Stent-tissue adhesion

Abstract

An implant includes an expandable frame and an adhesive covering. The adhesive covering extends along at least a portion of the expandable frame and has flexibility to allow the adhesive covering to expand with the expandable frame and adhere to surrounding tissue.

Description

Docket No.: ADV-23832WO01 STENT-TISSUE ADHESION RELATED APPLICATION(S)

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No.63 / 568,841, filed on March 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 stent implant devices. Stent implant devices can be designed for intravascular deployment. Blood stagnation between stent implant devices and blood vessel tissue, such as in gaps formed between stent frames and blood vessel walls, can affect patient outcomes. SUMMARY

[0003] Described herein are devices, methods, and systems relating to non- circular stent devices / assemblies including tissue-adhesion features / elements configured to adhere one or more portions / aspects of a stent implant device to a surrounding blood vessel wall, which can advantageously facilitate physical coupling between the implant and the anatomy. Stent-tissue adhesion features can be particularly useful with respect to stents that have medial portions that have a different, non-circular, cross-sectional shape compared to axial end portions thereof. For example, end portions of a stent may have generally circular axial cross-sectional shape, which may facilitate fluid sealing around the stent, while medial portion(s) of the stent can have a more-ovalized shape, which may facilitate cyclical stent reshaping to improve blood flow characteristics, as disclosed in detail herein.

[0004] For stent implant devices that include fluid-tight coverings, tissue-coupling features as disclosed herein can reduce the risk of blood stagnation radially outside of the stent. For stent implant devices that do not include fluid-tight coverings, tissue-coupling features as disclosed herein can couple the stent frame to the blood vessel wall in a manner as to allow for the blood vessel wall to serve as a flood flow channel that conforms to the shape / form of the stent frame.

[0005] For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described. It is to be understood that not necessarily all suchDocket No.: ADV-23832WO01 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.

[0006] 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 human or animal cadavers, or portions thereof; synthetic; or any combination of natural and synthetic. Virtual elements can be entirely in silica, or overlaid on one or more of the physical components. Virtual elements can be presented on any combination of screens, headsets, holographically, projected, loudspeakers, headphones, pressure transducers, temperature transducers, or using any combination of suitable technologies.

[0007] 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

[0008] 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.

[0009] Figure 1 shows example cardiac and vascular anatomy.

[0010] 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.

[0011] Figure 3 shows an example stiff aorta.Docket No.: ADV-23832WO01

[0012] Figures 4-1 and 4-2 show a blood vessel in circular and non-circular axial cross-sectional shapes, respectively.

[0013] Figures 5A and 5B show perspective and axial views, respectively, of a non-circular stent disposed in a blood vessel.

[0014] Figures 6A and 6B show perspective and axial views, respectively, of a non-circular stent disposed in a blood vessel in accordance with one or more examples.

[0015] Figures 7A-7D illustrate an example method of expanding and / or attaching a stent (e.g., oval-shaped stent) in accordance with one or more examples.

[0016] Figures 8A and 8B illustrate an example balloon for use in expanding one or more stents in accordance with one or more examples.

[0017] Figure 9 illustrates an example system for adhering a stent to a blood vessel 61 in accordance with one or more examples.

[0018] Figure 10 illustrates a stent comprising an inner cover in accordance with one or more examples.

[0019] Figure 11 illustrates another example stent comprising an outer skirt 1102 in accordance with one or more examples.

[0020] Figure 12 illustrates another example system for delivering adhesives at and / or around a stent in accordance with one or more examples.

[0021] Figure 13 provides a front view of a stent configured to adhere to blood vessel walls in accordance with one or more examples.

[0022] Figure 14 illustrates an example delivery device (e.g., catheter) configured for delivery of one or more implants (e.g., stents) and / or adhesives (e.g., glue capsules).

[0023] Figure 15 illustrates another example implant comprising features configured to facilitate attachment to native anatomy in accordance with one or more examples.

[0024] Figure 16 illustrates an example stent in accordance with one or more examples.

[0025] Figures 17A and 17B illustrate an example balloon (e.g., sealing device) configured to facilitate adhesion of one or more stents in accordance with one or more examples.

[0026] Figure 18 illustrates an example system for adhering a stent to a blood vessel in accordance with one or more examples.

[0027] Figures 19A and 19B illustrate another example system for adhering a stent to inner vessel walls of a blood vessel in accordance with one or more examples.Docket No.: ADV-23832WO01

[0028] Figure 20 illustrates an example stent (e.g., implant) configured to adhere to one or more blood vessel walls in accordance with one or more examples.

[0029] Figure 21 illustrates an example stent (e.g., implant) configured to adhere to one or more blood vessel walls in accordance with one or more examples.

[0030] Figure 22 illustrates an example stent (e.g., implant) configured to adhere to one or more blood vessel walls in accordance with one or more examples.

[0031] Figure 23 illustrates an example capsule in accordance with one or more examples described herein.

[0032] Figure 24 illustrates another example stent in accordance with one or more examples.

[0033] Figure 25 illustrates another example system comprising a stent in accordance with one or more examples.

[0034] Figure 26 is a flowchart of an example process for adhering a stent to a blood vessel, in accordance with one or more examples.

[0035] Figure 27 illustrates a stent comprising one or more coverings in accordance with one or more examples.

[0036] Figure 28 provides a flow chart illustrating an example process for applying a covering to a stent in accordance with one or more examples.

[0037] Figure 29 illustrates an example system for cutting and / or removing adhesive and / or delivery tubes from an implant, in accordance with one or more examples.

[0038] Figure 30 provides a flow chart illustrating an example process for cutting and / or removing one or more adhesive and / or delivery tubes from an implant, in accordance with one or more examples.

[0039] Figure 31 (Figures 31-1, 31-2, 31-3, and 31-4) provides illustrations associated with steps of the process of Figure 30.

[0040] Figure 32 illustrates a stent comprising one or more coverings in accordance with one or more examples.

[0041] Figure 33 (Figures 33-1 and 33-2) illustrates an example delivery system for delivering and / or deploying an implant, in accordance with one or more examples.

[0042] Figure 34 illustrates an example implant deployed within a blood vessel 3401 in accordance with one or more examples.

[0043] Figure 35 (Figures 35-1 and 35-2) illustrate an example implant system in accordance with one or more examples.Docket No.: ADV-23832WO01

[0044] Figure 36 illustrates an example delivery device in accordance with one or more examples.

[0045] Figure 37 illustrates an example system including a delivery device in accordance with one or more examples.

[0046] Figure 38 Illustrates another example delivery device configured to convey one or more adhesives and / or connectors (e.g., sutures) in accordance with one or more examples.

[0047] Figure 39 illustrates another example system for adhering a stent to surrounding tissue in accordance with one or more examples.

[0048] Figure 40 (Figures 40-1 and 40-2) illustrates an example system for severing and / or decoupling a delivery device in accordance with one or more examples.

[0049] Figure 41 illustrates a portion of another example delivery device configured to convey one or more adhesives and / or delivery tools in accordance with one or more examples.

[0050] Figure 42 illustrates an example system including an implant and / or a delivery device in accordance with one or more examples.

[0051] Figure 43 illustrates a portion of another example delivery device configured to convey one or more adhesives and / or delivery tools in accordance with one or more examples.

[0052] Figure 44 illustrates a portion of another example delivery device configured to convey one or more adhesives and / or delivery tools in accordance with one or more examples.

[0053] Figures 45A–45C illustrate a portion of another example delivery device configured to convey one or more adhesives and / or delivery tools in accordance with one or more examples.

[0054] Figures 46A–46B illustrate a portion of another example delivery device configured to convey one or more adhesives and / or delivery tools in accordance with one or more examples.

[0055] Figure 47 provides a flowchart illustrating an example process for detaching and / or removing at least a portion of a delivery device of a delivery system, in accordance with one or more examples.Docket No.: ADV-23832WO01 DETAILED DESCRIPTION

[0056] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0057] 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 / or not necessarily limited to any particular disclosed sequence. Various 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.

[0058] 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, 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.Docket No.: ADV-23832WO01

[0059] 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.

[0060] 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 subject 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

[0061] Certain examples are disclosed herein in the context of vascular implant devices, and in particular, implant devices comprising non-circular segments having tissue- engagement elements associated therewith, wherein such implant devices are implanted in the aorta. However, although certain principles disclosed herein may be particularly applicable to the anatomy of the aorta, it should be understood that stent implant devices having tissue- engagement elements in accordance with the present disclosure may be implanted in, or configured for implantation in, any suitable or desirable blood vessels or other anatomy, such as the inferior vena cava.Docket No.: ADV-23832WO01

[0062] The anatomy of the heart and vascular system is described below to assist in the understanding of certain inventive concepts disclosed herein. In humans and other vertebrate animals, the heart generally comprises a muscular organ having four pumping chambers, wherein the flow thereof is at least partially controlled by various heart valves, namely, the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves.

[0063] 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.

[0064] 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 blood 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.

[0065] The heart valves may generally comprise a relatively dense fibrous ring, referred to herein as the annulus, as well as a plurality of leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that when the heart contracts the resulting increased blood pressure produced within the corresponding heart chamber forces the leaflets at least partially open to allow flow from the heart chamber. As the pressure in the heart chamber subsides, the pressure in the subsequent chamber or bloodDocket No.: ADV-23832WO01 vessel may become dominant and press back against the leaflets. As a result, the leaflets / cusps come in apposition to each other, thereby closing the flow passage.

[0066] 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 19 and superior 18 venae cavae, carry blood back to the heart.

[0067] 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.

[0068] 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 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.

[0069] Arteries, such as the aorta 16, may utilize blood vessel compliance (e.g., arterial compliance) to store and release energy through the stretching of blood 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 increasingDocket No.: ADV-23832WO01 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.

[0070] Figures 2A and 2B show side and axial cross-sectional views, respectively, of the healthy aorta 16 of Figure 1 experiencing compliant expansion and contraction over a cardiac cycle.

[0071] 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 2A and 2B, with proper arterial compliance, an increase in volume Δv 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 Δv caused by compliant stretching of the blood vessel 16 from a non-expanded diameter d1 to an expanded diameter d2, 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.

[0072] 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 Δv is the change in volume (e.g., in mL) of the blood vessel, and Δp is the pulse pressure from systole to diastole (e.g., in mmHg): ^^^^ ^^ (1)

[0073] 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 such patients is a reduction in blood supply to the heart muscle itself. For example, during systole, generally little or noDocket No.: ADV-23832WO01 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.

[0074] Insufficient perfusion of the heart muscle can lead to and / or be associated with heart failure. Heart failure is a clinical syndrome characterized by certain symptoms, including breathlessness, ankle swelling, fatigue, and others. Heart failure may be accompanied by certain signs, including elevated jugular venous pressure, pulmonary crackles, and peripheral edema, for example, which may be caused by structural and / or functional cardiac abnormality. Such conditions can result in reduced cardiac output and / or elevated intra-cardiac pressures at rest or during stress.

[0075] Figure 3 shows an example stiff aorta 16’. As shown in Figure 3, the aorta tends to change in shape as a function of age, resulting in a higher degree of curvature and / or tortuosity over time. As the vasculature of a subject becomes less elastic, arterial blood pressure (e.g., left-ventricular afterload) becomes more pulsatile, which can have a deleterious effect. For example, undesirably pulsatile arterial blood flow, such as the thickening of the left ventricle muscle and / or diastolic heart failure. Stiffness in the aorta and / or other blood vessel(s) can occur due to an increase in collagen content and / or a corresponding decrease in elastin.

[0076] With the walls of the blood vessel 16’ being resistant to stretching due to the stiffness thereof, the expansion of the blood vessel diameter from the non-expanded diameter to the expanded diameter may be limited / reduced compared to the expansion of diameter of a healthy blood vessel. A stiff aorta 16’, as blood pressure increases, may experience a small amount of expansion and volume change, or the blood vessel may be sufficiently stiff that substantially no vessel expansion takes place during systole.

[0077] Generally, the majority of aortic compliance is provided in the ascending aorta 12 with respect to healthy anatomy. Furthermore, calcification frequently occurs in the area of the ascending aorta 12, near the aortic arch 13 and the great vessels emanating therefrom. Such anatomical areas can experience relatively higher stresses due to the geometry, elasticity, and flow dynamics associated therewith. Therefore, implantation / deployment of compliance-enhancing stent devices secured to blood vessel walls using circularizing support devices of the present disclosure can advantageously be in the ascending aorta 12 in some cases. While relatively less calcification tends to occur in the descending 14 and abdominal 15 aorta, implant devices of the present disclosure canDocket No.: ADV-23832WO01 advantageously be implanted / deployed in such areas as well for the purpose of increasing compliance in the aortic system. Examples of the present disclosure provide stent implant devices having non-circular frame segments including tissue-engagement elements, which may be implanted / secured within one or more locations in a compromised aorta and / or other vessel(s). For example, Figure 3 shows example positions of stents 101 secured to blood vessel walls using features / aspects disclosed herein, such stents being implanted / disposed in various potential areas of the aorta 16’. Compliance-Enhancing Stent Implants

[0078] The present disclosure relates to delivery systems and methods for delivering various prosthetic implant devices in anatomy, such as vasculature, of a patient. As an example, implant devices that can be delivered using systems, devices, and methods disclosed herein can include stent or other implant devices configured to add-back and / or increase 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. For example, example stent implant devices of the present disclosure can include stents that, when implanted, are configured to decrease the cross-sectional area / volume of a target blood vessel segment in which the stent is implanted during low-pressure conditions, such as diastole, which serves 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.

[0079] The non-circular (e.g., oval- and / or peanut-shaped) stents of the present disclosure can advantageously be configured to generate a differential cross-sectional area or volume of the target blood vessel(s) (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.

[0080] Using non-circular stents to produce complaint blood vessel volume change by manipulating / reshaping the native blood vessel walls can increase compliance in a target blood vessel without requiring blood vessel grafting or resection. Therefore, compared to blood flow solutions involving blood vessel grafting / resection, non-circular stent examples of the present disclosure can provide solutions that avoid certain risks that may be associatedDocket No.: ADV-23832WO01 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.

[0081] With respect to a blood vessel having a relatively fixed perimeter, wherein the blood vessel wall does not stretch / 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. Figures 4-1 and 4-2 show a blood vessel in circular and non-circular axial cross-sectional shapes, respectively.

[0082] Figure 4-1 shows an example blood vessel 91 (identified as blood vessel 91a in Figure 4-1) having a generally circular cross-sectional shape, such that the area Acthereof is maximized for the given perimeter / wall-length Pa. In the circular configuration, the diameter dais substantially constant at every angle about the axis of the vessel. The circular shape of the vessel 91a may be set or permitted by the shape of a stent 93 implanted within the vessel.

[0083] Diverging from a circular cross-sectional shape can produce a cross- sectional area / volume for a blood vessel that I s less than the maximum area Ac shown in Figure 4-1. For example, Figure 4-2 shows the blood vessel 91 (identified as vessel 91b in Figure 4-2) 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 91b may have a major axis am having a dimension dc that is greater than a dimension dbof the minor axis anthereof. The oval shape of the vessel 91b may be set / forced by the stent 93, which may have a biased oval shape.

[0084] With further reference to Figures 4-1 and 4-2, due to the area Aoof the oval vessel of Figure 4-1 being less than the area Ac of the circular configuration shown in Figure 4-1, transitioning from the circular shape 91a to the non-circular shape 91b, can provide a reduction in area / volume of the blood vessel, 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.Docket No.: ADV-23832WO01

[0085] 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 affect 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. Tissue-engagement features, including spikes, barbs, and the like, as disclosed herein in association with stent frames, can increase the blood-vessel-reshaping capability of a stent implant, thereby further improving vascular compliance. 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] Examples of the present disclosure provide for stent-type implants that are biased, with respect to at least a lengthwise portion / segment thereof, 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 such 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 / flex 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 shapes, 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 return / release energy to the blood circulation.

[0087] Figures 5A and 5B show perspective and axial views, respectively, of a non-circular stent 500 in accordance with one or more examples. Although not shown for clarity in Figures 5A and 5B, it should be understood that the stent 500 may comprise one orDocket No.: ADV-23832WO01 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. Description of aspects of any example tissue-engagement element / feature of the present disclosure may be understood to be implementable in example stents like that shown in Figures 5A and 5B. The illustrated stent 500 may represent a non-circular segment of a stent implant having one or more circular portions / segments, as described in detail herein.

[0088] The stent 500 may be formed of a tubular frame 531, which may form a wall around an axial channel 549, thereby defining the channel 549. The stent 500 may be an elongate / elongated stent, in that a length L of the stent is greater than a minor-axis diameter dminand / or major-axis diameter dmajof the stent 500. As described herein, the frame wall 531 of the stent 500 can be a single, circumferentially wrapped wall, or may beconsidered to comprise or wall segments. For example, with respect to oval stents and other non-circular stents, as illustrated in Figures 5A and 5B, such stents may be considered to comprise sidewall segments 525 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 527, which may connect the side walls 525axis ends of the stent 500. The end walls 527 may be outwardly curved / concave with respect to an axis As of the stent 500. The sidewalls 525 may bow / deflect outward, either in a resting, unpressurized state, or in conditions of hoop / wall stress on the frame 531. For example, the sidewalls 525 may bow outward such that the sidewalls 525 are concave from the perspective of the axis Asof the stent 500 and convex from the perspective of the exterior of the stent 500.

[0089] Certain stent shapes are described herein, including circular, 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 5B. 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 tissue- engagement elements disclosed herein can be configured to facilitate tissue-to-frame couplings of stent segments 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, physicalDocket No.: ADV-23832WO01 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.

[0090] The stent 500 may be considered an oval stent with respect to the shape of the axial cross-section thereof, as shown in Figure 5B. The term “oval” is used herein according to its broad and ordinary meaning and may be used 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 that 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 Amajand minor Aminaxes. 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 500 may be considered a “stadium”-shaped stent, or an elongated oval.

[0091] The stent frame 531 comprises stent wall(s) defining an elongated tubular structure having a first axial end 521a with a first opening 522a. The tubular structure may further comprise a second axial end 521b with a second opening 522b, wherein the lumen / channel 549 extends between the first opening 522a and the second opening 522b, traversing the length L of the stent 500. The frame 531 and / or wall(s) thereof may comprise an open-cell structure adapted to be expanded to secure the stent 500 to a blood vessel internal (or external) wall, such as through endothelialization of the frame 531 to the vesselDocket No.: ADV-23832WO01 tissue over time as the frame 531 holds the blood vessel wall using certain tissue-engagement features described in detail herein.

[0092] The stent 500 may be elastically deformable between a first, non-circular configuration and a second, more-circular configuration 500’ (see dashed-line representation in Figure 5B), with the stent 500 biased toward the non-circular configuration. In some examples, the stent frame 531 may comprise a shape-memory material, such as Nitinol. Although shown as an oval-shaped stent, the stent 500 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.

[0093] The stent 500 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 500 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 500 may be configured to be expanded such that the perimeter of the stent 500 approximates and / or exceeds a perimeter of the blood vessel portion where the stent 500 is implanted, at least immediately prior to deployment / expansion of the stent. Placement of the stent 500 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 527 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.

[0094] In the oval configuration shown in Figures 5A and 5B, the stent 500 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 major-axis diameter / dimension dmajmay advantageously be at least twice as long as the minor-axis diameter / dimension dmin, or even 3, 4, 5, 6, or 7 times greater. The stent 500 may be configured to increaseof 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.Docket No.: ADV-23832WO01

[0095] The stent frame wall(s) 531 may be at least partially composed of struts 538 and / or stent openings / cells 535 between the struts 538. The dimensions and / or shape of the stent 500 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 dmajmay be between 1–4 cm (or larger / smaller depending on the particular anatomy), and the minor axis dmincan be between 20–50 percent of the major axis dmaj. However, other sizes and / or shapes are also within the scope of this disclosure.

[0096] The configuration of the stent 500 in the oval shape can cause blood vessel 61 to assume a more oval shape to match the shape of the stent 500. However, depending on the relative size of the stent 500 to the vessel 61, the blood vessel 61 may not necessarily conform exactly to the circumference and / or shape of the stent 500, and gap(s) 68 may be present and / or form between the frame 531 and a major side wall 62 of the blood vessel 61 as the luminal pressure increases and pushes the major side walls 63 away from the frame sidewall 525. 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 525 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 500 to reshape the blood vessel, thereby negatively impacting the efficacy of the stent 500 with respect to compliance-enhancement. Furthermore, blood may collect and / or stagnate to some degree in the gaps 68, resulting in increased risk of embolus / thrombus formation.

[0097] When implanted in a blood vessel, the patient physiology may respond to the stent 500 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 embolus / 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-circular shape. Tissue overgrowth can be promoted through contact between the stent frame and the blood vessel walls. Examples of the present disclosureDocket No.: ADV-23832WO01 provide devices that facilitate contact between non-circular stent frames and blood vessel walls using tissue-engagement features associated with the stent frame, thereby increasing the efficacy of the stents with respect to reshaping / compliance-enhancement.

[0098] The stent 500 may be biased toward the illustrated oval and / or other non- circular relaxed / diastolic configuration (shown in solid-line in Figure 5B), and may, when subjected to mechanical forces associated with high luminal pressure, be configured to responsively transform to a more-circular systolic configuration (shown in dashed-line in Figure 5B) such that the minor axis dminapproaches, and may equal, the major axis dmaj. As with any of the examples disclosed herein, the stent 500 can be configured to deflect from the oval shape to a more-circular shape in the presence of threshold blood pressure levels greater than 80 mmHg, such as blood pressure levels greater than 90 mmHg (e.g., between 90–120 mmHg).

[0099] For examples in which the stent frame 531 is not covered by a fluid-tight covering, the cells 535 of the frame 531can provide openings in the frame 531 that allow blood in the blood vessel 61 to transfer pressure through the frame 531, to thereby load the inner diameter / surface of the blood vessel with a force resulting from increases in the luminal blood pressure as the heart beats. For example, luminal pressure forces against the blood vessel wall increase the hoop stress on the blood vessel, which may force the blood vessel, and with it the stent 500, to assume a more-circular shape. The resulting hoop stress from luminal pressure increase can exert radially outward force along the blood vessel’s inner circumference, such stresses / forces being tensile in nature, which can tend to cause the blood vessel to increase in diameter. The blood pressure force on the blood vessel wall and resulting inward deflection of the blood vessel wall (due to outward deflection of the vessel wall portions in the area of the minor axis Amin) at the major-axis-ends 527 of the stent 500 may cause inward deflection of the endsof the stent 500 to form a desired geometric change to a more-circular shape 500’ (shown in dashed line) of the stent 500 and the blood vessel 61. The transition of the stent from oval to the more-circular stent shape 500’ (shown in dashed- line in Figure 7-1) causes energy to be stored in the stent frame 531 (e.g., in the elasticity and / or shape memory thereof), such that energy is returned to the blood vessel walls, and therefore to the blood circulation within the blood vessel segment, when the frame transitions back to the oval shape 500 as pressure decreases.

[0100] For examples in which the stent frame 531 is covered internally and / or externally by a fluid-tight covering (not shown in Figures 5A and 5B for visual clarity), the openings of the cells 535 of the frame 531 may be closed to pass-through fluid and preventDocket No.: ADV-23832WO01 blood in the blood vessel 61 and within the channel 549 of the stent 500 from transferring pressure through the frame 531. Therefore, intraluminal pressure within the flow channel 549 of the stent 500 loads against the frame 531 (rather than directly against the blood vessel major side walls 63) to provoke reshaping thereof. The blood-pressure-induced force against the covering and / or stent frame 531 can increase the hoop stress on the frame 531 and / or covering, which may force the frame 531, and with it the blood vessel 61, to assume a more- circular shape. Unlike with bare-frame stents that do not include fluid-tight coverings, where a covering is present, the endoluminal pressure forces in the channel 549 of the covered stent 500 are distributed over / against the covering and / or frame 531 to directly reshape the stent 500, rather than indirectly reshaping the stent 500 through force on a finite number of end contact / pressure points of the frame 531. As the pressure in the channel 549 increases (e.g., in connection with the systolic phase of the cardiac cycle), the plastically deformable nature of the stent frame 531 allows for the sidewalls 525 of the frame 531 to be pushed outward along with the shortening of the stent 500 in the major axis dimension Amaj. When the sidewalls 525 are deflected outward, the channel 549 assumes a more circular cross-sectional shape.

[0101] The natural cross-sectional shape of the aorta (and other blood vessels) may generally be circular. With the oval stent 500 pushing outward to the oval configuration, the major side walls 63 may be pulled / drawn at least partially towards an axial center of the blood vessel 61 and / or towards each other in a manner as to cause the blood vessel 61 to form a non-circular shape, such as the oval shape shown in Figure 5B. However, where the blood vessel 61 does not necessarily conform exactly to the circumference and / or shape of the oval stent 500, the gap(s) 68 may be present and / or form between the frame 531 and the major side walls 63 as the luminal pressure increases and pushes the major side walls 63 away from the frame sidewall 525.

[0102] With respect to covered stent examples, the biasing / shape-memory of the stent frame 531 may cause the sidewalls 525 to naturally pull towards the center of the frame 531, thereby potentially pulling away from the major side walls 63 to form gap(s) 68 between the stent walls 525 and the vessel major side walls 63 if insufficient tissue coupling between the stent 500 and the vessel 61 has occurred. Therefore, as with bare-frame stent examples, it may be desirable to promote tissue-coupling / engagement between non-circular stents and a blood vessel, which can promote tissue ingrowth and / or increase the reshaping effect of the stent.

[0103] The stent 500 may be deployable within a blood vessel lumen, as described and illustrated herein. However, it should be understood that example stent devicesDocket No.: ADV-23832WO01 of the present disclosure may alternatively or additionally be deployable in a position around an outer surface of a target blood vessel, in which case tissue-engagement features of the stent may project radially-inwardly to engage with the blood vessel wall.

[0104] Figures 6A and 6B show perspective and axial views, respectively, of a non-circular stent, or stent segment, 200 having inwardly deflected sidewalls 225 in accordance with one or more examples. The stent 200 may represent an example implementation of any of the non-circular / oval stents / stent-segments disclosed herein, or portion(s) thereof. The shape of the stent 200 deviates from the stent 500 shown in Figures 5A and 5B only in that the minor-axis (e.g., relatively flat and / or long) sidewalls 225 deflect to a greater degree towards the center / axis Asof the stent 200 in a relaxed state. The resulting shape may resemble that of an hourglass and / or peanut shape with respect to the axial cross- section shown in Figure 6B. The stent 200 may have a major axis diameter / dimension that is greater than a minor axis diameter / dimension of the peanut cross-section.

[0105] In some examples, the stent 200 may be biased to a shape having a minor axis dimension dmin that is non-constant along the major axis Amaj dimension, which forms an externally-concave / internally convex surface / form with respect to the minor axis sidewalls 225. For example, the minor axis sidewalls 225 may have a diameter dimension dmin1 at a center thereof (with respect to the major axis dimension Amaj) that is less than the diameter / dimension dmin2at / towards the end portions of the minor-axis sidewalls 225. Non- circular stents of the present disclosure that have externally-concave / internally convex minor- axis sidewalls as shown in Figure 6A and 6B are referred to herein as peanut-shaped stents; such peanut shape can be considered a variation of an oval, or oval-shaped, stent as described herein. The inwardly deflected walls 225 can allow for a transition reshaping between peanut- shaped, to outwardly bowed oval shape, and ultimately to circular / more-circular shape, shows as the dashed circular stent shape 200’.

[0106] Compared to the oval stent 500 of Figures 5A and 5B, the peanut-shaped stent 200 may have a tendency to form even greater gaps 68 between the minor-axis sidewalls 225 and the blood vessel major side walls 61 due to the inward deflection of the walls 225 away from the blood vessel wall. That is, the tendency of the stent sidewalls 225 to pull away from the blood vessel major side walls 63 may be relatively high, and therefore, without tissue coupling between the vessel major side walls 63 and the stent walls 225, the reshaping ability / function of the stent 200 may be at least partially impaired / impeded. Furthermore, where the gaps 68 are present between the stent walls 225 and the vessel major side walls 63, blood may collect and stagnate in such spaces, presenting embolism risk and / orDocket No.: ADV-23832WO01 impeding outward deflection of the stent walls 225 to circularize during the systolic phase of the cardiac cycle. Therefore, facilitating tissue overgrowth of the stent walls 225 may be of particular significance with respect to peanut-shaped stents.

[0107] For bare-frame peanut-shaped stent configurations, the gaps 68 between the stent walls 225 and the vessel major side walls 63 may form as the luminal pressure increases and pushes the vessel side walls 63 away from the frame sidewalls 225, which in- turn forces the end walls 62 of the vessel 61 and the end walls 227 inward to cause the stent sidewalls 225 to outwardly deflect to the more-circular shape 200’ shown in dashed-line representation in Figure 6B. For covered peanut-shaped stent configurations, increases in luminal pressure may directly push against the sidewalls 225 (and / or covering) to cause outward deflection thereof. For covered and non-covered implementations, as pressure decreases, the shape memory of the frame 231 causes the sidewalls 225 to pull back away from the vessel side walls 63 to form the gaps 68.

[0108] The frame 231 may comprise a network of struts 238 that may be interwoven with each other in a mesh patter. The struts 238 may form cells 235 and / or gaps between the struts 238, which may allow flow of blood and / or fluid through the frame 231. In some examples, the frame 231 may form an inner lumen 249 configured to allow blood flow between proximal and distal ends of the frame 231.

[0109] In order to promote tissue ingrowth between sidewalls of non-circular (e.g., oval, peanut-shaped) stents of the present disclosure and blood vessel walls, certain tissue-engagement, anchors, spikes, barbs, hooks, or the like can be implemented to couple the minor-axis walls of a non-circular-biased stent to a target blood vessel wall to conform the blood vessel walls more closely to the shape and configuration of the stent frame walls.

[0110] When a minor-axis wall of a non-circular stent of the present disclosure is coupled to a blood vessel wall via one or more anchors or other tissue-engagement features, the stent may be able to pull the blood vessel wall inward to more effectively reshape the blood vessel to improve diastolic blood flow. Furthermore, such coupling can facilitate endothelialization of the blood vessel wall over the stent frame and / or covering associated therewith. Generally, the deployment of the stent in the target blood vessel can cause injury to the vascular wall and endothelium, which comprises a layer of endothelial cells lining the vascular wall that promotes homeostasis. The injury to the blood vessel wall can result in inflammation, repair, and the development of neointimal hyperplasia. The ability of the endothelium to repair itself can depend on the migration of surrounding mature endothelial cells, and the attraction and adhesion of circulating endothelial progenitor cells (EPCs) to theDocket No.: ADV-23832WO01 area where the stent is deployed, forming overgrowth of endothelial-like cells. In some examples, stent frames and / or coverings can be implemented with drug-eluting features / coatings that at least partially interrupt the natural tissue overgrowth process. Alternatively, stents can be implemented with treatments that accelerate the reendothelialization of the damaged arterial segment following stent deployment. Such tissue-growth promotion can reduce risks of neointimal hyperplasia and stent thrombosis. In order to promote the desired coupling between stent walls and blood vessel walls to facilitate blood vessel reshaping as described in detail herein, stent frames and / or coverings of stents of the present disclosure can be treated with agents that augment the generation and / or accumulation of endothelial cells or EPCs in the area of the deployed stent. In some implementations, the stent frame and / or covering can be seeded with endothelial cells or EPCs. For example, a stent can be coated with anti-CD34 antibodies to attract endothelial / EPC cells to the stent. The stent-reshaping / circularizing structures disclosed herein can be designed to hold the associated stent in a relatively circular shape for a period of time that correlates with the expected tissue overgrowth period based on the tissue-growth- promoting / inhibiting features of the stent implant.

[0111] In some examples, adhesives (e.g., glue) can be applied to a stent to promote and / or establish attachment between the stent and the surrounding blood vessel. For example, synthetic glue can be introduced between the stent and the surrounding blood vessel wall(s) prior to, during, and / or after implantation to connect the blood vessel wall(s) to at least a portion of the stent (e.g., inwardly extending walls). As a result, during normal operation of the stent, the blood vessel may move therewith as the stent and / or blood vessel transitions between oval and circular configurations.

[0112] Examples described herein can relate to stents configured to increase compliance of one or more blood vessels (e.g., aortic and / or pulmonary blood vessels). In some examples, various adhesives (e.g., glue) may be used to interface between the stents and the surrounding blood vessel walls upon implantation, such that during normal operation of the stents, the blood vessels can move therewith as they transition between oval and / or circular configurations.

[0113] Figures 7A-7D illustrate an example method of expanding and / or attaching a stent 700 (e.g., oval-shaped stent) in accordance with one or more examples. Figures 7A-7D provide front views of the stent 700 and blood vessel 61 and illustrate steps of a method of attaching the stent 700 to blood vessel 61. Figure 7A illustrates that the stent 700 (e.g., a covered and / or oval stent) can be advanced (e.g., via a catheter) and / or deployed in a targetDocket No.: ADV-23832WO01 region of the blood vessel 61. In some examples, the stent 700 may have a default peanut and / or oval shape and / or may have inwardly extending walls at a midsection of the stent 700.

[0114] As shown in Figure 7B, a balloon 780 may be deployed at least partially within the stent 700. Initially, the balloon 780 may be in a deflated and / or compacted state. The balloon 780 may then be inflated as shown in Figure 7C to press the stent 700 into an expanded and / or circular shape. For example, the balloon 780 may be configured to expand into a circular shape and / or may be configured to press the stent 700 into a similar shape to the balloon 780. In some examples, the balloon 780 may be configured to press the stent 700 into contact with the blood vessel 61. The blood vessel 61 may have a circular and / or oval shape. The balloon 780, stent 700, and / or other implanted features may be configured to establish a connection between the stent 700 and the blood vessel 61 at least while the stent 700 and blood vessel 61 are pressed into contact with each other.

[0115] For example, synthetic glue may be introduced into an interface between the stent 700 and the surrounding vessel walls. The balloon 780 and / or stent 700 may remain in an expanded configuration for a sufficient period of time to allow the stent 700 and / or a cover of the stent 700 to adhere to the vessel walls.

[0116] The balloon 780 may then be deflated and / or removed to allow the stent 700 to return to a default (e.g., peanut and / or oval) shape, as shown in Figure 7D. As the stent 700 moves towards the default shape, the blood vessel 61 may be pulled with the stent 700. In some examples, resistance from the blood vessel 61 may prevent the walls of the stent 700 from re-assuming an inward deflection (e.g., peanut shape), however, the blood vessel 61 and / or stent 700 may be configured to assume an oval shape in response to natural movement of the stent 700 towards a peanut shape, for example.

[0117] Figures 8A and 8B illustrate an example balloon 880 for use in expanding one or more stents in accordance with one or more examples. Figure 8A provides a front view of the balloon 880 and Figure 8B provides a side view of the balloon 880. In some examples, the balloon 880 can comprise a perfusion balloon and / or can have any suitable shape. For example, the balloon 880 can comprise one or more channels and / or contours (e.g., in a helical pattern) to allow blood flow along an outer surface of the balloon 880 and / or to prevent complete obstruction of a blood vessel. The balloon 880 may be configured to allow for continuous perfusion around the balloon during the relatively prolonged duration of time (for example, approximately ninety seconds or less) required to facilitate proper adherence of a stent and / or stent cover to the surrounding blood vessel walls.Docket No.: ADV-23832WO01

[0118] In some examples, a balloon 880 may comprise one or more radial protrusions 810 extending axially along an outer surface of the balloon 880 and / or defining perfusion channels through which the blood can flow when the balloon 880 inflated against an implant (e.g., stent). For example, the protrusions 810 can comprise rods, bars, extensions, elongate members, and / or other devices extending from an exterior surface of the balloon 880 and / or extending length-wise along the balloon such that gaps may be formed between the protrusions 810 to allow blood flow. The balloon 880 may be configured to expand implants (e.g., stents) having various sizes.

[0119] Figure 9 illustrates an example system for adhering a stent 902 to a blood vessel 61 in accordance with one or more examples. In some examples, the system may comprise one or more tubes 912 which may be detachably connected to the stent 902. The one or more tubes 912 may be configured to introduce one or more adhesives (e.g., glue) at and / or near the stent 902 from a reservoir 915 (e.g., syringe). While the system is illustrated comprising two tubes 912, fewer or more tubes 912 may be used.

[0120] In some examples, distal ends and / or portions of the tubes 912 can be disposed at and / or around the stent 902 and / or they proximal to the stent 902. The one or more tubes 912 can comprise one or more openings 917 directed towards a space between the stent and the vessel walls of the blood vessel 61.

[0121] During balloon inflation and / or approximation of the stent’s outer surface to the inner wall of the blood vessel 61, glue may be introduced therebetween via the tubes 912, with the balloon (not shown) remaining inflated to hold the stent 902 against the blood vessel 61 for a predetermined period of time (e.g., between twenty and ninety seconds), after which the balloon may be deflated and / or the tubes 912 may be detached from the stent 902 and / or retrieved, leaving the stent 902 in situ.

[0122] In some examples, the tubes 912 can comprise one or more side openings 917 through which glue can be ejected towards the stent 902 and / or blood vessel 61. In some examples, the stent 902 may comprise an absorbent skirt configured to absorb the glue. In such cases, the openings 917 may be configured to direct ejected glue towards the skirt. The system can comprise multiple 912, each configured to direct glue towards different areas of the stent 902 to adhere an entire circumference of the stent 902 to the blood vessel 61.

[0123] Figure 10 illustrates a stent 1002 comprising an inner cover 1003 in accordance with one or more examples. The stent 1002 can comprise a wire frame 1001 forming struts extending around cells of the stent 1002. In some examples, an inner cover 1003 (e.g., impermeable cover) can be disposed at least partially over an inner surface of theDocket No.: ADV-23832WO01 stent frame 1001 to restrict blood flow passage through the frame 1001. The inner cover 1003 can wrap at least partially over ends of the frame 1001 and / or extend at least partially along an outer surface of the frame 1001. For example, the cover 1003 can be configured to wrap around a proximal end 1006 and / or distal end 1008 of the frame 1001. The inner cover 1003 can comprise any suitable material(s), which can include thermoplastic polyurethane (TPU).

[0124] Figure 11 illustrates another example stent 1102 comprising an outer skirt 1104 in accordance with one or more examples. The outer skirt 1104 can comprise any suitable material(s), which can include velour and / or polyethylene terephthalate (PET). In some examples, the outer skirt 1104 can comprise one or more absorbing materials and / or may be configured to provide a glue-absorbing matrix. The outer skirt 1104 can be disposed centrally between a distal end 1106 and a proximal end 1108 of the stent 1102. In some examples, the stent 1102 may additionally comprise an inner cover (e.g., impermeable cover) extending along an inner and / or outer surface of the frame of the stent 1102 and / or configured to prevent the glue from entering into a lumen of the stent 1102.

[0125] Figure 12 illustrates another example system for delivering adhesives at and / or around a stent 1202 in accordance with one or more examples. In some examples, the stent 1202 may be detachably coupled to one or more tubes 1212 and / or guidewires configured to guide the tubes 1212 to the stent 1202. For example, the stent 1202 may be delivered attached to one or more guidewires and / or one or more tubes 1212 may be extended along the guidewires following delivery of the stent 1202. In some examples, the system may comprise a balloon 1280 configured to expand the stent 1202. The one or more tubes 1212 may be configured to attach to the balloon 1280 and / or to be inserted between the balloon 1280 and the stent 1202 prior to inflation of the balloon 1280. The balloon 1280 may be inflated via an inflation device 1270 (e.g., inflation tube).

[0126] The one or more tubes 1212 and / or guidewires can be detachably attached at their distal ends to an outer surface of the stent 1202. In some examples, the tubes 1212 and / or guidewires may be added to a middle and / or central portion of the stent 1202. The guidewires may be shape-set to bend away from the frame of the stent 1202 to allow advancement of the tubes 1212 without having the edges of the tubes 1212 snag and / or be impeded by the proximal edge of the stent 1202. Use of guidewires may advantageously reduce the profile of the system during delivery through the patient’s body.

[0127] The tubes 1212 may be configured to convey one or more adhesives (e.g., glue) from a reservoir 1215 to the stent 1202. In some examples, glue may be introduced at the stent 1202 before, during, and / or after inflation of the balloon 1280. Following inflationDocket No.: ADV-23832WO01 of the balloon 1280, the balloon 1280 may be deflated and / or the balloon 1280 and / or the tubes 1212 and / or wires can be detached from the stent 1202 and / or may be retrieved and / or removed from the patient's body.

[0128] The tubes 1212 may be configured to terminate proximally relative to a distal end of the stent 1202 and / or may be configured to extend past the stent 1202. The tubes 1212 may comprise one or more openings 1217 configured to allow flow of adhesive out of the tubes 1212 and / or towards the stent 1202 and / or a skirt of the stent 1202.

[0129] The tubes 1212 may be releasably attached to the stent 1202 and / or balloon 1280. In some examples, the stent 1202 can comprise one or more sealing rings and / or sealing members at a proximal end 1206 and / or distal end 1208 of the stent 1202 to prevent injected glue from drifting beyond the stent 1202 and / or into the blood stream.

[0130] Where the tubes 1212 are attached to the balloon 1280, the tubes 1212 may be configured to provide adhesive to an inner side of the stent 1202. In some examples, the inner cover and / or skirt of the stent 1202 may be at least partially permeable to allow adhesive to pass through the cells of the stent 1202 to the outer surface of the stent 1202 and / or to an absorbent skirt at the outer surface of the stent 1202. In some examples, the balloon 1280, guidewires, and / or tubes 1212 may be detached and / or retracted together following deflation of the balloon 1280.

[0131] Figure 13 provides a front view of a stent 1302 configured to adhere to blood vessel walls in accordance with one or more examples. The stent 1302 may comprise one or more capsules 1305 containing glue and / or other adhesives coupled to a frame 1301 of the stent 1302. The capsules 1305 may be disposed along inwardly-deflected sidewalls 1325 of the stent 1302. While eight capsules 1305 are shown in Figure 13, the stent 1302 can comprise any number of capsules 1305. Capsules 1305 may be distributed around a circumference of the stent 1302 such that the stent 1302 fully adheres to blood vessel walls.

[0132] After deployment, the stent 1302 may be configured to be balloon- expanded such that an outer surface of the stent 1302 is pressed into contacting with the surrounding blood vessel walls. In some examples, the stent 1302 may be expanded with sufficient force to burst the capsules 1305 against the blood vessel walls to expose the glue and / or adhesive contained within the capsules 1305. The stent 1302 may comprise an absorbent skirt configured to attract and / or absorb the adhesive and / or facilitate adherence to the blood vessel. Expansion of the stent 1302 can be maintained for a predetermined period of time (e.g., twenty to ninety seconds), after which a balloon may be deflated and / or retracted, leaving the stent 1302 in situ and / or adhered to the surrounding vessel wall.Docket No.: ADV-23832WO01

[0133] Figure 14 illustrates an example delivery device 1403 (e.g., catheter) configured for delivery of one or more implants (e.g., stents) and / or adhesives (e.g., glue capsules). The delivery device 1403 can comprise one or more recesses (1423) configured to accommodate one or more outwardly extending members (e.g., capsules) extending from an implant to avoid application of pressure on such members during delivery via the device 1403. For example, an implant may comprise one or more glue capsules disposed about an exterior surface of the implant. Such capsules may be susceptible to bursting in response to applied pressure. The recesses 1423 of the device 1403 may be configured to avoid applying pressure to such capsules. The device 1403 is shown comprising four recesses 1423 spaced and / or sized evenly about in interior surface of the device 1403. However, the device 1403 may comprise any number and / or size(s) of recesses 1423.

[0134] Figure 15 illustrates another example implant 1500 comprising features configured to facilitate attachment to native anatomy in accordance with one or more examples. The implant 1500 may comprise a stent 1502 (e.g., an oval and / or peanut stent) and / or a sealing device 1504 (e.g., balloon and / or balloon-expandable skirt). The implant 1500 may comprise one or more capsules 1505 (e.g., adhesive containers) containing glue and / or attached to the sealing device 1504. The one or more capsules 1505 may be attached to a proximal portion 1516 and / or distal portion 1518 of the sealing device 1504.

[0135] The device 1504 may be configured to extend at least partially through an inner lumen of the stent 1502 and / or beyond the stent 1502 at proximal and / or distal ends of the stent 1502. In some examples, the capsules 1505 may be attached to an outer surface of the device 1504 at portions of the device 1504 that extend beyond the stent 1502. During delivery, the portions of the device 1504 that extend beyond the stent 1502 may be configured to fold down and / or in-line with the inner lumen of the stent 1502 to protect the capsules 1505 during delivery and / or crimping of the stent 1502.

[0136] After deployment and / or upon inflation of the device 1504, the stent 1502 may present greater resistance to expansion of the device 1504 such that the portions of the device 1504 that extend beyond the stent 1502 may be configured to inflate to a larger degree than portions of the device 1504 within the stent 1502. As such, the device 1504 and / or stent 1502 may assume a "pumpkin" shape and / or configuration during initial stages of inflation, in which ends of the device 1504 have an increased diameter relative to the stent 1502 and / or relative to a midsection of the device 1504. This inflation of the end portions of the device 1504 may be configured to orient the capsules 1505 attached to the device 1504 towards theDocket No.: ADV-23832WO01 blood vessel walls and / or towards gaps between the stent 1502 and the surrounding vessel walls.

[0137] In some examples, the proximal portion 1516 and / or distal portion 1518 of the device 1504 may be configured to assume a circular cross-section and / or shape upon inflation. In this way, the device 1504 may assume a similar shape to a blood vessel and / or may facilitate adhesion along their entire circumference of the implant 1500 to the inner walls of the blood vessel.

[0138] The implant 1500 can comprise one or more impermeable inner layers disposed along the stent 1502 and / or device 1504. In some examples, an impermeable inner layer may extend along the device 1504 and / or beyond the ends of the stent 1502 to prevent glue and / or other adhesives from the capsules 1505 from passing through the device 1504 and / or stent 1502. The stent 1502 may comprise a skirt and / or absorbing matrix disposed along an exterior surface of the stent 1502 and / or along inwardly deflected sidewalls of the stent 1502. The skirt may be configured to attract glue released from the capsules 1505 as the capsules 1505 burst. In some examples, the skirt may be an extension of the device 1504 and / or may be part of the device 1504.

[0139] In some examples, the sealing device 1504 may comprise a skirt and / or sheet / layer of material configured to be expanded via one or more balloons. For example, a balloon may be inserted within the stent 1502 and / or device 1504 such that inflation of the balloon may cause outward expansion of the stent 1502 and / or device 1504. In some examples, the device 1504 may be an extension of an absorbent skirt disposed at least partially along the stent 1502.

[0140] Figure 16 illustrates an example stent 1602 in accordance with one or more examples. The stent 1602 may comprise a frame 1601 and / or a skirt 1604 extending at least partially along an outer surface of the frame 1601. For example, the skirt 1604 may extend along inwardly deflected sidewalls of the frame 1601. The skirt 1604 may be configured to attract glue released from capsules at or near the stent 1602 as the capsules burst. In some examples, the skirt 1604 may be configured to extend at least partially beyond the frame 1601. The frame 1601 and / or skirt 1604 may comprise one or more adhesive containers and / or capsules.

[0141] Figures 17A and 17B illustrate an example balloon 1704 (e.g., sealing device) configured to facilitate adhesion of one or more stents in accordance with one or more examples. The balloon 1704 can comprise a proximal portion 1716 and / or distal portion 1718 on either end of a central portion 1717 (e.g., midsection) of the balloon 1704. TheDocket No.: ADV-23832WO01 central portion 1717 may be configured to support and / or be disposed at least partially within a stent 1702. The proximal portion 1716 and / or distal portion 1718 may be configured to extend beyond proximal and / or distal ends of the stent 1702. In some examples, the balloon 1704 may be configured to press against at least portions of skirt extensions extending from a stent 1702 and / or to press the skirt extensions against an inner wall of a blood vessel.

[0142] The balloon 1704 can be configured to assume a dog-bone configuration upon inflation, such that the proximal portion 1716 and / or distal portion 1718 of the balloon 1704, aligned with skirt extensions, may be designed to expand to a larger diameter than the central portion 1717 of the balloon 1704 and / or stent 1702.

[0143] Upon inflation of the balloon 1704, the proximal portion 1716 and / or distal portion 1718 of the balloon 1704 approximate the skirt extension to the inner walls of the blood vessel, after which glue and / or other adhesive can be provided (e.g., injected) to attach the skirt extensions to the blood vessel. In some examples, the skirt extensions can comprise adhesive capsules (see, e.g., Figure 15) configured to burst in response to the balloon 1704 pressing the skirt and / or capsules against the blood vessel wall.

[0144] The balloon 1704 may be at least partially composed of perfusion materials. The balloon 1704 may be tube-shaped so as to define an inner lumen 1710 upon inflation. The inner lumen 1710 may be configured to allow for continued blood flow during the procedure of expansion of the stent 1702 and / or retainment against the blood vessel for a relatively prolonged period of time (e.g., between twenty and ninety seconds) to allow proper adhesion between 1702 the stent and the surrounding blood vessel wall.

[0145] Figure 18 illustrates an example system 1800 for adhering a stent 1802 to a blood vessel 61 in accordance with one or more examples. The system 1800 can comprise a tube 1811 and / or wire having a helical and / or other shape to approximate a shape of the blood vessel 61. The tube 1811 may be at least partially composed of one or more shape-memory materials, which can include Nitinol. In some examples, the tube 1811 may be deployed prior in insertion and / or deployment of the stent 1802. For example, the tube 1811 may be sized to accommodate the stent 1802 within an inner lumen formed by the tube 1811.

[0146] The tube can be delivered in a compact (e.g., approximately straight) configuration and / or may be shape-set to assume the helical and / or spiraling configuration shown in Figure 18 when removed from a delivery device (e.g., catheter). The tube 1811 can comprise one or more side openings 1813, which may be oriented radially inwards (e.g., facing and / or towards the stent 1802 and / or a skirt 1804 of the stent 1802).Docket No.: ADV-23832WO01

[0147] In some examples, one or more balloons may be used to expand the stent 1802 into contact with the tube 1811 and / or blood vessel 61. During balloon inflation and approximation of the outer surface of the stent 1802 and / or skirt 1804 to the helical tube 1811, glue and / or other adhesive may be introduced through the side openings 1813 of the tube 1811. Inflation balloons may remain inflated to hold the expanded position for a predetermined period of time, after which the balloon(s) may be deflated and / or the tube 1811 and / or balloon can be retracted prior to full curing of the glue.

[0148] In some examples, the tube 1811 can comprise a wire covered with a flexible tube that include side openings along at least a portion of the tube 1811. In such examples, both the wire and the tube 1811 may be retrieved after balloon deflation and / or prior to full curing of the glue.

[0149] Figures 19A and 19B illustrate another example system 1900 for adhering a stent 1902 to inner vessel walls of a blood vessel 61 in accordance with one or more examples. The system 1900 may comprise a generally flexible and / or compliant docking frame 1909. The docking frame 1909 may comprise a wireframe and / or mesh composed of any suitable material(s), which can include Nitinol and / or other shape-memory material(s).

[0150] In some examples, the frame 1909 can comprise one or more capsules 1905 containing glue and / or other adhesive(s). The one or more capsules 1905 can be attached to an inner surface of the docking frame 1909.

[0151] The docking frame 1909 can comprise one or more lateral spikes and / or hooks extending from the wireframe and / or along its outer surface. Such spikes and / or hooks may be configured to facilitate anchoring of the docking frame 1909 to the wall(s) of the blood vessel 61.

[0152] The system 1900 may comprise a stent 1902, which may be positioned inside the docking frame 1909, as shown in Figure 19B. For example, the frame 1909 may comprise an inner lumen configured to receive the stent 1902. In some examples, the system 1900 may comprise a balloon 1904 configured to inflate to expand the stent 1902 against the docking frame 1909, as shown in Figure 19B. The balloon 1904 may comprise perforation and / or perfusion material(s). In some examples, the balloon 1904 may be configured to apply sufficient force to press the stent 1902 against the capsules 1905 of the frame 1909 and / or burst the capsules 1905 to expose the glue contained therein. As the glue is exposed, the stent 1902 may be adhered to the docking frame 1909 and / or blood vessel walls.

[0153] In some examples, the docking frame 1909 may comprise a mesh having some measure of compliance to allow the frame 1909 to move along with the stent 1902 asDocket No.: ADV-23832WO01 the stent 1902 transitions between default and / or compressed (e.g., oval) configuration and an expanded (e.g., circular) configuration without restricting movement of the stent 1902.

[0154] Figure 20 illustrates an example stent 2002 (e.g., implant) configured to adhere to one or more blood vessel walls in accordance with one or more examples. The stent 2002 may comprise a frame 2001 (e.g., wireframe) including a networks of struts forming cells between the struts. The stent 2002 may comprise one or more skirts 2004, which may be at least partially composed of absorbent material(s). In some examples, the stent 2002 may comprise a first skirt 2004a and / or a second skirt 2004b. The first skirt 2004a and / or the second skirt 2004b may be formed into elongated strips extending along a major axis of the stent 2002. The second skirt 2004b may be configured to extend approximately in the same direction as the first skirt 2004a and / or generally in parallel with the first skirt 2004a.

[0155] The first skirt 2004a and / or the second skirt 2004b may be composed of any suitable material(s), which can include velour and / or other sponge-like material(s) configured to absorb glue and / or other adhesives. The first skirt 2004a and / or the second skirt 2004b may be configured to compress to reduce a crimped profile of the first skirt 2004a and / or the second skirt 2004b and / or stent 2002 during delivery.

[0156] The stent 2002 may comprise one or more glue containing capsules 2005 arranged between the first skirt 2004a and / or the second skirt 2004b and / or attached to the frame 2001. Utilizing two skirts 2004 instead of a one-piece continuous skirt 2004 may allow for separation between the position(s) of the skirt(s) 2004 and / or the position(s) of the capsules 2005, which can advantageously reduce a crimped profile of the stent 2002.

[0157] In some examples, the stent 2002 may be configured to expanded and / or inflated via a balloon and / or other inflation element. After deployment of the stent 2002 and / or as an inflation balloon is inflated (e.g., within a lumen of the stent 2002), the stent 2002 may be configured to expand against the blood vessel wall(s), applying sufficient force to burst the capsules 2005 and / or expose glue contained within the capsules 2005. The skirt(s) 2004 may be configured to attract the glue and / or facilitate adherence to the blood vessel.

[0158] The capsule(s) 2005 can be at least partially composed of an at least partially dissolvable material configured to dissolve as the stent 2002 is delivered into the patient’s body. Accordingly, glue may be released from the capsule(s) 2005 in a generally uniform manner.

[0159] In some examples, the capsules 2005 may be arranged in an alternating manner around the stent between the first skirt 2004a and / or the second skirt 2004b. ForDocket No.: ADV-23832WO01 example, the stent 2002 may comprise a first capsule 2005a disposed nearer to the first skirt 2004a than to the second skirt 2004b and / or the stent 2002 may comprise a second capsule 2005b disposed nearer to the second skirt 2004b than to the first skirt 2004a. The first capsule 2005a and the second capsule 2005b may be offset along a major axis and / or along a minor axis of the stent 2002. The capsules 2005 may be axially offset from each other and / or may be arranged in a zig-zagged pattern. The alternating arrangement of the capsules 2005 can advantageously reduce a crimped profile of the stent 2002. For example, the capsules 2005 disposed closer to the first skirt 2004a and / or the second skirt 2004b can define a greater circumferential distance from each other, allowing the capsules 2005 to move towards each other during crimping without interfering with capsules 2005 arranged on the opposite side of the stent 2002.

[0160] The capsules 2005 may have any suitable size and / or shape. In some examples, the capsules 2005 may have a generally circular and / or oval shape.

[0161] In some examples, the stent 2002 can comprise an impermeable layer 2003 disposed along an interior and / or exterior surface of the frame 2001. The impermeable layer 2003 may be configured to prevent flow of glue and / or other adhesives beyond the stent 2002 and / or into an inner lumen of the stent 2002. In some examples, the skirt(s) 2004 and / or capsule(s) 2005 may be disposed on and / or attached to the impermeable layer 2003 and / or the frame 2001.

[0162] Figure 21 illustrates an example stent 2102 (e.g., implant) configured to adhere to one or more blood vessel walls in accordance with one or more examples. The stent 2102 may comprise a frame 2101 (e.g., wireframe) including a networks of struts forming cells between the struts. The stent 2102 may comprise one or more skirts 2104, which may be at least partially composed of absorbent material(s). In some examples, the stent 2102 may comprise a first skirt 2104a and / or a second skirt 2104b. The first skirt 2104a and / or the second skirt 2104b may be formed into elongated strips extending along a major axis of the stent 2102.

[0163] The first skirt 2104a and / or the second skirt 2104b may be composed of any suitable material(s), which can include velour and / or other sponge-like material(s) configured to absorb glue and / or other adhesives. The first skirt 2104a and / or the second skirt 2104b may be configured to compress to reduce a crimped profile of the first skirt 2104a and / or the second skirt 2104b and / or stent 2102 during delivery.

[0164] The stent 2102 may comprise one or more glue-containing capsules 2105 arranged between the first skirt 2104a and / or the second skirt 2104b and / or attached to theDocket No.: ADV-23832WO01 frame 2101. Utilizing two skirts 2104 instead of a one-piece continuous skirt 2104 may allow for separation between the position(s) of the skirt(s) 2104 and / or the position(s) of the capsules 2105, which can advantageously reduce a crimped profile of the stent 2102.

[0165] In some examples, the stent 2102 may be configured to expanded and / or inflated via a balloon and / or other inflation element. After deployment of the stent 2102 and / or as an inflation balloon is inflated (e.g., within a lumen of the stent 2102), the stent 2102 may be configured to expand against the blood vessel wall(s), applying sufficient force to burst the capsules 2105 and / or expose glue contained within the capsules 2105. The skirt(s) 2104 may be configured to attract the glue and / or facilitate adherence to the blood vessel.

[0166] The capsule(s) 2105 can be at least partially composed of an at least partially dissolvable material configured to dissolve as the stent 2102 is delivered into the patient’s body. Accordingly, glue may be released from the capsule(s) 2105 in a generally uniform manner.

[0167] The first skirt 2104a and / or the second skirt 2104b may have different widths (e.g., in an axial and / or minor axis direction), such that the second skirt 2104b (e.g., disposed at an upstream end of the stent 2102) may be narrower relative to the first skirt 2104a and / or the first skirt 2104a (e.g., disposed an a downstream end of the stent 2102) may be wider relative to the second skirt 2104b.

[0168] The variable widths of the skirts 2104 may advantageously gather glue flowing downstream at the wider skirt (e.g., the first skirt 2104a), which can serve as a primary absorbing matrix.

[0169] When the pulmonary valve closes, it can create a small vacuuming effect that can cause modest upstream-directed flow. Thus, the second skirt 2104b may advantageously absorb any flow in the upstream direction.

[0170] In some examples, the capsules 2105 may be axially aligned around the circumference of the stent. The spacing between adjacent capsules 2105 can be selected to provide a favorable crimped configuration.

[0171] The capsules 2105 may have any suitable size and / or shape. In some examples, the capsules 2105 may have a generally circular and / or oval shape.

[0172] In some examples, the stent 2102 can comprise an impermeable layer 2103 disposed along an interior and / or exterior surface of the frame 2101. The impermeable layer 2103 may be configured to prevent flow of glue and / or other adhesives beyond the stent 2102 and / or into an inner lumen of the stent 2102. In some examples, the skirt(s) 2104 and / orDocket No.: ADV-23832WO01 capsule(s) 2105 may be disposed on and / or attached to the impermeable layer 2103 and / or the frame 2101.

[0173] Figure 22 illustrates an example stent 2202 (e.g., implant) configured to adhere to one or more blood vessel walls in accordance with one or more examples. The stent 2202 may comprise a frame 2201 (e.g., wireframe) including a networks of struts forming cells between the struts. The stent 2202 may comprise one or more skirts 2204, which may be at least partially composed of absorbent material(s). In some examples, the stent 2202 may comprise a first skirt 2204a and / or a second skirt 2204b. The first skirt 2204a and / or the second skirt 2204b may be formed into elongated strips extending along a major axis of the stent 2202.

[0174] The first skirt 2204a and / or the second skirt 2204b may be composed of any suitable material(s), which can include velour and / or other sponge-like material(s) configured to absorb glue and / or other adhesives. The first skirt 2204a and / or the second skirt 2204b may be configured to compress to reduce a crimped profile of the first skirt 2204a and / or the second skirt 2204b and / or stent 2202 during delivery.

[0175] The stent 2202 may comprise one or more glue-containing capsules 2205 arranged between the first skirt 2204a and / or the second skirt 2204b and / or attached to the frame 2201. Utilizing two skirts 2204 instead of a one-piece continuous skirt 2204 may allow for separation between the position(s) of the skirt(s) 2204 and / or the position(s) of the capsules 2205, which can advantageously reduce a crimped profile of the stent 2202.

[0176] In some examples, the stent 2202 may be configured to expanded and / or inflated via a balloon and / or other inflation element. After deployment of the stent 2202 and / or as an inflation balloon is inflated (e.g., within a lumen of the stent 2202), the stent 2202 may be configured to expand against the blood vessel wall(s), applying sufficient force to burst the capsules 2205 and / or expose glue contained within the capsules 2205. The skirt(s) 2204 may be configured to attract the glue and / or facilitate adherence to the blood vessel.

[0177] The capsule(s) 2205 can be at least partially composed of an at least partially dissolvable material configured to dissolve as the stent 2202 is delivered into the patient’s body. Accordingly, glue may be released from the capsule(s) 2205 in a generally uniform manner.

[0178] In some examples, the capsule(s) 2205 may have an elongated and / or oval shape. The elongated shape of the capsule(s) 2205 can assist in a crimped profile of the stent 2202, wherein a greater number of narrower capsules 2205 can be disposed around aDocket No.: ADV-23832WO01 circumference of the stent 2202 without unduly increasing the crimped profile of the stent 2202. Moreover, the elongated shape of the capsule(s) may advantageously direct released glue in an axial direction (e.g., towards the first skirt 2204a and / or second skirt 2204b).

[0179] The capsule(s) 2205 can have a non-uniform wall thickness and / or may be thinner at a region of desired release of the glue (e.g., towards the first skirt 2204a and / or second skirt 2204b). For example, the capsule(s) 2205 may be thinner at ends of the capsule(s) 2205.

[0180] In some examples, the capsules 2205 may be axially aligned around the circumference of the stent. The spacing between adjacent capsules 2205 can be selected to provide a favorable crimped configuration.

[0181] The capsules 2205 may have any suitable size and / or shape. In some examples, the capsules 2205 may have a generally circular and / or oval shape.

[0182] In some examples, the stent 2202 can comprise an impermeable layer 2203 disposed along an interior and / or exterior surface of the frame 2201. The impermeable layer 2203 may be configured to prevent flow of glue and / or other adhesives beyond the stent 2202 and / or into an inner lumen of the stent 2202. In some examples, the skirt(s) 2204 and / or capsule(s) 2205 may be disposed on and / or attached to the impermeable layer 2203 and / or the frame 2201.

[0183] Figure 23 illustrates an example capsule 2305 in accordance with one or more examples described herein. The capsule 2305 may be configured to hold glue and / or other adhesive within a center portion 2315 of the capsule 2305.

[0184] The capsule 2305 may comprise one or more layers. In some examples, an inner layer 2316 of the capsule 2305 may be composed of different material(s) than an outer layer 2318 of the capsule 2305. The inner layer 2316 may be configured to contain the glue therein up to a burst point during expansion of an implant (e.g., a stent) against a blood vessel wall. The outer layer 2318 may at least partially and / or fully surround the inner layer 2316 and / or may be a robust layer configured to protect the inner layer 2316 during loading of the implant, during storage (e.g., for a duration of the implant’s shelf-life), and / or during introduction into the patient’s body.

[0185] The outer layer 2318 may comprise a dissolvable and / or partially dissolvable material that may be configured to dissolve when introduced into the bloodstream and / or during delivery and implantation. In some examples, the outer layer 2318 may be configured to dissolve over the course of several minutes.Docket No.: ADV-23832WO01

[0186] Figure 24 illustrates another example stent 2402 in accordance with one or more examples. The stent 2402 may comprise a wire and / or mesh frame 2401, an impermeable layer 2403 extending along the frame 2401, a skirt 2404 disposed over the frame 2401 and / or impermeable layer 2403, and / or one or more capsules 2405 disposed on the skirt 2404.

[0187] In some examples, the one or more capsules 2405 may not be configured to burst while squeezed between a blood vessel and the stent 2402 during expansion of the stent 2402 (e.g., due to balloon inflation). Rather, the one or more capsules 2405 may be configured to have their shells (e.g., outer layers) broken and / or torn by a separate activation mechanism. For example, the one or more shells may comprise outer layers configured to break and / or dissolve in response to application of an energy source applied thereto by a separate device. In some examples, the outer layers of the one or more capsules 2405 may comprise various materials sensitive to application of energy sources. In some examples, the outer layers may be configured break and / or dissolve in response to a magnetic field, high local temperatures focused at a specific region, radiation oncology (RO) radiation, ultrasonic waves, lasers, and / or other sources.

[0188] As the one or more capsules 2405 burst upon activation, glue within the one or more capsules 2405 may be configured to spread over the skirt 2404 to facilitate adhesion of the stent 2402 to the surrounding blood vessel walls. In some examples, a balloon can be inflated prior to and / or during activation so as to improve adherence of the stent 2402 to the blood vessel. However, the inflation pressure of the balloon can be smaller, sufficient to expand the stent against the surrounding anatomy, but not necessarily to burst the capsule due to balloon pressure.

[0189] Figure 25 illustrates another example system 2500 comprising a stent 2502 in accordance with one or more examples. The stent 2502 may comprise a wire and / or mesh frame 2501, an impermeable layer 2503 extending along the frame 2501, a skirt 2504 disposed over the frame 2501 and / or impermeable layer 2503, and / or one or more capsules 2505 disposed on the skirt 2504.

[0190] The system 2500 may additionally comprise one or more wires 2525 attached at distal ends of the one or more wires 2525 to the capsules 2505. In some examples, the distal ends of the wires 2525 may comprise sharp edges (e.g., forming hooks engaged with outer layers of the capsule(s) 2505) such that after expansion of the stent 2502 to approximate the capsules 2505 to the blood vessel wall, the wires 2525 can be proximallyDocket No.: ADV-23832WO01 pulled, thereby tearing the outer layers of the capsule(s) 2505 to expose the glue contained inside.

[0191] Figure 26 is a flowchart of an example process 2600 for adhering a stent to a blood vessel, in accordance with one or more examples.

[0192] At step 2602, the process 2600 involves deploying a stent device in a blood vessel. The stent device can comprise one or more skirts, which can extend along an outer and / or inner surface of a frame of the stent device. In some examples, the stent device may have a non-circular cross-sectional shape. The stent device may comprise a major axis configured to contact vessel walls of the blood vessel upon deployment. Moreover, the stent device may comprise a minor axis that is smaller than the major axis and / or may not be configured to contact the vessel walls of the blood vessel upon deployment.

[0193] In some examples, the stent device may comprise one or more adhesive capsules (e.g., capsules containing one or more adhesives at least partially enclosed by one or more layers of the adhesive capsules). The adhesive capsules may be coupled to and / or disposed on the frame of the stent device and / or on a skirt of the stent device. In some examples, the one or more adhesive capsules may be disposed on a portion of a skirt extending beyond the frame of the stent device.

[0194] At step 2604, the process 2600 involves inserting and / or delivering a balloon at least partially within the stent device. For example, the stent device may form an inner lumen into which the balloon may be inserted. The balloon may be in a deflated state and / or form upon delivery to the stent device.

[0195] At step 2606, the process 2600 involves optionally delivering one or more tubes adjacent to and / or into contact with the frame and / or one or more skirts of the stent device. The one or more tubes may be configured to convey and / or introduce one or more adhesives (e.g., glue) to the stent device and / or balloon. In some examples, the one or more tubes may comprise one or more shape-memory materials configured to assume and / or form a helical shape at least partially enclosing the stent device. The one or more tubes may comprise one or more openings along lengths of the one or more tubes.

[0196] At step 2608, the process 2600 involves inflating the balloon to press the stent device against and / or into contact with the blood vessel. In some examples, the balloon may be configured to press the stent device into a generally circular shape to approximate a shape of the blood vessel. The balloon may comprise one or more portions extending beyond the stent device. In some examples, the balloon may be configured to inflate to a greaterDocket No.: ADV-23832WO01 width and / or diameter at the portions of the balloon extending beyond the stent device relative to portions of the balloon disposed within the stent device.

[0197] At step 2610, the process 2600 involves optionally injecting one or more adhesives via the one or more tubes to the stent device and / or balloon.

[0198] At step 2612, the process 2600 involves adhering the stent device to the blood vessel via one or more adhesives. In some examples, the stent device may comprise one or more capsules configured to burst and / or dissolve while the stent device is pressed by the balloon into an expanded form in which inwardly extending sidewalls of the stent device bend outwardly to form a generally circular shape and / or wherein the stent device generally forms a circular shape.

[0199] In some examples, the stent device may be pressed into contact with a docking stent disposed around the stent device. The docking stent may comprise one or more capsules configured to burst and / or dissolve while the stent device is in contact with the docking stent.

[0200] At step 2614, the process 2600 involves deflating the balloon to allow the stent device to relax and / or removing the balloon and / or one or more tubes from the blood vessel.

[0201] Figure 27 illustrates a stent 2702 comprising one or more coverings in accordance with one or more examples. The stent 2702 can comprise a wire frame 2701 forming struts extending around cells of the stent 2702. In some examples, the stent 2702 may comprise an inner cover 2703 (e.g., impermeable cover) disposed at least partially over an inner surface and / or outer surface of the stent frame 2701 to restrict blood flow passage through the frame 2701. The inner cover 2703 can wrap at least partially over ends of the frame 2701 and / or extend at least partially along an outer surface of the frame 2701. For example, the cover 2703 can be configured to wrap around a proximal end 2706 and / or distal end 2708 of the frame 2701. The inner cover 2703 can comprise any suitable material(s), which can include thermoplastic polyurethane (TPU).

[0202] The inner cover 2703 may be configured to extend along only a portion of the outer surface of the frame 2701. In this way, a central region 2709 of the stent 2702 may comprise only an inner layer of the cover 2703, thereby reducing overall crimped profile. The stent 2702 may comprise an additional skirt and / or covering disposed at least partially around the inner cover 2703.

[0203] In some examples, the stent 2702 may comprise a mask and / or film disposed between the frame 2701 and the inner cover 2703. The mask may comprise anyDocket No.: ADV-23832WO01 suitable material configured to protect the frame 2701 and / or extend across cells of the frame 2701.

[0204] Figure 28 provides a flow chart illustrating an example process 2800 for applying a covering to a stent in accordance with one or more examples. Some lamination procedures involve wrapping an inner TPU film around a mandrel, placing a stent over the film, and wrapping the outer side of the stent by an outer TPU film.

[0205] At a step 2802, the process 2800 involves applying a covering to an inner surface of a stent through use of a mandrill and / or similar device. In some examples the covering may extend and / or cover an entire inner surface of the stent.

[0206] At a step 2804, the process 2800 involves applying a mask or film to an outer surface of the stent through use of a mandrill and / or other device. In some examples, the mask may be applied to the entire outer surface of the stent and / or may be applied at least partially along an inner surface of the stent. However, the mask may be applied to only a portion of the outer surface. For example, the mask may be applied only to a central portion or region of the outer surface.

[0207] At a step 2806, the process 2800 involves applying the covering to the outer surface of the stent. In some examples, the mask may be configured to prevent adhesion of the covering to a central portion of the outer surface. For example, the mask may be applied at the central portion of the outer surface to prevent adhesion of the covering at the central portion of the outer surface.

[0208] The covering along the outside surface of the stent may be configured to adhere to portions of the covering extending along the inside surface of the stent. For example, the covering may comprise the material configured to adhere to itself. The mask at the midsection of the outer covering may be configured to prevent adhesion between the outer and inner layers of the covering. The mask may be composed of any suitable material(s), which may include expanded polytetrafluoroethylene (ePTFE) and / or similar materials.

[0209] At a step 2808, the process 2800 involves removing the covering from the central portion and / or midsection of the outer surface. The covering may be cut and / or peeled from the outer surface to reduce a profile of the stent at the midsection of the stent. In this way, the covering may be present only over inflow and / or outflow portions of the stent, while the central masked region may be absent of an outer covering, thereby reducing the implant's overall crimped profile.Docket No.: ADV-23832WO01

[0210] At a step 2810, the process 2800 may involve heating the stent in an oven to secure the covering to the frame of the stent.

[0211] Figure 29 illustrates an example system 2900 for cutting and / or removing adhesive and / or delivery tubes from an implant, in accordance with one or more examples. The system 2900 may comprise a cutting portion 2907 (e.g., cutting member, cutter, etc.) and / or a driver 2908 configured to actuate the cutting portion 2907. The system 2900 may further comprise a guidewire 2905 extending between the driver 2908 and the cutting portion 2907. The cutting portion 2907 may be disposed at a distal end of the system 2900.

[0212] The cutting portion 2907 may be configured to be slid over one or more adhesive and / or glue-delivering tubes to sever and / or cut the tubes. In some examples, the cutting portion 2907 may be equipped with a conical cutting blade that can be distally advanced to cut one or more tubes. Such tubes can include those described, for example, in Figure 12 and / or throughout the description herein. In some examples, the cutting portion 2907 may be configured to cut one or more tubes at and / or beyond a proximal end of a stent following delivery of adhesives via the one or more tubes.

[0213] Figure 30 provides a flow chart illustrating an example process 3000 for cutting and / or removing one or more adhesive and / or delivery tubes from an implant, in accordance with one or more examples. Figure 31 (Figures 31-1, 31-2, 31-3, and 31-4) provides illustrations associated with steps of the process 3000 of Figure 30. Figure 31 illustrates a cutting tool 3103 and / or cutting portion of a system similar to the cutting portion 2907 of Figure 29.

[0214] At a step 3002, the process 3000 involves delivering a cutting tool 3103 (e.g., cutting portion and / or cutter) at and / or adjacent to an implant (e.g., stent), as shown in Figure 31-1. The cutting tool 3103 may comprise a blade 3111 having a suitably sharp edge (e.g., bladed edge) configured to cut a delivery tube when pressed against the delivery tube. In some examples, the blade 3111 may have a conical shape in which a proximal end (e.g., further from a distal tip 3112 of the tool 3103) has a greater width and / or diameter relative to a distal and / or cutting edge 3113 of the blade 3111. The blade 3111 may be configured to be extended along a shaft 3115 of the tool 3103. The shaft 3115 may have a generally cylindrical shape.

[0215] In some examples, the tool 3103 may comprise a lumen 3114 and / or cavity forming one or more openings 3116 in the tool 3103. For example, the lumen 3114 may comprise an opening 3116 at the shaft 3115 and / or another opening 3116 at the distal tipDocket No.: ADV-23832WO01 3112 of the tool 3103. The lumen 3114 may be configured to receive one or more tubes and / or delivery devices.

[0216] At a step 3004, the process 3000 involves passing a tube 3117 (e.g., adhesive delivery tube) at least partially through the lumen 3114, as shown in Figure 31-2. In some examples, the tube 3117 may extend out of multiple openings of the lumen 3114. The tube 3117 may first be inserted at the distal tip 3112 of the tool 3103 and extended out of the opening 3116 at the shaft 3115 of the tool 3103.

[0217] At a step 3006, the process 3000 involves extending the cutting edge 3113 of the blade 3111 along the shaft 3115 and / or towards the lumen 3114, as shown in Figure 31-3. The blade 3111 and / or guidewire coupled to the blade 3111 may be configured to extend axially along the shaft 3115 and / or towards the distal tip 3112 of the tool 3103. The cutting edge 3113 may be configured to maintain a generally flush contact with the shaft 3115 as the cutting edge 3113 extends such that no gaps may be formed between the cutting edge 3113 and the shaft 3115.

[0218] At a step 3008, the process 3000 involves extending the cutting edge 3113 across the opening 3116 of the shaft 3115 such that the cutting edge 3113 severs and / or cuts the tube 3117 where the tube 3117 extended beyond the opening 3116, as shown in Figure 31-4. The distal tip 3112 of the tool 3103 may have a generally bulbous shape and / or may increase to a greater width and / or diameter than the shaft 3115 to prevent the blade 3111 from extending beyond the shaft 3115.

[0219] After cutting the tube 3117, the tool 3103 may be proximally pulled and / or may be slid distally over additional tubes 3117 to cut the additional tubes 3117 as needed. The severed portions of the tubes can be proximally pulled and / or retrieved from the patient's body, leaving no or minimal portions of the tubes attached to an implant and / or extended along the implant.

[0220] Implants described herein may be configured for anchoring and / or placement at various locations within a body and / or heart of a patient. For examples, implants may be configured for placement within and / or attachment to one or more blood vessels, blood vessel walls, anatomical chambers (e.g., atriums, ventricles, etc.) and / or valves.

[0221] Figure 32 illustrates a stent 3202 comprising one or more coverings in accordance with one or more examples. The stent 3202 can comprise a wire frame 3201 forming struts extending around cells of the stent 3202. In some examples, the stent 3202 may comprise a covering 3203 disposed at least partially over an inner surface and / or outer surface of the frame 3201. In some examples, the covering 3203 may comprise one or moreDocket No.: ADV-23832WO01 adhesive materials (e.g., hydrogel-based adhesion material) to facilitate attachment of the stent 3202 to surrounding tissue (e.g., blood vessels, blood vessel walls, anatomical chamber, atrium, ventricle, valve, etc.). The covering 3203 may form a tape configured to adhere to the frame 3201 and / or blood vessel walls. The covering 3203 may comprise any suitable materials. For example, the covering 3203 may comprise Sanaheal tape, 3M surgical tape, Secure Strip tape, and / or other materials.

[0222] The covering 3203 may comprise hydrogel and / or various biomaterials configured to encourage tissue regeneration and growth. In some examples, the covering 3203 may be at least partially elastic and / or may be flexible to expand and / or contract with the frame 3201. In some examples, the frame 3201 may comprise an oval-shaped stent and / or the covering 3203 may be configured to attach the frame 3201 to the surrounding blood vessel wall during expansion and / or upon contact with the vessel wall and / or serving as a para-valvular skirt surrounding the frame 3201.

[0223] Figure 33 (Figures 33-1 and 33-2) illustrates an example delivery system for delivering and / or deploying an implant 3302, in accordance with one or more examples. The implant 3302 may comprise an adhesive and / or covering 3303 (e.g., adhesive covering) configured to facilitate attachment and / or adhesion of the implant 3302 to blood vessel walls and / or other tissue. Figure 33-1 illustrates the system and / or implant 3302 in a compressed and / or crimped form and Figure 33-2 illustrates the system and / or implant 3302 in an expanded form.

[0224] The covering 3303 may be wrapped around the implant 3302 and / or around a frame of the implant 3302 while the implant 3302 is in a dry state. In some examples, the covering 3303 may comprise one or more materials and / or substances configured to adhere when wet and / or not adhere when dry. The implant 3302 may be crimped around a balloon 3309 and / or other delivery device and / or the covering 3303 may be wrapped around an exterior surface of the implant 3302. The implant 3302, balloon 3309, and / or covering 3303 may be inserted into a bath and / or otherwise coated with liquid to activate adhesion of the covering 3303.

[0225] The implant 3302 may be delivered via a catheter and / or other delivery device(s) while in the compressed and / or crimped form shown in Figure 33-1. The balloon 3309 may be inflated when the implant 3302 is delivered to a target location to cause expansion of the implant 3302 and / or to expand the implant 3302 and / or covering 3303 into contact with the surrounding tissue.Docket No.: ADV-23832WO01

[0226] The covering 3303 may be at least partially elastic and / or may comprise sufficient elasticity to enable the covering 3303 to stretch along with the implant 3302 during expansion of the balloon 3309 and / or implant 3302 while maintaining structural integrity of the covering 3303. For example, the implant 3302 may be at least partially expandable and / or compressible and / or may be configured to move between an expanded form and / or a compressed / collapsed form.

[0227] In some examples, the implant 3302 and / or covering 3303 may be delivered via a catheter and / or capsule comprising a hydrophilic inner coating and / or other features configured to prevent the covering 3303 from sticking to the catheter and / or capsule during delivery. Additionally, or alternatively, the covering 3303 can be coated by one or more layers configured to temporarily prevent adhesion during delivery. Such layer(s) can be implemented as a liner that can be actively peeled prior to expansion of the implant 3302. For example, the system may comprise one or more layers attached to a delivery catheter and / or capsule (and / or other component of the delivery system) such that during deployment, the layer(s) may be peeled off from the covering 3303. In some examples, the system may comprise one or more layers of a biodegradable material (e.g., Poly(ethylene glycol) (PEG)) configured to dissolve following and / or during delivery and / or expose the covering 3303 and / or adhesives of the covering 3303.

[0228] Figure 34 illustrates an example implant 3402 deployed within a blood vessel 3401 in accordance with one or more examples. The implant 3402 may comprise an oval-shaped stent and / or frame 3404 configured to be deployed in one or more blood vessels 3401, which can include aortic and / or pulmonary blood vessels, to increase compliance of the blood vessels. The implant 3402 may be configured to facilitate proper attachment to the blood vessel 3401 wall(s) such that during normal operation of the implant 3402, the blood vessel 3401 may move with the implant 3402 as the implant 3402 transitions between configurations and / or forms (e.g., between oval and circular configurations).

[0229] The implant 3402 can comprise a covering 3403 (e.g., tape and / or adhesive material) configured to be wrapped around the outer surface of the implant 3402 and / or disposed along an inner surface of the implant 3402. While the covering 3403 is shown in Figure 34 extending along the inner surface of the frame 3404 of the implant 3402, other configurations may be used. Where the covering 3403 is disposed along the inner surface of the implant 3402, the covering 3403 may be configured to contact the surrounding blood vessel 3401 through openings 3408 (e.g., cells) of the frame 3404 of the implant 3402.Docket No.: ADV-23832WO01

[0230] In some examples, the covering 3403 may be configured to extend at least partially beyond the frame 3404. For example, the covering 3403 may extend along an inner surface of the frame 3404 and / or may extend beyond a proximal end 3412 of the frame 3404 to form a proximal cuff 3422 and / or beyond a distal end 3414 of the frame 3404 to form a distal cuff 3424. The proximal cuff 3422 and / or distal cuff 3424 may be configured to improve sealing of the implant 3402 by increasing adhesion along regions of the blood vessel 3401 which are disposed proximal and / or distal to the frame 3404 (which can also remain relatively more circular during operation of the oval stent).

[0231] The covering 3403 may advantageously be configured to attach the implant 3402 to the surrounding vessel wall(s), prevent axial migration of the implant 3402 after implantation, and / or provide sealing between the implant 3402 and the blood vessel 3401. Coverings 3403 may be used on various types of implants. While the implant 3402 is shown comprising an oval-shaped frame 3404, coverings 3403 can be similarly used in combination with other prosthetic devices, which can include prosthetic valves.

[0232] Some examples described herein involve use of tubes and / or delivery devices configured to convey and / or facilitate conveyance of one or more adhesives (e.g., glues) at and / or adjacent to one or more implants. Such tubes and / or delivery devices may be delivered percutaneously and / or surgically into the body (e.g., into a blood vessel). Following delivery of the one or more adhesives, the tubes and / or delivery devices may be removed and / or disconnected from the implant and / or may be at least partially removed from the body. In some examples, an adhesive delivery tube may be severed, cut, and / or mechanically detached from a distal portion of the delivery tube and / or from the implant.

[0233] Figure 35 (Figures 35-1 and 35-2) illustrate an example implant system 3500 in accordance with one or more examples. The system may comprise an implant 3502 (e.g., stent) configured to be deployed within one or more blood vessels, chambers, and / or cavities of a human body. The implant 3502 may comprise any features described herein (e.g., frame, skirt, covering, etc.). The systems 3500 may further comprise a delivery device 3517 (e.g., tube, catheter, etc.) configured to convey one or more adhesives (e.g., glues) in a gaseous, liquid, and / or solid form to the implant 3502 and / or adjacent to the implant 3502. Figure 35-1 illustrates the system 3500 in a first state in which the delivery device 3517 is attached, adjacent to, and / or in contact with the implant 3502. Figure 35-1 illustrates the system 3500 in a second state in which the delivery device 3517 is fully removed from the implant 3502.Docket No.: ADV-23832WO01

[0234] The delivery device 3517 may be configured to be twisted, pulled, pushed, bent, and / or otherwise moved to facilitate removal of the delivery device 3517 from the implant 3502. In some examples, the delivery device 3517 may have a braided exterior and / or may comprise two or more braided and / or interwoven wires configured to reinforce the delivery device 3517 against twisting and / or other movement. The delivery device 3517 may comprise a tube at least partially enclosed by a support coil to provide support to the tube. For example, the delivery device 3517 may be cured and / or attached to the implant 3502 during delivery and / or following delivery. To break the connection and / or bond between the implant 3502 and the delivery device 3517, the delivery device 3517 may be twisted as shown in Figure 35-1. The implant 3502 may be configured to provide counterforce to the delivery device 3517 while twisting the delivery device 3517.

[0235] In some examples, the delivery device 3517 may be adhered to the implant 3502 via glue and / or other adhesives. The glue and / or other adhesives may be molded (e.g., injection molded) into desired forms to facilitate breaking the delivery device 3517 from the implant 3502. For example, the delivery device 3517 may comprise threads (e.g., male threads) and / or glue may be molded to form threads (e.g., female threads) configured to mate with the corresponding threads of the delivery device 3517. In this way, the delivery device 3517 may forward twist to thread onto the molded glue and / or may reverse twist to unthread and / or break away from the molded glue. Additionally, or alternatively, glue may be molded into a tapered form and / or the delivery device 3517 may have a tapered form to facilitate breaking the delivery device 3517 from the implant 3502.

[0236] Figure 36 illustrates an example delivery device 3617 in accordance with one or more examples. The delivery device 3617 may be configured to lock onto and / or otherwise attach to one or more implants (e.g., stents) as described herein. In some examples, the delivery device 3617 may comprise one or more openings 3618 (e.g., apertures, ports, cavities, lumens, etc.) sized to allow adhesives (e.g., liquid glue) to flow out of a lumen of the delivery device 3617 and / or at or near an implant to facilitate adhesion of the implant to surrounding tissue. The one or more openings 3618 may be disposed laterally along a side portion of the delivery device 3617 to allow adhesive to exit laterally from the delivery device 3617 and / or the one or more openings 3618 may be aligned along the delivery device 3617. The delivery device 3617 may comprise one or more sutures 3619 configured to facilitate attachment of the delivery device 3617 to an implant.

[0237] In some examples, the delivery device 3617 may comprise a distal end 3614 comprising an opening configured to allow the one or more sutures 3619 to exit theDocket No.: ADV-23832WO01 delivery device 3617 and / or attach to an implant. In some examples, the one or more sutures 3619 and / or one or more adhesives may be disposed and / or conveyed via a common lumen of the delivery device 3617. Alternatively, the delivery device 3617 may comprise multiple lumens and / or the one or more sutures 3619 may be disposed in a different lumen than the adhesive.

[0238] The one or more sutures 3619 may be configured to form one or more loops and / or may be configured to interweave with struts of the implant. For example, a delivery tool may be extended via the delivery device 3617 to control weaving and / or looping of the one or more sutures 3619 around and / or through struts and / or cells of the implant.

[0239] Figure 37 illustrates an example system 3700 including a delivery device 3717 in accordance with one or more examples. In some examples, a delivery device 3717 may be configured to couple to and / or attach to a stent 3702 and / or other implant. The stent 3702 may include any of the stents and / or implants described herein, including oval-shaped and / or peanut-shaped stents.

[0240] In some examples, the delivery device 3717 may be configured to convey one or more adhesives for adhering the stent 3702 to surrounding tissue. The delivery device 3717 may comprise one or more openings 3718 (e.g., apertures) sized to allow adhesive to exit the delivery device 3717 and / or to contact the stent 3702 and / or surrounding tissue. The openings 3718 may be disposed along sides of the delivery device 3717 and / or at a distal end of the delivery device 3717.

[0241] The delivery device 3717 may be further configured to convey one or more sutures 3719 and / or other attachment mechanisms. For example, a suture 3719 may be extended from a proximal end (not shown) of the delivery device 3717 to a distal end of the delivery device 3717 and / or may be configured to exit the delivery device 3717 to secure to the stent 3702. In some examples, the stent 3702 may comprise a network of struts 3706 forming one or more cells 3708 (e.g., gaps and / or openings). The suture 3719 may be configured to weave through struts 3706 of the stent 3702. In some examples, the suture 3719 may form one or more loops configured to be looped around struts 3706 of the stent 3702.

[0242] The delivery device 3717 may comprise one or more lumens configured to convey the suture 3719 and / or one or more adhesives. In some examples, the delivery device 3717 may comprise a single lumen configured to convey both the suture 3719 and the one or more adhesives. Alternatively, the delivery device 3717 may comprise multiple lumens and / or the suture 3719 may be conveyed via a different lumen than the one or more adhesives.Docket No.: ADV-23832WO01

[0243] In some examples, the delivery device 3717 may be configured to adhere to the stent 3702. For example, adhesive delivered via the delivery device 3717 may be configured to adhere the delivery device 3717 to struts 3706 of the stent 3702.

[0244] Securing the delivery device 3717 to the stent 3702 can advantageously facilitate delivery of adhesives via the delivery device 3717. For example, the delivery device 3717 may be secured to the stent 3702 via the one or more sutures 3719 upon delivery of the delivery device 3717 to the stent 3702. Once secured to the stent 3702 via the one or more sutures 3719, adhesives may be conveyed via the delivery device 3717 to the stent 3702 and / or surrounding tissue. In this way, adhesives may advantageously be delivered accurately to desired positions at and / or near the stent 3702. The one or more sutures 3719 may then be released (e.g., by extending one or more release tools via the delivery device 3717 to detach and / or disentangle the one or more sutures 3719 from the stent 3702) following delivery of the adhesives to allow removal of the delivery device 3717 from the body.

[0245] Figure 38 Illustrates another example delivery device 3817 configured to convey one or more adhesives and / or connectors (e.g., sutures) in accordance with one or more examples. The delivery device 3817 may comprise a first set of openings 3818 (e.g., apertures) sized to allow outward flow of adhesive from a lumen of the delivery device 3817 and / or the delivery device 3817 may comprise a second set of openings 3828 (e.g., apertures) sized and / or shaped to facilitate coupling between the one or more connectors and one or more implants.

[0246] The second set of openings 3828 may be disposed at an appendage 3825 (e.g., finger, arm, extension) extending from a distal end 3814 of the delivery device 3817 (e.g., a distal appendage). In some examples, the appendage 3825 may have an elongate and / or generally flat form and / or may extend from only a portion of a circumference of the distal and 3814. For example, the appendage 3825 may be configured to lay flatly against a surface of a stent and / or implant upon delivery of the delivery device 3817 to the stent and / or implant.

[0247] Figure 39 illustrates another example system 3900 for adhering a stent 3902 to surrounding tissue in accordance with one or more examples. The system 3900 may comprise a delivery device 3917 configured to convey one or more adhesives and / or one or more sutures 3919 to the stent 3902 to facilitate attachment of the stent 3902 to the surrounding tissue and / or to the delivery device 3917. Figure 39 provides an overhead view of the delivery device 3917 and stent 3902.Docket No.: ADV-23832WO01

[0248] The delivery device 3917 may comprise an appendage 3925 extending from a distal end of the delivery device 3917. The appendage 3925 may comprise one or more openings configured to receive the one or more sutures 3919 to facilitate coupling between the delivery device 3917 and the stent 3902. For example, the one or more sutures 3919 may be configured to exit a distal end of the delivery device 3917 and / or interweave through openings of the appendage 3925 and struts 3906 of the stent 3902. The stent 3902 may comprise a network of struts 3906 forming cells 3908. The one or more sutures 3919 may be configured to passed through openings of the appendage 3925 to loop around struts 3906 of the implant 3902 at an underside of the appendage 3925. The one or more sutures 3919 may also pass upwardly through the appendage 3925 in a weaving and / or lacing pattern to affix the appendage 3925 and / or delivery device 3917 to the stent 3902.

[0249] Securing the delivery device 3917 to the stent 3902 can advantageously facilitate delivery of adhesives via the delivery device 3917. For example, the delivery device 3917 may be secured to the stent 3902 via the one or more sutures 3919 upon delivery of the delivery device 3917 to the stent 3902. Once secured to the stent 3902 via the one or more sutures 3919, adhesives may be conveyed via the delivery device 3917 to the stent 3902 and / or surrounding tissue. In this way, adhesives may advantageously be delivered accurately to desired positions at and / or near the stent 3902. The one or more sutures 3919 may then be released (e.g., by extending one or more release tools via the delivery device 3917 to detach and / or disentangle the one or more sutures 3919 from the stent 3902) following delivery of the adhesives to allow removal of the delivery device 3917 from the body.

[0250] In some examples, the one or more sutures 3919 may comprise quick- release features and / or mechanisms configured to facilitate detachment of the one or more sutures 3919 from the stent 3902 and / or appendage 3925 following delivery of the one or more adhesives. For example, the one or more sutures 3919 may comprise latches, connectors, and / or other components configured to be released (e.g., via one or more tools deployed via the delivery device 3917). In some examples, the one or more sutures 3919 may be formed into loops at distal ends of the one or more sutures 3919 with free ends (e.g., two free ends per suture 3919) being outside the body and / or within the delivery device 3917. One or more free ends may be released to allow the one or more sutures 3919 to be unwound and / or retracted from the stent 3902 and / or appendage 3925.

[0251] Figure 40 (Figures 40-1 and 40-2) illustrates an example system 4000 for severing and / or decoupling a delivery device 4017 in accordance with one or more examples. The delivery device 4017 may be any device (e.g., catheter) configured to deliver one orDocket No.: ADV-23832WO01 more adhesives, sutures, and / or tools to one or more implants as described herein. Figure 40- 1 illustrates a first step in which a suture 4019 is advanced out of an opening 4018 (e.g., aperture) and formed into a loop around the delivery device 4017. In some examples, the suture 4019 may be pre-formed into a lasso and / or loop shape at a distal end of the suture 4019 prior to entry of the suture 4019 into the delivery device 4017. However, the suture 4019 may alternatively be configured to form a lasso and / or loop at the distal end of the suture 4019 upon removal out of the opening 4018. Figure 40-2 illustrates a second step in which the suture 4019 is wrapped around the delivery device 4017 and cinched and / or tightened around the delivery device 4017 to cause a break 4021 and / or cut in the delivery device 4017.

[0252] The delivery device 4017 may comprise one or more openings 4018 along sidewalls of the delivery device 4017 configured to allow one or more sutures 4019 extending through the delivery device 4017 to exit laterally out of the one or more openings 4018 and / or to contact an exterior surface of the delivery device 4017. The one or more sutures 4019 may be configured to exit the one or more openings 4018 and / or form a loop around the delivery device 4017 (e.g., for a pre-formed lasso and / or loop, the lasso and / or loop may be extended over a distal end of the delivery device 4017 to form a loop around the delivery device 4017).

[0253] The one or more sutures 4019 may be cinched and / or tightened by any suitable means to cause cutting and / or breaking of the delivery device 4017. In some examples, ends of the one or more sutures 4019 may be pulled proximally (e.g., from outside the body).

[0254] In some examples, the delivery device 4017 may be configured to facilitate breaking and / or cutting of the delivery device 4017 at one or more desired points. For example, the delivery device 4017 may comprise a perforated and / or partly severed point along a length of the delivery device 4017. In some examples, the delivery device 4017 may have variable wall thickness and / or may be relatively thin at one or more points to facilitate breakage and / or cutting of the delivery device 4017 at the one or more points.

[0255] Figure 41 illustrates a portion of another example delivery device 4117 configured to convey one or more adhesives and / or delivery tools in accordance with one or more examples. The delivery device 4117 may comprise a proximal portion 4121 and / or a distal portion 4122. The proximal portion 4121 and the distal portion 4122 may be interconnected and / or coupled via a connector 4124. The distal portion 4122 may be coupled to and / or in contact with a stent and / or other implant.Docket No.: ADV-23832WO01

[0256] In some examples, the connector 4124 may be at least partially composed of one or more biodegradable and / or bio dissolvable materials. For example, the connector 4124 may be configured to dissolve after a predetermined amount of time (e.g., approximately thirty minutes) within a patient's body and / or following implantation and / or delivery of the delivery device 4117 and / or connector 4124. When the connector 4124 dissolves, the proximal portion 4121 may become disconnected from the distal portion 4122. In this way, the proximal portion 4121 may be retrieved and / or removed from the patient's body while leaving the distal portion 4122 within the body and / or attached to the stent and / or implant. In some examples, the proximal portion 4121 may be coupled to the second portion 4122 and / or the connector 4124 may be disposed at or near a proximal end and / or edge of the stent and / or implant.

[0257] In some examples, the proximal portion 4121 and / or the distal portion 4122 may comprise features and / or components configured to independently couple to each other. For example, the proximal portion 4121 and / or the distal portion 4122 may comprise metallic and / or magnetic components configured to magnetically couple the proximal portion 4121 to the distal portion 4122. Such components may be disposed at end portions of the proximal portion 4121 and / or distal portion 4122. This magnetic and / or other coupling may be disengaged by proximally pulling the proximal portion 4121 away from the distal portion 4122. Where the proximal portion 4121 is coupled to the distal portion 4122 via connector 4124, the proximal portion 4121 may be disengaged from the distal portion 4122 following dissolving and / or removal of the connector 4124.

[0258] Figure 42 illustrates an example system 4200 including an implant 4202 and / or a delivery device 4217 in accordance with one or more examples. The delivery device 4217 may comprise a proximal portion 4221 and / or a distal portion 4222 interconnected via a joint 4225 (e.g., connector, ring, tube). The joint 4225 may be configured to be removed and / or broken to disconnect the proximal portion 4221 from the distal portion 4222 at a desired time (e.g., following delivery of one or more adhesives via the delivery device 4217).

[0259] The joint 4225 may be removed and / or broken by any suitable means. In some examples, the joint 4225 may be removed using electrocautery. For example, one or more wires (e.g., a guidewire) may be wrapped and / or snared around a lumen of the proximal portion 4221 and / or extended to the joint 4225. Proximal ends of the one or more wires may be attached to an electrocautery box and / or may be energized to transfer electric current to the joint 4225 to sever and / or break the joint 4225.Docket No.: ADV-23832WO01

[0260] In some examples, the joint 4225 may comprise features configured to facilitate breaking and / or removal of the joint 4225. For example, the joint 4225 may comprise relatively thin walls relative to the proximal portion 4221 and / or the distal portion 4222. In some examples, the joint 4225 may comprise one or more metallic components (e.g., rings and / or electrodes) which may be connected to an external power source.

[0261] Figure 43 illustrates a portion of another example delivery device 4317 configured to convey one or more adhesives and / or delivery tools in accordance with one or more examples. The delivery device 4317 may comprise a proximal portion 4321 and / or a distal portion 4322. The distal portion 4322 may be coupled to and / or in contact with a stent and / or other implant.

[0262] In some examples, the proximal portion 4321 and / or the distal portion 4322 may comprise threads and / or other features configured to inter couple the proximal portion 4321 and the distal portion 4322. For example, the distal portion 4322 may comprise female threads 4327 at an inner surface of the distal portion 4322 and / or the proximal portion 4321 may comprise male threads 4328 at an outer surface of the proximal portion 4321, or vice versa. In some examples, the proximal portion 4321 may be coupled to the distal portion 4322 via the threads prior to implantation in the body. One or more adhesives may be conveyed via the delivery device 4317 while the proximal portion 4321 is coupled to the distal portion 4322. Following delivery of the one or more adhesives, the proximal portion 4321 may be torqued and / or twisted to dislodge and / or unfasten the proximal portion 4321 from the distal portion 4322 and / or the proximal portion 4321 may be pulled proximately and / or removed from the body. The distal portion 4322 may remain within the body and / or may remain coupled to a stent and / or implant.

[0263] Figure 44 illustrates a portion of another example delivery device 4417 configured to convey one or more adhesives and / or delivery tools in accordance with one or more examples. The delivery device 4417 may comprise a proximal portion 4421 and / or a distal portion 4422. The distal portion 4422 may be coupled to and / or in contact with a stent and / or other implant.

[0264] In some examples, the proximal portion 4421 may be coupled to the distal portion 4422 via a temporary coupling. For example, a paste and / or material (e.g., reflow paste) may be used to couple the proximal portion 4421 to the distal portion 4422 temporarily during delivery of the delivery device 4417 to a target location within the body. The temporary coupling may be sufficiently strong to resist injection pressures of adhesives via the delivery device 4417. However, by pulling the proximal portion 4421 proximally, theDocket No.: ADV-23832WO01 coupling between the proximal portion 4421 and the distal portion 4422 may be broken. In some examples, the connection between the proximal portion 4421 and the distal portion 4422 may comprise perforations 4429 and / or a perforated line configured to facilitate breaking of the connection between the proximal portion 4421 and the distal portion 4422.

[0265] Figures 45A–45C illustrate a portion of another example delivery device 4517 configured to convey one or more adhesives and / or delivery tools in accordance with one or more examples. The delivery device 4517 may comprise a proximal portion 4521 and / or a distal portion 4522. The distal portion 4522 may be coupled to and / or in contact with a stent and / or other implant. Figure 45A illustrates a disconnected state of the delivery device 4517 in which the proximal portion 4521 is disconnected from the distal portion 4522. Figure 45B provides a cross-sectional side view of the delivery device 4517 in a connected state in which the proximal portion 4521 is attached to the distal portion 4522. Figure 45C provides a top view of the delivery device 4517 in which the proximal portion 4521 is coupled to the distal portion 4522.

[0266] The proximal portion 4521 may comprise one or more arms 4531 at a distal end of the proximal portion 4521. For example, the proximal portion 4521 may comprise two or more arms 4531. Each of the one or more arms 4531 may comprise one or more pegs 4533 (e.g., protrusions, extensions, prongs) and / or other attachment mechanisms configured to mate with corresponding attachment mechanisms of the distal portion 4522. The one or more arms 4531 may be configured to bend inwardly as indicated by dashed lines in Figure 45A. For example, the one or more arms 4531 may be configured to bend inwardly to facilitate placing the one or more pegs 4533 within corresponding features of the distal portion 4522.

[0267] In some examples, the distal portion 4522 may comprise one or more cavities 4535 (e.g., gaps, openings, notches, etc.) configured to receive the one or more pegs 4533 of the proximal portion 4521. For example, the distal portion 4522 may comprise an equal number of cavities 4535 to the number of arms 4531 and / or pegs 4533 of the proximal portion 4521. The one or more cavities for 535 may be disposed at or near a proximal end of the distal portion 4522. The one or more arms 4531 may be bent inwardly to fit within a lumen of the distal portion 4522 and / or may be straightened such that the one or more pegs 4533 may be inserted into the one or more cavities 4535 of the distal portion 4522 to lock the proximal portion 4521 in place with respect to the distal portion 4522.

[0268] Once the proximal portion 4521 is locked in place relative to the distal portion 4522, one or more tubes 4519 may be inserted via the proximal portion 4521 and / orDocket No.: ADV-23832WO01 into the distal portion 4522, as shown in Figure 45B. The one or more tubes 4519 may be configured to receive and / or dispense one or more adhesives at the distal portion 4522 such that the one or more adhesives may be delivered via one or more openings 4528 of the distal portion 4522. Following delivery of the one or more adhesives, the one or more arms 4531 of the proximal portion 4521 may be bent inwardly to release the proximal portion 4521 relative to the distal portion 4522. The proximal portion 4521 and / or the one or more tubes 4519 may then be retracted proximally and / or removed from the body while the distal portion 4522 may remain within the body (e.g., attached to a stent and / or implant).

[0269] Figures 46A–46B illustrate a portion of another example delivery device 4617 configured to convey one or more adhesives and / or delivery tools in accordance with one or more examples. The delivery device 4617 may comprise a proximal portion 4621 and / or a distal portion 4622. The distal portion 4622 may be coupled to and / or in contact with a stent and / or other implant. Figure 46A illustrates a first state of the delivery device 4617 in which the proximal portion 4621 is inserted into contact with the distal portion 4622. Figure 46B provides a cross-sectional side view of the delivery device 4617 in a locked state in which the proximal portion 4621 is locked in place relative to the distal portion 4622.

[0270] The proximal portion 4621 may comprise a proximal clip 4631 at a distal end of the proximal portion 4621 configured to mate with a distal clip 4632 of the distal portion 4622. The proximal clip 4631 may comprise one or more tabs 4633 (e.g., protrusions, extensions, prongs) and / or other attachment mechanisms configured to mate with corresponding attachment mechanisms (e.g., cavities, notches, grooves, etc.) of the distal clip 4632 of the distal portion 4622.

[0271] In some examples, the distal clip 4632 may comprise one or more cavities 4635 (e.g., gaps, openings, notches, etc.) configured to receive the one or more tabs 4633 of the proximal clip 4631. The one or more tabs 4633 may be sized and / or shaped to fit into and / or lock into place within the one or more cavities 4635 to lock the proximal portion 4621 into place relative to the distal portion 4622.

[0272] Once the proximal portion 4621 is locked in place relative to the distal portion 4622, one or more tubes may be inserted via the proximal portion 4621 and / or into the distal portion 4622. The one or more tubes may be configured to receive and / or dispense one or more adhesives at the distal portion 4622. Following delivery of the one or more adhesives, the one or more tabs 4633 of the proximal clip 4631 may be bent outwardly to release the proximal portion 4621 relative to the distal portion 4622. The proximal portionDocket No.: ADV-23832WO01 4621 may then be retracted proximally and / or removed from the body while the distal portion 4622 may remain within the body (e.g., attached to a stent and / or implant).

[0273] Figure 47 provides a flowchart illustrating an example process 4700 for detaching and / or removing at least a portion of a delivery device of a delivery system, in accordance with one or more examples. Steps of the process 4700 may be performed multiple times and / or in other orders.

[0274] At a step 4702, the process 4700 involves delivering an adhesive tube adjacent to and / or into contact with a stent and / or other implant. The adhesive may be delivered concurrently with the implant and / or following delivery of the implant. In some examples, the adhesive tube may be coupled to the implant.

[0275] At a step 4704, the process 4700 involves injecting adhesive to the implant via the adhesive tube. In some examples, the adhesive tube may comprise one or more openings configured to allow the adhesive to exit through sides of the adhesive tube and / or into contact with the implant and / or surrounding tissue.

[0276] At a step 4706, the process involves partially and / or fully detaching the adhesive tube from the implant. Example methods may include cutting, pulling, and / or detaching at least a portion of the adhesive tube from the implant. In some examples, a portion of the adhesive tube disposed approximately from the implant may be detached. The distal portion of the adhesive tube may be retained within the body and / or at the implant.

[0277] At a step 4708, the process 4700 involves partially and / or fully removing the adhesive tube from a patient’s body and / or from a blood vessel. In some examples, at least a portion of the adhesive tube may be pulled proximately away from the implant and / or a distal portion of the adhesive tube. Additional Examples

[0278] 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.

[0279] Example 1: An implant comprises a frame having inwardly extending sidewalls at a midsection of the frame, an impermeable covering extending along at least a portion of the frame, and a first skirt extending along at least a portion of the midsection of the frame, the first skirt at least partially composed of an absorbent material.

[0280] Example 2: The implant of any example herein, in particular example 1, wherein the first skirt extends along an outer surface of the midsection of the frame.Docket No.: ADV-23832WO01

[0281] Example 3: The implant of any example herein, in particular example 1, wherein the first skirt extends along an inner surface of the midsection of the frame.

[0282] Example 4: The implant of any example herein, in particular example 1, further comprising one or more capsules containing an adhesive and coupled to the midsection of the frame or the first skirt.

[0283] Example 5: The implant of any example herein, in particular example 4, wherein the first skirt comprises a proximal portion extending beyond a proximal side of the frame and a distal portion extending beyond a distal side of the frame, and wherein the one or more capsules are coupled to the proximal portion or the distal portion of the first skirt.

[0284] Example 6: The implant of any example herein, in particular example 1, further comprising a docking stent having an inner lumen configured to receive the frame, the docking stent comprising one or more adhesive capsules coupled to an inner surface of the docking stent.

[0285] Example 7: The implant of any example herein, in particular example 1, further comprising a second skirt extending approximately in parallel with the first skirt.

[0286] Example 8: The implant of any example herein, in particular example 7, wherein the first skirt has a greater width relative to the second skirt.

[0287] Example 9: The implant of any example herein, in particular example 7, further comprising one or more adhesive capsules coupled to the frame between the first skirt and the second skirt.

[0288] Example 10: The implant of any example herein, in particular example 9, wherein the one or more adhesive capsules are arranged in a zig-zag pattern.

[0289] Example 11: The implant of any example herein, in particular example 1, further comprising one or more adhesive capsules coupled to the frame or the first skirt, each of the one or more adhesive capsules comprising multiple layers enclosing an adhesive.

[0290] Example 12: The implant of any example herein, in particular example 1, further comprising one or more adhesive capsules coupled to a first portion of the first skirt that extends beyond the frame.

[0291] Example 13: A method of adhering a stent to a blood vessel, the method comprising deploying a stent device in a blood vessel, the stent device comprising a first skirt, delivering a balloon at least partially within the stent device, inflating the balloon to press the stent device into contact with the blood vessel, adhering the stent device to the blood vessel via an adhesive, and deflating the balloon.Docket No.: ADV-23832WO01

[0292] Example 14: The method of any example herein, in particular example 13, further comprising delivering a tube adjacent to the stent device and introducing the adhesive to the stent device via the tube.

[0293] Example 15: The method of any example herein, in particular example 14, further comprising delivering the tube to an outer surface of the stent device and along the first skirt.

[0294] Example 16: The method of any example herein, in particular example 14, further comprising delivering the tube between the stent device and the balloon.

[0295] Example 17: The method of any example herein, in particular example 14, wherein the tube comprising multiple openings along a length of the tube.

[0296] Example 18: The method of any example herein, in particular example 14, wherein the tube comprises a shape-memory material and is configured to form a helical shape around the stent device.

[0297] Example 19: The method of any example herein, in particular example 13, wherein the balloon comprises a proximal portion configured to extend beyond the stent device and a central portion configured to be disposed within the stent device, and wherein the proximal portion is configured to inflate to a greater width relative to the central portion.

[0298] Example 20: The method of any example herein, in particular example 13, wherein the stent device comprises one or more adhesive capsules configured to burst in response to the stent being pressed into contact with the blood vessel.

[0299] Example 21: An implant comprising: an expandable frame; and an adhesive covering extending along at least a portion of the expandable frame, the adhesive covering being flexible to expand with the expandable frame and adhere to surrounding tissue.

[0300] Example 22: The implant of any example herein, in particular example 21, wherein the expandable frame comprises inwardly-extending sidewalls at a midsection of the expandable frame.

[0301] Example 23: The implant of any example herein, in particular example 21, wherein the adhesive covering entirely encloses an inner surface of the expandable frame and only partially an outer surface of the expandable frame.

[0302] Example 24: The implant of any example herein, in particular example 21, wherein the adhesive covering extends beyond ends of the expandable frame.

[0303] Example 25: An implant comprising: a frame; and a covering extending along at least a portion of the frame.Docket No.: ADV-23832WO01

[0304] Example 26: The implant of any example herein, in particular example 25, further comprising a tube sized to attach to the frame or the covering and convey an adhesive to the frame or covering.

[0305] Example 27: The implant of any example herein, in particular example 26, wherein the tube is enclosed by braided wires to facilitate twisting of the tube.

[0306] Example 28: The implant of any example herein, in particular example 26, wherein the tube comprises one or more lateral openings sized to allow adhesive to exit laterally from the tube.

[0307] Example 29: The implant of any example herein, in particular example 26, further comprising a suture sized to extend out of a distal end of the tube and attach to the frame.

[0308] Example 30: The implant of any example herein, in particular example 29, wherein the tube comprises a distal appendage comprising apertures sized to facilitate lacing of the suture with the frame.

[0309] Example 31: The implant of any example herein, in particular example 26, further comprising a suture positioned to loop around and cut the tube.

[0310] Example 32: The implant of any example herein, in particular example 26, wherein the tube comprises a proximal portion and a distal portion.

[0311] Example 33: The implant of any example herein, in particular example 32, further comprising a dissolvable connector enclosing ends of the proximal portion and the distal portion to hold the proximal portion and the distal portion together.

[0312] Example 34: The implant of any example herein, in particular example 32, wherein the proximal portion is comprises magnetic components to magnetically couple to the distal portion.

[0313] Example 35: The implant of any example herein, in particular example 32, wherein the proximal portion and the distal portion comprise threads at ends of the proximal portion and the distal portion to facilitate threading the proximal portion into the distal portion.

[0314] Example 36: The implant of any example herein, in particular example 32, wherein the proximal portion comprises one or more pegs and the distal portion comprises one or more cavities sized to receive the one or more pegs.

[0315] Example 37: The implant of any example herein, in particular example 26, wherein the tube comprises perforations to facilitate breaking of the tube.Docket No.: ADV-23832WO01

[0316] Example 38: An implant comprising: a frame having inwardly extending sidewalls at a midsection of the frame; an impermeable covering extending along at least a portion of the frame; and a first skirt extending along at least a portion of the midsection of the frame, the first skirt at least partially composed of an absorbent material.

[0317] Example 39: The implant of any example herein, in particular example 38, wherein the first skirt extends along an outer surface of the midsection of the frame.

[0318] Example 40: The implant of any example herein, in particular example 38, wherein the first skirt extends along an inner surface of the midsection of the frame.

[0319] Example 41: The implant of any example herein, in particular example 38, further comprising one or more capsules containing an adhesive and coupled to the midsection of the frame or the first skirt.

[0320] Example 42: The implant of any example herein, in particular example 41, wherein the first skirt comprises a proximal portion extending beyond a proximal side of the frame and a distal portion extending beyond a distal side of the frame, and wherein the one or more capsules are coupled to the proximal portion or the distal portion of the first skirt.

[0321] Example 43: The implant of any example herein, in particular example 41, further comprising a docking stent having an inner lumen sized to receive the frame, the docking stent comprising one or more adhesive capsules coupled to an inner surface of the docking stent.

[0322] Example 44: The implant of any example herein, in particular example 41, further comprising a second skirt extending approximately in parallel with the first skirt.

[0323] Example 45: The implant of any example herein, in particular example 44, wherein the first skirt has a greater width relative to the second skirt.

[0324] Example 46: The implant of any example herein, in particular example 44, further comprising one or more adhesive capsules coupled to the frame between the first skirt and the second skirt.

[0325] Example 47: The implant of any example herein, in particular example 46, wherein the one or more adhesive capsules are arranged in a zig-zag pattern.

[0326] Example 48: The implant of any example herein, in particular example 41, further comprising one or more adhesive capsules coupled to the frame or the first skirt, each of the one or more adhesive capsules comprising multiple layers enclosing an adhesive.

[0327] Example 49: The implant of any example herein, in particular example 41, further comprising one or more adhesive capsules coupled to a first portion of the first skirt that extends beyond the frame.Docket No.: ADV-23832WO01

[0328] Example 50: An implant system comprising: a frame having inwardly extending sidewalls at a midsection of the frame, the frame sized to fit within a blood vessel; a tube coupled to the frame, the tube having an inner lumen to carry adhesive and comprising one or more openings to allow the adhesive to exit the tube adjacent to the frame; and a balloon sized to fit within the frame and being inflatable to expand at least the midsection of the frame against the blood vessel.

[0329] Example 51: The system of any example herein, in particular example 51, further comprising: an impermeable covering extending along at least a portion of the frame; and a first skirt extending along at least a portion of the midsection of the frame, the first skirt at least partially composed of an absorbent material to absorb the adhesive.

[0330] Example 52: The system of any example herein, in particular example 51, wherein the frame is at least partially composed of a shape-memory alloy.

[0331] Example 53: The system of claim 1 or claim 2, wherein the tube is enclosed by braided wires to facilitate twisting of the tube.

[0332] Example 54: The system of any example herein, in particular example 51, wherein the one or more openings are lateral openings to allow the adhesive to exit laterally from the tube.

[0333] Example 55: The system of any example herein, in particular example 51, further comprising a suture sized to extend out of a distal end of the tube and attach to the frame.

[0334] Example 56: The system of any example herein, in particular example 55, wherein the tube comprises a distal appendage comprising apertures sized to facilitate lacing of the suture with the frame.

[0335] Example 57: The system of any example herein, in particular example 51, further comprising a suture positioned to loop around and cut the tube.

[0336] Example 58: The system of any example herein, in particular example 51, wherein the tube comprises a proximal portion and a distal portion.

[0337] Example 59: The system of any example herein, in particular example 58, further comprising a dissolvable connector enclosing ends of the proximal portion and the distal portion to hold the proximal portion and the distal portion together.

[0338] Example 60: The system of any example herein, in particular example 58, wherein the proximal portion comprises magnetic components to magnetically couple to the distal portion.Docket No.: ADV-23832WO01

[0339] Example 61: The system of any example herein, in particular example 58, wherein the proximal portion and the distal portion comprise threads at ends of the proximal portion and the distal portion to facilitate threading the proximal portion into the distal portion.

[0340] Example 62: The system of any example herein, in particular example 58, wherein the proximal portion comprises one or more pegs and the distal portion comprises one or more cavities sized to receive the one or more pegs.

[0341] Example 63: The implant of any example herein, in particular example 51, wherein the tube comprises perforations to facilitate breaking of the tube.

[0342] 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.

[0343] 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 / or 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.

[0344] 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 moreDocket No.: ADV-23832WO01 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, 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.

[0345] 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.

[0346] 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.

[0347] 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,Docket No.: ADV-23832WO01 and thus the spatially relative terms may be interpreted differently depending on the orientations.

[0348] 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

Docket No.: ADV-23832WO01 WHAT IS CLAIMED IS:

1. An implant system comprising: a frame having inwardly extending sidewalls at a midsection of the frame, the frame sized to fit within a blood vessel; a tube coupled to the frame, the tube having an inner lumen to carry adhesive and comprising one or more openings to allow the adhesive to exit the tube adjacent to the frame; and a balloon sized to fit within the frame and being inflatable to expand at least the midsection of the frame against the blood vessel.

2. The system of claim 1, further comprising: an impermeable covering extending along at least a portion of the frame; and a first skirt extending along at least a portion of the midsection of the frame, the first skirt at least partially composed of an absorbent material to absorb the adhesive.

3. The system of claim 1 or claim 2, wherein the frame is at least partially composed of a shape-memory alloy.

4. The system of claim 1 or claim 2, wherein the tube is enclosed by braided wires to facilitate twisting of the tube.

5. The system of claim 1 or claim 2, wherein the one or more openings are lateral openings to allow the adhesive to exit laterally from the tube.

6. The system of claim 1 or claim 2, further comprising a suture sized to extend out of a distal end of the tube and attach to the frame.

7. The system of claim 6, wherein the tube comprises a distal appendage comprising apertures sized to facilitate lacing of the suture with the frame.

8. The system of claim 1 or claim 2, further comprising a suture positioned to loop around and cut the tube.

9. The system of claim 1 or claim 2, wherein the tube comprises a proximal portion and a distal portion.Docket No.: ADV-23832WO01 10. The system of claim 9, further comprising a dissolvable connector enclosing ends of the proximal portion and the distal portion to hold the proximal portion and the distal portion together.

11. The system of claim 9, wherein the proximal portion comprises magnetic components to magnetically couple to the distal portion.

12. The system of claim 9, wherein the proximal portion and the distal portion comprise threads at ends of the proximal portion and the distal portion to facilitate threading the proximal portion into the distal portion.

13. The system of claim 9, wherein the proximal portion comprises one or more pegs and the distal portion comprises one or more cavities sized to receive the one or more pegs.

14. The implant of claim 1 or claim 2, wherein the tube comprises perforations to facilitate breaking of the tube.

15. An implant comprising: a frame having inwardly extending sidewalls at a midsection of the frame; an impermeable covering extending along at least a portion of the frame; and a first skirt extending along at least a portion of the midsection of the frame, the first skirt at least partially composed of an absorbent material.

16. The implant of claim 15, wherein the first skirt extends along an outer surface of the midsection of the frame.

17. The implant of claim 15 or claim 16, wherein the first skirt extends along an inner surface of the midsection of the frame.

18. The implant of claim 15 or claim 16, further comprising one or more capsules containing an adhesive and coupled to the midsection of the frame or the first skirt.

19. The implant of claim 18, wherein the first skirt comprises a proximal portion extending beyond a proximal side of the frame and a distal portion extending beyond a distal side of the frame, and wherein the one or more capsules are coupled to the proximal portion or the distal portion of the first skirt.Docket No.: ADV-23832WO01 20. The implant of claim 18, further comprising a docking stent having an inner lumen sized to receive the frame, the docking stent comprising one or more adhesive capsules coupled to an inner surface of the docking stent.

21. The implant of claim 18, further comprising a second skirt extending approximately in parallel with the first skirt.

22. The implant of claim 21, wherein the first skirt has a greater width relative to the second skirt.

23. The implant of claim 21, further comprising one or more adhesive capsules coupled to the frame between the first skirt and the second skirt.

24. The implant of claim 23, wherein the one or more adhesive capsules are arranged in a zig-zag pattern.

25. The implant of claim 18, further comprising one or more adhesive capsules coupled to the frame or the first skirt, each of the one or more adhesive capsules comprising multiple layers enclosing adhesive material.

26. The implant of claim 18, further comprising one or more adhesive capsules coupled to a first portion of the first skirt that extends beyond the frame.

27. An implant comprising: a frame; and a covering extending along at least a portion of the frame.

28. The implant of claim 27, further comprising a tube coupled to the frame, the tube having an inner lumen to carry adhesive and comprising one or more openings to allow the adhesive to exit the tube adjacent to the frame.

29. The implant of claim 27 or claim 28, a balloon sized to fit within the frame and being inflatable to expand at least a midsection of the frame against a blood vessel.

30. The implant of claim 27 or claim 28, further comprising a first skirt extending along at least a portion of a midsection of the frame, the first skirt at least partially composed of an absorbent material.