure 17 An example deployment system and frame components according to one embodiment are shown.

[0076] Figure 18 An example deployment system and end portion of a frame component according to one embodiment are shown.

[0077] Figure 19 An example gripper for recapturing a frame component according to one embodiment is shown. Detailed Implementation

[0078] Definitions and Terms

[0079] 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.

[0080] 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%.

[0081] Description of various embodiments

[0082] 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.

[0083] Various aspects of this disclosure relate to 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 apparatus for treating heart failure by creating (forming) a decompression shunt to reduce elevated blood pressure in the ventricles. Furthermore, some embodiments relate to methods and apparatus for customizing, adjusting, or manipulating blood flow (blood volume) through the shunt to enhance the therapeutic effect of the decompression shunt.

[0084] Figure 1This 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.

[0085] The sheath 140 and restraint 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 the 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 the 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.

[0086] 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).

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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, the catheter portion 130 can reduce the possibility of thrombosis.

[0092] 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 membrane film (e.g., a first membrane film disposed on the first frame member 110 and a second membrane film disposed on the second frame member 120). In these cases, one or more membrane 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).

[0093] 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 possibility of frame corrosion of the first frame member 110 and / or the second frame member 120. The arrangement 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.

[0094] 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 material 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.

[0095] 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 obstructing inward growth within catheter portion 130. Membrane 132 may promote endothelialization without obstructive overgrowth of tissue into catheter portion 130.

[0096] In some cases, device 100 is capable of delivering a drug to a desired therapeutic site within a patient. 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).

[0097] 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 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.

[0098] 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.

[0099] The device 100 is generally deployable from a delivery configuration or expandable 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 may 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 swirling pathways).

[0100] 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.

[0101] 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 separated from each other, such that each of the first set of elongated elements 112 can move independently of the 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 separated from each other, such that each of the second set of elongated elements 122 can move independently of the adjacent elongated elements.

[0102] 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). Furthermore, 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 flared, while the other is flat. In other cases, both the first frame member 110 and the second frame member 120 can be flared. Furthermore, one of the first frame member 110 and the second frame member 120 can be convex, while the other is flat or recessed, or both can be convex. Furthermore, one of the first frame component 110 and the second frame component 120 may be recessed, while the other may be flat or convex, or both may be recessed. Additionally, the first frame component 110 and the second frame component 120 may have different dimensions.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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 component 400 may include one or more eyelets 406 disposed with at least one of the outer vertex 402 and the inner vertex 404. The frame component 400 also includes an outer side 408 and an inner side 410. In some cases, one or more eyelets 406 may be disposed on either side of the inner vertex 404 and / or the outer vertex 402. In some cases, each inner vertex 404 includes one of the eyelets 406 disposed on the outer side 408 of the frame 400. Furthermore, in some cases, each outer vertex 402 may include one of the eyelets 406 disposed on the inner side 410 of the frame 400. In other cases, one of the eyelets 406 may be disposed on the outer side 408 of the frame 400, without any eyelets disposed on the inner side 410 of the frame 400. In other cases, one of the eyelets 406 may be located on the inner side 410 of the frame 400, while no eyelet may be located on the outer side 408 of the frame 400. The eyelets 406 may be configured to interface with a delivery system to facilitate the deployment of the frame component 400.

[0110] 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, 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.

[0111] 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 500. 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.

[0112] In some cases, the elongated element 112 is formed as follows: Figure 5 The star shape is shown. Component 500 includes an outer vertex 402 and an inner vertex 404. In some cases, frame component 500 may include one or more eyelets 406 disposed with at least one of the outer vertex 402 and inner vertex 404. Frame component 500 also includes an outer side 408 and an inner side 410. In some cases, one or more eyelets 406 may be disposed on either side of the inner vertex 404 and / or the outer vertex 402. As shown, eyelets 406 are disposed on the inner side 410 of each outer vertex 402. Eyelets 406 may be configured to interface with a delivery system to facilitate the deployment of frame component 500.

[0113] Figure 6 An example frame component 600 according to an embodiment is shown for use in an implantable medical device for regulating blood pressure. 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, 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.

[0114] 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.

[0115] In some cases, the elongated element 112 is formed as follows: Figure 6 The frame component 600 is star-shaped. It includes an outer vertex 402 and an inner vertex 404. In some cases, the frame component 600 may include one or more eyelets 406a, 406b, which are disposed with at least one of the outer vertex 402 and the inner vertex 404. The frame component 600 also includes an outer side 408 and an inner side 410. In some cases, one or more eyelets 406a, 406b may be disposed on either side of the inner vertex 404 and / or the outer vertex 402. In some cases, eyelets 406, 406b may be disposed with both the inner vertex 404 and the outer vertex 402. Furthermore, the eyelet 406b disposed with the inner vertex 404 opens toward the outer side 408 of the frame component 600, while the eyelet 406a disposed with the outer vertex 402 opens toward the inner side 410 of the frame component 600. The eyelet 406 may be configured to interface with a delivery system to facilitate the deployment of the frame component 500.

[0116] 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, 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 constituting 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 the star-shaped frame component 700 and form the conduit portion 130.

[0117] 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 around the diaphragm. Furthermore, the elongated elements 112 may lie flat against the tissue surface.

[0118] In some cases, the elongated element 112 is formed as follows: Figure 7 The diagram shows a curved star shape. The star-shaped frame component 700 includes elongated elements 112 that have curvature between vertices 402. The frame component 700 includes an outer vertex 402 and an inner vertex 404. In some cases, the frame component 700 may include one or more eyelets 406 disposed with at least one of the outer vertex 402 and the inner vertex 404. The frame component 400 also includes an outer side 408 and an inner side 410. In some cases, one or more eyelets 406 may be disposed on either side of the inner vertex 404 and / or the outer vertex 402. In some cases, the eyelet 406 may be disposed with both the inner vertex 404 and the outer vertex 402. Furthermore, as shown, the eyelet 406 may be disposed with the outer vertex 402 and may open into the inner side 410 of the frame component 700. The eyelet 406 may be configured to interface with a delivery system to facilitate the deployment of the frame component 700.

[0119] Figure 8 An example frame component 800 according to an embodiment is shown for use in an implantable medical device for regulating blood pressure. The frame component 800 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 800 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 800 may include elongated elements 112 constituting frame component 800. 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 800 and form conduit portion 130.

[0120] 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 800. In these cases, the membrane is configured to reduce the likelihood of frame corrosion of the frame member 800. 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.

[0121] In some cases, the elongated element 112 is formed as follows: Figure 8The star shape is shown. Component 800 includes an outer vertex 402 and an inner vertex 404. In some cases, frame component 800 may include one or more eyelets 406 disposed with at least one of the outer vertex 402 and the inner vertex 404. Frame component 800 also includes an outer side 408 and an inner side 410. In some cases, one or more eyelets 406 may be disposed on either side of the inner vertex 404 and / or the outer vertex 402. As shown, the eyelets 406 extend outward from the outer vertex 402 relative to frame component 800. Frame component 800 includes a straight section 850 disposed between the eyelets 406 and the outer vertex 402. The eyelets 406 may be configured to interface with a delivery system to facilitate the deployment of frame component 800.

[0122] Figure 9 An example frame component 900 according to an embodiment is shown for use in an implantable medical device for regulating blood pressure. The frame component 900 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 900 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 900 may include elongated elements 112 forming frame component 900. 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 900 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 900. In these cases, the membrane is configured to reduce the likelihood of frame corrosion of the frame member 900. 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 9 The frame component 900 is star-shaped. It includes an outer vertex 402 and an inner vertex 404. In some cases, the frame component 900 may include one or more eyelets 406 disposed with at least one of the outer vertex 402 and the inner vertex 404. The frame component 900 also includes an outer side 408 and an inner side 410. In some cases, one or more eyelets 406 may be disposed on either side of the inner vertex 404 and / or the outer vertex 402. As shown, the eyelets 406 extend outward from the outer vertex 402 relative to the frame component 900. Furthermore, the eyelets 406 may be elliptical. The eyelets 406 may be configured to interface with a delivery system to facilitate the deployment of the frame component 900.

[0125] Figure 10A A top view of an example frame component 1000 for use in an implantable medical device for regulating blood pressure, according to one embodiment, is shown. The frame component 1000 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 1000 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 1000 may include elongated elements 112 forming frame component 1000. 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 1000 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 1000. In these cases, the membrane is configured to reduce the likelihood of frame corrosion of the frame member 1000. 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 forms a star shape as shown in FIG. 10. Component 1000 includes an outer vertex 402 and an inner vertex 404. In some cases, the frame component 1000 may include one or more eyelets 406 disposed with at least one of the outer vertex 402 and the inner vertex 404. The frame component 1000 also includes an outer side 408 and an inner side 410. In some cases, one or more eyelets 406 may be disposed on either side of the inner vertex 404 and / or the outer vertex 402. As shown, the eyelet 406 is disposed with the outer vertex 402 and opens into the inner side 410 of the frame component 1000. Figure 10B An embodiment is shown. Figure 10A The side view of the frame component 1000 shown. In some cases, the frame component 1000 includes a variable slope. When the elongated element 112 extends inward from the outer vertex 402, the elongated element 112 may include curvature (e.g., increasing the height of the frame component 1000).

[0128] Figure 11 An example frame component 1100 for use in an implantable medical device for regulating blood pressure is shown according to one embodiment. Frame component 1100 does not include eyelets, unlike other frame components discussed herein. Any frame component shape or other features (e.g., such as...) Figure 2-1 (As shown in 0 and 12-16) may also exclude the eyelets.

[0129] Figure 12 An example frame component 1200 according to an embodiment is shown for use in an implantable medical device for regulating blood pressure. The 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 constituting 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.

[0130] 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 around the septum. Furthermore, the elongated elements 112 may lie flat against the tissue surface.

[0131] In some cases, the elongated element 112 is formed as follows: Figure 12 The star shape is shown. Component 1200 includes an outer vertex 402 and an inner vertex 404. Frame component 1200 also includes an outer side 408 and an inner side 410. In some cases, the elongated element 112 may include a variable width or one or more curvatures (bends) between the outer vertex 402 and the inner vertex 404. Furthermore, the elongated element 112 has a curved pattern near the outer vertex 402, such that the elongated element 112 can taper the frame component 1200 inward at the outer vertex 402. In this case, the outer vertex 420 may be configured as an eyelet.

[0132] Figure 13A A top view of an example frame component 1300 for use in an implantable medical device for regulating blood pressure, according to an embodiment, is shown. The frame component 1300 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 1300 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 1300 may include elongated elements 112 forming frame component 1300. 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 1300 and form conduit portion 130.

[0133] 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 1300. In these cases, the membrane is configured to reduce the likelihood of frame corrosion of the frame member 1300. 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.

[0134] In some cases, the elongated element 112 forms a star shape as shown in Figure 13. Component 1300 includes an outer vertex 402 and an inner vertex 404. Frame component 1300 also includes an outer side 408 and an inner side 410. In some cases, the elongated element 112 is connected by interconnecting struts 1360 near the inner vertex 404. Furthermore, as... Figure 13B As shown, the inner vertex 404 can cause the frame component 1300 to bend to change the height of the frame component 1300.

[0135] Figure 14A A top view of an example frame component 400 for use in an implantable medical device for regulating blood pressure, according to one embodiment, is shown. Figure 14B An embodiment is shown. Figure 14A The side view of the frame component 1400 shown. Figure 14C An embodiment is shown. Figure 14A -B is a perspective view of frame component 1400. Frame component 1400 may be a combination of other frame components or aspects of the frame components shown and discussed above. For example, frame component 1400 may include aspects of frame component 1300 (e.g., interconnecting struts 1360 near inner vertex 404) and frame component 600 (e.g., an eyelet 406a disposed with outer vertex 402 opening into the inner side 410 of frame component 600).

[0136] Figure 15A A top view of an example frame component 1500 for use in an implantable medical device for regulating blood pressure, according to an embodiment, is shown. Figure 15B An embodiment is shown. Figure 15AThe side view of the frame component 1500 shown. Figure 15C An embodiment is shown. Figure 15A -B is a perspective view of frame component 1500. Frame component 1500 may be a combination of other frame components or aspects of the frame components shown and discussed above. For example, frame component 1500 may include aspects of frame component 1300 (e.g., interconnecting struts 1360 near inner vertex 404) and frame component 600 (e.g., an eyelet 406a disposed with outer vertex 402 opening into the inner side 410 of frame component 600).

[0137] Figure 16A A cut pattern of an example frame component 1600 for use in an implantable medical device for regulating blood pressure is shown according to an embodiment. Figure 16B An embodiment is shown. Figure 16A The side view of the frame component 1600 shown. The frame component 1600 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 1600 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 1600 may include elongated elements 112 forming frame component 1600. In some cases, elongated elements 112 may be attached to each other via a membrane (not shown). Furthermore, and as discussed in detail above, a membrane such as an expanded polytetrafluoroethylene (ePTFE) membrane may connect frame component 1600 and form conduit portion 130.

[0138] 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 1600. In these cases, the membrane is configured to reduce the likelihood of frame corrosion of the frame member 1600. 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.

[0139] In some cases, the elongated element 112 is formed as follows: Figure 16BThe star shape is shown. The star-shaped frame component 1600 includes an outer vertex 402 and an inner vertex 404. In some cases, the frame component 1600 may include one or more eyelets 406 disposed with at least one of the outer vertex 402 and the inner vertex 404. The frame component 1600 also includes an outer side 408 and an inner side 410. In some cases, one or more eyelets 406 may be disposed on either side of the inner vertex 404 and / or the outer vertex 402. In some cases, each inner vertex 404 includes one of the eyelets 406 disposed on the outer side 408 of the frame 1600. Furthermore, in some cases, each outer vertex 402 may include one of the eyelets 406 disposed on the inner side 410 of the frame 1600. In other cases, one of the eyelets 406 may be disposed on the outer side 408 of the frame 1600, without any eyelets disposed on the inner side 410 of the frame 1600. In other cases, one of the eyelets 406 may be located on the inner side 410 of the frame 1600, while no eyelet may be located on the outer side 408 of the frame 1600. The eyelets 406 may be configured to interface with a delivery system to facilitate the deployment of the frame component 1600.

[0140] Figure 17 An example deployment system 1700 and a frame component 110 according to one embodiment are shown. The deployment system 1700 may include engagement elements 1702, 1704 configured to engage with the frame component 110. As discussed in detail above, the frame component 110 may include eyelets 406. Engagement elements 1702, 1704, which may be formed from a structure similar to a slub tube or a cut tube, may be configured to engage with one or more eyelets 406 of the frame component 110.

[0141] In some cases, the delivery system 1700 may also include release lines 1706, 1708 that can be disposed within engagement elements 1702, 1704. As shown, release lines 1706, 1708 may be disposed through orifice 406. In some cases, release lines 1706, 1708 may be retracted to release frame member 110 from delivery system 1700. When engaged with frame member 110, engagement elements 1702, 1704 may be retracted to cause frame member 100 to collapse toward conduit 1710. In some cases, tension may be applied to engagement elements 1702, 1704 (or elements coupled to engagement elements 1702, 1704) to cause engagement elements 1702, 1704 and frame member 110 to collapse toward conduit 1710. In some cases, the delivery system 1700 may include a delivery sheath 1712 in which engagement elements 1702, 1704 and frame component 110 (and medical devices that may include one or more frame components 110) can collapse. Retraction of engagement elements 1702, 1704 into the delivery sheath 1712 may cause engagement elements 1702, 1704 to collapse.

[0142] Figure 18 An example deployment system 1700 and the end portion of a frame component 110 according to one embodiment are shown. Engaging element 1702 and release line 1706 are shown together with the frame component 110. Release line 1706 is configured to pass through eyelet 406. As described above, release lines 1706, 1708 can be retracted to separate the frame component 110 from the delivery system 1700 and engaging element 1702.

[0143] Figure 19 Example grippers 1900 and 1902 for re-capturing a frame component are shown according to one embodiment. Grippers 1900 and 1902 can be used to grip or attach to a frame component or medical device. Grippers 1900 and 1902 can be used to re-capture a frame component or medical device or to facilitate the deployment of a frame component or medical device. Grippers 1900 and 1902 may include hooks 1904 and 1906, which may be configured to pass through eyelets in the frame component.

[0144] 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 configured to conform to an anatomy of a patient; a second frame component configured to conform to an anatomy of a patient, wherein at least one of the first frame component and the second frame, and the first frame component and the second frame component, comprises an inner vertex and an outer vertex; and wherein at least one of the first frame component and the second frame component comprises a star shape having an inner vertex and an outer vertex, and at least one of the first frame component and the second frame component comprises an outer side and an inner side, and one or more eyelets are disposed on either side of at least one of the inner vertex and the outer vertex, wherein each of the inner vertices comprises one of the eyelets disposed on the outer side of the at least one of the first frame component and the second frame component, and each of the outer vertices comprises one of the eyelets disposed on the inner side of the at least one of the first frame component and the second frame component, and wherein the implantable medical device further comprises a conduit portion disposed between the first frame component and the second frame component, the conduit portion comprising a membrane connecting the first frame component and the second frame component, the conduit portion defining an inner lumen, and the first frame component and the second frame component are configured to force the conduit portion open laterally in a deployed configuration.

2. The apparatus of claim 1, wherein, at least one of the first frame component and the second frame component comprises an outer side and an inner side, and the eyelets disposed with the inner vertices open to the outer side of at least one of the first frame component and the second frame component, and the eyelets disposed with the outer vertices open to the inner side of at least one of the first frame component and the second frame component.

3. The apparatus of claim 1, wherein, the star shape is a curved star shape.

4. The apparatus of claim 3, wherein, the eyelets open to the inner side of at least one of the first frame component and the second frame component.

5. The apparatus of claim 1, wherein, the one or more eyelets are disposed on either side of at least one of the inner vertex and the outer vertex, and at least one of the first frame component and the second frame component comprises a straight portion disposed between the eyelets and the outer vertex.

6. The apparatus of any one of claims 1-5, wherein, the eyelets are elliptical.

7. The apparatus of claim 1, wherein, the one or more eyelets are disposed with the outer vertices and open to the inner side of at least one of the first frame component and the second frame component.

8. The apparatus of claim 1, wherein, at least one of the first frame component and the second frame component comprises a star shape having an elongated element having a variable width or one or more curvatures between the outer vertex and the inner vertex.

9. The apparatus of claim 1, wherein, at least one of the first frame component and the second frame component comprises a star shape having an elongated element connected by interconnecting struts near the inner vertex.

10. The apparatus of claim 1, wherein, the one or more eyelets are disposed with the outer vertices and open toward the inner side of at least one of the first frame component and the second frame component.

11. A delivery system for deploying an implantable medical device for regulating blood pressure between a left atrium and a right atrium of a heart, the implantable medical device comprising: a first frame component configured to conform to an anatomy of a patient; a second frame component configured to conform to the anatomy of a patient, wherein the first frame component and second frame, and at least one of the first frame component and the second frame component includes an inner vertex and an outer 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 at least one of the first frame component and the second frame component includes an outer side and an inner side, and one or more eyelets are disposed on either side of at least one of the inner vertex and the outer vertex, wherein each of the inner vertices includes one of the eyelets disposed on the outer side of the at least one of the first frame component and the second frame component, and each of the outer vertices includes one of the eyelets disposed on the inner side of the at least one of the first frame component and the second frame component, and wherein the implantable medical device further includes 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, the conduit portion defining an inner lumen, and the first frame component and the second frame component are configured to force the conduit portion to open laterally in a deployed configuration, the system comprising: one or more engagement elements; and one or more release wires disposed through the engagement elements and configured to pass through the one or more eyelets to couple at least one of the first frame component and the second frame component to the delivery system.

12. The system of claim 11, wherein, the one or more engagement elements are configured to collapse at least one of the first frame component and the second frame component toward a catheter.

13. The system of any of claims 11-12, wherein, the release wires are configured to be withdrawn from the one or more eyelets to release the frame components from the delivery system.

14. The system of claim 11, wherein, at least one of the first frame component and the second frame component includes an outer side and an inner side, and the eyelets disposed with the inner vertices open to the outer side of at least one of the first frame component and the second frame component, and the eyelets disposed with the outer vertices open to the inner side of at least one of the first frame component and the second frame component.

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