Oval aortic stent

Abstract

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

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 332,989, filed on April 20, 2022, and entitled “OVAL AORTICSTENT,” the disclosure of which is hereby incorporated by reference in its entirety. Background Art

[0003] The present disclosure generally relates to devices and methods for vascular repair.

[0004] 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 an artificial heart valve, at a location within the body. An artificial heart valve can be delivered to a treatment site (e.g., an aortic valve, mitral valve, tricuspid valve, and / or pulmonary valve location) within a patient using transcatheter techniques. Summary of the invention

[0005] Described herein are systems, devices, and methods for restoring compliance to a non-compliant vascular structure by causing a temporary change in the cross-sectional geometry of the vessel during initial implantation without changing or minimizing the change in the circumferential wall length of the vessel. More specifically, the relaxed / diastolic 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 systole). Since the highest area-to-periphery ratio can 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 allow for an expansion of the cross-sectional area. Thus, some examples herein may allow for an expansion / contraction of the cross-sectional area of ​​the vessel between diastole / systole without requiring high elasticity of the vessel wall.

[0006] To summarize the present disclosure, certain aspects, advantages and novel features have been described herein. It should be understood that not all such advantages may be achieved according to any particular example. Therefore, the disclosed examples may be performed in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0007] It should be understood that each of the elements disclosed herein can be used with any and all elements disclosed herein, even though a specific combination of elements may not be explicitly shown in the drawings herein. In other words, based on the interpretation of a particular device, one skilled in the art should have no difficulty combining the features of one of two such devices. Therefore, it should be understood that many elements are interchangeable and that the present invention encompasses all permutations thereof.

[0008] Other objects, features and advantages of the present invention will become apparent through consideration of the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] For the purpose of illustration, various examples are depicted in the accompanying drawings, and the examples should never be interpreted as limiting the scope of the present invention. In addition, the various features of the different disclosed examples can be combined to form additional examples as part of the present disclosure. In all the accompanying drawings, reference numerals can be reused to indicate the corresponding relationship between the reference elements.

[0010] Figure 1 An example representation of a heart and associated arteries is shown having various features relevant to certain examples of the present disclosure.

[0011] Figure 2A and Figure 2B Depicts a blood vessel with elastic walls.

[0012] Figure 3A and Figure 3B Depicts a blood vessel having an inelastic and / or lost elasticity vessel wall.

[0013] Figure 4A and Figure 4B A compliant stent implanted within a blood vessel according to one or more examples is depicted.

[0014] FIG. 5A to FIG. 5D Depicts views of a stent according to some examples.

[0015] Figure 6 Top views of example stents in a default and / or rest form and in an expanded and / or undisturbed form according to one or more examples are provided.

[0016] Fig. 7A and Figure 7B Depicted is a blood vessel having a stented portion with a lumen through which blood can flow freely according to one or more examples.

[0017] Figure 8 An example stent positioned within a blood vessel according to one or more examples is depicted.

[0018] Fig.9A An example of a system with a delivery catheter for deploying a stent is depicted.

[0019] Fig. 9B , Fig. 9C and Fig.9D A side view depicting the deployment of a stent within a blood vessel using a delivery catheter.

[0020] Fig.10Top views of example stents in a default and / or rest form and in an expanded and / or undisturbed form according to one or more examples are provided.

[0021] Fig.11 Top views of example stents including angled support arms in a default and / or rest form and in an expanded and / or extended form according to one or more examples are provided. DETAILED DESCRIPTION

[0022] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0023] Although certain preferred examples and examples are disclosed below, the subject matter of the present invention extends beyond the specifically disclosed examples to other alternative examples and / or uses, as well as modifications and equivalents thereof. Therefore, the scope of the resulting claims is not limited to any of the specific examples described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described as multiple discrete operations in sequence in a manner that may help understand certain examples; however, the order of description should not be interpreted 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 separate components. In order to compare various embodiments, certain aspects and advantages of these examples are described. Not all of these aspects or advantages are necessarily achieved by any particular example. Therefore, for example, various examples may be performed in a manner that achieves or optimizes one advantage or a group of advantages taught herein, without necessarily achieving other aspects or advantages also taught or suggested herein.

[0024] In humans and other vertebrates, blood circulation throughout the body is facilitated by a blood circulatory system that includes various arteries, capillaries, veins, and coronary vessels that work with the heart to supply blood to various areas of the body. The heart typically includes a muscular organ with four pumping chambers, wherein the flow thereof is at least partially controlled by various heart valves (i.e., 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., diastole and systole) to at least partially control the flow of blood to corresponding regions and / or blood vessels (e.g., the pulmonary artery, the aorta, etc.) of the heart. The valves may allow fluid flow between the heart and various arteries of the cardiovascular system.

[0025] Figure 1An example representation of a heart 1 and associated arteries 15 having various features relevant to certain examples of the present disclosure is shown. The heart 1 includes four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. The heart 1 also includes four valves for assisting blood circulation therein, including a tricuspid valve 8 that separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 may typically have three cusps or leaflets, and may typically close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The valves of the heart 1 also include a pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery, and may be configured to open during systole so that blood can be pumped toward the lungs, and to close during diastole to prevent blood from leaking back into the heart from the pulmonary artery. The pulmonary valve 9 typically has three cusps / leaflets (not shown). The heart 1 also 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 so that blood in the left atrium 2 can flow into the left ventricle 3, and advantageously close during diastole to prevent blood from leaking back into the left atrium 2. The 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 leaving the left ventricle 3 to enter the aorta 11, and to close during diastole to prevent blood from leaking back into the left ventricle 3.

[0026] The aorta is coupled to the heart via the aortic valve 7 , wherein the ascending aorta 11 arises from the heart 1 and gives rise to the innominate artery 27 , the left common carotid artery 25 , and the left subclavian artery 29 , before continuing as the descending thoracic aorta 13 and further as the abdominal aorta 15 .

[0027] Arteries such as the aorta 15 can utilize arterial compliance to store and release energy through stretching of the vessel wall. As described herein, arterial "compliance" can refer to the ability of an arterial vessel to expand and increase in volume as transmural pressure increases, or the tendency of an artery or portion thereof to resist retraction toward its original size when an expansion or compression force is applied.

[0028] In normally compliant blood vessels, volume expansion and contraction occurs by the stretching and retraction of the blood vessel wall in response to the heartbeat. Aging, hypertension, and other factors may cause a decrease in the elasticity of the blood vessel walls in the vascular system, resulting in a decrease in vascular compliance. This decrease in vascular compliance (also known as arterial stiffness or vascular stiffness) may result in minimal volume change during the change from diastolic to systolic pressure. Depending on where the reduced vascular compliance occurs, the patient's health may be impaired. For example, loss of compliance in the aorta 15 may result in an increase in pulse pressure (e.g., an increase in systolic pressure and / or a decrease in diastolic pressure), and may result in an increase in left ventricular workload (and / or a decrease in cardiac efficiency). Loss of aortic compliance may also have an adverse effect on coronary perfusion. Treatments to improve restoration of vascular compliance may include adding a compliance chamber attached to the vascular system, wherein the compliance chamber provides additional compliance. Such chambers may introduce challenges, such as thrombosis and fatigue issues.

[0029] The present invention provides systems, devices and methods for restoring compliance to non-compliant vascular structures by causing a temporary change in the cross-sectional geometry of the vessel during initial implantation without changing or minimizing the change in the circumferential wall length of the vessel. More specifically, the relaxed / diastolic cross-sectional shape of the vessel can be changed to a non-circular shape, and / or when subjected to increased pressure (e.g., during systole), the vessel can assume a circular (or more circular) shape. Since the highest area to perimeter ratio can be achieved with a circular shape, a device that provides a transition between a non-circular shape and a circular (or more circular) shape can allow for an expansion of the cross-sectional area. Thus, some examples herein can allow for an expansion / contraction of the cross-sectional area of ​​the vessel between diastole / systole without requiring high elasticity of the vessel wall.

[0030] Some example systems may include an elastic spring-like device that can distort (e.g., via pushing, pulling, etc.) the cross-sectional shape of a vessel into a cross-sectional shape that can have a smaller cross-sectional area during diastole (i.e., during lower applied pressures). During systole (i.e., during higher applied pressures), the elastic device can expand or otherwise bend to increase the cross-sectional area of ​​the vessel (e.g., via changes in vessel and / or device geometry, but with little or no change in vessel and / or device circumference) to provide the desired additional compliance.

[0031] In some instances, stents and / or similar devices may provide additional compliance (i.e., additional volume changes with constant pressure changes) to any blood vessel in which they are placed. The term "stent" is used herein according to its broad and common meaning, and may refer to any device configured to be implanted in a blood vessel to improve the compliance of a blood vessel. This additional compliance may be beneficial to any part of a pulsating blood flow system that may suffer from increased systolic pressure (e.g., hypertension). Some example devices may be configured to convert systolic flow to diastolic flow (e.g., produce increased heart efficiency) with constant cardiac output, which may be highly beneficial in aortic and / or coronary perfusion. Examples of blood vessels that may benefit from additional compliance may include aorta, pulmonary artery and / or superior vena cava / inferior vena cava.

[0032] In some instances, when in a diastolic / relaxed / biased state, flexible stents and / or other implants can be used to reshape non-compliant / non-elastic blood vessels into non-circular shapes. Non-circular shapes may include ovals, triangles, peanuts, 8-shaped shapes, etc. Stents and / or other implants may be configured to be biased toward non-circular shapes, and / or may be able to deform into circular / more circular shapes (and thus deform into larger cross-sectional areas) in response to pressure. For example, blood flow through non-compliant / non-elastic blood vessels may be able to cause deformation of 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, stents and blood vessels can maintain the same circumference and / or have minimal circumference changes while changing shape in response to blood flow changes. In some instances, the non-circular shape may have a smaller cross-sectional area than the more circular shape. When the heart beats, the blood vessel may be deformed into a more circular shape, after which the stent / implant may be configured to press the blood vessel back and / or pull it back into a more non-circular shape. In this manner, the stent / graft may be configured to restore some compliance to an otherwise non-compliant vessel.

[0033] In some instances, the stent may be deployed within a blood vessel. However, one or more stents may additionally or alternatively be configured to be positioned around the outer surface of a blood vessel. The stent may include one or more hooks and / or other attachment mechanisms suitable for helping to secure the stent to the tissue of the blood vessel wall.

[0034] The stent may include a stent wall defining an elongated tubular member having a first end with a first opening. The tubular member may also include a second end having a second opening, a lumen extending between the first opening and the second opening, and / or a stent length extending between the first end and the second end. The stent wall may include an aperture wall, and / or may be adapted to be fixed to a vessel wall of a blood vessel, for example, via an outwardly directed hook and / or endothelialization. The stent wall and / or the lumen at least partially surrounded by the stent wall may be configured to form a cross-sectional shape, a cross-sectional area, a major dimension, and / or a minor dimension. The stent may be elastically deformed between a first configuration and a second configuration, wherein 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, and the cross-sectional shape may be a second cross-sectional shape. The first secondary dimension may be smaller than the second secondary 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.

[0035] In some examples, one or more stents can be at least partially comprised of a shape memory material such as nitinol. The stent can be configured to be biased toward a first cross-sectional shape. The first cross-sectional shape can be any shape, including an ellipse, a triangle, a peanut, a figure eight, and / or a kidney.

[0036] The stent may be configured to be delivered percutaneously to the blood vessel with a compressed configuration. Once in the blood vessel, the stent and / or the stent wall of the stent may be configured to radially expand into direct surface contact with the blood vessel wall (e.g., the aortic wall of the aorta). In some instances, the stent may be configured to expand so that the circumference of the lumen of the stent may approximate and / or exceed the circumference of the blood vessel at least before the stent is expanded. In some cases, the stent configured to expand to a circumference at least slightly larger than that of the natural blood vessel may provide improved traction and / or resistance to migration within the blood vessel. In addition, the stent with a circumference approximating and / or greater than that of the blood vessel may increase and / or ensure active engagement with the blood vessel and / or maximize compliance effects. The stent wall and / or a portion of the stent wall may be configured to endothelialize into the blood vessel wall. In some instances, the blood vessel may be the aorta, and / or the second cross-sectional area of ​​the lumen may approximate the cross-sectional area of ​​the aortic segment where the stent is deployed.

[0037] The stent may be adapted to be physically maintained in a particular configuration after the stent and / or stent wall is radially expanded within the vessel and expanded into direct contact with the vessel wall, which may provide time for the stent to be fixed to the vessel wall, for example, via endothelialization. For example, the stent may include and / or may be configured to be attached to a tension wire that may be configured to physically maintain the stent in a particular desired configuration, for example, wherein the tension wire is adapted to constrain the stent major or minor dimensions to a desired size (e.g., maintaining the stent in a more elliptical shape or a more circular shape). The tension wire may be configured to be soluble in the patient's blood. The tension wire may be configured to be removed percutaneously from the stent by a user, such as an interventional cardiologist.

[0038] Some systems described herein for providing compliance to natural blood vessels may include catheters and / or implants such as stents. 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 instances, the catheter may be suitable for the catheter distal portion to be percutaneously advanced to a blood vessel in the patient's vascular system. The catheter distal portion may include an expandable balloon suitable for radially expanding the stent into contact with the vessel wall. The catheter distal portion may include a retractable sheath suitable for preventing the stent from radially expanding. For example, the catheter distal portion may be configured to prevent the stent from expanding to a second (e.g., expansion) configuration from a first (e.g., compression) configuration.

[0039] Some example devices may include hybrid / composite structures, such as a device having a stent suitable for fixing the device within the patient's vasculature, the stent being combined with a self-expanding / biasing stent for deforming between a smaller cross-sectional area and a larger cross-sectional area in response to blood pressure when the heart beats. For example, the device may include a distal stent, which may include a distal stent lumen and a distal stent cross-sectional area in an expanded configuration. The distal stent may include a distal stent wall having an open-pore configuration, the open-pore configuration being suitable for directly engaging the vessel wall of the blood vessel and / or allowing blood to flow from the distal stent lumen to the vessel wall. The device may also include a proximal stent having a configuration similar to the distal stent, such as 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-pore configuration, the open-pore configuration being suitable for directly engaging the vessel wall and allowing blood to flow from the proximal stent lumen to the vessel wall. The device may also include an intermediate support configured to be positioned between the distal support and the proximal support, the intermediate support being formed of a memory material and forming an intermediate support lumen. The intermediate support may be configured to elastically deform between a first configuration and a second configuration, and / or may be configured to be biased toward a first configuration, wherein in the first configuration, the intermediate support and / or the intermediate support lumen may include 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 support cross-sectional area and / or smaller than the proximal support cross-sectional area. The device may include a liner extending between the distal support and the proximal support and along the intermediate support wall of the intermediate support portion. The liner may be adapted to prevent blood from flowing therethrough.

[0040] In a second configuration, the intermediate stent and / or the intermediate stent lumen may have a second cross-sectional shape, a second cross-sectional area, a second major dimension, and / or a second secondary dimension, wherein the first secondary dimension is smaller than the second secondary dimension. The first major dimension may be smaller than the second major dimension. The distal stent and the proximal stent may be adapted to radially expand into contact with a vessel wall (e.g., an aortic wall of the aorta). The second cross-sectional area of ​​the lumen may approximate the cross-sectional area of ​​the aorta.

[0041] The distal and proximal supports may be at least partially comprised of a plastically deformable material (e.g., stainless steel or a cobalt alloy) to produce a more circular cross-section. The intermediate support may be at least partially comprised of a shape memory material (e.g., nitinol). The first cross-sectional shape of the intermediate support may have any shape, such as an elliptical, triangular, kidney-shaped, peanut-shaped, and / or figure-of-eight.

[0042] Some examples may relate to methods for restoring compliance to a blood vessel. The method may include providing a system including a delivery catheter and / or a stent, wherein the delivery catheter has a catheter distal portion, a catheter proximal portion, and a catheter elongated body. The delivery catheter may be adapted to be advanced into the patient's vascular system to position the catheter distal portion within the desired blood vessel. The stent may be any implant as disclosed herein. The method may involve advancing the catheter distal portion through the patient's vascular system to the desired blood vessel, positioning the catheter distal portion at the desired treatment site in the desired blood vessel, radially expanding the stent to contact the vessel wall at the desired treatment site, and / or removing the delivery catheter from the patient's vascular system. The catheter distal portion may include an expandable balloon, wherein the radially expanding stent may involve an expansion balloon. When the catheter distal portion is advanced through the patient's vascular system, the stent may be configured to be positioned on the expandable balloon. The catheter distal portion may include a sheath configured to slide at least partially above the stent, so that when the catheter distal portion is advanced through the patient's vascular system, the sheath may be configured to be positioned at least partially above the stent.

[0043] After radially expanding the stent into contact with the vessel wall at the desired treatment site, the stent can be configured to be physically maintained by the restraint in the desired configuration, for example, maintained in the first configuration or the second configuration. After the delivery catheter is removed from the patient (for example, including after the stent has been endothelialized or otherwise fixed to the vessel wall and / or after a few hours or days), the restraint can be released from the stent so that the stent can no longer be maintained in the first configuration or the second configuration and / or can adopt either configuration and / or deform between the configurations. In some instances, the restraint may include a tension wire. Releasing the restraint may involve cutting and / or removing the tension wire. The tension wire may be absorbable, and the release of the stent from the restraint may be configured to occur in response to exposure of the absorbable tension wire to the patient's blood. The absorbable tension wire may be adapted to be absorbed in a sufficient time so that the stent can be endothelialized or otherwise fixed to the vessel wall before the absorbable tension wire is absorbed and the stent is released from the restraint.

[0044] The stent may include a tubular / cylindrical shape, a simple ring, a C-clip / clamp, and / or a spring-like mechanism. In some examples, the stent may be at least partially comprised of a shape memory material, such as Nitinol, which may allow the stent to deform so that the vessel assumes 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 to reduce the cross-sectional area of ​​the vessel.

[0045] In some instances, the stent may be at least partially self-expanding, such as when formed by a memory material such as nitinol. The stent may be configured to be delivered to a desired position in, around, or near a blood vessel via a catheter. The catheter may include an expandable balloon to help expand the stent into initial contact with the blood vessel firmly, such as where the balloon expands the stent to an expanded size / diameter greater than its programming / bias state. The expanded size / diameter may even be greater than the expanded size / diameter that the stent may achieve later when expanded due to blood flow / heartbeat. This expanded size / diameter may be sufficient to embed or otherwise fix the stent to the vessel wall. In some instances, the stent may be at least partially perforated to avoid blocking branch vessels. However, in another instance, the stent may be completely covered to isolate the aorta or other blood vessels from fluid pressure (e.g., aneurysmal areas or damaged vessel walls).

[0046] The stent may include barbs and / or other attachment mechanisms that may prevent migration and / or may help securely retain the stent to the vessel wall so that the vessel cross-sectional shape changes in response to changes in the shape of the stent. Such barbs and / or other attachment devices may be adapted to engage the wall of the vessel in which the stent is deployed.

[0047] In some examples, the stent may include one or more anchors extending from a main stent body (e.g., 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, for example, where the branch vessel branches away from the 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 position between the first end and the second end of the main stent body, or extend from the first end or the second end of the main stent body. One or more of the anchors may be adapted to be deployed to contact the wall of a renal artery, or to be deployed into the wall of an iliac artery. One or more of the anchors may include a linear structure (e.g., formed of a shape memory material), and / or may be adapted to pass within a branch vessel and / or adapted to engage wall tissue of a branch vessel, such as an iliac artery or a renal artery. One or more of the anchors may include an anchor stent body having an anchor stent wall defining an anchor stent lumen, and / or the anchor stent body may be adapted to radially expand to contact the wall of a branch vessel, such as an iliac artery or a renal artery. The anchor stent body can be at least partially comprised of a shape memory material and / or can be biased toward a configuration in which the anchor stent lumen includes a non-circular cross-sectional shape (e.g., oval, triangular, peanut, or kidney-shaped). In some examples, the anchor stent body can have an overall length in the range of 0.5 cm and 7 cm.

[0048] In some instances, the stent may include one or more support arms configured to at least partially resist deformation of the stent under certain blood pressure conditions. For example, during diastolic pressure, the support arms may be configured to keep the stent in a relaxed form (e.g., a substantially 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 substantially circular cross-sectional shape). The stent may include any number of support arms, and / or the support arms may be located near and / or away from the central axis of the stent. In some instances, one or more support arms may be configured to extend laterally across the lumen formed by the stent.

[0049] In some examples, a system including one or more stents as described herein can be used for endoluminal repair (e.g., endoluminal repair of abdominal aortic aneurysm (AAA)). For example, a catheter can be inserted into a patient's blood vessel to deliver the stent at or near the aneurysm. The stent can be configured to act as a graft, and / or can be configured to expand and / or deform from a less round shape to a more round shape within a blood vessel to form a more stable channel for blood flow.

[0050] The systems, devices and / or methods described herein can be used in various catheter-based surgeries, including minimally invasive surgery and percutaneous surgery. In some instances, the method / system / device may be directed to transaortic delivery through a small chest (or abdominal) incision. In other instances, the method / system / device can be used in minimally invasive surgery. In yet other instances, the method / system / device can be used in percutaneous surgery, such as entering the patient's arterial system (e.g., through the femoral or brachial artery) via one or more catheters.

[0051] Figure 2A and Figure 2B Depicts a blood vessel 10 having an elastic vessel wall 12. At diastolic pressure ( Figure 2A ) may have a relatively small diameter 14a and cross-sectional area 16a, but ... Figure 2B ) the vessel wall 12 stretches, causing the vessel 10 to present a larger diameter 14b and cross-sectional area 16b.

[0052] Figure 3A and Figure 3B Depicts a blood vessel 10 having an inelastic and / or de-elastic vessel wall 12. Diastolic diameter 14a and / or diastolic cross-sectional area 16a ( Figure 3A ) may be only slightly smaller than the contraction diameter 14b and the contraction cross-sectional area 16b ( Figure 3B ).

[0053] Figure 4A and Figure 4BDepicts a compliant stent 700 implanted within a blood vessel 10. Stent 700 may be configured to restore compliance to blood vessel 10. Stent 700 may include a stent wall configured to engage blood vessel wall 12. In response to diastolic pressure, stent 700 may be configured to have an elliptical diastolic shape with a major axis 26a and a minor axis 28a. Stent 700 may be configured to cause blood vessel 10 to present a corresponding diastolic elliptical shape and / or diastolic cross-sectional area 16a. In response to systolic pressure, stent 700 may be configured to present a more circular contracted shape, which may cause blood vessel wall 12 to present a corresponding more circular contracted shape in which stent minor axis 28b approaches or is equal to stent major axis 26b and / or has an enlarged contracted cross-sectional area 16b.

[0054] FIG. 5A to FIG. 5D Depicted are views of a stent 500 according to some examples. Figure 5A A first side view along the long axis of the stent 500 is shown, Figure 5B A second side view along the minor axis of the stent 500 is shown, Figure 5C A first perspective view of the bracket 500 is provided, and Figure 5D A second perspective view of the stent 500 is provided. As used herein, the terms "primary" and "secondary" 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 secondary side 504a and / or the second secondary side 504b. In some examples, the first major side 502a may be positioned substantially across the lumen 510 of the stent from the second major side 502b. Similarly, the first secondary side 504a may be positioned substantially across the lumen 510 of the stent 500 from the second secondary side 504b. The first major side 502a and the second major side 502b may extend along a first plane, and / or the first secondary side 504a and / or the second secondary side 504b may extend along a second plane.

[0055] The various components of the support 500 described herein may be separate components, and / or may include extensions of the same components. 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-different parts of the support 500. The support 500 may not include different separation points and / or transition points between the components described herein. However, for illustrative purposes herein, these components may be described in different terms.

[0056] The stent 500 can be configured to form a generally elliptical lumen 510 in a default and / or resting state of the stent 500. For example, the sides of the stent 500 can be at least partially curved, particularly at a transition region 512 between, for example, the first major side 502a and the first secondary side 504a and / or the second secondary side 504b. In some examples, at least in the default and / or resting form of the stent 500, the first secondary side 504a and / or the second secondary side 504b can have a relatively greater curvature than the first major side 502a and / or the second major side 502b.

[0057] In some examples, stent 500 can include a network of one or more struts 506 that can be interconnected and / or form one or more cells 508 between struts 506. One or more cells 508 formed by struts 506 can have a generally diamond and / or rectangular form.

[0058] The stent 500 may include 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 include a middle portion 517 of the stent 500. The middle portion 517 may be located between the first end portion 515 and the second end portion 519 of the stent 500. The first end portion 515, the middle portion 517, and / or the second end portion 519 may each extend substantially the full length of the minor axis (e.g., extending from the first major side 502a to the second major side 502b). The first end portion 515 and / or the second end portion 519 may similarly extend substantially the full length of the major axis (e.g., extending from the first secondary side 504a to the second secondary side 504b). However, the middle portion 517 may not extend the full length of the major axis. In some examples, the middle portion 517 may extend substantially half the length of the major axis. In other words, the stent 500 may have a substantially constant width across the first end portion 515, the middle portion 517, and / or the second end portion 519, and / or may have a substantially constant depth across the first end portion 515 and the second end portion 519. However, the stent 500 may have a smaller depth at the middle portion 517.

[0059] Middle portion 517 can form a generally elliptical inner lumen 530 that can have a smaller area than lumen 510 formed by first end portion 515 and / or second end portion 519. In some examples, inner lumen 530 can comprise a subsection of lumen 510 of stent 500.

[0060] The struts 506 can be configured to bend and / or navigate relative to each other to provide flexibility to the stent 500. For example, the struts 506 can be configured to bend to allow the stent 500 to assume a substantially compressed form within a catheter and / or other delivery device. When removed from a catheter and / or other delivery device, the stent 500 and / or the struts 506 can be configured to relax and / or assume a default expanded and / or relaxed form. The stent 500 can be configured so that when placed in a blood vessel, the first secondary side 504a and / or the second secondary side 504b of the first end portion 515 and / or the second end portion 519 can contact the vessel wall and / or apply force to the vessel wall.

[0061] The middle portion 517 may include one or more support arms 520 configured to extend at least partially across the lumen 510 of the stent 500. In some instances, the support arms 520 may include one or more tension springs 525 configured to naturally assume a curled and / or compressed form and / or expand and / or straighten in response to changes in blood pressure and / or an increase in blood pressure above a threshold amount. The one or more tension springs 525 may have a generally wavy form in a static / compressed / curled form. In addition, the one or more tension springs 525 may have a certain rigidity and / or may at least partially resist expansion and / or straightening. Thus, the one or more tension springs 525 may be configured to deform, expand and / or straighten only in response to increased pressure (e.g., in the range of 90 mmHg to 160 mmHg), and / or may return to a static and / or curled form after removing such pressure.

[0062] The one or more tension springs 525 can be configured to form one or more rings 527, which can have a drop shape to provide stability and / or rigidity to the support arm 520. The tension springs 525 can be aligned in an accordion shape, such as Figure 5B Best displayed in.

[0063] like Figure 5A 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 substantially equal width that may be greater than the width of the middle portion 517. The width of each of the first end portion 515, the middle portion 517, and / or the second end portion 519 may be substantially constant over each individual portion. In other words, the width of the stent 500 may not be tapered and / or may change abruptly from the first end portion 515 to the middle portion 517 and / or from the middle portion 517 to the second end portion 519.

[0064] like Figure 5BAs best shown in FIG. 5 , the bracket 500 can have a substantially constant width (ie, depth) when viewed facing the first secondary side 504a and / or the second secondary side 504b. The support arm 520 can be configured to have a substantially constant width (ie, depth). FIG. 5A to FIG. 5D The relaxed and / or compressed forms shown in present a length substantially equal to the distance between the first major side 502a and the second major side 502b of the first end portion 515, the middle portion 517, and / or the second end portion 519.

[0065] One or more support arms 520 may be configured to extend at least partially across the lumen formed by the first end portion 515 and / or the second end portion 519. For example, the first end portion 515 and / or the second end portion 519 may be approximately equal in size, and / or may be aligned so that the lumen formed by the first end portion 515 extends linearly to the lumen formed by the second end portion 519. The one or more support arms 520 of the middle portion 517 may extend transversely across the space between the lumen formed by the first end portion 515 and the lumen formed by the second end portion 519. For example, blood flowing through the lumens of the first end portion 515 and / or the second end portion 519 may contact the one or more support arms 520. The one or more support arms 520 may include a tension spring and / or a linear structure that is at least partially coiled and configured to increase in length in response to a force (e.g., a change in blood pressure).

[0066] The first end portion 515, the second end portion 519, and / or the middle portion 517 can be configured to contact one or more blood vessel walls. For example, the first secondary side 504a and / or the second secondary side 504b of the stent 500 and / or the first end portion 515, the middle portion 517, and / or the second end portion 519 can be configured to contact a vessel wall. FIG. 5A to FIG. 5D In response to changes in blood flow and / or blood pressure, one or more support arms 520 may be configured to expand, and / or the first end portion 515 and / or the second end portion 519 may be configured to bend and / or deform into a more rounded form. Thus, the first major side 502a and / or the second major side 502b of the stent 500 and / or the first end portion 515 and / or the second end portion 519 may be configured to contact one or more vessel walls and / or apply a compressive force on the vessel walls.

[0067] The stent 500 and / or the first end portion 515, the middle portion 517, and / or the second end portion 519 may include a mesh structure of elastically deformable struts 506 that are configured to bend and / or deform in response to changes in blood flow and / or blood pressure. For example, the struts 506 may be configured to expand radially, and / or the first end portion 515, the middle portion 517, and / or the second end portion 519 may be configured to expand from a first configuration (e.g., FIG. 5A to FIG. 5D ) radially expands to a second configuration (e.g., a more circular form; 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 to be in 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. When moving from the first configuration to the second configuration, the cross-sectional area of ​​the stent 500 may increase.

[0068] The distance between the first major side 502a and the second major side 502b in the first configuration can define a first minor dimension of the bracket 500. The distance between the first minor side 504a and the second minor side 504b in the first configuration can define the first major dimension. When the bracket 500 moves from the first configuration to the second configuration, the bracket 500 can present 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 bracket 500 moves from the first configuration to the second configuration, the bracket 500 can present 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.

[0069] Bracket 500 can be FIG. 5A to FIG. 5D 500 has a generally elliptical cross-sectional shape in the resting state shown in . 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 vessels. Therefore, as the stent 500 is deformed into 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 vessels.

[0070] exist FIG. 5A to FIG. 5D In the first configuration of the stent 500 shown in , the length of the first end portion 515 and / or the second end portion 519 (e.g., along the major axis) (e.g., the distance between the first secondary side 504a and the second secondary side 504b) can be greater than the width of the first end portion 515 and / or the second end portion 519 (e.g., along the minor axis) (e.g., the distance between the first major side 502a and the second major side 502b). The first end portion 515 and / or the second end portion 519 can be configured to deform in response to changes in blood flow and / or blood pressure, such that the length of the first end portion 515 and / or the second end portion 519 is at least partially reduced, and / or the width of the first end portion 515 and / or the second end portion 519 is at least partially increased.

[0071] The middle portion 517 may have a generally oval and / or rectangular shape. For example, the middle portion 517 may be generally flat along the first major side 502a and / or the second major side 502b. In addition, one or more support arms 520 of the middle portion 517 may extend generally linearly across the first major dimension of the stent 500. Thus, the middle portion 517 may include four generally straight sides. The corners and / or edges of the middle portion 517, the first end portion 515, and / or the second end portion 519 may be generally rounded.

[0072] The length of the middle portion 517 in the first configuration (e.g., the distance between the support arms 520 of the middle portion 517) can be less than the length of the first end portion 515 and / or the second end portion 519. The width of the middle portion 517 in the first configuration (e.g., the distance between the first major side 502a and the second major side 502b) can be approximately equal to the width of the first end portion 515 and / or the second end portion 519. In the first configuration, the length of the middle portion 517 can be approximately half, seventy-five percent, and / or any other amount less than one hundred percent of the length of the first end portion 515 and / or the length of the second end portion 519. In the second configuration, when the stent 500 assumes a more rounded form, the width of the middle portion 517 can increase beyond the width of the first end portion 515 and / or the second end portion 519.

[0073] The middle portion 517 may include a first side extending along the first major side 502a of the bracket 500 and / or a second side extending along the second major side 502b of the bracket 500. The first side and / or the second side of the middle portion 517 may be coplanar with corresponding sides of the first end portion 515 and the second end portion 519.

[0074] One or more support arms 520 can be substantially straight. The first end portion 515 and / or the second end portion 519 can include substantially rounded ends and / or edges along the first secondary side 504a and / or the second secondary side 504b and / or along the minor axis of the stent 500.

[0075] Although the first end portion 515 and the second end portion 519 are shown as having generally straight sides (e.g., along the first major side 502a, the second major side 502b, the first secondary side 504a, and / or the second secondary side 504b), the first end portion 515 and / or the second end portion 519 can have tapered and / or sloped sides. For example, the first end portion 515 and / or the second end portion 519 can gradually narrow and / or reduce in width along the first secondary side 504a and / or the second secondary side 504b, such that the width of the first end portion 515 and / or the second end portion 519 is the smallest at or near the middle portion 517.

[0076] In some examples, at least a portion of stent 500 and / or at least a portion of struts 506 and / or cells 508 of stent 500 can be at least partially covered by a covering. The covering can be configured to increase friction of struts 506 and / or close cells 508 to reduce blood flow through cells 508.

[0077] One or more support arms 520 may be at least partially comprised of nitinol and / or other materials and / or alloys having shape memory characteristics. For example, nitinol support arms 520 may be configured to increase strain before reaching a level at which deformation of support arm 520 may occur (e.g., approximately 8% strain). In this manner, support arms 520 may resist diastolic pressure, and / or may be configured to deform and / or expand only in response to systolic pressure and / or increased pressure and / or pressure at or above a given amount.

[0078] Although the stand 500 is shown as including two support arms 520, the stand 500 may include any number of support arms 520. For example, the stand 500 may include four support arms 520.

[0079] Figure 6 Provides a default and / or static form 605 (in Figure 6 ) and in expanded and / or expanded form 607 (shown in solid lines in Figure 6 600 (shown using dashed lines in FIG. 600 ). Stent 600 can be configured to expand from a resting form 605 to an expanded form 607 in response to changes in pressure within and / or around a vessel and / or other anatomical structure in which stent 600 is located.

[0080] 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 by a first end portion and a second end portion of the stent 600. A middle portion of the stent 600 may form an inner lumen 630 (e.g., between the support arms 620 of the middle portion). In some examples, the stent 600 may have a generally elliptical and / or pill-shaped form in the static form 605, wherein one or more end portions of the stent 600 form rounded edges 604 (e.g., minor sides 504a, 504b of FIG. 5 ), and / or wherein one or more end portions and / or the middle portion form generally straight sides 602 (e.g., major sides 502a, 502b of 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.

[0081] When stent 600 experiences a change in pressure, stent 600 can be configured to assume a more curved and / or generally circular expanded form 607. Figure 6 , the expanded form 607 can extend the support arm 620 to extend across a greater width of the stent 600. The extension of the support arm 620 can be achieved by forming a bend and / or navigation of the struts 606 of the stent 600 and / or by reducing the length of the middle portion of the stent 600.

[0082] In the relaxed form 605, the stent 600 may have a relatively small cross-sectional area. The stent 600 may be configured to expand to an expanded form 607 in response to an increase in aortic blood pressure (e.g., during systole). Thus, the stent 600 may present a more circular cross-section, which may increase the cross-sectional area of ​​the stent 600 (e.g., by bending and / or movement of 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 the pulsating electrical shock of systole. After systole, the stent 600 and / or the blood vessel may return to the relaxed form 605 and / or the generally elliptical shape. Returning to the relaxed form 605 may force blood to pass through the aorta. Thus, the blood pressure pulses through the aorta may be smoothed to mimic the performance of a more compliant aorta.

[0083] The stent 600 portion may have a generally non-circular (e.g., elliptical) shape with a major axis 26a and a minor axis 28a in a rest and / or default form 605. When blood pressure in the vessel 10 increases, the stent 600 may be configured to allow blood to pass through the lumen 610 and / or to be pressed against the vessel wall 12. During a period of increased pressure, the stent 600 may be configured to compress at least partially along the major axis 26a of the stent 600, such that the stent 600 assumes a less elliptical / more circular shape of the expanded form 607, wherein the major axis 26b may be shorter than it was prior to the increase in blood pressure, and / or the vessel 10 may have a greater volume than during the period of increased pressure. Figure 6 A larger cross-sectional area in a more oval shape.

[0084] Although the struts 606 forming the stent 600 may be at least partially flexible to enable the cross-sectional area of ​​the stent 600 to be changed, the struts 606 may at least partially resist shape changes. For example, if the stent 600 is too responsive (e.g., too flexible), the stent 600 may not be able to adequately resist the increase in blood pressure during systole, and / or may change shape prematurely. Therefore, the struts 606 may be configured to bend and / or change shape in response to pressure exceeding a threshold amount. In some instances, the struts 606 may become thicker, however, the thickening of the struts 606 may increase the stress on the material of the struts 606 when the struts 606 are bent.

[0085] The middle portion of the stent 600 can be configured to extend at least partially across the lumen 610 of the stent 600 to form a support arm and / or chord of the stent 600. Thus, the middle portion can provide increased resistance to cyclization, and / or can increase the force that pulls the stent 600 back to the relaxed form 605 after systole.

[0086] At least a portion of the middle portion (e.g., support arm) may be formed of tension springs and / or struts 606 having a more curved shape to provide increased spring behavior to the support arm extending across the lumen 610 of the stent 600. The tension springs of the support arm may be tuned (e.g., through its geometry and / or heat treatment using struts 606) to allow the support arm to have spring behavior at least partially independent of the tubular geometry of the stent 600. In some examples, the support arm may and / or other struts 606 of the stent 600 may be at least partially formed of one or more shape memory alloys (e.g., nitinol) to allow the support arm to have a relatively high resistance until a threshold blood pressure level is reached and / or to allow movement from the relaxed form 605 to the expanded form 607 when the threshold blood pressure level is reached. For example, the stent 600 may be configured to not immediately move from the relaxed form 605 to the expanded form 607 at a given point during systole and / or at the beginning of systole. For example, the support arm may be tuned so that the martensitic stress is reached at a threshold blood pressure.

[0087] The elliptical shape of stent 600 in relaxed form 605 can provide a relatively high cross-sectional change along the minor axis of stent 600 between relaxed form 605 and expanded form 607. Most of the volume change of stent 600 can be applied above diastolic pressure and / or not immediately at the onset of cardiac contraction. In some examples, the middle portion of the stent can include one or more biphasic springs.

[0088] In some examples, stent 600 can be formed from a laser cut hypotube.

[0089] Fig. 7A and Figure 7B A blood vessel 10 is depicted having a stent portion 700 having a lumen 710 through which blood can flow freely. In FIG. 7 , the stent portion 700 can have a generally non-circular (e.g., elliptical) shape with a major axis 26a and a minor axis 28a. When blood pressure in the blood vessel 10 increases, the stent 700 can be configured to allow blood to pass through the lumen 710 and / or press against the vessel wall 12. As a result, the blood pressure can generate tension 48 in the vessel wall 12, particularly in portions of the vessel wall that extend generally parallel to the major axis 26a of the stent. The tension 48 can cause the blood vessel 10 to compress the stent 700 along the major axis 26a of the stent 700, causing the stent 700 to appear as shown. Figure 7B7, wherein the major axis 26b may be shorter than it was before the blood pressure increases (shown in FIG. 7), and / or the blood vessel 10 may have a larger cross-sectional area than in the more oval shape of FIG. 7. Stent 700 may include one or more support arms 720 extending transversely across the lumen of stent 700.

[0090] For a closed / covered stent 700, blood may be prevented from flowing through the stent 700 to press outwardly against the vessel wall 12. Instead, the pressure load may act directly on the stent 700 via the lining material (e.g., polymer film, bioprosthetic material, cloth, etc.) of the stent 700. For such a closed / covered / lined stent 700, one or more materials of the stent 700 may create 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 deployed in the same vessel 10. This seal may be achieved using deflections in the outer surface of the stent 700, such as in the form of raised and / or lowered features in the outer surface of the stent 700. Examples of such features may include raised and / or lowered features (e.g., raised bumps or edges or lowered grooves) at the distal and / or proximal ends of the stent 700 to improve sealing at the leading and / or trailing stent edges and / or against natural anatomical structures. Raised and / or lowered features, such as bumps and / or ridges and / or grooves, can be configured to be positioned at various locations along the length of stent 700. Raised and / or lowered features can be formed in various ways, such as using compliant materials such as cloth, foam, elastomers, etc.

[0091] Figure 8 An example stent 800 is depicted positioned within a blood vessel 10 according to one or more examples. The stent can be open (i.e., can allow blood to flow through the stent 800). In some examples, the stent 800 can be configured to at least partially contact one or more vessel walls 12 of the blood vessel 10 and / or apply a force to the one or more vessel walls.

[0092] The stent 800 may include a first end portion 815, a middle portion 817, and / or a second end portion 819. In some examples, the first end portion 815 and / or the second end portion 819 may be configured to engage and / or contact one or more walls 12 of the blood vessel 10. The middle portion 817 may have a width that is less than the width of the first end portion 815 and / or the second end portion 819, and / or may not be configured to contact the wall 12 of the blood vessel 10. The middle portion 817 may include one or more expandable support arms 820 formed by a tension spring and / or similar mechanism.

[0093] Although in some instances, the support 800 may include a single length of linear tube, the support may include multiple lengths of linear tube and / or other forms. For example, the support 800 may include a Y-shaped structure, in which a support with a bifurcated end may be provided to match the anatomical bifurcation. In this example, the various portions of the Y-shape may be biased toward the same general shape, and / or may be biased toward different shapes. For example, the main base / leg of the Y-shaped structure may be biased toward a first shape (e.g., an elliptical shape), the left upper arm portion of the Y-shape may be biased toward a second shape (e.g., a kidney shape), and / or the right upper arm portion of the Y-shape may be biased toward a third shape (e.g., a circular shape). Any combination of the shapes disclosed herein may be applied to various portions of the devices of the various examples described herein.

[0094] In some instances, 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 lead to reduced elasticity in the arterial system and / or may lead to loss of vascular compliance (e.g., arterial stiffness and / or vascular stiffness). For example, loss of compliance in the aorta may lead to increased pulse pressure (e.g., systolic pressure) and / or may lead to increased left ventricular workload. Loss of aortic compliance may also have an adverse effect on coronary perfusion. Adding one or more sensors 804 coupled to the stent 800 described herein may help quantify and / or monitor the effects of restored compliance and / or reduced stiffness. Sensor 804 may be incorporated into any of the stents described herein.

[0095] Aortic compliance loss can increase central pulse pressure and / or systolic pressure, and / or reduce diastolic pressure. One or more onboard pressure sensors 804 can provide accurate central blood pressure measurements (e.g., pressure in the aorta), and / or can monitor the pressure benefits of restored compliance. Pressure sensor 804 can be positioned on oval stent 800 so that sensor 804 can be at least partially exposed to aortic pressure before stent 800 is fully deployed. For example, sensor 804 can be positioned at the distal end of stent 800 during transcatheter delivery of stent 800. Sensor 804 can provide basal pressure data to measure pressure changes due to deployment of stent 800 and / or restoration of aortic compliance.

[0096] One or more sensors 804 may be used to track movement of stent 800 and / or may provide a quantitative measurement of the volume change from the collapsed shape to the expanded shape of stent 800. One or more sensors 804 may include proximity and / or position sensors that produce volume change data, which may be coupled with pressure change data that produces quantitative data regarding the amount of restored compliance.

[0097] The one or more sensors 804 may include a temperature sensor configured to provide core temperature measurements that may be used in various medical applications. For example, the temperature sensor may be used in conjunction with the sensed current to estimate blood flow.

[0098] Although sensor 804 is Figure 8 800, but one or more sensors 804 may be coupled to any portion of the bracket 800, including the first end portion 815 and / or the middle portion 817. The sensor 804 may be coupled to the bracket 800 using any suitable attachment device and / or mechanism. For example, Figure 8 As shown in , one or more coils 813 can be used to at least partially enclose the sensor 804 and / or one or more struts 809 of the stent 800 to secure the sensor 804 to the stent 800.

[0099] Fig.9A An example of a system 140 having a delivery catheter 142 for deploying a stent 900 is depicted. The delivery catheter 142 may include a proximal end 146 with a handle 148 having a control thereon. The delivery catheter 142 may also include a distal end 150 adapted to be advanced into a blood vessel, for example, via a percutaneous method. The system 140 may also include a retractable sheath 152 configured to cover and / or protect the stent 900 during delivery. In some examples, 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 expandable to expand the stent 900 securely into contact with the vessel wall. For self-expanding stents, the balloon 154 may add further expansion to securely engage the stent 900 against the vessel wall. In some examples, the components of the system 140 may be configured to be loaded onto the delivery catheter 142 via various methods. For example, radial corrugation, folding, and / or rolling may be used to load onto the catheter 142.

[0100] Fig. 9B , Fig. 9C and Fig.9D A side view of a stent 900 deployed within a blood vessel 156 using a delivery catheter 142 is depicted. The distal end 150 of the delivery catheter 142 may be advanced into the blood vessel 156 to a desired deployment location, such as Fig. 9B The sheath 152 can be retracted, at which point the self-expanding stent 900 can be configured to expand radially, as shown. Fig. 9C The balloon 154 can be expanded to expand the stent 900 and / or over-expand the self-expanding stent 900, thereby firmly pressing the stent 900 against the wall of the blood vessel 156, as shown in FIG. Fig.9D. After the stent 900 is properly deployed, the catheter 142 can be withdrawn from the patient. Before withdrawing the catheter 142, the sheath 152 can be advanced to a closed position (e.g., back over the balloon 154). With the stent 900 deployed in the vessel 156, the stent 900 can be configured to deform the vessel 156 as needed during diastole and / or systole to change the vessel cross-sectional area in response to the patient's heartbeat so as to restore some vessel compliance. The stent 900 may include a first end portion 915, a middle portion 917, and / or a second end portion 919.

[0101] Various treatment methods including advancing the catheter 142 to the appropriate position via the sheath 152 are within the scope of the present disclosure. In some instances, arterial access can be obtained via the access sheath 152 sized to be used in some surgeries. An incision leading to an internal blood vessel 156 (e.g., a femoral artery) can be produced in the patient's body. The distal end of the access sheath 152 can be advanced through the incision and the internal blood and into the desired position in the target blood vessel 156, wherein the catheter handle 148 is positioned adjacent to the incision / access site outside the patient's body. Echo and / or fluoroscopy and / or other visualization techniques can be used to confirm the correct position of the stent 900. Treatment and / or implant deployment can occur, for example, by deploying the stent 900 at the target position. Once the correct deployment is confirmed, the catheter 142 can be removed from the patient, and one or more incisions can be closed, for example, via sutures.

[0102] Fig.10 Provides a default and / or static form 1005 (in Fig.10 ) and in expanded and / or expanded form 1007 (in Fig.10 1000 is a top view of an example stent 1000 (shown using dashed lines in FIG. 1000 ). Stent 1000 can be configured to expand from a rest form 1005 to an expanded form 1007 in response to changes in pressure within and / or around a vessel and / or other anatomical structure in which stent 1000 is located.

[0103] 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 by a first end portion and / or a second end portion of the stent 1000. A middle portion of the stent 1000 may form an inner lumen 1030 (e.g., between the support arms 1020 of the middle portion). In some examples, the stent 1000 may have a generally elliptical and / or pill-shaped form in the static form 1005, wherein one or more end portions of the stent 1000 form rounded edges 1004 (e.g., minor sides 504a, 504b of FIG. 5 ), and / or wherein one or more end portions and / or the middle portion form generally straight sides 1002 (e.g., major sides 502a, 502b of FIG. 5 ). The stent 1000 may include a first major side 1002a, a second major side 1002b, a first minor side 1004a, and / or a second minor side 1004b.

[0104] When stent 1000 experiences a change in pressure, stent 1000 can be configured to assume a more curved and / or generally circular expanded form 1007. Fig.10 , the expanded form 1007 can extend the support arm 1020 to extend across a greater width of the stent 1000. The extension of the support arm 1020 can be achieved by forming a bend and / or navigation of the struts of the stent 1000 and / or by reducing the length of the middle portion of the stent 1000.

[0105] In the relaxed form 1005, the stent 1000 may have a relatively small cross-sectional area. The stent 1000 may be configured to expand to the expanded form 1007 in response to an increase in aortic blood pressure (e.g., during systole). Thus, the stent 1000 may present a more circular cross-section, which may increase the cross-sectional area of ​​the stent 1000 (e.g., by bending and / or movement of the struts of the stent 1000) while generally maintaining the circumference of the stent 1000. The increase in cross-sectional area may facilitate absorption of the pulsating electrical shock of systole. After systole, the stent 1000 and / or the blood vessel may return to the relaxed form 1005 and / or the generally elliptical shape. Returning to the relaxed form 1005 may force blood to pass through the aorta. Thus, the blood pressure pulses through the aorta may be smoothed to mimic the performance of a more compliant aorta.

[0106] The stent 1000 portion may have a generally non-circular (e.g., elliptical) shape with a major axis 26a and a minor axis 28a in the rest and / or default form 1005. When blood pressure in the vessel 10 increases, the stent 1000 may be configured to allow blood to pass through the lumen 1010 and / or press against the vessel wall 12. During the period of increased pressure, the stent 1000 may be configured to compress at least partially along the major axis 26a of the stent 1000, so that the stent 1000 assumes a less elliptical / more circular shape of the expanded form 1007, wherein the major axis 26b may be shorter than it was before the increase in blood pressure, and / or the vessel 10 may have a smaller diameter than it did during the period of increased pressure. Fig.10 A larger cross-sectional area in a more oval shape.

[0107] Although the struts forming the stent 1000 may be at least partially flexible and / or deformable to enable the cross-sectional area of ​​the stent 1000 to be changed, the struts may at least partially resist shape change. For example, if the stent 1000 is too responsive (e.g., too flexible), the stent 1000 may not be able to adequately resist the increase in blood pressure during systole, and / or may change shape prematurely. Therefore, the struts may be configured to bend and / or change shape in response to pressure exceeding a threshold amount. In some instances, the struts may become thicker, however, the thickening of the struts may increase the stress on the material of the struts when the struts are bent.

[0108] The middle portion of the stent 1000 can be configured to extend at least partially across the lumen 1010 of the stent 1000 to form a support arm and / or chord of the stent 1000. Thus, the middle portion can provide increased resistance to cyclization, and / or can increase the force that pulls the stent 1000 back to the relaxed form 1005 after cardiac contraction.

[0109] At least a portion of the middle portion (e.g., support arm 1020) may be formed of tension springs and / or struts having a more curved shape to provide increased spring behavior to the support arm extending across the lumen 1010 of the stent 1000. The tension springs of the support arms may be tuned (e.g., through their geometry and / or heat treatment of the struts) to allow the support arms to have spring behavior at least partially independent of the tubular geometry of the stent 1000. In some examples, the support arms may and / or other struts of the stent 1000 may be at least partially formed of one or more shape memory alloys (e.g., nitinol) to allow the support arms to have relatively high resistance until a threshold blood pressure level is reached and / or to allow movement from the relaxed form 1005 to the expanded form 1007 when the threshold blood pressure level is reached. For example, the stent 1000 may be configured to not immediately move from the relaxed form 1005 to the expanded form 1007 at a given point during systole and / or at the onset of systole. For example, the support arms may be tuned so that the martensitic stress is reached at a threshold blood pressure.

[0110] The elliptical shape of the stent 1000 in the relaxed form 1005 can provide a relatively high cross-sectional change along the minor axis of the stent 1000 between the relaxed form 1005 and the expanded form 1007. Most of the volume change of the stent 1000 can be applied above diastolic pressure and / or not immediately at the beginning of cardiac contraction. In some examples, the middle portion of the stent can include one or more biphasic springs.

[0111] The middle portion may have any suitable length and / or any suitable distance between the support arms 1020 of the middle portion. For example, one or more support arms 1020 may be located near and / or adjacent to the minor side 1004 of the bracket 1000, such as Fig.10 The length of the middle portion and / or any distance between the support arms 1020 of the middle portion may be approximately 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., approximately seventy-five percent of the length of the stent 1000 and / or 3 / 4 of the length of the stent 1000).

[0112] The support arms 1020 can be configured to support the stent 1000 without interfering with the corrugation of the stent 1000. In some examples, one or more support arms 1020 can be vertically disposed between walls and / or sides of the first end portion and / or the second end portion of the stent 1000. One or more support arms 1020 can be at least partially offset from the central axis of the stent and / or can be near and / or adjacent to the rounded minor side 1004 of the stent 1000.

[0113] The support arm 1020 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 features of the support arms 1020 may be selected to resist deformation of the support 1000 when subjected to a pressure not exceeding a desired threshold, and / or may be configured to yield under elevated pressure (e.g., in the range of 90 mmHg to 160 mmHg).

[0114] Fig.11 Provides a default and / or static form 1105 (in Fig.11 ) and in expanded and / or expanded form 1107 (shown in solid lines in Fig.11 1100 is a top view of an example stent 1100 (shown using dashed lines in FIG. 1100 ). Stent 1100 can be configured to expand from a rest form 1105 to an expanded form 1107 in response to changes in pressure within and / or around a vessel and / or other anatomical structure in which stent 1100 is located.

[0115] 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 portion and / or a second end portion of the stent 1100. A middle portion of the stent 1100 may form an inner lumen 1130 (e.g., between the support arms 1120 of the middle portion). In some examples, the stent 1100 may have a generally elliptical and / or pill-shaped form in the resting form 1105, wherein one or more end portions of the stent 1100 form rounded edges 1104 (e.g., minor sides 504a, 504b of FIG. 5 ), and / or wherein one or more end portions and / or the middle portion form generally straight sides 1102 (e.g., major sides 502a, 502b of FIG. 5 ).

[0116] When stent 1100 experiences a change in pressure, stent 1100 can be configured to assume a more curved and / or generally circular expanded form 1107. Fig.11 , the expanded form 1107 can extend the support arm 1120 to extend across a greater width of the stent 1100. The extension of the support arm 1120 can be achieved by forming a bend and / or navigation of the struts of the stent 1100 and / or by reducing the length of the middle portion of the stent 1100.

[0117] 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 an expanded form 1107 in response to an increase in aortic blood pressure (e.g., during systole). Thus, the stent 1100 may present a more circular cross-section, which may increase the cross-sectional area of ​​the stent 1100 (e.g., by bending and / or movement of the struts of the stent 1100) while generally maintaining the circumference of the stent 1100. The increase in cross-sectional area may facilitate absorption of the pulsating electrical shock of systole. After systole, the stent 1100 and / or the blood vessel may return to the relaxed form 1105 and / or the generally elliptical shape. Returning to the relaxed form 1105 may force blood through the aorta. Thus, the blood pressure pulse through the aorta may be smoothed to mimic the performance of a more compliant aorta.

[0118] The stent 1100 portion may have a generally non-circular (e.g., elliptical) shape with a major axis 26a and a minor axis 28a in a rest and / or default form 1105. When blood pressure in the vessel 11 increases, the stent 700 may be configured to allow blood to pass through the lumen 710 and / or to press against the vessel wall 12. During periods of increased pressure, the stent 700 may be configured to compress at least partially along the major axis 26a of the stent 1100, such that the stent 1100 assumes a less elliptical / more circular shape of the expanded form 1107, wherein the major axis 26b may be shorter than it was prior to the increase in blood pressure, and / or the vessel 11 may have a larger cross-sectional area than in the more elliptical shape of FIG. 7 .

[0119] Although the struts forming the stent 1100 may be at least partially flexible and / or deformable to enable the cross-sectional area of ​​the stent 1100 to be changed, the struts may at least partially resist shape change. For example, if the stent 1100 is too responsive (e.g., too flexible), the stent 1100 may not be able to adequately resist the increase in blood pressure during systole, and / or may change shape prematurely. Therefore, the struts may be configured to bend and / or change shape in response to pressure exceeding a threshold amount. In some instances, the struts may be thickened, however, the thickening of the struts may increase the stress on the material of the struts when the struts are bent.

[0120] The middle portion of the stent 1100 can be configured to extend at least partially across the lumen 1110 of the stent 1100 to form a support arm and / or chord of the stent 1100. Thus, the middle portion can provide increased resistance to cyclization, and / or can increase the force that pulls the stent 1100 back to the relaxed form 1105 after cardiac contraction.

[0121] At least a portion of the middle portion (e.g., support arm 1120) may be formed of tension springs and / or struts having a more curved shape to provide increased spring behavior to the support arm extending across the lumen 1110 of the stent 1100. The tension springs of the support arms may be tuned (e.g., through their geometry and / or heat treatment using the struts) to allow the support arms to have spring behavior at least partially independent of the tubular geometry of the stent 1100. In some examples, the support arms may and / or other struts of the stent 1100 may be at least partially formed of one or more shape memory alloys (e.g., nitinol) to allow the support arms to have relatively high resistance until a threshold blood pressure level is reached and / or to allow movement from the relaxed form 1105 to the expanded form 1107 when the threshold blood pressure level is reached. For example, the stent 1100 may be configured to not immediately move from the relaxed form 1105 to the expanded form 1107 at a given point during systole and / or at the onset of systole. For example, the support arms may be tuned so that the martensitic stress is reached at a threshold blood pressure.

[0122] The elliptical shape of the stent 1100 in the relaxed form 1105 can provide a relatively high cross-sectional change along the minor axis of the stent 1100 between the relaxed form 1105 and the expanded form 1107. Most of the volume change of the stent 1100 can be applied above diastolic pressure and / or not immediately at the beginning of cardiac contraction. In some examples, the middle portion of the stent can include one or more biphasic springs.

[0123] The middle portion may have a generally hexagonal shape, such as Fig.11 As shown in . For example, the middle portion may extend at least partially along the first major side 1102a and / or the second major side 1102b, and / or multiple sets of two support arms 1120 may be formed at either end of the middle portion. The middle portion may include a first support arm 1120a and / or a second support arm 1120b, which are configured to extend to and / or form a point at or near the first secondary side 1104a of the bracket 1100. For example, the point formed by the first support arm 1120a and the second support arm 1120b may be generally in line and / or coplanar with the first secondary side 1104a formed by the first end portion and / or the second end portion of the bracket 1100. The middle portion may similarly include a set of two support arms 1120, which are formed at a point at or in line with the second secondary side 1104b, such as Fig.11 Thus, the middle portion can have a width that is substantially equal to the width of the first end portion and / or the second end portion of the stent 1100.

[0124] The first support arm 1120a and the second support arm 1120b may be interconnected and / or may extend into each other. In some examples, the joint between the first support arm 1120a and the second support arm 1120b at the first secondary side 1104a of the bracket may be connected to and / or extend into the rounded side of the first end portion and / or the second end portion of the bracket 1100 at the first secondary side 1104a. The first support arm 1120a and / or the second support arm 1120b may be generally angled and / or may extend from the first major side 1102a and / or the second major side 1102b, respectively, at a substantially 45 degree angle and / or may be angled to each other.

[0125] Various methods, elements and combinations thereof can be used to prevent the migration of stents and / or other devices according to the present invention. For example, endothelialization of the stent wall and / or protruding barbs can be used to fix the device to the vessel wall. In addition to and / or in place of such elements / techniques, the device of the present invention may include an anchor suitable for extending into a branch vessel / structure, which can be used to anchor the device in a main vessel in which the main stent body is deployed. For example, the device may include a main stent body (e.g., any one of the stent assemblies previously discussed in this application) suitable for deployment in the main vessel to provide compliance thereto, such as where the main stent body is suitable for changing from a smaller cross-sectional area to a larger cross-sectional area. The device may also have one or more anchors extending from the main stent body in a non-parallel manner. Specific anchors may each include an anchor stent body, which is suitable for deployment (e.g., via radial expansion) to contact with tissue (e.g., wall tissue) of a secondary vessel or other vascular structure, which can branch from the main vessel and / or otherwise extend generally laterally. Note that, depending on the particular application, 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. One or more anchors may preferably be positioned at a position that can be aligned with the accessory vessel / structure when the accessory vessel / structure branches / extends from the main vessel. In some instances, the anchor may be self-expanding or plastically deformable (e.g., via balloon expansion). Once expanded or otherwise deployed in contact with the tissue of the accessory vessel / structure, the anchor may form a generally circular lumen, an elliptical lumen, a peanut-shaped lumen, etc., and / or may be adapted to maintain a generally constant cross-sectional area, and / or may be adapted to change from a smaller cross-sectional area to a larger cross-sectional area configuration in response to blood flow.

[0126] According to one or more embodiments of the present disclosure, a stent includes: a mesh structure of elastically deformable struts, which forms a first end portion, a second end portion and a middle portion, wherein the middle portion is located between the first end portion and the second end portion and includes one or more support arms that at least partially extend across a lumen formed by the first end portion and the second end portion.

[0127] The first end portion can be configured to contact a vessel wall of a blood vessel. In some examples, the mesh structure of elastically deformable struts is configured to radially expand within the blood vessel into direct contact with the vessel wall from a first configuration to a second configuration, the first configuration defining a first major dimension, a first secondary dimension, a first cross-sectional area, a first cross-sectional shape, and a first perimeter of the stent wall, and the second configuration defining a second major 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 of the stent wall.

[0128] In some examples, the first major dimension is larger than the second major dimension. The first minor dimension may be smaller than the second minor dimension.

[0129] The first cross-sectional shape may include an elliptical shape.In some examples, the blood vessel is the aorta, and wherein the first circumference approximates or exceeds the circumference of the aorta.

[0130] In some examples, one or more support arms include a tension spring configured to increase in length.The first end portion may be generally elliptical, and a length of the first end portion along a major axis may be greater than a width of the first end portion along a minor axis.

[0131] The first end portion can be configured to deform in response to blood flow such that a length of the first end portion is at least partially reduced and a width of the first end portion is at least partially increased. In some examples, the second end portion is generally elliptical and a length of the second end portion along a major axis is greater than a width of the second end portion along a minor axis.

[0132] In some examples, the second end portion is configured to deform in response to blood flow such that a length of the second end portion at least partially decreases and a width of the second end portion at least partially increases.The middle portion may be generally elliptical.

[0133] The middle portion can be generally rectangular. In some examples, the length of the middle portion is less than the length of the first end portion, and the width of the middle portion is approximately equal to the width of the first end portion.

[0134] In some examples, the middle portion includes two support arms extending along the short axis and two side surfaces extending along the long axis. Each of the two side surfaces of the middle portion may be coplanar with the side surfaces of the first end portion and the second end portion.

[0135] The length of the middle portion may be approximately half the length of the first portion. In some examples, the length of the middle portion is approximately seventy-five percent of the length of the first portion.

[0136] In some examples, one or more support arms are configured to expand in response to an increase in blood pressure above a threshold amount.

[0137] The first portion may form a generally rounded end extending generally along the minor axis of the first portion. In some examples, the one or more support arms include multiple sets of two angled support arms at either end of the middle portion, the support arms being connected at a point coplanar with the rounded end of the first portion.

[0138] In some examples, the middle portion has a generally hexagonal shape.

[0139] Some embodiments of the present disclosure relate to a system for providing compliance to a native blood vessel. The system includes: a catheter including a catheter distal portion configured to be percutaneously advanced to a native blood vessel within a patient's vasculature; and a stent releasably secured to the catheter distal portion and forming a lumen extending between a first opening and a second opening of the stent, a first end portion having a first width, a second end portion having a width substantially equal to the first width, a middle portion having a width less than the first width, and one or more support arms extending at least partially across the lumen from the middle portion.

[0140] In some examples, the first end portion is configured to be secured to a vessel wall of a blood vessel. In some examples, the stent is configured to radially expand within the blood vessel into direct contact with the vessel wall from a first configuration to a second configuration, the first configuration defining a first major dimension, a first secondary dimension, a first cross-sectional area, a first cross-sectional shape, and a first perimeter of the stent wall, and the second configuration defining a second major 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 of the stent wall.

[0141] The first major dimension can be greater than the second major dimension.In some examples, the first cross-sectional shape includes an elliptical shape.

[0142] In some examples, the blood vessel is the aorta, and wherein the first circumference approximates or exceeds the circumference of the aorta.One or more support arms may include a tension spring configured to increase in length.

[0143] The first end portion can be generally elliptical, and the length of the first end portion along the major axis is greater than the width of the first end portion along the minor axis. In some examples, the first end portion is configured to deform in response to blood flow such that the length of the first end portion at least partially decreases and the width of the first end portion at least partially increases.

[0144] In some examples, the second end portion is generally elliptical, and the length of the second end portion along the major axis is greater than the width of the second end portion along the minor axis. The second end portion can be configured to deform in response to blood flow such that the length of the second end portion at least partially decreases and the width of the second end portion at least partially increases.

[0145] The middle portion may be generally oval.In some examples, the middle portion is generally rectangular.

[0146] In some examples, the length of the middle portion is less than the length of the first end portion, and the width of the middle portion is substantially equal to the width of the first end portion.The middle portion may include two support arms extending along the minor axis and two side surfaces extending along the major axis.

[0147] Each of the two sides of the middle portion may be coplanar with the sides of the first end portion and the second end portion.In some examples, the length of the middle portion is approximately half the length of the first portion.

[0148] The length of the middle portion may be approximately seventy-five percent of the length of the first portion.

[0149] In some examples, 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.

[0150] The one or more support arms may include sets of two angled support arms at either end of the middle portion, the support arms being coupled at points coplanar with the rounded end of the first portion.In some examples, the middle portion has a generally hexagonal shape.

[0151] Depending on the example, some actions, events or functions of any process or algorithm described in this article may be performed in a different order, may be added, combined or omitted entirely. Therefore, in some examples, not all described actions or events are necessary to practice the process.

[0152] Some examples

[0153] Example 1: A system for providing compliance to a natural blood vessel, the system comprising: a catheter including a catheter distal portion configured to be percutaneously advanced to the natural blood vessel within the patient's vasculature; and a stent releasably secured to the catheter distal portion and forming a lumen extending between a first opening and a second opening of the stent, a first end portion having a first width, a second end portion having a width approximately equal to the first width, a middle portion having a width less than the first width, and one or more support arms extending at least partially across the lumen from the middle portion.

[0154] Example 2: The system of Example 1, wherein the first end portion is configured to be fixed to a vessel wall of a blood vessel.

[0155] Example 3: A system according to Example 2, wherein the stent is configured to radially expand from a first configuration to a second configuration within a blood vessel into direct contact with the vessel wall, the first configuration defining a first major dimension, a first secondary 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 secondary dimension larger than the first secondary dimension, a second cross-sectional area larger than the first cross-sectional area, and a first circumference.

[0156] Example 4: The system of Example 3, wherein the first major dimension is greater than the second major dimension.

[0157] Example 5: The system of example 3 or example 4, wherein the first cross-sectional shape comprises an elliptical shape.

[0158] Example 6: The system of any one of Examples 3 to 5, wherein the blood vessel is the aorta, and wherein the first circumference approximates or exceeds the circumference of the aorta.

[0159] 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.

[0160] Example 8: The system of any of Examples 1-6, wherein the first end portion is generally elliptical, and a length of the first end portion along the major axis is greater than a width of the first end portion along the minor axis.

[0161] Example 9: The system of Example 8, wherein the first end portion is configured to deform in response to blood flow such that a length of the first end portion is at least partially reduced and a width of the first end portion is at least partially increased.

[0162] Example 10: The system of example 8 or example 9, wherein the second end portion is generally elliptical and a length of the second end portion along the major axis is greater than a width of the second end portion along the minor axis.

[0163] Example 11: The system of Example 10, wherein the second end portion is configured to deform in response to blood flow such that a length of the second end portion is at least partially reduced and a width of the second end portion is at least partially increased.

[0164] Example 12: The system of any of Examples 8 to 11, wherein the middle portion is generally elliptical.

[0165] Example 13: The system of any of Examples 8 to 12, wherein the middle portion is generally rectangular.

[0166] Example 14: The system of any of Examples 8-13, wherein the length of the middle portion is less than the length of the first end portion, and the width of the middle portion is approximately equal to the width of the first end portion.

[0167] Example 15: The system of Example 14, wherein the middle portion includes two support arms extending along the short axis and two sides extending along the long axis.

[0168] Example 16: The system of Example 15, wherein each of the two sides of the middle portion is coplanar with the sides of the first end portion and the second end portion.

[0169] Example 17: The system of any of Examples 8-16, wherein the length of the middle portion is approximately half the length of the first end portion.

[0170] Example 18: The system of any of Examples 8-17, wherein the length of the middle portion is approximately seventy-five percent of the length of the first end portion.

[0171] Example 19: The system of any of Examples 1 to 18, wherein one or more support arms are configured to expand in response to changes in blood flow.

[0172] Example 20: The system of any of Examples 1-19, wherein the first end portion forms a generally rounded end portion extending generally along a minor axis of the first end portion.

[0173] Example 21: The system of Example 20, wherein the one or more support arms include multiple sets of two angled support arms at either end of the middle portion, the support arms connected at a point coplanar with the rounded end of the first end portion.

[0174] Example 22: A system according to any of Examples 1 to 21, wherein the middle portion has a generally hexagonal shape.

[0175] Conditional language used herein, such as "may", "can", "could", "might", "for example", etc., unless otherwise expressly stated or otherwise understood in the context of use, is generally intended and generally intended to express that certain instances include certain features, elements and / or steps, while other instances do not include certain features, elements and / or steps. Therefore, such conditional language is generally not intended to imply that features, elements and / or steps are required for one or more instances in any case, or that one or more instances must include logic for determining whether these features, elements and / or steps are included in any particular instance or will be performed in any particular instance with or without author input or prompting. The terms "include", "comprise", "have", etc. are synonyms, used in their ordinary sense, and are used inclusively in an open-ended manner, and do not exclude additional elements, features, actions, operations, etc. In addition, the term "or" is used in a non-exclusive sense (and is not used in an exclusive sense), so that when, for example, a list of connected elements is used, the term "or" means one, some, or all of the elements in the list. Unless specifically stated otherwise, connective language used to express items, terms, elements, etc., such as the phrase "at least one of X, Y, and Z," is generally understood in the context to mean that, X, Y, or Z, can be, unless specifically stated otherwise. Thus, such connective language is generally not intended to imply that certain instances require that at least one of X, at least one of Y, and at least one of Z each be present.

[0176] It should be understood that in the above description of the examples, various features are sometimes grouped together in a single example, figure or description thereof for the purpose of simplifying the present disclosure and helping to understand one or more of the various inventive aspects. However, this method of the present disclosure should not be interpreted as reflecting the intention that any claim requires more features than the features clearly recorded in the claim. In addition, any parts, features or steps shown and / or described in the specific examples herein can be applied to any other example or used together with any other example. In addition, for each example, no component, feature, step or group of components, features or steps is necessary or indispensable. Therefore, it is expected that the scope of the present invention disclosed herein and claimed below should not be limited by the specific examples described above, but should only be determined by clearly reading the attached claims.

[0177] Each element of each example disclosed herein and its corresponding element can be used together with any other example disclosed herein and its corresponding element. All dimensions listed are examples, and the device according to the present invention may have dimensions outside these specific values ​​and ranges. The size and shape of the device and its elements depend on the specific application. Unless otherwise indicated, all technical and scientific terms used herein have the same meaning as those generally understood by those of ordinary skill in the art to which the present disclosure belongs. In order to facilitate the review of various examples of the present disclosure, the following term explanations are provided:

[0178] Unless the context clearly indicates otherwise, the singular terms "a", "an", and "the" include plural referents. Unless the context clearly indicates otherwise, the term "or" refers to a single element of the stated alternative elements, or a combination of two or more elements. The term "comprising" means "including". For example, a device that comprises or includes A and B contains A and B, but may optionally contain C or other components in addition to A and B. In addition, a device that comprises or includes A or B may contain A or B or A and B, and optionally one or more other components, such as C.

[0179] The term "subject" refers to both humans and other animal subjects. In certain instances, the subject is a human or other mammal, such as a primate, cat, dog, cow, horse, rodent, sheep, goat or pig. In a specific instance, the subject is a human patient.

[0180] Although methods similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, suitable methods and materials are described below. In the event of a conflict, the present specification including the term shall prevail. In addition, the materials, methods and examples are illustrative only and are not intended to be limiting.

[0181] In view of the many possible examples to which the principles of the disclosed invention may be applied, it should be recognized that the examples shown are merely examples of the invention and should not be considered to limit the scope of the invention. Instead, the scope of the invention is defined by the following claims. Therefore, we claim as our invention all that is within the scope and spirit of these claims.

Claims

1. A bracket, comprising: A network of elastically deformable struts forming: a first end portion; a second end portion; as well as A middle portion is located between the first end portion and the second end portion and includes one or more support arms extending at least partially across a lumen formed by the first end portion and the second end portion.

2. The stent of claim 1, wherein the first end portion is configured to contact a vessel wall of a blood vessel.

3. The stent of claim 2, wherein the mesh structure of the elastically deformable struts is configured to radially expand within the blood vessel from a first configuration to a second configuration into direct contact with the blood vessel wall, the first configuration defining a first major dimension, a first secondary 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 secondary dimension greater than the first secondary dimension, a second cross-sectional area greater than the first cross-sectional area, and the first circumference. The stent of claim 3 , wherein the first major dimension is greater than the second major dimension.

5. A stent according to claim 3 or claim 4, wherein the first secondary dimension is smaller than the second secondary dimension.

6. The stent of any one of claims 3 to 5, wherein the first cross-sectional shape comprises an elliptical shape.

7. The stent according to any one of claims 3 to 6, wherein the blood vessel is the aorta, and wherein the first circumference approximates or exceeds the circumference of the aorta.

8. The stand of any one of claims 1 to 7, wherein the one or more support arms comprise tension springs configured to increase in length.

9. The stent of any one of claims 1 to 8, wherein the first end portion is substantially elliptical, and a length of the first end portion along a major axis is greater than a width of the first end portion along a minor axis.

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

11. A stent according to claim 9 or claim 10, wherein the second end portion is substantially elliptical and the length of the second end portion along the major axis is greater than the width of the second end portion along the minor axis.

12. The stent of claim 11, wherein the second end portion is configured to deform in response to blood flow such that the length of the second end portion is at least partially reduced and the width of the second end portion is at least partially increased.

13. A stent according to any one of claims 9 to 12, wherein the intermediate portion is generally oval.

14. A stent according to any one of claims 9 to 13, wherein the intermediate portion is generally rectangular.

15. The stent of any one of claims 9 to 14, wherein the length of the middle portion is less than the length of the first end portion, and the width of the middle portion is substantially equal to the width of the first end portion.

16. The stent of claim 15, wherein the middle portion comprises two support arms extending along the minor axis and two side surfaces extending along the major axis.

17. The stent of claim 16, wherein each of the two sides of the middle portion is coplanar with sides of the first and second end portions.

18. A stent according to any one of claims 9 to 17, wherein the length of the middle portion is substantially half the length of the first end portion.

19. The stent of any one of claims 9 to 18, wherein the length of the middle portion is approximately seventy-five percent of the length of the first end portion.

20. The stent of any one of claims 1 to 19, wherein the one or more support arms are configured to expand in response to an increase in blood pressure above a threshold amount.

21. The stent of any one of claims 1 to 20, wherein the first end portion forms a generally rounded end portion extending generally along a minor axis of the first end portion.

22. A bracket according to claim 21, wherein the one or more support arms include multiple groups of two angled support arms at either end of the middle portion, and the support arms are connected at points that are coplanar with the rounded end of the first end portion.

23. The stent of any one of claims 1 to 22, wherein the intermediate portion has a generally hexagonal shape.

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