Oval aortic stent

Abstract

The stent includes a network of elastically deformable struts forming a first end portion, a second end portion, and an intermediate portion located between the first and second end portions and including one or more support arms extending at least partially across a lumen formed by the first and second end portions.

Description

[Technical field]

[0001] (Related Applications) This application claims priority to U.S. Provisional Application No. 63 / 332,989, filed April 20, 2022, and entitled "OVAL AORTIC STENT," the disclosure of which is hereby incorporated by reference in its entirety. background [Background technology]

[0002] The present disclosure relates generally to devices and methods for vascular repair.

[0003] Catheter systems, such as treatment, delivery, and / or deployment catheters, can be used to treat a patient internally. For example, a delivery catheter system can be used to deliver and deploy a prosthetic device, such as a prosthetic heart valve, to a location within the body. The prosthetic heart valve can be delivered to a treatment site within the patient (e.g., aortic, mitral, tricuspid, and / or pulmonary valve location) using transcatheter techniques. Summary of the Invention

[0004] Described herein are systems, devices, and methods for restoring compliance to non-compliant vascular structures by inducing a temporary change in the cross-sectional shape of the vessel without or with minimal change in the length of the vessel's peripheral wall during initial implantation. More specifically, the relaxed / expanded cross-sectional shape of the vessel may be changed to a non-circular shape and / or the vessel may assume a circular (or more circular) shape when subjected to increased pressure (e.g., during contraction). Since the highest area-to-perimeter ratio may be achieved with a circular shape, a device that provides a transition between a non-circular shape and a circular (or more circular) shape may enable the expansion of the cross-sectional area. Thus, some embodiments herein may enable the expansion / contraction of the vessel cross-sectional area during diastole / systole without requiring high elasticity of the vessel wall.

[0005] 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.

[0006] Of course, each of the elements disclosed herein can be used with any and all of the elements disclosed herein, even though the specific combination of elements may not be explicitly shown in the figures herein. In other words, based on the description of a particular device, a person skilled in the art should have little difficulty in combining the specific features of two such devices. Thus, it should be understood that many elements are interchangeable and the present invention covers all permutations thereof.

[0007] Other objects, features and advantages of the present invention will become apparent from consideration of the following detailed description.

[0008] Various examples are shown in the accompanying drawings for illustrative purposes, but 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 numbers may be reused to indicate correspondence between referenced elements. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 illustrates an exemplary representation of a heart and associated arteries having various features relevant to certain examples of the present disclosure. [Figure 2A] 2A and 2B illustrate a blood vessel having a vessel wall that is elastic. [Figure 2B] 2A and 2B illustrate a blood vessel having a vessel wall that is elastic. [Figure 3A]3A and 3B illustrate a blood vessel having inelastic and / or inelastic vessel walls. [Figure 3B] 3A and 3B illustrate a blood vessel having inelastic and / or inelastic vessel walls. [Figure 4A] 4A and 4B illustrate a compliant stent implanted in a blood vessel according to one or more embodiments. [Figure 4B] 4A and 4B illustrate a compliant stent implanted in a blood vessel according to one or more embodiments. [Figure 5A] 5A, 5B, 5C and 5D show diagrams of stents according to some embodiments. [Figure 5B] 5A, 5B, 5C and 5D show diagrams of stents according to some embodiments. [Figure 5C] 5A, 5B, 5C and 5D show diagrams of stents according to some embodiments. [Figure 5D] 5A, 5B, 5C and 5D show diagrams of stents according to some embodiments. [Figure 6] FIG. 6 provides an overhead view of an exemplary stent in a default and / or resting configuration and an expanded and / or expanded configuration, according to one or more embodiments. [Figure 7A] 7A and 7B illustrate a blood vessel having a stented portion having a lumen through which blood can freely flow in accordance with one or more embodiments. [Figure 7B] 7A and 7B illustrate a blood vessel having a stented portion having a lumen through which blood can freely flow in accordance with one or more embodiments. [Figure 8] FIG. 8 illustrates an exemplary stent positioned within a blood vessel in accordance with one or more embodiments. [Figure 9A] FIG. 9A shows an example of a system including a delivery catheter for deploying a stent. [Figure 9B] 9B, 9C, and 9D show side views of the placement of a stent within a blood vessel using a delivery catheter. [Figure 9C]9B, 9C, and 9D show side views of the placement of a stent within a blood vessel using a delivery catheter. [Figure 9D] 9B, 9C, and 9D show side views of the placement of a stent within a blood vessel using a delivery catheter. [Figure 10] FIG. 10 provides an overhead view of an exemplary stent in a default and / or resting configuration and an expanded and / or expanded configuration, according to one or more embodiments. [Figure 11] FIG. 11 provides an overhead view of an exemplary stent including angled support arms in a default and / or resting configuration and an expanded and / or extended configuration, according to one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0011] Although specific preferred embodiment(s) are disclosed below, the inventive subject matter extends beyond the specifically disclosed examples to other alternative examples and / or uses, as well as to modifications and equivalents thereof. Thus, 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 a particular example, the order of description should not be construed as implying that these operations are order dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not all such aspects or advantages are necessarily achieved by any particular example. Thus, for example, the various examples 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.

[0012] In humans and other vertebrates, systemic blood circulation is facilitated by a blood circulatory system that includes various arteries, capillaries, veins, and coronary arteries, which cooperate with the heart to supply blood to various regions of the body. The heart generally includes a muscular organ with four pumping chambers, the flow of which is controlled at least in part by various heart valves, namely, the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves may be configured to open and close in response to pressure gradients present during various phases of the cardiac cycle (e.g., relaxation and systole) to at least in part control the flow of blood to respective regions and / or vessels of the heart (e.g., the pulmonary artery, the aorta, etc.). The valves may allow fluid flow between the heart and various arteries of the cardiovascular system.

[0013] FIG. 1 illustrates an exemplary representation of a heart 1 and associated arteries 15 with various features associated with certain examples of the present disclosure. Heart 1 includes four heart chambers: left atrium 2, left ventricle 3, right ventricle 4, and right atrium 5. Heart 1 further includes four valves to aid in blood circulation therein, including a tricuspid valve 8 that separates right atrium 5 from right ventricle 4. Tricuspid valve 8 may generally have three cusps or leaflets and may generally close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The valves of heart 1 further include a pulmonary valve 9 that separates right ventricle 4 from the pulmonary artery and may be configured to open during systole to allow blood to be pumped towards the lungs and close during diastole to prevent blood from flowing back from the pulmonary artery into the heart. Pulmonary valve 9 generally has three cusps / leaflets (not shown). The heart 1 further includes a mitral valve 6, which typically has two cusps / leaflets (not shown), and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 may generally be configured to open during diastole to allow blood in the left atrium 2 to flow into the left ventricle 3, and advantageously close during diastole to prevent blood from flowing back into the left atrium 2. An aortic valve 7 separates the left ventricle 3 from the aorta 11. The aortic valve 7 is configured to open during systole to allow blood from the left ventricle 3 to enter the aorta 11, and to close during diastole to prevent blood from flowing back into the left ventricle 3.

[0014] The aorta is connected to the heart via the aortic valve 7, and the ascending aorta 11 arises from the heart 1 and gives rise to the sternal artery 27, left common carotid artery 25, and left subclavian artery 29 before continuing as the descending thoracic aorta 13 and then the abdominal aorta 15.

[0015] Arteries, such as the aorta 15, may utilize arterial compliance to store and release energy through the stretching of the vessel walls. As described herein, arterial "compliance" may refer to the ability of an arterial vessel to stretch and increase in volume with increasing transmural pressure, or the tendency of an artery, or a portion thereof, to resist recoil toward its original dimensions upon the application of a stretching or compressive force.

[0016] In normal compliant blood vessels, volume expansion and contraction occurs by stretching and contracting the vessel walls in response to heartbeat. Aging, hypertension and other factors can result in a decrease in the elasticity of the vessel walls of the vasculature, resulting in a decrease in vascular compliance. Such a decrease in vascular compliance (also called arterial stiffness or vascular stiffness) can result in minimal volume change during pressure changes from diastole to systole. Depending on where the decrease in vascular compliance occurs, the patient's health can be compromised. For example, loss of compliance in the aorta 15 can result in increased pulse pressure (e.g., increased systolic pressure and / or decreased diastolic pressure), leading to increased left ventricular workload (and / or decreased cardiac efficiency). Loss of aortic compliance can also have a detrimental effect on coronary perfusion. Treatments to improve vascular compliance restoration can include the addition of compliant chambers attached to the vasculature, which provide additional compliance. Such chambers can result in challenges such as thrombosis and fatigue problems.

[0017] The present invention provides systems, devices, and methods for restoring compliance to non-compliant vascular structures by inducing a temporary change in the cross-sectional shape of the vessel with no or minimal change in the length of the vessel's peripheral wall during initial implantation. More specifically, the relaxed / expanded cross-sectional shape of the vessel may be changed to a non-circular shape and / or the vessel may assume a circular (or more circular) shape when subjected to increased pressure (e.g., during contraction). Since the highest area-to-perimeter ratio may be achieved with a circular shape, a device that provides a transition between a non-circular shape and a circular (or more circular) shape may enable the expansion of the cross-sectional area. Thus, some embodiments herein may enable the expansion / contraction of the vessel cross-sectional area during diastole / systole without requiring high elasticity of the vessel wall.

[0018] Some exemplary systems may include an elastic spring-like device that can distort (e.g., via pushing, pulling, etc.) the cross-sectional shape of the blood vessel into a cross-sectional shape that may have a smaller cross-sectional area during diastole (i.e., during lower applied pressure). During systole (i.e., during higher applied pressure), the elastic device can expand or otherwise flex to increase the cross-sectional area of ​​the blood vessel (e.g., via a change in blood vessel and / or device shape, but with little or no change in the blood vessel and / or device surroundings) to provide the desired additional compliance.

[0019] In some examples, a stent and / or similar device may provide additional compliance (i.e., additional volume change over a constant pressure change) to any blood vessel in which it is placed or on which it is placed. The term "stent" is used herein according to its broad and ordinary meaning and may refer to any device configured to be implanted in a blood vessel to improve the compliance of the vessel. Such additional compliance may benefit any portion of a pulsatile flow system that may suffer from increased systolic pressure (e.g., hypertension). Some exemplary devices may be configured to shift systolic flow to diastolic flow at a constant cardiac output (e.g., resulting in increased cardiac efficiency), which may be highly beneficial to aortic and / or coronary perfusion. Examples of blood vessels that may benefit from improved compliance may include the aorta, pulmonary artery, and / or superior / inferior vena cava.

[0020] In some examples, flexible stents and / or other implants may be used to reshape non-compliant / inelastic vessels into a non-circular shape when in a diastolic / relaxed / biased state. Non-circular shapes may include ovals, triangles, peanut shapes, figure-of-eight shapes, etc. The stents and / or other implants may be configured to be biased toward a non-circular shape and / or may have the ability to deform into a circular / more circular shape (and therefore a larger cross-sectional area) in response to pressure. For example, blood flow through a non-compliant / inelastic vessel may have the ability to cause deformation of the stents and / or similar devices described herein. The circumference of the non-circular shape may be the same or similar to the more circular shape. In this way, the stent and vessel may maintain the same circumference and / or have minimal changes in circumference while changing shape in response to changes in blood flow. In some examples, the non-circular shape may have a smaller cross-sectional area than the more circular shape. As the heart beats, the blood vessel may be deformed into a more circular shape, and the stent / implant may then be configured to push and / or pull the blood vessel back toward a more non-circular shape. In this way, the stent / implant may be configured to restore some conformity to an otherwise non-conforming blood vessel.

[0021] In some embodiments, the stent may be disposed within a blood vessel. However, one or more stents may additionally or alternatively be configured to be positioned about an exterior surface of a blood vessel. The stent may include one or more hooks and / or other attachment mechanisms adapted to help secure the stent to tissue of a blood vessel wall.

[0022] The stent may comprise a stent wall defining an elongated tubular member having a first end with a first opening. The tubular member may further comprise a second end with a second opening, a lumen extending between the first and second openings, and / or a stent length extending between the first and second ends. The stent wall may include open cell walls and / or may be adapted to be secured to a vessel wall of a blood vessel, such as via outwardly directed hooks and / or endothelialization. The stent wall and / or the lumen at least partially enclosed by the stent wall may be configured to define a cross-sectional shape, a cross-sectional area, a major dimension, and / or a minor dimension. The stent may be elastically deformable between a first configuration and a second configuration, and the stent is biased toward the first configuration. The first configuration may define various characteristics of the stent, for example, the major dimension may be a first major dimension, the minor dimension may be a first minor dimension, the cross-sectional area may be a first cross-sectional area, and the cross-sectional shape may be a first cross-sectional shape. The second configuration may define various characteristics of the stent, for example, the major dimension may be a second major dimension, the minor dimension may be a second minor dimension, the cross-sectional area may be a second cross-sectional area, the cross-sectional shape may be a second cross-sectional shape, the first minor dimension may be smaller than the second minor dimension, the first major dimension may be larger than the second major dimension, and / or the first cross-sectional area may be smaller than the second cross-sectional area.

[0023] In some embodiments, one or more stents may be at least partially constructed from a shape memory material, such as Nitinol. The stent may be configured to be biased toward a first cross-sectional shape. The first cross-sectional shape may be any shape, including an oval, a triangle, a peanut shape, a figure-eight shape, and / or a kidney shape.

[0024] The stent may be configured to be delivered percutaneously to the blood vessel in a compressed configuration. Once in the blood vessel, the stent and / or stent walls of the stent may be configured to be radially expanded to make direct surface contact with the vessel wall (e.g., the aortic wall of the aorta). In some examples, the stent may be configured to be expanded such that the circumference of the lumen of the stent may approximate and / or exceed the circumference of the vessel at least prior to expansion of the stent. In some cases, a stent configured to expand to a circumference at least slightly larger than the native vessel may provide improved traction and / or resistance to movement within the vessel. Additionally, a stent having a circumference that approximates and / or is larger than the vessel may increase and / or ensure positive engagement with the vessel and / or maximize compliance effects. The stent walls and / or a portion of the stent walls may be configured to be endothelialized within the vessel wall. In some examples, the vessel may be the aorta and / or the second cross-sectional area of ​​the lumen may approximate the cross-sectional area of ​​the aortic section in which the stent is deployed.

[0025] The stent may be adapted to be physically held in a particular configuration after radial expansion of the stent and / or stent wall in the vessel and after direct contact with the vessel wall, which may provide time for the stent to be secured to the vessel wall, for example, via endothelialization. For example, the stent may include and / or be configured to attach tension lines that may be configured to physically hold the stent in a particular desired configuration, such as where the tension lines are adapted to restrict a major or minor dimension of the stent to a desired size (e.g., to hold the stent in a more elliptical or more circular shape). The tension lines may be configured to be dissolvable in the patient's blood. The tension lines may be configured to be percutaneously removed from the stent by a user, such as an interventional cardiologist.

[0026] Some systems described herein for providing compliance to a native vessel may include an implant such as a catheter and / or a stent. The catheter may include a catheter distal portion, a catheter proximal portion, and / or an elongated catheter body extending from the catheter distal portion to the catheter proximal portion. In some examples, the catheter may be adapted such that the catheter distal portion is percutaneously advanced into a vessel within the patient's vasculature. The catheter distal portion may include an expandable balloon adapted to radially expand the stent into contact with the vessel wall. The catheter distal portion may include a retractable sheath adapted to prevent radial expansion of the stent. For example, the catheter distal portion may be configured to prevent the stent from expanding from a first (e.g., compressed) configuration to a second (e.g., expanded) configuration.

[0027] Some exemplary devices may include hybrid / composite structures, such as a device having a stent adapted to anchor the device within the patient's vasculature, combined with a self-expanding / biased stent to transform between a smaller and a larger cross-sectional area in response to blood pressure as the heart beats. For example, the device may include a distal stent, which in an expanded configuration may include a distal stent lumen and a distal stent cross-sectional area. The distal stent may include a distal stent wall having an open cell configuration adapted to directly engage the vessel wall of the blood vessel and / or allow blood to flow from the distal stent lumen to the vessel wall. The device may also include a proximal stent of a similar configuration to the distal stent, such as having an expanded configuration with a proximal stent lumen and a proximal stent cross-sectional area, and / or including a proximal stent wall having an open cell configuration adapted to directly engage the vessel wall and allow blood to flow from the proximal stent lumen to the vessel wall. The device may further include an intermediate stent configured to be positioned between the distal and proximal stents, the intermediate stent being formed from a memory material and forming an intermediate stent lumen. The intermediate stent may be configured to be elastically deformable between a first configuration and a second configuration and / or configured to be biased toward the first configuration, in which the intermediate stent and / or intermediate stent lumen may comprise a first cross-sectional shape, a first cross-sectional area, a first major dimension, and a first minor dimension. The first minor dimension may be smaller than the first major dimension and / or the first cross-sectional area may be smaller than the distal stent cross-sectional area and / or smaller than the proximal stent cross-sectional area. The device may comprise a lining extending between the distal and proximal stents and along the intermediate stent wall of the intermediate stent portion. The lining may be adapted to prevent blood flow therethrough.

[0028] In the second configuration, the intermediate stent and / or intermediate stent lumen may have a second cross-sectional shape, a second cross-sectional area, a second major dimension, and / or a second minor dimension, the first minor dimension being smaller than the second minor dimension. The first major dimension may be smaller than the second major dimension. The distal and proximal stents may be adapted to be radially expanded into contact with a vessel wall, such as an aortic wall of the aorta. The second cross-sectional area of ​​the lumen may approximate a cross-sectional area of ​​the aorta.

[0029] The distal and proximal stents may be at least partially constructed from a plastically deformable material, such as stainless steel or a cobalt alloy, resulting in a more circular cross-section. The middle stent may be at least partially constructed from a shape memory material (e.g., Nitinol). The first cross-sectional shape of the middle stent may have any shape, for example, an oval, a triangle, a kidney, a peanut, and / or a figure-eight shape.

[0030] Some examples may relate to a method of restoring compliance to a blood vessel. The method may include providing a system including a delivery catheter and / or a stent, the delivery catheter having a catheter distal portion, a catheter proximal portion, and a catheter elongate body. The delivery catheter may be adapted to be advanced into the patient's vasculature to position the catheter distal portion within the desired blood vessel. The stent may be any implant disclosed herein. The method may involve advancing the catheter distal portion through the patient's vasculature into the desired blood vessel, positioning the catheter distal portion at a desired treatment site of the desired blood vessel, radially expanding the stent into contact with a vessel wall at the desired treatment site, and / or removing the delivery catheter from the patient's vasculature. The catheter distal portion may include an expandable balloon, and radially expanding the stent may involve expanding the balloon. The stent may be configured to be positioned on the expandable balloon as the catheter distal portion advances through the patient's vasculature. The catheter distal portion may include a sheath configured to slide at least partially over the stent such that the sheath may be configured to be positioned at least partially over the stent when the catheter distal portion is advanced through the patient's vasculature.

[0031] After radially expanding the stent to contact the vessel wall at the desired treatment site, the stent may be configured to be physically held by a restraint in a desired configuration, such as being held in a first configuration or a second configuration. After removal of the delivery catheter from the patient (including, for example, after hours or days and / or after the stent has been endothelialized or otherwise secured to the vessel wall), the restraint may be released from the stent such that the stent may no longer be held in the first or second configuration and / or may adopt any of the configurations and / or transformations between the configurations. In some examples, the restraint may include a tension line. Releasing the restraint may involve cutting and / or removing the tension line. The tension line may be absorbable, and releasing the stent from the restraint may be configured to occur in response to exposure of the absorbable tension line to the patient's blood. The absorbable tension line may be adapted to be absorbed for a sufficient time such that the stent may be endothelialized or otherwise secured to the vessel wall before the absorbable tension line is absorbed and the stent is released from the restraint.

[0032] The stent may include a tubular / cylindrical shape, a simple hoop, a C-shaped clip / clamp, and / or a spring-like mechanism. In some examples, the stent may be at least partially constructed from a shape memory material, such as Nitinol, which may allow the stent to deform and force the vessel into a circular shape when subjected to an external force (e.g., a force caused by blood flow) and then return to a non-circular shape, reducing the vessel cross-sectional area.

[0033] In some embodiments, the stent may be at least partially self-expanding, such as when formed from a memory material such as Nitinol. The stent may be configured to be delivered via a catheter to a desired location within, around, or adjacent to a blood vessel. The catheter may include an expandable balloon that aids in the deployment of the stent to a firm initial contact with the blood vessel, such as when the balloon expands the stent to a deployed size / diameter larger than its programmed / biased state. The deployed size / diameter may be even larger than the expanded size / diameter the stent may later achieve when expanded by blood flow / heartbeat. This deployed size / diameter may be sufficient to embed or otherwise anchor the stent in the vessel wall. In some embodiments, the stent may be at least partially open-celled, for example, to avoid blocking branch vessels. Meanwhile, in other embodiments, the stent may be fully covered, for example, to isolate the aorta or other vessel from fluid pressure (e.g., in the area of ​​an aneurysm, or injury to the vessel wall).

[0034] The stent may include barbs and / or other attachment mechanisms that can prevent migration and / or help hold the stent securely to the vessel wall to change the cross-sectional shape of the vessel in response to changes in the stent shape. Such barbs and / or other attachment devices may be adapted to engage the wall of the vessel in which the stent is deployed.

[0035] In some embodiments, the stent may include one or more anchors extending from a main stent body (such as any of the main stent bodies disclosed herein). Each of the one or more anchors may be adapted to be deployed to engage tissue of a branch vessel or other vascular structure, such as when a branch vessel branches off from a main vessel. The branch vessel may have a diameter that may be smaller than the diameter of the main vessel in which the main stent body is deployed. One or more of the anchors may extend from the main stent body at a location between a first end and a second end of the main stent body, or from the first end or from the second end of the main stent body. The one or more anchors may be adapted to contact a wall of a renal artery or to be disposed within a wall of an iliac artery. The one or more anchors may include a wireform (e.g., formed from a shape memory material) and / or may be adapted to pass within the branch vessel and / or may be adapted to engage wall tissue of a branch vessel, such as an iliac or renal artery. One or more of the anchors may comprise an anchor stent body having an anchor stent wall defining an anchor stent lumen, and / or the anchor stent body may be adapted to be radially expanded into contact with a wall of a branch vessel, such as an iliac or renal artery. The anchor stent body may be at least partially constructed from a shape memory material, and / or the anchor stent lumen may be biased toward a configuration including a non-circular (e.g., elliptical, triangular, peanut-shaped, or kidney-shaped) cross-sectional shape. In some embodiments, the anchor stent body may have an overall length in the range of 0.5-7 cm.

[0036] In some embodiments, the stent may include one or more support arms configured to at least partially resist deformation of the stent at a particular blood pressure condition. For example, during diastolic pressure, the support arms may be configured to hold the stent in a relaxed configuration (e.g., a generally elliptical cross-sectional shape). During systolic pressure, the support arms may be configured to yield and / or stretch to allow the stent to deform to a second configuration (e.g., a generally circular cross-sectional shape). The stent may include any number of support arms, and / or the support arms may be located near and / or distal to a central axis of the stent. In some embodiments, the one or more support arms may be configured to extend laterally across a lumen formed by the stent.

[0037] In some examples, a system including one or more stents described herein may be used for endovascular repair (e.g., endovascular abdominal aortic aneurysm (AAA) repair). For example, a catheter may be inserted into a patient's blood vessel to deliver a stent at or near the aneurysm. The stent may be configured to act as a graft and / or may be configured to expand and / or change shape from a less circular shape within the vessel to a more circular shape to form a more stable channel for blood flow.

[0038] The systems, devices, and / or methods described herein may be utilized in a variety of catheter-based procedures, including minimally invasive and percutaneous procedures. In some examples, the method / system / device may involve trans-aortic delivery through a small thoracic (or abdominal) incision. In other examples, the method / system / device may be used in minimally invasive surgical procedures. In still other examples, the method / system / device may be used in percutaneous procedures, such as via a catheter or catheters into a patient's arterial system (e.g., through the femoral or brachial artery).

[0039] 2A and 2B illustrate a blood vessel 10 having elastic vessel walls 12. At diastolic pressures (FIG. 2A), the blood vessel 10 may have a relatively small diameter 14a and cross-sectional area 16a, but at systolic pressures (FIG. 2B), the blood vessel walls 12 stretch such that the blood vessel 10 assumes a larger diameter 14b and cross-sectional area 16b.

[0040] 3A and 3B illustrate a blood vessel 10 having an inelastic and / or inelastic vessel wall 12. The diastolic diameter 14a and / or diastolic cross-sectional area 16a (FIG. 3A) may be only slightly smaller than the systolic diameter 14b and systolic cross-sectional area 16b (FIG. 3B).

[0041] 4A and 4B illustrate a compliant stent 700 implanted within a blood vessel 10. The stent 700 may be configured to restore compliance to the blood vessel 10. The stent 700 may comprise a stent wall configured to engage the vessel wall 12. In response to diastolic pressure, the stent 700 may be configured to have an elliptical diastolic shape having a major axis 26a and a minor axis 28a. The stent 700 may be configured to cause the blood vessel 10 to assume a corresponding diastolic elliptical shape and / or diastolic cross-sectional area 16a. In response to systolic pressure, the stent 700 may be configured to assume a more circular contracted shape, which allows the vessel wall 12 to assume a corresponding more circular contracted shape with the stent minor axis 28b approaching or equal to the stent major axis 26b and / or having an expanded contracted cross-sectional area 16b.

[0042] 5A-5D show views of a stent 500 according to some embodiments. FIG. 5A illustrates a first side view along a major axis of the stent 500, FIG. 5B illustrates a second side view along a minor axis of the stent 500, FIG. 5C provides a first perspective view of the stent 500, and FIG. 5D provides a second perspective view of the stent 500. As used herein, the terms "major" and "minor" are relative terms and / or the stent 500 may include a first major side 502a and / or a second major side 502b that may have a greater length than the first minor side 504a and / or the second minor side 504b. In some embodiments, the first major side 502a may be located generally across the lumen 510 of the stent from the second major side 502b. Similarly, the first minor side 504a may be located generally across the lumen 510 of the stent 500 from the second minor side 504b. The first major side 502a and the second major side 502b may extend along a first plane, and / or the first minor side 504a and / or the second minor side 504b may extend along a second plane.

[0043] The various components of the stent 500 described herein may be separate components and / or may comprise extensions of the same component. For example, the first major side 502a, the first minor side 504a, the second major side 502b, and / or the second minor side 504b may not be separate components and / or may refer to non-separate portions of the stent 500. The stent 500 may not include separate separations and / or transitions between the components described herein. However, these components may be described in separate terms for illustrative purposes herein.

[0044] The stent 500 can be configured to form a generally elliptical shaped lumen 510 in a default and / or rest state of the stent 500. For example, the sides of the stent 500 can be at least partially curved, particularly in a transition region 512 between, for example, the first major side 502a and the first minor side 504a and / or the second minor side 504b. In some embodiments, the first minor side 504a and / or the second minor side 504b can have a relatively greater curvature than the first major side 502a and / or the second major side 502b, at least in the default and / or rest configuration of the stent 500.

[0045] In some embodiments, the stent 500 may comprise a network of one or more struts 506 that may interconnect and / or form one or more cells 508 between the struts 506. The one or more cells 508 formed by the struts 506 may have a generally diamond-shaped and / or rectangular configuration.

[0046] The stent 500 may comprise one or more support arms 520 configured to extend at least partially across the lumen 510 of the stent 500. The one or more support arms 520 may comprise an intermediate portion 517 of the stent 500. The intermediate portion 517 may be located between a first end 515 and a second end 519 of the stent 500. The first end 515, the intermediate portion 517, and / or the second end 519 may each extend approximately the entire length of the minor shaft (e.g., from the first major side 502a to the second major side 502b). The first end 515 and / or the second end 519 may also extend approximately the entire length of the major shaft (e.g., from the first minor side 504a to the second minor side 504b). However, the intermediate portion 517 may not extend the entire length of the major shaft. In some embodiments, the intermediate portion 517 may extend approximately half the length of the major shaft. In other words, the stent 500 may have a generally constant width across the first end 515, the intermediate portion 517, and / or the second end 519, and / or may have a generally constant depth across the first end 515 and the second end 519. However, the stent 500 may have a smaller depth at the intermediate portion 517.

[0047] Intermediate portion 517 may form a generally elliptical inner lumen 530 that may have a smaller area than the lumen 510 formed by first end 515 and / or second end 519. In some embodiments, inner lumen 530 may comprise a subsection of lumen 510 of stent 500.

[0048] The struts 506 may be configured to flex and / or move relative to one another to provide flexibility to the stent 500. For example, the struts 506 may be configured to flex to allow the stent 500 to assume a generally compressed configuration within a catheter and / or other delivery device. Upon removal from the catheter and / or other delivery device, the stent 500 and / or the struts 506 may be configured to relax and / or assume a default expanded and / or relaxed configuration. The stent 500 may be configured such that the first minor side 504a and / or the second minor side 504b of the first end portion 515 and / or the second end portion 519 may contact and / or apply a force to a vessel wall when positioned within a vessel.

[0049] The intermediate section 517 may comprise one or more support arms 520 configured to extend at least partially across the lumen 510 of the stent 500. In some embodiments, the support arms 520 may comprise one or more tension springs 525 configured to naturally assume a coiled and / or compressed configuration and / or to expand and / or straighten in response to a change in blood pressure and / or blood pressure increasing above a threshold amount. The one or more tension springs 525 may have a generally wavy configuration in a rest / compressed / coiled configuration. Additionally, the one or more tension springs 525 may have some stiffness and / or be at least partially resistant to expansion and / or straightening. As a result, the one or more tension springs 525 may be configured to deform, expand, and / or straighten only in response to an increase in pressure (e.g., in the range of 90-160 mmHg) and / or may return to the rest and / or coiled configuration after removal of such pressure.

[0050] One or more tension springs 525 may be configured to form one or more loops 527, which may have a drop shape, to provide stability and / or rigidity to the support arm 520. The tension springs 525 may be arranged in an accordion shape, as best shown in FIG.

[0051] As best shown in FIG. 5A, the stent 500 may have a variable width when viewed facing the first major side 502a and / or the second major side 502b. For example, the first end portion 515 and / or the second end portion 519 may have a generally equal width that may be greater than the width of the intermediate portion 517. The width of each of the first end portion 515, the intermediate portion 517, and / or the second end portion 519 may be generally constant throughout each respective portion. In other words, the width of the stent 500 may not taper and / or may change abruptly from the first end portion 515 to the intermediate portion 517 and / or from the intermediate portion 517 to the second end portion 519.

[0052] As best shown in Figure 5B, the stent 500 can have a generally constant width (i.e., depth) when viewed facing the first minor side 504a and / or the second minor side 504b. The support arms 520 can be configured to assume a length in the relaxed and / or compressed configuration shown in Figures 5A-5D that is approximately equal to the distance between the first major side 502a and the second major side 502b of the first end 515, the intermediate portion 517, and / or the second end 519.

[0053] The one or more support arms 520 may be configured to extend at least partially across a lumen formed by the first end 515 and / or the second end 519. For example, the first end 515 and / or the second end 519 may be approximately equal in size and / or aligned such that the lumen formed by the first end 515 extends linearly into the lumen formed by the second end 519. The one or more support arms 520 of the intermediate portion 517 may extend laterally across a space between the lumen formed by the first end 515 and the lumen formed by the second end 519. For example, blood flowing through the lumen of the first end 515 and / or the second end 519 may contact the one or more support arms 520. The one or more support arms 520 may include a tension spring and / or an at least partially coiled wire form configured to increase in length in response to a force (e.g., blood pressure changes).

[0054] The first end portion 515, the second end portion 519, and / or the middle portion 517 may be configured to contact one or more vessel walls. For example, the first minor side 504a and / or the second minor side 504b of the stent 500 and / or the first end 515, the middle portion 517, and / or the second end 519 may be configured to contact one or more vessel walls in the relaxed and / or unexpanded configuration shown in FIGS. 5A-5D. In response to changes in blood flow and / or pressure, the one or more support arms 520 may be configured to expand and / or the first end 515 and / or the second end 519 may be configured to bend and / or deform into a more circular configuration. As a result, the first major side 502a and / or the second major side 502b of the stent 500 and / or the first end 515 and / or the second end 519 may be configured to contact and / or apply a pushing force against one or more vessel walls.

[0055] The stent 500 and / or the first end 515, the middle portion 517, and / or the second end 519 may include a network of elastically deformable struts 506 configured to bend and / or deform in response to blood flow and / or pressure changes. For example, the struts 506 may be configured to radially expand, and / or the first end 515, the middle portion 517, and / or the second end 519 may be configured to radially expand from a first configuration (e.g., a resting and / or unexpanded configuration shown in Figures 5A-5D) to a second configuration (e.g., a more circular configuration, see Figure 6). One or more portions of the stent 500 that are not in contact with one or more vessel walls in the first configuration may be moved into direct contact with one or more vessel walls in the second configuration. The circumference of the stent 500 may remain unchanged between the first configuration and the second configuration. The cross-sectional area of ​​the stent 500 may increase when moving from the first configuration to the second configuration.

[0056] The distance between the first major side 502a and the second major side 502b in the first configuration may define a first minor dimension of the stent 500. The distance between the first minor side 504a and the second minor side 504b in the first configuration may define a first major dimension. When the stent 500 moves from the first configuration to the second configuration, the stent 500 may assume a second minor dimension (e.g., the distance between the first major side 502a and the second major side 502b) that is greater than the first minor dimension. Similarly, when the stent 500 moves from the first configuration to the second configuration, the stent 500 may assume a second major dimension (e.g., the distance between the first minor side 504a and the second minor side 504b) that is less than the first major dimension.

[0057] 5A-5D. The circumference of the stent 500 may exceed and / or approximate the circumference and / or cross-sectional area of ​​the aorta and / or other blood vessel. Thus, as the stent 500 deforms to a more circular cross-sectional shape in the second configuration, the sides of the stent 500 may be increasingly pressed against the walls of the aorta and / or other blood vessel.

[0058] 5A-5D, a length (e.g., along the major axis) of the first end 515 and / or the second end 519 (e.g., the distance between the first minor side 504a and the second minor side 504b) may be greater than a width (e.g., along the minor axis) of the first end 515 and / or the second end 519 (e.g., the distance between the first major side 502a and the second major side 502b). The first end 515 and / or the second end 519 may be configured to deform in response to changes in blood flow and / or blood pressure such that the length of the first end 515 and / or the second end 519 at least partially decreases and / or the width of the first end 515 and / or the second end 519 at least partially increases.

[0059] The intermediate portion 517 may have a generally oval and / or rectangular shape. For example, the intermediate portion 517 may be generally flat along the first major side 502a and / or the second major side 502b. Further, the one or more support arms 520 of the intermediate portion 517 may extend generally linearly across the first major dimension of the stent 500. As a result, the intermediate portion 517 may include four generally linear sides. Corners and / or edges of the intermediate portion 517, the first end portion 515, and / or the second end portion 519 may be generally rounded.

[0060] The length of the intermediate portion 517 in the first configuration (e.g., the distance between the support arms 520 of the intermediate portion 517) may be less than the length of the first end 515 and / or the second end 519. The width of the intermediate portion 517 in the first configuration (e.g., the distance between the first major side 502a and the second major side 502b) may be approximately equal to the width of the first end 515 and / or the second end 519. In the first configuration, the length of the intermediate portion 517 may be approximately half, 75 percent, and / or any other amount less than 100 percent of the length of the first end 515 and / or the length of the second end 519. In the second configuration, the width of the intermediate portion 517 may increase beyond the width of the first end 515 and / or the second end 519 as the stent 500 assumes a more circular configuration.

[0061] Intermediate portion 517 may include a first side extending along first major side 502a of stent 500 and / or a second side extending along second major side 502b of stent 500. The first side and / or second side of intermediate portion 517 may be coplanar with corresponding sides of first end 515 and second end 519.

[0062] The one or more support arms 520 may be generally straight. The first end 515 and / or the second end 519 may include a generally rounded end and / or edge along the first minor side 504a and / or the second minor side 504b and / or along a minor axis of the stent 500.

[0063] Although the first end portion 515 and the second end portion 519 are shown having generally straight sides (e.g., along the first major side 502a, the second major side 502b, the first minor side 504a, and / or the second minor side 504b), the first end portion 515 and / or the second end portion 519 may have tapered and / or sloping sides. For example, the first end portion 515 and / or the second end portion 519 may taper and / or decrease in width along the first minor side 504a and / or the second minor side 504b such that the width of the first end portion 515 and / or the second end portion 519 is at a minimum at or near the intermediate portion 517.

[0064] In some embodiments, at least a portion of the stent 500 and / or at least a portion of the struts 506 and / or cells 508 of the stent 500 may be at least partially covered by a covering. The covering may be configured to increase friction of the struts 506 and / or close the cells 508 to reduce blood flow through the cells 508.

[0065] One or more of the support arms 520 may be constructed at least in part from Nitinol and / or other materials and / or alloys having shape memory characteristics. For example, a Nitinol support arm 520 may be configured to allow for increased strain before reaching a plateau (e.g., about 8% strain) at which deformation of the support arm 520 may occur. In this manner, the support arm 520 may be resistant to diastolic pressure and / or configured to deform and / or expand only in response to systolic and / or increased pressure and / or pressure above a given amount.

[0066] Although the stent 500 is shown with two support arms 520, the stent 500 may include any number of support arms 520. For example, the stent 500 may include four support arms 520.

[0067] 6 provides an overhead view of an exemplary stent 600 in a default and / or resting configuration 605 (illustrated in FIG. 6 using solid lines) and an expanded and / or expanded configuration 607 (illustrated in FIG. 6 using dashed lines), according to one or more embodiments. Stent 600 can be configured to expand from resting configuration 605 to expanded configuration 607 in response to changes in pressure in and / or about a blood vessel and / or other anatomical structure in which stent 600 is located.

[0068] The stent 600 may include one or more support arms 620 configured to extend across a lumen 610 formed by the stent 600 and / or formed by a first end portion and a second end portion of the stent 600. An intermediate portion of the stent 600 may define an inner lumen 630 (e.g., between the support arms 620 of the intermediate portion). In some embodiments, the stent 600 may have a generally oval and / or pill-shaped configuration in a resting configuration 605, where one or more ends of the stent 600 form rounded edges 604 (e.g., minor sides 504a, 504b in FIG. 5) and / or one or more ends and / or intermediate portions form generally straight sides 602 (e.g., major sides 502a, 502b in FIG. 5). The stent 600 may include a first major side 602a, a second major side 602b, a first minor side 604a, and / or a second minor side 604b.

[0069] When the stent 600 experiences a pressure change, the stent 600 can be configured to assume a more curved and / or generally circular expanded configuration 607. As shown in Figure 6, the expanded configuration 607 can cause the support arms 620 to extend across a greater width of the stent 600. The extension of the support arms 620 can be enabled by bending and / or navigation of the struts 606 that form the stent 600 and / or by a reduced length of a mid-section of the stent 600.

[0070] In the relaxed configuration 605, the stent 600 may have a relatively small cross-sectional area. The stent 600 may be configured to expand to the expanded configuration 607 in response to increased aortic blood pressure (e.g., during contraction). As a result, the stent 600 may assume a more circular cross-section, which may increase the cross-sectional area of ​​the stent 600 (e.g., by bending and / or moving the struts 606 of the stent 600) while generally maintaining the circumference of the stent 600. The increase in cross-sectional area may facilitate absorption of pulsatile shock during systole. After contraction, the stent 600 and / or the blood vessel may return to the relaxed configuration 605 and / or a generally elliptical shape. Upon returning to the relaxed configuration 605, blood may pass through the aorta. As a result, blood pressure pulses through the aorta may be smoothed to mimic the performance of a more compliant aorta.

[0071] The stent 600 portions may have a generally non-circular (e.g., elliptical) shape with major axis 26a and minor axis 28a in a resting and / or default configuration 605. As blood pressure increases within the blood vessel 10, the stent 600 may be configured to allow blood to pass through the lumen 610 and / or be forced against the vessel wall 12. During periods of increased pressure, the stent 600 may be configured to at least partially compress along the major axis 26a of the stent 600, causing the stent 600 to assume the less elliptical / more circular shape of the expanded configuration 607, where the major axis 26b may be shorter than before the increase in blood pressure and / or the blood vessel 10 may have a larger cross-sectional area than the more elliptical shape of FIG.

[0072] The struts 606 forming the stent 600 may be at least partially flexible to allow for changes in the cross-sectional area of ​​the stent 600, but the struts 606 may be at least partially resistant to changes in shape. For example, if the stent 600 is too responsive (e.g., too flexible), the stent 600 may not adequately resist increases in blood pressure during systole and / or may change shape prematurely. Thus, the struts 606 may be configured to bend and / or change shape in response to pressure above a threshold amount. In some examples, the struts 606 may be thickened, but thickening the struts 606 may cause increased stress in the material of the struts 606 as the struts 606 bend.

[0073] The intermediate portion of the stent 600 may be configured to extend at least partially across the lumen 610 of the stent 600 to form support arms and / or chords for the stent 600. As a result, the intermediate portion can provide increased resistance to circularization and / or increased force to return the stent 600 to the relaxed configuration 605 after contraction.

[0074] At least a portion of the intermediate portion (e.g., the support arms) may be formed with tension springs and / or struts 606 having a more curved shape to provide increased spring behavior to the support arms extending across the lumen 610 of the stent 600. The tension springs of the support arms may be tuned (e.g., by their shape and / or using heat treatment of the struts 606) to allow the support arms to have a spring behavior at least partially independent of the tubular shape of the stent 600. In some embodiments, the support arms and / or other struts 606 of the stent 600 may be at least partially composed of one or more shape memory alloys (e.g., Nitinol) to allow the support arms to have a relatively high resistance until a threshold level of blood pressure is reached and / or to allow movement from the relaxed configuration 605 to the expanded configuration 607 when a threshold level of blood pressure is reached. For example, the stent 600 may be configured to move from the relaxed configuration 605 to the expanded configuration 607 at a given point during contraction and / or not immediately after the start of contraction. For example, the support arms may be adjusted so that the martensitic stress is reached at a threshold blood pressure.

[0075] The elliptical shape of the stent 600 in the relaxed configuration 605 may provide a relatively high cross-sectional change along a minor axis of the stent 600 between the relaxed configuration 605 and the expanded configuration 607. The majority of the volume change of the stent 600 may be applied above diastolic pressure and / or may not be applied immediately at the onset of systole. In some embodiments, an intermediate portion of the stent may comprise one or more biphasic springs.

[0076] In some embodiments, the stent 600 may be formed from a laser cut hypotube.

[0077] 7A and 7B illustrate a blood vessel 10 having a stent 700 portion having a lumen 710 through which blood can flow freely. In FIG. 7, the stent 700 portion may have a generally non-circular (e.g., elliptical) shape having a major axis 26a and a minor axis 28a. As blood pressure increases within the blood vessel 10, the stent 700 may be configured to allow blood to pass through the lumen 710 and / or be forced against the vessel wall 12. Thus, the blood pressure may create tension 48 in the vessel wall 12, particularly in the vessel wall portion that runs approximately parallel to the stent major axis 26a. The tension 48 may cause the vessel 10 to compress the stent 700 along its major axis 26a, causing the stent 700 to assume a less elliptical / more circular shape as shown in Figure 7B, where the major axis 26b may be shorter than before the increase in blood pressure (as shown in Figure 7) and / or the vessel 10 may have a larger cross-sectional area than the more elliptical shape of Figure 7. The stent 700 may include one or more support arms 720 that extend laterally across the lumen of the stent 700.

[0078] For a closed / covered stent 700, blood may be prevented from flowing through the stent 700 and forcing outward against the vessel wall 12. Instead, pressure loads may act directly on the stent 700 through the lining material of the stent 700 (e.g., a polymeric film, a bioprosthetic material, a fabric, etc.). For such a closed / covered / lined stent 700, one or more materials of the stent 700 may form a seal between the stent 700 and the vessel wall 12 and / or between the stent 700 and one or more adjacent stents that may be disposed within the same vessel 10. Such a seal may be achieved using deflections of the outer surface of the stent 700, such as in the form of raised and / or depressed features on the outer surface of the stent 700. Examples of such features may include raised and / or depressed features (e.g., raised bumps or edges or depressed valleys) at the leading and / or trailing stent edges and / or at the distal and / or proximal ends of the stent 700 for improved sealing against natural anatomical structures. The raised and / or depressed features, such as bumps and / or ridges and / or valleys, may be configured to be positioned at various locations along the length of the stent 700. The raised and / or depressed features may be formed in a variety of ways, for example, using compliant materials such as fabrics, foams, elastomers, etc.

[0079] 8 illustrates an example of a stent 800 positioned within a blood vessel 10 in accordance with one or more embodiments. The stent may be open (i.e., may allow blood flow through the stent 800). In some embodiments, the stent 800 may be configured to at least partially contact and / or apply force to one or more vascular walls 12 of the blood vessel 10.

[0080] Stent 800 may include a first end 815, an intermediate portion 817, and / or a second end 819. In some embodiments, first end portion 815 and / or second end portion 819 may be configured to engage and / or contact one or more walls 12 of blood vessel 10. Intermediate portion 817 may have a width less than the width of first end portion 815 and / or second end portion 819 and / or may not be configured to contact wall 12 of blood vessel 10. Intermediate portion 817 may include one or more expandable support arms 820 formed by tension springs and / or similar mechanisms.

[0081] In some embodiments, the stent 800 may comprise a single length of linear tubing, although the stent may comprise multiple lengths of linear tubing and / or other configurations. For example, the stent 800 may include a Y-shaped structure, where a stent with two bifurcated ends may be provided to fit an anatomical bifurcation. In such embodiments, various portions of the Y-shape may be biased toward the same general shape and / or toward different shapes. For example, the main base / leg of the Y-shaped structure may be biased toward a first shape (e.g., elliptical), the left upper arm portion of the Y-shape may be biased toward a second shape (e.g., kidney-shaped), and / or the right upper arm portion of the Y-shape may be biased toward a third shape (e.g., circular). Any combination of shapes disclosed herein may be applied to various portions of the devices of the various embodiments described herein.

[0082] In some embodiments, the stent 800 may include one or more sensors 804, which may include pressure sensors and / or other sensors. Aging and / or other factors may result in a decrease in the elasticity of the arterial system and / or a loss of vascular compliance (e.g., arterial stiffening and / or vascular stiffening). For example, loss of compliance in the aorta may lead to an increase in pulse pressure (e.g., systolic pressure) and / or an increase in left ventricular workload. Loss of aortic compliance may also have a detrimental effect on coronary perfusion. The addition of one or more sensors 804 coupled to the stent 800 described herein can help to quantify and / or monitor the effects of restored compliance and / or reduced stiffness. The sensor 804 may be incorporated into any of the stents described herein.

[0083] Loss of aortic compliance can increase central pulse pressure and / or systolic pressure and / or decrease diastolic pressure. One or more on-board pressure sensors 804 can provide accurate central blood pressure measurements (e.g., pressure in the aorta) and / or monitor the pressure benefits of restored compliance. The pressure sensor 804 can be positioned on the elliptical stent 800 such that the sensor 804 can be at least partially exposed to aortic pressure prior to full deployment of the stent 800. For example, the sensor 804 can be positioned at a distal end of the stent 800 during transcatheter delivery of the stent 800. The sensor 804 can provide baseline pressure data to measure the resulting pressure changes due to deployment of the stent 800 and / or restoration of aortic compliance.

[0084] The one or more sensors 804 may be used to track the movement of the stent 800 and / or provide a quantitative measurement of the change in volume from the systolic to the diastolic shape of the stent 800. The one or more sensors 804 may include proximity and / or position sensors that generate volume change data that may be combined with pressure change data to yield quantitative data regarding the amount of restored compliance.

[0085] The one or more sensors 804 may include a temperature sensor configured to provide a central temperature measurement that may be useful for various medical applications. For example, the temperature sensor may be used in conjunction with an induced current to estimate blood flow.

[0086] Although the sensor 804 is shown coupled to the second end 819 in Figure 8, one or more sensors 804 may be coupled to any portion of the stent 800, including the first end 815 and / or the intermediate portion 817. The sensor 804 may be coupled to the stent 800 using any suitable attachment device and / or mechanism. For example, as shown in Figure 8, one or more coils 813 may be used to at least partially encapsulate the sensor 804 and / or one or more struts 809 of the stent 800 to secure the sensor 804 to the stent 800.

[0087] FIG. 9A illustrates an example of a system 140 including a delivery catheter 142 for deploying a stent 900. The delivery catheter 142 may include a proximal end 146 with a handle 148 having controls thereon. The delivery catheter 142 may further include a distal end 150 adapted for advancement into a blood vessel, such as via a percutaneous method. The system 140 may further include a retractable sheath 152 configured to cover and / or protect the stent 900 during delivery. In some embodiments, the sheath 152 may be configured to retract to allow the stent 900 to expand at a desired deployment location. The catheter 142 may include an expandable balloon 154 that may be selectively expanded to expand the stent 900 into firm contact with the vessel wall. For a self-expanding stent, the balloon 154 may provide additional expansion to firmly engage the stent 900 against the vessel wall. In some embodiments, the components of the system 140 may be configured to be loaded onto the delivery catheter 142 via a variety of methods. For example, radial crimping, folding, and / or rolling may be used to load onto the catheter 142.

[0088] 9B, 9C, and 9D show side views of the deployment of a stent 900 in a blood vessel 156 using a delivery catheter 142. The distal end 150 of the delivery catheter 142 may be advanced into the blood vessel 156 to a desired placement location, as shown in FIG. 9B. The sheath 152 may be retracted, at which point the self-expanding stent 900 may be configured to radially expand, as shown in FIG. 9C. The balloon 154 may be expanded to expand the stent 900 and / or to overexpand the self-expanding stent 900 to press the stent 900 firmly against the wall of the blood vessel 156, as shown in FIG. 9D. After the stent 900 is properly deployed, the catheter 142 may be withdrawn from the patient. The sheath 152 may be advanced to a closed position (e.g., back over the balloon 154) prior to withdrawal of the catheter 142. With the stent 900 deployed within the blood vessel 156, the stent 900 can be configured to change the vascular cross-sectional area in response to the patient's heart rate to deform the blood vessel 156 as desired during diastole and / or systole to restore some vascular compliance. The stent 900 can include a first end portion 915, an intermediate portion 917, and / or a second end portion 919.

[0089] Various approaches for treatment are within the scope of this disclosure, including advancing the catheter 142 into position through the sheath 152. In some examples, arterial access may be obtained through the access sheath 152 sized for use in some procedures. An incision may be made in the patient leading to an internal vessel 156 (e.g., the femoral artery). The distal end of the access sheath 152 may be advanced through the incision and internal blood vessel to a desired location within the target vessel 156, with the catheter handle 148 positioned outside the patient adjacent the incision / access site. Echo and / or fluoroscopy and / or other visualization techniques may be used to confirm proper positioning of the stent 900. Placement of the treatment and / or implant may occur, such as by positioning the stent 900 at the target location. Once proper deployment is confirmed, the catheter 142 may be removed from the patient and the incision(s) may be closed, for example, via sutures.

[0090] 10 provides an overhead view of an exemplary stent 1000 in a default and / or resting configuration 1005 (illustrated in FIG. 10 using solid lines) and an expanded and / or expanded configuration 1007 (illustrated in FIG. 10 using dashed lines), according to one or more embodiments. The stent 1000 can be configured to expand from the resting configuration 1005 to the expanded configuration 1007 in response to changes in pressure in and / or about a blood vessel and / or other anatomical structure in which the stent 1000 is located.

[0091] The stent 1000 may include one or more support arms 1020 configured to extend across a lumen 1010 formed by the stent 1000 and / or formed by a first end portion and / or a second end portion of the stent 1000. An intermediate portion of the stent 1000 may form an inner lumen 1030 (e.g., between the support arms 1020 of the intermediate portion). In some embodiments, the stent 1000 may have a generally oval and / or pill-shaped configuration in a resting configuration 1005, where one or more ends of the stent 1000 form rounded edges 1004 (e.g., minor sides 504a, 504b in FIG. 5 ) and / or one or more ends and / or intermediate portions form generally straight sides 1002 (e.g., major sides 502a, 502b in FIG. 5 ). The stent 1000 can include a first major side 1002a, a second major side 1002b, a first minor side 1004a, and / or a second minor side 1004b.

[0092] When the stent 1000 experiences a pressure change, the stent 1000 can be configured to assume a more curved and / or generally circular expanded configuration 1007. As shown in Figure 10, the expanded configuration 1007 can cause the support arms 1020 to extend across a greater width of the stent 1000. The extension of the support arms 1020 may be enabled by bending and / or navigation of the struts forming the stent 1000 and / or by a reduction in the length of a mid-section of the stent 1000.

[0093] In the relaxed configuration 1005, the stent 1000 may have a relatively small cross-sectional area. The stent 1000 may be configured to expand to the expanded configuration 1007 in response to increased aortic blood pressure (e.g., during contraction). As a result, the stent 1000 may assume a more circular cross-section, which may increase the cross-sectional area of ​​the stent 1000 (e.g., by bending and / or moving struts of the stent 1000) while generally maintaining the circumference of the stent 1000. The increase in cross-sectional area may facilitate absorption of pulsatile impulses during systole. After contraction, the stent 1000 and / or the blood vessel may return to the relaxed configuration 1005 and / or a generally elliptical shape. Upon returning to the relaxed configuration 1005, blood may pass through the aorta. As a result, blood pressure pulses through the aorta may be smoothed to mimic the performance of a more compliant aorta.

[0094] The stent 1000 portions may have a generally non-circular (e.g., elliptical) shape with major axis 26a and minor axis 28a in a resting and / or default configuration 1005. As blood pressure increases within the blood vessel 10, the stent 1000 may be configured to allow blood to pass through the lumen 1010 and / or be forced against the vessel wall 12. During periods of increased pressure, the stent 1000 may be configured to at least partially compress along the major axis 26a of the stent 1000, causing the stent 1000 to assume the less elliptical / more circular shape of the expanded configuration 1007, where the major axis 26b may be shorter than before the increase in blood pressure and / or the blood vessel 10 may have a larger cross-sectional area than the more elliptical shape of FIG.

[0095] The struts forming the stent 1000 may be at least partially flexible and / or deformable to allow for changes in the cross-sectional area of ​​the stent 1000, but the struts may be at least partially resistant to changes in shape. For example, if the stent 1000 is too responsive (e.g., too flexible), the stent 1000 may not adequately resist increases in blood pressure during systole and / or may change shape prematurely. Thus, the struts may be configured to bend and / or change shape in response to pressure above a threshold amount. In some examples, the struts may be thickened, but thickening the struts may cause increased stress in the material of the struts as they bend.

[0096] The intermediate portion of the stent 1000 may be configured to extend at least partially across the lumen 1010 of the stent 1000 to form support arms and / or chords for the stent 1000. As a result, the intermediate portion can provide increased resistance to circularization and / or increased force to return the stent 1000 to the relaxed form 1005 after contraction.

[0097] At least a portion of the intermediate portion (e.g., support arms 1020) may be formed with tension springs and / or struts having a more curved shape to provide increased spring behavior to the support arms extending across the lumen 1010 of the stent 1000. The tension springs of the support arms may be tuned (e.g., by their shape and / or using heat treatment of the struts) to allow the support arms to have a spring behavior at least partially independent of the tubular shape of the stent 1000. In some embodiments, the support arms and / or other struts of the stent 1000 may be at least partially constructed from one or more shape memory alloys (e.g., Nitinol) to allow the support arms to have a relatively high resistance until a threshold level of blood pressure is reached and / or to allow movement from the relaxed form 1005 to the expanded form 1007 when a threshold level of blood pressure is reached. For example, the stent 1000 may be configured to move from the relaxed form 1005 to the expanded form 1007 at a given point during contraction and / or not immediately after the start of contraction. For example, the support arms may be adjusted so that the martensitic stress is reached at a threshold blood pressure.

[0098] The elliptical shape of the stent 1000 in the relaxed configuration 1005 may provide a relatively high cross-sectional change along a minor axis of the stent 1000 between the relaxed configuration 1005 and the expanded configuration 1007. The majority of the volume change of the stent 1000 may be applied above diastolic pressure and / or not immediately at the onset of systole. In some embodiments, an intermediate portion of the stent may comprise one or more biphasic springs.

[0099] The intermediate portion may have any suitable length and / or any suitable distance between the support arms 1020 of the intermediate portion. For example, one or more support arms 1020 may be located near and / or adjacent to the minor side 1004 of the stent 1000, as shown in FIG. 10. The length of the intermediate portion and / or any distance between the support arms 1020 of the intermediate portion may be about half the length of the stent 1000 along the major axis 26a and / or may be greater than half the length of the stent 1000 (e.g., about 75 percent of the length of the stent 1000 and / or 3 / 4 of the length of the stent 1000).

[0100] The support arms 1020 may be configured to support the stent 1000 without impeding the crimping of the stent 1000. In some embodiments, the one or more support arms 1020 may be disposed perpendicularly between the walls and / or sides of the first end and / or second end of the stent 1000. The one or more support arms 1020 may be at least partially offset from a central axis of the stent and / or may be near and / or adjacent to a rounded minor side 1004 of the stent 1000.

[0101] The stent 1000 may include any number of support arms 1020 and / or the support arms 1020 may have any suitable size. The spring constant and / or other geometric characteristics of the support arms 1020 may be selected to resist deformation of the stent 1000 when subjected to pressures that do not exceed a desired threshold and / or may be configured to yield at high pressures (e.g., in the range of 90-160 mmHg).

[0102] 11 provides an overhead view of an exemplary stent 1100 in a default and / or resting configuration 1105 (illustrated in FIG. 11 using solid lines) and an expanded and / or expanded configuration 1107 (illustrated in FIG. 11 using dashed lines), according to one or more embodiments. The stent 1100 can be configured to expand from the resting configuration 1105 to the expanded configuration 1107 in response to changes in pressure in and / or about a blood vessel and / or other anatomical structure in which the stent 1100 is located.

[0103] The stent 1100 may include one or more support arms 1120 configured to extend across a lumen 1110 formed by the stent 1100 and / or formed by a first end and / or a second end of the stent 1100. An intermediate portion of the stent 1100 may form an inner lumen 1130 (e.g., between the support arms 1120 of the intermediate portion). In some embodiments, the stent 1100 may have a generally oval and / or pill-shaped configuration in a resting configuration 1105, where one or more ends of the stent 1100 form rounded edges 1104 (e.g., minor sides 504a, 504b in FIG. 5 ) and / or one or more ends and / or intermediate portions form generally straight sides 1102 (e.g., major sides 502a, 502b in FIG. 5 ).

[0104] When the stent 1100 experiences a pressure change, the stent 1100 can be configured to assume a more curved and / or generally circular expanded form 1107. As shown in Figure 11, the expanded form 1107 can cause the support arms 1120 to extend across a greater width of the stent 1100. The extension of the support arms 1120 may be enabled by bending and / or navigation of the struts forming the stent 1100 and / or by a reduction in the length of a mid-section of the stent 1100.

[0105] In the relaxed form 1105, the stent 1100 may have a relatively small cross-sectional area. The stent 1100 may be configured to expand to the expanded form 1107 in response to increased aortic blood pressure (e.g., during contraction). As a result, the stent 1100 may assume a more circular cross-section, which may increase the cross-sectional area of ​​the stent 1100 (e.g., by bending and / or moving struts of the stent 1100) while generally maintaining the circumference of the stent 1100. The increase in cross-sectional area may facilitate absorption of pulsatile shock during systole. After contraction, the stent 1100 and / or the blood vessel may return to the relaxed form 1105 and / or a generally elliptical shape. Upon returning to the relaxed form 1105, blood may pass through the aorta. As a result, blood pressure pulses through the aorta may be smoothed to mimic the performance of a more compliant aorta.

[0106] The stent 1100 portion may have a generally non-circular (e.g., elliptical) shape with major axis 26a and minor axis 28a in the resting and / or default configuration 1105. As blood pressure increases within the blood vessel 11, the stent 700 may be configured to allow blood to pass through the lumen 710 and / or press against the vessel wall 12. During periods of increased pressure, the stent 700 may be configured to at least partially compress along the major axis 26a of the stent 1100, causing the stent 1100 to assume the less elliptical / more circular shape of the expanded configuration 1107, where the major axis 26b may be shorter than before the increase in blood pressure and / or the blood vessel 11 may have a larger cross-sectional area than the more elliptical shape of FIG.

[0107] The struts forming the stent 1100 may be at least partially flexible and / or deformable to allow for changes in the cross-sectional area of ​​the stent 1100, but the struts may be at least partially resistant to changes in shape. For example, if the stent 1100 is too responsive (e.g., too flexible), the stent 1100 may not adequately resist increases in blood pressure during systole and / or may change shape prematurely. Thus, the struts may be configured to bend and / or change shape in response to pressure above a threshold amount. In some examples, the struts may be thickened, but thickening the struts may cause increased stress in the material of the struts as they bend.

[0108] The intermediate portion of the stent 1100 may be configured to extend at least partially across the lumen 1110 of the stent 1100 to form support arms and / or chords for the stent 1100. As a result, the intermediate portion can provide increased resistance to circularization and / or increased force to return the stent 1100 to the relaxed form 1105 after contraction.

[0109] At least a portion of the intermediate portion (e.g., support arms 1120) may be formed with tension springs and / or struts having a more curved shape to provide increased spring behavior to the support arms extending across the lumen 1110 of the stent 1100. The tension springs of the support arms may be tuned (e.g., by their shape and / or using heat treatment of the struts) to allow the support arms to have a spring behavior at least partially independent of the tubular shape of the stent 1100. In some embodiments, the support arms and / or other struts of the stent 1100 may be at least partially constructed from one or more shape memory alloys (e.g., Nitinol) to allow the support arms to have a relatively high resistance until a threshold level of blood pressure is reached and / or to allow movement from the relaxed form 1105 to the expanded form 1107 when a threshold level of blood pressure is reached. For example, the stent 1100 may be configured to move from the relaxed form 1105 to the expanded form 1107 at a given point during contraction and / or not immediately after the start of contraction. For example, the support arms may be adjusted so that the martensitic stress is reached at a threshold blood pressure.

[0110] The elliptical shape of the stent 1100 in the relaxed configuration 1105 may provide a relatively high cross-sectional change along a minor axis of the stent 1100 between the relaxed configuration 1105 and the expanded configuration 1107. The majority of the volume change of the stent 1100 may be applied above the diastolic pressure and / or not immediately at the onset of systole. In some embodiments, an intermediate portion of the stent may comprise one or more biphasic springs.

[0111] The intermediate portion may have a generally hexagonal shape, as illustrated in FIG. 11. For example, the intermediate portion may extend at least partially along the first major side 1102a and / or the second major side 1102b and / or may form a set of two support arms 1120 at either end of the intermediate portion. The intermediate portion may include a first support arm 1120a and / or a second support arm 1120b configured to extend to the first minor side 1104a of the stent 1100 and / or form a point at or near the first minor side 1104a. For example, the point formed by the first support arm 1120a and the second support arm 1120b may be approximately aligned and / or coplanar with the first minor side 1104a formed by the first end and / or second end of the stent 1100. The intermediate portion may also include a set of two support arms 1120 forming a point at or in line with the second minor side 1104b, as shown in FIG. 11. As a result, the intermediate portion may have a width that is approximately equal to the width of the first end and / or the second end of the stent 1100 .

[0112] The first support arm 1120a and the second support arm 1120b may be interconnected and / or extend from one another. In some embodiments, the joint between the first support arm 1120a and the second support arm 1120b at the first minor side 1104a of the stent may be connected to and / or extend to the rounded side of the first end and / or the second end of the stent 1100 at the first minor side 1104a. The first support arm 1120a and / or the second support arm 1120b may be generally angled and / or may extend at an angle of about 45 degrees from the first major side 1102a and / or the second major side 1102b, respectively, and / or may be angled toward one another.

[0113] Migration of stents and / or other devices according to the invention can be prevented using various methods, elements, and combinations thereof. For example, endothelialization of the stent walls and / or protruding barbs can be used to anchor the device to the vessel wall. In addition to and / or in lieu of such elements / techniques, the device of the present invention may include anchors adapted to extend into the branch vessel / structure, which may function to anchor the device to the main vessel in which the main stent body is deployed. For example, the device may comprise a main stent body (such as any of the stent assemblies previously described in this application) adapted to be deployed into and provide compliance to the main vessel, such as when the main stent body is adapted to change from a smaller cross-sectional area to a larger cross-sectional area. The device may further have one or more anchors extending non-parallel from the main stent body. Each particular anchor may comprise an anchor stent body adapted to be deployed (such as via radial expansion) into contact with tissue (e.g., wall tissue) of a secondary vessel, or other vascular structure that may branch and / or otherwise extend generally laterally from the main vessel. It should be noted that multiple anchors and / or stents may be used and / or may extend from different locations along the length and / or radial circumference of the main stent body depending on the particular application. One or more anchors may be preferably positioned at locations that can align with the secondary vessel / structure as it branches / extends from the main vessel. In some embodiments, the anchors may be self-expanding (e.g., via balloon expansion) or plastically deformable. The anchors may form a generally circular lumen, an elliptical lumen, a peanut-shaped lumen, etc., when expanded or otherwise placed into contact with tissue of the secondary vessel / structure, and / or may be adapted to maintain a generally constant cross-sectional area, and / or may be adapted to change from a smaller to a larger cross-sectional area configuration in response to blood flow.

[0114] According to one or more implementations of the present disclosure, the stent includes a network of elastically deformable struts forming a first end portion, a second end portion, and an intermediate portion located between the first end portion and the second end portion, the stent including one or more support arms extending at least partially across a lumen formed by the first end portion and the second end portion.

[0115] The first end may be configured to contact a vessel wall of the blood vessel. In some embodiments, the network of elastically deformable struts is configured to radially expand from a first configuration within the blood vessel to a second configuration to directly contact the vessel wall, the first configuration defining a first major dimension, a first minor dimension, a first cross-sectional area, a first cross-sectional shape, and a first circumference of the stent wall, and the second configuration defining a second major dimension, a second minor dimension greater than the first minor dimension, a second cross-sectional area greater than the first cross-sectional area, and a first circumference of the stent wall.

[0116] In some embodiments, the first major dimension is greater than the second major dimension. The first minor dimension may be less than the second minor dimension.

[0117] The first cross-sectional shape may comprise an elliptical shape, hi some embodiments, the blood vessel is an aorta and the first circumference approximates or exceeds the circumference of the aorta.

[0118] In some embodiments, one or more of the support arms comprises a tension spring configured to increase in length. The first end may be generally elliptical and the length of the first end along the major axis may be greater than the width of the first end along the minor axis.

[0119] The first end may be configured to deform in response to blood flow such that a length of the first end at least partially decreases and a width of the first end at least partially increases, hi some examples, the second end is generally elliptical and the length of the second end along the major axis is greater than the width of the second end along the minor axis.

[0120] In some embodiments, the second end is configured to deform in response to blood flow such that a length of the second end at least partially decreases and a width of the second end at least partially increases. The intermediate portion may be generally elliptical.

[0121] The intermediate portion may be generally rectangular in shape, hi some embodiments, the length of the intermediate portion is less than the length of the first end portion, and the width of the intermediate portion is approximately equal to the width of the first end portion.

[0122] In some embodiments, the intermediate portion comprises two support arms extending along the minor axis and two sides extending along the major axis, each of the two sides of the intermediate portion may be coplanar with a side of the first end portion and the second end portion.

[0123] The length of the intermediate portion may be approximately half the length of the first portion, hi some embodiments, the length of the intermediate portion is approximately 75 percent of the length of the first portion.

[0124] In some embodiments, the one or more support arms are configured to expand in response to blood pressure increasing above a threshold amount.

[0125] The first portion may form a generally rounded end that extends generally along the minor axis of the first portion, in some embodiments, the one or more support arms comprise a set of two angled support arms on either end of the intermediate portion that join at a point that is flush with the rounded end of the first portion.

[0126] In some embodiments, the intermediate portion has a generally hexagonal shape.

[0127] Some implementations of the present disclosure relate to a system for providing compliance to a native vessel, the system including a catheter having a catheter distal section configured for percutaneous advancement within a patient's vasculature into a native vessel, a stent removably secured to the catheter distal section and defining a lumen extending between a first opening and a second opening in the stent, a first end having a first width, a second end having a width approximately equal to the first width, an intermediate section having a width less than the first width, and one or more support arms extending at least partially across the lumen from the intermediate section.

[0128] In some embodiments, the first end is configured to be anchored to a vessel wall of the blood vessel. In some embodiments, the stent is configured to radially expand from a first configuration within the blood vessel to a second configuration to directly contact the vessel wall, the first configuration defining a first major dimension, a first minor dimension, a first cross-sectional area, a first cross-sectional shape, and a first circumference of the stent wall, and the second configuration defining a second major dimension, a second minor dimension greater than the first minor dimension, a second cross-sectional area greater than the first cross-sectional area, and the first circumference of the stent wall.

[0129] The first major dimension can be greater than the second major dimension, hi some embodiments, the first cross-sectional shape comprises an elliptical shape.

[0130] In some embodiments, the blood vessel is the aorta and the first circumference approximates or exceeds the circumference of the aorta. The one or more support arms may comprise a tension spring configured to increase in length.

[0131] The first end may be generally elliptical, with a length of the first end along the major axis being greater than a width of the first end along the minor axis, hi some examples, the first end is configured to deform in response to blood flow such that the length of the first end at least partially decreases and the width of the first end at least partially increases.

[0132] In some embodiments, the second end is generally elliptical, and a length of the second end along the major axis is greater than a width of the second end along the minor axis. The second end may be configured to deform in response to blood flow such that the length of the second end at least partially decreases and the width of the second end at least partially increases.

[0133] The intermediate portion may be generally oval shaped. In some embodiments, the intermediate portion is generally rectangular shaped.

[0134] In some embodiments, a length of the intermediate portion is less than a length of the first end portion and a width of the intermediate portion is approximately equal to a width of the first end portion. The intermediate portion may comprise two support arms extending along a minor axis and two sides extending along a major axis.

[0135] Each of the two sides of the intermediate portion may be flush with the sides of the first end portion and the second end portion, hi some embodiments, the length of the intermediate portion is about half the length of the first portion.

[0136] The length of the intermediate portion may be about 75 percent of the length of the first portion.

[0137] In some embodiments, the one or more support arms are configured to expand in response to changes in blood flow. The first portion may form a generally rounded end extending generally along a minor axis of the first portion.

[0138] The one or more support arms may comprise a set of two angled support arms at either end of a middle portion that join at a point that is flush with the rounded end of the first portion, hi some embodiments, the middle portion has a generally hexagonal shape.

[0139] 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, and thus, in a particular embodiment, not all described acts or events are required to practice a process. Specific Examples

[0140] Example 1. A system for providing compliance to a native vessel, the system comprising: a catheter including a catheter distal portion configured for percutaneous advancement within a patient's vasculature into the native vessel; and a stent removably secured to the catheter distal portion, the stent forming a lumen extending between a first opening and a second opening in the stent, a first end having a first width, a second end having a width approximately equal to the first width, an intermediate portion having a width less than the first width, and one or more support arms extending at least partially across the lumen from the intermediate portion.

[0141] Example 2: The system of example 1, wherein the first end is configured to be anchored to a vessel wall of a blood vessel.

[0142] Example 3: The system of example 2, wherein the stent is configured to radially expand from a first configuration to a second configuration within the vessel to directly contact the vessel wall, the first configuration defining a first major dimension, a first minor dimension, a first cross-sectional area, a first cross-sectional shape, and a first circumference, and the second configuration defining a second major dimension, a second minor dimension greater than the first minor dimension, a second cross-sectional area greater than the first cross-sectional area, and the first circumference.

[0143] Example 4: The system of example 3, wherein the first major dimension is greater than the second major dimension.

[0144] Example 5: The system of example 3 or example 4, wherein the first cross-sectional shape comprises an elliptical shape.

[0145] Example 6: The system of any of Examples 3-5, wherein the blood vessel is an aorta and the first circumference approximates or exceeds the circumference of the aorta.

[0146] Example 7: The system of any of Examples 1-6, wherein one or more support arms include a tension spring configured to increase in length.

[0147] Example 8: The system of any of Examples 1-6, wherein the first end is generally elliptical and the length of the first end along the major axis is greater than the width of the first end along the minor axis.

[0148] Example 9: The system of Example 8, wherein the first end is configured to deform in response to blood flow such that a length of the first end at least partially decreases and a width of the first end at least partially increases.

[0149] Example 10: The system of example 8 or example 9, wherein the second end is generally elliptical and the length of the second end along the major axis is greater than the width of the second end along the minor axis.

[0150] Example 11: The system of Example 10, wherein the second end is configured to deform in response to blood flow such that a length of the second end at least partially decreases and a width of the second end at least partially increases.

[0151] Example 12: A system as described in any of Examples 8-11, wherein the intermediate portion is generally elliptical.

[0152] Example 13: A system as described in any of Examples 8-12, wherein the intermediate portion is generally rectangular in shape.

[0153] Example 14: A system described in any of Examples 8-13, wherein the length of the intermediate portion is less than the length of the first end portion, and the width of the intermediate portion is approximately equal to the width of the first end portion.

[0154] Example 15: The system of example 14, wherein the intermediate portion comprises two support arms extending along a minor axis and two sides extending along a major axis.

[0155] Example 16: The system of example 15, wherein each of the two sides of the intermediate portion is flush with the sides of the first end and the second end.

[0156] Example 17: A system described in any of Examples 8-16, wherein the length of the intermediate portion is approximately half the length of the first end portion.

[0157] Example 18: A system described in any of Examples 8-17, wherein the length of the intermediate portion is about 75 percent of the length of the first end portion.

[0158] Example 19: A system described in any of Examples 1-18, wherein one or more support arms are configured to expand in response to changes in blood flow.

[0159] Example 20: A system described in any of Examples 1-19, wherein the first end forms a generally rounded end that extends generally along a minor axis of the first end.

[0160] Example 21: The system of example 20, wherein the one or more support arms include a set of two angled support arms at either end of the intermediate portion that join at a point that is flush with the rounded end of the first end.

[0161] Example 22: A system described in any of Examples 1-21, wherein the intermediate portion has a generally hexagonal shape.

[0162] In particular, conditional language used herein, such as "can," "could," "might," "may," "eg," and the like, unless specifically stated otherwise or understood otherwise within the context in which it is used, is intended to have its ordinary meaning and is generally intended to convey that certain embodiments include certain features, elements, and / or steps, but not other embodiments. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any manner required for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without authorial input or prompting, whether those features, elements, and / or steps are included in or should be performed in any particular embodiment. 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, and the like. 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, such that the term "or" means one, some, or all of the elements in the list. Conjunctive 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 conjunctive language is not generally 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.

[0163] In the above description of examples, it should be understood that various features are sometimes grouped together in a single example, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of 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 example herein can be applied to or used with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is necessary or essential to each embodiment. Thus, it is intended that the scope of the invention herein, as disclosed and claimed below, should not be limited by the particular embodiments described above, but should be determined solely by a fair reading of the following claims.

[0164] Each element of each embodiment and its respective elements disclosed herein can be used with any other embodiment and its respective elements disclosed herein. All dimensions listed are given as examples, and devices according to the present invention may have dimensions outside of those particular values ​​and ranges. The dimensions and shapes of the device and its elements depend on the particular application. All technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure belongs, unless otherwise noted. The following explanations of terms are provided to facilitate review of the various embodiments of the present disclosure.

[0165] The singular terms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "or" refers to a single element of listed alternative elements or a combination of two or more elements, unless the context clearly dictates otherwise. The term "includes" means "comprises." For example, a device that includes or comprises A and B includes A and B, but may optionally include C or other components other than A and B. Furthermore, a device that includes or comprises A or B may include A or B or A and B, and optionally one or more other components, such as C.

[0166] The term "subject" refers to both human and other animal subjects. In certain embodiments, the subject is a human or other mammal, such as a primate, cat, dog, cow, horse, rodent, sheep, goat, or pig. In certain embodiments, the subject is a human patient.

[0167] Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of this disclosure, suitable methods and materials are described below. In case of conflict, the present specification, including the terminology, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be limiting.

[0168] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are merely examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.

Claims

1. It is a stent, A network of elastically deformable supports, The first end and The second end and An intermediate portion comprising a network forming a network, which includes one or more support arms located between the first end and the second end and extending at least partially across the lumen formed by the first end and the second end, The one or more support arms are equipped with tension springs configured to increase in length, The first end is substantially non-circular, and the length of the first end along the major axis is greater than the width of the first end along the minor axis. A stent in which the length of the intermediate portion is shorter than the length of the first end, and the width of the intermediate portion is approximately equal to the width of the first end.

2. The stent according to claim 1, wherein the network of elastically deformable supports is configured to extend radially from a first configuration to a second configuration within a blood vessel so as to be in direct contact with the blood vessel wall, the first configuration defining a first principal dimension, a first secondary dimension, a first cross-sectional area, a first cross-sectional shape, and a first perimeter, and the second configuration defining a second principal dimension, a second secondary dimension greater than the first secondary dimension, a second cross-sectional area greater than the first cross-sectional area, and the first perimeter.

3. The stent according to claim 2, wherein the first main dimension is larger than the second main dimension, and / or the first secondary dimension is smaller than the second secondary dimension.

4. The stent according to claim 2 or 3, wherein the first cross-sectional shape includes an elliptical shape.

5. The stent according to claim 2, wherein the blood vessel is the aorta, and the first periphery approximates or exceeds the periphery of the aorta.

6. The stent according to claim 1, wherein the first end is substantially elliptical.

7. The stent according to claim 1, wherein the first end is configured to deform in response to blood flow such that the length of the first end is at least partially reduced and the width of the first end is at least partially increased.

8. The stent according to claim 1, wherein the second end is substantially elliptical, and the length of the second end along the main axis is greater than the width of the second end along the secondary axis.

9. The stent according to claim 8, wherein the second end is configured to deform in response to blood flow such that the length of the second end is at least partially reduced and the width of the second end is at least partially increased.

10. The stent according to any one of claims 1, wherein the aforementioned intermediate portion is generally elliptical.

11. The stent according to any one of claims 1, wherein the aforementioned intermediate portion is generally rectangular.

12. The stent according to claim 1, wherein the intermediate portion comprises two support arms extending along the minor axis and two sides extending along the major axis.

13. The stent according to claim 12, wherein each of the two sides of the intermediate portion lies on the same plane as the first end and the second end.

14. The length of the intermediate portion is approximately half the length of the first end, and / or The stent according to claim 1, wherein the length of the intermediate portion is approximately 75 percent of the length of the first end.

15. The stent according to claim 1, wherein one or more support arms are configured to expand in response to an increase in blood pressure beyond a threshold amount.

16. The stent according to claim 1, wherein the first end forms a generally rounded end that generally extends along the sub-axis of the first end.

17. The stent according to claim 16, wherein one or more support arms are joined at a point on the same plane as the rounded end of the first end, and each end of the intermediate portion is a set of two angled support arms.

18. The stent according to claim 1, wherein the intermediate portion generally has a hexagonal shape.

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