Transitionable nosecones

Abstract

An implant delivery system includes an elongate sheath, and a tapered distal nosecone integrated with the elongate sheath, the tapered distal nosecone having one or more longitudinal slits between portions of the tapered distal nosecone that are configured to be urged apart to provide an opening for instrument deployment.

Description

Docket No.: ADV-23668WO01 TRANSITIONABLE NOSECONES RELATED APPLICATION(S)

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No.63 / 572,533, filed on April 1, 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 delivery systems for medical implant devices. Implant devices can be advanced to target anatomy using percutaneous and / or minimally-invasive access. For example, transcatheter procedures can be implemented to transport an implant device through the vasculature of a patient using an elongated tubular delivery system. The particular configuration of implant delivery systems and / or components thereof can affect the efficiency, risks, and / or efficacy associated with device implantation procedures. SUMMARY

[0003] Described herein are devices, methods, and systems that facilitate the delivery and / or deployment of certain implant devices. Devices associated with the various examples of the present disclosure can include delivery system shafts / lumens that have integrally formed distal transitioning / opening features configured to allow a distal portion of the delivery system to open to accommodate passage of a tool or device therethrough. Such opening / transitioning features can be implemented as a sheath portion shaped with a tapering surface configured to provide a distal atraumatic nosecone form when the opening thereof is in a closed state. For example, the sheath may have longitudinally-oriented edges that, in the closed state, fold over or otherwise at least partially overlap one another in a circumferential dimension, wherein the edges can be urged apart by forces / pushing from within the sheath to present an opening through which instrumentation can be passed.

[0004] Various further examples of the present disclosure provide distal nosecones for delivery systems, wherein such nosecones are configured to split / splay to present a passageway through which instrumentation can pass. For example, in some implementations, nosecone features of the present disclosure are bipartite in configuration, wherein the parts of the nosecone are configured to be urged / deflected apart, such as from forces within the nosecone and / or associated sheath, to provide a passageway for instrumentation deployment. SuchDocket No.: ADV-23668WO01 deflectable nosecones can be integrated with an associated elongate sheath / shaft at a distal end / portion thereof and / or can include locking features configured to hold the deflectable parts of the nosecone in a closed / locked configuration. A guidewire or similar elongate locking control member can be used to engage with and lock the locking feature(s).

[0005] For the purpose of summarizing the disclosure, certain aspects, advantages and novel features have been described. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular example. Thus, the disclosed examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] 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.

[0007] Figure 1 illustrates example cardiac and vascular anatomy of a patient having a healthy, compliant aorta.

[0008] Figures 2 and 3 show a blood vessel in circular and non-circular shapes, respectively.

[0009] Figure 4 shows a perspective views of a non-circular stent in accordance with one or more examples.

[0010] Figures 5A and 5B show side views of a delivery system having a nosecone with a diameter that is greater than a minor-axis diameter of an implant device delivered using the delivery system in accordance with one or more examples.

[0011] Figure 6 shows a delivery system with a folded nosecone in accordance with one or more examples.

[0012] Figures 7A and 7B illustrate a flow diagram for a process for forming an integrated nosecone in accordance with one or more examples.

[0013] Figures 8, 9, 10, and 11 provide images of delivery system components corresponding to operations of the process of Figures 7A and 7B according to one or more examples.Docket No.: ADV-23668WO01

[0014] Figures 12A, 12B, and 12C illustrate a flow diagram for a process for deploying an implant device using a delivery system with a folded nosecone in accordance with one or more examples.

[0015] Figures 13, 14, and 15 provide images of delivery system components and certain anatomy corresponding to operations of the process of Figures 12A, 12B, and 12C according to one or more examples.

[0016] Figure 16 shows a delivery system including an expandable nosecone feature in accordance with one or more examples.

[0017] Figure 17 shows the delivery system of Figure 16 in an expanded state in accordance with one or more examples.

[0018] Figures 18A–18H show views of a bipartite, deflectable nosecone in accordance with one or more examples.

[0019] Figures 19A–19F show views of a bipartite, deflectable nosecone in accordance with one or more examples.

[0020] Figures 20A, 20B, and 20C show views of a bipartite, deflectable nosecone in accordance with one or more examples.

[0021] Figures 21A–21F show views of a bipartite nosecone in accordance with one or more examples.

[0022] Figures 22A and 22B show views of a deflectable nosecone in accordance with one or more examples.

[0023] Figures 23A and 23B show views of a deflectable nosecone having distal locking features in accordance with one or more examples. DETAILED DESCRIPTION

[0024] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0025] Although certain preferred examples are disclosed below, it should be understood that the inventive subject matter extends beyond the specifically disclosed examples to other alternative examples and / or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. 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 areDocket No.: ADV-23668WO01 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.

[0026] 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, loud speakers, headphones, pressure transducers, temperature transducers, or using any combination of suitable technologies.

[0027] 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.).

[0028] 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,Docket No.: ADV-23668WO01 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.

[0029] 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.

[0030] 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. 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. Relevant Anatomy and Physiology

[0031] Certain examples are disclosed herein in the context of vascular implant devices. However, it should be understood that delivery systems and transitionable nosecones in accordance with the present disclosure may be implemented in connection with any suitable or desirable implant devices and / or instrumentation.

[0032] 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. The valves may be configured to open and close in response to a pressure gradient present during various stages of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to aDocket No.: ADV-23668WO01 respective region of the heart and / or to blood vessels (e.g., ventricles, pulmonary artery, aorta, etc.). The contraction of the various heart muscles may be prompted by signals generated by the electrical system of the heart.

[0033] 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.

[0034] 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, referred to as the septum, separates the left 2 and right 5 atria and the left 3 and right 4 ventricles.

[0035] 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 17 venae cavae, carry blood back to the heart.

[0036] 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 theDocket No.: ADV-23668WO01 aortic valve 7 in the left ventricle of the heart. The transition from ascending aorta 12 to aortic arch 13 is at the pericardial reflection on the aorta. The aortic valve 7 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 (or venous) blood vessel or portion thereof.

[0037] 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 increasing transmural pressure, and / or the tendency of a blood vessel (e.g., artery) or prosthetic implant device, or portion thereof, to recoil toward its original dimensions as transmural pressure decreases.

[0038] Arterial compliance facilitates perfusion of organs in the body with oxygenated blood from the heart. Generally, a healthy aorta and other major arteries in the body are at least partially elastic and compliant, such that they can act as a reservoir for blood, filling up with blood when the heart contracts during systole and continuing to generate pressure and push blood to the organs of the body during diastole. As perfusion of the heart muscle relies on diastolic flow, and therefore on aortic / arterial compliance, insufficient perfusion of the heart muscle can lead to and / or be associated with heart failure.

[0039] 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. A compliant aorta may generally stretch with each heartbeat, such that the diameter of at least a portion of the aorta expands. 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.

[0040] Aortic stiffness and reduced compliance can lead to elevated systolic blood pressure, which can in turn lead to elevated intracardiac pressures, increased afterload, and / or other complications that can exacerbate heart failure. Aortic stiffness further can lead to reduced diastolic flow, which can lead to reduced coronary perfusion, decreased cardiac supply, and / or other complications that can likewise exacerbate 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 decreaseDocket No.: ADV-23668WO01 in elastin. While stiff / non-compliant blood vessels can generally suffer from a lack of elasticity in the walls thereof, such vessels can maintain some amount of flexibility / bendability, such that reshaping of the blood vessels can occur without necessarily requiring the stretching of the walls of the blood vessel. Examples of the present disclosure provide delivery systems that can be used for deploying compliance-enhancing stent implant devices, which may be implanted in one or more locations in a compromised aorta and / or other vessel(s). For example, compliance- enhancing implant devices (e.g., non-circular stent devices) can be deployed in various areas of the aorta 16, such as using delivery systems of the present disclosure that include transitionable nosecone features configured to accommodate passage of irregularly-shaped (e.g., non-circular) implant devices. Compliance-Enhancing, Non-Circular Stent Implants

[0041] 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. Example implant devices that can be delivered using delivery systems of the present disclosure can include stents that, when implanted, are configured to decrease the cross-sectional area / volume of the blood vessel segment in which the stent is implanted during low-pressure conditions, such as diastole, 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.

[0042] The non-circular (e.g., oval- and / or peanut-shaped) stents that can be implanted with delivery systems 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. 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.

[0043] With respect to a blood vessel having a relatively fixed perimeter, wherein the blood vessel wall does not expand sufficiently due to stiffness and / or other factors of non-Docket No.: ADV-23668WO01 compliance, generally, the greatest area / volume of the blood vessel may be present / achieved when the blood vessel wall forms a circular cross-sectional shape, which may maximize the cross-sectional area and volume of the blood vessel. Figure 2 shows an example blood vessel 501 (identified as blood vessel 501a in Figure 2) having a generally circular cross-sectional shape formed by the blood vessel wall 502, such that the area Acthereof is maximized for the given perimeter / wall-length Pa. In the circular configuration, the diameter da is substantiallyconstant at every angle about the axis of the vessel. The shape of the vessel 501a may be set or permitted by the shape of a stent 503 implanted within the vessel.

[0044] Diverging from a circular cross-sectional shape can produce a cross-sectional area / volume for a blood vessel that is less than the maximum area Ac shown in Figure 2. For example, Figure 3 shows the blood vessel 501 (identified as vessel 501b in Figure 3) having a shape that resembles an oval / ellipse, which produces the cross-sectional area Ao that is less than the area Ac with the same blood vessel wall / perimeter length Pa. The oval shape of the vessel 501b may have a major axis amhaving a dimension ddthat is greater than a dimension dbof the minor axis an thereof. The oval shape of the vessel 501b may be set / forced by the stent 503, which may have a biased non-circular / oval shape.

[0045] With further reference to Figures 2 and 3, due to the area Ao of the oval vessel of Figure 3 being less than the area Acof the circular configuration shown in Figure 2, transitioning from the circular shape 501a to the non-circular shape 501b, 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. Non- circular stents, as described in further detail below, can be used to effect cyclical, compliance enhancing shape change in target blood vessels by forcing the target blood vessel to assume a non-circular shape in relatively low-pressure conditions, wherein increase in luminal pressure can cause the stent to transition to a more-circular shape, thereby storing compliant energy that is returned to the circulation when the luminal pressure decreases and the stent again forces the blood vessel to a non-circular cross-sectional shape.

[0046] In view of the foregoing, examples of the present disclosure provide delivery systems for deploying stent implant devices through transitionable nosecones configured to splay or otherwise part / open to permit passage therethrough, which can be helpful for deployment of non-circular stents or other irregularly-shaped devices as not requiring retrieval of a separable nosecone component through a lumen of the implant after deployment. The term “stent” is used herein in accordance with its broad and ordinary meaning and may refer to any deviceDocket No.: ADV-23668WO01 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.

[0047] Figure 4 shows a perspective view of a non-circular stent 600 in accordance with one or more examples. The stent 600 may be deployable within a blood vessel lumen using any delivery system example disclosed herein. The stent 600 may be formed of a tubular frame 621, which may form a wall around an axial channel 649, thereby defining the channel 649. The stent 600 includes sidewall segments 625 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 627 on major-axis ends of the stent 600. The sidewalls 625 may be generally straight and / or less-curved compared to the end walls 627 over at least a portion of a length thereof, and / or may bow / deflect inward and / or outward, either in a resting, unpressurized state, or in conditions of hoop / wall stress on the frame 621.

[0048] It should be understood that such description of stent shapes refers to a shape of an axial cross-section of a stent. Although oval-shaped stents are described, it should be understood that the principles of the present disclosure may relate to stents having any non- circular shape (e.g., peanut shape) in at least some configurations thereof (e.g., relaxed configuration). Descriptions of stents in a relaxed configuration should be understood to relate to a configuration that a stent naturally assumes in the absence of tension on the stent wall(s) from external forces (e.g., ambient fluid pressure, physical contact forces, etc.).

[0049] The stent 600 may be elastically deformable between a non-circular configuration (e.g., configuration of stent 503 in Figure 3) and a more-circular configuration (e.g., configuration of stent 503 in Figure 2), with the stent 600 biased toward the first configuration. In some examples, the stent frame 621 may comprise a shape-memory and / or super-elastic material, such as nitinol. The stent 600 may be configured to be percutaneously delivered to a blood vessel in a compressed delivery configuration. Once within the blood vessel lumen at the target deployment site, the stent 600 and / or frame 621 thereof 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 the oval configuration shown in Figure 4, the stent 600 may have a cross- sectional area having a major / long-axis Amajdiameter that is substantially larger than the minor / short-axis Amin diameter, which can present various challenges for delivery using traditional delivery systems, such as relating to implant deployment and / or nosecone retrieval. Some such issues can be understood with respect to the example delivery systems and stents illustrated in Figures 5A and 5B.Docket No.: ADV-23668WO01

[0050] Figures 5A and 5B shows a delivery system 30 configured for delivery of a non-circular stent implant device 32. The delivery system 30 comprises one or more catheters or sheaths 31 used to advance and / or deploy the stent implant device 32, which may be disposed at least partially within the delivery system 30 during portions of a transcatheter delivery process. The terms “capsule,” “sheath,” “catheter,” “shaft,” “lumen,” and the like are used herein according to their broad and ordinary meanings, and may refer to any tubular structure or component forming an axial / longitudinal channel or lumen therein. In some contexts, an outer sheath / shaft of a delivery system may be referred to as a ‘capsule.’ Alternatively, such outer sheath may be referred to as a ‘catheter’ or ‘shaft,’ or simply a ‘sheath.’

[0051] The distal portion 703 of the delivery system sheath 31 may serve as an implant retention mechanism, wherein an implant and / or other component(s) of the delivery system may be covered by the outermost sheath 31 to form a capsule prior to deployment from the distal portion 703.

[0052] The delivery system 30 includes a nosecone 35 that forms the tip of the delivery system 30 when transporting the implant 32. The nosecone 35 may advantageously present an atraumatic interface for the distal end of the delivery system. For example, the nosecone 35 may be pliable / flexible to reduce the risk of injury to the patient anatomy when contacted by the tip of the delivery system. The nosecone 35 may have a tapered shape from its proximal end / base 36 to its distal end / tip. The nosecone 35 may facilitate advancement of the distal end of the delivery system 30 through the tortuous anatomy of the patient and / or an outer delivery sheath or other conduit / path.

[0053] The nosecone 35 may be coupled to the delivery system via a shaft 33, which may be coupled to and / or integrated with the base 36 of the nosecone. The shaft 33 can be disposed at least partially within the outer sheath 31 and configured to be axially advanced relative to the sheath 31, thereby causing the nosecone 35, shaft 33 distal portion, and implant 32 to advance distally from the distal end of the sheath 31. For example, the operation of the delivery system 30 for deployment of the stent 32 may involve advancing the shaft 33 distally and / or retracting the sheath 31 proximally to thereby cause the shaft 33 and implant 32 to pass through a distal opening of the sheath 31 to permit deployment of the implant 32 outside of the sheath 31. The shaft 33 may comprise a straight shaft and / or may include various features for holding the implant 32 in-place during delivery.

[0054] In some implementations, the delivery system 30 may optionally comprise a pusher shaft (not shown), which may be slidingly disposed within the outer sheath 31 proximal and / or adjacent to the implant device 32. Such a pusher may be coupled to or integrated with theDocket No.: ADV-23668WO01 nosecone shaft 33, or may be configured to slidingly pass over the shaft in some examples. Pusher components, where implemented, can be used to push / advance the implant 32 and / or nosecone 35 relative to the outer shaft / sheath 31 as a means to deploy the device 32 from the sheath 31.

[0055] The delivery system 30 may further be configured to have a guidewire disposed at least partially within the delivery system 30 and / or coupled thereto in a manner to allow the delivery system 30 to follow a path defined by the guidewire. In some implementations, a guidewire may pass through an interior lumen / channel of the implant device, a lumen of a pusher device or tube of the delivery system 30, and / or through a channel that runs through the nosecone 35. In some implementations, the nosecone shaft 33 may be, or may be disposed around / over, an innermost component of the delivery system 30 that comprises / forms the inner guidewire lumen.

[0056] In the implementation of Figures 5A and 5B, the nosecone 35 of the delivery system 30 has a diameter dnthat is greater than a minor-axis diameter dminof the non-circular stent 32. The axial cross-sectional shape of the stent 32, when expanded, presents a major-axis dimension dmajand a minor-axis dimension dminthat is substantially less than the major-axis dimension dmaj. Figures 5A and 5B show the delivery system 30 with the nosecone shaft 33 and the nosecone 35 extended distally from the distal end of the sheath 31, such that a sufficient portion of the nosecone shaft 33 is exposed from the sheath 31 to fully deploy the stent 32 from the sheath 31. When the stent 32 is deployed, the circular nosecone base 36, having a diameter dngreater than at least one diameter / dimension of the implant device 32 deployed between the nosecone 35 and the distal end of the outer sheath 31, may encounter obstruction / interference on a proximal surface / edge 39 thereof when attempting to draw the nosecone 35 proximally back through the lumen / channel of the implant device 32. Folded Nosecones

[0057] Examples of the present disclosure provide delivery system components that have nosecones with transitional opening features configured to permit instrumentation deployment without the need to distally project the nosecone and subsequently proximally retract the nosecone (e.g., through a deployed implant lumen) in connection with deployment of an implant device or other instrumentation. Such nosecones can be integrally formed with an outer sheath of a delivery system. For example, the transitional opening feature(s) can be formed by cutting and folding a distal portion / end of a delivery sheath / capsule / shaft and shape-setting the cut and folded section of the sheath in the shape of a tapered nosecone that provides an atraumatic leading end for the delivery system. The folded-over edges can be pushed / urged awayDocket No.: ADV-23668WO01 from each other to provide a deployment opening when a prosthetic device or other instrumentation is pushed therethrough.

[0058] Figure 6 shows a delivery system 40 including a sheath 41 having an integrated folded nosecone 45 associated with a distal portion 43 of the sheath 41 in accordance with one or more examples. The distal portion 43 of the outer delivery sheath 41 can be shaped with a tapering surface / side 48 formed by folded / wrapped edge(s) of the cut sheath 41 to provide an atraumatic leading end that serves as a nosecone 45 for delivering a stent (e.g., an oval stent) or any other prosthetic device and / or instrumentation. The tapered nosecone 45 can be formed by folding cut or otherwise-formed edges 46, 47 (see, e.g., Figure 10) to at least partially overlap the edges and / or flaps associated therewith in a circumferential dimension dc, and further heat- setting, or otherwise setting the shape of, the nosecone 45. The shape-set, folded nosecone 45 can advantageously provide an integrally formed nosecone having a tapering narrow profile in a default shape / configuration thereof. The folded edges 46, 47 of the nosecone 45, which are defined by a break / cut in the nosecone 45, can be splayed / urged apart in response to the presence and / or distal movement / force of instrumentation within the nosecone portion 45 of the delivery system 40, thereby forming an egress opening / window through which instrumentation can pass to exit the sheath 41. The delivery system 40 can include a proximal handle 42 for manual operations.

[0059] Figures 7A and 7B illustrate a flow diagram for a process 700 for forming an integrated, folded nosecone for a delivery system in accordance with one or more examples. Figures 8, 9, 10, and 11 provide images of delivery system components corresponding to operations of the process 700 of Figures 7A and 7B according to one or more examples.

[0060] At block 701, the process 700 involves providing a tubular sheath 41 suitable for insertion in the body of a subject. The shaft of the sheath 41 can advantageously be flexible to navigate the tortuous paths of blood vessels, while providing sufficient rigidity to be advanced to a target location through anatomy. The sheath 41 may have an inner lumen diameter sized to accommodate an implant device, such as a stent. For example, the sheath 41 may have a 5–24 French diameter (e.g., between 1–10 mm). The length of the sheath 41 may be sufficient to pass through various tortuous vascular pathways, such as a length between 40–130 cm. The sheath 41 may comprise any suitable or desirable material(s), such as polytetrafluoroethylene (PTFE), polyurethane, nylon, silicone, and / or the like. In some implementations, the sheath 41 includes a hydrophilic coating configured to reduce friction and improve navigability through the blood vessels. The material composition and / or dimensions of the sheath 41 may be selected toDocket No.: ADV-23668WO01 accommodate the specific requirements of the relevant use with respect to the type of implant and / or the target deployment area within the vascular system.

[0061] At block 702, the process 700 involves making a first diagonal cut 801 in a distal portion 43 of the sheath 41. For example, the cut 801 may originate at a distal end 44 of the sheath 41 at any suitable or desirable circumferential point / position 805 and proceed proximally along a length of the distal nosecone segment 43 of the sheath 41 at an angle θ1 relative to the axis Atof the sheath 41. That is, the cut 801 is not parallel with the axis At. Figure 8 shows an example implementation of the cut 801 along an angled path from the end 44 of the tube 41 to a termination point 804 that has a different circumferential position from the originating point 805 of the cut 801. The cut 801 can be any desirable length, such as approximately 1” (2.54 cm), as an example. The cut 801 may advantageously be made at an angle θ1 between 10–40° relative to the axis At, or any other angle according to the desired shape of the tapered / conical end portion 45. When executed, the cut 801 produces a cut edge 46 (see Figure 9).

[0062] At block 704, the process 700 involves making a second cut 802 originating at a different circumferential position 809 at the end 44 of the sheath 41 compared to the origination point 805 of the first cut 801. The second cut 802 may be angled with respect to the axis At, or may be parallel with the axis At. Furthermore, the cut 802, with respect to the axis At, may be angled in a same direction as the first angled cut 801, or may be angled at an opposing angle relative to the first cut 801. In some implementations, the second cut 802 is angled in the same direction as the first cut 801 relative to the axis At, wherein the second cut 802 is less angled than the first cut 801 relative to the axis At. The second cut 802 can have any angle θ2relative to the first cut 801. In some implementations, the angle θ2 between the first 801 and second 802 cuts is less than 45°.

[0063] With the first 801 and second 802 cuts having been implemented, an area 803 of the sheath 41 between the cuts 801, 802 may be removable. For example, such removable segment 803 may have a ‘V’ or wedge shape, wherein the segment 803 may be removable due to the second cut 802 meeting the first cut 801 at a position somewhere along the length of the cut 801, or coming into close enough proximity with the first cut 801 to allow for further cutting or tearing to free the removable segment 803. Figure 9 shows the executed first cut 801, as well as the cut line for the second cut 802. The first cut 801 may produce a first cut edge 46 along / adjacent-to a first flap 806, and the second cut 802 may produce a second cut edge 47 along / adjacent-to a second flap 807. Removing the excess segment 803 may produce a wedge-Docket No.: ADV-23668WO01 shaped circumferential and longitudinal void in the distal portion 43 of the sheath 41. The cuts 801, 802 may be implemented using any type of cutting tool, such as a blade or similar.

[0064] With the excess segment 803 having been removed, the free edges 46, 47 and respective associated flaps 806, 807 may be exposed and / or free to manipulate. At block 706, the process 700 involves folding or curling one or both of the flaps 806, 807 until an outer edge and associated flap overlaps the inner edge and associated flap, as shown in Figure 10. Figure 10 shows the flap 806 associated with the first cut edge 46 folded over at least a portion of the flap 807 and edge 47 associated with the second cut 802. Along the length of either of the cuts 801, 802, the cut edges 46, 47 and associated flaps may overlap any desirable amount or distance. For example, in some implementations, the edges 46, 47 overlap between 0.1–0.3” (.25–.76 cm), such as by about 0.25” (0.64 cm). The term “flap” is used according to its broad and ordinary meaning, and may refer to sheath material adjacent or otherwise associated with a cut edge, wherein the material can be folded, bent, or curled in some manner.

[0065] At block 708, the process 700 involves shape-setting the distal portion 43 of the sheath of the sheath 41 in the folded-edge configuration described above to form an integrated nosecone 45. Such shape-setting may be implemented in any suitable or desirable manner. Figure 11 shows an example of the shape-set nosecone 45. As shape-set, the tip 49 of the nosecone 45 may or may not be fixed or closed. For example, the tip 49 can be fixed or closed by fusing / sealing the end 44 of the sheath tube 41 at and / or between the origin points 805, 809 of the cuts 801, 802. With the tip 49 fixed / closed, when opening, the flaps 806, 807 may open / spread in a manner as to provide an egress window that has an axis that is angled relative to the axis Atof the sheath 41, such that deployment of instrumentation through the window may be generally at an angle relative to the axis At. Alternatively, in some implementations, the tip 49 may be un-fixed / fused, such that the nosecone 45 can open to a tubular cross-section when the flaps 806, 807 part and deployed instrumentation can pass out of the sheath 41 approximately on a line parallel with the axis At.

[0066] Shape-setting may involve using a heat-application process to cause a transformation in the shape of the sheath material. For example, shape-setting in accordance with the process 700 may involve reflowing and / or annealing the material (e.g., polymeric material) of the sheath 41 in a way as to cause a retention bias towards the folded shape shown in Figure 10, with the flaps 806, 807 pressed closely against each other in a free state of the nosecone 45. The resulting nosecone 45 advantageously provides a narrowly-shaped tapering portion integrated with the sheath 41, which can be used for advancement towards the site ofDocket No.: ADV-23668WO01 implantation as an alternative to utilizing a nosecone component that is separable from the sheath 41, as with certain other solutions.

[0067] Figures 12A, 12B, and 12C illustrate a flow diagram for a process 1200 for deploying an implant device using a delivery system with a folded nosecone in accordance with one or more examples. Figures 13, 14, and 15 provide images of a delivery system 40 and certain anatomy corresponding to operations of the process 1200 of Figures 12A, 12B, and 12C according to one or more examples.

[0068] At block 1202, the process 1200 involves advancing a delivery system 40 that comprises an integrated, foldable nosecone 45 to a target position in a blood vessel 161, such as the aorta (e.g., abdominal or thoracic aorta), the delivery system 40 containing an implant device 32 that the delivery system 40 is configured to deploy. Figure 13 shows the example delivery system 40 positioned in the blood vessel 161, wherein the delivery system 40 has disposed in a distal portion / capsule thereof the implant device 32 in a crimped / compressed delivery configuration. For example, the implant device 32 may comprise an oval / non-circular stent comprising a wireframe that is configured to be radially compressed for delivery and held within the sheath 41 of the delivery system 40.

[0069] At block 1204, the process 1200 involves advancing the implant 32, such as by distally advancing a pusher / shaft 162 with the implant 32, relative to the sheath 41 to radially push against the flaps 806, 807 of the folded nosecone 45 to urge / splay the flaps 806, 807 apart to form an egress window 811 through which the implant 32 and / or pusher / shaft 162 can pass. In cases in which the distal tip 49 of the nosecone 45 is sealed / fixed, the implant 32 and / or shaft 162 may exit the window 811 at an angle θ3relative to the axis Atof the sheath tube 41, rather than parallel with the axis At. The shaft 162 may comprise an adapter structure on which the implant 32 is disposed during delivery, such that advancing the shaft 162 distally advances the implant device 32 to unsheathe the implant 32 to allow for expansion thereof, which may be implemented using shape-memory / superelasticity characteristics of the frame of the device 32 and / or through the use of a balloon expansion component (not shown).

[0070] At block 1206, the process 1200 involves expanding the implant 32 distal of the nosecone 45, such as using self-expansion and / or balloon expansion, to deploy the implant 32. Whereas in some solutions, implant deployment involves distal advancement of a nosecone preceding implant deployment and post-deployment nosecone withdrawal through the implant lumen, with the nosecone 45 integrated with the distal portion of the delivery sheath / capsule 41, the nosecone 45 need not be advanced and retracted relative to the sheath 41 as part of the delivery process, but rather remains in a fixed position relative to the sheath 41 throughout theDocket No.: ADV-23668WO01 implant deployment. Figure 15 shows the shaft 162 being proximally withdrawn back into the nosecone 45 after implant deployment.

[0071] At block 1208, the process 1200 involves withdrawing the shaft 162 back through the implant 32 and into the sheath 41 through the window of the splayed nosecone flaps 806, 807. As the shaft 162 is brought back into the lumen of the sheath 41, the flaps 806, 807 and edges 46, 47 of the folded nosecone 45 may remain parted until the shaft 162 is brought proximal of the nosecone 45, at which point the shape memory of the flaps 806, 806 can cause the nosecone 45 to naturally close back to a folded, overlapped configuration. At block 1210, the process 1200 involves withdrawing the delivery system 40 from the patient, thereby retaining the implant 32 in place indefinitely as a flow-control or other treatment means / mechanism. Deflectable Nosecones

[0072] Figure 16 shows a delivery system 80 including an expandable nosecone feature 85 in accordance with one or more examples. Figure 17 shows the delivery system 80 of Figure 16 in an expanded / deflected state in according to one or more examples. The nosecone 85 includes a plurality of deflectable flaps 89. The flaps 89 can be configured to pivot or otherwise move about a hinge (e.g., living hinge, where the flap and piece / body to which it is connected via the hinge comprise the same or similar material as the hinge) or other flexure, including any type of leaf, petal, wing, lobe, panel, or other segment / structure having such configuration.

[0073] As described in detail above, withdrawal of a nosecone back through a deployed implant device may be necessary or desirable in some implant procedures. However, where a nosecone has dimensions that are wider than dimension(s) of a channel / passage through a deployed implant device through which the nosecone must pass for retrieval, retrieval can be impeded or prevented due to contact interference between the nosecone and the implant device. Therefore, it can be desirable to utilize attached nosecones having flexible, deflectable flaps that open to allow for deployment from the distal end of a delivery system sheath / capsule to thereby provide for atraumatic insertion of the delivery system while allowing for easy retrieval of instrumentation without the nosecone needing to be retracted through a deployed implant device.

[0074] The deflectable nosecone 85 may be coupled to and / or associated with the distal end / portion of a delivery system outer sheath / capsule 81. For example, the nosecone 85 may be attached to the distal end of the sheath 81 and / or integrated therewith as a unitary form / portion with the sheath 81. In some implementations, an additional leading nosecone 87 is provided that is configured to be disposed within the delivery system 80 and / or flexible nosecone 85, such that the distal tip 84 thereof can be passed through / out of the nosecone 85 in a delivery configuration of the delivery system 80, as shown in Figure 16.Docket No.: ADV-23668WO01

[0075] As with other deflectable flap nosecone features disclosed herein, the flaps 89 of the deflectable nosecone 85 can be separated by one or more longitudinal slits, cutouts, and / or gaps 88, which may be distributed circumferentially around at least a portion of the nosecone 85. The flaps 89 may be biased towards each other to form a tapered leading end / surface, which, in combination with the exposed portion 84 of the leading nosecone 87, provide for smooth advancement of the delivery system through the patient anatomy. The leading nosecone advantageously has a diameter dvthat is less than a diameter dwof the implant 32 (e.g., stent) and the diameter of the sheath 81, which can facilitate post-deployment retraction of the nosecone 87.

[0076] At least a portion of the leading nosecone 87 may be concealed / covered by the deflectable nosecone 85 during delivery. For example, a proximal base / end 86 of the leading nosecone 87 may be maintained within the deflectable nosecone 85 during delivery, as shown. The natural tapering form / shape of the portion of the deflectable nosecone 85 that spans between the distal end of the sheath 81 and the distal end of the nosecone 85 can function as an extension of the leading nosecone 85 during delivery to the site of implantation. In some implementations, the flaps 89 and / or other portions of the nosecone 85 may be configured to be deflected radially outward, such that upon reaching the implantation site, the leading nosecone 87, as well as the nosecone shaft 83 and implant 32 disposed thereon can be advanced through the deflectable nosecone 85, thereby opening-up the distal opening 82 of the nosecone 85 (e.g., urging open flaps 89 of the nosecone 85). Although certain deflectable nosecones are described herein as having radially deflectable flaps, it should be understood that in some implementations, such nosecones may not have flaps, but rather may be configured to stretch to expand an opening thereof as instrumentation is pushed through the opening. For example, such nosecones may comprise a drape configured to collapse and stretch to provide smaller and larger openings therein.

[0077] In the particular example of Figures 16 and 17, the deflectable nosecone 85 and the leading nosecone 87 are assembled together to collectively provide the function of a nosecone with respect to advancement through the patient anatomy. However, it should be understood that any deflectable nosecones disclosed herein can be implemented with or without a low-profile leading nosecone. As shown in Figure 17, during implant deployment, the leading nosecone 87 and the expandable / deflectable nosecone 85 can separate, such that the deflectable nosecone 87 is proximal of the implant device 32 and the leading nosecone 85 when the implant device 32 is deployed, thereby allowing for the narrower leading nosecone 85 to be retrieved through the lumen of the implant device.Docket No.: ADV-23668WO01

[0078] The deflectable nosecone 85 may comprise any suitable or desirable deflectable material, such as a deflectable polymer, which may or may not have braided wire embedded therein. As with any deflectable nosecone flaps disclosed herein, in some implementations, the flaps 89 of the nosecone 85 are not deflectable via living hinges, but rather are configured to radially deflect using mechanical hinge features. Bi-Partite Flexion Nosecones

[0079] In some implementations, the present disclosure relates to deflectable nosecones that are separable in two halves or segments configured to come together to form a tapered conical form and to be deflected radially outwardly to provide a distal opening for instrumentation deployment. Such examples can include be held in a locked / closed configuration by disposing a guidewire in alignment funnel features of the nosecone segments. Figures 18A– 18H show views of a bi-partite, deflectable nosecone 55 integrated with a sheath 51 of a delivery system 50 in accordance with one or more examples. The delivery system 50 provides an atraumatic distal nosecone 55 comprised of two parts / flaps 53 that form a full conical form having a tapering narrow profile, wherein both flaps 53 of the nosecone 55 can be pushed away from each other when a prosthetic device, such as an oval stent or a closed balloon, is pushed therethrough. The flaps 53 can have a semicircular truncated conical shell, as shown, which may be at least partially hollow (e.g., hollowed-out).

[0080] The outer delivery sheath 51 can be integrally formed with the distal nosecone portion 55, which is shaped with a tapering surface configured to serve as a nosecone for delivering a stent (e.g., an ovel stent) or any other prosthetic device. The nosecone 55 can be considered a bi-partite nosecone in that it comprises a structural division into two parts 53a, 53b, which are configured for movement or flexion. In some implementations, nosecones of the present disclosure are designed with a distinct separation into two halves or segments, which are configured to abut in one or more areas to form a streamlined, tapered end. With respect to the example of Figures 18A–18F, the bi-partite division of the nosecone allows for a transition from a closed state, as shown in Figure 18A, to an open state, as shown in Figure 18B. The dual- segment nature of the nosecone 55 facilitates the transitional behavior / functionality of the nosecone.

[0081] The nosecone flaps 53 can have a truncated conical shell form, as demonstrated in Figures 18G and 18H. When the edges of the flaps 53a, 53b abut each other, the nosecone 55 is formed by the combined structure of the two flaps. The flaps 53 can be defined by breaks 1802 (e.g., slits / cuts) on opposite circumferential sides of the truncated conical shell form. The term “break” is used herein according to its broad and ordinary meaning and may referDocket No.: ADV-23668WO01 to any structural discontinuity, separation, or weakening in the material of a nosecone or sheath that allows for controlled opening, splaying, or parting of the structure to facilitate deployment of a device. “Breaks,” “slits,” “cuts,” and the like, as described herein can be any type of breaks, slits, cuts, perforations, score lines, frangible sections, hinges, separable junctions, stretchable or deformable regions, and any other engineered feature or material property that enables a nosecone / sheath to open or expand.

[0082] The nosecone flaps 53a, 53b are advantageously configured to flex or bend at a hinge / joint area 57 between the nosecone 55 and the body of the sheath 51. Such flexion occurs at the predetermined flexure areas or hinge points 57a, 57b, enabling the two flaps 53a, 53b to deflect or pivot outward. The flexion mechanism of the flaps 53a, 53b can be activated in response to an internal force, such as the advancement of a medical device or instrument through the sheath 51, pushing the flaps 53a, 53b apart to create an opening for device deployment. The flexion capability of the nosecone 55 allows for the controlled expansion of the nosecone’s tip, facilitating the safe and precise deployment of therapeutic devices or instruments, which can be beneficial for minimally invasive medical procedures, where navigational precision and the ability to minimize tissue trauma can be important.

[0083] The nosecone 55 can be integrated with the sheath 51, forming a unified delivery system 50. Such integration can provide a relatively streamlined profile for insertion and navigation, with the ability to transition to an expanded state for deployment. The nosecone 55 includes guidewire locking features 54a, 54b, which may comprise co-axial alignment funnels / channels for aligning and holding the flaps 53a, 53b together. The locking features 54a, 54b can have a tube or ring form, as shown. Figure 18F shows the nosecone 55 in a locked configuration with a guidewire 59 passing through the lumen 58 of the sheath 51 and through the locking channels / tubes 54a, 54b, which may be coupled to respective ones of the flaps 53a, 53b. For example, within the conical halves 53, small tubes 54 may be held to run coaxially with the axis As of the sheath 51 when the flaps 53 are brought together as shown in Figures 18A and 18F. The tubes 54a, 54b can act as channels for the guidewire 59 (or other control tool / element), which prevents / limits outward deflection of the flaps 53, and thus opening of the nosecone 55. For example, when the guidewire 59 is threaded through the nosecone axial channels 54a, 54b and out the apical window / opening 52 in the distal tip 1801 of the nosecone, the guidewire 59 can lock the conical halves 53a, 53b together, preventing deflection thereof. The locking channels 54a, 54b, when the nosecone is in the closed state, can be axially aligned and offset from one another such that they do not interfere with one another when the flaps 53a, 53b are brought together.Docket No.: ADV-23668WO01

[0084] The locked state can maintain the a streamlined / compact profile of the nosecone 55 for insertion and navigation. Withdrawal of the guidewire 59 unlocks the flexion capability of the nosecone 55, allowing the nosecone 55 to transition to its open state (see Figure 18B) for instrumentation deployment purposes. Upon retraction of the guidewire 59, the flaps 53 are free to transition to their expanded state through the actuation of an internal force mechanism. This force, applied via the advancement of a therapeutic device or instrument within the sheath 51, prompts / causes the flaps 53 to flex outward, creating an axial opening for device or instrument deployment.

[0085] The nosecone 55 is shown as comprising deflectable, conical flaps. However, it should be understood that transitionable nosecones of the present disclosure can include any shape, number, and / or configuration of deflectable segments which may be separable / deflectable in any manner. The break(s) 1802 (e.g., slit(s) / cut(s)) that separate the opposing flaps 53a, 53b can extend from the tip / apex 1801 of the nosecone 55 to, or slightly beyond, its base 1803, which may correspond the proximal beginning / interface of the tapering of the nosecone 55. The joints / hinges 57a, 57b can represent flexure zones about which the flaps 53 can fold / bend.

[0086] The locking channels 54 can be held / supported by any structure associated with the flaps 53 configured to hold / position the channels 54 in a position offset from the conical walls, such as in an axial position, as shown. In the illustrated embodiment, the locking channels 54 are held by longitudinal blades / ribs 56, though such features may be broader volumes, or may be laterally oriented (e.g., perpendicular to the axis As). By implementing the flaps as mostly hollow semi-conical flaps, the nosecone structure can be maintained as relatively light-weight and / or having desirable flexibility. The locking channel supports 56 can be considered, and / or implemented as, spacers, guides, struts, stays, supports, or the like with respect to the channel features 54. Implementation of longitudinal or radial rib form to hold the locking channel / funnel 54 can advantageously provide a minimalistic yet stable structure for securely holding the channel / funnel 54.

[0087] Figures 19A–19F show views of a delivery system 60 including a bipartite, deflectable nosecone 65 in accordance with one or more examples. The nosecone 65 can have split capability and one or more alignment channels / funnels 64 to allow for locking of the nosecone 65 in a closed configuration using a guidewire 69 or other elongate element.

[0088] The nosecone 65 is attached to and / or integrated with a sheath / capsule 61, wherein the sheath 61 defines a lumen 68 for instrumentation transport / delivery. The distal portion of the delivery system 60 transitions from the hollow shaft / sheath 61 to the at least partially solid, tapered nosecone 65. The boundary between the hollow sheath 61 and the solidDocket No.: ADV-23668WO01 nosecone 65 can be delineated at least in part by a proximal surface 66 of a base flap 63a and / or a hinge / joint feature 67 configured to facilitate radially outward deflection of base 63a and / or tip / apex 63b flaps of the nosecone 65. The proximal surface 66 may be at least partially tapered / angled in the distal direction so as to funnel into a guidewire channel 64 through the nosecone 65, wherein the guidewire channel 64, including base channel 64a and tip channel 64b, runs through at least a portion of the base flap 63a and the conforming tip / apex flap 63b.

[0089] The base 63a and tip 63b flaps are at least partially solid-form, which can advantageously provide desirable durability and stability for the nosecone 65, as well as provide volumes for defining / forming the guidewire channel 64. The guidewire channel 64 can comprise a relatively small axial channel that runs through portions of the flaps 63a, 63b from a distal aperture 62 in the tip flap 63b to the opening at the proximal surface / area 66 of the base flap 63a, opening into the lumen 68 of the sheath 61.

[0090] The base 63a and tip 63b flaps are separated and / or defined by an angular plane / cut 163, which provides for separability of the flaps 63a, 63b, wherein the plane / cut 163 intersects the axial channel 64 through the nosecone 65. Therefore, the channel 64 passes through portions of both flaps 63a, 63b. The channel opening 62 at the distal end of the tip flap 63b allows for the passage of the guidewire 69 through and distally out of the nosecone 65. The planar cut 163 separating the base 63a and tip 63b flaps can begin on one of the tapered sides 1901 of the nosecone 65 and slopes towards the center axis As of the delivery system 60, crossing the center axis As, and continuing to the opposite diametrical side (e.g., the cut 163 can pass from one diametrical side S1 to another S2). For example, a division of the nosecone 65 along its diameter into two halves (e.g., S1, S2) may be considered, wherein the cut 163 begins on one side S1 of such diameter (the axis As running parallel with the diametrical plane) and ending on the other side S2, passing through the sheath’s / nosecone’s central longitudinal axis As. In such configurations, the cut 163 can cross far enough laterally across the nosecone 65 to nearly sever the tip flap 63b from the delivery system 60, while leaving enough structural connection 1902 (e.g., strip or other connector) to act as a flexible hinge, allowing the tip flap 63b and / or base flap 63a to flex or deflect outward relative to one another, while remaining attached to the body of the delivery system 60.

[0091] As shown in Figure 19F, the cut / plane 163 dividing the flaps 63a, 63b can originate on the side 1901 of the nosecone tapered tip 65, not at the very apex 1903, but rather partway down the taper. The cut / plane 163 angles inwards towards the longitudinal center axis As, crossing the center axis As, such that the cut 163 affects a substantial portion of the nosecone’s circumference by the time it reaches to or near the base of the taper, as demonstratedDocket No.: ADV-23668WO01 in Figure 19D. A relatively small amount of circumferential area / material 1902 may be left intact, which can serve as a hinge.

[0092] As described, the connection 1902 between the tip flap 63b and the body of the sheath 61 can operate as a hinge / joint. Additionally or alternatively, a portion of the delivery system 60 at a base of the nosecone 65 where the base flap 63a connects to the sheath 61 can include one or more hinge / joint features configured to facilitate outward deflection of the base flap 63a relative to the axis Asof the sheath 61. For example, a shallow cut 67 that fully or partially penetrates the outer diameter / surface of the sheath 61 may be implemented to facilitate bending at the base of the base flap 63a. The hinge / joint 67 can be implemented as a shallow scoring cut around at least a portion of the circumference of the sheath shaft 61. In some implementations, the cut does not fully penetrate the material, leaving enough intact structure to act as a flexible hinge. The depth of the cut can be deep enough to allow flexibility but not so as to be susceptible to breakage. In some implementations, the cut 67c (see Figure 19B) passes fully through the thickness of the sheath 61, resulting in a gap / channel with lateral support on either side, wherein the gap / channel 67c facilitates outward deflection of the flap 63a. Hole / fenestration features 67h can additionally or alternatively be implemented in the wall of the sheath 61 to facilitate flexion of the flap(s).

[0093] Figures 20A and 20B show views of delivery system 200 including a bipartite, deflectable nosecone 205 with locking channels 204a, 204b in accordance with one or more examples. The nosecone 205 is integrated with a sheath 201 that forms a lumen for implant and / or instrumentation transport and delivery. For example, the distal portions of the sheath 201 may be formed into opposing deflectable flaps to 203a, 203b configured to splay / deflect radially outwardly to permit egress of instrumentation. For example, instrumentation within the lumen 208 may be advanced distally to urge the flaps 203a, 203b apart to provide an opening, wherein the opening may be substantially coaxial with the axis of the sheath 201, or may be angled relative thereto.

[0094] The nosecone 205 may include a tip flap 203b, wherein a distal end of the opposing flap 203a terminates proximal of the distal end of the tip flap 203b. Each of the flaps 203a, 203b may have associated therewith a distal guidewire locking channel 204. For example, as shown in Figure 20C, the tip flap 203b may include a guidewire channel 204b, whereas the proximal / base flap 203a may include a separate guidewire channel 204a, wherein when the flaps 203a, 203b are brought into a closed configuration as shown in Figure 20A, the guidewire channel 204a aligns with the tip guidewire channel 204b in a position proximal of the tip channel 204b. For example, the base flap 203a may nest at least partially within and / or proximal of theDocket No.: ADV-23668WO01 base flap 203b, wherein lateral edges of one or more of the flaps 203a, 203b overlap the other to provide a closed nosecone as in Figure 20A. With the flaps 203a, 203b brought together as in Figure 20A, with the guidewire channels 204a, 204b at least partially axially overlapping / aligned, the guidewire 209 may be inserted through the lumen 208 of the sheath 201 and through the locking channels 204a, 204b, to thereby hold / lock the flaps 203a, 203b in the closed configuration shown in Figure 20A.

[0095] Proximally withdrawing the guidewire 209, as shown in Figure 20B, can allow for outward deflection of the flaps 203a, 203b. Therefore, the guidewire 209 may be operated as a control element for unlocking the nosecone 205 to allow for deployment of instrumentation at the target site. That is, the delivery system 200 may be maintained in a locked configuration with the guidewire 209 when advancing toward the target site, wherein upon arrival at the target site, the guidewire 209 may be withdrawn for implant deployment.

[0096] Figures 21A–21F show views of a bipartite nosecone 75 with proximal attachment loops 77 for remote release control when used with a delivery sheath 71 as part of a delivery system 70 in accordance with one or more examples. The proximal attachment loops 77 can be considered filament-attachment loops and may be used to couple to any suitable or desirable type of filament. The nosecone 75 includes two separable volume 73a, 73b, wherein such volumes may have a tapered leading portion 79 and a proximal sheath-nesting portion 78. The tapered portions 79 of the nosecones 73a, 73b can have any tapered contour / side 251 and may generally narrow towards the distal end of the nosecone 75, wherein a guidewire channel 74 is formed between the halves 73a, 73b to provide guidewire access through the nosecone 75.

[0097] The nosecone halves 73a, 73b can have a semicone volume / shape. The volumes of the halves 73a, 73b may be solid, or lease partially solid, outside of the carved-out volume 74 of the guidewire channel. The proximal end / edge of the tapered portion 79 of the nosecone halves may have a proximally-facing stopper surfaces 76 configured to be disposed on or against a distal end of the sheath 71 of the delivery system 70. Therefore, when proximally pulled or held, such as via attachment loops 77a, 77b, the proximal surface 76 may abut the sheath 71 and maintain the nosecone 75 in the desired relative position relative to the sheath 71. The stopper lip / ledge 76 may further provide a seal around the circumference of the distal end of the sheath 71 so as to prevent the passage of fluid between the lumen of the sheath 71 and the exterior environment.

[0098] The nosecone halves 73a, 73b may further comprise proximal nesting portions 78a, 78b, which may be configured to be disposed at least partially within the distal portion of the lumen of the sheath 71 when the nosecone 75 is held against the sheath 71. The nestedDocket No.: ADV-23668WO01 extension(s) 78 may provide stability for the nosecone 75 within the sheath 71. For example, in some implementations, the nested base 78 may have a diameter / dimension configured to provide a friction fit within the inner diameter of the sheath 71 to further secure the nosecone 75 in place within the sheath 71. Tension applied on the filaments 252a, 252b can serve to keep the halves / parts 73a, 73b at least partially inside the outer shaft 71 with the distal end of the sheath 71 abutting the shoulder / lip surface 76 to create a continuous transition between the nosecone 75 and sheath 71, which may be flush in some implementations along the outer diameter of such components.

[0099] In some implementations, the proximal base portions 78a, 78b may have associated therewith respective filament-engagement loops, hooks, or similar structures configured to be engaged with and / or have passed therethrough one or more filaments, such as any type of suture, wire, clamp, hook, or other elongate element. For example, the wires or sutures 252a, 252b may be threaded through respective ones of the loops 77a, 77b, and pass proximally through the sheath 71 to provide remote-controllability of the position of the nosecone 75 and / or halves 73a, 73b relative to the sheath 71. For example, the filaments 252 can be slackened to allow for the nosecone 75 to advance distally relative to the sheath 71 to allow for deployment of instrumentation, such as an implant device, out of the distal end of the sheath 71. For example, when the nosecone 75 is deployed from the sheath 71, the halves 73a, 73b may be inclined to separate, thereby allowing for an implant device, such as a stent, to be deployed between the separated halves 73a, 73b. After deployment of the implant device, the nosecone 75 may be withdrawn by approximately pulling the halves 73a, 73b around the implant device and back toward the distal end of the sheath 71. In some implementations, the filaments 252a, 252b have sufficient rigidity to allow for pushing of the nosecone 75 therewith to cause the nosecone to deploy and / or separate. In some implementations, the nosecone halves 73a, 73b may be withdrawn through the inner lumen of the deployed stent or other device. For example, in such implementations, the halves 73a, 73b may be withdrawn separately and / or sequentially, such that only one half is drawn through a given area of the implant at a time, thereby allowing for lower profile devices and nosecone retraction therethrough.

[0100] The attachment loops 77a, 77b may have any desirable form or structure. For example, the features 77a, 77b may comprise closed loops, as illustrated, or may have the configuration of an open hook or other structure which filaments or clamps may be secured. When the nosecone halves 73a, 73b are positioned such that they abut one another in the closed configuration shown in Figures 21A–21D, the inner flat sides of the halves 73a, 73b may press against one another in axial alignment to provide a combined tapered nosecone form, asDocket No.: ADV-23668WO01 illustrated. The distal end of the nosecone 75 may provide an opening 72 into the guidewire channel 74, as with various other examples disclosed herein.

[0101] Figures 22A and 22B show views of a delivery system 90 including a deflectable nosecone 92 formed by shape-memory petals / panels in accordance with one or more examples. The nosecone 92 may comprise nitinol or other memory metal material mounted on a shaft / sheath 91. Figure 22A shows the nosecone 92 in a closed configuration, whereas Figure 22B shows the nosecone 92 in an open configuration.

[0102] At the distal end of the shaft / sheath 91, the nosecone may comprise a plurality (e.g., four) segmented petals / panels 93, which may project distally from the end of the sheath 91, as shown. The panels 93 (e.g., panels 93a, 93b, 93c, 93d) can be triangular in shape, having the form of relatively thin slices arranged circumferentially around the distal end of the sheath 91. Such an arrangement can allow for a compact, tapered profile when the panels / petals 93 are in the closed position shown in Figure 22A, forming an atraumatic leading nosecone.

[0103] The triangular panels 93 can comprise a shape memory alloy, such as nitinol, or other material having a characteristic ability to return to a predetermined shape after deformation. The shape memory of the panels 93 can advantageously cause the panels 93 to automatically return to their original, closed configuration after outward deflection as shown in Figure 22B. The panels 93 can be configured to diverge / expand radially outward when an instrument or implant is advanced distally through the shaft 91 and out through the nosecone 92. Such mechanism can allow for the controlled release or deployment of surgical materials or devices. Once the instrument or implant is retracted, or once the deployment force is removed, the shape memory bias of the panels 93 facilitates the return to their closed, tapered configuration. That is, the shape memory of the panels 93 can provide a self-closing natural behavior of the nosecone 92. The shape memory material of the panels 93 (e.g., nitinol, a nickel- titanium alloy), can imbue the panels 93 with the ability to assume the two distinct configurations shown in Figures 22A and 22B, namely the default, or ‘remembered,’ configuration of Figure 22A, where the tips of the panels 93 converge to form a tapered, atraumatic nosecone, and the open / deflected configuration of Figure 22B, where the tips are deflected radially outward.

[0104] When an instrument or implant is advanced through the sheath / shaft 91 and pushes against the inside surfaces / edges of the panels 93, the panels 93 are prone to deflect outward, as shown in Figure 22B. Such outward deflection can be controlled and / or temporary, allowing for the precise deployment of implants or the performance of surgical actions at the target site. The outward deflection of the panels 93 generally increases the diameter of theDocket No.: ADV-23668WO01 nosecone 92, which can facilitate deploying an implant, or possibly tool anchoring or expanding tissue. The expanded state or Figure 22B may generally be maintained as long as the internal pushing / urging force is applied within the nosecone 92.

[0105] The transition from the closed to the open configurations of the nosecone 92 involves elastic deformation of the shape memory material of the panels 93. Despite this deformation, the material may advantageously not reach its plastic deformation threshold, allowing it to return to its programmed shape once the force is removed. In examples in which the nosecone 92 comprises nitinol, such material can exhibit superelasticity at temperatures above its transformation temperature, allowing it to undergo significant deformation without permanent bending or kinking, which can allow for repeated transition between states / configurations without damage.

[0106] In the closed configuration of Figure 22A, the tips of the panels 93 converge to form a unified, pointed end. The resulting tapered sides of the panels 93 provide the desired atraumatic leading end for the delivery system 90. The atraumatic nature of the closed nosecone 92 can be provided not only through the tapered geometry of the converged panel tips, but also through smooth surface finish and / or rounded edges of the panels 93. Adjacent ones of the panels 93 may or may not overlap circumferentially in the closed configuration. In some implementations, in the closed configuration, the panels 93 may align closely with one another and / or the shaft / sheath 91, creating a smooth and / or seamless outer surface along the nosecone 92 and at the transition between the nosecone 92 and the sheath 91, which can advantageously provide reduced friction and / or prevent tissue snagging or catching as the delivery system 90 is advanced.

[0107] Figures 23A and 23B show views of a deflectable nosecone 97 coupled to or otherwise integrated with a sheath 96, which may be similar in form and / or function to the nosecone 92 described above in one or more aspects, wherein the deflectable nosecone 97 includes distal panel-locking features in accordance with one or more examples. For example, the panels 98 of the nosecone 97 may be similar to the panels of the nosecone 92 of Figures 22A and 22B, and therefore any of the description above of Figures 22A and 22B may be understood to relate to the examples of Figures 23A and 23B.

[0108] The panels / petals 98 (e.g., panels 98a, 98b, 98c, 98d) can advantageously incorporate a locking mechanism through apertures, hooks, tabs, or other locking features 94 at the tips of the panels 98. For example, each panel 98 can have an aperture 94 formed in a tip 231 thereof. Such apertures 94 can be designed to come into axially-offset, co-axial alignment whenDocket No.: ADV-23668WO01 the panels 98 are in their closed configuration (see Figure 23A), creating a unified guidewire pathway through the converging tips 231.

[0109] The overlapping of the apertures 94 of the tips 231 in the closed configuration can serve to maintain the nosecone’s 97 atraumatic profile, while also providing a locking mechanism. The aligned apertures across the overlapped panel tips 231 can form a continuous channel that accommodates the insertion of a guidewire 99. The guidewire 99 can act as a locking pin, securing the panels 98 in their closed configuration. The insertion of the guidewire 99 through the panel apertures 94 effectively locks the panels 98 together, preventing unintentional opening and maintaining the integrity of the tapered shape of the nosecone 97 during insertion and navigation of the delivery system 95.

[0110] The guidewire 99 can serve not only as a locking mechanism but also as a means for controlled release of the nosecone 97. By withdrawing the guidewire 99, the locking engagement is released, allowing the panels 98 to be opened / deflected for the deployment of implants or surgical instruments. Such withdrawal can be performed as a deliberate action, ensuring that the panels are only opened at the appropriate stage of the procedure. The shape memory of the panels 98 may be towards the closed configuration of Figure 23A, wherein, after withdrawal of the guidewire 99, urging force may be required to cause the opening / deflection of the panels, such as by pushing instrumentation distally through the nosecone 97. Alternatively, the shape memory of the panels 98 may be towards the opened / deflected configuration of Figure 23B, wherein, after withdrawal of the guidewire 99, the panels 98 may be inclined to automatically open / deflect to provide the distal egress opening.

[0111] To achieve the overlapping of the apertures 94 of the tips 231 of the respective panels 98, the panel tips 231 may have certain extended features having the form of a tab or a flange, which may protrude slightly beyond the main body of the panel. Such tabs / flanges can comprise bent or curved tips designed to meet at the center when the panels 98 are in the closed configuration. The extended tab features at the panel tips 231 can be dimensioned such that when the panels 98 converge, the apertures 94 located on these extensions / tips 231 align coaxially to create a straight, continuous channel through which the guidewire 99 can be inserted, effectively locking the panels 98 together. Additional Description of Examples

[0112] 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.Docket No.: ADV-23668WO01

[0113] Example 1: An implant delivery system comprising an elongate sheath, and a tapered distal nosecone integrated with the elongate sheath, the tapered distal nosecone having one or more longitudinal slits between portions of the tapered distal nosecone that are configured to be urged apart to provide an opening for instrument deployment.

[0114] Example 2: The implant delivery system of any example herein, in particular example 1, wherein the one or more longitudinal slits comprises a slit formed by a first edge that is angled relative to an axis of the elongate sheath, and a second edge that opposes the first edge.

[0115] Example 3: The implant delivery system of any example herein, in particular example 2, wherein at least a portion of the second edge of the slit is less angled than the first edge relative to the axis of the elongate sheath.

[0116] Example 4: The implant delivery system of any example herein, in particular example 2, wherein the tapered distal nosecone is shape-set to a configuration where at least a portion of the second edge circumferentially overlaps at least a portion of the first edge.

[0117] Example 5: The implant delivery system of any example herein, in particular example 2, wherein the first edge and the second edge are sealed at a tip of the tapered distal nosecone.

[0118] Example 6: The implant delivery system of any example herein, in particular example 2, wherein the opening is angled relative to the axis of the elongate sheath.

[0119] Example 7: The implant delivery system of any example herein, in particular example 1, wherein the one or more longitudinal slits comprises first and second slits on opposite circumferential sides of the elongate sheath, the first and second slits separating first and second nosecone flaps.

[0120] Example 8: The implant delivery system of any example herein, in particular example 7, wherein the first nosecone flap includes a first locking channel, and the second nosecone flap includes a second locking channel.

[0121] Example 9: The implant delivery system of any example herein, in particular example 8, wherein, when the first and second nosecone flaps abut one another, the first locking channel and the second locking channel are coaxial with an axis of the elongate sheath.

[0122] Example 10: The implant delivery system of any example herein, in particular example 8, wherein the first locking channel and the second locking channel comprise at least one of a tube or a ring structure.

[0123] Example 11: The implant delivery system of any example herein, in particular example 8, wherein the first locking channel is attached to a first spacer that projects from an inner diameter of the first nosecone flap and holds the first locking channel co-axial with theDocket No.: ADV-23668WO01 elongate sheath, and the second locking channel is attached to a second spacer that projects from an inner diameter of the second nosecone flap and holds the second locking channel co-axial with the elongate sheath.

[0124] Example 12: The implant delivery system of any example herein, in particular example 11, wherein, when the first and second nosecone flaps abut one another, the first locking channel and the second locking channel are axially-offset from one another.

[0125] Example 13: The implant delivery system of any example herein, in particular example 8, wherein the first nosecone flap is semicircular truncated conical shell that is hollow except for at least a portion of the first locking channel and a spacer that holds the first locking channel.

[0126] Example 14: The implant delivery system of any example herein, in particular example 13, wherein the spacer has a rib form that runs longitudinally along a length of the first nosecone flap.

[0127] Example 15: The implant delivery system of any example herein, in particular example 8, wherein each of the first and second nosecone flaps has an apical window that forms half of an apical guidewire aperture in the tapered distal nosecone when the first and second nosecone flaps abut one another.

[0128] Example 16: The implant delivery system of any example herein, in particular example 8, wherein the first nosecone flap has a hinge at a base thereof that facilitates radial deflection of the first nosecone flap.

[0129] Example 17: The implant delivery system of any example herein, in particular example 1, wherein the one or more longitudinal slits comprises an angled planar cut originating on a tapered side of the tapered distal nosecone and passing through an axis of the tapered distal nosecone.

[0130] Example 18: The implant delivery system of any example herein, in particular example 17, wherein the angled planar cut originates on a distal half of the tapered distal nosecone and terminates on a proximal half of the tapered distal nosecone.

[0131] Example 19: The implant delivery system of any example herein, in particular example 18, wherein the angled planar cut originates on one diametrical half of the tapered distal nosecone and terminates on an opposite diametrical half of the tapered distal nosecone.

[0132] Example 20: The implant delivery system of any example herein, in particular example 17, wherein the angled planar cut divides the tapered distal nosecone into a tip segment and a base segment.Docket No.: ADV-23668WO01

[0133] Example 21: The implant delivery system of any example herein, in particular example 20, wherein volumes of the tip segment and the base segment are mostly solid.

[0134] Example 22: The implant delivery system of any example herein, in particular example 21, wherein an axial channel runs over a central axis of the tapered distal nosecone through the tip segment and the base segment.

[0135] Example 23: The implant delivery system of any example herein, in particular example 22, wherein the axial channel passes through the angled planar cut.

[0136] Example 24: The implant delivery system of any example herein, in particular example 20, further including a hinge cut at a base of the base segment.

[0137] Example 25: The implant delivery system of any example herein, in particular example 20, further including a hinge flexure at a base of the base segment.

[0138] Example 26: The implant delivery system of any example herein, in particular example 20, further including a hinge flexure at a base of the tip segment.

[0139] Example 27: The implant delivery system of any example herein, in particular example 1, wherein the one or more longitudinal slits comprise a plurality of circumferentially distributed slits that form a plurality of circumferentially distributed, distally-projecting petals.

[0140] Example 28: The implant delivery system of any example herein, in particular example 27, wherein the plurality of petals are shape-memory biased towards a closed configuration in which tips of the plurality of petals converge to form a pointed tip.

[0141] Example 29: The implant delivery system of any example herein, in particular example 28, wherein the plurality of petals are configured such that distal force on an inner surface of the plurality of petals causes outward deflection of the petals to present a distal opening in the tapered distal nosecone.

[0142] Example 30: The implant delivery system of any example herein, in particular example 27, wherein tips of each of the plurality of petals have apertures that overlap when the petals are in a closed configuration.

[0143] Example 31: The implant delivery system of any example herein, in particular example 30, wherein the tips of each of the plurality of petals are bent to allow for the apertures to co-axially overlap in the closed configuration.

[0144] Example 32: An implant delivery system comprising an elongate sheath and a nosecone configured to be held against a distal end of the elongate sheath, the nosecone comprising a first semicone form having a first filament-attachment loop associated with a proximal end of the first semicone form, and a second semicone form having a second filament- attachment loop associated with a proximal end of the second semicone form. The implantDocket No.: ADV-23668WO01 delivery system further comprises a first filament engaged with the first filament-attachment loop, the first filament running through a length of the elongate sheath and a second filament engaged with the second filament-attachment loop, the second filament running through a length of the elongate sheath.

[0145] 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.

[0146] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain examples include, while other examples do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular example. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain examples require at least one of X, at least one of Y and at least one of Z to each be present.

[0147] It should be appreciated that in the above description of examples, various features are sometimes grouped together in a single example, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and / or described in a particular example herein can be applied to or used with any other example(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for eachDocket No.: ADV-23668WO01 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.

[0148] 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.

[0149] 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.

[0150] The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.

[0151] 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-23668WO01 WHAT IS CLAIMED IS:

1. An implant delivery system comprising: an elongate sheath; a tapered distal nosecone integrated with the elongate sheath, the tapered distal nosecone including first and second slits on opposite circumferential sides of the elongate sheath, the first and second slits separating first and second nosecone flaps positioned and adapted to be urged apart to provide an opening for instrument deployment from withing the elongate sheath; a first locking channel associated with the first nosecone flap; and a second locking channel associated with the second nosecone flap, the first and second locking channels comprising at least one of a tube or a ring structure.

2. The implant delivery system of claim 1, wherein, when the first and second nosecone flaps abut one another, the first locking channel and the second locking channel are coaxial with an axis of the elongate sheath.

3. The implant delivery system of claim 1, wherein: the first locking channel is attached to a first spacer that projects from an inner diameter of the first nosecone flap and holds the first locking channel co-axial with the elongate sheath; and the second locking channel is attached to a second spacer that projects from an inner diameter of the second nosecone flap and holds the second locking channel co-axial with the elongate sheath.

4. The implant delivery system of claim 3, wherein, when the first and second nosecone flaps abut one another, the first locking channel and the second locking channel are axially-offset from one another.

5. The implant delivery system of any of claims 1–3, wherein the first nosecone flap is a semicircular truncated conical shell that is hollow except for at least a portion of the first locking channel and a spacer that holds the first locking channel.

6. The implant delivery system of claim 5, wherein the spacer has a rib form that runs longitudinally along a length of the first nosecone flap.Docket No.: ADV-23668WO01 7. The implant delivery system of any of claims 1–3, wherein each of the first and second nosecone flaps has an apical window that forms half of an apical guidewire aperture in the tapered distal nosecone when the first and second nosecone flaps abut one another.

8. The implant delivery system of any of claims 1–3, wherein the first nosecone flap has a hinge at a base thereof that facilitates radial deflection of the first nosecone flap.

9. An implant delivery device comprising: an elongate sheath; and a tapered distal nosecone integrated with the elongate sheath, the tapered distal nosecone having a distal longitudinal slit extending from a distal end of the tapered distal nosecone between first and second portions of the tapered distal nosecone that are positioned and adapted to be urged apart to provide an opening for instrument deployment from within the elongate sheath, the distal longitudinal slit being formed by: a first edge associated with the first portion of the tapered distal nosecone, the first edge being angled relative to an axis of the elongate sheath; and a second edge associated with the second portion of the tapered distal nosecone, the second edge opposing the first edge.

10. The implant delivery device of claim 9, wherein at least a portion of the second edge less angled than the first edge relative to the axis of the elongate sheath.

11. The implant delivery device of claim 9, wherein the tapered distal nosecone is shape-set to a configuration where at least a portion of the second edge circumferentially overlaps at least a portion of the first edge.

12. The implant delivery device of any of claims 9–11, wherein the first edge and the second edge are sealed at a tip of the tapered distal nosecone.

13. The implant delivery device of any of claims 9–11, wherein the opening is angled relative to the axis of the elongate sheath.

14. The implant delivery device of any of claims 9–11, wherein the tapered distal nosecone includes a second slits positioned on an opposite circumferential side of the elongate sheath from the distal longitudinal slit.

15. An implant delivery system comprising: an elongate sheath; andDocket No.: ADV-23668WO01 a tapered distal nosecone integrated with the elongate sheath, the tapered distal nosecone having one or more longitudinal breaks between portions of the tapered distal nosecone that are configured to be urged apart to provide an opening for instrument deployment.

16. The implant delivery system of claim 15, wherein the one or more longitudinal breaks comprises an angled planar cut originating on a tapered side of the tapered distal nosecone and passing through an axis of the tapered distal nosecone.

17. The implant delivery system of claim 16, wherein: the angled planar cut originates on a distal half of the tapered distal nosecone and terminates on a proximal half of the tapered distal nosecone; and the angled planar cut originates on one diametrical half of the tapered distal nosecone and terminates on an opposite diametrical half of the tapered distal nosecone.

18. The implant delivery system of claim 16 or claim 17, wherein the angled planar cut divides the tapered distal nosecone into a tip segment and a base segment.

19. The implant delivery system of claim 18, wherein: an axial channel runs over a central axis of the tapered distal nosecone through the tip segment and the base segment; and the axial channel passes through the angled planar cut.

20. The implant delivery system of claim 18, further including a hinge cut at a base of the base segment.

21. An implant delivery system comprising: an elongate sheath; a tapered distal nosecone integrated with the elongate sheath, the nosecone having first and second slits on opposite circumferential sides of the nosecone, the first and second slits allowing first and second nosecone flaps defined by the first and second slits to be urged apart to provide an opening for instrument deployment; a first longitudinal blade running along an inside surface of the first nosecone flap; a first guidewire locking tube attached to the first longitudinal blade and aligned with an axis of the first nosecone flap;Docket No.: ADV-23668WO01 a second longitudinal blade running along an inside surface of the second nosecone flap; and a second guidewire locking tube attached to the second longitudinal blade and aligned with an axis of the second nosecone flap, the second guidewire locking tube being disposed at a position that is longitudinally-offset from a position of the first guidewire locking tube.

22. The implant delivery system of claim 21, wherein, when the first and second nosecone flaps are in a closed configuration, the first guidewire locking tube and the second guidewire locking tube are coaxial.

23. An implant delivery system comprising: an elongate sheath; and a tapered distal nosecone integrated with the elongate sheath, the nosecone having an angled planar cut originating on a tapered side on a distal half of the nosecone and passing through an axis of the nosecone to terminate on a proximal half of the nosecone, the angled planar cut dividing the nosecone into mostly solid tip and base segments.

24. The implant delivery system of claim 23, wherein the angled planar cut originates on one diametrical half of the nosecone and terminates on an opposite diametrical half of the nosecone.

25. The implant delivery system of claim 23, wherein: an axial channel runs over the axis of the nosecone through the tip segment and the base segment; and the axial channel passes through the angled planar cut.

26. The implant delivery system of claim 23, further including at least one of: a hinge cut at a base of the base segment; a hinge flexure at a base of the base segment; or a hinge flexure at a base of the tip segment.

27. An implant delivery system comprising: an elongate sheath; and a tapered distal nosecone integrated with the elongate sheath, the tapered distal nosecone having a plurality of circumferentially-distributed longitudinal slits, the plurality of slits forming a plurality of distally-projecting petals;Docket No.: ADV-23668WO01 wherein: the plurality of petals are shape-memory biased towards a closed configuration in which tips of the plurality of petals converge to form a pointed tip; the plurality of petals are positioned such that distal force on an inner surface of the plurality of petals causes outward deflection thereof to present a distal opening of the nosecone; and tips of each of the plurality of petals have apertures that overlap when the petals are in a closed configuration.

28. The implant delivery system of claim 27, wherein the tips of each of the plurality of petals are bent to allow for the apertures to co-axially overlap in the closed configuration.

29. An implant delivery system comprising: an elongate sheath; a nosecone configured to be held against a distal end of the elongate sheath, the nosecone comprising: a first semicone form having a first filament-attachment loop associated with a proximal end of the first semicone form; and a second semicone form having a second filament-attachment loop associated with a proximal end of the second semicone form; a first filament engaged with the first filament-attachment loop, the first filament running through a length of the elongate sheath; and a second filament engaged with the second filament-attachment loop, the second filament running through a length of the elongate sheath.

30. The implant delivery system of claim 29, wherein each of first semicone form and the second semicone has an inner semi-cylinder carveout volume that runs a length of the respective semicone.

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