Visceral blood flow control valve

Abstract

A medical implant for managing blood flow through a blood vessel includes a plug, an attachment ring, and one or more arms interconnecting the plug and the attachment ring, the one or more arms configured to allow movement of the plug relative to the attachment ring.

Description

[Technical Field]

[0001] background This application claims priority to U.S. Provisional Patent Application No. 63 / 370,165, filed August 2, 2022, entitled SPLANCHNIC FLOW RESTRICTOR VALVES, and U.S. Provisional Patent Application No. 63 / 482,275, filed January 30, 2023, entitled SPLANCHNIC FLOW PLUGGING DEVICES, the disclosures of which are hereby incorporated by reference in their entireties.

[0002] The present invention relates generally to the field of medical devices and procedures. [Background technology]

[0003] Redistribution of blood from the splanchnic venous circulation to the inferior vena cava (IVC) can contribute to increases in central venous pressure (CVP), pulmonary artery pressure, and / or pulmonary capillary wedge pressure (PCWP), particularly during periods of increased sympathetic nervous system tone (e.g., exercise) in patients with heart failure. Summary of the Invention [Means for solving the problem]

[0004] Some implementations of the present disclosure relate to a medical implant for managing blood flow through a blood vessel, the medical implant including a plug, an attachment ring, and one or more arms interconnecting the plug and the attachment ring, the one or more arms configured to allow movement of the plug relative to the attachment ring.

[0005] In some aspects, the technology described herein relates to a medical implant wherein the blood vessel is the inferior vena cava.

[0006] In some aspects, the technology described herein relates to a medical implant, wherein the plug includes a conical proximal end.

[0007] In some aspects, the technology described herein relates to a medical implant, wherein the plug comprises a rounded distal end.

[0008] In some aspects, the technology described herein relates to medical implants in which the plug includes an intermediate portion between the proximal and distal ends, the intermediate portion having a width greater than the proximal and distal ends.

[0009] In some aspects, the technology described herein relates to medical implants in which one or more arms, when in a default state, have a proximal end disposed proximal to the attachment ring.

[0010] In some aspects, the technology described herein relates to medical implants in which one or more arms form a bend.

[0011] In some aspects, the technology described herein relates to medical implants in which one or more arms are configured to a default state.

[0012] In some aspects, the technology described herein relates to a medical implant in which one or more arms are configured to elastically deform in response to blood pressure against a distal end of the plug.

[0013] In some aspects, the technology described herein relates to medical implants in which one or more arms are configured to allow a plug to enter at least partially into a lumen of the attachment ring.

[0014] In some aspects, the technology described herein relates to medical implants in which one or more arms are configured to allow a plug to pass completely through the lumen of the attachment ring.

[0015] In some aspects, the technology described herein relates to a medical implant in which at least one of the one or more arms has a constant width.

[0016] In some aspects, the technology described herein relates to a medical implant, wherein at least one of the one or more arms includes a proximal end and a distal end, the proximal end being wider than the distal end.

[0017] In some aspects, the technology described herein relates to a medical implant in which at least one of the one or more arms has a tapered width.

[0018] In some aspects, the technology described herein relates to a medical implant in which at least one of the one or more arms has a stepped width.

[0019] In some aspects, the technology described herein relates to a medical implant for managing blood flow through a blood vessel, the medical implant comprising: a stent body having an inner lumen; and a control valve having a tapered distal end extending at least partially across the inner lumen of the stent body.

[0020] In some aspects, the technology described herein relates to a medical implant in which a tapered distal end of a control valve is configured to face the direction of blood flow through a blood vessel.

[0021] In some aspects, the technology described herein relates to a medical implant in which a tapered distal end of a control valve is configured to at least partially flatten in response to an increase in the pressure of blood passing through a blood vessel.

[0022] In some aspects, the technology described herein relates to a medical implant wherein the blood vessel is the inferior vena cava.

[0023] In some aspects, the technology described herein relates to medical implants in which the tapered distal end of a control valve forms an orifice within the inner lumen of the stent body.

[0024] In some aspects, the technology described herein relates to a medical implant in which the orifice is at a central location of the control valve.

[0025] In some aspects, the technology described herein relates to a medical implant in which a tapered distal end of a control valve is configured to reduce the size of an orifice in response to an increase in blood pressure through a blood vessel.

[0026] In some aspects, the technology described herein relates to a medical implant in which a tapered distal end of a control valve is configured to completely close an orifice in response to an increase in blood pressure through a blood vessel.

[0027] In some aspects, the technology described herein relates to medical implants in which a control valve includes one or more bypass openings that allow blood flow through the control valve.

[0028] In some aspects, the technology described herein relates to medical implants in which one or more bypass openings are located at the tapered distal end of a control valve.

[0029] In some aspects, the technology described herein relates to a medical implant in which one or more bypass openings are located in a proximal portion of a control valve.

[0030] In some aspects, the technology described herein relates to medical implants in which one or more bypass openings are located at the transition between a proximal portion of a control valve and a tapered distal end of the control valve.

[0031] In some aspects, the technology described herein relates to medical implants in which one or more bypass openings are configured to increase in size in response to flattening of a tapered distal end of a control valve.

[0032] In some aspects, the technology described herein relates to a medical implant in which the tapered distal end of the control valve includes two or more leaflets.

[0033] In some aspects, the technology described herein relates to medical implants in which two or more leaflets at least partially overlap.

[0034] In some aspects, the technology described herein relates to medical implants in which the control valve includes a coating that extends at least partially over the exterior surface of the stent body.

[0035] In some aspects, the technology described herein relates to medical implants in which the control valve includes a coating that extends at least partially along the inner surface of the stent body.

[0036] In some aspects, the technology described herein relates to medical implants in which a stent body includes one or more curved arms configured to support a tapered distal end of a control valve.

[0037] In some aspects, the technology described herein relates to a medical implant further comprising a plug coupled to the stent body via a tether.

[0038] In some aspects, the technology described herein relates to medical implants in which the tether comprises a coiled wire.

[0039] In some aspects, the technology described herein relates to medical implants in which a tether is configured to hold a plug distally from a stent body.

[0040] In some aspects, the technology described herein relates to medical implants in which the tether is configured to allow the plug to move toward the stent body in response to an increase in blood pressure through a vessel.

[0041] In some aspects, the technology described herein relates to a medical implant in which a plug is configured to fit into an orifice at the tapered distal end of a control valve.

[0042] In some aspects, the technology described herein relates to a medical implant, wherein the plug includes a conical proximal end.

[0043] In some aspects, the technology described herein relates to a medical implant, wherein the plug includes a rounded distal end.

[0044] In some aspects, the technology described herein relates to medical implants in which a control valve is coupled to a stent body via a tether.

[0045] In some aspects, the technology described herein relates to a medical implant in which the control valve comprises a bowl forming a spherical cap extending toward the inner lumen of the stent body and a concave interior facing the direction of blood flow through the vessel.

[0046] In some aspects, the technology described herein relates to a medical implant in which a control valve includes cross arms that support a bowl.

[0047] In some aspects, the technology described herein relates to medical implants in which the stent body includes a stopper configured to prevent at least a portion of the cross arms from entering the inner lumen of the stent body.

[0048] In some aspects, the technology described herein relates to a method that includes percutaneously delivering, via a catheter, a medical implant for managing blood flow through a blood vessel, the medical implant comprising a stent body having an inner lumen and a control valve having a tapered distal end that extends at least partially across the inner lumen of the stent body.

[0049] For purposes of summarizing the disclosure, certain aspects, advantages, and novel features have been described herein. It is to be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be practiced in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages that may be taught or suggested herein.

[0050] The methods and structures disclosed herein for treating a patient also encompass similar methods and structures performed on or placed on a simulated patient, which are useful, for example, for training, demonstration, treatment and / or device development, and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. The simulation may include a simulation of all or part of a patient, such as, for example, the whole body, a body part (e.g., the chest), a system (e.g., the cardiovascular system), an organ (e.g., the heart), or any combination thereof. The physical elements may be natural, including human or animal cadavers or parts thereof, synthetic, or any combination of natural and synthetic. The virtual elements may be entirely in silico or may be overlaid on one or more of the physical components. The virtual elements may be presented on any combination of screens, headsets, holographic, projection, loudspeakers, headphones, pressure transducers, temperature transducers, or presented using any combination of suitable technologies.

[0051] BRIEF DESCRIPTION OF THE DRAWINGS Various embodiments are shown in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the present invention in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements. However, it should be understood that the use of similar reference numerals in relation to multiple drawings does not necessarily imply similarity between the respective embodiments associated therewith. Furthermore, it should be understood that features in the respective drawings are not necessarily drawn to scale, and that their illustrated sizes are presented for the purpose of illustrating aspects of the invention. In general, some of the illustrated features may be relatively smaller than illustrated in some embodiments or configurations. [Brief explanation of the drawings]

[0052] [Figure 1] Figure 1 provides a schematic diagram of a portion of the splanchnic circulation. [Figure 2] Figure 2 provides another schematic diagram of the splanchnic circulation, showing blood flow from the aorta to the inferior vena cava (IVC). [Figure 3] Figure 3 shows a portion of the splanchnic venous circulation that acts as a blood reservoir between the aorta and the IVC. [Figure 4] FIG. 4 illustrates an exemplary medical implant in a default configuration, positioned within a cardiac vessel (eg, hepatic vein), according to one or more embodiments. [Figure 5] FIG. 5 illustrates an exemplary medical implant in a compressed configuration and positioned within a vessel of the heart, according to one or more embodiments. [Figure 6A] 6A-6D show an exemplary occlusion device positioned within a blood vessel (eg, a hepatic vein) according to one or more embodiments. [Figure 6B] 6A-6D show an exemplary occlusion device positioned within a blood vessel (eg, a hepatic vein) according to one or more embodiments. [Figure 6C]6A-6D show an exemplary occlusion device positioned within a blood vessel (eg, a hepatic vein) according to one or more embodiments. [Figure 6D] 6A-6D show an exemplary occlusion device positioned within a blood vessel (eg, a hepatic vein) according to one or more embodiments. [Figure 7A] 7A and 7B illustrate an exemplary occlusion device having one or more leaflets positioned within a blood vessel (eg, a hepatic vein) according to one or more embodiments. [Figure 7B] 7A and 7B illustrate an exemplary occlusion device having one or more leaflets positioned within a blood vessel (eg, a hepatic vein) according to one or more embodiments. [Figure 8A] 8A-8C illustrate another exemplary occlusion device having one or more leaflets positioned within a blood vessel (eg, a hepatic vein) according to one or more embodiments. [Figure 8B] 8A-8C illustrate another exemplary occlusion device having one or more leaflets positioned within a blood vessel (eg, a hepatic vein) according to one or more embodiments. [Figure 8C] 8A-8C illustrate another exemplary occlusion device having one or more leaflets positioned within a blood vessel (eg, a hepatic vein) according to one or more embodiments. [Figure 9] FIG. 9 illustrates an exemplary plug configured to plug and / or close an opening in an occlusion device, according to one or more embodiments. [Figure 10A] FIG. 10A illustrates an exemplary occlusion device in a blood vessel comprising a plug in a default and / or expanded configuration, according to one or more embodiments. [Figure 10B] FIG. 10B illustrates an exemplary occlusion device in a compressed configuration, according to one or more embodiments. [Figure 11A] 11A-11C illustrate another exemplary occlusion device configured to selectively occlude a blood vessel, according to one or more embodiments. [Figure 11B]11A-11C illustrate another exemplary occlusion device configured to selectively occlude a blood vessel, according to one or more embodiments. [Figure 11C] 11A-11C illustrate another exemplary occlusion device configured to selectively occlude a blood vessel, according to one or more embodiments. [Figure 12A] 12A-12C illustrate an exemplary occlusion device in a blood vessel comprising a plug in a default and / or expanded configuration, according to one or more embodiments. [Figure 12B] 12A-12C illustrate an exemplary occlusion device in a blood vessel comprising a plug in a default and / or expanded configuration, according to one or more embodiments. [Figure 12C] 12A-12C illustrate an exemplary occlusion device in a blood vessel comprising a plug in a default and / or expanded configuration, according to one or more embodiments. [Figure 13A] 13A-13C illustrate an exemplary occlusion device within a blood vessel comprising a plug according to one or more embodiments. [Figure 13B] 13A-13C illustrate an exemplary occlusion device within a blood vessel comprising a plug according to one or more embodiments. [Figure 13C] 13A-13C illustrate an exemplary occlusion device within a blood vessel comprising a plug according to one or more embodiments. [Figure 14] FIG. 14 shows arms having a generally constant width. [Figure 15] FIG. 15 shows an arm with a single layer variable width. [Figure 16] FIG. 16 shows arms with graduated and / or variable widths. [Figure 17] FIG. 17 shows an arm with multiple variable widths. [Figure 18] FIG. 18 provides a flow chart illustrating an exemplary process for delivering and / or anchoring the various occlusion devices described herein. DETAILED DESCRIPTION OF THE INVENTION

[0053] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0054] Although certain preferred embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Accordingly, the scope of claims that may arise from this specification is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described sequentially as multiple separate operations, in a manner that may be useful in understanding particular embodiments, but the order of description should not be construed as implying that these operations are order-dependent. Additionally, structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein. Abstract

[0055] The following includes a general description of human cardiac anatomy that is relevant to certain inventive features and embodiments disclosed herein and is included to provide context for certain aspects of the present disclosure.

[0056] FIG. 1 provides a schematic diagram of a portion of the splanchnic circulation 100. The term "splanchnic circulation" refers to blood flow from the celiac, superior mesenteric, and inferior mesenteric arteries of origin to the abdominal digestive tract. The splanchnic circulation 100 receives approximately 25% of cardiac output and retains a similar proportion of total blood volume under normal conditions. The splanchnic circulation 100 can act as a site of cardiac output regulation and / or as a blood reservoir. Multiple regulatory pathways are involved in the distribution of the splanchnic circulation.

[0057] Total blood flow to the splanchnic organs is controlled by resistance vessels in the mesenteric and hepatic arterial systems. Venous outflow from the splanchnic organs converges to form the portal vein 3, which provides approximately 75% of the total blood supply to the liver 5. Portal blood tends to contain high concentrations of substrates provided by intestinal absorption, as well as bacteria and endotoxins.

[0058] The renal veins 12 drain blood from the right kidney 14 and left kidney 16 and connect to the inferior vena cava 10 (IVC). The superior mesenteric vein 6 lies transverse to the superior mesenteric artery and is a major venous tributary of the abdominal cavity, responsible for draining most of the abdominal organs. The inferior mesenteric vein 8 drains blood from the large intestine. The splenic vein 12 is a vessel that drains blood from the spleen, the fundus of the stomach, and part of the pancreas.

[0059] The portal vein 3 receives blood from the stomach, intestines, pancreas, and spleen 7 and carries it through the porta hepatis to the liver 5. The porta hepatis serves as the entrance for the portal vein 3 and the proper hepatic artery, and is the outlet for the biliary tract.

[0060] After blood is processed by the liver 5, it pools in the central veins of the lobule cores. Blood from these central veins eventually converges into the right hepatic vein 9 and the left hepatic vein 9, which exit the superior surface of the liver 5 and drain into the IVC 10 for distribution to the rest of the body.

[0061] The splanchnic venous circulation 100 is highly adaptive and can act as a blood reservoir that can be recruited to support the need for increased blood volume during periods of increased sympathetic nervous system tone, such as exertion, to support increased cardiac output and vasodilation of peripheral vasculature in support of working muscles. However, heart failure patients may have multiple comorbidities that prevent them from using that additional blood volume. Such comorbidities may include chronotropic insufficiency, an inability to increase stroke volume, and / or peripheral microvascular dysfunction. This can lead to venous congestion and / or a sudden increase in pulmonary capillary wedge pressure (PCWP).

[0062] 2 provides another schematic diagram of the splanchnic circulation 200, showing blood flow from the aorta 8 to the IVC 10. Blood travels from the aorta 8 to the abdominal digestive tract, including the stomach 11, liver 5, spleen 7, pancreas 13, small intestine 15, and large intestine 17. The splanchnic circulation 200 includes three major branches of the abdominal vena cava 9, including the celiac artery 19, superior mesenteric artery 21 (SMA), and inferior mesenteric artery 23 (IMA). The hepatic portal circulation (e.g., hepatic artery 18 and / or portal vein 3) delivers the majority of blood flow to the liver 5.

[0063] The celiac trunk 19 is the first major division of the abdominal aorta 8, approximately 1.25 cm long, bifurcating horizontally at T12. It has three main divisions: the left gastric artery, the common hepatic artery 18, and the splenic artery, which provide the main blood supply to the stomach 11, upper duodenum, spleen 7, and pancreas 13.

[0064] The SMA 21 arises from the abdominal aorta 8 anteriorly, usually at L1, 1 cm inferior to the celiac trunk 19. The five major divisions of the SMA 21 are the inferior pancreaticoduodenal artery, the iliac artery, the ileocolic artery, the right colic artery, and the middle colic artery. The SMA 21 supplies the lower duodenum, jejunum, ileum, cecum, appendix, ascending colon, and two-thirds of the transverse colon. It is the largest splanchnic arterial vessel, delivering >10% of cardiac output and therefore has a significant impact on embolic mesenteric ischemia.

[0065] The IMA 23 branches off the abdominal aorta 8 anteriorly at L3, midway between the renal arteries and the iliac bifurcation. The major branches of the IMA 23 are the left colic artery, the sigmoid bifurcation, and the superior rectal artery. It forms a watershed with the middle colic artery and supplies the remaining one-third of the transverse colon, the descending colon, and the upper rectum.

[0066] Blood flows to the liver 5 via the portal vein 3 and into the sinusoids 25 of the liver 5. The hepatic vein 9 carries blood from the liver 5 to the IVC 10.

[0067] 3 shows a portion of the splanchnic venous circulation 300, which acts as a blood reservoir 30 between the aorta 8 and the IVC 10. The portal vein 30 carries blood between the visceral organs 27 (e.g., stomach, spleen, etc.) and the hepatic sinusoids 25, which also receive blood from the hepatic artery 18. The visceral organs 27 receive blood from the aorta 8 via various splanchnic arteries 29 (e.g., SMA, IMA, etc.). At any given time, the amount of blood contained in the portal vein 30 can be variable.

[0068] For some patients (particularly those suffering from heart failure), fluid redistribution and / or stress blood volume from the splanchnic venous reservoir 30 to the IVC 10 can contribute to increases in central venous pressure (CVP), pulmonary artery pressure, and / or PCWP, which can be particularly problematic during periods of increased sympathetic nervous system tone, such as exertion, and / or can lead to pulmonary congestion that can impact the patient's quality of life and / or result in acute decompensation.

[0069] The splanchnic venous circulation 300, particularly the portal vein 3, may advantageously provide a blood reserve to support the need for increased blood volume loading during periods of increased sympathetic nervous system tone. Because blood flow in the splanchnic venous circulation 300 is directed through the hepatic vein 9 and into the IVC 10, devices placed within the hepatic vein 9 and / or IVC 10 to restrict blood flow may allow the reservoir 30 to expand with increased blood volume.

[0070] Embodiments described herein may advantageously relate to devices and / or methods that can restrict, stagnate, and / or impede blood flow from the hepatic vein 9 to the IVC 10 to increase the pressure gradient between the IVC 10 and the hepatic and / or splanchnic venous circulation 300. In some embodiments, one or more flow-regulating implants may be configured for at least partial placement within the hepatic vein 9 and / or IVC 10 and / or at one or more junctions between the hepatic vein 9 and the IVC 10. As a result, blood flowing from the splanchnic venous reservoir 30 into the hepatic vein 9 may be slowed to increase the volume of blood in the splanchnic venous reservoir 30.

[0071] Patients with heart failure with preserved ejection fraction (HFpEF) may be hospitalized due to increased pressure within the left atrium. The increased pressure in the left atrium may be transmitted to the pulmonary circulation, ultimately leading to pulmonary congestion and respiratory distress. Blood volume redistribution from the splanchnic vascular network 300 to the circulation may contribute to the patient's decompensation.

[0072] The splanchnic vascular network 300 is the body's largest blood reservoir and can hold up to approximately 20% of the body's total blood volume. During exertion or increased sympathetic autonomic nervous system activity, much of this blood is redistributed into the circulation, causing a rapid increase in cardiac preload. In healthy physiology, this increase in preload allows the ventricles to fill more, following the Frank-Starling curve and increasing their stroke volume.

[0073] However, in patients with HFpEF, elevated preload fails to increase ventricular filling due to diastolic dysfunction (ventricular stiffness). As a result, elevated preload backs up into the left atrium and lungs, leading to pulmonary congestion, shortness of breath, and / or hospitalization.

[0074] The splanchnic circulation 300 redistributes blood volume within the circulation during periods of increased sympathetic nervous system tone (stress response, exertion, etc.). This extra blood volume increases preload, resulting in higher contractility (Frank-Starling law), and helps supply the increased cardiac output demands. In patients with HFpEF, this extra blood volume in the circulation cannot be accommodated by the failing ventricles with diastolic dysfunction. This causes pressure backflow into the left atrium, leading to pulmonary congestion.

[0075] Splanchnic blood redistribution occurs through the hepatic veins. Limiting blood redistribution into the circulation can help prevent elevated preload, pulmonary congestion, shortness of breath, and hospitalization due to heart failure.

[0076] Some approaches to reducing blood volume redistribution may involve placing a fixed orifice flow controller. Restricting flow from the hepatic vein may be beneficial to prevent blood volume redistribution. However, excessive restriction may cause hepatic congestion. Only during blood volume redistribution may it be advantageous to adjust the response and increase restriction.

[0077] Some embodiments presented herein relate to methods and devices for increasing restriction of blood flow from the hepatic veins and IVC into the right atrium as blood pressure increases. In some examples, the device comprises a stent and / or similar device placed within the IVC. The device may have multiple leaflets and / or tapered ends, similar to a prosthetic heart valve. The leaflets and / or ends may be configured to at least partially close in response to an increase in blood pressure and / or open in response to a decrease in blood pressure.

[0078] Some of the devices described herein can be placed within the IVC such that the leaflets and / or ends of the device are positioned at the bottom of the device and / or can face the inflow of blood as they move upward (e.g., into the right atrium).

[0079] Some devices described herein can be implanted using transcatheter and / or transvenous approaches. The devices can be biased toward an open position and / or can be configured to correct / adjust to a partially and / or fully closed state in response to changes in blood pressure. Thus, the devices can be configured to return to an open state when blood pressure decreases.

[0080] Some embodiments described herein relate to devices and / or processes for limiting blood redistribution (e.g., from the IVC). An exemplary device may include a stent body forming and / or comprising a distal end facing the direction of blood flow within a blood vessel (e.g., the IVC). For example, blood flowing through the blood vessel may first contact the distal end of the device and then contact other portions of the device. The stent body and / or the distal end of the stent body may form an orifice that allows blood flow through and / or into the lumen of the stent body. The distal end of the stent body may be configured by default to an open state in which the orifice through the distal end is open and / or may be relatively large. The distal end may be configured to naturally move / adjust in response to an increase in blood pressure to a closed state in which the orifice through the distal end is blocked and / or relatively small.

[0081] In some embodiments, the distal end of the stent body can include two or more leaflets extending from the stent body and / or configured to extend between and / or around and / or over an orifice located centrally therebetween. The distal end can include a tapered and / or conical sheet of material. In some embodiments, the distal end includes one or more bypass openings to allow some blood flow through the leaflets and / or sheet. The one or more bypass openings can be located at intersections between the leaflets / sheets and the stent body and can increase in size as the leaflets / sheets close.

[0082] In some exemplary devices described herein, the distal stent body can include a plug configured to be held open and distal from the stent body by a coil extending from the stent body. The plug and / or coil can be configured to move toward the stent body in response to an increase in blood pressure relative to the plug and / or coil.

[0083] 4 illustrates an exemplary medical implant 401 positioned within a cardiac vessel 9 (e.g., a hepatic vein) in a default (e.g., expanded and / or resting) configuration, according to one or more embodiments. The vessel 9 may provide a conduit for blood flow from a splanchnic blood reservoir to the IVC 10 and / or other vessels. As indicated by the arrows in FIG. 4 , blood may flow from the right side of the page to the left side and / or toward the IVC 10. While the implant 401 is shown implanted within the hepatic vein 9, the exemplary implants 401 described herein may be suitable for use in other vessels and / or chambers of the heart.

[0084] The medical implant 401 may comprise a stent body 402 and / or a valve 404. The term "valve" is used herein according to its plain and ordinary meaning and may refer to any device configured to passively, selectively, and / or otherwise manage, restrict, occlude, and / or block blood flow through a vessel and / or chamber of the heart. A valve may include any occlusion means, occlusion element, blocking means, blocking element, restriction means, and / or restriction element. While the term "valve" is used in FIG. 4 to refer to a restriction element located within the stent body, in some examples herein, the term "valve" may refer to a device comprising both a stent body and a restriction element.

[0085] In some embodiments, the valve 404 may be similar to a prosthetic heart valve. For example, the valve 404 may include one or more leaflets and / or may selectively form openings 410 for blood flow through the valve 404 and / or the stent body 402 and / or close the openings 410 during periods of elevated blood pressure. The openings 410 in the valve 404 may face the direction of blood flow. For example, the openings 410 may be formed at a distal end 408 of the valve 404, distal from a proximal end 406 of the valve 404. In some embodiments, the proximal end 406 may form a larger opening and / or orifice than the openings 410 formed at the distal end 408, based at least in part on the conical shape of the valve 404.

[0086] In some embodiments, implant 401 may be biased and / or default to an at least partially open configuration, as shown in Figure 4. For example, implant 401 may be implanted in a configuration in which opening 410 provides at least a partial and / or relatively high blood flow to and / or through valve 404. In response to changes in blood flow and / or pressure within blood vessel 9, implant 401 may be configured to adjust and / or deform such that opening 410 provides relatively less blood flow to and / or through valve 404.

[0087] The valve 404 may comprise a distal portion 405 configured to adjust and / or deform to regulate blood flow to and / or through the valve 404. In some embodiments, the distal portion 405 may have a conical and / or tapered configuration having a diameter that decreases relative to the diameter of the proximal portion 407 of the valve 404 and / or the diameter of the stent body 402.

[0088] In some embodiments, distal portion 405 may include a generally conical sheet of material having an opening 410 and / or orifice formed through a central portion of distal portion 405. In other embodiments, distal portion 405 may include two or more overlapping and / or adjacent leaflets extending around opening 410. Distal portion 405 may include a generally flexible material configured to fold, bend, and / or otherwise deform in response to an increase in blood pressure. In some embodiments, distal portion 405 may comprise multiple segments and / or leaflets configured to interconnect and / or at least partially overlap. In response to an increase in pressure, the segments of distal portion 405 may adjust to a greater amount of overlap, and / or distal portion 405 may relax and / or at least partially stretch and / or flatten.

[0089] Blood flow through blood vessel 9 can be configured to compress the distal portion 405 and / or the outer surface of valve 404. For example, distal portion 405 can be angled such that at least a portion of distal portion 405 faces the direction of flow through blood vessel 9. In some examples, distal portion 405 can be configured to respond to blood flow above a threshold pressure level. High blood pressure through blood vessel 9 can be configured to compress the outer surface of distal portion 405 and / or cause distal portion 405 to compress, stretch, flatten, and / or otherwise move, thereby reducing the size of opening 410.

[0090] The stent body 402 may have a cylindrical and / or tubular configuration and / or may define an inner lumen extending therethrough. The inner lumen may be generally cylindrical in shape and / or configured to be disposed coaxially with the blood vessel 9. In some embodiments, the tapered distal portion 405 of the valve 404 may be disposed at least partially within and / or beyond the inner lumen of the stent body 402. The opening 410 and / or orifice formed by the distal portion 405 may be in a central portion of the valve 404 and / or may be generally coaxial with the inner lumen of the stent body 402. In some embodiments, the tapered distal portion 405 of the valve 404 may be configured to extend at least partially across the inner lumen of the stent body 402. The distal portion 405 of the valve 404 may be configured to reduce the size of the opening 410 in response to an increase in the pressure of blood passing through the blood vessel 9. In some embodiments, distal portion 405 can be configured to completely close opening 410 in response to an increase in the pressure of blood passing through vessel 9 .

[0091] In some embodiments, the valve 404 may include a side 409 configured to contact and / or form a seal with the vessel 9. For example, the valve 404 may form a generally circular cross-section and / or form a generally circular area in contact with the vessel 9.

[0092] FIG. 4 illustrates blood flow from one or more splanchnic arteries, through a splanchnic blood reservoir, to vessel 9, and ultimately into IVC 10. While only a single vessel 9 is shown in FIG. 4 for illustrative purposes, multiple vessels (e.g., hepatic veins) can carry blood from the reservoir to IVC 10. Vessel 9 can supply junction 40 of IVC 10. Accordingly, to restrict blood flow into IVC 10, one or more flow-restricting implants 401 can be configured for placement within vessel 9 and / or at least partially within junction 40 of IVC 10.

[0093] The present disclosure provides methods and devices (including various medical implants) for managing blood flow within the human body. The term "implant" is used herein according to its plain and ordinary meaning and may refer to any medical implant, frame, valve, shunt, stent, anchor, and / or similar device for use in treating various conditions of the human body. Implants may be delivered percutaneously and / or via a catheter (i.e., transcatheter) for various medical procedures and may generally have a rigid and / or flexible structure. The term "catheter" is used herein according to its broad and ordinary meaning and may include any tube, sheath, steerable sheath, steerable catheter, and / or any other type of elongated tubular delivery device with an inner lumen configured to slidably receive an instrument, such as for positioning within the IVC and / or hepatic veins, including, for example, a delivery catheter and / or cannula.

[0094] 5 illustrates an exemplary medical implant 501 in a compressed configuration positioned within a cardiac vessel 9, according to one or more embodiments. The medical implant 501 may comprise a stent body 502 and / or a valve 504. In some embodiments, the valve 504 may resemble a prosthetic heart valve. For example, the valve 504 may comprise one or more leaflets and / or may form openings for blood flow through the valve 504 and / or the stent body 502. The openings in the valve 504 may face in the direction of blood flow. For example, the openings may be formed in a distal end 506 of the valve 504, distal from a proximal end 508 of the valve 504. The distal end 506 may be positioned downstream of the proximal end 508.

[0095] The valve 504 may comprise a distal portion 505 configured to flatten and / or otherwise deform in response to an increase in blood pressure against an outer surface of the distal portion 505. As a result, the opening may decrease in size in response to an increase in blood pressure through the blood vessel 9. In some embodiments, the distal portion 505 may have a conical and / or tapered form having a diameter that decreases relative to the diameter of the proximal portion 507 and / or proximal end 508 of the valve 504 and / or the diameter of the stent body 502. The distal portion 505 and / or distal end 506 may be configured to completely close in response to an increase in blood pressure such that the opening does not allow any blood flow through. In some embodiments, the valve 504 may allow blood flow at a side 509 of the valve 504 when the opening is at least partially closed.

[0096] In some embodiments, the valve 504 may include a side 509 configured to contact and / or form a seal with the vessel 9. For example, the valve 504 may form a generally circular cross-section and / or form a generally circular area in contact with the vessel 9. In some embodiments, the valve 504 may include one or more openings 511 configured to allow blood flow through the valve 504 when in the closed and / or compressed configuration shown in FIG. 5 . In some embodiments, the openings 511 may move toward the distal end and / or the end facing the blood flow of the valve 504 when the distal portion 505 closes. When the distal portion 505 flattens, the side 509 may pull away from the wall of the vessel 9 and / or the valve 504 may form one or more gaps between the valve 504 and the wall of the vessel 9.

[0097] An increase in blood pressure on the distal portion 505 can cause a decrease in the length of the valve 504. For example, the distal portion 505 can be pushed toward the proximal end 508 of the valve 504, decreasing the distance between the distal end 506 and the proximal end 508 of the valve 504.

[0098] The valve 504 may include a covering extending at least partially along the interior and / or exterior surfaces of an inner frame and / or skeleton (not shown) of the valve 504. The covering may include one or more fabrics, polymers, rubbers, and / or other materials. In some examples, the covering may have a generally flexible, soft, and / or stretchable structure. The covering may be generally fluid-tight and / or may prevent blood flow through the covering. In some examples, the covering may include one or more bypass openings configured to allow blood flow.

[0099] 6A-6D illustrate an exemplary occlusion device 601 (e.g., a prosthetic valve) positioned within a blood vessel 9 (e.g., a hepatic vein) according to one or more embodiments. FIG. 6A provides a side view of the device 601 in an expanded and / or default configuration. The device 601 can include a stent body 602 (e.g., a cylindrical and / or tubular wire stent) and / or a covering 603 at least partially surrounding the stent body 602 and / or attached to the exterior and / or interior surfaces of the stent body 602. In some embodiments, the covering 603 can be at least partially constructed from cloth and / or other generally flexible material. In some embodiments, the device 601 and / or the stent body 602 can have a generally conical (e.g., partially conical) and / or tapered shape and / or include a distal portion 605 that reduces in diameter from the diameter of a proximal portion 607 of the stent body 602. The distal portion 605 may include one or more arms 612 and / or elongate members extending generally longitudinally and / or at approximately a 45-degree angle along the device 601. For example, the one or more arms 612 may be configured to extend toward the distal end 606 of the device 601 and / or generally opposite the direction of blood flow when the device 601 is positioned within the blood vessel 9. The one or more arms 612 may be configured to extend toward each other and / or toward a common point (e.g., toward the central axis of the device 601). In some embodiments, the one or more arms 612 may be configured to bend (e.g., elastically bend) in a default configuration and / or may be at least partially bent to create the tapered configuration of the distal portion 605. The one or more arms 612 may be at least partially constructed from nitinol and / or other shape memory alloys configured to be shape-set in the curved configuration shown in FIG. 6A . The covering 603 may be configured to extend along the outer and / or inner surfaces of one or more arms 612 and / or may have a generally conical and / or tapered shape at the distal portion 605 and / or may be configured to be shape-set by one or more arms 612.

[0100] Although device 601 is shown with six arms 612, device 601 may include any number of arms 612. The arms 612 may be configured to extend at least partially toward each other and / or toward a common point (e.g., toward the central axis of device 601). FIG. 6B provides a front view of device 601 in an expanded and / or default configuration. As shown in FIG. 6B, one or more arms 612 and / or covering 603 may be configured to form an opening 610 (e.g., an orifice) about the central axis of device 601. The opening 610 may be smaller than the maximum / extreme diameter of the stent body 602. In some embodiments, one or more arms 612 may be at least partially offset and / or may not directly face each other and / or extend toward each other, as shown in FIG. 6B. In other embodiments, arms 612 may include paired arms 612 positioned and / or extending generally opposite each other across opening 610.

[0101] In some embodiments, the proximal portion 607 of the stent body 602 can include a network of interconnected and / or woven wires and / or other elongated materials. One or more arms 612 can extend from the proximal portion 607. As shown in FIG. 6A , the one or more arms 612 can be slightly closed (e.g., bent and / or angled) in a default and / or expanded configuration. The stent body 602 can include a proximal end 608 having a generally equal diameter relative to the proximal portion 607. The proximal end 608 can define an opening and / or orifice having a larger diameter than the distal end 606.

[0102] FIG. 6C provides a side view of device 601 in at least a partially compressed configuration. When blood pressure and / or blood flow increases (e.g., during splanchnic blood volume redistribution), distal portion 605 (e.g., arms 612 and / or covering 603) can be configured to close. For example, blood flow may be directed against the outer surface of covering 603 and / or arms 612 and / or may push against covering 603 and / or arms 612, thus flattening distal portion 605 and / or pushing toward stent body 602 and / or reducing the size of opening 610. FIG. 6D provides a front view of device 601 in a compressed configuration. The reduction in size of opening 610 reduces the amount of flow through the orifice of device 601. In some embodiments, the angle of one or more arms 612 relative to proximal portion 607 can increase as distal portion 605 flattens in response to increased pressure.

[0103] In some embodiments, the covering 603 may include one or more openings 614 and / or bypass holes configured to receive blood flow and / or allow blood flow to enter the orifice of the device 601. The one or more apertures 614 may be positioned in the distal portion 605 (e.g., in the generally curved portion of the covering 603) and / or in the transition portion between the proximal portion 607 and the distal portion 605 (e.g., between the covering 603 having a generally straight configuration at the proximal portion 607 and the covering 603 having a generally curved configuration at the distal portion 605). In some embodiments, the one or more apertures 614 may have a generally oval (e.g., circular) shape and / or any suitable shape and / or size. The covering 603 may include at least one aperture 614 between each pair of arms 612 of the device 601. However, the covering 603 may alternatively include any number of apertures 614. In some embodiments, the apertures 614 may be configured to prevent and / or reduce stagnation and / or thrombus formation at or near the device 601.

[0104] Although device 601 is shown including coating 603 and / or openings 614, device 601 and / or other devices herein may not include coating 603 and / or openings 614 at all. For example, device 601 may not include a generally rigid stent body 602 and / or distal portion 605, and / or device 601 may include a generally dense wire mesh such that only limited blood flow is permitted through stent body 602 and / or distal portion 605. The wire mesh may form a tapered distal portion 605 and / or openings 610 as described above.

[0105] 7A and 7B illustrate an exemplary occlusion device 701 configured for placement within a blood vessel (e.g., a hepatic vein) comprising one or more leaflets 715, according to one or more embodiments. The term “leaflet” is used herein according to its plain and ordinary meaning and may refer to any covering and / or appendage configured to extend at least partially over the lumen of an occlusion device (e.g., a stent) and / or blood vessel. In some embodiments, the occlusion device 701 may comprise multiple leaflets 715 that at least partially overlap and / or extend sequentially around the circumference of the occlusion device 701. The one or more leaflets 715 may extend from an outer diameter of the occlusion device 701 toward a central axis of the occlusion device 701.

[0106] 7A provides a front view of the occlusion device 701 in an open and / or default state. In some cases, one or more of the leaflets 715 may include bypass openings 714 (e.g., holes and / or openings) to allow blood flow through the leaflets 715 and / or reduce thrombus formation. The bypass openings 714 may be oriented along a generally circular path about the longitudinal axis and / or center of the opening 710 formed by one or more leaflets 715. The openings 714 may have any suitable size and / or shape. While the openings 714 are shown having a generally circular configuration, exemplary openings 714 may comprise generally elongated and / or thin openings cut in one or more leaflets 715.

[0107] Although occlusion device 701 is shown having three leaflets 715, occlusion device 701 may include any number of leaflets 715. In some embodiments, one or more leaflets 715 may extend from a covering configured to extend at least partially along a proximal portion (not shown, see e.g., FIGS. 6A-6D ) of occlusion device 701. One or more leaflets 715 may comprise a generally soft and / or flexible material configured to at least partially respond to pressure from blood passing through and / or around occlusion device 701.

[0108] FIG. 7B provides a front view of the occlusion device 701 in an at least partially closed state. The occlusion device 701 can be positioned within a blood vessel such that blood flow through the vessel is directed toward the leaflets 715 of the device 701. For example, in the embodiments shown in FIGS. 7A and 7B, blood flow may be directed into the leaflets. As blood pressure increases, the increased blood flow exerts increased pressure on the leaflets 715, causing the leaflets 715 to naturally close and / or cover the central opening 710 formed by the leaflets 715. Thus, the opening 710 may decrease in size as blood pressure increases, resulting in increased occlusion of blood flow. In some embodiments, one or more leaflets 715 can form gaps 713 (e.g., laterally extending and / or elongated gaps 713) between the leaflets 715. These gaps 713 can similarly close in response to increased blood pressure. In some embodiments, flattening of the leaflets 715 in response to blood pressure may cause one or more apertures 714 to move toward a central axis of the device 701, as shown in FIG. 7B. For example, the one or more apertures 714 may be positioned generally near an edge portion of one or more leaflets 715. Thus, as the edge portion moves toward the central axis of the device 701 in response to flattening of the leaflets 715, the apertures 714 may likewise move toward the central axis.

[0109] The device 701 may comprise a stent body (not shown) and / or a covering at least partially surrounding the stent body. In some embodiments, the device 701 and / or leaflets 715 may form a generally conical and / or tapered shape, and / or the device 701 may reduce in diameter from the maximum diameter of the stent body. One or more leaflets 715 may be supported by one or more arms and / or elongate members extending generally longitudinally along the device 701. For example, one or more leaflets 715 may extend along the outer surface of one or more elongate arms having a curved and / or tapered configuration.

[0110] 8A-8C illustrate another exemplary occlusion device 801 configured to be placed within a blood vessel (e.g., a hepatic vein) according to one or more embodiments, the occlusion device 801 including one or more leaflets 815. In some embodiments, the occlusion device 801 can include multiple leaflets 815 that at least partially overlap and / or extend sequentially around the circumference of the occlusion device 801.

[0111] 8A provides a front view of the occlusion device 801 in an open and / or default state. In some cases, one or more of the leaflets 815 may include bypass openings 814 (e.g., holes) to allow blood flow through the leaflets 815 and / or reduce thrombus formation. Although the occlusion device 801 is shown having three leaflets 815, the occlusion device 801 may include any number of leaflets 815.

[0112] The bypass openings 814 may be located at or near the intersection of the leaflets 815 and / or stent body of the device 801. For example, one or more openings 814 may be located at the transition between the proximal portion of the stent body and the distal portion of the stent body. FIG. 8B provides a front view of the occlusion device 801 in at least a partially closed state, and FIG. 8C provides a front view of the device 801 in a fully closed state. The occlusion device 801 may be positioned within a blood vessel such that blood flow through the vessel is directed toward the leaflets 815 of the device 801. For example, in the embodiment shown in FIGS. 8A and 8B, blood flow may be directed into the leaflets. As blood pressure increases, the increased blood flow exerts increased pressure on the leaflets 815, which may cause the leaflets 815 to naturally close and / or cover the central opening 810 formed by the leaflets 815. Thus, the openings 810 may decrease in size as blood pressure increases, resulting in increased obstruction of blood flow. In some embodiments, one or more leaflets 815 may form gaps 813 (e.g., laterally extending and / or elongated gaps 813) between the leaflets 815. These gaps 813 may similarly close in response to an increase in blood pressure.

[0113] Device 801 may comprise a stent body (not shown) and / or a covering at least partially surrounding the stent body. In some embodiments, device 801 and / or leaflets 815 may form a generally conical and / or tapered shape and / or device 801 may reduce in diameter from the diameter of the stent body. One or more leaflets 815 may be supported by one or more arms and / or elongate members extending generally longitudinally along device 801.

[0114] Bypass opening 814 may be configured to increase in size and / or move toward a forward region of device 801 as blood pressure increases. For example, an increase in blood pressure may cause one or more leaflets 815 to flatten and / or stretch across opening 810 between leaflets 815. As a result, opening 814 may extend further across the lumen of device 801 and / or across a front portion of device 801. As a result, opening 814 may increase in frontal portion / area and / or stretch distally and / or toward a front portion of device 801 such that blood flow to leaflets 815 can increasingly pass through opening 814 as blood pressure increases.

[0115] FIG. 9 illustrates an exemplary plug 920 configured to plug, block, and / or close an opening in an occlusion device according to one or more embodiments. In some embodiments, the plug 920 can include a wire and / or a rigid frame and / or similar material having a hollow and / or filled core. For example, the plug 920 can include a wire frame at least partially surrounded by a covering composed of a fabric, a polymer, and / or other material. The plug 920 can include a proximal portion 927 and / or a proximal end 928, an intermediate portion 925, and / or a distal end 926. The proximal portion 927 can have a conical shape and / or can be configured such that at least the proximal end 928 extends at least partially into the occlusion device to enter the lumen and / or opening of the occlusion device. The proximal portion 927 can be configured to conform and / or fit within a generally oval-shaped opening and / or orifice of the occlusion device.

[0116] Intermediate portion 925 may have a generally cylindrical and / or tubular shape. Distal end 926 may be generally flat or rounded, and / or may include a spherical cap and / or may have a semi-spherical and / or flat shape. In some embodiments, distal end 926 may be configured to face the direction of blood flow and / or may have an appropriate surface area such that blood flow against distal end 926 exerts a pushing force against distal end 926.

[0117] 10A shows an exemplary occlusion device 1001 within a blood vessel 9 including a plug 1020 in a default and / or expanded configuration, according to one or more embodiments. The plug 1020 may be coupled and / or attached to a distal end 1006 of a stent body 1002 of the occlusion device 1001. In some embodiments, the distal end 1006 of the stent body 1002 may include a generally oval (e.g., circular) opening configured to at least partially receive the plug 1020. In some embodiments, the occlusion device 1001 may include a valve 1004 including an orifice configured to receive the plug 1020. The plug 1020 may include a proximal end 1027 configured to at least partially enter the opening 1010 at the distal end 1006 of the stent body 1002 and / or enter an orifice in the valve 1004. The plug 1020 may increase in diameter from the proximal end 1027 of the plug 1020 to the intermediate portion and / or the distal end 1026. In some embodiments, the intermediate portion may be wider than the opening 1010 at the distal end 1006 of the stent body 1002. Thus, the intermediate portion may prevent the plug 1020 from passing completely through the opening 1010 and / or through the valve 1004 (i.e., the control valve). The valve 1004 may include a tapered distal portion comprising an orifice configured to receive the proximal end 1027 of the plug 1020. The stent body 1002 may have a generally cylindrical shape extending between the distal end 1006 and the proximal end 1008.

[0118] In some embodiments, the tether 1022 may extend from the stent body 1002 and / or may be coupled to the plug 1020. For example, the tether 1022 may comprise a coil, a spring, a wire, a string, a cord, a tether, and / or a similar device. In some embodiments, the tether 1022 may at least partially surround the plug 1020 and / or form one or more coils around the plug 1020. The tether 1022 may be configured to bias the plug 1020 at least partially away from and / or distally away from the stent body 1002 to form a gap between the plug 1020 and the stent body 1002. For example, the tether 1022 may have a generally rigid configuration and / or may be sufficiently stiff to hold the plug 1020 away from the stent body 1002 in the absence of an external force. Thus, blood may be able to pass through the gap between the plug 1020 and the opening of the valve 1004 and / or enter the orifice of the stent body 1002 in the default and / or biased configuration.

[0119] 10B shows an exemplary occlusion device 1001 in a compressed configuration, according to one or more embodiments. In some embodiments, the internal bias of the tether 1022 can be configured to be overcome by pressure from increased blood flow through the blood vessel 9. In response to an increase in blood pressure, the plug 1020 can be configured to be pulled toward the opening 1010 of the stent body 1002, at least partially closing the opening 1010 and / or preventing blood flow into the opening 1010. An increase in blood pressure at or near the device 1001 can cause the stent body 1002 to move, naturally pushing the tether 1022 and / or plug 1020 toward the opening 1010. Similarly, a decrease in blood pressure can cause the device 1001 to relax and / or the plug 1020 and / or tether 1022 to move away from the opening 1010.

[0120] Although tether 1022 is shown having a helical coil configuration, tether 1022 may have other configurations. For example, tether 1022 may include one or more beam springs and / or braided wire.

[0121] 11A-11C illustrate another exemplary occlusion device 1101 configured to selectively occlude a blood vessel, according to one or more embodiments. Figure 11A provides a side view of device 1101 in a relaxed and / or default configuration, Figure 11B provides a perspective view of device 1101 in a relaxed and / or default configuration, and Figure 11C provides a front view of device 1101 in a compressed configuration.

[0122] The device 1101 may comprise a stent body 1102 and / or a valve coupled to the stent body 1102 via a tether 1118. The valve may comprise a frame 1132 and / or a cap 1134. The stent body 1102 may comprise a stopper 1140 configured to prevent the frame 1132 from entering the orifice 1110 of the stent body 1102. The cap 1134 may be configured to at least partially enter the orifice 1110 of the stent body 1102. The stopper 1140 may be configured to extend at least partially across the orifice 1110 and / or inner lumen of the stent body. In some embodiments, the stopper 1140 may have a generally rectangular configuration and / or any suitable size and / or shape.

[0123] The cap 1134 may be at least partially constructed from silicone and / or other generally rigid materials. The cap 1134 may be configured to block blood flow. In some embodiments, the cap 1134 may have a hemispherical and / or bowl-shaped configuration. For example, the cap 1134 may extend away from the midpoint of the frame 1132. In some embodiments, the cap 1134 may be oval and / or have a length that is greater than its width. The length of the cap 1134 may be approximately equal to the diameter of the stent body 1102, and / or the width of the cap 1134 may be less than the diameter of the stent body 1102.

[0124] The frame 1132 may include cross arms including a first arm 1136 and / or a second arm 1138. The first arm 1136 may extend across the length of the cap 1134, and / or the second arm 1138 may extend across the width of the cap 1134. The first arm 1136 and the second arm 1138 may intersect at a midpoint of the cap 1134. In some embodiments, the second arm 1138 may extend downward and / or away from the first arm 1136. For example, the first arm 1136 may approximate the curvature of the cap 1134.

[0125] In some embodiments, cap 1134 may have a concave configuration relative to the direction of blood flow. For example, when placed in a blood vessel, blood may flow into the bowl-shaped interior of cap 1134. Tether 1118 may be at least partially rigid and / or configured to at least partially resist movement due to pressure applied at relatively low blood pressure. However, in response to an increase in blood pressure, the rigidity of tether 1118 may be overcome and / or cap 1134 may be pushed toward orifice 1110 of stent body 1102.

[0126] 12A-12C illustrate an exemplary occlusion device 1201 within a blood vessel 9, comprising a plug 1220 in a default and / or expanded configuration, according to one or more embodiments. FIG. 12A provides a perspective view of the occlusion device 1201, FIG. 12B provides a side view of the occlusion device 1201, and FIG. 12C provides a top view of the occlusion device 1201. The exemplary plug 1220 can be configured to plug, block, and / or close an opening in the attachment ring 1205 of the occlusion device 1201, according to one or more embodiments. In some embodiments, the plug 1220 can comprise a wire and / or a rigid frame and / or similar material having a hollow and / or filled core. For example, the plug 1220 can comprise a wire frame at least partially surrounded by a covering composed of fabric, polymer, and / or other material. Plug 1220 may include a proximal portion 1227 and / or proximal end 1228, an intermediate portion 1229, and / or a distal end 1226. Proximal portion 1227 may have a conical shape and / or may be configured to extend at least partially into attachment ring 1205 such that at least proximal end 1228 enters a lumen and / or opening in attachment ring 1205. Proximal portion 1227 may be configured to conform and / or fit within a generally oval-shaped opening and / or orifice in attachment ring 1205.

[0127] Intermediate portion 1229 may have a generally cylindrical and / or tubular shape and / or may comprise the largest diameter and / or width of plug 1220. Distal end 1226 may be generally flat or rounded, and / or may include a spherical cap and / or may have a hemispherical and / or flat shape. In some embodiments, distal end 1226 may be configured to face the direction of blood flow and / or may have an appropriate surface area such that blood flow against distal end 1226 exerts a pushing force against distal end 1226.

[0128] The plug 1220 may be coupled to and / or attached to the attachment ring 1205, a stent, and / or other anchoring device. In some embodiments, the attachment ring 1205 may include a generally oval (e.g., circular) opening configured to at least partially receive the plug 1220. In some embodiments, the attachment ring 1205 may include a valve and / or orifice configured to receive the plug 1220. The plug 1220 may include a proximal end 1228 configured to at least partially enter the opening in the attachment ring 1205 and / or the valve in the attachment ring 1205. The plug 1220 may increase in diameter from the proximal end 1228 to the intermediate portion and / or distal end 1226 of the plug 1220. In some embodiments, the intermediate portion 1229 may be wider than the opening in the attachment ring 1205. Thus, intermediate portion 1229 may prevent plug 1220 from passing completely through the opening in mounting ring 1205 and / or through a valve (e.g., a control valve). However, the opening in mounting ring 1205 may be wider than intermediate portion 1229 of plug 1220.

[0129] In some examples, the plug 1220 may be coupled to the attachment ring 1205 via one or more arms 1222. The one or more arms 1222 may be configured to establish a movable coupling between the plug 1220 and the attachment ring 1205. In some embodiments, the one or more arms may be at least partially flexible and / or bendable. Each of the one or more arms 1222 may include a flexure 1231 and / or may be coupled to a distal end 1226 of the attachment ring 1205 and / or plug 1220. In response to blood pressure at the distal end 1226, the flexure 1231 of the one or more arms 1222 may move along the one or more arms 1222 as the plug 1220 moves toward the attachment ring 1205. The one or more arms 1222 may be configured to permit and / or enable movement of the plug 1220 relative to the attachment ring 1205. For example, the attachment ring 1205 may be anchored and / or otherwise held in a fixed position relative to the surrounding tissue, and / or the plug 1220 may be configured to move relative to the attachment ring 1205 (e.g., toward and / or away from the attachment ring 1205).

[0130] The one or more arms 1222 may include coils, springs, wires, strings, cords, tethers, and / or similar devices. The occlusion device 1201 may include any number of arms 1222. Although three arms 1222 are shown in FIGS. 12A-12C , in some embodiments, the one or more arms 1222 may be generally evenly spaced around the attachment ring 1205 and / or around the plug 1220. The one or more arms 1222 may be configured to bias the plug 1220 at least partially and / or distally away from the attachment ring 1205 to form a gap between the plug 1220 and / or at least a middle portion 1229 of the plug 1220 and the attachment ring 1205. For example, the one or more arms 1222 may have a generally rigid configuration and / or may be sufficiently rigid to hold the plug 1220 away from the attachment ring 1205 in the absence of an external force. Thus, blood may be able to pass through the gap between the plug 1220 and the opening in the mounting ring 1205 and / or enter the orifice in the mounting ring 1205 in the default and / or biased configuration.

[0131] In some embodiments, the internal bias of one or more arms 1222 can be configured to be overcome by pressure from an increase in blood flow through blood vessel 9. In response to an increase in blood pressure, plug 1220 can be configured to be pulled toward attachment ring 1205 to at least partially close the opening in attachment ring 1205 and / or prevent blood flow into attachment ring 1205. An increase in blood pressure at or near device 1201 can cause plug 1220 to move toward attachment ring 1205. Similarly, a decrease in blood pressure can cause relaxation of device 1201 and / or movement of plug 1220 away from attachment ring 1205.

[0132] Plug 1220 may have a generally conical shape and / or may have a gradually decreasing diameter and / or width from intermediate portion 1229 to proximal end 1228. As plug 1220 gradually descends into attachment ring 1205, the gradually increasing diameter and / or width of plug 1220 may gradually increase the obstruction of blood flow through attachment ring 1205 from proximal end 1228 to intermediate portion 1229.

[0133] In some embodiments, the attachment ring 1205 and / or arms 1222 may be generally flexible and / or configured to compress to enable transcatheter delivery through one or more catheters and / or shafts. For example, the arms 1222 and / or attachment ring 1205 may be configured to fold around the plug 1220. The plug 1220 may be sized to fit within one or more catheters without requiring compression of the plug 1220. However, the plug 1220 may be at least partially compressible. In some embodiments, the plug 1220 may comprise a rigid and / or braided structure. For example, the plug 1220 may comprise a mesh of braided polyurethane wires and / or strips configured to form the plug 1220. In some embodiments, the plug 1220 may be at least partially hollow within its outer structure.

[0134] The one or more arms 1222 and / or the attachment ring 1205 may be at least partially constructed from one or more shape memory alloys (e.g., nitinol). In some embodiments, the one or more arms 1222 and / or the attachment ring 1205 may be shaped in a desired configuration (e.g., the configuration shown in FIG. 12A ) prior to delivery to a patient's body. Thus, the device 1201 may be configured to naturally assume the configuration shown in FIG. 12A in the absence of substantial elevated pressure on the plug 1220 and / or the device 1201. The one or more arms 1222 may be configured to elastically deform in response to blood pressure on and / or around the plug 1220 (e.g., relative to the distal end 1226 of the plug 1220). The proximal end 1228 of the plug 1220 may be disposed proximal to the attachment ring 1205 in a default state of the one or more arms 1222 and / or the device 1201. In some embodiments, one or more of 1222 can be configured to allow the plug 1220 to move into and / or through the attachment ring 1205 such that the distal end 1226 of the plug 1220 can be positioned distally relative to the attachment ring 1205.

[0135] In some embodiments, one or more arms 1222 may have a varying width and / or density. For example, the stiffness of one or more arms 1222 may increase toward the connection point with attachment ring 1205 based at least in part on the gradually varying width and / or density of one or more arms 1222. Thus, one or more arms 1222 may be more flexible at or near the connection point with plug 1220 than at or near the connection point with attachment ring 1205.

[0136] 13A-13C illustrate an exemplary occlusion device 1301 within a blood vessel 9, comprising a plug 1320, according to one or more embodiments. FIG. 13A provides a side view of the occlusion device 1301 in a default and / or expanded configuration, FIG. 13B provides a side view of the occlusion device 1301 in a closed and / or partially deformed state, and FIG. 13C provides a side view of the occlusion device 1301 in an open and / or fully deformed state. The exemplary plug 1320 can be configured to occlude, block, and / or close an opening in the attachment ring 1305 of the occlusion device 1301 according to one or more embodiments. In some embodiments, the plug 1320 can comprise a wire and / or a rigid frame and / or similar material with a hollow and / or filled core. For example, the plug 1320 can comprise a wire frame at least partially surrounded by a covering composed of fabric, polymer, and / or other material. Plug 1320 may include a proximal portion 1327 and / or proximal end 1328, an intermediate portion 1329, and / or a distal end 1326. Proximal portion 1327 may have a conical shape and / or may be configured to extend at least partially into attachment ring 1305 such that at least proximal end 1328 enters a lumen and / or opening in attachment ring 1305. Proximal portion 1327 may be configured to conform and / or fit within a generally oval-shaped opening and / or orifice in attachment ring 1305.

[0137] Intermediate portion 1329 may have a generally cylindrical and / or tubular shape and / or may have the largest diameter and / or width of plug 1320. Distal end 1326 may be generally flat or rounded, and / or may include a spherical cap and / or may have a hemispherical and / or flat shape. In some embodiments, distal end 1326 may be configured to face the direction of blood flow and / or may have an appropriate surface area so that blood flow against distal end 1326 exerts a pushing force against distal end 1326.

[0138] The plug 1320 may be coupled to and / or attached to the attachment ring 1305, a stent, and / or other anchoring device. In some embodiments, the attachment ring 1305 may include a generally oval (e.g., circular) opening configured to at least partially receive the plug 1320. In some embodiments, the attachment ring 1305 may include a valve including an orifice configured to receive the plug 1320. The plug 1320 may include a proximal end 1328 configured to at least partially enter the opening in the attachment ring 1305 and / or the valve in the attachment ring 1305. The plug 1320 may increase in diameter from the proximal end 1328 to the intermediate portion and / or distal end 1326 of the plug 1320. In some embodiments, the intermediate portion 1329 may be wider than the opening in the attachment ring 1305. Thus, the intermediate portion 1329 may prevent the plug 1320 from passing completely through the opening in the mounting ring 1305 and / or through a valve (e.g., a control valve). However, the opening in the mounting ring 1305 may be wider than the intermediate portion 1329 of the plug 1320.

[0139] In some examples, the plug 1320 may be coupled to the attachment ring 1305 via one or more arms 1322. The one or more arms 1322 may be configured to establish a movable coupling between the plug 1320 and the attachment ring 1305. In some embodiments, the one or more arms may be at least partially flexible and / or bendable. Each of the one or more arms 1322 may include a flexure 1331 and / or may be coupled to a distal end 1326 of the attachment ring 1305 and / or plug 1320. In response to blood pressure at the distal end 1326, the flexure 1331 of the one or more arms 1322 may move along the one or more arms 1322 as the plug 1320 moves toward the attachment ring 1305.

[0140] The one or more arms 1322 may include coils, springs, wires, strings, cords, tethers, and / or similar devices. The occlusion device 1301 may include any number of arms 1322. Although three arms 1322 are shown in FIGS. 13A-12C , in some embodiments, the one or more arms 1322 may be generally evenly spaced around the attachment ring 1305 and / or around the plug 1320. The one or more arms 1322 may be configured to bias the plug 1320 at least partially and / or distally away from the attachment ring 1305 to form a gap between the plug 1320 and / or at least a middle portion 1329 of the plug 1320 and the attachment ring 1305. For example, the one or more arms 1322 may have a generally rigid configuration and / or may be sufficiently rigid to hold the plug 1320 away from the attachment ring 1305 in the absence of an external force. Thus, blood may be able to pass through the gap between the plug 1320 and the opening in the mounting ring 1305 and / or enter the orifice in the mounting ring 1305 in the default and / or biased configuration.

[0141] In some embodiments, the internal bias of one or more arms 1322 can be configured to be overcome by pressure from increased blood flow through blood vessel 9. As shown in FIG. 13B , in response to an increase in blood pressure, plug 1320 can be configured to be pulled toward attachment ring 1305 and / or in the direction of blood flow to at least partially close the opening in attachment ring 1305 and / or prevent blood flow into attachment ring 1305. An increase in blood pressure at or near device 1301 can cause plug 1320 to move toward attachment ring 1305. Similarly, a decrease in blood pressure can cause relaxation of device 1301 and / or movement of plug 1320 away from attachment ring 1305. As plug 1320 moves in the direction of blood flow, the portion of plug 1320 located within attachment ring 1305 may gradually widen based at least in part on the conical and / or tapered shape of plug 1320 until intermediate portion 1329 of plug 1320 is located within attachment ring 1305 (closed and / or partially deformed state). With intermediate portion 1329 positioned within attachment ring 1305, occlusion device 1301 may be in a closed state and / or may allow minimal blood flow through attachment ring 1305.

[0142] If plug 1320 continues to be pushed in the direction of blood flow after reaching the closed configuration shown in FIG. 13B , one or more arms 1322 may continue to bend to allow advancement of plug 1320 down attachment ring 1305. As plug 1320 continues to move downstream, the portion of plug 1320 located within attachment ring 1305 may become gradually thinner beyond intermediate portion 1329, based at least in part on the conical and / or rounded configuration of distal end 1326 of plug 1320. As shown in FIG. 13C , plug 1320 may eventually be pushed completely past attachment ring 1305, resulting in an open state of occlusion device 1301 and / or maximum blood flow through attachment ring 1305.

[0143] Figures 14-17 show various exemplary arms for interconnecting an exemplary plug to an exemplary attachment ring. While Figures 14-17 each depict a single arm, an occlusion device can include multiple arms (see, e.g., Figures 12A-12C). Each of the arms of an occlusion device can have a common structure and / or configuration and / or can have different structures and / or configurations.

[0144] 14 shows arms 1422 having a generally constant width. Arms 1422 may have a tubular, rectangular, octagonal, and / or similar configuration.

[0145] 15 shows an arm 1522 having a single layer variable width. The arm 1522 may comprise a proximal portion 1544 and / or a distal portion 1542. The distal portion 1542 may have a smaller width than the proximal portion 1544. The arm 1522 may have a stepped width and / or configuration between the proximal portion 1544 and the distal portion 1542. In some embodiments, the arm 1522 may include a single layer and / or a single stepped width change between the proximal portion 1544 and the distal portion 1542.

[0146] 16 shows an arm 1622 having a graduated and / or variable width. The arm 1622 may include a proximal end 1648 and / or a distal end 1646. The distal end 1646 may have a smaller width than the proximal end 1648. The arm 1622 may have a tapered and / or conical configuration and / or may gradually decrease in width between the proximal end 1648 and the distal end 1646.

[0147] 17 shows an arm 1722 having multiple layers of variable width. The arm 1722 can include a proximal portion 1744, an intermediate portion 1743, and / or a distal portion 1742. The distal portion 1742 can have a smaller width than the intermediate portion 1743, and / or the intermediate portion 1743 can have a smaller width than the proximal portion 1744. The arm 1722 can have a stepped configuration between the proximal portion 1744 and the intermediate portion 1743 and / or between the intermediate portion 1743 and the distal portion 1742. In some embodiments, the arm 1722 can include multiple (e.g., two) layers and / or multiple (e.g., two) stepped width changes between the proximal portion 1744 and the distal portion 1742.

[0148] 18 provides a flowchart illustrating an exemplary process 1800 for delivering and / or anchoring the various occlusion devices described herein. The steps of process 1800 may be performed in any suitable order, and / or steps may be omitted and / or added as desired.

[0149] At step 1802, process 1800 calls for setting one or more arms of the occlusion device to an open position in which at least a medial portion of the plug is at least partially offset from the attachment ring. The one or more arms can interconnect the plug and the attachment ring and / or may be at least partially flexible. In some examples, the one or more arms may be at least partially constructed from nitinol and / or other shape memory alloys.

[0150] The intermediate portion can occupy a portion of the largest diameter and / or width of the plug. In some embodiments, the plug can be completely offset from the attachment ring in the open position and / or state. For example, the plug can be positioned upstream of the attachment ring when the occlusion device is delivered to the vessel.

[0151] At step 1804, process 1800 calls for compressing the occlusion device. In some embodiments, one or more arms and / or attachment rings may be at least partially flexible to allow bending and / or compression. One or more arms and / or attachment rings may be at least partially constructed from one or more shape memory alloys.

[0152] At step 1806, process 1800 calls for delivering an occlusion device to a target tissue site (e.g., inside a blood vessel) via a catheter. The occlusion device may be compressible to fit into any suitable catheter.

[0153] At step 1808, process 1800 calls for removing the occlusion device from the catheter and / or allowing the occlusion device to expand. In some embodiments, the occlusion device may be configured to expand naturally in response to removal from the catheter. For example, one or more arms and / or attachment rings may return to an unbent and / or shaped configuration after removal from the catheter.

[0154] At step 1810, process 1800 calls for anchoring the attachment ring to the target tissue (e.g., the interior wall of a blood vessel). In some embodiments, the attachment ring may be configured to anchor via friction between the sides of the attachment ring and the interior wall of the blood vessel due to outward expansion of the attachment ring. However, various anchoring mechanisms can be used to facilitate anchoring of the attachment ring. For example, the attachment ring may include one or more fingers, needles, screws, hooks, and / or similar mechanisms configured to penetrate and / or embed into native tissue.

[0155] Various exemplary medical implants and / or delivery methods are described herein. Some of the examples described herein may be used in combination and / or independently.

[0156] Example 1: A medical implant for managing blood flow through a blood vessel, the medical implant comprising: a stent body having an inner lumen; and a control valve having a tapered distal end extending at least partially across the inner lumen of the stent body.

[0157] Example 2: The medical implant of any example herein, wherein the tapered distal end of the control valve is configured to face the direction of blood flow through the blood vessel.

[0158] Example 3: The medical implant of any example herein, wherein the tapered distal end of the control valve is configured to at least partially flatten in response to an increase in pressure of blood passing through the blood vessel.

[0159] Example 4: The medical implant described in any example herein, wherein the blood vessel is the inferior vena cava.

[0160] Example 5: The medical implant of any example herein, wherein the tapered distal end of the control valve forms an orifice into the inner lumen of the stent body.

[0161] Example 6: The medical implant of any example herein, wherein the orifice is at a central location of the control valve.

[0162] Example 7: The medical implant of any example herein, wherein the tapered distal end of the control valve is configured to reduce the size of the orifice in response to an increase in the pressure of blood passing through the blood vessel.

[0163] Example 8: The medical implant of any example herein, wherein the tapered distal end of the control valve is configured to completely close the orifice in response to an increase in blood pressure through the blood vessel.

[0164] Example 9: The medical implant of any example herein, wherein the control valve comprises one or more bypass openings that allow blood flow through the control valve.

[0165] Example 10: The medical implant of any example herein, wherein the one or more bypass openings are disposed at the tapered distal end of the control valve.

[0166] Example 11: The medical implant of any example herein, wherein the one or more bypass openings are located in a proximal portion of the control valve.

[0167] Example 12: The medical implant of any example herein, wherein the one or more bypass openings are located at a transition between a proximal portion of the control valve and a tapered distal end of the control valve.

[0168] Example 13: The medical implant of any example herein, wherein the one or more bypass openings are configured to increase in size in response to flattening of the tapered distal end of the control valve.

[0169] Example 14: The medical implant of any example herein, wherein the tapered distal end of the control valve comprises two or more leaflets.

[0170] Example 15: The medical implant of any example herein, wherein two or more leaflets at least partially overlap.

[0171] Example 16: The medical implant of any example herein, wherein the control valve comprises a coating extending at least partially over the exterior surface of the stent body.

[0172] Example 17: The medical implant of any example herein, wherein the control valve comprises a coating extending at least partially along the inner surface of the stent body.

[0173] Example 18: The medical implant of any example herein, wherein the stent body comprises one or more curved arms configured to support a tapered distal end of the control valve.

[0174] Example 19: The medical implant of any example herein, further comprising a plug coupled to the stent body via a tether.

[0175] Example 20: The medical implant of any example herein, wherein the tether comprises a coiled wire.

[0176] Example 21: The medical implant of any example herein, wherein the tether is configured to hold a plug distal to the stent body.

[0177] Example 22: The medical implant of any example herein, wherein the tether is configured to allow the plug to move toward the stent body in response to an increase in blood pressure through the blood vessel.

[0178] Example 23: The medical implant of any example herein, wherein the plug is configured to fit into an orifice at the tapered distal end of the control valve.

[0179] Example 24: The medical implant of any example herein, wherein the plug comprises a conical proximal end.

[0180] Example 25: The medical implant of any example herein, wherein the plug comprises a rounded distal end.

[0181] Example 26: The medical implant of any example herein, wherein the control valve is coupled to the stent body via a tether.

[0182] Example 27: A medical implant as described in any example herein, wherein the control valve comprises a bowl forming a spherical cap extending toward the inner lumen of the stent body and a concave interior facing the direction of blood flow through the blood vessel.

[0183] Example 28: The medical implant of any example herein, wherein the control valve comprises cross arms that support the bowl.

[0184] Example 29: The medical implant of any example herein, wherein the stent body comprises a stopper configured to prevent at least a portion of the cross arms from entering the inner lumen of the stent body.

[0185] Example 30: A method comprising percutaneously delivering via a catheter a medical implant for managing blood flow through a blood vessel, the medical implant comprising a stent body having an inner lumen and a control valve having a tapered distal end extending at least partially across the inner lumen of the stent body. Additional Examples

[0186] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a different order, added, combined, or omitted entirely. Thus, in a particular embodiment, not all described acts or events may be required to practice a process.

[0187] In particular, conditional language used herein, such as "can," "could," "might," "may," "e.g.," and the like, is intended to have its ordinary meaning unless specifically stated otherwise or understood otherwise within the context of use, and is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way by one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps are included or performed in any particular embodiment, with or without authorial input or prompting. Terms such as "comprising," "including," "having," and the like are synonymous and used in their ordinary sense, and are used in an inclusive, non-limiting manner and do not exclude additional elements, features, acts, operations, etc. Additionally, the term "or" is used in its inclusive sense (and not its exclusive sense), for example, when used to connect a list of elements, so that the term "or" refers to one, some, or all of the elements in the list. Connective language such as the phrase "at least one of X, Y, and Z" is understood in context to be used generally to convey that an item, term, element, etc., can be either X, Y, or Z, unless specifically stated otherwise. Thus, such connective language is generally not intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z are each present.

[0188] In the foregoing description of the embodiments, it should be understood that various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in understanding one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein may be applied to or used in conjunction with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is required or essential to each embodiment. Accordingly, it is intended that the scope of the invention(s) herein, as disclosed and claimed below, should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the following claims.

[0189] It should be understood that certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish an element from another element having a similar or identical name (other than the use of sequential terms). Additionally, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an action performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0190] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which the illustrative examples belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and are not to be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0191] Although certain preferred embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Accordingly, the scope of claims that may arise from this specification is not limited by any of the specific examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Although various operations may be described sequentially as multiple separate operations in a manner that may be useful for understanding particular embodiments, the order of description should not be construed as implying that these operations are order-dependent. Additionally, structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0192] Spatially relative terms such as "outside," "inside," "upper," "lower," "below," "upper," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component, as illustrated in the drawings. It is understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if a device shown in the drawings is turned upside down, a device positioned "below" or "directly below" another device may be positioned "above" another device. Thus, the exemplary term "below" can include both a lower position and an upper position. Devices may also be oriented in other directions, and thus spatially relative terms may have different interpretations depending on the orientation.

[0193] Unless expressly stated otherwise, comparative and / or quantitative terms such as "less," "more," "greater than," and the like are intended to encompass equivalent concepts. For example, "less" can mean "less than" as well as "less than" in the strictest mathematical sense.

[0194] The delivery systems described herein can be used to position catheter tips and / or catheters in various regions of the human heart. For example, the catheter tips and / or catheters can be configured to pass from the right atrium to the coronary sinus. However, the descriptions may refer to or generally apply to positioning a catheter tip and / or catheter from a first body chamber or lumen to a second body chamber or lumen, where it is understood that the catheter tip and / or catheter may be bent when positioned from the first body chamber or lumen to the second body chamber or lumen. A body chamber or lumen can refer to any one of a number of fluid channels, blood vessels, and / or organ chambers (e.g., heart chambers). Furthermore, references herein to "catheter," "tube," "sheath," "steerable sheath," and / or "steerable catheter" can generally refer to or apply to any type of elongated tubular delivery device including an inner lumen configured to slidably receive an instrument, such as for positioning within the atrium or coronary sinus, including, for example, a delivery catheter and / or cannula. It will be appreciated that other types of medical implant devices and / or procedures can be delivered to the coronary sinus using the delivery systems described herein, including, for example, ablation procedures, drug delivery, and / or coronary sinus lead placement.

Claims

1. 1. A medical implant for managing blood flow through a blood vessel, comprising: Plug and A mounting ring and one or more arms interconnecting the plug and the attachment ring, the one or more arms configured to allow movement of the plug relative to the attachment ring.

2. 10. The medical implant of claim 1, wherein said blood vessel is the inferior vena cava.

3. The medical implant of claim 1 or 2, wherein the plug comprises a conical proximal end.

4. The medical implant of claim 3 , wherein the plug comprises a rounded distal end.

5. 5. The medical implant of claim 4, wherein said plug comprises an intermediate portion between said proximal end and said distal end, said intermediate portion having a width greater than said proximal end and said distal end.

6. 6. The medical implant of claim 4 or 5, wherein the proximal end is disposed proximal to the attachment ring when the one or more arms are in a default state.

7. The medical implant of any one of claims 1 to 6, wherein the one or more arms form a bend.

8. The medical implant of any one of claims 1 to 7, wherein the one or more arms are configured in a default state.

9. 9. The medical implant of any one of claims 1 to 8, wherein the one or more arms are configured to elastically deform in response to blood pressure against the distal end of the plug.

10. 10. The medical implant of claim 9, wherein the one or more arms are configured to allow the plug to enter at least partially into a lumen of the mounting ring.

11. 11. The medical implant of claim 10, wherein the one or more arms are configured to allow the plug to pass completely through the lumen of the attachment ring.

12. The medical implant of any one of claims 1 to 11, wherein at least one of the one or more arms has a constant width.

13. 13. The medical implant of any one of claims 1 to 12, wherein at least one of the one or more arms comprises a proximal end and a distal end, the proximal end being wider than the distal end.

14. 14. The medical implant of claim 13, wherein said at least one of said one or more arms has a tapered width.

15. 15. The medical implant of claim 13 or 14, wherein said at least one of said one or more arms has a stepped width.

16. 1. A medical implant for managing blood flow through a blood vessel, comprising: a stent body having an inner lumen; a control valve having a tapered distal end extending at least partially across the inner lumen of the stent body.

17. 17. The medical implant of claim 16, wherein the tapered distal end of the control valve is configured to face in the direction of blood flow through the blood vessel.

18. 18. The medical implant of claim 17, wherein the tapered distal end of the control valve is configured to at least partially flatten in response to an increase in blood pressure through the blood vessel.

19. The medical implant according to any one of claims 16 to 18, wherein said blood vessel is the inferior vena cava.

20. The medical implant of any of claims 16 to 19, wherein the tapered distal end of the control valve forms an orifice into the inner lumen of the stent body.

21. 21. The medical implant of claim 20, wherein the orifice is at a central location of the control valve.

22. 22. The medical implant of claim 20 or claim 21, wherein the tapered distal end of the control valve is configured to reduce the size of the orifice in response to an increase in blood pressure through the blood vessel.

23. 23. The medical implant of claim 22, wherein the tapered distal end of the control valve is configured to completely close the orifice in response to an increase in blood pressure through the blood vessel.

24. 24. The medical implant of any one of claims 16 to 23, wherein the control valve comprises one or more bypass openings to allow blood flow through the control valve.

25. 25. The medical implant of claim 24, wherein the one or more bypass openings are disposed at the tapered distal end of the control valve.

26. 25. The medical implant of claim 24, wherein the one or more bypass openings are located in a proximal portion of the control valve.

27. 25. The medical implant of claim 24, wherein the one or more bypass openings are located at a transition between a proximal portion of the control valve and the tapered distal end of the control valve.

28. 25. The medical implant of claim 24, wherein the one or more bypass openings are configured to increase in size in response to flattening of the tapered distal end of the control valve.

29. The medical implant of any one of claims 16 to 28, wherein the tapered distal end of the control valve comprises two or more leaflets.

30. 30. The medical implant of claim 29, wherein said two or more leaflets at least partially overlap.

31. The medical implant of any one of claims 16 to 30, wherein the control valve comprises a coating extending at least partially over an outer surface of the stent body.

32. The medical implant of any one of claims 16 to 31, wherein the control valve comprises a coating extending at least partially along an inner surface of the stent body.

33. 33. The medical implant of any one of claims 16 to 32, wherein the stent body comprises one or more curved arms configured to support the tapered distal end of the control valve.

34. The medical implant of any one of claims 16 to 33, further comprising a plug coupled to the stent body via a tether.

35. 35. The medical implant of claim 34, wherein the tether comprises a coiled wire.

36. 36. The medical implant of claim 34 or claim 35, wherein the tether is configured to hold the plug distally from the stent body.

37. 37. The medical implant of any one of claims 34 to 36, wherein the tether is configured to allow the plug to move toward the stent body in response to an increase in blood pressure through the blood vessel.

38. 38. The medical implant of claim 37, wherein the plug is configured to fit into an orifice at the tapered distal end of the control valve.

39. The medical implant of any one of claims 34 to 38, wherein the plug comprises a conical proximal end.

40. The medical implant of any one of claims 34 to 39, wherein the plug comprises a rounded distal end.

41. The medical implant of any one of claims 16 to 40, wherein the control valve is coupled to the stent body via a tether.

42. 42. The medical implant of claim 41, wherein the control valve comprises a bowl forming a spherical cap extending toward the inner lumen of the stent body and a concave interior facing the direction of blood flow through the vessel.

43. 43. The medical implant of claim 42, wherein the control valve comprises cross arms that support the bowl.

44. 44. The medical implant of claim 43, wherein the stent body comprises a stop configured to prevent at least a portion of the cross arms from entering the inner lumen of the stent body.

45. 1. A method comprising percutaneously delivering, via a catheter, a medical implant for managing blood flow through a blood vessel, said medical implant comprising: a stent body having an inner lumen; a control valve having a tapered distal end extending at least partially across the inner lumen of the stent body.

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