Stent adhesion and anchoring

Abstract

A device may include a sleeve sized to approximate a size of the blood vessel and adhere to the blood vessel. The sleeve can include one or more first attachment features. A device may include a stent having a network of elastically deformable struts forming a scaffold being biased in a non-circular axial cross-sectional shape. The stent can have one or more second attachment features that align with or mate with the one or more first attachment features while the sleeve is adhered to the blood vessel.

Description

Attorney Docket No.: ADV-24177WO01STENT ADHESION AND ANCHORINGRELATED APPLICATIONS 1

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 685,924, filed on August 22, 2024, the complete disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND

[0002] The present disclosure generally relates to the field of medical implant devices, including compliance-enhancing implant devices. Adhering such implant devices to surrounding tissue can affect the efficacy of such implant devices in various respects.SUMMARY

[0003] Described herein are devices, methods, and systems relating to compliant and / or peel-resistant sleeves and / or coverings for medical implant devices.

[0004] Some implementations of the present disclosure relate to an implant device including: a stent having a biased non-circular axial cross-sectional shape; a sleeve coupled to the stent and extending beyond the stent to form a first cuff beyond a first end of the stent; and a covering at least partially enclosing the stent and the sleeve.

[0005] In some examples, the stent includes struts forming cells. The stent may include one or more coils. In some examples, an end portion of the first cuff forms one or more peaks and one or more valleys.

[0006] The sleeve may have variable flexibility and increase in flexibility towards end portions of the sleeve. In some examples, the covering is at least partially composed of different material than the sleeve and is more rigid than the sleeve.

[0007] In some examples, the biased non-circular shape of the stent has a major-axis dimension and a minor-axis dimension, the major-axis dimension being greater than the minor-axis dimension. The biased non-circular shape may be an oval shape. In some examples, the biased non-circular shape is a peanut shape.

[0008] Some implementations of the present disclosure relate to a method including: deploying a sleeve in a target blood vessel segment; expanding the sleeveAttorney Docket No.: ADV-24177WO01 into contact with a wall of the target blood vessel segment to attach the sleeve to the wall of the target blood vessel segment; deploying a stent within the sleeve, the stent having a non-circular relaxed shape; and expanding the stent into contact with the sleeve to attach the stent to the sleeve.

[0009] In some examples, the method further includes maintaining the sleeve in an expanded form for a period of time sufficient to allow tissue overgrowth to couple the sleeve to a wall of the target blood vessel segment. Said expanding the sleeve may be performed using a balloon device disposed within a channel of the sleeve. In some examples, said expanding the stent is performed using a balloon device disposed within a channel of the sleeve.

[0010] The method may further include advancing the sleeve and the stent to the target blood vessel segment in a transcatheter delivery system. In some examples, the sleeve has a greater length relative to the stent. The sleeve may include a covering at least partially enclosing the sleeve.

[0011] In some examples, the covering is at least partially composed of different material than the sleeve and is more rigid than the sleeve. The method may further include delivering adhesive to the sleeve to attach the sleeve to the wall of the target blood vessel segment. In some examples, the stent includes struts forming cells. The stent may include one or more coils.

[0012] For purposes of summarizing the disclosure, certain aspects, advantages, and novel features have been described. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular example. Thus, the disclosed examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0013] Any of the example methods and structures disclosed herein for treating a patient also encompass analogous methods and structures performed on or placed on a simulated patient, which is useful, for example, for training; for demonstration; for procedure and / or device development; and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. A simulation can include a simulation of all or a portion of a patient, for example, an entire body, a portion of a body (e.g., thorax), a system (e.g., cardiovascular system), an organ (e.g., heart), or any combination thereof. Physical elements can be natural, including humanAttorney Docket No.: ADV-24177WO01 or animal cadavers, or portions thereof; synthetic; or any combination of natural and synthetic.

[0014] Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Various examples are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed examples can be combined to form additional examples, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements.

[0016] Figure 1 shows example cardiac and vascular anatomy.

[0017] Figures 2A and 2B show side and axial cross-sectional views, respectively, of a compliant blood vessel experiencing compliant expansion and contraction over a cardiac cycle.

[0018] Figure 3-1 shows an example blood vessel having a generally circular cross-sectional shape.

[0019] Figure 3-2 shows the blood vessel having a shape that resembles an oval / ellipse.

[0020] Figures 4A and 4B show perspective and axial views, respectively, of a non-circular stent.

[0021] Figure 5 illustrates a compliance implant disposed within a blood vessel.

[0022] Figures 6A and 6B illustrate an example implant configured to improve compliance of a blood vessel.

[0023] Figures 7A and 7B illustrate an example implant deployed within a blood vessel.

[0024] Figures 8A and 8B illustrate an example implant deployed within a blood vessel.Attorney Docket No.: ADV-24177WO01

[0025] Figure 9 illustrates an example implant configured to improve compliance of one or more blood vessels.

[0026] Figure 10 illustrates a compliance-enhancing implant deployed within a blood vessel and configured to improve compliance at the blood vessel.

[0027] Figure 11 provides a flowchart for an example process of deploying and / or using one or more implants described herein.

[0028] Figure 12 provides a perspective view of a non-circular stent having increased flexibility in accordance with one or more examples.

[0029] Figures 13A-13C provide side views of an expansion process of a stent 1300 in accordance with one or more examples.

[0030] Figure 14 provides a cross-sectional side view of another example stent in accordance with one or more examples.

[0031] Figure 15 provides a cross-sectional front view of another example stent 1500 in accordance with one or more examples.

[0032] Figures 16A and 16B provide cross-sectional side views of another example stent in accordance with one or more examples.

[0033] Figure 17 provides a perspective view of another example stent in accordance with one or more examples.

[0034] Figure 18 provides a cross-sectional side view of a delivery system 1800 in accordance with one or more examples.

[0035] Figure 19 provides a cross-sectional side view of another example stent 1900 in accordance with one or more examples.

[0036] Figure 20 provides a cross-sectional side view of an example implant including a stent in accordance with one or more examples.

[0037] Figures 21A and 21B illustrate an example implant including a stent in accordance with one or more examples.

[0038] Figures 22A and 22B provide isolated front views of interlocking and / or aligning components of a stent and / or sleeve in accordance with one or more examples.

[0039] Figure 23 provides a provides a front view of an implant including a stent and a sleeve in accordance with one or more examples.

[0040] Figure 24 provides a provides a front view of an implant including a stent and a sleeve in accordance with one or more examples.Attorney Docket No.: ADV-24177WO01

[0041] Figure 25 provides a provides a front view of an implant including a stent and a sleeve in accordance with one or more examples.

[0042] Figure 26 provides a provides a front view of an implant including a stent and a sleeve in accordance with one or more examples.

[0043] Figure 27 provides a provides a perspective view of an implant including a stent and a sleeve in accordance with one or more examples.

[0044] Figures 28A and 28B provide front views of an implant including a stent and a sleeve in accordance with one or more examples.

[0045] Figure 29 provides a flowchart for an example process of deploying and / or using one or more implants described herein.

[0046] Figure 30 provides a flowchart illustrating an example process for adhering an implant to a blood vessel, in accordance with one or more examples.

[0047] Figure 31 illustrates an example implant deployed within a blood vessel in accordance with one or more examples.

[0048] Figure illustrates an implant expanded into contact with walls of a blood vessel in accordance with one or more examples.

[0049] Figure 33 illustrates an implant adhered to a blood vessel in accordance with one or more examples.

[0050] Figure 34 illustrates an example implant for adhering to a blood vessel in accordance with one or more examples.

[0051] Figures 35 illustrates an example docking device (e.g., dock) for docking one or more implants in accordance with one or more examples.

[0052] Figure 36 provides a cross-sectional view of a docking device in accordance with one or more examples.

[0053] Figure 37 provides a flowchart illustrating an example process for adhering a dock (e.g., docking device) to a blood vessel, in accordance with one or more examples.

[0054] Figure 38 illustrates an example dock deployed within a blood vessel 61 in accordance with one or more examples.

[0055] Figure 39 illustrates a dock expanded into contact with walls of a blood vessel 61 in accordance with one or more examples.

[0056] Figure 40 illustrates a dock adhered to a blood vessel in accordance with one or more examples.Attorney Docket No.: ADV-24177WO01

[0057] Figure 41 illustrates another example dock in accordance with one or more examples.

[0058] Figures 42A and 42B illustrate an implant and / or delivery system for delivering adhesive to one or implants in accordance with one or more examples.

[0059] Figure 43 provides a perspective view of delivery system(s) following delivery of adhesive in accordance with one or more examples.

[0060] Figure 44 provides a front view of an implant and delivery system(s) within a blood vessel in accordance with one or more examples.DETAILED DESCRIPTION

[0061] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0062] Although certain preferred examples are disclosed below, it should be understood that the inventive subject matter extends beyond the specifically disclosed examples to other alternative examples and / or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. V arious operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain examples; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not necessarily all such aspects or advantages are achieved by any particular example. Thus, for example, various examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0063] Certain reference numbers are re-used across different figures of the figure set of the present disclosure as a matter of convenience for devices, components, systems, features, and / or modules having features that may be similar in one or more respects. However, with respect to any of the examples disclosed herein,Attorney Docket No.: ADV-24177WO01 re-use of common reference numbers in the drawings does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one having ordinary skill in the art may be informed by context with respect to the degree to which usage of common reference numbers can imply similarity between referenced subject matter. Use of a particular reference number in the context of the description of a particular figure can be understood to relate to the identified device, component, aspect, feature, module, or system in that particular figure, and not necessarily to any devices, components, aspects, features, modules, or systems identified by the same reference number in another figure. Furthermore, aspects of separate figures identified with common reference numbers can be interpreted to share characteristics or to be entirely independent of one another.

[0064] Where an alphanumeric reference identifier is used that comprises a numeric portion and an alphabetic portion (e.g., ‘10a,’ ‘10’ is the numeric portion and ‘a’ is the alphabetic portion), references in the written description to only the numeric portion (e.g., ‘10’) may refer to any feature identified in the figures using such numeric portion (e.g., ‘10a,’ ‘ 10b,’ ‘10c,’ etc.), even where such features are identified with reference identifiers that concatenate the numeric portion thereof with one or more alphabetic characters (e.g., ‘a,’ ‘b,’ ‘c,’ etc.). That is, a reference in the present written description to a feature ‘10’ may be understood to refer to either an identified feature ‘ 10a’ in a particular figure of the present disclosure or to an identifier ‘10’ or ‘10b’ in the same figure or another figure, as an example.

[0065] Certain standard anatomical terms of location are used herein to refer to the anatomy of animals, and namely humans, with respect to various examples. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms, are used herein to describe a spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s) / structures(s), as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the element(s) / structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element / structure described as “above” another element / structure may represent a position that is below or beside such other element / structure with respect to alternate orientations of the subjectAttorney Docket No.: ADV-24177WO01 patient or element / structure, and vice-versa. It should be understood that spatially relative terms, including those listed above, may be understood relative to a respective illustrated orientation of a referenced figure.Vascular Anatomy and Compliance

[0066] Certain examples are disclosed herein in the context of vascular implant devices, and in particular, implant devices including sleeves to prevent and / or resist peeling between the implant devices and surrounding tissue. Implant devices in accordance with the present disclosure may be implanted at least in part in, or configured for implantation at least in part in, any suitable or desirable blood vessels or other anatomy, which can include the aorta and / or inferior vena cava, among others.

[0067] Anatomy of the heart and vascular system is described below to assist in the understanding of certain inventive concepts disclosed herein. Figure 1 illustrates an example representation of a heart 1 and associated vasculature having various features relevant to one or more examples of the present inventive disclosure. The heart 1 includes four chambers, namely the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. In terms of blood flow, blood generally flows from the right ventricle 4 into the pulmonary artery via the pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole so that blood may be pumped toward the lungs and close during diastole to prevent blood from leaking back into the heart from the pulmonary artery 11. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs. The pulmonary artery 11 includes a pulmonary trunk and left and right pulmonary arteries that branch off of the pulmonary trunk, as shown.

[0068] The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 generally has three cusps / leaflets and may generally close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The mitral valve 6 generally has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole so that blood in the left atrium 2 can flow into the left ventricle 3, and, when functioning properly, closes during systole to prevent blood from leaking back into the left atrium 2. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow bloodAttorney Docket No.: ADV-24177WO01 leaving the left ventricle 3 to enter the aorta 12, and close during diastole to prevent blood from leaking back into the left ventricle 3. A wall of muscle 17, referred to as the septum, separates the left 2 and right 5 atria and the left 3 and right 4 ventricles.

[0069] The vasculature of the human body, which may be referred to as the circulatory system, cardiovascular system, or vascular system, contains a complex network of blood vessels with various structures and functions and includes various veins (venous system) and arteries (arterial system). Generally, arteries, such as the aorta 16, carry blood away from the heart, whereas veins, such as the inferior vena cava 19 and the superior venae cava 18, carry blood back to the heart.

[0070] The aorta 16 is a compliant arterial blood vessel that buffers and conducts pulsatile left ventricular output and contributes the largest component of total compliance of the arterial tree. The aorta 16 includes the ascending aorta 12, which begins at the opening of the aortic valve 7 in the left ventricle of the heart. The ascending aorta 12 and pulmonary trunk 11 twist around each other, causing the aorta 12 to start out posterior to the pulmonary trunk 11, but end by twisting to its right and anterior side. Among the various segments of the aorta 16, the ascending aorta 12 is relatively more frequently affected by aneurysms and dissections, often requiring open heart surgery to be repaired. The transition from ascending aorta 12 to aortic arch 13 is at the pericardial reflection on the aorta. At the root of the ascending aorta 12, the lumen has three small pockets between the cusps of the aortic valve and the wall of the aorta, which are called the aortic sinuses or the sinuses of Valsalva. The left aortic sinus contains the origin of the left coronary artery, and the right aortic sinus likewise gives rise to the right coronary artery. Together, these two arteries supply the heart.

[0071] As mentioned above, the aorta 16 is coupled to the heart 1 via the aortic valve 7, which leads into the ascending aorta 12 and gives rise to the innominate artery 27, the left common carotid artery 28, and the left subclavian artery 26 along the aortic arch 13 before continuing as the descending thoracic aorta 14 and further to the abdominal aorta 15. References herein to the aorta may be understood to refer to the ascending aorta 12 (also referred to as the “ascending thoracic aorta”), aortic arch 13, descending or thoracic aorta 14 (also referred to as the “descending thoracic aorta”), abdominal aorta 15, or other arterial blood vessel or portion thereof.

[0072] Arteries, such as the aorta 16, may utilize blood vessel compliance (e.g., arterial compliance) to store and release energy through the stretching of bloodAttorney Docket No.: ADV-24177WO01 vessel walls. The term “compliance” is used herein according to its broad and ordinary meaning, and may refer to the ability of an arterial blood vessel or prosthetic implant device to distend, expand, stretch, or otherwise deform in a manner as to increase in volume in response to increasing transmural pressure, and / or the tendency of a blood vessel (e.g., artery) or prosthetic implant device, or portion thereof, to recoil toward its original dimensions as transmural pressure decreases.

[0073] As referenced above, the systolic phase of the cardiac cycle is associated with the pumping phase of the left ventricle, while the diastolic phase of the cardiac cycle is associated with the resting or filling phase of the left ventricle. As shown in Figures 2 A and 2B, with proper arterial compliance, an increase in volume Av will generally occur in an artery when the pressure in the artery is increased from diastole to systole. As blood is pumped into the aorta 16 through the aortic valve 7, the pressure in the aorta increases and the diameter of at least a portion thereof expands. A first portion of the blood entering the aorta 16 during systole may pass through the artery during the systolic phase, while a second portion (e.g., approximately half of the total blood volume) may be stored in the expanded volume Av caused by compliant stretching of the blood vessel 16 from a non-expanded diameter d, to an expanded diameter de, thereby storing energy for contributing to perfusion during the diastolic phase. A compliant aorta may generally stretch with each heartbeat, such that the diameter of at least a portion of the aorta expands.

[0074] The tendency of the arteries to stretch in response to pressure as a result of arterial compliance may have a significant effect on perfusion and / or blood pressure in some patients. For example, arteries with relatively higher compliance may be conditioned to more easily deform than lower-compliance arteries under the same pressure conditions. Compliance (C) may be calculated using the following equation, where Av is the change in volume (e.g., in mL) of the blood vessel, and Ap is the pulse pressure from systole to diastole (e.g., in mmHg):

[0075] C = — Ap (1)

[0076] In older individuals and patients suffering from heart failure and / or atherosclerosis, compliance of the aorta and other arteries can be diminished to some degree or lost. Such reduction in compliance can reduce the supply of blood to the organs of the body due to the decrease in blood flow during diastole. Among the risks associated with insufficient arterial compliance, a significant risk presented in suchAttorney Docket No.: ADV-24177WO01 patients is a reduction in blood supply to the heart muscle itself. For example, during systole, generally little or no blood may flow in the coronary arteries and into the heart muscle due to the contraction of the heart which holds the heart at relatively high pressures. During diastole, the heart muscle generally relaxes and allows flow into the coronary arteries. Therefore, perfusion of the heart muscle relies on diastolic flow, and therefore on aortic / arterial compliance. Insufficient perfusion of the heart muscle can result in reduced cardiac output and / or elevated intra-cardiac pressures at rest or during stress. Systolic pressure in arteriosclerosis patients generally increases more than diastolic pressure, wherein less blood leaves the arterioles during diastole. Increases in peripheral resistance cause decreased peripheral run-off (i.e., reduced amount of blood leafing the arterioles), resulting in increases in arterial blood volume that can be detrimental to patient health.Blood- Vessel-Reshaping Stent Implants

[0077] The present disclosure relates to systems, devices, and methods for adding-back and / or increasing compliance in the aorta or other arterial (or venous) blood vessel(s) to provide improved perfusion of the heart muscle and / or other organ(s) of the body. Examples of the present disclosure can include support devices configured to reshape / circularize stents that, when implanted and freed from the reshaping / circularizing support(s) (e.g., support(s) dissolved or otherwise removed), are configured to decrease the cross-sectional area / volume of the blood vessel segment in which the stent is implanted during low-pressure conditions, such as diastole. Reshaping the blood vessel segment to a non-circular cross-sectional shape can serve to force blood through the blood vessel segment by pushing the blood through the vessel as the vessel volume reduces in connection with stent contraction induced by cyclical drops in blood pressure.

[0078] Stents of the present disclosure that have a biased non-circular shape (e.g., oval- and / or peanut-shaped) can advantageously be configured to reshape a target blood vessel segment to generate a differential cross-sectional area or volume of the target blood vessel (e.g., aorta) between high- and low-pressure phases of the cardiac cycle to facilitate perfusion. As described above, relatively non-compliant blood vessels generally may not be able to stretch to thereby lengthen the perimeter of the blood vessel in response to increased pressure conditions. Such inability to stretch can prevent compliant expansion of the blood vessel.Attorney Docket No.: ADV-24177WO01

[0079] As the stents associated with examples of the present disclosure produce complaint blood vessel volume change by manipulating / reshaping the native blood vessel walls, compliance can be increased in the target blood vessel without requiring blood vessel grafting or resection. Therefore, compared to blood flow solutions involving blood vessel grafting / resection, examples of the present disclosure can provide a compliance-enhancing solution that avoids the risks that may be associated with cutting of the vessel and / or devices grafted in / to such vessels, which may present risk of rupture and blood leakage outside of the circulatory system. Hazards associated with extravascular arterial blood leakage, such as within the abdominal and / or chest cavity, can include the risk of serious injury or death.

[0080] As described above, desirable diastolic flow in arterial blood vessels is enabled by the decrease in cross-sectional area / volume of the blood vessels when transitioning from higher-pressure conditions (e.g., systole) to lower-pressure conditions (e.g., diastole). Where the relevant blood vessel has become stiff and non- compliant, stretching / expanding and subsequent contraction / shrinking of the blood vessel to cause the desired change in area / volume of the blood vessel may be limited due to the perimeter / wall of the blood vessel being resistant to stretching. Examples of the present disclosure provide implants that cause a change in cross-sectional area / volume of a target blood vessel without requiring stretching in the blood vessel wall. Rather, such cyclical change in blood vessel area / volume can be achieved through manipulation of the shape (e.g., cross-sectional shape) of the target blood vessel, wherein a transition between blood vessel shapes occurring in response to changing pressure conditions can reduce and increase the area / volume of the blood vessel in a cyclical manner to promote more even flow of blood through the blood vessel throughout the cardiac cycle.

[0081] With respect to a blood vessel having a relatively fixed perimeter, wherein the blood vessel wall does not expand sufficiently due to stiffness and / or other factors of non-compliance, generally, the greatest area / volume of the blood vessel may be present / achieved when the blood vessel wall forms a circular cross- sectional shape, which may maximize the cross-sectional area and volume of the blood vessel. Figure 3-1 shows an example blood vessel 301 (identified as blood vessel 301a in Figure 3-1) having a generally circular cross-sectional shape, such that the area Acthereof is maximized for the given blood vessel wallAttorney Docket No.: ADV-24177WO01 perimeter / circumference Pa. In the circular configuration, the diameter dais substantially constant at every angle about the axis of the vessel.

[0082] Diverging from a circular cross-sectional shape can produce a cross-sectional area / volume for a blood vessel that is less than the maximum area Acshown in Figure 3-1. For example, Figure 3-2 shows the blood vessel 301 (identified as vessel 301b in Figure 3-2) having a shape that resembles an oval / ellipse, which produces the cross-sectional area Aothat is less than the area Acwith the same blood vessel wall / perimeter length Pa. The oval shape of the vessel 301b may have a major axis amhaving a dimension d. that is greater than a dimension db of the minor axis anthereof.

[0083] With further reference to Figures 3- 1 and 3-2, due to the area Aoof the oval vessel of Figure 3-1 being less than the area Acof the circular configuration shown in Figure 3-1, transitioning from the circular shape 301a to the non-circular shape 301b can provide a reduction in area / volume of the blood vessel 301, and therefore solutions that cause transitions between circular and non-circular blood vessel shapes between cardiac phases can provide compliance characteristics without the need for elasticity in the blood vessel wall tissue. For example, where a mechanism is implemented to cause a blood vessel to transition between circular and non-circular shapes in response to changing pressure conditions, such manipulation of the blood vessel shape can introduce volumetric change in the blood vessel in response to the typical changes in pressure experienced during the cardiac cycle, thereby increasing cardiac efficiency and reducing pulsatile load.

[0084] In view of the foregoing, examples of the present disclosure provide stent implant devices and associated processes configured to transition the shape / area of a blood vessel from circular / more-circular to non-circular / less-circular shapes, and vice versa, to enhance compliance with respect to the area of the implant reshaping. Such stent implant devices / processes may effect vessel reshaping through dynamic reshaping of the structural shape of the stent in a way that produces a change in shape of the blood vessel in which it is implanted to produce a change in blood vessel area / volume between the systolic and diastolic phases of the cardiac cycle.

[0085] Examples of the present disclosure provide for stent-type implants that are biased to a non-circular cross-sectional area, such that, in a relaxed / non- pressurized state, a first diameter of the stent has a greater dimension along a major axis compared to a second diameter of the stent along a minor axis, wherein suchAttorney Docket No.: ADV-24177WO01 stents are configured to transition to a more-circular shape when pressure within the blood vessel overcomes the non-circular bias of the stent and causes the stent walls to be pushed to the more-circular configuration. The ability of stent implant devices of the present disclosure to reshape the target blood vessel in the manner described above to produce the desired oval cross-section of the blood vessel can be achievable due to stiff / non-compliant blood vessels, which may be unable to stretch to a substantial degree, still retaining the ability to bend to a sufficient degree to allow for such shaping of the blood vessel. That is, the bending stiffness of a non-compliant blood vessel may be relatively lower compared to the stretching stiffness thereof. Therefore, examples of the present disclosure achieve compliance through bending energy with respect to the blood vessel wall, as opposed to stretching energy. When stents of the present disclosure are forced to a circular, or relatively more-circular, axial cross-sectional shape, energy may be stored in the shape memory of the walls of the stent, wherein recoil / contraction of the stent towards its biased, oval / non-circular configuration can retum / release energy to the blood circulation. The term “stent” is used herein in accordance with its broad and ordinary meaning and may refer to any device configured to be implanted in a lumen of a blood vessel, the device having a tubular form forming a lumen through which blood can flow.

[0086] Figures 4A and 4B show perspective and axial views, respectively, of a non-circular stent 400 in accordance with one or more examples. The stent may be deployable within a blood vessel lumen. However, it should be understood that example stent devices of the present disclosure may alternatively or additionally be deployable in a position around an outer surface of a target blood vessel. Although not shown for clarity in the figures of the present disclosure, it should be understood that example stents described herein may comprise one or more hooks, barbs, and / or other attachment features / means adapted to facilitate secure attachment of the stent to the tissue of the target blood vessel wall. The description of the stent 400 may be understood to relate to, and / or describe aspects of, any of the stents described herein, wherein such stents can be associated with circularizing / shaping support devices / structures; that is, description of aspects of any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure.Attorney Docket No.: ADV-24177WO01

[0087] The stent 400 may be formed of a tubular frame 431, which may form a wall around an axial channel 449, thereby defining the channel 449. The stent 400 may be an elongate / elongated stent, in that a length L of the stent is greater than a minor diameter dmin and / or maximum diameter dmaj of the stent. As described herein, the frame wall 431 of the stent 400 can be considered a single, circumferentially- wrapped wall, or may be considered to comprise multiple walls, or wall segments. For example, with respect to oval stents and other non-circular stents, as illustrated in Figures 4A and 4B, such stents may be considered to comprise sidewall segments 425 that run along relatively long sides of the stent that are aligned generally with the orientation of the major axis / dimension Amaj of the stent, as well as end wall segments 427, which may connect the side walls 425 on major-axis ends of the stent 400. The end walls 427 may be outwardly-curved / concave with respect to an axis Asof the stent 400. The sidewalls 425 may bow / deflect outward, either in a resting, unpressurized state, or in conditions of hoop / wall stress on the frame 431. For example, the sidewalls 425 may bow outward such that the sidewalls 425 are concave from the perspective of the axis Asof the stent 400 and convex from the perspective of the exterior of the stent 400.

[0088] Certain stent shapes are described herein, including non-circular-, oval-, peanut-, and other-shaped stents. It should be understood that such description of stent shapes refers to a shape of an axial cross-section of a stent, as depicted in the view of Figure 4B. Although oval- and peanut-shaped stents are described, it should be understood that the principles of the present disclosure may relate to stents having any non-circular shape in at least some configurations thereof (e.g., in a relaxed / biased configuration), and circularizing / reshaping supports of the present disclosure may be configured to circularize stents having non-circular shapes that are other than the illustrated oval- and peanut- shaped stents. Descriptions of stents in a relaxed or biased configuration should be understood to relate to a configuration that a stent naturally assumes in the absence of tension on the stent wall(s) from external forces (e.g., ambient fluid pressure, physical contact forces, etc.). For example, the biased / relaxed shape of the stent may be due to shape memory of the stent and / or frame thereof.

[0089] The stent 400 may be considered an oval stent with respect to the shape of the axial cross-section thereof, as shown in Figure 4B. The term “oval’" is used herein according to its broad and ordinary meaning and may be usedAttorney Docket No.: ADV-24177WO01 substantially interchangeably with the term “ellipse” and / or “oblong,” which terms are likewise used according to their broad and ordinary meanings. The term “oval” may be used to refer to any non-circular closed curve having major and minor axes, the major axis being greater than the minor axis. With respect to “oval”-shaped stents disclosed herein, such stents may have relatively flatter minor-axis sidewalls (compared to curved major-axis end walls), wherein the sidewalls may bow radially outward, and / or may be deflected / curved radially inward so as to produce external concavity and internal convexity in such sidewalls (e.g., forming a peanut-shaped stent). Major-axis walls of an oval stent as described herein may be considered wall portions of a stent that are intersected by a major axis of the stent that runs through an axial center of the stent. Minor-axis walls of such oval stents may be considered wall portions that are intersected by a minor axis of the stent that runs through the axial center of the stent. Example stents of the present disclosure may be considered to have an oval shape whether or not the shape thereof is definable by an algebraic curve. Example stents of the present disclosure may be considered oval stents when the wall(s) of the stent in an axial-cross-sectional perspective form(s) a closed or open curve in a plane Psthat is non-circular; one or more segments / areas thereof may resemble the outline of a portion of an egg. Oval stents of the present disclosure may include either one or two axes of symmetry of an ellipse, such as the illustrated major Amaj and minor Amin axes. The axial cross-section of some examples of oval stents of the present disclosure may resemble the union of two semicircles on opposite sides of a rectangle, providing a shape evoking the likeness of a speed skating rink or an athletics track. In some contexts, the oval stent 400 may be referred to as a “stadium”- shaped stent, or an elongated oval.

[0090] The stent frame 431 comprises stent wall(s) defining an elongated tubular structure having a first axial end 421a with a first opening 422a. The tubular structure may further comprise a second axial end 421b with a second opening 422b, wherein the lumen / channel 449 extends between the first opening 422a and the second opening 422b, traversing the length L of the stent 400. The frame 431 and / or wall(s) thereof may comprise an open-cell structure adapted to be expanded to secure the stent 400 to a blood vessel internal (or external) wall, such as through endothelialization of the frame 431 to the vessel tissue over time as the frame 431 is held in a generally-circular form by one or more circularizing / reshaping support structures, such as a circular stent and / or major-axis tether / tie.Attorney Docket No.: ADV-24177WO01

[0091] The stent 400 may be elastically deformable between a first, noncircular configuration and a second, more-circular configuration 400’ (see dashed-line representation in Figure 4B), with the stent 400 biased toward the non-circular configuration. In some examples, the stent frame 431 may comprise a shape-memory material, such as Nitinol. Although shown as an oval-shaped stent, the stent 400 may be any non-circular shape in a relaxed state thereof, such as a triangle, peanut, figure- 8, star, clover / lobed, and / or kidney shape.

[0092] The stent 400 may be configured to be percutaneously delivered to a blood vessel 61 in a compressed delivery configuration. Once within the blood vessel lumen at the target deployment site, the stent 400 may be configured to be radially expanded into direct surface contact with the blood vessel wall (e.g., the inner wall of an aorta segment). In some examples, the stent 400 may be configured to be expanded such that the perimeter of the stent 400 approximates and / or exceeds a perimeter of the blood vessel portion where the stent 400 is implanted, at least immediately prior to deployment / expansion of the stent. Placement of the stent 400 in the blood vessel may cause at least slight stretching in the blood vessel wall, such as due to pressure at the major-axis ends 427 against the blood vessel wall. In some cases, a stent configured to expand to a greater perimeter than the native blood vessel may provide improved traction and / or resistance to migration within the blood vessel. Implanting a stent that has a perimeter approximate to and / or slightly greater than the blood vessel perimeter may increase positive engagement with the blood vessel wall and / or maximize a compliance effect. The stent wall and / or a portion thereof may be configured to be endothelialized to the blood vessel wall.

[0093] In the oval configuration shown in Figures 4A and 4B, the stent 400 may have a cross-sectional area having a major / long-axis diameter dmaj that is substantially larger than the minor / short-axis diameter dmin- For example, the majoraxis diameter / dimension dmaj may advantageously be at least twice as long as the minor-axis diameter / dimension dmin, or even 3, 4, 4, 6, or 7 times greater. The stent 400 may be configured to increase compliance of a blood vessel though constant or near-constant pressure at one or more points along a perimeter / circumference of the blood vessel that causes a change in the perimeter geometry of the vessel. For example, the blood vessel may be changed and / or moved from a non-circular / less- circular shape to a circular / more-circular shape.Attorney Docket No.: ADV-24177WO01

[0094] The stent frame wall(s) 431 may be at least partially composed of struts 438 and / or stent openings / cells 435 between the struts 438. The dimensions and / or shape of the stent 400 may vary based on the particular application and / or target implantation anatomy. For example, the stent length L may be selected to extend over all or a portion of an identified non-compliant length of a target blood vessel. The stent major axis dmaj and minor axis dmin, when averaged, may be approximately equal to the diameter of the native blood vessel. For example, for a stent configured for deployment in an aorta, the length L may be between 1-30 cm, and in the biased oval / diastolic configuration the major axis dmaj may be between 1-4 cm (or larger / smaller depending on the particular anatomy), and the minor axis dmin can be between 20-50 percent of the major axis dmaj- However, other sizes and / or shapes are also within the scope of this disclosure.

[0095] The configuration of the stent 400 in the oval shape can cause blood vessel wall 61 to assume a more oval shape to match the shape of the stent 400. However, depending on the relative size of the stent 400 to the vessel 61, the blood vessel 61 may not necessarily conform exactly to the circumference and / or shape of the stent 400, and gap(s) 68 may be present and / or form between the frame 431 and the blood vessel wall 61 as the luminal pressure increases and pushes the vessel side walls away from the frame sidewall 425. Due to the presence of the gaps 68, which may form cyclically as the pressure drops (e.g., during diastole) and the stent transitions to the oval shape, such that the walls 425 pull farther away from the blood vessel wall, desirable sealing between the stent and the blood vessel may be impeded. The presence of the gaps 68 can reduce the ability of the stent 400 to reshape the blood vessel, thereby negatively impacting the efficacy of the stent 400 with respect to compliance-enhancement.

[0096] When implanted in a blood vessel, the patient physiology may respond to the stent 400 as a foreign object. For example, macrophages can accumulate around the stent, and nearby smooth muscle cells can proliferate to cover the stent. Over time, a new endothelial layer can form over the stent, which can inhibit clot formation. In addition to preventing thrombus formation, endothelialization can enhance the ability of the stent to reshape the target blood vessel by strengthening the physical coupling between the stent and the blood vessel, thereby reducing the presence of gaps forming between the stent and blood vessel wall when the stent walls pull away from the blood vessel wall as the stent reshapes to an oval / non-circularAttorney Docket No.: ADV-24177WO01 shape. Tissue overgrowth can be promoted through contact between the stent frame and the blood vessel walls. Examples of the present disclosure provide devices that facilitate contact between non-circular stent frames and blood vessel walls, thereby increasing the efficacy of the stents with respect to reshaping / compliance- enhancement.Compliant Implant Sleeves

[0097] Aspects of the present disclosure relate to sleeves and / or similar devices configured to improve performance and / or reliability of mechanical implants (e.g., stents) and / or vascular compliance restoration devices. A stent and / or other implant may be configured to act like a vascular “spring” configured to shape (e.g., ovalize) the vessel once implanted and / or move with the vessel (e.g., circularize) with increased systolic pressure. Such shape changes (e.g., oval-circle change) can increases volume change per cardiac cycle, which can help restore compliance to the vessel. Compliance can be equated to volume change divided by pressure change.

[0098] For a compliance implant (e.g., stent) to be effective, the blood vessel may be required to follow and / or move with the implant (e.g., at least an outer diameter of the implant) from diastole to systole. One way to achieve this is by adhering the outer diameter / surface and / or other portion of the stent to the inner diameter and / or surface of the blood vessel with mechanical means and / or adhesives. In some examples, an adhesive may be configured to form a seal such that when the blood pressure within the blood vessel increases, it can act on the implant inner diameter and / or outer diameter to circularize the implant.

[0099] In some examples, an implant may comprise a leak-proof membrane and / or a sponge-like cloth and / or material (e.g., covering) configured to contain and / or absorb the adhesive. Adhesive may be applied uniformly around the implant, membrane, and / or covering. The implant may be expanded and / or ballooned to a generally circular shape and / or cross-section to contact the inner surface of the blood vessel and / or to bond to it. By bonding the implant to the blood vessel, leak spaces along the implant (e.g., along a short axis of the implant) may be eliminated and / or minimized.

[0100] In some examples, the type of adhesives used can be fast-acting adhesives that are able to reach a non-fluidic or a nearly non- fluidic state in a short time frame (e.g., less than 5 seconds, less than 30 seconds, less than a minute, lessAttorney Docket No.: ADV-24177WO01 than 90 seconds). The complete cure time (e.g., bonding time) can be greater than its fixture time (e.g., its transition time from liquid to either a solid or highly viscous state). In some examples, the cure time and the fixture time are substantially the same (e.g., equal). An example of a fast-acting adhesive can be a cyanoacrylate (CA) adhesive (e.g., super glue). In some instances, an accelerator can be added to the adhesive such that the fixture and / or cure time is accelerated, and, alternatively, a retardant (e.g., a de- accelerator) can be added to the adhesive such that the fixture and / or cure time is de- accelerated. The need for a fast-acting adhesive is based on reducing the possibility of producing emboli (e.g., from adhesive droplets entering the bloodstream). One skilled in the art would appreciate that many different formulations can be derived based on at least the procedure time, the length of the administering catheter, the perfusion time of the adhesive in the stent, temperature (e.g., in transportation, in operating room, and during procedure (e.g., in the patient’s body)), pressure, etc. Any recitation of adhesive, glue or the like discussed in this application can be a fast-acting adhesive as described above.

[0101] Figure 5 illustrates a compliance implant 502 disposed within a blood vessel 501 in accordance with one or more examples. The implant 502 may comprise a stent as shown, for example, in Figure 4A. The implant 502 may comprise a covering configured to contain and / or absorb adhesive at the implant 502. Adhesive may be applied at and / or around the implant 502, for example at least partially along an outer surface and / or outer diameter of the implant 502.

[0102] In some examples, the implant 502 may be expanded and / or ballooned into contact with the blood vessel 501. The implant 502 may be configured to expand to a generally circular cross-sectional shape to assume a shape similar to the blood vessel 501. In some examples, one or more balloons and / or similar devices may be used to expand the implant 502. By expanding the implant 502 into contact with the blood vessel 501, adhesive at and / or around the implant 502 and / or blood vessel 501 may form a bond between the implant 502 and the blood vessel 501. The bonded implant 502 and blood vessel 501 may eliminate and / or minimize leak spaces and / or gaps between the implant 502 and the blood vessel 501. For example, a shape of the implant 502 at a short axis of the implant 502 may be susceptible to allowing blood flow around the implant 502 due, for example, to inwardly bent walls at the short axis of the implant 502.Attorney Docket No.: ADV-24177WO01

[0103] When the blood vessel 501 transitions between diastole and systole, the pressure change can expand portions of the blood vessel 501 not in contact with and / or not adhered to the implant 502. In some cases, the blood vessel501 can exert a concentrated peel force on the ends of the implant 502 and / or where the blood vessel 501 meets the implant 502. This peel force can cause the adhesive to delaminate with cyclical loading and / or create device failure as well as undesired stress on the native blood vessel 501 wall. In some cases, peel force may cause initial peeling at ends of the implant 502 (e.g., at an intersection point 511 between the stent502 and / or blood vessel 501) and / or can spread along a length of the implant 502 over time.

[0104] In cases where blood is allowed to pass between the implant 502 and the blood vessel 501, blood pressure may press inwardly against an outer surface of the implant 502. This inward pressure can prevent the implant 502 from expanding (e.g., to a generally circular form) with the blood vessel 501 (e.g., during systole). In order for the implant 502 to expand in response to increased pressure within the blood vessel 501, it may be advantageous for a delta of pressure to be formed wherein pressure within the implant 502 pressing the implant 502 outwardly into an expanded form exceeds pressure pressing the implant 502 into a compressed and / or oval shape. When blood pools between the implant 502 and the blood vessel 501, there can be equal or greater pressure pushing the implant 502 inward, which can prevent the stent from becoming circular with the blood vessel 501.

[0105] Figures 6A and 6B illustrate an example implant 602 configured to improve compliance of a blood vessel 601, in accordance with one or more examples. Figure 6A provides a perspective view of the implant 602. Figure 6B provides a front view and / or cross-sectional view of the implant 602 disposed within a blood vessel 601.

[0106] The implant 602 may comprise a stent 604 and / or wire frame similar to other stents and / or implants described herein. For example, the stent 604 may have an oval and / or peanut cross-sectional shape and / or may comprise inwardly- extending walls in a default and / or resting state of the stent 604. The stent 604 may be configured to change shape in response to blood pressure changes within a blood vessel. For example, the stent 604 may be configured to expand to a circular cross- sectional shape and / or near circular cross-sectional shape in response to increased blood flow and / or blood pressure through a lumen of the stent 604.Attorney Docket No.: ADV-24177WO01

[0107] The implant 602 may comprise a sleeve 605 configured to attach to the stent 604 and / or extend along an inner diameter / surface and / or outer diameter / surface of the stent 604. The sleeve 605 may comprise a sheet of material and / or can comprise one or more bands and / or distinct pieces of material. In some examples, the sleeve 605 may comprise a single piece and / or multiple pieces forming a tube and / or tubular shape. For example, the sleeve 605 may have a default circular cross-sectional shape. In some examples, the sleeve 605 may comprise multiple bands attached to each other.

[0108] The sleeve 605 may be composed of any suitable materials. In some examples, the sleeve 605 may have a generally flexible and / or elastic structure and / or may be configured to stretch and / or bend. The sleeve 605 may comprise a pericardial and / or similar tissue. In some examples, the sleeve 605 may be composed at least partially of a porous and / or similar material. The sleeve 605 may be composed of cloth and / or polymer.

[0109] The sleeve 605 may be composed of one or more generally stiff and / or generally flexible materials. In some examples, the sleeve 605 may have a variable and / or transitional stiffness and / or flexibility. For example, the sleeve 605 may be configured to increase in flexibility along a length of the sleeve 605 and / or towards the ends of the sleeve 605. That is, the sleeve 605 may be relatively more flexible at the ends of the sleeve 605 (e.g., at portions of the sleeve 605 that extend beyond the stent 604 and / or at free ends of the sleeve 605) than at a midsection of the sleeve 605 (e.g., at portions of the sleeve 605 disposed along and / or adjacent to the stent 604).

[0110] In some examples, the sleeve 605 may be configured to extend beyond ends of the stent 604. For example, the sleeve 605 may have a greater length relative to the stent 604. In some examples, the sleeve 605 may extend beyond the stent 604 at either end of the stent 604. For example, the sleeve 605 may form a first cuff 607 extending beyond a first end of the stent 604 and / or a second cuff 608 extending beyond a second end of the stent 604.

[0111] The sleeve 605 may be configured to attach and / or couple to the stent 604. For example, the sleeve 605 may be adhered to the stent 604 using one or more adhesives and / or glues. Similarly, the covering 610 may be coupled and / or adhered to the stent 604 and / or the sleeve 605 using adhesives and / or coupling mechanisms.Attorney Docket No.: ADV-24177WO01

[0112] In some examples, the implant 602 may comprise a covering 610 and / or multiple coverings configured to at least partially enclose the stent 604 and / or sleeve 605. The first cuff 607 and / or the second cuff 608 may extend beyond ends of the covering 610. In some examples, the covering 610 may have a tubular shape and / or circular cross-sectional shape.

[0113] In some examples, the first cuff 607 and / or the second cuff 608 may be configured to relieve peel stress at the implant 602. For example, the first cuff 607 and / or the second cuff 608 move form extensions of the stent 604 such that peeling force between the blood vessel and the implant 602 may be distributed along the sleeve 605 and / or the stent 604. The sleeve 605 and / or the stent 604 may be configured to pull in shear. For example, the sleeve 605 may be configured to pull generally in line with the stent 604 and / or in parallel with the stent 604. In this way, peeling force between the implant 602 and the blood vessel may be configured to form a shear load rather than a peel load. The cuffs may be configured to transition between the stent 604 and the blood vessel to convert peel force to shearing force.

[0114] The first cuff 607 and / or the second cuff 608 may have any suitable length. In some examples, the first cuff 607 and / or the second cuff 608 may have lengths less than a length of the stent 604. For example, the first cuff 607 and / or the second cuff 608 may each have a length that is approximately half a length of the stent 604. However, the first cuff 607 and / or the second cuff 608 may have lengths approximately equal to and / or greater than the length of the stent 604. In some examples, a length of the first cuff 607 may be approximately equal to a length of the second cuff 608. However, the first cuff 607 and the second cuff 608 may have different lengths. Lengths of the first cuff 607 and / or the second cuff 608 may alter the peeling force applied to any given point along the sleeve 605 and / or the stent 604. The longer the cuffs are, the less peeling force may be applied at the junction between the implant 602 and the blood vessel . However, it may be advantageous to shorten the cuffs as much as possible while minimizing peeling force.

[0115] In some examples, the sleeve 605 may couple to and / or extend along an outer surface and / or outer diameter of the stent 604. However, the sleeve 605 may couple to and / or extend along an inner surface and / or inner diameter of the stent 604. In some examples, the sleeve 605 may be configured to be disposed within a lumen of the stent 604 during delivery of the implant 602 into the blood vessel. In this way, the delivery profile of the implant 602 may be minimized and / or the sleeve 605Attorney Docket No.: ADV-24177WO01 may add no or minimal additional size to the implant 602 during delivery. For example, the sleeve 605 may be configured to fit into any gaps within the stent 604 while the stent 604 is in a crimped or compressed profile.

[0116] In some examples, the implant 602 may be configured to adhere to a blood vessel. For example, the covering 610, sleeve 605, and / or stent 604 may comprise one or more adhesives and / or coupling mechanisms configured to facilitate attachment to the blood vessel. In some examples, adhesive may be applied to the implant 602 prior to delivery of the implant 602 and / or following delivery of the implant 602. For example, adhesive may be delivered to the implant 602 via one or more access tubes and / or other delivery devices. In some examples, the implant 602 may comprise containers carrying adhesives configured to be released at the implant 602 following delivery of the implant 602.

[0117] The sleeve 605 and / or covering 610 may be configured to absorb and / or contain adhesives at the implant 602. For example, the covering 610 may be composed of an absorbent material configured to absorb and / or retain liquid adhesive at the implant 602. In some examples, the covering 610 may have a generally taut structure and / or may be configured to generally maintain its shape and / or resist reshaping due to pressure changes within the blood vessel. The covering 610 may have a generally non-compliant form and / or structure so as to limit strain in a coupling between the implant 602 and a blood vessel. However, the covering 610 may alternatively have a generally flexible structure and / or may be composed of generally flexible materials.

[0118] As shown in Figure 6B, the covering 610 and / or sleeve 605 may be configured to couple and / or adhere to the blood vessel 601 via an adhesive 615 and / or adhesive layer. Figure 6B provides a cross-sectional view of the implant 602 at a midsection of the implant 602, wherein the covering 610 is disposed between the sleeve 605 and the blood vessel 601. However, at the first cuff 607 and / or second cuff 608, the sleeve 605 may be configured to couple and / or adhere directly to the blood vessel 601 via an adhesive 615. While the implant 602 is shown having a circular cross-section in Figure 6A and Figure 6B, the stent 604 may be configured to assume a generally oval and / or peanut-shaped form and / or may be configured to pull the covering 610, sleeve 605, and / or blood vessel 601 into a compressed (e.g., oval and / or peanut) form, particularly during systole and / or low pressure.Attorney Docket No.: ADV-24177WO01

[0119] Figures 7A and 7B illustrate an example implant 702 deployed within a blood vessel 701 in accordance with one or more examples. Figure 7A provides a perspective view of the implant 702 within the blood vessel 701. Figure 7B provides a front view and / or cross-sectional view of a midsection of the implant 702 within the blood vessel 701. Figures 7A and 7B illustrate the implant 702 and blood vessel 701 in an expanded form (e.g., during systole).

[0120] The implant 702 may comprise a stent 704 and / or wire frame similar to other stents and / or implants described herein. For example, the stent 704 may have an oval and / or peanut cross-sectional shape and / or may comprise inwardly extending walls in a default and / or resting state of the stent 704. The stent 704 may be configured to change shape in response to blood pressure changes within the blood vessel 701. For example, the stent 704 may be configured to expand to a circular cross-sectional shape and / or near circular cross-sectional shape in response to increased blood flow and / or blood pressure through a lumen of the stent 704.

[0121] The implant 702 may comprise a sleeve 705 configured to attach to the stent 704 and / or extend along an inner diameter and / or outer diameter of the stent 704. The sleeve 705 may comprise a sheet of material and / or can comprise one or more bands and / or distinct pieces of material. In some examples, the sleeve 705 may comprise a single piece and / or multiple pieces forming a tube and / or tubular shape. For example, the sleeve 705 may have a default circular cross-sectional shape. In some examples, the sleeve 705 may comprise multiple bands attached to each other.

[0122] In some examples, the sleeve 705 may have a variable and / or transitional stiffness and / or flexibility. For example, the sleeve 705 may be configured to increase in flexibility along a length of the sleeve 705 and / or towards the ends of the sleeve 705. That is, the sleeve 705 may be relatively more flexible at the ends of the sleeve 705 (e.g., at portions of the sleeve 705 that extend beyond the stent 704 and / or at free ends of the sleeve 705) than at a midsection of the sleeve 705 (e.g., at portions of the sleeve 705 disposed along and / or adjacent to the stent 704).

[0123] In some examples, the sleeve 705 may be configured to extend beyond ends of the stent 704. For example, the sleeve 705 may have a greater length relative to the stent 704. In some examples, the sleeve 705 may extend beyond the stent 704 at either end of the stent 704. For example, the sleeve 705 may form a first cuff 707 extending beyond a first end of the stent 704 and / or a second cuff 708 extending beyond a second end of the stent 704.Attorney Docket No.: ADV-24177WO01

[0124] The sleeve 705 may be configured to attach and / or couple to the stent 704. For example, the sleeve 705 may be adhered to the stent 704 using one or more adhesives and / or glues. The implant 702 may comprise a covering 710 coupled and / or adhered to the stent 704 and / or the sleeve 705 using adhesives and / or coupling mechanisms.

[0125] In some examples, the implant 702 may comprise a covering 710 and / or multiple coverings configured to at least partially enclose the stent 704 and / or sleeve 705. The first cuff 707 and / or the second cuff 708 may extend beyond ends of the covering 710. In some examples, the covering 710 may have a tubular shape and / or circular cross-sectional shape.

[0126] The implant 702 is shown compressing the blood vessel 701 to a smaller diameter than portions of the blood vessel 701 beyond the implant 702. The implant 702 may be configured to adhere to and / or couple to the blood vessel 701 via one or more adhesives and / or anchors. The implant 702 may be configured to pull the blood vessel 701 inwardly due at least in part to inwardly biased walls of the implant 702 and / or stent 704 of the implant 702. For example, following adhesion of the implant 702 to the blood vessel 701, The implant 702 and / or stent 704 may be configured to assume a compressed form (e.g., an oval shape) and / or may be configured to pull the blood vessel 701 into the compressed form.

[0127] Beyond the stent 704, the blood vessel 701 may retain a natural shape (e.g., a generally circular cross-sectional shape). The first cuff 707 and / or the second cuff 708 may have a generally flexible and / or non-rigid structure such that the first cuff 707 and / or the second cuff 708 may present minimal resistance and / or compression force to the blood vessel 601. In some examples, the covering 710 may have a generally rigid and / or non-compliant structure such that the covering 710 may facilitate reshaping of the blood vessel 701 to the compressed form of the stent 704.

[0128] In some examples, the first cuff 707 and / or the second cuff 708 may be configured to relieve peel stress at the implant 702. For example, the first cuff 707 and / or the second cuff 708 move form extensions of the stent 704 such that peeling force between the blood vessel and the implant 702 may be distributed along the sleeve 705 and / or the stent 704. The sleeve 705 and / or the stent 704 may be configured to pull in shear. For example, the sleeve 705 may be configured to pull generally in line with the stent 704 and / or in parallel with the stent 704. In this way, peeling force between the implant 702 and the blood vessel may be configured toAttorney Docket No.: ADV-24177WO01 form a shear load rather than a peel load. The cuffs may be configured to transition between the stent 704 and the blood vessel to convert peel force to shearing force.

[0129] The first cuff 707 and / or the second cuff 708 may have any suitable length. In some examples, the first cuff 707 and / or the second cuff 708 may have lengths less than a length of the stent 704. For example, the first cuff 707 and / or the second cuff 708 may each have a length that is approximately half a length of the stent 704. However, the first cuff 707 and / or the second cuff 708 may have lengths approximately equal to and / or greater than the length of the stent 704. In some examples, a length of the first cuff 707 may be approximately equal to a length of the second cuff 708. However, the first cuff 707 and the second cuff 708 may have different lengths. Lengths of the first cuff 707 and / or the second cuff 708 may alter the peeling force applied to any given point along the sleeve 705 and / or the stent 704. The longer the cuffs are, the less peeling force may be applied at the junction between the implant 702 and the blood vessel. However, it may be advantageous to shorten the cuffs as much as possible while minimizing peeling force.

[0130] In some examples, the sleeve 705 may couple to and / or extend along an outer surface and / or outer diameter of the stent 704. However, the sleeve 705 may couple to and / or extend along an inner surface and / or inner diameter of the stent 704. In some examples, the sleeve 705 may be configured to be disposed within a lumen of the stent 704 during delivery of the implant 702 into the blood vessel. In this way, the delivery profile of the implant 702 may be minimized and / or the sleeve 705 may add no or minimal additional size to the implant 702 during delivery. For example, the sleeve 705 may be configured to fit into any gaps within the stent 704 while the stent 704 is in a crimped or compressed profile.

[0131] In some examples, the implant 702 may be configured to adhere to a blood vessel. For example, the covering 710, sleeve 705, and / or stent 704 may comprise one or more adhesives 715 and / or coupling mechanisms configured to facilitate attachment to the blood vessel. In some examples, adhesive may be applied to the implant 702 prior to delivery of the implant 702 and / or following delivery of the implant 702. For example, adhesive may be delivered to the implant 702 and / or fluid may be suctioned from around the implant 702 via one or more access tubes and / or other delivery devices. In some examples, the implant 702 may comprise containers carrying adhesives configured to be released at the implant 702 following delivery of the implant 702.Attorney Docket No.: ADV-24177WO01

[0132] The sleeve 705 and / or covering 710 may be configured to absorb and / or contain adhesives at the implant 702. For example, the covering 710 may be composed of an absorbent material configured configure to absorb and / or retain liquid adhesive at the implant 702. In some examples, the covering 710 may have a generally taut structure and / or may be configured to generally maintain its shape and / or resist reshaping due to pressure changes within the blood vessel. The covering 710 may have a generally non-compliant form and / or structure so as to limit strain in a coupling between the implant 702 and a blood vessel. However, the covering 710 may alternatively have a generally flexible structure and / or may be composed of generally flexible materials.

[0133] Figures 8A and 8B illustrate an example implant 802 deployed within a blood vessel 801 in accordance with one or more examples. Figure 8 A provides a perspective view of the implant 802. Figure 8B provides a front view and / or cross-sectional view of the implant 802. Figures 8A and 8B illustrate the implant 802 and blood vessel 801 in a relatively compressed form (e.g., during diastole). During diastole, compression of the blood vessel 801 may cause further compression of the implant 802.

[0134] The implant 802 may comprise a stent 804 and / or wire frame similar to other stents and / or implants described herein. For example, the stent 804 may have an oval and / or peanut cross-sectional shape and / or may comprise inwardly extending walls in a default and / or resting state of the stent 804. The stent 804 may be configured to change shape in response to blood pressure changes within the blood vessel 801. For example, the stent 804 may be configured to expand to a circular cross-sectional shape and / or near circular cross-sectional shape in response to increased blood flow and / or blood pressure through a lumen of the stent 804.

[0135] The implant 802 may comprise a sleeve 805 configured to attach to the stent 804 and / or extend along an inner diameter and / or outer diameter of the stent 804. The sleeve 805 may comprise a sheet of material and / or can comprise one or more bands and / or distinct pieces of material. In some examples, the sleeve 805 may comprise a single piece and / or multiple pieces forming a tube and / or tubular shape. For example, the sleeve 805 may have a default circular cross-sectional shape. In some examples, the sleeve 805 may comprise multiple bands attached to each other.

[0136] The sleeve 805 may be configured to attach and / or couple to the stent 804. For example, the sleeve 805 may be adhered to the stent 804 using one orAttorney Docket No.: ADV-24177WO01 more adhesives and / or glues. The implant 802 may comprise a covering 810 coupled and / or adhered to the stent 804 and / or the sleeve 805 using adhesives and / or coupling mechanisms. The implant 802 (e.g., sleeve 805 and / or covering 810) may be configured to couple to the blood vessel 801 via an adhesive layer 815.

[0137] In some examples, the sleeve 805 may be configured to extend beyond ends of the stent 804. For example, the sleeve 805 may have a greater length relative to the stent 804. In some examples, the sleeve 805 may extend beyond the stent 804 at either end of the stent 804. For example, the sleeve 805 may form a first cuff 807 extending beyond a first end of the stent 804 and / or a second cuff 808 extending beyond a second end of the stent 804.

[0138] Figure 9 illustrates an example implant 902 configured to improve compliance of one or more blood vessels, in accordance with one or more examples. The implant 902 may comprise a stent and / or wire frame similar to other stents and / or implants described herein. For example, the stent may have an oval and / or peanut cross-sectional shape and / or may comprise inwardly extending walls in a default and / or resting state of the stent.

[0139] The implant 902 may comprise a sleeve 905 configured to attach to the stent and / or extend along an inner diameter and / or outer diameter of the stent. The sleeve 905 may comprise a sheet of material and / or can comprise one or more bands and / or distinct pieces of material. In some examples, the sleeve 905 may comprise a single piece and / or multiple pieces forming a tube and / or tubular shape. For example, the sleeve 905 may have a default circular cross-sectional shape. In some examples, the sleeve 905 may comprise multiple bands attached to each other.

[0140] In some examples, the sleeve 905 may have a generally tubular and / or cylindrical shape. However, the sleeve 905 may be composed of generally flexible material(s) and / or may be configured to conform to other shapes and / or forms. The sleeve 905 may be composed of any suitable materials. In some examples, the sleeve 905 may have a generally flexible and / or elastic structure and / or may be configured to stretch and / or bend. The sleeve 905 may comprise a pericardial and / or similar tissue. In some examples, the sleeve 905 may be composed at least partially of a porous and / or similar material. The sleeve 905 may be composed of cloth and / or polymer.

[0141] The sleeve 905 may be composed of one or more generally stiff and / or generally flexible materials. In some examples, the sleeve 905 may have aAttorney Docket No.: ADV-24177WO01 variable and / or transitional stiffness and / or flexibility. For example, the sleeve 905 may be configured to increase in flexibility along a length of the sleeve 905 and / or towards the ends of the sleeve 905. That is, the sleeve 905 may be relatively more flexible at the ends of the sleeve 905 than at a midsection of the sleeve 905.

[0142] In some examples, the implant 902 may comprise a covering 910 and / or multiple coverings configured to at least partially enclose the stent and / or sleeve 905. The covering 910 may be coupled and / or adhered to the stent and / or the sleeve 905 using adhesives and / or coupling mechanisms.

[0143] In some examples, the sleeve 905 may be configured to extend beyond ends of the stent and / or covering 910. For example, the sleeve 905 may have a greater length relative to the covering 910. In some examples, the sleeve 905 may extend beyond the covering 910 at either end of the covering 910. For example, the sleeve 905 may form a first cuff 907 extending beyond a first end of the stent 904 and / or a second cuff 908 extending beyond a second end of the stent 904.

[0144] The first cuff 907 and / or the second cuff 908 may form generally circular cross-sectional shapes along the first cuff 907 and / or the second cuff 908. However, shapes of the first cuff 907 and / or the second cuff 908 may be variable along lengths of the first cuff 907 and / or the second cuff 908. For example, ends 912 of the first cuff 907 and / or the second cuff 908 may have different cross-sectional shapes than other sections and / or portions of the sleeve 905. In some examples, the first cuff 907 and / or the second cuff 908 may comprise ends 912 having wavy and / or oscillating shapes and / or forming peaks 914 and / or valleys 916. For example, the sleeve 905 may extend outwardly from the covering 910 and / or stent further at some points (e.g., peaks 914) than at other points (e.g., valleys 916). However, the first cuff 907 and / or the second cuff 908 may have any suitable shape to accommodate surrounding tissue (e.g., branching blood vessels). In some examples, the first cuff 907 and / or the second cuff 908 and / or the ends 912 may be non-uniform. For example, the first cuff 907 may comprise a single peak 914 extending further than other portions of the first cuff 907 and / or the first cuff 907 may comprise a single valley 916 receding closer to the covering 910 and / or stent than other portions of the first cuff 907.

[0145] Figure 10 illustrates a compliance-enhancing implant 1002 configured to improve compliance at one or more blood vessels, in accordance with one or more examples. The implant 1002 may comprise coils 1003 and / or variousAttorney Docket No.: ADV-24177WO01 mechanical components configured to facilitate movement between a compressed form and / or an expanded form of the implant 1002. For example, the implant 1002 may be configured to compress in response to increased pressure (e.g., diastolic pressure). Moreover, the implant 1002 may be configured to expand to a default expanded form in response to a decrease in pressure (e.g., systolic pressure). The implant 1002 may be configured to bear tensile stress around the implant 1002 such that the blood vessel may not be required to bear the tensile stress.

[0146] In some examples the implant 1002 may comprise a sleeve 1005 coupled to an exterior and / or interior surface of the implant 1002. The sleeve 1005 may be integrated into the implant 1002 and / or may be a separate device configured to couple to the implant 1002. For example, hook and loop fasteners (e.g., Velcro), adhesives, fasteners, and / or anchors may be used to couple the implant 1002 and / or frame to the sleeve 1005. The sleeve 1005 may be configured to form a relatively strong attachment to the implant 1002.

[0147] The sleeve 1005 may comprise various components configured to shape the sleeve 1005 in a desired shape. For example, the sleeve 1005 may comprise shape-memory wire (e.g., Nitinol wire) at ends of the sleeve 1005 (e.g., at cuffs of the sleeve 1005). In some examples, the implant 1002 may comprise a frame 1009 and / or device including mechanical components (e.g., coils 1003 and / or springs) may be configured to press the sleeve 1005 against the blood vessel. Adhesive may not be required to maintain contact between the implant 1002 and the blood vessel due to the expandible features (e.g., coils 1003) of the implant 1002. The implant 1002 may comprise a covering 1010 at least partially enclosing the sleeve 1005.

[0148] Figure 11 provides a flowchart for an example process 1100 of deploying and / or using one or more implants described herein. Steps of the process 1100 may be performed in any suitable order and / or steps may be repeated.

[0149] At a step 1102, the process 1100 involves deploying a sleeve and / or covering within a blood vessel. In some examples, the sleeve may have a tubular and / or cylindrical shape and / or may be configured to conform to a shape of the blood vessel. The sleeve may be composed of any suitable materials and / or may be generally flexible and / or partially rigid. In some examples, the sleeve may have variable flexibility and / or may increase in flexibility towards ends of the sleeve. The sleeve may comprise a frame and / or one or more wires and / or rigid elementsAttorney Docket No.: ADV-24177WO01 configured to shape the sleeve. For example, the sleeve may comprise generally circular wires at ends of the sleeve to promote a circular shape of the sleeve.

[0150] The sleeve may comprise attachment features and / or adhesives configured to attach to a stent and / or covering. For example, an inner surface of the sleeve may be coated with adhesive and / or may comprise adhesive capsules configured to facilitate adherence to a stent and / or covering. Moreover, the sleeve may comprise attachment features and / or adhesives configured to attach to the blood vessel. For example, the sleeve may comprise one or more anchors configured to embed into the tissue of the blood vessel. In another example, an outer surface of the sleeve may be coated with adhesive and / or may comprise adhesive containers configured to facilitate attachment of the sleeve to the blood vessel.

[0151] At a step 1104, the process 1100 involves expanding the sleeve to an open and / or expanded form. In some examples, expanding the sleeve may involve stretching the sleeve. The sleeve may be expanded by any suitable means, which can include placing a balloon within the sleeve and inflating the balloon to press the sleeve against the surrounding blood vessel. The balloon may have a suitable shape configured to press the sleeve fully against the blood vessel such that the sleeve does not sag away from the blood vessel at any points.

[0152] At a step 1106, the process 1100 involves adhering the sleeve to the blood vessel. In some examples, adhesives may be disposed at the sleeve and / or may be deployed at the blood vessel and / or sleeve to adhere the sleeve to the blood vessel. In other examples, the sleeve may comprise anchors and / or other attachment features configured to facilitate attachment to the blood vessel.

[0153] In some examples, the sleeve may be held against the blood vessel for a suitable amount of time such that the surrounding tissue may grow over the sleeve to hold the sleeve against the blood vessel. The sleeve may be composed of and / or may comprise materials configured to facilitate and / or promote in-growth of tissue at the sleeve. For example, the sleeve may comprise a textured surface including fibers configured to promote in-growth. In some examples, the sleeve may be maintained in the expanded form by a balloon and / or other device while in-growth occurs.

[0154] At a step 1108, the process 1100 involves deploying a stent within the sleeve. Example stents can include those described herein (e.g., oval-shaped stents). The stent may comprise adhesive and / or mechanical features configured toAttorney Docket No.: ADV-24177WO01 facilitate attachment to the sleeve. For example, the stent may comprise a cover including Velcro, anchors, hooks, adhesives, and / or other attachment features.

[0155] At a step 1110, the process 1100 involves expanding the stent to attach the stent to the sleeve. For example, a balloon expander and / or other device may be deployed within the stent and / or may be expanded to cause corresponding expansion of the stent and / or sleeve. The stent may be held against the sleeve for a suitable amount of time for coupling to occur between the stent and the sleeve. Delivery devices (e.g., balloons and / or inflation devices) may then be removed.

[0156] Some examples described herein involve increasing and / or adding compliance to a blood vessel (e.g., pulmonary artery) by forcing and / or promoting the native vessel to make a cross-sectional shape change by physically adhering a stent onto the inside of the vessel. Adhesive and / or similar materials may be used to physically stick and / or adhere the stent to the vessel. In some cases, adhesives may have an immediate cure reaction with blood and / or other fluids. Accordingly, it may be advantageous to adhere the stent to the blood vessel while avoiding and / or minimizing exposure of the adhesive to blood and / or other fluids while the adhesive spreads and / or adheres to the blood vessel and / or stent.

[0157] Figure 12 provides a perspective view of a non-circular stent 1200 having increased flexibility in accordance with one or more examples. The stent may be deployable within a blood vessel lumen. However, it should be understood that example stent devices of the present disclosure may alternatively or additionally be deployable in a position around an outer surface of a target blood vessel. Although not shows for clarity in the figures of the present disclosure, it should be understood that example stents described herein may comprise one or more hooks, barbs, and / or other attachment features / means adapted to facilitate secure attachment of the stent to the tissue of the target blood vessel wall. The description of the stent 1200 may be understood to relate to, and / or describe aspects of, any of the stents described herein, wherein such stents can be associated with circularizing / shaping support devices / structures; that is, description of aspects of any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure.

[0158] The stent 1200 may be formed of a tubular frame 1231. The frame 1231 and / or wall(s) thereof may comprise an open-cell structure adapted to beAttorney Docket No.: ADV-24177WO01 expanded to secure the stent 1200 to a blood vessel internal (or external) wall, such as through endothelialization of the frame 1231 to the vessel tissue over time as the frame 1231 is held in a generally-circular form by one or more circularizing / reshaping support structures, such as a circular stent and / or major-axis tether / tie. The wall(s) of the stent frame 1231 may be at least partially composed of struts 1238 and / or stent openings / cells 1235 between the struts 1238. The dimensions and / or shape of the stent 1200 may vary based on the particular application and / or target implantation anatomy. The stent 1200 may comprise a covering at least partially enclosing the frame 1231 and / or extending across the openings / cells 1235 of the frame 1231.

[0159] In some examples, the frame 1231 may comprise one or more linkages 1240 (e.g., joints, hinges, connectors, etc.) configured to form movable connections between portions of the stent 1200. A linkage 1240 may be a moveable and / or adjustable connection between portions of the stent 1200. The linkages 1240 may be aligned in rows, columns, and / or groups. For example, the stent 1200 may comprise rows and / or columns of diamond- shaped and / or eye-shaped cells 1235. The linkages 1240 may be configured to join the cells 1235 in an end-to-end manner and / or may be aligned similarly to the cells 1235. Accordingly, each row and / or column of cells 1235 may form a distinct portion of the stent 1200. For example, the stent 1200 may comprise a proximal portion 1242 comprising a first set of aligned cells 1235, a middle portion 1244 disposed adjacent to the proximal portion 1242 and comprising a second set of aligned cells 1235, and / or a distal portion 1246 comprising a third set of aligned cells 1235 and / or disposed adjacent to the middle portion 1244 such that the middle portion 1244 is disposed between the proximal portion 1242 and the distal portion 1246.

[0160] The linkages 1240 may be configured to allow bending of the portions of the stent 1200 relative to each other. For example, inflation of a balloon within the middle portion 1244 may cause complete expansion of the middle portion 1244 while causing partial and / or minimal expansion of the proximal portion 1242 and / or distal portion 1246. In this way, the linkages 1240 may facilitate a staggered and / or step-like inflation and / or expansion of the stent 1200 to push trapped blood away from the stent 1200 in an effective manner. In some examples, the linkages 1240 may be configured to bend and / or allow free and / or independent movement of portions of the stent 1200 relative to each other as influenced by an inflation device and / or other forces. However, the stent 1200 may comprise one or more lockingAttorney Docket No.: ADV-24177WO01 mechanisms to allow for controlled movement of the linkages 1240 and / or portions of the stent 1200. For example, the stent 1200 may comprise locking mechanisms configured to restrict movement of the linkages 1240 and / or portions of the stent 1200 until a desired point (e.g., upon inflation of an inflation device within the stent 1200).

[0161] The stent 1200 may be configured to be percutaneously delivered to a blood vessel 61 in a compressed delivery configuration. Once within the blood vessel lumen at the target deployment site, the stent 1200 may be configured to be radially expanded into direct surface contact with the blood vessel wall (e.g., the inner wall of an aorta segment). In some examples, the stent 1200 may be configured to be radially expanded in stages and / or in a step-wise manner in which the middle portion 1244 is expanded before and / or in a greater extent than the proximal portion 1242 and / or distal portion 1246. In some examples, the stent 1200 may be configured to be expanded such that one or more portions of a perimeter of the stent 1200 approximates and / or exceeds a perimeter of the blood vessel portion where the stent 1200 is implanted, at least immediately prior to deployment / expansion of the stent. Placement of the stent 1200 in the blood vessel may cause at least slight stretching in the blood vessel wall.

[0162] Figures 13A-13C provide side views of an expansion process of a stent 1300 in accordance with one or more examples. Figure 13A illustrates the stent 1300 in an unexpanded state, Figure 13B illustrates the stent 1300 in a partially inflated state, and Figure 13C illustrates the stent 1300 in a fully inflated state.

[0163] The stent 1300 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 1300 may comprise a non-circular wire form comprising a network of struts forming cells or openings. The stent 1300 may comprise one or more linkages 1340 and / or movable joints configured to movably connect multiple portions of the stent 1300.

[0164] As shown in Figure 13 A, the stent 1300 may be delivered into a blood vessel 61 in a compressed and / or unexpanded form. In the unexpanded form, the stent 1300 may have a diameter that is less than a diameter of the blood vessel 61. Accordingly, blood 1350 and / or other fluid may be trapped between outer walls of the stent 1300 and walls of the blood vessel 61.Attorney Docket No.: ADV-24177WO01

[0165] An inflation device 1352 (e.g., a balloon) may be introduced into the blood vessel and / or may be extended at least partially into and / or through a lumen formed by the stent 1300. In some examples, the inflation device 1352 may be placed within an or adjacent to the stent 1300 while in a deflated form. The inflation device 1352 may comprise multiple sections. The multiple sections may be configured to inflate in different stages and / or in a step-wise manner. For example, the inflation device 1352 may comprise a middle portion 1364 disposed between a distal portion 1366 and a proximal portion 1362 of the inflation device 1352. The portions of the inflation device 1352 may be divided via barriers and are stitching. In some examples, the portions may be composed of different materials and / or different thicknesses of materials to facilitate a staggered inflation of the inflation device 1352. For example, the middle portion 1364 may be composed of a relatively thin material and / or a material having relatively high elasticity relative to the proximal portion 1362 and the distal portion 1366.

[0166] In some examples, the inflation device 1352 may be placed within the stent 1300 in a manner such that the middle portion 1364 of the inflation device 1352 is aligned with a middle portion 1344 of the stent 1300, the distal portion 1366 of the inflation device 1352 is aligned with a distal portion 1346 of the stent 1300, and the proximal portion 1362 of the inflation device 1352 is aligned with a proximal portion 1342 of the stent 1300. The portions of the inflation device 1352 may be sized to approximate sizes of the portions of the stent 1300.

[0167] As shown in Figure 13B, the middle portion 1364 may be configured to inflate earlier and / or more quickly than the distal portion 1366 and / or proximal portion 1362 of the inflation device 1352. Accordingly, the inflation device 1352 may be configured to expand the middle portion 1344 of the stent 1300 while the proximal portion 1342 and / or distal portion 1346 of the stent 1300 may not be fully expanded. The linkages 1340 of the stent 1300 may be configured to allow the stent 1300 to bend and / or allow the proximal portion 1342 and / or distal portion 1346 to bend and / or sag from the middle portion 1344 of the stent 1300.

[0168] Expansion of the middle portion 1344 of the stent 1300 may cause blood and / or fluid previously disposed and / or pooled between the middle portion 1344 and the blood vessel 61 to be pressed away from the middle portion 1344 and / or towards the proximal portion 1342 and / or distal portion 1346. Due to the proximal portion 1342 and / or distal portion 1346 being in an at least partially compressedAttorney Docket No.: ADV-24177WO01 and / or bent form, blood and / or fluid may be allowed to escape along an outer wall of the stent 1300 through gaps between the blood vessel 61 and the proximal portion 1342 and / or distal portion 1346.

[0169] In some examples, the proximal portion 1362 and / or distal portion 1366 may be configured to not inflate until the middle portion 1364 is fully inflated. The distal portion 1366 and / or proximal portion 1362 of the inflation device 1352 may inflate at least partially while the middle portion 1364 inflates. However, inflation of the proximal portion 1362 and / or distal portion 1366 of the inflation device 1352 may be slower and / or delayed relative to inflation of the middle portion 1364.

[0170] As shown in Figure 13C, the proximal portion 1362 and / or distal portion 1366 of the inflation device 1352 may be configured to fully inflate and / or to inflate to a similar extent as the middle portion 1364. Inflation of the proximal portion 1362 and / or distal portion 1366 may be configured to press the proximal portion 1342 and / or distal portion 1346 of the stent 1300 fully against the walls of the blood vessel 61. As the proximal portion 1342 and / or distal portion 1346 are pressed fully against the blood vessel 61, blood and / or fluid previously disposed and / or pooled between the stent 1300 and the blood vessel 61 may be pressed beyond the stent 1300 such that no or minimal blood and / or fluid is disposed between the stent 1300 and the blood vessel 61 following inflation of the inflation device 1352. Staggered and / or stepwise inflation of the inflation device 1352 may advantageously remove fluid from between the stent 1300 and / or the blood vessel 61 more effectively than inflating all portions of the inflation device 1352 simultaneously. Once the stent 1300 is fully expanded, adhesive may be delivered to the stent 1300 via one or more access tubes. In some examples, fluid (e.g., blood and / or saline) may be removed from around the stent 1300 via the one or more access tubes prior to and / or following delivery of the adhesive via the one or more access tubes Adhesive may be delivered while the inflation device 1352 is inflated and / or following removal of the inflation device 1352 from the stent 1300.

[0171] Figure 14 provides a cross-sectional side view of another example stent 1400 in accordance with one or more examples. The stent 1400 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples,Attorney Docket No.: ADV-24177WO01 the stent 1400 may comprise a non-circular wire form and / or frame 1408 comprising a network of struts forming cells or openings.

[0172] In some examples, the stent 1400 may comprise multiple outer layers enclosing and / or extending along an outer surface of the frame of the stent 1400. The multiple layers can include one or more hydrophobic layers 1474 and are hydrophilic layers 1472. For example, the stent 1400 may comprise one or more hydrophilic layers 1472 attached to and / or adjacent to the frame 1408 of the stent 1400 and / or one or more hydrophobic layers 1474 enclosing the one or more hydrophilic layers 1472. In this way, the one or more hydrophilic layers 1472 may be disposed between the one or more hydrophobic layers 1474 and the frame 1408 of the stent 1400.

[0173] The one or more layers may be configured to facilitate removal of blood 1450 disposed and / or pooled between the stent 1400 and the blood vessel 61. The one or more hydrophobic layers 1474 may be in contact with the blood 1450 and / or may be configured to repel the blood 1450 towards that one or more hydrophilic layers 1472. The one or more hydrophilic layers 1472 may be configured to allow blood flow through the one or more hydrophilic layers 1472 and / or through the frame 1408 of the stent 1400. However, blood and / or fluid may be prevented from flowing in the opposite direction and / or through the one or more hydrophilic layers 1472 to the one or more hydrophobic layers 1474 based on the arrangement of the one or more layers. Accordingly, the stent 1400 may be configured to effectively facilitate removal of blood 1450 from between the stent 1400 and the blood vessel 61 while preventing flow of blood towards any gaps between the stent 1400 and the blood vessel 61.

[0174] The double-layer textile assembly of the stent 1400 may be configured to create unidirectional flow to assist evacuating the trapped blood 1450 between the stent 1400 and the wall of the blood vessel 61 and / or away from the stent 1400. The layers may be arranged such that textile density increases from the wall of the blood vessel 61 inwards in order to create a capillary effect to increase the unidirectional effect on blood flow through the assembly.

[0175] In some examples, the stent 1400 may be expanded via balloon and / or other methods. One method may involve gradually and / or in a step-like manner expanding and / or ballooning the stent 1400 to assist in pushing blood out from around the stent 1400. In some examples, the stent 1400 may be expanded untilAttorney Docket No.: ADV-24177WO01 a desired balloon pressure is reached. Adhesive may then be introduced and / or applied at the stent 1400 and / or blood vessel 61. Expansion of the stent 1400 can assist in blocking adhesive from escaping during injection of the adhesive.

[0176] Once the trapped blood 1450 is sufficiently dispersed from between the stent 1400 and the blood vessel 61, adhesive may be delivered to adhere the stent 1400 to the blood vessel 61. For example, one or more delivery tubes may be delivered within a lumen of the stent 1400 and / or between the stent 1400 and the blood vessel 61 to deliver liquid and / or other adhesives (e.g., glue). In some examples, one or more vacuum tubes may be used to suction excess fluid from at and / or adjacent to the stent 1400 prior to and / or during delivery of adhesive.

[0177] Figure 15 provides a cross-sectional front view of another example stent 1500 in accordance with one or more examples. The stent 1500 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 1500 may comprise a non-circular wire form and / or frame 1508 comprising a network of struts forming cells or openings.

[0178] In some examples, the stent 1500 may comprise one or more capsules 1511 containing various fluid-absorbing and / or fluid- absorbent materials. For example, the capsule 1511 may contain one or more powders configured to absorb fluid when in contact with one or more fluids. The one or more capsules 1511 may be disposed and / or coupled at an inner and / or outer surface of the frame 1508. In some examples, the one or more capsules 1511 may be disposed at an outer surface of the frame 1508 to facilitate pressing of the one or more capsules 1511 between the frame 1508 and the blood vessel 61. The one or more capsules 1511 may be configured to burst in response to pressure applied by pressing of the frame 1508 outwardly against the blood vessel 61. For example, a balloon and / or inflation device may be used to expand the frame 1508 outwardly towards the blood vessel 61 and / or the one or more capsules 1511 may be pressed against the blood vessel 61 with sufficient force that they burst to allow the powder within the capsules 1511 to come into contact with fluid (e.g., blood) disposed between the frame 1508 and the blood vessel 61. Any fluid disposed between the frame 1508 and the blood vessel 61 may be absorbed by the powder within the capsules 1511 to prevent pooling of fluid between the frame 1508 and the blood vessel 61.Attorney Docket No.: ADV-24177WO01

[0179] The one or more capsules 1511 may contain a moisture-absorbing powder that dries out an area between the stent 1500 and the blood vessel 61 once the stent 1500 is inflated and / or expanded. The powder may remain in the body as part of the bond structure between the stent 1500 and the blood vessel 61. In some examples, the stent 1500 may comprise a textile and / or fabric covering that may become saturated with blood upon delivery into the blood vessel 61. The one or more capsules 1511 may be configured to burst as the stent 1500 expands against the blood vessel 61 such that the material within the capsules 1511 can absorb the remainder of the blood left between the stent 1500 and / or within a textile layer of the stent 1500 and tissue of the blood vessel 61 after expansion.

[0180] Once the capsules 1511 may ruptured and / or blood at and / or adjacent the stent 1500 is sufficiently absorbed by powder and / or material within the capsules 1511, adhesive may be delivered to adhere the stent 1500 to the blood vessel 61. For example, one or more delivery tubes may be delivered within a lumen of the stent 1500 and / or between the stent 1500 and the blood vessel 61 to deliver liquid and / or other adhesives (e.g., glue). In some examples, one or more vacuum tubes may be used to suction excess fluid from at and / or adjacent to the stent 1500 prior to and / or during delivery of adhesive.

[0181] Figures 16A and 16B provide cross-sectional side views of another example stent 1600 in accordance with one or more examples. The stent 1600 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 1600 may comprise a non-circular wire form and / or frame 1608 comprising a network of struts forming cells or openings.

[0182] As shown in Figure 16 A, the stent 1600 may comprise a sleeve 1620 configure to at least partially enclose the frame 1608 of the stent 1600. In some examples, the stent 1600 may comprise an adhesive layer 1615 disposed around and / or coated to the frame 1608. The stent may be delivered and / or deployed within the blood vessel 61 with the sleeve 1620 enclosing the frame 1608 such that the adhesive layer 1615 may not be exposed to blood and / or other fluids within the body of the patient.

[0183] As shown in Figure 16B, following delivery of the stent 1600, the sleeve 1620 may be removed from the stent 1600 and / or from between the stent 1600Attorney Docket No.: ADV-24177WO01 and the blood vessel 61. In some examples, the sleeve 1620 may be retracted and / or pulled proximally and / or longitudinally away from the stent and / or removed from the body. Removal of the sleeve 1620 may allow the adhesive layer 1615 to spread and / or to contact the walls of the blood vessel 61. In this way, the adhesive layer 1615 may be allowed to form an adhesion between the stent 1600 and the blood vessel 61.

[0184] The stent 1600 may comprise a fabric and / or textile covering. Use of the sleeve 1620 may advantageously keep the covering as dry as possible during delivery and / or adhesion at the blood vessel 61. In some examples, the sleeve 1620 may be at least partially impermeable to keep the stent 1600 and / or covering dry while also preventing adhesion between the sleeve 1620 and adhesive applied between the sleeve 1620 and the stent 1600. The stent 1600 may be deployed at least partially inside the sleeve 1620. After expanding the stent 1600 (e.g., inflating a balloon within the stent 1600) and / or squeezing out blood from the region, the sleeve 1620 can be removed, leaving most of the region (e.g., a covering of the stent 1600) unsaturated with blood or minimally saturated with blood.

[0185] In some examples, adhesive may be delivered and / or injected at the stent 1600 and / or between the stent 1600 and the sleeve 1620. Introducing adhesive at the stent 1600 may allow the adhesive to spread along a covering of the stent 1600. In some examples, the sleeve 1620 can have a rough and / or uneven texture at least on an outward-facing (e.g., facing and / or against the blood vessel 61) so that the sleeve 1620 can scrape and / or extract a maximum amount of blood from the blood vessel 61 upon removal of the sleeve 1620.

[0186] Cinching sutures may be used to hold the sleeve 1620 in place as the stent 1600 is deployed. Delivery system devices (e.g., catheters) may be removed while keeping one or more delivery devices (e.g., hypotubes) and / or guidewire access devices delivering the cinching sutures in place within the vessel 61. An expansion / inflation device (e.g., balloon) and / or a balloon catheter may be delivered over one of the hypotubes. The cinching suture(s) can be pulled proximally (e.g., from a handle) and the sleeve 1620 can be collapsed into the hypotube following removal from the stent 1600.

[0187] Figure 17 provides a perspective view of another example stent 1700 in accordance with one or more examples. The stent 1700 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent orAttorney Docket No.: ADV-24177WO01 stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 1700 may comprise a non-circular wire form and / or frame 1708 comprising a network of struts forming cells or openings.

[0188] In some examples, the stent 1700 may comprise one or more sealing skirts coupled to the frame 1708 of the stent 1700. For example, the stent 1700 may comprise a proximal skirt 1722a and / or a distal skirt 1722b. The one or more skirts may be configured to seal the area around the stent 1700. For example, the one or more skirts may be configured to fill space at proximal and / or distal ends of the frame 1708 and / or to expand to fill any space between the frame 1708 the walls of a blood vessel while the stent 1700 is disposed within a blood vessel.

[0189] With the skirts forming a sealing area around the stent 1700, one or more tubes may be deployed to and / or into the stent 1700 to dispense adhesives and / or remove gases and / or fluid from at and / or around the stent 1700 and / or within the sealing zone around the stent 1700. For example, a first tube 1726a may be configured to facilitate delivery of one or more adhesives to the stent 1700 to adhere the stent 1700 to the blood vessel. A second tube 1726b may be configured to create suction within the sealing zone 1725 to pull any fluid and / or gas within the sealing zone 1725 away from the stent 1700 and / or out of the body. In some examples, suction created by the one or more tubes may pull fluid out of a covering around the stent 1700. The one or more tubes may be attached to the stent 1700 and / or may comprise free ends configured to be moved freely within the sealing zone 1725.

[0190] The proximal skirt 1722a and / or distal skirt 1722b may be configured to form a vacuum seal. In some examples, the proximal skirt 1722a and / or distal skirt 1722b may comprise flared ends that extend outwardly towards the blood vessel to seal the stent 1700 against the blood vessel. The one or more tubes may be coupled to the stent 1700.

[0191] Figure 18 provides a cross-sectional side view of a delivery system 1800 in accordance with one or more examples. The delivery system 1800 may be configured for delivery and / or placement of a stent 1801 and / or similar device. The stent 1801 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 1801 may comprise a non-circular wire form and / or frame comprising a network of struts forming cells or openings.Attorney Docket No.: ADV-24177WO01

[0192] The delivery system 1800 may comprise an inflation device 1852 configured to inflate the stent 1801 from a compressed form to an expanded form. The inflation device 1852 may be configured for placement within a lumen of the stent 1801. The inflation device 1852 may be delivered in a deflated form and / or may be inflated while disposed within the stent 1801. The inflation device 1852 may comprise an opening 1817 configured to receive gas to inflate the inflation device 1852 and / or to allow for removal of gas from the inflation device 1852.

[0193] In some examples, the system 1800 may comprise a vacuum layer 1818 at least partially enclosing the inflation device 1852. For example, a vacuum tube may be inserted between the inflation device 1852 and the vacuum layer 1818 to create a vacuum around the inflation device 1852. In some examples, the vacuum layer 1818 may comprise one or more apertures and / or holes such that blood and / or other fluid may be pulled into the vacuum layer 1818 and / or through the stent 1801. The inflation device 1852 may be configured to push blood away from a region between the stent 1801 and the blood vessel 61. Adhesive may be injected into the region and / or vacuum suction may be applied to remove additional blood volume that may be trapped in the region.

[0194] Figure 19 provides a cross-sectional side view of another example stent 1900 in accordance with one or more examples. The stent 1900 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 1900 may comprise a non-circular wire form and / or frame 1908 comprising a network of struts forming cells or openings.

[0195] In some examples, the stent 1900 may comprise one or more sealing rings coupled to the frame 1908 and / or configured to create a sealing zone 1925 at and / or around the stent 1900. For example, the stent 1900 may comprise a proximal ring 1921 and / or a distal ring 1922 forming the sealing zone 1925 between the proximal ring 1921 and the distal ring 1922. In some examples, the proximal ring 1921 and / or distal ring 1922 may be inflatable and / or expandable and / or may be configured to expand to fill any gap between the frame 1908 and the blood vessel 61 following delivery of the stent 1900 to the blood vessel 61.

[0196] One or more vacuum tubes 1940 (e.g., access tubes) may be delivered to the stent 1900 to remove blood 1950 and / or other fluid from the sealingAttorney Docket No.: ADV-24177WO01 zone 1925. For example, the one or more vacuum tubes 1940 may be configured to extend along the frame 1908 and / or below the proximal ring 1921 to reach the sealing zone 1925. While two vacuum tubes 1940 are shown in Figure 19, a single vacuum tube 1940 and / or other numbers of vacuum tubes 1940 may be utilized. Adhesives may be delivered into the sealing zone 1925 following removal of the trapped blood 1950 to adhere the stent 1900 to the blood vessel 61. In some examples, the proximal ring 1921 and / or distal ring 1922 may be deflated and / or collapsed following removal of the trapped blood 1950 and / or following delivery of adhesives to allow the sides of the stent 1900 to expand into contact with the blood vessel 61. The one or more vacuum tubes 1940 may provide access to suction and / or deliver fluid and / or gas at and / or around the stent 1900. For example, the one or more vacuum tubes 1940 may be sized and / or positioned to suction blood and / or saline from around the stent 1900 and / or to deliver adhesive (e.g., glue) to the stent 1900 following removal of blood and / or saline.

[0197] Figure 20 provides a cross-sectional side view of an example implant 2000 including a stent 2001 in accordance with one or more examples. The stent 2001 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 2001 may comprise a non-circular wire form and / or frame comprising a network of struts forming cells or openings.

[0198] In some examples, the stent 2001 may be used in combination with an inflation device 2031, which can include a balloon and / or similar device. The inflation device 2031 may be configured to perform multiple functions. For example, the inflation device 2031 may be configured to expand the stent 2001 from a compressed and / or default delivery form to an expanded form in which the stent 2001 approximates a size and / or shape of a blood vessel 61 in which the stent is placed. The stent 2001 may be configured to press against walls of the blood vessel 61 in the expanded form.

[0199] In some examples, the inflation device 2031 may be configured to create a sealing zone and / or to create a seal around the stent 2001. For example, the inflation device 2031 may be configured to form a proximal bulb 2032 extending beyond a proximal end 2022 of the stent 2001 and / or a distal bulb 2033 extending beyond a distal end 2023 of the stent 2001. The proximal bulb 2032 and / or distal bulbAttorney Docket No.: ADV-24177WO012033 may be configured to expand to a greater width and / or diameter than the stent 2001 and / or portions of the inflation device 2031 disposed within the stent 2001. In this way, the proximal bulb 2032 and / or distal bulb 2033 may be configured to block blood and / or other fluid from entering the sealing zone between the proximal bulb 2032 and the distal bulb 2033. In some examples, one or more tubes may be delivered into the sealing zone and / or to the stent 2001 to remove any blood and / or fluid trapped between the proximal bulb 2032 and the distal bulb 2033. Once fluid has been removed from around the stent 2001, one or more adhesives may be delivered at the stent 2001 to adhere the stent 2001 to the blood vessel 61.

[0200] Once the proximal bulb 2032 and / or distal bulb 2033 are expanded to form a sealing zone, adhesive may be delivered to adhere the stent 2001 to the blood vessel 61. For example, one or more delivery tubes may be delivered within a lumen of the stent 2001 and / or between the stent 2001 and the blood vessel 61 to deliver liquid and / or other adhesives (e.g., glue). In some examples, one or more vacuum tubes may be used to suction excess fluid from at and / or adjacent to the stent 2001 prior to and / or during delivery of adhesive.

[0201] Some examples described herein relate to devices and / or methods for bonding a docking device (e.g., stent, sleeve, etc.) to a blood vessel (e.g., a pulmonary artery and / or aorta) using various adhesive tools (e.g., glue injection, glue capsules, biotape, etc.). Examples may additionally or alternatively involve ballooning a non-circular (e.g., oval) stent to attach it to a pre-bonded docking device.

[0202] Figures 21A and 21B illustrate an example implant 2100 including a stent 2101 in accordance with one or more examples. Figure 21 A provides a perspective view of the stent 2101 and Figure 21B provides a front view of the implant 2100 including the stent 2101 and a sleeve 2104. The stent 2101 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 2101 may comprise a non-circular wire form and / or frame comprising a network of struts forming cells or openings.

[0203] As shown in Figure 21A, the stent 2101 may comprise one or more protrusions 2118 extending from an outer surface of the stent 2101. The one or more protrusions 2118 may comprise lumens 2115 and / or cavities configured to receive a rod 2117, which can include any elongate device configured to be extended at leastAttorney Docket No.: ADV-24177WO01 partially through one or more lumens 2115 of the stent 2101 and / or sleeve 2104. The one or more protrusions 2118 may be configured to be aligned with corresponding pegs 2119 of the sleeve 2104. The pegs 2119 may similarly comprise lumens 2115 configured to be aligned with lumens 2115 of the one or more protrusions 2118.

[0204] As shown in Figure 21B, the sleeve 2104 may be configured to be disposed between a blood vessel 61 and the stent 2101 and / or may be configured to at least partially enclose the stent 2101. The pegs 2119 of the sleeve 2104 may be configured to be aligned with the protrusions 2118 of the stent 2101 in an alternating manner as shown in Figure 21A. The protrusions 2118 and / or pegs 2119 may be aligned longitudinally along the stent 2101. Once the protrusions 2118 and / or pegs 2119 are aligned, the rod 2117 may be extended through the lumens 2115 of the protrusions 2118 and / or pegs 2119 to lock the stent 2101 and / or sleeve 2104 in place relative to each other.

[0205] The rod 2117 have a generally rigid structure and / or may be configured to maintain positioning of the stent 2101 relative to the sleeve 2104 once placed with the lumens 2115. In some examples, the rod 2117 may be removable to allow for detachment of the stent 2101 from the sleeve 2104.

[0206] Figures 22A and 22B provide isolated front views of interlocking and / or aligning components of a stent 2201 and / or sleeve 2204 in accordance with one or more examples. Figure 22A illustrates the stent 2201 and the sleeve 2204 separated and / or disconnected. Figure 22B illustrates the stent 2201 and the sleeve 2204 aligned and / or interlocking with each other.

[0207] As shown in Figure 22A, the stent 2201 may comprise a first lumen 2215a and / or the sleeve 2204 may comprise a second lumen 2215b configured to be aligned with the first lumen 2215a. The first lumen 2215a may be disposed at and / or adjacent to a protrusion 2218 extending from the stent 2201. The second lumen 2215b may be disposed at and / or adjacent to a peg 2219 extending from the sleeve 2204. As shown in Figure 22B, as the stent 2201 and / or the sleeve 2204 are moved into close proximity, the first lumen 2215a and the second lumen 2215b may be aligned to form a single lumen.

[0208] Figure 23 provides a provides a front view of an implant 2300 including a stent 2301 and a sleeve 2304 in accordance with one or more examples. The stent 2301 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in anyAttorney Docket No.: ADV-24177WO01 other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 2301 may comprise a non-circular wire form and / or frame comprising a network of struts forming cells or openings.

[0209] In some examples, the stent 2301 and / or sleeve 2304 may comprise one or more features and / or mechanisms configured to facilitate connection and / or interlocking between the stent 2301 and the sleeve 2304. For example, the stent 2301 may comprise one or more pegs 2318, which can include any protrusions and / or male and / or female attachment features and / or the sleeve 2304 may comprise one or more notches 2319, which can include cavities, openings, and / or other female and / or male attachment features.

[0210] The sleeve 2304 may be configured to be delivered to a blood vessel 61 prior to delivery of the stent 2301. In some examples, the sleeve 2304 may be adhered to the blood vessel 61 using one or more adhesives and / or other features. Following attachment or adhesion of the sleeve 2304 to the blood vessel 61, the stent 2301 may be coupled to the sleeve 2304 via the one or more pegs 2318 and / or notches 2319. In some examples, the one or more pegs 2318 may be inserted into the one or more notches 2319 and / or may be configured to slide and / or otherwise adjust to lock into place with respect to the sleeve 2304.

[0211] In some examples, the sleeve 2304 may comprise one or more female mating features and the stent 2301 may comprise one or more male mating features configured to mate with the female mating features of the sleeve 2304. The stent 2301 may be deployed into the sleeve 2304 and then pressed into the one or more mating features, attaching the stent 2301 and the sleeve 2304 together.

[0212] Figure 24 provides a provides a front view of an implant 2400 including a stent 2401 and a sleeve 2404 in accordance with one or more examples. The stent 2401 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 2401 may comprise a non-circular wire form and / or frame comprising a network of struts forming cells or openings.

[0213] In some examples, the stent 2401 and / or sleeve 2404 may comprise one or more features and / or mechanisms configured to facilitate connection and / or interlocking between the stent 2401 and the sleeve 2404. For example, the stent 2401 may comprise one or more pegs 2418, which can include any protrusions and / or maleAttorney Docket No.: ADV-24177WO01 and / or female attachment features and / or the sleeve 2404 may comprise one or more notches 2419, which can include cavities, openings, and / or other female and / or male attachment features. In some examples, a peg 2418 can comprise a cone-shaped tip having a base with an increase diameter relative to a body of the peg 2418 and / or a decreasing width and / or diameter from the base to a tip of the peg 2418. The base of the peg 2418 may have a width and / or diameter greater than a width and / or diameter of a slot and / or opening of the one or more notches 2419. The one or more notches 2419 can comprise an opening having a reduced width and / or diameter relative to an interior cavity of the one or more notches 2419 to facilitate locking the one or more pegs 2418 in place relative to the one or more notches 2419.

[0214] In some examples, the one or more notches 2419 may have an at least partially elastic and / or flexible structure to allow for a temporary increase in width to allow the one or more pegs 2418 to be inserted, starting with tips of the one or more pegs 2418. However, the one or more notches 2419 may have a structure sufficient to prevent the one or more pegs 2418 from being retracted out of the one or more notches 2419 due to the bases of the one or more pegs 2418 being abutted to the openings of the one or more notches 2419.

[0215] The sleeve 2404 may comprise a female mating feature and the stent 2401 may comprise a male mating feature. The stent 2401 may be deployed into the sleeve 2404 and then pressed into the mating feature, which can cause at least temporary plastic deformation of the sleeve 2404 and / or one or more notches 2419.

[0216] The sleeve 2404 may be configured to be delivered to a blood vessel 61 prior to delivery of the stent 2401. In some examples, the sleeve 2404 may be adhered to the blood vessel 61 using one or more adhesives and / or other features. Following attachment nor adhesion of the sleeve 2404 to the blood vessel 61, the stent 2401 may be coupled to the sleeve 2404 via the one or more pegs 2418 and / or notches 2419. In some examples, the one or more pegs 2418 may be inserted into the one or more notches 2419 and / or may be configured to slide and / or otherwise adjust to lock into place with respect to the sleeve 2404.

[0217] Figure 25 provides a provides a front view of an implant 2500 including a stent 2501 and a sleeve 2504 in accordance with one or more examples. The stent 2501 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure.Attorney Docket No.: ADV-24177WO01In some examples, the stent 2501 may comprise a non-circular wire form and / or frame comprising a network of struts forming cells or openings.

[0218] In some examples, the stent 2501 and / or sleeve 2504 may comprise one or more features and / or mechanisms configured to facilitate connection and / or interlocking between the stent 2501 and the sleeve 2504. For example, the stent 2501 may comprise one or more fastening strips 2518, which can include loops, hooks, and / or Velcro material and / or the sleeve 2504 may comprise one or more fastening strips 2519, which can include loops, hooks, and / or Velcro material. In some examples, the one or more fastening strips 2518 of the stent 2501 may be configure to attach to and / or mate with the one or more fastening strips 2519 of the sleeve 2504. For example, the one or more fastening strips 2518 may comprise loops configured to mate with hooks of the one or more fastening strips 2519, or vice versa.

[0219] The sleeve 2504 may be configured to be delivered to a blood vessel 61 prior to delivery of the stent 2501. In some examples, the sleeve 2504 may be adhered to the blood vessel 61 using one or more adhesives and / or other features. Following attachment nor adhesion of the sleeve 2504 to the blood vessel 61, the stent 2501 may be aligned with the sleeve 2504 such that attachment features of the stent 2501 are aligned with attachment features of the sleeve 2504.

[0220] Figure 26 provides a provides a front view of an implant 2600 including a stent 2601 and a sleeve 2604 in accordance with one or more examples. The stent 2601 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 2601 may comprise a non-circular wire form and / or frame comprising a network of struts forming cells or openings.

[0221] In some examples, one or more features and / or mechanisms may be used to facilitate connection and / or interlocking between the stent 2601 and the sleeve 2604. For example, a first liner 2606a and / or second liner 2606b may be disposed between the stent 2601 and the sleeve 2604. The first liner 2606a and / or second liner 2606b may comprise an embedded mesh and / or may be configured to mate and / or adhere together. In some examples, the first liner 2606a may be coupled to the stent 2601 and / or the second liner 2606b may be coupled to the sleeve 2604 such that attachment between the first liner 2606a and the second liner 2606b creates a connection between the stent 2601 and the sleeve 2604.Attorney Docket No.: ADV-24177WO01

[0222] The first liner 2606a and / or second liner 2606b may be at least partially composed of plastic and / or other suitable materials. In some examples, the first liner 2606a and / or second liner 2606b may be configured to melt. For example, radio-frequency (RF) waves may be used to energize embedded braids within the first liner 2606a and / or second liner 2606b, thus melting the plastic layers together and attaching the stent 2601 to the sleeve 2604.

[0223] The sleeve 2604 and / or second liner 2606b may be configured to be delivered to a blood vessel 61 prior to delivery of the stent 2601 and / or first liner 2606a. In some examples, the sleeve 2604 may be adhered to the blood vessel 61 using one or more adhesives and / or other features. Following attachment nor adhesion of the sleeve 2604 to the blood vessel 61, the first liner 2606a may be coupled to the second liner 2606b via any suitable means.

[0224] Figure 27 provides a provides a perspective view of an implant2700 including a stent 2701 and a sleeve 2704 in accordance with one or more examples. The stent 2701 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 2701 may comprise a non-circular wire form and / or frame comprising a network of struts forming cells or openings.

[0225] In some examples, one or more features and / or mechanisms may be used to facilitate connection and / or interlocking between the stent 2701 and the sleeve 2704. For example, one or more sutures 2717 may be configured to interconnect and / or enclose the stent 2701 and / or the sleeve 2704. In some examples, the one or more sutures 2717 may be wrapped in a helical manner around the stent2701 and / or the sleeve 2704. One or more free ends of the suture 2717 may be pulled to cause tensioning and / or tightening of the suture 2717 to apply force to the stent 2701 and / or the sleeve 2704 and / or to bring the stent 2701 and / or the sleeve 2704 closer together. In some examples, the one or more sutures 2717 may be configured to pass through the sleeve 2704 and / or through cells of the stent 2701.

[0226] In some examples, the stent 2701 may be pre-attached to the sleeve 2704 prior to delivery into the body and / or into the blood vessel using the one or more sutures 2717. Once deployed within the blood vessel, the sutures 2717 may be tightened to bring the stent 2701 into close contact with the sleeve 2704.Attorney Docket No.: ADV-24177WO01

[0227] The sleeve 2704 may be configured to be delivered to a blood vessel prior to delivery of the stent 2701. In some examples, the sleeve 2704 may be adhered to the blood vessel 61 using one or more adhesives and / or other features. Following attachment or adhesion of the sleeve 2704 to the blood vessel 61, the stent 2701 and / or one or more sutures 2717 may be coupled to the sleeve 2704.

[0228] Figures 28A and 28B provide front views of an implant 2800 including a stent 2801 and a sleeve 2804 in accordance with one or more examples. The stent 2801 may include any example stent and / or associated circularizing / shaping supports of the present disclosure may be understood to be implementable in any other example stent or stent-circularizing / reshaping structure of the present disclosure. In some examples, the stent 2801 may comprise a non-circular wire form and / or frame comprising a network of struts forming cells or openings. Figure 28A shows the implant 2800 in a relaxed and / or compressed form and Figure 28B shows the implant 2800 in an expanded form.

[0229] In some examples, one or more features and / or mechanisms may be used to facilitate connection and / or interlocking between the stent 2801 and the sleeve 2804. For example, the stent 2801 may comprise one or more barbs 2808 configured to pierce and / or attach to a coupling strip 2814 of the sleeve 2804. Upon delivery of the stent 2801 to the sleeve 2804, the stent 2801 and / or barbs 2808 may be in a relaxed and / or compressed configuration in which the barbs 2808 may not extend beyond a covering 2811 of the stent 2801. For example, the covering 2811 may be coupled to the stent and / or may be configured to at least partially enclose the one or more barbs 2808. As shown in Figure 28A, a balloon and / or inflation device 2852 may be delivered to the implant 2800 in a deflated form. As the inflation device 2852 expands as shown in Figure 28B, the inflation device 2852 may press the stent 2801 and / or one or more barbs 2808 outwardly and / or towards the sleeve 2804. In some examples, the one or more barbs 2808 may be configured to pass and / or extend through the covering 2811 and / or stent 2801 to reach the coupling strip 2814 of the sleeve 2804. The one or more barbs 2808 may be configured to pierce and / or otherwise attach to the coupling strip 2814. Following attachment of the one or more barbs 2808 at the coupling strip 2814, the inflation device 2852 may be deflated and / or removed.

[0230] The sleeve 2804 may be configured to be delivered to a blood vessel 61 prior to delivery of the stent 2801. In some examples, the sleeve 2804 mayAttorney Docket No.: ADV-24177WO01 be adhered to the blood vessel 61 using one or more adhesives and / or other features. Following attachment nor adhesion of the sleeve 2804 to the blood vessel 61, the stent 2801 may be coupled to the sleeve 2804.

[0231] Figure 29 provides a flowchart for an example process 2900 of deploying and / or using one or more implants described herein. Steps of the process 2900 may be performed in any suitable order and / or steps may be repeated.

[0232] At a step 2902, the process 2900 involves deploying a stent within a blood vessel. The stent may be adhered to the blood vessel using adhesives and / or attachment mechanisms, which can include tissue anchors. In some examples, the stent may comprise one or more attachment mechanisms (e.g., cavities, pegs, hooks, loops, liners, etc.) configured to facilitate attachment of the stent to one or more sleeves. The stent may have a biased non-circular cross-sectional shape (e.g., an oval and / or peanut shape). In some examples, the stent may comprise one or more coverings at least partially enclosing the stent and / or extending along an outer and / or inner surface of the stent.

[0233] At a step 2904, the process 2900 involves suctioning blood from around and / or within the stent. In some examples, the stent may comprise a covering that may become saturated with blood. Suctioning may involve removing blood from the covering and / or from between the stent and the blood vessel. In some examples, one or more vacuum tubes may be delivered to the stent to facilitate suctioning blood out of the body and / or to other areas of the body.

[0234] In some examples, the stent may comprise one or more components configured to create a sealing zone around the stent. Additionally or alternatively, one or more inflation devices may be used to create a sealing zone around the stent. For example, a sealing zone may extend along a midsection of the stent and / or between a proximal and distal end of the stent. Suctioning of blood may be performed within the sealing zone.

[0235] At a step 2906, the process 2900 involves delivering one or more adhesives to the blood vessel and / or to the stent. In some examples, adhesives may be delivered via one or more tubes that extend along the stent to deliver adhesives at and / or around the stent. Adhesives may be delivered during and / or after blood is suctioned from around or within the stent to minimize contact between the adhesives and blood prior to adhesion between the stent and the blood vessel.Attorney Docket No.: ADV-24177WO01

[0236] At a step 2908, the process 2900 involves expanding the stent into contact with the blood vessel to adhere the stent to the blood vessel via the one or more adhesives. In some examples, an inflation device (e.g., a balloon) may be used to expand the stent into contact with the blood vessel. The inflation device may be configured to expand the stent in stages. For example, the inflation device may be configured to initially expand a midsection of the stent prior to expanding proximal and / or distal ends of the stent.

[0237] Figure 30 provides a flowchart illustrating an example process 3000 for adhering an implant to a blood vessel, in accordance with one or more examples. The process 3000 may involve using controlled suction (e.g., vacuum) to controllably dispense an adhesive at or near an implant. Figures 31-33 provide illustrations associated with steps of the process 3000 of Figure 30. Figure 31 illustrates an example implant 3102 deployed within a blood vessel 61 in accordance with one or more examples. Figure 32 illustrates an implant 3202 expanded into contact with walls of a blood vessel 61 in accordance with one or more examples. Figure 33 illustrates an implant 3302 adhered to a blood vessel in accordance with one or more examples.

[0238] At a step 3002, the process 3000 involves deploying the implant 3102 (e.g., stent) in a target blood vessel 61, as shown in Figure 31. In some examples, the implant 3102 may have a default and / or delivery configuration in which a width and / or diameter of the implant 3102 may be smaller than a width and / or diameter of the blood vessel 61. The implant 3102 may comprise a frame 3104 and / or a covering 3106 (e.g., sleeve) extending at least partially along the frame 3104 and / or at least partially enclosing the frame 3104.

[0239] In some examples, the covering 3106 may extend beyond the frame 3104 and / or may form a proximal cuff 3107 extending beyond a proximal end of the frame 3104 and / or a distal cuff 3109 extending beyond a distal end of the frame 3104. The frame 3104 may comprise a network of wires and / or struts forming cells and / or openings. The covering 3106 may be positioned to extend across at least some of the cells and / or openings to prevent leakage of fluid through the frame 3104. The frame 3104 may be shape-set to a compressed form and / or may be flexible to allow the frame 3104 to expand to an expanded form in response to applied pressure. The covering 3106 may similarly be flexible to allow the covering 3106 to expand and / or stretch with the frame 3104.Attorney Docket No.: ADV-24177WO01

[0240] The implant 3102 may be sized for placement in a single blood vessel 61and / or in multiple blood vessels. In some examples, the blood vessel 61 may include an artery (e.g., pulmonary artery, aorta, etc.), vein, and / or other blood flow pathway.

[0241] The frame 3104 and / or covering 3106 may be delivered and / or deployed together and / or separately. In some examples, the covering 3106 may first be placed into the blood vessel 61 and the frame 3104 may subsequently be placed inside the covering 3106. However, the frame 3104 may be delivered with the covering 3106 and / or prior to the covering 3106.

[0242] In some examples, the implant 3102 may comprise and / or may be coupled to one or more delivery tubes 3108 having inner lumens to convey fluid and / or gas to and / or away from the implant 3102. While two tubes 3108 are shown in Figure 31, other numbers of tubes 3108 may be used. The one or more tubes 3108 may convey one or more adhesives to the implant 3102 for adhering the implant 3102 to the blood vessel 61. In some examples, the one or more tubes 3108 may be used to suction gas and / or fluid from at and / or around the implant 3102.

[0243] At a step 3004, the process 3000 involves expanding the frame 3204, covering 3206, and / or implant 3202 into contact with the blood vessel 61, as shown in Figure 32. In some examples, a balloon 3210 and / or other expansion device may be used to expand the implant 3202 from a compressed configuration to an expanded configuration. The implant 3202 (e.g., the frame 3204 of the implant 3202) may be at least partially elastic and / or may elastically return to a compressed (e.g., oval-shaped) configuration. Accordingly, the balloon 3210 may be used to hold the implant 3202 in an expanded (e.g., circular) configuration following expansion. The balloon 3210 may be inflated via an inflation tube 3218.

[0244] The proximal cuff 3107, distal cuff 3109, and / or other sealing elements may create a seal around the frame 3204 and / or implant 3202 to prevent flow of fluid (e.g., blood) between the implant 3202 and the blood vessel 61 while the implant 3202 is in an expanded configuration. For example, the proximal cuff 3107 and / or distal cuff 3109 may create a seal at the implant 3202 and / or the one or more tubes 3208 may suction fluid from around the implant 3202 while the seal is formed. In some examples, blood may be suctioned from at and / or around the implant 3202 via the tubes 3208 and / or adhesive may be delivered into the chamber via the tubesAttorney Docket No.: ADV-24177WO013208 (e.g., using a vacuum). The adhesive may be used to attach implant 3202 to the vessel wall.

[0245] At a step 3006, the process 3000 involves flushing and / or rinsing at and / or around the implant 3202 via the one or more tubes 3208. For example, blood and / or other fluid may be suctioned and / or pumped from and / or to around the implant 3202. In some examples, the one or more tubes 3208 may be disposed along the covering 3206 and / or frame 3204 and / or may be disposed between the covering 3206 and the frame 3204 to pull fluid from and / or deliver fluid to a space between the implant 3202 and the blood vessel 61. Saline and / or other fluids may be delivered to the implant 3202 via the one or more tubes 3208 to facilitate rinsing and / or flushing at and / or around the implant 3202.

[0246] At a step 3008, the implant 3202 and / or an area around the implant 3202 may be dried to prevent adhesives from reacting to fluid upon delivery. For example, fluid may be suctioned via the one or more tubes 3208 to create a generally dry area around the implant 3202. In this way, subsequently delivered adhesives that may be prone to reacting with fluid may effectively adhere the implant 3202 to the blood vessel 61 without reacting to surrounding fluids.

[0247] At a step 3010, the process 3000 involves delivering and / or removing adhesive to and / or from the area around the implant 3202 following drying at the implant 3202. In some examples, liquid adhesives may be delivered to the implant 3202 via one or more tubes 3208 and / or excess liquid adhesives may be suctioned from the implant 3202 via one or more tubes 3208. In some examples, the implant 3202 may comprise absorbent materials that may soak up adhesive to direct adhesive to desire points along the implant 3202.

[0248] At a step 3012, the process 3000 involves removing and / or severing various delivery devices, which can include the balloon and / or the one or more tubes 3308, as shown in Figure 33. For examples, the one or more tubes 3308 may be severed while distal ends of the one or more tubes 3308 may remain coupled to the implant 3302.

[0249] The balloon may be deflated and / or removed following a suitable amount of adhering time following delivery of adhesives. When the balloon is deflated and / or removed, the blood vessel 61 and / or implant 3202 may return to a default reduced width and / or diameter due at least in part to elasticity and / or bias of the frame 3204 of the implant 3202.Attorney Docket No.: ADV-24177WO01

[0250] Figure 34 illustrates an example implant 3402 for adhering to a blood vessel in accordance with one or more examples. The implant 3402 may comprise a frame 3404 enclosing by a covering 3406 and / or one or more cuffs 3407 extending at and / or beyond distal ends of the frame 3404 to create a seal at ends of the implant 3402. In some examples, the implant 3402 may comprise and / or may be coupled to one or more delivery tubes 3408 for delivering and / or suctioning adhesives and / or other fluids.

[0251] An outer surface of the frame 3404 may be enclosed with the covering 3406, which may comprise various textiles. The covering 3406 may be at least partially porous to facilitate flow of fluid around the implant 3402 and / or can provide a scaffold and / or surface for adhesive to stick to.

[0252] In some examples, the covering 3406 may comprise weave lines that act as channels to direct delivered liquid. An orientation of these weave lines may be perpendicular to the tubes 3408 in order to allow for efficient flow around the covering 3406. The one or more cuffs 3407 may be composed of any suitable material, which can include foam and / or other expandable materials. The cuffs 3407 may be positioned and / or formed to provide sealing between the implant 3402 and a surrounding blood vessel. The cuffs 3407 may advantageously conform to the inner wall(s) of the blood vessel but may be compressible into a significantly smaller profile catheter for deployment.

[0253] The cuffs 3407 may be at least partially composed of foam having an open cell configuration that may be compressible. Outer surfaces of the cuffs 3407 may be sealed off with a polymer film to prevent leakage going through the cuffs 3407. Inner surfaces of the cuffs 3407 may not be sealed off so that when the cuffs3407 is / are compressed, gas and / or fluid can be squeezed out.

[0254] The tubes 3408 may comprise inner lumens to provide vacuuming and / or dispensing of fluid. In some examples, the tubes 3408 may be perforated inside the covering 3406 to allow for flow around the implant 3402. The implant 3402 can comprise more than two tubes 3408. In some examples, junctions between the tubes3408 and other portions of the implant 3402 may be sealed off (e.g., by foam and / or adhesive) to prevent leakage.

[0255] The frame 3404 may have a biased oval-shaped form and / or can be attached to the covering 3406 (e.g., using sutures). An inner surface of the covering 3406 may be coated with water-impermeable Thermoplastic Polyurethane (TPU).Attorney Docket No.: ADV-24177WO01Such a coating can provide a vacuum seal and / or maintain adhesive between the covering 3406 and blood vessel wall.

[0256] Vacuum suction and / or delivery can be applied via the tubes 3408. Use of vacuum suction advantageously allows adhesives and / or other fluids to be pulled and / or suctioned into the body and / or to the implant 3402 rather than injected, which can prevent embolization. Moreover, the implant 3402 may be placed and / or a proper seating and / or seal of the implant 3402 may be verified prior to delivery of adhesive by evaluating a vacuum seal. In some examples, the implant 3402 may comprise one or more sensors configured to determine and / or transmit data relating to a vacuum seal at the implant 3402. Vacuum suction and / or delivery can also advantageously allow for controlled contact pressure and / or may be independent of mechanical properties of the native blood vessel.

[0257] Venous systems can have relatively high elasticity, creating challenges in implanting cardiovascular devices in veins. It may be advantageous for stents and / or other implants to be able to radially approximate the blood vessel walls in order to gain implant stability. However, because some blood vessels dilate with radial pressure, the implant may not be able to maintain stability and / or may migrate with time and / or flow. For instance, it can be difficult to minimally invasively place valves in the vein of patients experiencing Chronic Venous Insufficiency (CVI). In some cases, a dock may be implanted into the vein to provide radial support through a larger contact surface area. However, if the dock is larger (e.g., longer) than the implant, options for placing the dock can be limited and / or there may be mechanical failures associated with the dock. Described herein are various example dock devices with minimal size profiles to facilitate delivery and / or placement of the dock devices and / or implants at and / or within the dock devices.

[0258] Figures 35 illustrates an example docking device 3502 (e.g., dock) for docking one or more implants in accordance with one or more examples. For example, the docking device 3502 may be sized to receive the implant(s) described in Figure 34 and / or throughout this document. The docking device 3502 may comprise one or more end cuffs 3507 protruding from and / or extending from a midsection 3511 of the docking device 3502. The midsection 3511 may have a circular and / or cylindrical form having a generally continuous diameter and / or width. The one or more cuffs 3507 may be disposed at a proximal end and / or distal end of the midsection 3511 and / or may have an increased diameter and / or width relative to theAttorney Docket No.: ADV-24177WO01 midsection 3511. In some examples, the cuffs 3507 may be at least partially composed of foam and / or other soft and / or compressible materials. The cuffs 3507 may be formed to create a seal between the docking device 3502 and a surrounding blood vessel.

[0259] In some examples, the midsection 3511 may comprise a sleeve and / or covering extending along an outer and / or inner surface of the midsection 3511. The sleeve may be composed of textile and / or any suitable materials. In some examples, the midsection 3511 and / or sleeve may provide a scaffold and / or surface for gluing and / or adhering the docking device 3502 to the blood vessel and / or may be configured to expand (e.g., elastically expand) as needed.

[0260] The docking device 3502 may comprise and / or may be coupled to one or more tubes 3508 for delivery and / or removal of saline, CO2 gas, and / or adhesive. In some examples, the tubes 3508 may comprise openings 3513 at least along the docking device 3502 (e.g., along the midsection 3511) to allow the gas and / or fluid within to escape at and / or near the docking device 3502. In some examples, an inner surface of the midsection 3511 may comprise one or more layers (e.g., TPU layers) to form a leak-proof seal and / or to prevent migration of adhesive and / or other substances through the docking device 3502.

[0261] Figure 36 provides a cross-sectional view of a docking device 3602 in accordance with one or more examples. The docking device 3602 may comprise a midsection 3611 including one or more inner and / or outer layers, cuffs 3607 at ends of the midsection 3611, and / or tubes 3608 comprising openings 3613 for delivery of various gases and / or liquids. The docking device 3602 may have a generally hollow structure and / or may be sized to receive one or more implants within a lumen formed by the docking device 3602.

[0262] Figure 37 provides a flowchart illustrating an example process 3700 for adhering a dock (e.g., docking device) to a blood vessel, in accordance with one or more examples. The process 3700 may involve using controlled suction (e.g., a vacuum) to controllably dispense an adhesive at or near a docking device. Figures 38- 40 provide illustrations associated with steps of the process 3700 of Figure 37. Figure 38 illustrates an example dock 3802 deployed within a blood vessel 61 in accordance with one or more examples. Figure 39 illustrates a dock 3902 expanded into contact with walls of a blood vessel 61 in accordance with one or more examples. Figure 40Attorney Docket No.: ADV-24177WO01 illustrates a dock 4002 adhered to a blood vessel in accordance with one or more examples.

[0263] At a step 3702, the process 3700 involves unsheathing a delivery device (e.g., catheter) to deploy the dock 3802 in a target blood vessel 61, as shown in Figure 38. The dock 3802 may have a biased and / or default compressed configuration during and / or after delivery. Accordingly, a width and / or radius of the dock 3802 may be less than a width and / or radius of the blood vessel 61 upon delivery of the dock 3802. The blood vessel 61 may include a pulmonary artery, aorta, and / or other blood vessel.

[0264] The dock 3802 may comprise and / or may be coupled to one or more tubes 3808 at delivery and / or one or more tubes 3808 may be attached to the dock 3802 following delivery. The tubes 3808 may comprise openings along a midsection 3811 of the dock 3802 to allow delivery of gas and / or fluid from the tubes 3808 and / or to allow removal of gas and / or fluid into the tubes 3808. The openings of the tubes 3808 may be disposed between cuffs 3807 of the dock 3802. The cuffs 3807 may be disposed to create a seal around the midsection 3811 to prevent contact between fluid (e.g., blood) and adhesives and / or other substances delivered via the tubes 3808.

[0265] At a step 3704, the process 3700 involves expanding the dock 3902 into contact with the blood vessel 61 wall(s) using a balloon 3910 and / or other expansion device, as shown in Figure 39. The balloon 3910 may be inflated via an inflation tube 3918 to cause corresponding inflation and / or expansion of the docking device 3902. Expansion of the docking device 3902 may cause a midsection 3911 and / or cuffs 3907 of the docking device 3902 to be pressed into contact with the blood vessel 61. Tubes 3908 of the dock 3902 may extend between the cuffs 3907 and the midsection 3911 and / or may be disposed at least partially along the midsection.

[0266] At a step 3706, the process 3700 involves removing and / or clearing out blood and / or fluid from around the dock 3902 by activating a vacuum and / or via suctioning of CO2 gas to the dock 3902 to dry the space around the midsection 3911 and / or between the midsection 3911 and the blood vessel 61, as shown in Figure 39.

[0267] At a step 3708, the process 3700 involves suctioning and / or delivery of adhesive at and / or around the dock 3902 and / or implant via the tubes 3908. Following delivery the of the adhesive, the adhesive may be allowed to set for aAttorney Docket No.: ADV-24177WO01 desired amount of time to create an effective seal between the dock 3902 and the blood vessel 61.

[0268] At a step 3710, the process 3700 involves removing and / or severing various delivery devices, as shown in Figure 40. The balloon may be deflated and / or retracted out of the body. In some examples, the tubes 4008 may be severed and / or may remain coupled to the dock 4002 and / or to the midsection 4011 of the dock 4002. The tubes 4008 may extend slightly beyond the cuffs 4007 following severing of the tubes 4008. Alternatively, the tubes 4008 may be removed from the body.

[0269] The dock 4002 may advantageously provide a stable scaffold and / or surface for deploying various implants and / or stents described herein. The dock 4002 may be glued to the vessel wall and / or may not exert radial pressure on the blood vessel 61. Implants docked to the dock 4002 can exert radial pressure on the dock 4002 and / or the dock 4002 may be designed to limit radial expansion with the force pressure exerted by implants. The dock 4002 may be partially flexible and / or may be designed not to expand radially and / or to limit radial expansion of implants.

[0270] Figure 41 illustrates another example dock 4102 in accordance with one or more examples. The dock 4102 may comprise one or more end cuffs 4107 protruding from a midsection 4111 of the docking device 4102. The midsection 4111 may have a circular and / or cylindrical form having a generally continuous diameter and / or width. The one or more cuffs 4107 may be disposed at a proximal end and / or distal end of the midsection 4111 and / or may have an increased diameter and / or width relative to the midsection 4111. In some examples, the cuffs 4107 may be at least partially composed of foam and / or other soft and / or compressible materials. The cuffs 4107 may be formed to create a seal between the docking device 4102 and a surrounding blood vessel.

[0271] In some examples, the midsection 4111 may comprise a sleeve and / or covering extending along an outer and / or inner surface of the midsection 4111. The sleeve may be composed of textile and / or any suitable materials. In some examples, the midsection 4111 and / or sleeve may provide a scaffold and / or surface for gluing and / or adhering the docking device 4102 to the blood vessel and / or may be configured to expand (e.g., elastically expand) as needed.

[0272] The docking device 4102 may comprise and / or may be coupled to one or more tubes 4108 for delivery and / or removal of saline, CO2 gas, and / orAttorney Docket No.: ADV-24177WO01 adhesive. In some examples, the tubes 4108 may comprise openings at least along the docking device 4102 (e.g., along the midsection 4111) to allow the gas and / or fluid within to escape at and / or near the docking device 4102. In some examples, an inner surface of the midsection 4111 may comprise one or more layers (e.g., TPU layers) to form a leak-proof seal and / or to prevent migration of adhesive and / or other substances through the docking device 3502.

[0273] In some examples, the dock 4102 may comprise a self-expanding mesh 4115 and / or stent structure extending along an inner surface and / or inner diameter of the dock 4102. The mesh 4115 may be incorporated inside (e.g., overmolded) a TPU layer. The mesh 4115 may allow the dock 4102 to self-expand and / or may eliminate a need for a balloon and / or other expansion device to expand the dock 4102.

[0274] Figures 42A and 42B illustrate an implant and / or delivery system for delivering adhesive to one or implants 4202 in accordance with one or more examples. Figure 42A provides a perspective view of the implant 4202 and delivery system(s) and Figure 42B provides a close-up view of a portion of the delivery system(s). The implant and / or delivery system(s) of Figures 42A and 42B may be incorporated into other embodiments described herein.

[0275] The delivery system(s) may comprise a distal shaft 4204 and / or a proximal shaft 4206. The distal shaft 4204 and / or proximal shaft 4206 may be configured and / or sized to convey adhesive and / or gas and / or to suction gas and / or fluid from at and / or around the implant 4202. For example, fluid (e.g., blood, adhesive, and / or saline) may be suctioned, evacuated, and / or vacuumed away from the implant 4202 via the distal shaft 4204 and / or proximal shaft 4206 to create a dry area around the implant 4202 and / or along the distal shaft 4204. Adhesive may be delivered first into the proximal shaft 4206 and / or via the proximal shaft 4206 into the distal shaft 4204 following removal of fluid from around the implant 4202. The distal shaft 4204 may comprise one or more apertures 4214 and / or openings to allow outflow of adhesive out of the distal shaft 4204 and / or onto the stent 4202 and / or an absorbent sleeve of the stent 4202. The one or more apertures 4214 may be disposed along sides of the distal shaft 4204 to allow lateral suction and / or delivery through sides of the distal shaft 4204. Accordingly, the distal shaft 4204 may be positioned and / or sized for placement at least partially along and / or in contact with the stent 4202. In some examples, the distal shaft 4204 may be coupled to the stent 4202.Attorney Docket No.: ADV-24177WO01

[0276] The proximal shaft 4206 may be at least partially fluid-tight and / or may be structured to convey fluid without allowing leakage of fluid. In some examples, the proximal shaft 4206 may be at least partially flexible and / or may comprise features to allow the proximal shaft 4206 to bend to facilitate delivery of the proximal shaft 4206. For example, the proximal shaft 4206 may comprise one or more ridges 4216 and / or indentations that facilitate bending of the proximal shaft 4206 without exposing an inner lumen of the proximal shaft 4206.

[0277] In some examples, the proximal shaft 4206 and / or distal shaft 4204 may have generally flattened cylindrical shape and / or may comprise flat opposing sides to minimize profiles of the proximal shaft 4206 and / or distal shaft 4204. For example, the distal shaft 4204 and / or proximal shaft 4206 may comprise two rounded opposing sides and / or two flat opposing sides. One of the flat sides of the distal shaft 4204 may be disposed along the stent 4202.

[0278] In some examples, the delivery system(s) may comprise a sealing element 4210 sized to fill empty space around the distal shaft 4204 and / or proximal shaft 4206 and / or between the stent 4202 and the delivery system(s). The sealing element 4210 may be a sealer, sealing ring, sealing wing, spacer, seal, and / or other device sized and / or positioned to fill space, maintain a vacuum seal, and / or prevent leakage of gas and / or fluid from at and / or around the delivery system(s).

[0279] In some examples, the sealing element 4210 may at least partially and / or fully enclose the proximal shaft 4206 and / or at least the one or more ridges 4216 of the proximal shaft 4206. The sealing element 4210 may have variable thickness and / or width. For example, the sealing element 4210 may have a thickness approximately equal to the proximal shaft 4206 at a central portion of the sealing element 4210 and / or where the sealing element 4210 contacts and / or is adjacent to the proximal shaft 4206. In some examples, the sealing element 4210 may comprise a hollow and / or interior lumen through which the proximal shaft 4206 may pass. For example, the sealing element 4210 may comprise a lumen sized to receive the proximal shaft 4206.

[0280] The sealing element 4210 may gradually reduce in width and / or thickness from the central portion to ends on either side of the central portion. This reduction in width and / or thickness may advantageously allow the sealing element 4210 to fill empty space and / or gaps which may be present in the absence of the sealing element 4210. For example, the proximal shaft 4206 and / or distal shaft 4204Attorney Docket No.: ADV-24177WO01 may extend above the stent 4202, thus pressing the surrounding tissue (e.g., blood vessel wall) away and / or creating a gap between the surrounding tissue and the stent 4202. The gap may be greatest adjacent to the proximal shaft 4206 and / or may reduce in size laterally from the proximal shaft 4206.

[0281] The proximal shaft 4206 may be attachable to and / or detachable from the distal shaft 4204. Figure 42B provides a close-up view of how the distal shaft 4204 attaches to the proximal shaft 4206. In some examples, the delivery system(s) may comprise one or more rods 4208, which can include sutures, cords, wires, and / or lines that extend at least partially along the distal shaft 4204 and / or proximal shaft 4206. The proximal shaft 4206 may comprise one or more arms 4218 (e.g., locking elements and / or attachment elements) extending from a distal end of the proximal shaft 4206. The distal shaft 4204 may comprise one or more cavities 4228 (e.g., engagement elements) sized and / or shaped to fit and / or mate with the one or more arms 4218. Each of the one or more arms 4218 may comprise apertures 4219 and / or openings sized to fit at least one of the one or more rods 4208. During delivery and / or prior to detachment of the proximal shaft 4206 from the distal shaft 4204, the one or more rods 4208 may extend through the proximal shaft 4206, the apertures 4219, and the distal shaft 4204 to secure the components together. The one or more rods 4208 may be retracted following delivery of adhesive to allow the proximal shaft 4206 to be decoupled from the distal shaft 4204.

[0282] Figure 43 provides a perspective view of delivery system(s) following delivery of adhesive in accordance with one or more examples. One or more rods 4308 may be retracted following delivery of adhesive to allow a proximal shaft 4306 to be decoupled from a distal shaft 4304. For example, before and / or during delivery of adhesive, the one or more rods 4308 may be extended through one or more arms 4318 of the proximal shaft 4306 and / or along the distal shaft 4304 to secure the distal shaft 4304 and the proximal shaft 4306 together. By retracting the one or more rods 4308, the proximal shaft 4306 and / or a sealing element 4310 attached to the proximal shaft 4306 may be removed / removable while the distal shaft 4304 may be retained within the body and / or coupled to one or more implants.

[0283] Figure 44 provides a front view of an implant 4402 and delivery system(s) within a blood vessel 61 in accordance with one or more examples. The delivery system(s) may comprise one or more shafts 4405 (e.g., a proximal shaft and / or distal shaft). The one or more shafts 4405 may be configured and / or sized toAttorney Docket No.: ADV-24177WO01 convey adhesive. In some examples, the one or more shafts 4405 may be positioned and / or sized for placement at least partially along and / or in contact with the stent 4402. In some examples, the one or more shafts 4405 may be coupled to the stent 4402.

[0284] In some examples, the one or more shafts 4405 may have generally flattened cylindrical shapes and / or may comprise flat opposing sides to minimize profiles of the one or more shafts 4405. For example, the one or more shafts 4405 may comprise two rounded opposing sides and / or two flat opposing sides. One of the flat sides of the one or more shafts 4405 may be disposed along the stent 4402.

[0285] In some examples, the delivery system(s) may comprise a sealing element 4410 sized to fill empty space around the one or more shafts 4405 and / or between the stent 4402 and the delivery system(s). The sealing element 4410 may be a sealer, sealing ring, spacer, seal, and / or other device sized and / or positioned to fill space, maintain a vacuum seal, and / or prevent leakage of gas and / or fluid from at and / or around the delivery system(s).

[0286] In some examples, the sealing element 4410 may at least partially and / or fully enclose at least a portion of the one or more shafts 4405. The sealing element 4410 may have variable thickness and / or width. For example, the sealing element 4410 may have a thickness approximately equal to the one or more shafts 4405 at a central portion of the sealing element 4410 and / or where the sealing element 4410 contacts and / or is adjacent to the one or more shafts 4405. In some examples, the sealing element 4410 may comprise a hollow and / or interior lumen through which the one or more shafts 4405 may pass. For example, the sealing element 4410 may comprise a lumen sized to receive the one or more shafts 4405.

[0287] The sealing element 4410 may gradually reduce in width and / or thickness from the central portion to ends on either side of the central portion. This reduction in width and / or thickness may advantageously allow the sealing element 4410 to fill empty space and / or gaps which may be present in the absence of the sealing element 4410. For example, the one or more shafts 4405 may extend above the stent 4402, thus pressing the surrounding tissue (e.g., blood vessel wall) away and / or creating a gap between the surrounding tissue and the stent 4402. The gap may be greatest adjacent to one or more shafts 4405 and / or may reduce in size laterally from the one or more shafts 4405.Attorney Docket No.: ADV-24177WO01

[0288] The sealing element 4410 may be at least partially compressible and / or may be composed of generally soft and / or elastic material(s). In some examples, the sealing element 4410 may be at least partially composed of one or more elastomers. The sealing element 4410 may be at least partially expandable to allow the sealing element 4410 to fill space and / or gaps around the stent 4402 and / or delivery system(s). The sealing element 4410 and / or various components of the delivery system(s) may comprise coatings to prevent reacting to adhesives delivered via the delivery system(s).Additional Description of Examples

[0289] Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Furthermore, aspects of any example described above may be implemented in any of the numbered examples provided below.

[0290] Depending on the example, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain examples, not all described acts or events are necessary for the practice of the processes.

[0291] Example 1: An implant device comprising: a stent having a biased non-circular axial cross-sectional shape; a sleeve coupled to the stent and extending beyond the stent to form a first cuff beyond a first end of the stent; and a covering at least partially enclosing the stent and the sleeve.

[0292] Example 2: The implant device of any example herein, in particular example 1, wherein the stent comprises struts forming cells.

[0293] Example 3: The implant device of any example herein, in particular example 1, wherein the stent comprises one or more coils.

[0294] Example 4: The implant device of any example herein, in particular example 1 , wherein an end portion of the first cuff forms one or more peaks and one or more valleys.

[0295] Example 5: The implant device of any example herein, in particular example 1, wherein the sleeve has variable flexibility and increases in flexibility towards end portions of the sleeve.Attorney Docket No.: ADV-24177WO01

[0296] Example 6: The implant device of any example herein, in particular example 1 , wherein the covering is at least partially composed of different material than the sleeve and is more rigid than the sleeve.

[0297] Example 7 : The implant device of any example herein, in particular example 1, wherein the biased non-circular shape of the stent has a major-axis dimension and a minor-axis dimension, the major-axis dimension being greater than the minor-axis dimension.

[0298] Example 8: The implant device of any example herein, in particular example 7, wherein the biased non-circular shape is an oval shape.

[0299] Example 9: The implant device of any example herein, in particular example 7, wherein the biased non-circular shape is a peanut shape.

[0300] Example 10: A method comprising: deploying a sleeve in a target blood vessel segment; expanding the sleeve into contact with a wall of the target blood vessel segment to attach the sleeve to the wall of the target blood vessel segment; deploying a stent within the sleeve, the stent having a non-circular relaxed shape; and expanding the stent into contact with the sleeve to attach the stent to the sleeve.

[0301] Example 11: The method of claim 10, further comprising maintaining the sleeve in an expanded form for a period of time sufficient to allow tissue overgrowth to couple the sleeve to a wall of the target blood vessel segment.

[0302] Example 12: The method of any example herein, in particular example 10, wherein said expanding the sleeve is performed using a balloon device disposed within a channel of the sleeve.

[0303] Example 13: The method of any example herein, in particular example 10, wherein said expanding the stent is performed using a balloon device disposed within a channel of the sleeve.

[0304] Example 14: The method of any example herein, in particular example 10, further comprising advancing the sleeve and the stent to the target blood vessel segment in a transcatheter delivery system.

[0305] Example 15: The method of any example herein, in particular example 10, wherein the sleeve has a greater length relative to the stent.

[0306] Example 16: The method of any example herein, in particular example 10, wherein the sleeve comprises a covering at least partially enclosing the sleeve.Attorney Docket No.: ADV-24177WO01

[0307] Example 17: The method of any example herein, in particular example 16, wherein the covering is at least partially composed of different material than the sleeve and is more rigid than the sleeve.

[0308] Example 18: The method of any example herein, in particular example 10, further comprising delivering adhesive to the sleeve to attach the sleeve to the wall of the target blood vessel segment.

[0309] Example 19: The method of any example herein, in particular example 10, wherein the stent comprises struts forming cells.

[0310] Example 20: The method of any example herein, in particular example 10, wherein the stent comprises one or more coils.

[0311] Example 21: The method of any example herein, in particular example 10, wherein an end portion of the sleeve forms one or more peaks and one or more valleys.

[0312] Example 22: The method of any example herein, in particular example 10, wherein the sleeve has variable flexibility and increases in flexibility towards end portions of the sleeve.

[0313] Example 23: The method of any example herein, in particular example 10, wherein the non-circular relaxed shape of the stent has a major-axis dimension and a minor-axis dimension, the major-axis dimension being greater than the minor-axis dimension.

[0314] Example 24: The method of any example herein, in particular example 23, wherein the non-circular relaxed shape is an oval shape.

[0315] Example 25: The method of any example herein, in particular example 23, wherein the non-circular relaxed shape is a peanut shape.

[0316] Example 26: An implant device for adding compliance to a blood vessel, the implant device comprising: a sleeve sized to approximate a size of the blood vessel and adhere to the blood vessel, the sleeve comprising one or more first attachment features; and a stent having a network of elastically deformable struts forming a scaffold being biased in a non-circular axial cross-sectional shape, the stent comprising one or more second attachment features that align with or mate with the one or more first attachment features while the sleeve is adhered to the blood vessel.

[0317] Example 27: The implant device of claim 26, wherein: the sleeve comprises a first set of protrusions and the one or more first attachment features include first lumens extending through the first set of protrusions; and the stentAttorney Docket No.: ADV-24177WO01 comprises a second set of protrusions and the one or more second attachment features include second lumens extending through the second set of protrusions.

[0318] Example 28: The implant device of any example herein, in particular example 27, further comprising a elongate rod that extends through the first lumens and the second lumens when the first lumens are aligned with the second lumens.

[0319] Example 29: The implant device of any example herein, in particular example 26, wherein the one or more first attachment features comprise cavities and the one or more second attachment features comprise pegs configured to fit into and lock within the cavities.

[0320] Example 30: The implant device of any example herein, in particular example 29, wherein the pegs have conical ends forming bases with widths that exceeds widths of the cavities.

[0321] Example 31 : The implant device of any example herein, in particular example 26, wherein the one or more first attachment features comprise hooks or loops and the one or more second attachment features comprise hooks or loops that attach to the hooks or loops of the one or more first attachment features.

[0322] Example 32: The implant device of any example herein, in particular example 26, wherein the one or more first attachment features comprise a first plastic layer and the one or more second attachment features comprise a second plastic layer, and wherein the first plastic layer and the second plastic layer melt together in response to radio-frequency waves.

[0323] Example 33: The implant device of any example herein, in particular example 26, wherein the one or more first attachment features include a suture that weaves through openings of the stent.

[0324] Example 34: The implant device of any example herein, in particular example 26, wherein the one or more second attachment features include needles disposed within a lumen of the stent that extend beyond the stent towards the sleeve in response to outward force within the lumen of the stent.

[0325] Example 35: The implant device of any example herein, in particular example 26, wherein the stent comprises one or more bendable linkages.

[0326] Example 36: The implant device of any example herein, in particular example 26, wherein the stent comprises a hydrophilic layer and a hydrophobic layer.Attorney Docket No.: ADV-24177WO01

[0327] Example 37 : An implant device for adding compliance to a blood vessel, the implant device comprising: a stent having a network of elastically deformable struts forming a scaffold being biased in a non-circular axial cross- sectional shape, the stent comprising one or more bendable linkages forming a first proximal section, a first midsection, and a first distal section of the stent; and an inflation device that expands the first midsection against the blood vessel while not fully expanding the first proximal section and the first distal section against the blood vessel.

[0328] Example 38: The implant device of any example herein, in particular example 37, wherein: the inflation device includes a second proximal section that aligns with the first proximal section, a second midsection that aligns with the first midsection, and a second distal section that aligns with the first distal section of the stent; and the second midsection inflates before the second proximal section and the second distal section.

[0329] Example 39: An implant device for adding compliance to a blood vessel, the implant device comprising: a dock comprising a cylindrical body, a proximal cuff disposed at a proximal end of the cylindrical body, and a distal cuff disposed at a distal end of the cylindrical body, the proximal cuff and the distal cuff sized to protrude from the cylindrical body, and the cylindrical body being flexible to expand; and an implant sized for placement within the dock.

[0330] Example 40: The implant of any example herein, in particular example 39, further comprising one or more delivery tubes coupled to the cylindrical body.

[0331] Example 41: The implant of any example herein, in particular example 40, wherein the one or more delivery tubes extend between the cylindrical body and the proximal cuff.

[0332] Example 42: The implant of any example herein, in particular example 40, wherein the one or more delivery tubes comprise openings disposed along the cylindrical body and between the proximal cuff and the distal cuff.

[0333] Example 43: The implant of any example herein, in particular example 39, wherein the proximal cuff is at least partially composed of foam.

[0334] Example 44: The implant of any example herein, in particular example 39, further comprising a self-expanding mesh disposed along an inner surface of the cylindrical body.Attorney Docket No.: ADV-24177WO01

[0335] Example 45: The implant of any example herein, in particular example 39, wherein the cylindrical body forms an inner lumen to receive the implant.

[0336] Example 46: The implant of any example herein, in particular example 41, further comprising a sealing spacer coupled to at least one of the one or more delivery tubes to fill gaps around the one or more delivery tubes.

[0337] Example 47 : An implant device for adding compliance to a blood vessel, the implant device comprising a stent having a network of elastically deformable struts forming a scaffold being biased in a non-circular axial cross- sectional shape and comprising interconnected struts forming cells; a covering at least partially enclosing the stent; and an access tube extending along the covering to suction fluid from around the covering and to deliver adhesive to the covering.

[0338] Example 48: The implant device of any example herein, in particular example 22, further comprising a proximal sealing ring and a distal sealing ring coupled to the stent or covering to create a sealing zone.

[0339] Example 49: The implant device of any example herein, in particular example 23, wherein the proximal sealing ring and distal sealing ring are inflatable.

[0340] Example 50: The implant device of any example herein, in particular example 23, wherein the access tube extends between the proximal sealing ring and the covering.

[0341] Example 51 : The implant device of any example herein, in particular example 23, wherein the proximal sealing ring and the distal sealing ring fill gaps between the stent or covering and a blood vessel wall.

[0342] Example 52: The implant device of any example herein, in particular example 22, wherein the access tube comprises a proximal portion and a distal portion, and wherein the proximal portion is detachable from the distal portion.

[0343] Example 53: The implant device of any example herein, in particular example 22, wherein the access tube comprises one or more apertures along a side of the access tube to allow suctioning or delivery through the side of the access tube.

[0344] Example 54: The implant device of any example herein, in particular example 22, wherein the stent comprises one or more bendable linkages to allow for step-like expansion of the stent.Attorney Docket No.: ADV-24177WO01

[0345] Example 55: The implant device of any example herein, in particular example 22, further comprising a sleeve comprising one or more cuffs extending beyond the stent to create a sealing zone.

[0346] Example 56: The implant device of any example herein, in particular example 22, further comprising a sensor positioned to determine a vacuum seal at or around the stent.

[0347] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain examples include, while other examples do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular example. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open- ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain examples require at least one of X, at least one of Y and at least one of Z to each be present.

[0348] It should be appreciated that in the above description of examples, various features are sometimes grouped together in a single example, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and / or described in a particular example herein can be applied to or used with any other example(s). Further, no component,Attorney Docket No.: ADV-24177WO01 feature, step, or group of components, features, or steps are necessary or indispensable for each example. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular examples described above, but should be determined only by a fair reading of the claims that follow.

[0349] It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.

[0350] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example examples belong. It be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0351] The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.Attorney Docket No.: ADV-24177WO01

[0352] Unless otherwise expressly stated, comparative and / or quantitative terms, such as “less,” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”

Claims

Attorney Docket No.: ADV-24177WO01WHAT IS CLAIMED IS:

1. An implant device for adding compliance to a blood vessel, the implant device comprising: a sleeve sized to approximate a size of the blood vessel and adhere to the blood vessel, the sleeve comprising one or more first attachment features; and a stent having a network of elastically deformable struts forming a scaffold being biased in a non-circular axial cross-sectional shape, the stent comprising one or more second attachment features that align with or mate with the one or more first attachment features while the sleeve is adhered to the blood vessel.

2. The implant device of claim 1 , wherein: the sleeve comprises a first set of protrusions and the one or more first attachment features include first lumens extending through the first set of protrusions; and the stent comprises a second set of protrusions and the one or more second attachment features include second lumens extending through the second set of protrusions.

3. The implant device of claim 2, further comprising an elongate rod that extends through the first lumens and the second lumens when the first lumens are aligned with the second lumens.

4. The implant device of any of claims 1-3, wherein the one or more first attachment features comprise cavities and the one or more second attachment features comprise pegs configured to fit into and lock within the cavities.

5. The implant device of any of claims 1-3, wherein the one or more first attachment features comprise hooks or loops and the one or more second attachment features comprise hooks or loops that attach to the hooks or loops of the one or more first attachment features.

6. The implant device of any of claims 1-3, wherein the one or more first attachment features comprise a first plastic layer and the one or more secondAttorney Docket No.: ADV-24177WO01 attachment features comprise a second plastic layer, and wherein the first plastic layer and the second plastic layer melt together in response to radio-frequency waves.

7. The implant device of any of claims 1-3, wherein the one or more second attachment features include needles disposed within a lumen of the stent that extend beyond the stent towards the sleeve in response to outward force within the lumen of the stent.

8. The implant device of any of claims 1-3, wherein the stent comprises one or more bendable linkages.

9. The implant device of any of claims 1-3, wherein the stent comprises a hydrophilic layer and a hydrophobic layer.

10. An implant device for adding compliance to a blood vessel, the implant device comprising: a dock comprising a cylindrical body, a proximal cuff disposed at a proximal end of the cylindrical body, and a distal cuff disposed at a distal end of the cylindrical body, the proximal cuff and the distal cuff sized to protrude from the cylindrical body, and the cylindrical body being flexible to expand; and an implant sized for placement within the dock.

11. The implant of claim 10, further comprising one or more delivery tubes coupled to the cylindrical body.

12. The implant of claim 11, wherein the one or more delivery tubes comprise openings disposed along the cylindrical body and between the proximal cuff and the distal cuff.

13. The implant of claim 11, further comprising a sealing spacer coupled to at least one of the one or more delivery tubes to fill gaps around the one or more delivery tubes.

14. The implant of any of claims 10-13, wherein the proximal cuff is at least partially composed of foam.Attorney Docket No.: ADV-24177WO0115. The implant of any of claims 10-13, further comprising a selfexpanding mesh disposed along an inner surface of the cylindrical body.

16. The implant of any of claims 10-13, wherein the cylindrical body forms an inner lumen to receive the implant.

17. An implant device for adding compliance to a blood vessel, the implant device comprising: a stent having a network of elastically deformable struts forming a scaffold being biased in a non-circular axial cross-sectional shape and comprising interconnected struts forming cells; a sleeve attached to the stent and extending beyond the stent to form a first cuff beyond a first end of the stent, the sleeve being sized to approximate a size of the blood vessel and adhere to the blood vessel; and a covering at least partially enclosing the stent and the sleeve.

18. The implant device of claim 17, wherein the stent comprises one or more coils.

19. The implant device of claim 17 or claim 18, wherein an end portion of the first cuff forms one or more peaks and one or more valleys.

20. The implant device of claim 17 or claim 18, wherein the sleeve has variable flexibility and increases in flexibility towards end portions of the sleeve.

21. The implant device of claim 17 or claim 18, wherein the covering is at least partially composed of different material than the sleeve and is more rigid than the sleeve.

22. An implant device for adding compliance to a blood vessel, the implant device comprising: a stent having a network of elastically deformable struts forming a scaffold being biased in a non-circular axial cross-sectional shape and comprising interconnected struts forming cells; a covering at least partially enclosing the stent; andAttorney Docket No.: ADV-24177WO01 an access tube extending along the covering to suction fluid from around the covering and to deliver adhesive to the covering.

23. The implant device of claim 22, further comprising a proximal sealing ring and a distal sealing ring coupled to the stent or covering to create a sealing zone.

24. The implant device of claim 23, wherein the proximal sealing ring and distal sealing ring are inflatable.

25. The implant device of claim 23 or claim 24, wherein the access tube extends between the proximal sealing ring and the covering.

26. The implant device of claim 23 or claim 24, wherein the proximal sealing ring and the distal sealing ring fill gaps between the stent or covering and a blood vessel wall.

27. The implant device of claim 22 or claim 23, wherein the access tube comprises a proximal portion and a distal portion, and wherein the proximal portion is detachable from the distal portion.

28. The implant device of claim 22 or claim 23, wherein the access tube comprises one or more apertures along a side of the access tube to allow suctioning or delivery through the side of the access tube.

29. The implant device of claim 22 or claim 23, wherein the stent comprises one or more bendable linkages to allow for step-like expansion of the stent.

30. The implant device of claim 22 or claim 23, further comprising a sleeve comprising one or more cuffs extending beyond the stent to create a sealing zone.

31. The implant device of claim 22 or claim 23, further comprising a sensor positioned to determine a vacuum seal at or around the stent.

32. An implant device comprising: a stent having a network of elastically deformable struts forming a scaffold being biased in a non-circular axial cross-sectional shape; andAttorney Docket No.: ADV-24177WO01 a sleeve sized to approximate a size of a blood vessel and adhere to the blood vessel.

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