DELIVERY SYSTEM HAVING EXPANDABLE DISTAL CAPSULE - Patent application

Abstract

The implant delivery system includes a distal portion configured to naturally assume a first width and expand beyond the first width in response to an implant device being inserted into the distal portion through an opening at a distal end of the distal portion, and a proximal portion configured to generally maintain the first width.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 309,290, filed February 11, 2022, and entitled “DELIVERY SYSTEM WITH EXPANDABLE DISTAL CAPSULE,” the disclosure of which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates generally to the field of medical implant delivery devices. [Background technology]

[0003] 2. Description of Related Art Various medical procedures involve the implantation of medical implant devices within the cardiac anatomy. The medical implant devices may be delivered to a patient's body and / or heart for a variety of purposes, which may include supporting blood circulation. Summary of the Invention [Means for solving the problem]

[0004] Described herein are one or more methods and / or devices for facilitating the delivery of various medical implant devices, which may include mechanical circulatory systems.

[0005] Some implementations of the present disclosure relate to an implant delivery system comprising a distal portion configured to naturally assume and expand beyond a first width in response to an implant device being inserted into the distal portion through an opening at a distal end of the distal portion, and a proximal portion configured to generally maintain the first width.

[0006] The proximal portion may not be configured to expand in response to an implant device extending into or relative to the proximal portion, hi some embodiments, the distal portion comprises one or more bendable rods configured to bend in response to an implant device being inserted into the distal portion.

[0007] In some embodiments, the distal portion further comprises a first coating configured to extend across the one or more bendable rods to form an inner diameter of the distal portion. The distal portion may further comprise a second coating configured to extend across the one or more bendable rods to form an outer diameter of the distal portion.

[0008] The one or more bendable rods may be evenly spaced around the circumference of the distal portion, hi some embodiments, the one or more bendable rods extend longitudinally along the distal portion.

[0009] In some embodiments, the proximal portion comprises a braided network of fibers.The implant delivery system may further comprise a nosecone configured to provide a tip for the implant device.

[0010] The nosecone may be configured to extend at least partially across a distal end of the distal portion, hi some embodiments, the nosecone is configured to extend from the implant device.

[0011] In some embodiments, the proximal portion is configured to receive a tubular portion of the implant device. The tubular portion may have a generally flexible construction. In some embodiments, the tubular portion is configured to bend to facilitate navigation of the implant device through the aortic arch.

[0012] According to some implementations of the disclosure, a method includes delivering a delivery device carrying an implant device into a blood vessel, the delivery device including a distal portion configured to naturally assume and expand beyond a first width in response to a distal member of the implant device being inserted into the distal portion through an opening at a distal end of the distal portion, and a proximal portion configured to generally maintain the first width. The method further includes extending at least the distal member of the implant device beyond a distal end of the delivery device causing the distal portion of the delivery device to assume the first width, and retracting at least the distal member of the implant device into the distal portion of the delivery device causing the distal portion of the delivery device to expand beyond the first width.

[0013] In some examples, the proximal portion is not configured to expand in response to a distal member of the implant device being retracted into the distal portion of the delivery device. The distal portion may include one or more bendable rods configured to bend in response to the implant device being inserted into the distal portion.

[0014] The distal portion may comprise a first coating configured to extend across the one or more bendable rods to form an inner diameter of the distal portion, hi some embodiments, the distal portion further comprises a second coating configured to extend across the one or more bendable rods to form an outer diameter of the distal portion.

[0015] In some embodiments, the proximal portion comprises a braided network of fibers. The proximal portion may be configured to receive a tubular portion of the implant device.

[0016] The tubular portion may have a generally flexible construction and may be configured to bend to facilitate navigation of the distal member through the aortic arch.

[0017] Some implementations of the present disclosure relate to an implant delivery shaft including a distal portion configured to naturally assume and expand beyond a first width in response to an implant device being inserted into the distal portion through an opening at a distal end of the distal portion, and a proximal portion configured to generally maintain the first width.

[0018] In some aspects, the technology described herein relates to an implant delivery shaft, where a proximal portion is not configured to expand in response to an implant device extending into or relative to the proximal portion.

[0019] In some aspects, the technology described herein relates to an implant delivery shaft or claim 23, wherein a distal portion includes one or more bendable rods configured to bend in response to an implant device being inserted into the distal portion.

[0020] In some aspects, the technology described herein relates to an implant delivery shaft, the distal portion further comprising a first coating configured to extend across an inner surface of one or more bendable rods to form an inner diameter of the distal portion.

[0021] In some aspects, the technology described herein relates to an implant delivery shaft, the distal portion further comprising a second coating configured to extend over an outer surface of one or more bendable rods to form an outer diameter of the distal portion.

[0022] In some aspects, the technology described herein relates to an implant delivery shaft, wherein one or more bendable rods are evenly spaced around the circumference of a distal portion.

[0023] In some aspects, the technology described herein relates to an implant delivery shaft, wherein one or more bendable rods extend longitudinally along a distal portion.

[0024] In some aspects, the technology described herein relates to an implant delivery shaft, a proximal portion of which comprises a braided network of fibers.

[0025] In some aspects, the technology described herein relates to an implant delivery shaft, a proximal portion of which is configured to receive a tubular portion of an implant device.

[0026] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features have been described. It will be understood that not all such advantages may necessarily be achieved in accordance with any particular example. Thus, the disclosed embodiments may be practiced in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages that may be taught or suggested herein.

[0027] Various examples are shown in the accompanying drawings for illustrative purposes, but should not be construed as limiting the scope of the present invention in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference characters may be reused to indicate correspondence between referenced elements. [Brief description of the drawings]

[0028] [Figure 1] FIG. 1 illustrates an exemplary representation of a human heart, according to one or more embodiments. [Diagram 2] FIG. 2 illustrates an example of a delivery system including one or more delivery devices configured to carry and / or percutaneously deliver one or more medical implants according to one or more embodiments. [Diagram 3]FIG. 3 illustrates an example of a delivery system comprising one or more delivery devices configured to carry and / or percutaneously deliver one or more medical implants according to one or more embodiments. [Figure 4] FIG. 4 illustrates an example of a delivery system comprising one or more delivery devices configured to carry and / or percutaneously deliver one or more medical implants according to one or more embodiments. [Figure 5A] 5A and 5B show internal side and front views, respectively, of at least a portion of an exemplary delivery device, according to one or more embodiments. [Figure 5B] 5A and 5B show internal side and front views, respectively, of at least a portion of an exemplary delivery device, according to one or more embodiments. [Figure 6-1] FIG. 6-1 provides a flowchart illustrating a process, including one or more steps, for delivering one or more medical implants to one or more target locations within the heart (e.g., the left ventricle), according to one or more embodiments. [Figure 6-2] FIG. 6-2 provides a flowchart illustrating a process, including one or more steps, for delivering one or more medical implants to one or more target locations within the heart (e.g., the left ventricle), according to one or more embodiments. [Figure 6-3] FIG. 6-3 provides a flowchart illustrating a process, including one or more steps, for delivering one or more medical implants to one or more target locations within the heart (e.g., the left ventricle), according to one or more embodiments. [Figure 7-1] FIG. 7-1 provides images that correspond to the steps of the process in FIG. [Figure 7-2] FIG. 7-2 provides images that correspond to the steps of the process in FIG. [Figure 7-3] FIG. 7-3 provides images that correspond to the steps of the process in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0030] Although certain preferred embodiment(s) are disclosed below, the inventive subject matter extends beyond the specifically disclosed examples to other alternative examples and / or uses, as well as to modifications and equivalents thereof. Thus, the scope of claims that may arise from this specification is not limited by any of the specific examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Although various operations may be described sequentially as multiple separate operations in a manner that may be useful for understanding a particular example, the order of description should not be construed as implying that these operations are order dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, the various examples may be implemented in a manner that achieves or optimizes one advantage or advantages taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0031] Certain reference numbers are reused across different figures in all figures of this disclosure for convenience in reference to devices, components, systems, features, and / or modules having characteristics that may be similar in one or more respects. However, in reference to any of the examples disclosed herein, the reuse of a common reference number in a figure does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one skilled in the art can learn from the context as to the degree to which the use of a common reference number may suggest similarity between the referenced subject matter. The use of a particular reference number in the context of a description of a particular figure can be understood as relating to the device, component, aspect, feature, module, or system identified in that particular figure, and not necessarily to any device, component, aspect, feature, module, or system identified with the same reference number in another figure. Furthermore, aspects of separate figures identified with a common reference number can be interpreted as sharing features or as being entirely independent of each other.

[0032] Certain standard anatomical terms of location are used herein to refer to animal, i.e., human, anatomical structures for the preferred example. While certain spatially relative terms such as "outer", "inner", "superior", "lower", "down", "upper", "vertical", "horizontal", "top", "bottom" and similar terms are used herein to describe the 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 the element(s) / structure(s) illustrated in the drawings. It should be understood that the spatially relative terms are intended to encompass different orientations of the element(s) / structure(s) in use or operation in addition to the orientation depicted in the drawings. For example, an element / structure described as "above" another element / structure may represent a position below or to the side of such other element / structure with respect to the intended patient or alternative orientations of the element / structure, and vice versa.

[0033] The present disclosure relates to systems, devices, and methods for delivering one or more medical implant devices (e.g., mechanical circulatory systems) through various anatomical structures, which may include delivery to the left ventricle via the aorta. In some implementations, the present disclosure relates to a delivery system comprising an expandable distal capsule that may be associated with and / or configured to receive and / or carry one or more medical implant devices. The term "associated with" is used herein according to its broad and ordinary meaning. For example, when a first feature, element, component, device, or member is described as "associated with" a second feature, element, component, device, or member, such description should be understood as indicating that the first feature, element, component, device, or member is physically coupled, attached, connected, integrated with, at least partially embedded within, or otherwise physically associated with the second feature, element, component, device, or member, whether directly or indirectly. Specific examples are disclosed herein in terms of cardiac implant devices. However, while certain principles disclosed herein are particularly applicable to cardiac anatomical structures, it should be understood that an implant device delivery system in accordance with the present disclosure may be implanted within, or configured to be implanted into, any suitable or desired anatomical structure.

[0034] Some medical implant devices (e.g., mechanical circulatory systems) may be difficult to advance through a delivery device (e.g., a sheath) due, at least in part, to friction buildup and / or lack of column strength from the delivery device due to extrusion potential. In some cases, a coating (e.g., a thermoplastic polyurethane coating) on ​​the medical implant device may be damaged while the medical implant device is advanced through the delivery device.

[0035] Some embodiments described herein relate to an at least partially expandable delivery device configured to receive and / or protect one or more medical implant devices, which may include a mechanical circulatory system. The medical implant device may include multiple components. For example, the medical implant device may include a distal member (e.g., a motor) and / or a proximal member (e.g., inflow and / or outflow tubes) extending from and / or coupled to the distal member. In some embodiments, the distal member may have an increased diameter and / or width relative to the proximal member. The increased width and / or diameter of the distal member may at least partially impede blood flow through various blood vessels during delivery of the medical implant device to a target location.

[0036] In some embodiments, the delivery device (e.g., catheter, shaft, and / or tube) may comprise an expandable and / or distal portion configured to at least partially receive and / or expand around a distal member of the medical implant device. The delivery device may further comprise a proximal portion configured to approximately maintain a predetermined width and / or diameter. In some embodiments, the distal portion of the delivery device may comprise a distal end of the delivery device. Once the delivery device reaches the target location, the medical implant device may be released from within the distal portion of the delivery device, which may allow the distal portion to naturally compress to a width and / or diameter approximately equal to the width and / or diameter of the proximal portion. In this manner, the delivery device may assume and / or maintain a low and / or minimal profile while located within the body. Additionally, the medical implant device may be advantageously disposed at the distal end of the delivery device to avoid advancing the medical implant device through the length of the delivery device, which may cause damage to the medical implant device.

[0037] The medical implant device may be retracted into the delivery device after detaching the medical implant device from the delivery device. For example, the medical implant device and the delivery device may be connected together via a guidewire and / or similar device that extends at least partially through the delivery device and the medical implant device. The medical implant device may be retracted (e.g., by pulling a proximal member of the medical implant device) until the medical implant device contacts a distal end and / or distal portion of the delivery device. The distal portion may be configured to expand in response to an external force applied by the medical implant device at the distal end of the delivery device to allow the medical implant device to re-enter the distal portion. Cardiac Physiology

[0038] The anatomical structure of the heart is described below to aid in understanding certain inventive concepts disclosed herein. In humans, and other vertebrates, the heart generally comprises a muscular organ having four pumping chambers, the flow of which is controlled, at least in part, by various cardiac valves, namely the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves may be configured to open and close in response to pressure gradients that exist during various phases of the cardiac cycle (e.g., relaxation and systole), thereby at least in part controlling the flow of blood to corresponding regions of the heart and / or to blood vessels (e.g., lungs, aorta, etc.).

[0039] FIG. 1 illustrates an exemplary representation of a heart 1 having various features associated with certain embodiments of the present disclosure. The heart 1 includes four chambers: a left atrium 2, a left ventricle 3, a right ventricle 4, and a right atrium 5. With respect to blood flow, blood generally flows from the right ventricle 4 into a pulmonary artery 11 via a pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole to allow blood to be pumped towards the lungs and to close during diastole to prevent blood from flowing back from the pulmonary artery 11 into the heart. 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 a left pulmonary artery 15 and a right pulmonary artery 13, which branch off from the pulmonary trunk, as shown. A pulmonary vein 23 carries blood from the lungs to the left atrium 2.

[0040] In addition to the pulmonary valve 9, the heart 1 includes three additional valves to aid in blood circulation therein, including a tricuspid valve 8, an aortic valve 7, and a mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 generally has three cusps, or leaflets, and generally may 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 to allow blood from the left atrium 2 to flow into the left ventricle 3, and to close during systole to prevent blood from flowing back into the left atrium 2 when functioning properly. 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 to close during diastole to prevent blood from flowing back into the left ventricle 3.

[0041] A heart valve may generally include a relatively dense fibrous ring, referred to herein as the annulus, and a number of leaflets, or cusps, attached to the annulus. Generally, the size of the leaflets, or cusps, may be such that when the heart contracts, the increased blood pressure generated within the corresponding heart chamber causes the leaflets to at least partially open, thereby allowing flow from the heart chamber. When pressure within a heart chamber decreases, pressure within the subsequent heart chamber or blood vessel may prevail and push the leaflets back. As a result, the leaflets / cusps become apposed to one another, thereby obstructing the flow path. Incompetence of a heart valve and / or associated leaflets (e.g., incompetence of the pulmonary valve) may result in valve leakage and / or other health complications.

[0042] Atrioventricular (i.e., mitral and tricuspid) heart valves may further include a collection of chordae tendineae and papillary muscles (not shown) for securing the leaflets of each corresponding valve to promote and / or facilitate proper fusion of the leaflets and to prevent their prolapse. For example, the papillary muscles may generally include finger-like projections from the ventricular wall. The leaflets of the valve are connected to the papillary muscles by the chordae tendineae. A muscular wall called the septum separates the left heart chamber from the right heart chamber. In particular, an atrial septum wall portion 18 (referred to herein as the "atrial septum", "interatrial septum", or "septum") separates the left atrium 2 from the right atrium 5, while an ventricular septum wall portion 17 (referred to herein as the "ventricular septum", "interventricular septum", or "septum") separates the left ventricle 3 from the right ventricle 4. The inferior tip 26 of the heart 1 is called the apex and is generally located in the fifth intercostal space, at or near the clavicular midline.

[0043] The coronary sinus 16 comprises a collection of veins that join together to form a large vessel that collects blood from the heart muscle (myocardium). The ostium of the coronary sinus, which may be at least partially protected by the Thebesian valve in some patients, opens into the right atrium 5 as shown. The coronary sinus extends along the posterior surface of the left atrium 2 and supplies less oxygenated blood to the right atrium 5. The coronary sinus generally extends laterally within the left atrioventricular groove, which is located on the posterior side of the heart.

[0044] Any of a number of access paths within the heart 1 may be utilized to manipulate guidewires and catheters within and around the heart 1 to deploy the implants and / or devices of the present application. For example, access may be from above, via either the subclavian or jugular vein, into the superior vena cava (SVC) 19 and into the right atrium 5, and from there into the coronary sinus 16. Alternatively, an access path may begin from the femoral vein and be introduced into the heart 1 through the inferior vena cava (IVC) 29. Other access paths may also be used, each of which may utilize a percutaneous incision through which guidewires and catheters are inserted into the vasculature, usually through a sealed introducer, from which the physician may control the distal end of the device from outside the body.

[0045] Medical Implant Device Delivery System 2 illustrates an example of a delivery system 200 including one or more delivery devices configured to carry and / or percutaneously deliver one or more medical implants according to one or more embodiments. The delivery device may include multiple components, which may include a fixed (e.g., proximal) portion 206 and / or an expandable (e.g., distal) portion 208. In some embodiments, the proximal portion 206 and the distal portion 208 may comprise different structures and / or materials.

[0046] In some embodiments, the proximal portion 206 may have a generally fixed width (e.g., a first width) and / or diameter and / or may be configured to generally maintain a fixed width and / or to resist deformation in response to external forces from one or more implant devices and / or internal forces and / or frictional forces during delivery through one or more anatomical regions. The proximal portion 206 may comprise an inner lumen having a generally fixed width and / or diameter. The inner lumen of the proximal portion 206 may be configured to receive at least a portion of one or more implant devices. The proximal portion 206 and / or the inner lumen of the proximal portion 206 may not be configured to expand in response to pressure from one or more implant devices having a width and / or diameter greater than the width and / or diameter of the proximal portion 206.

[0047] The distal portion 208 may have a generally flexible structure and / or may be configured to expand from a default width (e.g., a first width) and / or diameter (e.g., approximately equal to the width and / or diameter of the proximal portion 206) in response to a force applied by one or more implant devices. For example, one or more implant devices may be configured to pass through an inner lumen of the distal portion 208, as shown in FIG. 2. If the width and / or diameter of the implant device exceeds the default width and / or diameter of the distal portion 208, the distal portion 208 may be configured to naturally expand beyond the first width in response to pressure and / or force from the implant device. The expansion of the distal portion 208 may be driven by the implant device. For example, the distal portion 208 may be configured to expand only until it reaches a width and / or diameter that allows the implant device to fit within the distal portion 208. The distal portion 208 may be configured to fit snugly around the implant device to minimize the profile of the delivery device while housing the implant device.

[0048] In some embodiments, the delivery device may be configured to carry and / or deliver an implant device that comprises multiple components, including a proximal member 202 (e.g., inflow and / or outflow tubing), a distal member 204, and / or a nosecone 210. The proximal member 202 may be coupled to and / or extend into the distal member 204. The distal member 204 may be coupled to and / or extend into the nosecone 210.

[0049] The distal member 204 may have a larger width and / or diameter than the proximal member 202. For example, the distal member 204 may include a motor and / or other elements that require an increased profile. The proximal member 202 may have a reduced width and / or diameter relative to the distal member 204 to minimize the profile along the length of the implant device.

[0050] In some embodiments, the distal member 204 of the implant device may be configured to fit within the distal portion 208 of the delivery device and / or the distal portion 208 of the delivery device may be configured to hold the distal member 204 of the implant device. The proximal member 202 of the implant device may be configured to fit within the proximal portion 206 of the delivery device and / or the proximal portion 206 of the delivery device may be configured to hold the proximal member 202 of the implant device.

[0051] The width and / or diameter of the proximal portion 206 may be smaller than the width and / or diameter of the distal member 204 of the implant device. Additionally, the proximal portion 206 may have a generally rigid structure and / or may be configured to resist and / or prevent the distal member 204 from entering the inner lumen of the proximal portion 206. For example, as the distal member 204 is pulled into the distal portion 208 at the distal end 212 of the delivery device, the proximal member 202 may pass through the proximal portion 206 and / or the distal member 204 may press against the junction between the proximal portion 206 and the distal portion 208 (see FIG. 5A). The distal portion 208 may be configured to gradually decrease in diameter and / or width at the junction until the diameter and / or width is approximately equal to the diameter and / or width of the proximal portion 206.

[0052] In some embodiments, the distal end 212 of the delivery device and / or the distal portion 208 may comprise a generally blunt surface configured to press against tissue, if desired, without damaging the tissue. In the embodiment shown in FIG. 2, the nosecone 210 may be configured to at least partially fit into the distal end 212 of the distal portion 208. For example, the distal member 204 and / or the nosecone 210 may have a maximum diameter and / or width that may be smaller than the inner diameter 216 of the distal portion 208. Further, the maximum width and / or diameter of the nosecone 210 may be approximately equal to the diameter and / or width of the distal member 204 such that the edge 211 of the nosecone 210 does not extend beyond the distal member 204. In such embodiments, the distal end 212 of the delivery device and / or the distal portion 208 may be configured to contact and / or expand tissue as the delivery device and / or the implant are delivered through the patient's body. The distal portion 208 and / or the proximal portion 206 may have any suitable thickness between the outer diameter 214 and the inner diameter 216 .

[0053] The nosecone 210 may be configured to fit at least partially within the distal portion 208. In this manner, the nosecone 210 and / or the distal end 212 of the distal portion 208 may be configured to receive forces applied to the delivery device and / or the nosecone 210 as the delivery device and / or the nosecone 210 extends through the body and / or to protect the distal member 204 from such forces. The nosecone 210 may be configured to extend into contact with an inner diameter 216 and / or an inner wall of the distal portion 208.

[0054] Certain embodiments of the delivery devices and / or implants disclosed herein include a substantially circular cross-section, however, in some embodiments, a delivery device and / or implant according to the present disclosure may have an oval, rectangular, diamond, or elliptical configuration.

[0055] In some embodiments, at least a portion of the implant may have a relatively delicate and / or fragile structure. For example, the distal member 204 may include one or more motors, wires, control circuits, and / or various electronic components that may be susceptible to damage. Thus, at least a portion of the delivery device may be configured to protect the implant from damage during the delivery process. For example, the distal portion 208 may include a soft, durable, and / or reinforced structure configured to prevent damage to the implant.

[0056] The distal portion 208 may be configured to completely and / or nearly completely enclose and / or surround the distal member 204 of the implant. For example, the distal member 204 of the implant may not be exposed to tissue when a delivery device delivers the implant to a target location within the body.

[0057] In some embodiments, the proximal portion 206 may be configured to translate push and / or pull forces at the proximal portion 206 to the distal portion 208. For example, an extension of the proximal portion 206 may be configured to cause a corresponding extension of the distal portion 208. Thus, the proximal portion 206 may include a generally rigid structure. In some embodiments, the proximal portion 206 may comprise a braided reinforced shaft and / or may be configured to maximize the push and / or column strength of the delivery device. For example, the proximal portion 206 may include one or more networks of braided and / or woven fibers. In some embodiments, the proximal portion 206 may have a generally rigid structure and / or may be resistant to increasing and / or decreasing in width and / or may be configured to generally maintain a default width even when an implant device is inserted through a lumen of the proximal portion 206, the distal portion 208, and / or other portions of the delivery system 200.

[0058] The nosecone 210 may be secured and / or coupled to the distal member 204 of the implant device and / or may be configured to provide a leading edge and / or end for the implant device and / or delivery device. In some embodiments, the nosecone 210 may comprise one or more suitable materials including polyetheretherketone (PEEK), hydromat, and / or polybutylene adipate terephthalate (PBAT).

[0059] In some embodiments, the proximal portion 206 and the distal portion 208 may be at least partially fused and / or bonded together. For example, the distal portion 208 may comprise one or more rods and / or a covering that may be configured to be fused to the proximal portion 206. The proximal portion 206 may include a reinforced and / or braided network of cords and / or fibers.

[0060] In some embodiments, the proximal member 202 may be configured to provide lumens and / or containers for various wires and / or cables extending from the distal member 204. For example, the distal member 204 may include one or more motors and / or electronics that may have wiring configured to extend through the proximal member 202 and / or connect to one or more processing devices outside the body. The proximal member 202 may have a generally thin and / or flexible structure and / or the proximal portion 206 may be configured to receive and / or support the proximal member 202. In some embodiments, the proximal member 202 may have a generally tubular structure and / or include a generally tubular portion of an implant device.

[0061] In some examples, an additional sheath (not shown) may be configured to extend at least partially over the delivery device and / or implant device during delivery into and / or through the body. For example, a sheath may extend over the delivery device and / or implant device during delivery through a major artery and / or vein. During delivery, the delivery device and / or implant device may extend at least partially beyond the sheath and / or continue into the descending aorta and / or other anatomical structure. The implant device may then be configured to extend out of the delivery device in the descending aorta and / or similar anatomical structure.

[0062] 3 illustrates an example of a delivery system 300 including one or more delivery devices configured to carry and / or percutaneously deliver one or more medical implants according to one or more embodiments. The delivery device may include multiple components, which may include a fixed (e.g., proximal) portion 306 and / or an expandable (e.g., distal) portion 308. In some embodiments, the proximal portion 306 and the distal portion 308 may include different structures and / or materials.

[0063] In some embodiments, the proximal portion 306 may have a generally fixed width and / or diameter and / or may be configured to resist deformation in response to external forces from one or more implant devices and / or frictional forces during delivery through one or more anatomical regions. The proximal portion 306 may comprise an inner lumen having a generally fixed width and / or diameter. The inner lumen of the proximal portion 306 may be configured to receive at least a portion of one or more implant devices. The proximal portion 306 and / or the inner lumen of the proximal portion 306 may not be configured to expand in response to pressure from one or more implant devices having a width and / or diameter larger than the width and / or diameter of the proximal portion 306.

[0064] The distal portion 308 may have a generally flexible structure and / or may be configured to expand from a default width and / or diameter (e.g., approximately equal to the width and / or diameter of the proximal portion 306) in response to a force applied by one or more implant devices. For example, one or more implant devices may be configured to pass through an inner lumen of the distal portion 308, as shown in FIG. 3. If the width and / or diameter of the implant device exceeds the default width and / or diameter of the distal portion 308, the distal portion 308 may be configured to naturally expand in response to pressure and / or force from the implant device. The expansion of the distal portion 308 may be driven by the implant device. For example, the distal portion 308 may be configured to expand only until it reaches a width and / or diameter to allow the implant device to fit within the distal portion 308. The distal portion 308 may be configured to fit snugly around the implant device to minimize the profile of the delivery device while accommodating the implant device.

[0065] In some embodiments, the delivery device may be configured to carry and / or deliver an implant device that comprises multiple components, including a proximal member 302 (e.g., inflow and / or outflow tubing), a distal member 304, and / or a nosecone 310. The proximal member 302 may be coupled to and / or extend into the distal member 304. The distal member 304 may be coupled to and / or extend into the nosecone 310.

[0066] The distal member 304 may have a larger width and / or diameter than the proximal member 302. For example, the distal member 304 may include a motor and / or other elements that require an increased profile. The proximal member 302 may have a reduced width and / or diameter relative to the distal member 304 to minimize the profile along the length of the implant device.

[0067] In some examples, the distal member 304 of the implant device may be configured to fit within the distal portion 308 of the delivery device and / or the distal portion 308 of the delivery device may be configured to hold the distal member 304 of the implant device. The proximal member 302 of the implant device may be configured to fit within the proximal portion 306 of the delivery device and / or the proximal portion 306 of the delivery device may be configured to hold the proximal member 302 of the implant device.

[0068] The width and / or diameter of the proximal portion 306 may be smaller than the width and / or diameter of the distal member 304 of the implant device. Additionally, the proximal portion 306 may have a generally rigid structure and / or may be configured to resist and / or prevent the distal member 304 from entering the inner lumen of the proximal portion 306. For example, when the distal member 304 is pulled into the distal portion 308 at the distal end of the delivery device, the proximal member 302 may pass through the proximal portion 306 and / or the distal member 304 may press against the junction between the proximal portion 306 and the distal portion 308 (see FIG. 5A). The distal portion 308 may be configured to gradually decrease in diameter and / or width at the junction until the diameter and / or width is approximately equal to the diameter and / or width of the proximal portion 306.

[0069] In some embodiments, the nosecone 310 may be configured to extend at least partially over the distal end of the distal portion 308. For example, the nosecone 310 may have a maximum diameter and / or width that may be greater than the inner diameter 316 of the distal portion 308. Further, the maximum width and / or diameter of the nosecone 310 may be greater than the diameter and / or width of the distal member 304 such that the edge 311 of the nosecone 310 may extend at least partially beyond the distal member 304. In such embodiments, the nosecone 310 may be configured to prevent the delivery device and / or the distal end of the distal portion 308 from contacting tissue as the delivery device and / or implant are delivered through the patient's body. The distal portion 308 and / or the proximal portion 306 may have any suitable thickness between the outer diameter 314 and the inner diameter 316. In some embodiments, the maximum diameter and / or width of the nosecone 310 may be approximately equal to the outer diameter 314 when the distal member 304 is located within the distal portion 308 .

[0070] The edge 311 of the nose cone 310 may be configured to form a step configured to extend at least partially over one or more edges of the distal portion 308. As a result, forces applied to the nose cone 310 by tissue and / or blood flow may translate through the nose cone 310 to the distal portion 308 and / or may not translate to the distal member 304 of the implant. Additionally, the distal portion 308 may be configured to support the nose cone 310 at the edge 311. The nose cone 310 may be configured not to compress significantly, thereby minimizing and / or avoiding translation of forces to the distal member 304.

[0071] 4 illustrates an example of a delivery system 400 including one or more delivery devices configured to carry and / or percutaneously deliver one or more medical implants according to one or more embodiments. The delivery device may include multiple components, which may include a fixed (e.g., proximal) portion 406 and / or an expandable (e.g., distal) portion 408. In some embodiments, the proximal portion 406 and the distal portion 408 may include different structures and / or materials.

[0072] 4, at least a portion of the implant (e.g., distal member 404 and / or nosecone 410) may be configured to exit the delivery device from a distal end of the delivery device. When distal member 404 is not positioned within distal portion 408, distal portion 408 may be configured to naturally compress and / or reduce to a width and / or diameter approximately equal to the width and / or diameter of proximal portion 406. In this manner, the delivery device may be configured to present a minimal profile while positioned within a patient's body.

[0073] In some embodiments, the proximal portion 406 may have a generally fixed width and / or diameter and / or may be configured to resist deformation in response to external and / or frictional forces from one or more implant devices during delivery through one or more anatomical regions. The proximal portion 406 may comprise an inner lumen having a generally fixed width and / or diameter. The inner lumen of the proximal portion 406 may be configured to receive at least a portion of one or more implant devices. The proximal portion 406 and / or the inner lumen of the proximal portion 406 may not be configured to expand in response to pressure from one or more implant devices having a width and / or diameter greater than the width and / or diameter of the proximal portion 406.

[0074] The distal portion 408 may have a generally flexible structure and / or may be configured to expand from a default width and / or diameter (e.g., approximately equal to the width and / or diameter of the proximal portion 406) in response to a force applied by one or more implant devices. For example, one or more implant devices may be configured to pass through an inner lumen of the distal portion 408, as shown in FIG. 4. If the width and / or diameter of the implant device exceeds the default width and / or diameter of the distal portion 408, the distal portion 408 may be configured to naturally expand in response to pressure and / or force from the implant device. The expansion of the distal portion 408 may be driven by the implant device. For example, the distal portion 408 may be configured to expand only until it reaches a width and / or diameter to allow the implant device to fit within the distal portion 408. The distal portion 408 may be configured to fit snugly around the implant device to minimize the profile of the delivery device while accommodating the implant device.

[0075] In some embodiments, the delivery device may be configured to carry and / or deliver an implant device that comprises multiple components, including a proximal member 402 (e.g., inflow and / or outflow tubing), a distal member 404, and / or a nosecone 410. The proximal member 402 may be coupled to and / or extend into the distal member 404. The distal member 404 may be coupled to and / or extend into the nosecone 410.

[0076] The distal member 404 may have a larger width and / or diameter than the proximal member 402. For example, the distal member 404 may include a motor and / or other elements that require an increased profile. The proximal member 402 may have a reduced width and / or diameter relative to the distal member 404 to minimize the profile along the length of the implant device.

[0077] In some embodiments, the distal member 404 of the implant device may be configured to fit within the distal portion 408 of the delivery device and / or the distal portion 408 of the delivery device may be configured to hold the distal member 404 of the implant device. The proximal member 402 of the implant device may be configured to fit within the proximal portion 406 of the delivery device and / or the proximal portion 406 of the delivery device may be configured to hold the proximal member 402 of the implant device.

[0078] The width and / or diameter of the proximal portion 406 may be smaller than the width and / or diameter of the distal member 404 of the implant device. Additionally, the proximal portion 406 may have a generally rigid structure and / or may be configured to resist and / or prevent the distal member 404 from entering the inner lumen of the proximal portion 406. For example, when the distal member 404 is pulled into the distal portion 408 at the distal end of the delivery device, the proximal member 402 may pass through the proximal portion 406 and / or the distal member 404 may press against the junction between the proximal portion 406 and the distal portion 408 (see FIG. 5A). The distal portion 408 may be configured to gradually decrease in diameter and / or width at the junction until the diameter and / or width is approximately equal to the diameter and / or width of the proximal portion 406.

[0079] In some embodiments, the distal end of the delivery device and / or the distal portion 408 may include a generally blunt surface configured to press against tissue, if desired, without damaging the tissue. The distal portion 408 and / or the proximal portion 406 may have any suitable thickness between the outer diameter and the inner diameter.

[0080] 4 after removal of the distal member 204 of the implant from the distal portion 408, and / or the distal portion 408 may be configured to be manually compressed. Compression of the distal portion 408 may enable the delivery device to prevent blood occlusion through one or more blood vessels.

[0081] 5A and 5B show side and front views, respectively, of the interior of at least a portion of an exemplary delivery device 500, according to one or more embodiments. In some embodiments, the delivery device 500 may be at least partially comprised of one or more bending, malleable, and / or flexible rods 520 that extend at least partially along the length of the delivery device 500. For example, the distal portion 508 of the delivery device 500 may comprise one or more (e.g., six) rods 520. In some embodiments, the proximal portion 506 of the delivery device 500 may also include one or more rods 520 or may not include any rods 520. In some embodiments, the one or more rods 520 may be at least partially surrounded by one or more covers 518 configured to close gaps between the individual rods 520. For illustrative purposes, FIGS. 5A and 5B provide an interior view through which at least a portion of the covers 518 and / or other components of the delivery device 500 may be seen.

[0082] The delivery device 500 may include an inner lumen 517 extending through the proximal portion 506 and / or the distal portion 508. In some embodiments, the delivery device 500 may have a generally tubular and / or cylindrical body and / or the inner lumen 517 may have a cylindrical and / or tubular shape. One or more rods 520 may be configured to extend longitudinally along the delivery device 500, the distal portion 508, and / or the lumen 517.

[0083] Although the delivery device 500 is shown as including six rods 520, the delivery device 500 may include any number of rods 520. The rods 520 may be located approximately equidistant from one another along a circumferential surface of the delivery device 500 and / or the distal portion 508. In some embodiments, the delivery device 500 and / or the distal portion 508 may include an inner diameter 516 and / or an outer diameter 514 that are comprised of one or more covers 518 configured to cover one or more rods 520 and / or close gaps between one or more rods 520. In some embodiments, the rods 520 and / or covers 518 may have a generally soft construction to provide cushioning to the distal members of the implant device and / or otherwise prevent unnecessary forces on the distal members of the implant device.

[0084] The rod 520 may include any suitable material, which may include nylon and / or nitinol. In some embodiments, the rod 520 may be configured to bend and / or resiliently return to a shape-set configuration (e.g., a generally flat and / or straight configuration). The rod 520 may have any suitable shape and / or may have a generally circular cross-section. The cover(s) 518 may be constructed of any suitable material, which may include NeoSoft and / or similar materials. The cover(s) 518 may be configured to stretch and / or expand as the rod 520 bends and / or moves. In some embodiments, the NeoSoft and / or similar coating 518 may be applied over the rod 520 to form the inner diameter 516 of the distal portion 508, and / or an additional hydrophilic coating may be applied over the rod 520 to form the outer diameter 514 of the distal portion 508. The delivery device 500 may include a space between the inner diameter 516 and the outer diameter 514, and / or one or more covering materials may fill the space between the inner diameter 516 and the outer diameter 514. The covering(s) 518 and / or coating may form a generally tubular shaft, and / or one or more rods 520 may be configured to extend between the inner and / or outer surfaces of the tubular shaft.

[0085] The bendable rod 520 may be configured to bend in response to an implant device being at least partially inserted into the distal portion 508 of the delivery device. For example, the implant device may have a width that is greater than a default and / or rest width of the proximal portion 506 and / or the distal portion 508. Thus, the rod 520 may be configured to bend to increase the width of the distal portion 508 such that the distal portion 508 can accommodate at least a portion of the implant device.

[0086] In some embodiments, the rods 520 may be configured to provide column support to the delivery device and / or to translate push and / or pull forces from the proximal portion 206. The rods 520 may form a cage configured to at least partially house a distal member of a medical implant, and / or one or more covers 518 may be configured to coat and / or extend between the rods 520. In some embodiments, the one or more rods 520 may be approximately evenly spaced around the circumference of the distal portion 508, as shown in FIG. 5B. The distance between the rods 520 may increase as the rods 520 bend to allow expansion of the distal portion 508.

[0087] The proximal portion 506 may be configured to be fused and / or bonded to the distal portion 508. For example, the proximal portion 506 may be configured to be fused to one or more rods 520 and / or cover 518 of the distal portion 508. In some embodiments, a heat lamination and / or overmolding process may be used to bond the proximal portion 506 to the distal portion 508.

[0088] Figure 6 (Figures 6-1, 6-2, and 6-3) presents a flowchart illustrating a process 600 including one or more steps for delivering one or more medical implants to one or more target locations within the heart (e.g., the left ventricle 3) according to one or more embodiments. Figure 7 (Figures 7-1, 7-2, and 7-3) provide images corresponding to steps of process 600 of Figure 6.

[0089] At step 602, process 600 includes delivering a medical implant, at least partially within a distal portion 708 (e.g., a capsule) of a delivery device, to the descending aorta of the aorta 12, as shown in image 700a of Figure 7. The delivery device may comprise a distal portion 708 and / or a proximal portion 706. The distal portion 708 may comprise a distal end 712 and / or be located closer to the distal end 712 than the proximal portion 706.

[0090] In some embodiments, the medical implant may comprise multiple components. For example, the medical implant may comprise a proximal member 702, a distal member 704, and / or a nosecone 710. The proximal member 702 may comprise a generally thin tubular portion that may be configured to convey circuits and / or fluids to and / or from the distal member 704. The distal member 704 may have an increased width and / or diameter relative to the proximal member 702 and / or may be located at least partially between the proximal member 702 and the nosecone 710.

[0091] The distal member 704 may be at least partially located within a distal portion 708 of the delivery device and / or the proximal member 702 may be at least partially located within a proximal portion 706 of the delivery device during delivery. The nosecone 710 may extend at least partially beyond the distal end 712 of the delivery device during delivery.

[0092] In some embodiments, the delivery device and / or medical implant may be configured to track along the guidewire 730. For example, the guidewire 730 may be delivered through the aorta 12 and / or may gain access to the left ventricle 3 during an earlier delivery process. The delivery device and / or implant may then follow the guidewire 730. In some embodiments, the guidewire 730 may be configured to pass through a lumen of the nosecone 710, the distal member 704, the proximal member 702, the distal portion 708, and / or the proximal portion 706.

[0093] The distal portion 708 may be configured to assume a relatively expanded profile while the distal member 704 of the implant is at least partially located within the distal portion 708. For example, the distal portion 708 may be configured to stretch, expand, and / or flex in response to a force applied by the distal member 704 at an inner diameter of the distal portion 708. The distal portion 708 may comprise one or more flexible rods and / or covers configured to elastically deform in response to pressure from the distal member 704.

[0094] In step 604, the process 600 involves extending the delivery device and / or implant at least partially beyond the distal end 712 of the distal portion 708, as shown in image 700b of FIG. 7. For example, the proximal member 702 may be configured to be extended to cause a corresponding extension of the distal member 704 beyond the distal end 712. Upon the distal member 704 exiting the delivery device, the distal portion 708 may resiliently return to a default and / or compressed configuration in which the width and / or diameter of the distal portion 708 may be smaller than the width and / or diameter of the distal member 704 and / or the width and / or diameter of the distal portion 708 may be approximately equal to the width and / or diameter of the proximal portion 706.

[0095] In step 606, process 600 involves delivering the implant along the aortic arch of the aorta 12 and / or through the aortic valve 7 and into the left ventricle 3, as shown in image 700c of Figure 7. The delivery device may be configured such that the implant device remains in a relatively compressed configuration within the descending aorta while being delivered into the left ventricle 3.

[0096] As shown in image 700c, the proximal member 702 of the delivery device may be configured to bend to facilitate navigation of the distal member 704 through the patient's anatomy and / or to a target location. For example, the proximal member 702 may be configured to bend around the aortic arch of the aorta 12 to allow the distal member 704 to traverse the aorta 12 and / or reach the aortic valve 7. In some embodiments, the proximal member 702 may have a generally tubular and / or flexible structure.

[0097] In step 608, the process 600 involves retracting the implant back through the aortic valve 7 and / or into the descending aorta of the aorta 12, as shown in image 700d of FIG.

[0098] In step 610, the process 600 involves retracting and / or displacing the distal member 704 of the implant into the distal portion 708 of the delivery device, as shown in image 700e of FIG. 7. The distal portion 708 may be configured to expand and / or increase in width and / or diameter in response to the distal member 704 entering the distal portion 708. The proximal portion 706 of the delivery device may not be configured to expand in response to the distal member 704 retracting into the distal portion 708, and / or the proximal portion 706 may be configured to maintain a fixed width and / or diameter as the distal member 704 enters the distal portion 708. In some embodiments, the distal member 704 may be retracted until it presses against the distal end 712 of the delivery device, which may cause the distal end 712 and / or the distal portion 708 to expand. Additional Examples

[0099] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a different order, added, combined, or omitted entirely, and thus, in a particular embodiment, not all described acts or events are required to practice a process.

[0100] In particular, conditional language used herein, such as "can," "could," "might," "may," "eg," and the like, unless specifically stated otherwise or understood otherwise within the context in which it is used, is intended to have its ordinary meaning and is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any manner required for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without authorial input or prompting, whether those features, elements, and / or steps are included in or should be performed in any particular embodiment. Terms such as "comprising," "including," "having," and the like, are synonymous and used in their ordinary sense and are used in an inclusive, non-limiting manner and do not exclude additional elements, features, acts, operations, and the like. Also, the term "or," for example, when used to connect a list of elements, is used in its inclusive sense (and not its exclusive sense) so that the term "or" means one, some, or all of the elements in the list. Conjunctive language such as the phrase "at least one of X, Y, and Z" is understood with the context as used generally to convey that an item, term, element, etc., can be either X, Y, or Z, unless specifically stated otherwise. Thus, such conjunctive language is not generally intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present.

[0101] In the above description of the embodiments, it should be understood that various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein can be applied to or used with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is necessarily required or essential to each embodiment. Thus, it is intended that the scope of the invention herein disclosed and claimed below should not be limited by the particular embodiments described above, but should be determined solely by a fair reading of the following claims.

[0102] It should be understood that certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish an element from other elements having a similar or identical name (except for the use of sequential terms). In addition, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an operation performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0103] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which the illustrative examples belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and are not to be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0104] Spatially relative terms such as "outside," "inside," "upper," "lower," "bottom," "up," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component as depicted in the drawings. It is 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, if a device depicted in the drawings is turned over, a device that is positioned "below" or "directly below" another device may be positioned "above" another device. Thus, the exemplary term "below" may include both a lower position and an upper position. Devices may also be oriented in other directions, and thus the spatially relative terms may have different interpretations depending on the orientation.

[0105] Unless expressly stated otherwise, comparison and / or quantitative terms such as "less," "more," "greater than," and the like, are intended to encompass equivalent concepts. For example, "less" can mean "less than" as well as "less than" in the strictest mathematical sense.

Claims

1. 1. An implant delivery system comprising: a distal portion configured to naturally assume a first width and expand beyond the first width in response to an implant device being inserted into the distal portion through an opening at a distal end of the distal portion; a proximal portion configured to generally maintain the first width.

2. The implant delivery system of claim 1 , wherein the proximal portion is not configured to expand in response to the implant device extending into or relative to the proximal portion.

3. 3. The implant delivery system of claim 1 or claim 2, wherein the distal portion comprises one or more bendable rods configured to bend in response to the implant device being inserted into the distal portion.

4. 4. The implant delivery system of claim 3, wherein the distal portion further comprises a first coating configured to extend across an inner surface of the one or more bendable rods to form an inner diameter of the distal portion.

5. 5. The implant delivery system of claim 4, wherein the distal portion further comprises a second coating configured to extend across an outer surface of the one or more bendable rods to form an outer diameter of the distal portion.

6. The implant delivery system of any one of claims 3 to 5, wherein the one or more bendable rods are evenly spaced around the circumference of the distal portion.

7. The implant delivery system of any one of claims 3 to 6, wherein the one or more bendable rods extend longitudinally along the distal portion.

8. The implant delivery system of any one of claims 1 to 7, wherein the proximal portion comprises a braided network of fibers.

9. The implant delivery system of any one of claims 1 to 7, further comprising a nose cone configured to provide a tip for the implant device.

10. The implant delivery system of claim 9 , wherein the nosecone is configured to extend at least partially across the distal end of the distal portion.

11. 11. The implant delivery system of claim 9 or claim 10, wherein the nosecone is configured to extend from the implant device.

12. The implant delivery system of any one of claims 1 to 11, wherein the proximal portion is configured to receive a tubular portion of the implant device.

13. The implant delivery system of claim 12 , wherein the tubular portion has a generally flexible construction and is configured to bend to facilitate navigation of the implant device through the aortic arch.

14. 1. A method comprising: Delivering a delivery device carrying the implant device into a blood vessel, the delivery device comprising: a distal portion configured to naturally assume a first width and expand beyond the first width in response to a distal member of the implant device being inserted into the distal portion through an opening at a distal end of the distal portion; a proximal portion configured to generally maintain the first width; extending at least the distal member of the implant device beyond the distal end of the delivery device causing the distal portion of the delivery device to assume the first width; and retracting at least the distal member of the implant device into the distal portion of the delivery device to expand the distal portion of the delivery device beyond the first width.

15. The method of claim 14 , wherein the proximal portion is not configured to expand in response to the distal member of the implant device being retracted into the distal portion of the delivery device.

16. 16. The method of claim 14 or claim 15, wherein the distal portion comprises one or more bendable rods configured to bend in response to the implant device being inserted into the distal portion.

17. 17. The method of claim 16, wherein the distal portion further comprises a first coating configured to extend across the one or more bendable rods and form an inner diameter of the distal portion.

18. 20. The method of claim 17, wherein the distal portion further comprises a second coating configured to extend across the one or more bendable rods and form an outer diameter of the distal portion.

19. The method of any one of claims 14 to 18, wherein the proximal portion comprises a braided network of fibers.

20. The method according to any one of claims 14 to 19, wherein the proximal portion is configured to receive a tubular portion of the implant device.

21. 21. The method of claim 20, wherein the tubular portion has a generally flexible construction and is configured to bend to facilitate navigation of the distal member through the aortic arch.

22. 1. An implant delivery shaft comprising: a distal portion configured to naturally assume a first width and expand beyond the first width in response to an implant device being inserted into the distal portion through an opening at a distal end of the distal portion; a proximal portion configured to generally maintain the first width.

23. 23. The implant delivery shaft of claim 22, wherein the proximal portion is not configured to expand in response to the implant device being extended into or relative to the proximal portion.

24. 24. The implant delivery shaft of claim 22 or claim 23, wherein the distal portion comprises one or more bendable rods configured to bend in response to the implant device being inserted into the distal portion.

25. 25. The implant delivery shaft of claim 24, wherein the distal portion further comprises a first coating configured to extend across an inner surface of the one or more bendable rods to form an inner diameter of the distal portion.

26. 26. The implant delivery shaft of claim 25, wherein the distal portion further comprises a second coating configured to extend across an outer surface of the one or more bendable rods to form an outer diameter of the distal portion.

27. An implant delivery shaft according to any one of claims 24 to 26, wherein the one or more bendable rods are evenly spaced around the circumference of the distal portion.

28. The implant delivery shaft of any one of claims 24 to 27, wherein the one or more bendable rods extend longitudinally along the distal portion.

29. The implant delivery shaft of any one of claims 22 to 28, wherein the proximal portion comprises a braided network of fibers.

30. An implant delivery shaft according to any one of claims 22 to 29, wherein the proximal portion is configured to receive a tubular portion of the implant device.

Images