Devices, systems, and methods for deploying and recapturing medical devices

Abstract

A device for assisting the recapture of a medical device may include an elongated shaft and an expandable sheath extension coupled to the distal end of the elongated shaft. The expandable sheath extension may be laterally offset from the elongated shaft and self-biased toward a radially compressed form. A system for deploying and recapturing a medical device may include a deployment catheter including an elongated member having a lumen configured to slidably receive a medical device, and a device for assisting the recapture of the medical device after it has been deployed. The elongated shaft may be configured to slidably advance the expandable sheath extension through the lumen to a guide position in which the proximal end of the expandable sheath extension is positioned within the lumen and the distal end of the expandable sheath extension is positioned distal to the elongated tubular member.

Description

Technical Field

[0001] The present disclosure generally relates to devices, systems, and methods for deploying and / or recapturing medical devices.

Background Art

[0002] In some cases, when performing a percutaneous medical procedure, it may be necessary to insert and / or manipulate an expandable medical device through a patient's vasculature. However, inserting a medical device into the vasculature can result in undesirable forces being applied to the vessel wall. Further, an expandable medical device may need to be recaptured, repositioned, and / or removed after expansion. Known devices, systems, and methods for deploying and / or recapturing medical devices each have certain advantages and disadvantages. There continues to be a need for alternative devices, systems, and / or methods.

Summary of the Invention

[0003] In one example, a device for assisting in recapturing a medical device may include an elongate shaft and an expandable sheath extension coupled to a distal end of the elongate shaft. The expandable sheath extension may be offset laterally from the elongate shaft. The expandable sheath extension may be self-biased toward a radially compressed configuration.

[0004] In addition to or as an alternative to any example disclosed herein, the expandable sheath extension may extend circumferentially around a central longitudinal axis extending parallel to the elongate shaft. In addition to or as an alternative to any example disclosed herein, the expandable sheath extension may be circumferentially discontinuous.

[0005] In addition to or as an alternative to any example disclosed herein, the expandable sheath extension may include a C-shaped collar disposed proximate a proximal end of the expandable sheath extension. In addition to or as an alternative to any example disclosed herein, the C-shaped collar is fixedly attached to a long shaft.

[0006] In addition to or as an alternative to any examples disclosed herein, the C-shaped collar is formed from a metallic material. In addition to or as an alternative to any examples disclosed herein, an expandable sheath extension comprises at least one polymer sheet wound around a tubular member in a radially compressed form.

[0007] In addition to or as an alternative to any examples disclosed herein, the C-shaped collar is at least partially embedded within at least one polymer sheet. In addition to or as an alternative to any examples disclosed herein, the tubular member has an outer diameter of less than 4.667 millimeters in a radially compressed form.

[0008] In addition to or alternative to any examples disclosed herein, at least one polymer sheet is expanded radially and circumferentially by applying a radially outward force to the inner surface of the expandable sheath extension.

[0009] In addition to or as an alternative to any examples disclosed herein, a system for deploying and recapturing a medical device may comprise a deployment catheter comprising an elongated tubular member having a lumen extending inside, the lumen being configured to slidably receive a medical device, and a device for assisting in recapturing the medical device after it has been deployed distal to the elongated tubular member. The device may comprise an elongated shaft and an expandable sheath extension coupled to the distal end of the elongated shaft. The expandable sheath extension may be offset laterally from the elongated shaft. The expandable sheath extension may be self-biased toward a radially compressed form.

[0010] In addition to or as an alternative to any examples disclosed herein, an elongated shaft is configured to advance an expandable sheath extension slidably through the lumen of an elongated tubular member to a guide position where the proximal end of the expandable sheath extension is positioned within the lumen of the elongated tubular member and the distal end of the expandable sheath extension is positioned distal to the elongated tubular member.

[0011] In addition to or alternative to any examples disclosed herein, at the guide position, the expandable sheath extension is configured to guide the medical device radially inward toward the lumen of the elongated tubular member as the medical device is retracted proximally.

[0012] In addition to or as an alternative to any examples disclosed herein, the medical device, in an unrestrained configuration, has an outer dimension greater than the inner diameter of the elongated tubular member at the distal end of the elongated tubular member.

[0013] In addition to or alternative to any examples disclosed herein, an expandable sheath extension is configured to be laterally translated relative to an elongated member extending proximal to a medical device through the lumen of an elongated tubular member, thereby shifting the expandable sheath extension from a first position along the lateral to the elongated member to a second position where the elongated member extends longitudinally through the expandable sheath extension.

[0014] In addition to or as an alternative to any examples disclosed herein, the elongated shaft is sized and configured to slide longitudinally along the elongated member within the lumen of the elongated tubular member.

[0015] In addition to or as an alternative to any examples disclosed herein, a method for deploying and recapturing a medical device includes the steps of deploying a medical device from a deployment catheter, the deployment catheter comprising an elongated tubular member having a lumen extending inside, the lumen being configured to slidably receive a medical device positioned at the distal end of the elongated member, and positioning an expandable sheath extension coupled to the distal end of the elongated shaft at a first position along the elongated member, the expandable sheath extension being laterally offset from the elongated shaft. The expandable sheath extension is self-biased toward a radially compressed form. The steps include: positioning the expandable sheath extension in a first position; translating the expandable sheath extension from the first position to a second position laterally relative to the elongated member, where the elongated member extends longitudinally through the expandable sheath extension; advancing the expandable sheath extension along the elongated member to a guide position near the distal end of the elongated tubular member; and retracting a medical device proximal to the elongated tubular member through the expandable sheath extension.

[0016] In addition to or alternative to any examples disclosed herein, at least a portion of the expandable sheath extension is configured to expand radially when engaged with a medical device. In addition to or alternative to any examples disclosed herein, when the expandable sheath extension is positioned in a radially compressed form, at least a portion of the expandable sheath extension completely encloses the elongated tubular member.

[0017] In addition to or as an alternative to any examples disclosed herein, after the medical device has been deployed from the deployment catheter, the medical device expands radially to an outer dimension greater than the inner diameter of the elongated tubular member at the distal end of the elongated tubular member.

[0018] In addition to or as an alternative to any example disclosed herein, the expandable sheath extension is discontinuous in the circumferential direction. In addition to or as an alternative to any examples disclosed herein, the expandable sheath extensions themselves overlap circumferentially to form a radially compressed tubular member.

[0019] The above summary of some embodiments, aspects, and / or examples is not intended to describe each embodiment or all implementations disclosed in this disclosure. The following drawings and “Modes for Carrying Out the Invention” illustrate these embodiments more specifically. [Brief explanation of the drawing]

[0020] This disclosure can be better understood by considering the following "Modes for Carrying Out the Invention" in relation to the attached drawings. [Figure 1] This is a schematic diagram showing selected embodiments of a deployment catheter and the medical device deployed therefrom. [Figure 2] Figure 1 is a schematic diagram showing a selected embodiment of an attempt to recapture a medical device using a deployment catheter. [Figure 3] This is a schematic diagram showing a selected embodiment of a device for assisting in the recapture of medical devices. [Figure 4] This is a schematic diagram showing a selected embodiment of the device in Figure 3 that engages with a medical device. [Figure 5] Figures 3 and 4 schematically illustrate selected embodiments of methods for deploying and / or recapturing medical devices using the devices shown in Figures 3 and 4. [Figure 6] Figures 3 and 4 schematically illustrate selected embodiments of methods for deploying and / or recapturing medical devices using the devices shown in Figures 3 and 4. [Figure 7] Figures 3 and 4 schematically illustrate selected embodiments of methods for deploying and / or recapturing medical devices using the devices shown in Figures 3 and 4. [Figure 8]FIG. 3 to FIG. 4 schematically illustrate selected aspects of a method of deploying and / or recapturing a medical device using the devices shown therein. DETAILED DESCRIPTION OF THE INVENTION

[0021] Aspects of the present disclosure are applicable to various modifications and alternative forms, and details thereof are shown by way of example in the drawings and will be described in detail. However, it should be understood that the intention is not to limit the aspects of the present disclosure to the specific embodiments described. On the contrary, the present invention encompasses all modifications, equivalents, and alternative forms that fall within the spirit and scope of the present disclosure.

[0022] The following description should be read with reference to the drawings, which are not necessarily to scale, but like reference numerals indicate like elements throughout several views. The detailed description and drawings are not intended to limit, but to illustrate. Those skilled in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description of the invention and the drawings illustrate exemplary embodiments of the present disclosure.

[0023] The definitions set forth below are applicable to the terms as used herein, unless otherwise defined in the claims or elsewhere in this specification. In this specification, all numerical values are assumed to be modified by the term "about," whether or not explicitly indicated. The term "about" in the context of a numerical value generally refers to a range of numbers that a person of ordinary skill in the art would consider equivalent (e.g., having the same function or result) to the recited value. In many cases, the term "about" can include numbers rounded to the nearest significant digit. Other uses of the term "about" (e.g., in contexts other than numerical values) are assumed to be understood from the context of this specification and to have their ordinary customary definitions consistent with the context of this specification, unless otherwise specified.

[0024] Numerical ranges specified by endpoints include all numbers within that range, including the endpoint (for example, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). While several appropriate dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, a person skilled in the art, inspired by this disclosure, will understand that desired dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0025] When used herein and in the appended claims, the singular forms “a,” “an,” and “the” include multiple references unless the context clearly indicates otherwise. When used herein and in the appended claims, the term “or” is generally used to include “and / or” unless the context clearly indicates otherwise. For ease of understanding, note that some features of this disclosure may be described in the singular form even if they may be multiple or repeated within the embodiments in which they are disclosed. Each example of a feature includes and / or may be encompassed by a singular disclosure unless the opposite is explicitly stated. For example, a reference to a feature may also apply to all other instances and quantities of that feature unless the opposite is explicitly stated. Therefore, it should be understood that the following descriptions may also apply to any and / or all components that exist in multiples within a device, etc., unless the opposite is explicitly stated.

[0026] Relative terms such as “proximal,” “distal,” “forward,” “backward,” and their variations may generally be considered in relation to the position, orientation, and / or movement of various elements of the apparatus with respect to the user / operator / manipulator. “Proximal” and “backward” indicate or refer to being closer to or toward the user, while “distal” and “forward” indicate or refer to being further away from or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily assigned to facilitate understanding of this disclosure, and in such cases, will be readily apparent to those skilled in the art. Other relative terms such as “upstream,” “downstream,” “inflow,” and “outflow” refer to the direction of fluid flow within a lumen, such as a body lumen, a blood vessel, or within an apparatus. Yet other relative terms and / or their variations, such as “axial,” “circumferential,” “longitudinal,” “lateral,” and “radial,” generally refer to the direction and / or orientation with respect to the central longitudinal axis of the disclosed structure or apparatus.

[0027] The term “range” can be understood to mean the maximum measurement of a stated or specified dimension unless it is prefixed with “minimum” or specified as “minimum,” which can be understood to mean the minimum measurement of the stated or specified dimension. For example, “outer range” may be understood to mean the outer dimension, “radial range” may be understood to mean the radial dimension, and “longitudinal range” may be understood to mean the longitudinal dimension. Each instance of “range” may differ (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be apparent to a person skilled in the art from the context of the individual use. Generally, “range” can be considered the maximum possible dimension measured according to the intended use, while “minimum range” can be considered the minimum possible dimension measured according to the intended use. In some cases, “range” can generally be measured orthogonally in a plane and / or cross-section, but may also be measured differently, such as angularly, radially, circumferentially (e.g., along an arc), as will be apparent from the particular context, though not limited to these.

[0028] The terms “monolithic” and “single” generally refer to one or more elements made from or consisting of a single structure or base unit / element. Monolithic and / or single elements exclude structures and / or features made by assembling or otherwise joining together multiple separate structures or elements.

[0029] It should be noted that references in this specification to “one embodiment,” “several embodiments,” and “other embodiments” indicate that the embodiments described may include certain features, structures, or characteristics, but not all embodiments necessarily include such features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiments. Moreover, where certain features, structures, or characteristics are described in relation to an embodiment, it would be within the knowledge of those skilled in the art to implement those features, structures, or characteristics in relation to other embodiments, whether or not they are explicitly described, unless the opposite is explicitly stated. That is, the various individual elements described below, even if not explicitly shown in specific combinations, are considered to be combinable or configurable with each other to form other additional embodiments or to complement and / or enhance the embodiments described, as will be understood by those skilled in the art.

[0030] For clarification purposes, certain identifying numerical nomenclature (e.g., First, Second, Third, Fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various features of the specification and / or claims. It should be understood that numerical nomenclature is not intended to be limiting, but merely illustrative. In some embodiments, for brevity and clarity, modifications and deviations from previously used numerical nomenclature may be made. That is, a feature identified as the “First” element may later be referred to as the “Second” element, the “Third” element, and so on, or may be omitted entirely, and / or a different feature may be referred to as the “First” element. The meaning and / or names in each example will be obvious to those skilled in the art.

[0031] In addition, it should be noted that in any given figure, some features may be omitted or schematically represented for clarity and / or simplification. Additional details regarding some components and / or method steps may be illustrated in more detail in other figures. The devices and / or methods disclosed herein may offer several desirable features and advantages, as will be described in more detail below.

[0032] Figure 1 shows a selected embodiment of the deployment catheter 100. In some embodiments, the term “deployment catheter” may be used synonymously with “introducer,” etc. In some embodiments, the deployment catheter 100 may comprise an elongated tubular member 110 having a lumen 120 extending through the elongated tubular member 110. In some embodiments, the deployment catheter 100 may comprise a proximal hub 130 located at and / or connected to the proximal end of the elongated tubular member 110. The proximal hub 130 may be in fluid communication with the lumen 120. In some embodiments, the proximal hub 130 may include a hemostatic valve or seal located inside it.

[0033] In some embodiments, the elongated tubular member 110 may comprise an outer sheath 112 and an inner liner 114. In some embodiments, the lumen 120 may extend within and / or through the inner liner 114. In some embodiments, the outer sheath 112 may be positioned on, around, and / or around the inner liner 114. In some embodiments, the elongated tubular member 110 may include a tapered region positioned proximal to the distal region of the elongated tubular member 110. In at least some embodiments, the tapered region may taper radially inward toward the distal region and / or distal end of the elongated tubular member 110.

[0034] The inner liner 114 may include at least one folding portion that extends along at least the distal region of the elongated tubular member 110 in the delivery and / or folded configuration. In some embodiments, the inner liner 114 may extend along at least the distal region and the tapered region of the elongated tubular member 110 in the delivery and / or folded configuration. In some embodiments, at least one folding portion may extend along the entire length of the inner liner 114 and / or the elongated tubular member 110 in the delivery and / or folded configuration. In some embodiments, the at least one folding portion may include one folding portion, two folding portions, three folding portions, four folding portions, five folding portions, or more, as desired in a particular configuration. The inner liner 114 may be positioned radially inward of the outer sheath 112. In some embodiments, each and / or part of at least one folding portion may fold over itself when viewed in cross-section in the delivery and / or folded form to form, for example, a corrugated, S-shaped, T-shaped, Z-shaped, and / or a combination thereof. Other shapes and / or other forms are also contemplated.

[0035] In the delivery configuration, the inner liner 114 may have a substantially annular shape. Other shapes and / or configurations are also conceivable. In the delivery configuration and / or folded configuration, the lumen 120 may have a first inner diameter and / or first inner dimension measured in a direction perpendicular to the central longitudinal axis defined by the inner surface of the inner liner 114 and perpendicular to the central longitudinal axis at the distal region and / or distal end of the elongated tubular member 110. The inner liner 114 may be configured to radially expand from the delivery configuration and / or folded configuration to the expanded configuration when subjected to a radially outward force from within the lumen 120, as shown in Figure 1.

[0036] In the extended configuration, the lumen 120 may have a second internal diameter and / or second internal dimension measured in a direction perpendicular to the central longitudinal axis, passing through the central longitudinal axis, which is larger than the first internal diameter and / or first internal dimension, in the distal region and / or distal end of the elongated tubular member 110. At least one of the at least one folding portion may be at least partially unfolded as the inner liner 114 expands radially from the delivery configuration and / or folded configuration to the extended configuration and / or into the extended configuration. Similarly, in the delivery configuration and / or folded configuration, the inner liner 114 may have a first external diameter and / or first external dimension measured in a direction perpendicular to the central longitudinal axis, passing through the central longitudinal axis defined by the outer surface of the inner liner 114, in the distal region and / or distal end of the elongated tubular member 110. In the extended form, the inner liner 114 may have a second outer diameter and / or second outer dimension measured in a direction passing through the central longitudinal axis and perpendicular to the central longitudinal axis, which is larger than the first outer diameter and / or first outer dimension, at the distal region and / or distal end of the elongated tubular member 110.

[0037] In some embodiments, the inner liner 114 may be configured to allow the lumen 120 to expand radially outward from a first inner diameter and / or first inner dimension toward and to a second inner diameter and / or second inner dimension when subjected to a radially outward force from within the lumen 120. In some embodiments, the inner liner 114 may be configured to expand radially outward from a first inner diameter and / or first inner dimension toward a predetermined second inner diameter and / or predetermined second inner dimension. For example, the second inner diameter and / or second inner dimension may have a predetermined value, and the inner liner 114 may be configured to prevent it from stretching or expanding radially outward beyond that predetermined value.

[0038] In at least some embodiments, the inner liner 114 may be substantially and / or fully compliant and / or may not have radial self-bias. For example, the inner liner 114 may not have radial inward self-bias and / or radial outward self-bias. In at least some embodiments, the inner liner 114 may be non-self-supporting and may not include a mechanism that expands and / or opens radially on its own (e.g., there is no radial outward force applied to the inner liner 114 from inside the lumen 120). For example, the inner liner 114 requires a device or object (e.g., a medical device) having an outer diameter larger than the first inner diameter and / or first inner dimension of the lumen 120, and the device or object may press and / or bias the inner liner 114 radially outward from a delivery and / or folded state to an expanded state.

[0039] In some embodiments, the inner liner 114 does not require a radially inward force to be applied to its outer surface in order to compress it radially inward when no devices, objects, etc. are placed within the lumen 120. For example, the inner liner 114 may not be held open by itself, nor maintain a particular expanded size, or the inner liner 114 may be non-self-supporting. Similarly, the inner liner 114 may not be biased to compress radially inward by itself. For example, the inner liner 114 may take on the shape and / or form of the surrounding tissue and / or its outer surface may conform to and / or contact the surrounding tissue as it moves from a delivery and / or folded state to an expanded state and / or after it has expanded to the expanded state. In one example, the narrowed portion of a blood vessel or body lumen in which the inner liner 114 is located may bias the inner liner 114 radially inward in the absence of radially outward forces, objects, devices, etc. that expand the inner liner 114, but the inner liner 114 is not self-biased radially inward by itself (for example, the inner liner 114 may have a zero-return force after expansion / release).

[0040] In some embodiments, the inner liner 114 may be formed from a compliant material. In some embodiments, the inner liner 114 may be formed from an inelastic material. In another embodiment, the inner liner 114 may be formed from an elastic material or a combination of an inelastic and elastic material. In some embodiments, the inner liner 114 may be configured to prevent axial elongation of the inner liner 114 along the lumen 120. For example, the inner liner 114 may be configured to expand radially outward from the central longitudinal axis without elongating or expanding axially or longitudinally along the central longitudinal axis. In some embodiments, the inner liner 114 may be formed from a polymer material and / or plastic material. In some embodiments, the inner liner 114 may be formed from a non-thermoplastic material designed to resist melting while heat is applied to reflow other components and / or adjacent components, as described herein. For example, in at least some embodiments, the inner liner 114 may be formed from a material having a higher melting point than the outer sheath 112. Some suitable but non-limiting examples of materials for the outer sheath 112, inner liner 114, etc., are described below.

[0041] In some embodiments, the inner surface of the inner liner 114 wall may include one or more layers or coatings (e.g., lubricating coatings, hydrophilic coatings, hydrophobic coatings, and / or other suitable coatings, etc.). In some embodiments, the inner liner 114 may include a lubricant disposed on the inner surface of the inner liner 114 wall and / or within the lumen 120. In some embodiments, the outer surface of the outer sheath 112 may include one or more layers or coatings (e.g., lubricating coatings, hydrophilic coatings, hydrophobic coatings, and / or other suitable coatings, etc., etc.). In some embodiments, the outer sheath 112 may include a lubricant disposed on the outer surface of the outer sheath 112.

[0042] In some embodiments, the elongated tubular member 110 may comprise one or more reinforcing members extending along its length. In some embodiments, one or more reinforcing members may include a plurality of longitudinal spines spaced circumferentially around a central longitudinal axis. In some embodiments, one or more reinforcing members may be fixedly attached to and / or embedded within the outer sheath 112. Other configurations are also conceivable.

[0043] In some embodiments, the outer sheath 112 may be fixedly attached to the inner liner 114. In some embodiments, the outer sheath 112 may include at least one perforation 113 (e.g., at least one aperture, at least one window, at least one opening, etc.) formed in and / or extending along and / or along at least one portion of the length of the outer sheath 112.

[0044] In some embodiments, at least one perforation 113 may contain and / or form multiple elements (e.g., multiple apertures, multiple windows, multiple openings, multiple notches, multiple holes, multiple weakened features, etc.) within it. In some embodiments, at least one perforation may extend laterally and / or transversely to the wall of the outer sheath 112. In some embodiments, at least one perforation 113 may effectively remove at least a portion of the wall of the outer sheath 112. In some embodiments, at least one perforation 113 may extend only partially laterally and / or transversely to the wall of the outer sheath 112 to form a region of reduced wall thickness of the outer sheath 112. In some embodiments, at least one perforation 113 may extend completely through the wall of the outer sheath 112, while in other embodiments, at least one perforation 113 may be formed as a substantially "thinner" section of the wall of the outer sheath 112. Other configurations, including combinations thereof, are also contemplated. In some embodiments, the outer sheath 112 may extend continuously around the inner liner 114 in the circumferential direction. In some embodiments, at least a portion of the outer sheath 112 may be discontinuous.

[0045] In some embodiments, at least one perforation 113 forms a preferred and / or preferred tear line along the outer sheath 112, configured to split in response to the expansion of the inner liner 114 from a delivery and / or folded state to an expanded state. In some embodiments, the outer sheath 112 may be configured to separate, split, perforate, and / or tear as the inner liner 114 expands radially outward from a delivery and / or folded state to an expanded state. In some embodiments, the outer sheath 112 may be configured to separate, split, perforate, and / or tear along and / or through at least one perforation 113 formed in the wall of the outer sheath 112. In some embodiments, the outer sheath 112 may be configured to separate, split, perforate, and / or tear at locations where the outer sheath 112 is discontinuous and / or where the outer sheath 112 is composed of and / or formed of thinner material.

[0046] In at least some embodiments, at least one perforation 113 may be aligned axially with the central longitudinal axis. In some embodiments, the outer sheath 112 includes at least one perforation 113 positioned above each folding portion of the inner liner 114, aligned radially with the folding portion and / or overlapping with the folding portion circumferentially. In some embodiments, at least one perforation 113 may be arranged along one or more longitudinal lines and / or axial lines along the length of the outer sheath 112. In some embodiments, one or more longitudinal lines and / or axial lines may directly correspond to and / or align with at least one folding portion.

[0047] The outer sheath 112 may have a given wall thickness at various positions along its length. In some embodiments, the wall thickness of the outer sheath 112 may vary along its length. In some embodiments, the wall thickness of the outer sheath 112 may be tapered along the circumferential circumference of the inner liner 114 such that the thickness reduction region of the outer sheath 112 is located radially outward, adjacent to at least one folded portion, aligned with it circumferentially, communicating with it, and / or positioned directly above it. In some embodiments, the thickness reduction region is at least one perforation 113.

[0048] In some embodiments, at least one perforation may be spaced apart from one another in the axial, longitudinal, and / or circumferential directions, etc. In some embodiments, at least one perforation 113 adjacent to the distal end of the outer sheath 112 may have a plurality of elements spaced apart from one another by a first distance. In some embodiments, at least one perforation 113 adjacent to the proximal end of the outer sheath 112 may have a plurality of elements spaced apart from one another by a second distance, where the second distance is greater than the first distance. In some embodiments, the first distance may be greater than the second distance. In some embodiments, the first distance and the second distance may be substantially equal. In some embodiments, the spacing between adjacent elements of at least one perforation may vary along the length of the outer sheath 112. In some embodiments, the spacing between adjacent elements may gradually increase, gradually decrease, and / or be a combination thereof along the length of the outer sheath 112.

[0049] In some embodiments, at least one perforation 113 has and / or can have a surface area. As used herein, the term “surface area” with respect to at least one perforation 113 may be defined as the “area” bounded by the shape, outline, and / or perimeter of one of the at least one perforation 113. In some embodiments, at least one perforation 113 may have a polygonal shape, a regular shape, an irregular shape, a circular shape, a triangular shape, a square or rectangular shape, a hexagonal shape, an octagonal shape, a trapezoidal shape, a rhombic shape, or any other suitable shape. For example, in embodiments where each of the at least one perforation 113 has a polygonal shape, the “surface area” of a given element may be defined as the area bounded by the individual polygons. In some embodiments, the surface area of ​​at least one perforation 113 may be constant and / or equal along the length of the outer sheath 112. In some embodiments, the surface area of ​​at least one perforation 113 may vary along the length of the outer sheath 112. In some embodiments, the surface area of ​​at least one perforation 113 may gradually decrease from the distal end of the outer sheath 112 to the proximal end of the outer sheath 112. In one example, at least one perforation 113 may include multiple windows, the size of which may decrease from the distal end of the outer sheath 112 to the proximal end of the outer sheath 112. Other configurations, including but not limited to combinations of features described herein, are also conceivable.

[0050] In some embodiments, the elongated tubular member 110 and / or lumen 120 may be configured to slidably receive the medical device 200. In at least some embodiments, the medical device 200 may be configured to expand radially when deployed from the lumen 120 and / or elongated tubular member 110. In some embodiments, the medical device 200 may be self-expanding and / or self-biased toward an expanded form. For illustrative purposes only, the medical device 200 is shown and / or designated in the figure by a dashed ellipse. In some embodiments, the medical device 200 may be and / or include a replacement heart valve implant, an occlusion implant, an inflatable balloon, an embolization protection device, or other expandable device. In at least some embodiments, the elongated member 210 may extend proximal to the medical device 200 and / or the elongated member 210 may be slidably positioned within the elongated tubular member 110 and / or lumen 120. In some embodiments, the elongated member 210 may be coupled to and / or attached to the medical device 200. In some embodiments, the elongated member 210 may be selectively and / or detachably coupled to and / or attached to the medical device 200.

[0051] In some embodiments, the medical device 200 may have a first outer dimension in a radially constrained configuration, the first outer dimension being greater than the first inner diameter and / or first inner dimension of the elongated tubular member 110 and / or lumen 120 and / or inner liner 114 in the distal region and / or distal end of the elongated tubular member 110. Thus, as the medical device 200 advances through the lumen 120, it can exert a radially outward force on the inner liner 114, causing the inner liner 114 to expand radially from a delivery configuration and / or folded configuration to an expanded configuration, and / or the outer sheath 112 may undergo separation, splitting, perforation, and / or tearing as the inner liner 114 expands radially outward from a delivery configuration and / or folded configuration to an expanded configuration, thereby allowing the medical device 200 to pass through its interior in a radially constrained configuration.

[0052] Alternatively, in some embodiments, a separate dilator (not shown) may be inserted into and / or advanced through the elongated tubular member 110 and / or lumen 120 before the medical device 200 is advanced through the elongated tubular member 110 and / or lumen 120. The dilator may have an outer dimension larger than the first inner diameter and / or first inner dimension of the inner liner 114. The dilator may apply a radially outward force to the inner liner 114, causing the inner liner 114 to expand radially from the delivery and / or folded configuration to the expanded configuration, and / or causing separation, splitting, perforation, and / or tearing of the outer sheath 112 as the inner liner 114 expands radially outward from the delivery and / or folded configuration to the expanded configuration. Subsequently, the dilator is removed from lumen 120, and the medical device 200 can be inserted into and / or advanced through lumen 120.

[0053] After deploying the medical device 200 from the elongated tubular member 110 and / or lumen 120 at the treatment site, the medical device 200 may be configured to expand radially when the constraint of the elongated tubular member 110 is released, as shown in Figure 1. In some embodiments, deploying the medical device 200 from the elongated tubular member 110 and / or lumen 120 may include advancing the medical device 200 and / or elongated member 210 through the lumen 120.

[0054] In some embodiments, the medical device 200 may have a second outer dimension when unrestrained and / or in an unrestrained configuration, the second outer dimension being larger than the first outer dimension of the medical device 200 and / or larger than the inner liner 114 and / or the second inner diameter and / or second inner dimension of the elongated tubular member 110 in the distal region and / or distal end. In some procedures, it may be necessary to recapture, reposition, and / or remove the medical device 200 after initial deployment. However, recapture from an unrestrained configuration after the medical device 200 has been expanded from a radially restrained configuration may be difficult in some cases. In some cases, the medical device 200 may not compress easily, as shown in Figure 2, and / or may get caught, crushed, or otherwise interfere with the distal end of the elongated tubular member 110, thereby preventing the medical device 200 from being recaptured and / or pulled back into the lumen 120 and / or damaging the distal end of the elongated tubular member 110, which may then cause injury to the patient as the elongated tubular member 110 moves through the patient's anatomical structure (e.g., when the elongated tubular member 110 is withdrawn).

[0055] Figure 3 shows a selected embodiment of a device 300 for assisting the recapture of a medical device 200. The device 300 may comprise an elongated shaft 310 and an expandable sheath extension 320 coupled to the distal end of the elongated shaft 310. In some embodiments, the elongated shaft 310 may comprise a handle member 312 located at the proximal end of the elongated shaft 310 and / or near the proximal end. For illustrative purposes, the handle member 312 is shown in the drawings as a square block, but those skilled in the art will recognize that other configurations and / or forms are also possible. For example, the handle member 312 may have an elongated shape, a barrel shape, a pistol grip shape, a knurled surface, or other known handle configurations.

[0056] In some embodiments, the expandable sheath extension 320 may be fixedly attached to the distal end of the elongated shaft 310. In some embodiments, the expandable sheath extension 320 may extend laterally from the elongated shaft 310 and / or be laterally offset relative to the elongated shaft 310. In at least some embodiments, the expandable sheath extension 320 may extend distally from the distal end of the elongated shaft 310 and / or distally beyond the distal end. In at least some embodiments, the elongated shaft 310 may be formed from a metallic material. In some embodiments, the elongated shaft 310 may be formed from a polymer material. Some preferred but non-limiting examples of materials for the elongated shaft 310, including metallic materials, polymer materials, etc., and / or combinations thereof, are described below.

[0057] In some embodiments, the expandable sheath extension 320 may extend circumferentially around a central longitudinal axis 322 that extends parallel to the longitudinal axis of the elongated shaft 310 and / or the longitudinal axis of the elongated shaft 310, as shown in Figure 3, and / or may extend around the central longitudinal axis 322. In some embodiments, the expandable sheath extension 320 may extend along the central longitudinal axis 322 and / or parallel to the central longitudinal axis 322. In some embodiments, the expandable sheath extension 320 may be discontinuous in the circumferential direction. In some embodiments, the expandable sheath extension 320 may form a tubular structure or tubular member, but may not be constructed from a complete tube.

[0058] In some embodiments, the expandable sheath extension 320 may include a C-shaped collar 330 positioned near the proximal end of the expandable sheath extension 320. In some embodiments, the C-shaped collar 330 may be positioned at the proximal end of the expandable sheath extension 320. In some embodiments, the expandable sheath extension 320 may extend distally from the C-shaped collar 330. The C-shaped collar 330 may be fixedly attached to the elongated shaft 310. In some embodiments, the C-shaped collar 330 may be fixedly attached to the distal end of the elongated shaft 310. In some embodiments, the C-shaped collar 330 may be at least partially embedded within the expandable sheath extension 320. In at least some embodiments, the C-shaped collar 330 may be formed from a metallic material. In some embodiments, the C-shaped collar 330 may be formed from a polymer material. Some preferred but non-limiting examples of materials for the C-shaped collar 330, including metallic materials, polymer materials, and / or combinations thereof, are described below.

[0059] In some embodiments, the expandable sheath extension 320 may comprise at least one polymer sheet 340. In some embodiments, the expandable sheath extension 320 and / or at least one polymer sheet 340 may comprise multiple polymer sheets. In some embodiments, the expandable sheath extension 320, at least one polymer sheet 340, and / or multiple polymer sheets may comprise two polymer sheets, three polymer sheets, four polymer sheets, and so on. In some embodiments, multiple polymer sheets may be laminated together and / or bonded to each other to form a layered structure. In some embodiments, multiple polymer sheets may be melted together, melt-bonded, molecularly mixed, and / or co-extruded to form a single structure. In some embodiments, multiple polymer sheets may be formed integrally with each other and / or monolithically. In some embodiments, multiple polymer sheets may extend from a common spine or base element. Other configurations are also conceivable.

[0060] In some embodiments, at least one polymer sheet 340 can be wound around a tubular member. In some embodiments, the expandable sheath extension 320 can be self-biased toward and / or into a radially compressed form (e.g., Figure 3). In some embodiments, at least one polymer sheet 340 can be wound around a tubular member in a radially compressed form. In some embodiments, the expandable sheath extension 320 can overlap each other circumferentially to form a tubular member in a radially compressed form. In some embodiments, at least one polymer sheet 340 and / or a plurality of polymer sheets can overlap each other circumferentially to form a tubular member in a radially compressed form.

[0061] In some embodiments, the expandable sheath extension 320 and / or at least one polymer sheet 340 may be configured to expand radially and / or circumferentially from a radially compressed form when a radially outward force is applied to the inner surface of the expandable sheath extension 320, as shown in Figure 4. In some embodiments, the application of a radially outward force to the inner surface of the expandable sheath extension 320 may cause the expandable sheath extension 320 and / or at least one polymer sheet 340 to expand radially and / or circumferentially.

[0062] In some embodiments, the C-shaped collar 330 may be at least partially embedded within at least one polymer sheet 340. The C-shaped collar 330 is discontinuous in the circumferential direction. In some embodiments, the C-shaped collar 330 may have a gap 332 defined by a first end 334 of the C-shaped collar 330 and a second end 336 of the C-shaped collar 330 located opposite the first end 334. In some embodiments, the gap 332 may be located on the opposite side from the generally elongated shaft 310. In some embodiments, the C-shaped collar 330 does not overlap itself in the circumferential direction in any configuration. In some alternative embodiments, the C-shaped collar 330 may overlap itself in the circumferential direction in a radially compressed form, and not overlap itself in the circumferential direction when expanded radially and / or circumferentially from a radially compressed form.

[0063] In some embodiments, the expandable sheath extension 320 and / or tubular member may have a first outer diameter in a radially compressed form and a second outer diameter that is larger than the first outer diameter when expanded radially and / or circumferentially. In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be less than 6.000 millimeters (0.236 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be less than 5.667 millimeters (0.223 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be less than 5.333 millimeters (0.210 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be less than 5.000 millimeters (0.197 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be less than 4.667 millimeters (0.184 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be less than 4.333 millimeters (0.170 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be less than 4.000 millimeters (0.158 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be less than 3.667 millimeters (0.144 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be less than 3.333 millimeters (0.131 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be less than 3.000 millimeters (0.118 inches). Other configurations are also being considered.

[0064] In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be smaller than the first inner diameter and / or first inner dimension of the elongated tubular member 110 and / or lumen 120 and / or inner liner 114 in the distal region and / or distal end of the elongated tubular member 110. In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or tubular member may be smaller than the second inner diameter and / or second inner dimension of the elongated tubular member 110 and / or lumen 120 and / or inner liner 114 in the distal region and / or distal end of the elongated tubular member 110.

[0065] In some embodiments, the expandable sheath extension 320 and / or tubular member may have a first inner diameter in a radially compressed form and a second inner diameter that is larger than the first inner diameter when expanded radially and / or circumferentially. In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or tubular member may be at least 1.000 millimeters (0.039 inches). In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or tubular member may be at least 1.333 millimeters (0.053 inches). In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or tubular member may be at least 1.667 millimeters (0.066 inches). In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or tubular member may be at least 2.000 millimeters (0.079 inches). In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or tubular member may be at least 2.333 millimeters (0.092 inches). In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or tubular member may be at least 2.667 millimeters (0.105 inches). Other configurations are also contemplated. In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or tubular member may be larger than the outer diameter of the elongated member 210.

[0066] A system for deploying and recapturing a medical device 200 may comprise, as shown in Figures 5-6, a deployment catheter 100 as described herein, and a device 300 for assisting in recapturing the medical device 200 after it has been deployed distal to the elongated tubular member 110 of the deployment catheter 100. In some embodiments, the elongated shaft 310 of the device 300 may be configured to advance an expandable sheath extension 320 slidably through the elongated tubular member 110 and / or the inner liner 114 and / or lumen 120 of the deployment catheter 100. In some embodiments, the elongated shaft 310 of the device 300 may be configured to advance an expandable sheath extension 320 slidably through the elongated tubular member 110 and / or the lumen 120 of the deployment catheter 100 to a guide position shown in Figure 7. In some embodiments, the elongated shaft 310 of the device 300 may be sized, molded, and / or configured to slide longitudinally and / or axially along the elongated member 210 within the lumen 120 of the elongated tubular member 110 and / or inner liner 114.

[0067] In some embodiments, at the guide position, the proximal end of the expandable sheath extension 320 may be located within the lumen 120 and / or inner liner 114 of the elongated tubular member 110, and the distal end of the expandable sheath extension 320 may be located distal to the distal end of the elongated tubular member 110. The expandable sheath extension 320 can be advanced to the guide position in a radially compressed form through the lumen 120 of the elongated tubular member 110 and / or the deployment catheter 100. When the medical device 200 engages with the expandable sheath extension 320, and / or when a radially outward force is applied to the inner surface of the expandable sheath extension 320 by, for example, the medical device 200, the expandable sheath extension 320 may expand radially and / or circumferentially. Specifically, the distal end of the expandable sheath extension 320 expands radially and / or circumferentially, while the proximal end of the expandable sheath extension 320 is constrained in a form that is radially compressed by and / or near the distal end of the elongated tubular member 110 and / or inner liner 114, thereby giving the expandable sheath extension 320 a substantially conical shape that opens distally and / or expands radially. The expandable sheath extension 320 can form a funnel-shaped and / or tapered structure for compressing the medical device 200 radially inward as the medical device 200 is drawn into and / or guided into the lumen 120 and / or inner liner 114. Therefore, in the guide position, the expandable sheath extension 320 may be configured to guide the medical device 200 radially inward toward the lumen 120 and / or inner liner 114 of the elongated tubular member 110 as the medical device 200 is retracted proximally.

[0068] Figures 5 to 8 schematically illustrate selected embodiments of a method for deploying and recapturing the medical device 200. In some embodiments, the method may include the step of deploying the medical device 200 from a deployment catheter 100 which includes an elongated tubular member 110 with a lumen 120 extending inside, as shown in Figure 5. In some embodiments, the method may include the step of pushing the medical device 200 through and / or out from the elongated tubular member 110, the lumen 120, and / or the inner liner 114, and / or advancing it, with the elongated member 210 extending proximal to the medical device 200. In some embodiments, the medical device 200 may be located at the distal end of the elongated member 210.

[0069] In some embodiments, after deploying the medical device 200 from the deployment catheter 100, the elongated tubular member 110, the lumen 120, and / or the inner liner 114, the medical device 200 may expand radially at the distal end of the elongated tubular member 110 to an outer diameter and / or outer dimension that is larger than the inner diameter and / or inner dimension of the elongated tubular member 110, the lumen 120, and / or the inner liner 114. In some embodiments, after deploying the medical device 200 from the deployment catheter 100, the elongated tubular member 110, the lumen 120, and / or the inner liner 114, the medical device 200 may expand radially at the distal end of the elongated tubular member 110 to a second outer diameter and / or second outer dimension that is larger than the second inner diameter and / or second inner dimension of the elongated tubular member 110, the lumen 120, and / or the inner liner 114.

[0070] In some embodiments, the method may include the step of positioning an expandable sheath extension 320 of the device 300, coupled to the distal end of the elongated shaft 310 of the device 300, at a first position along the lateral side of the elongated member 210, as shown in Figure 5. The expandable sheath extension 320 may extend laterally from the elongated shaft 310 and / or be laterally offset relative to the elongated shaft 310. In at least some embodiments, the expandable sheath extension 320 may be self-biased toward a radially compressed form.

[0071] In some embodiments, the expandable sheath extension 320 is configured to be laterally translated relative to the elongated member 210 that extends proximal to the medical device 200 and through the lumen 120 of the elongated tubular member 110, thereby shifting the expandable sheath extension from a first position along the elongated member 210 to a second position where the elongated member 210 extends longitudinally and / or axially through the expandable sheath extension 320, and / or to a second position where the expandable sheath extension 320 surrounds the elongated member 210.

[0072] In some embodiments, the method may include the step of translating the device 300 and / or expandable sheath extension 320 laterally from a first position to a second position relative to and / or toward the elongated member 210, as shown in Figures 5-6, where the elongated member 210 extends longitudinally and / or axially through the expandable sheath extension 320. In some embodiments, the method may include the step of translating the device 300 and / or expandable sheath extension 320 laterally from a first position relative to and / or toward the elongated member 210 to a second position where the expandable sheath extension 320 surrounds the elongated member 210. In some embodiments, when the expandable sheath extension 320 is positioned in the second position in a radially compressed form, at least a portion of the expandable sheath extension 320 completely surrounds the elongated member 210. In some embodiments, when the expandable sheath extension 320 is positioned in a second position in a radially compressed form, at least a portion of the tubular member completely surrounds the elongated member 210. In some embodiments, when the expandable sheath extension 320 is positioned in a second position in a radially compressed form, at least one polymer sheet 340 and / or a plurality of polymer sheets completely surround the elongated member 210.

[0073] In some embodiments, the method may include the step of advancing the device 300 and / or expandable sheath extension 320 along the elongated member 210 to a guide position near the distal end of the elongated tubular member 110, as shown in Figures 6-7. In some embodiments, the method may include the step of advancing the device 300 and / or expandable sheath extension 320 within the elongated tubular member 110, lumen 120, and / or inner liner 114 to a guide position near the distal end of the elongated tubular member 110. In some embodiments, the method may include the step of advancing the device 300 and / or expandable sheath extension 320 through the elongated tubular member 110, lumen 120, and / or inner liner 114 to a guide position near the distal end of the elongated tubular member 110.

[0074] In some embodiments, the method may include the step of retracting the medical device 300 proximal to the elongated tubular member 110, lumen 120, and / or inner liner 114 through the expandable sheath extension 320 of the device 200, as shown in Figure 8. In some embodiments, the expandable sheath extension 320 may be configured to expand radially and / or circumferentially when engaged with the medical device 200. In some embodiments, the expandable sheath extension 320 may be configured to expand radially and / or circumferentially when a radially outward force is applied to the inner surface of the expandable sheath extension 320. In some embodiments, the expandable sheath extension 320 may be configured to expand radially and / or circumferentially while the medical device 200 is retracted into and / or through the expandable sheath extension 320.

[0075] In some embodiments, the method may include the step of retracting the expandable sheath extension 320 into the elongated tubular member 110, the lumen 120, and / or the inner liner 114. In some embodiments, the method may include the step of retracting the expandable sheath extension 320 into the elongated tubular member 110, the lumen 120, and / or the inner liner 114 together with and / or alongside the medical device 200. In some embodiments, the method may include the step of retracting the expandable sheath extension 320 into the elongated tubular member 110, the lumen 120, and / or the inner liner 114 after the medical device 200.

[0076] In some embodiments, the method may include the step of withdrawing the deployment catheter 100 from the patient's biological structure. In some embodiments, the method may include the step of completely withdrawing the medical device 200 through the deployment catheter 100, the elongated tubular member 110, the lumen 120, and / or the inner liner 114. In some embodiments, the method may include the step of completely withdrawing the medical device 200 through the deployment catheter 100, the elongated tubular member 110, the lumen 120, and / or the inner liner 114 before withdrawing the deployment catheter 100 from the patient's biological structure. Other configurations are also contemplated.

[0077] The devices, systems, and materials usable for their various components disclosed herein may include materials generally associated with medical devices. For simplicity of explanation, the following description refers to systems. However, this is not intended to limit the devices, components, and methods described herein, and the description may apply to other elements, members, components, or devices disclosed herein, including but not limited to elongated shafts, expandable sheath extensions, deployment catheters, tubular members, and / or elements or components thereof.

[0078] In some embodiments, the system and / or its components may be made from metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, or other suitable materials.

[0079] Other examples of some suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluoroethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®), polyether block esters, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL®), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers (HYTREL®, etc.)), polyamides (e.g., DURETHAN® or CRISTAMID®), elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly-p-phenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (GRILAMID®, etc.), perfluoro(propyl hydroxypropyl nitrile) This may include nyl ethers (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonates, polycarbonates, polyurethane silicone copolymers (e.g., Elast-Eon® or ChronoSil®), ions, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc.In some embodiments, the system and / or its components may be blended with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0080] Some examples of suitable metals and metal alloys include stainless steel such as 304 and / or 316 stainless steel and / or its variations; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic Nitinol; and nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, HASTELLOY® C276®). Any UNS:N10276, other HASTELLOY® alloys, etc., nickel-copper alloys (e.g., UNS:N04400, etc., such as MONEL® 400, NICKELVAC® 400, NICORROS® 400), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, etc., such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY Other nickel alloys such as UNS:N10665 (e.g., B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, e.g., ELGILOY®, PHYNOX®); platinum-enriched stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0081] In at least some embodiments, some or all of the system and / or components may also be doped with, fabricated from, or include radiopaque materials. Radiopaque materials are understood to be materials that can produce relatively bright images on a fluoroscopy screen or by other imaging techniques (e.g., ultrasound, etc.) during medical procedures. These relatively bright images assist the system user in determining their location. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymer materials loaded with radiopaque fillers. Furthermore, other radiopaque marker bands and / or coils may be incorporated into the system design to achieve the same result.

[0082] In some embodiments, the systems and / or other elements disclosed herein may include and / or be treated with a suitable therapeutic agent. Some examples of appropriate therapeutic agents include: antithrombotic agents (heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethyl ketone), etc.); proliferation inhibitors (enoxaparin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid, etc.); anti-inflammatory agents (dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine, etc.); antitumor / antiproliferative / antimitotic agents (paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epotilon, endostatin, angiostatin, and thymidine kinase inhibitors, etc.); anesthetics (lidocaine, bupivacaine, and ropivacaine, etc.); anticoagulants (D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin) Examples of drugs include antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and mite antiplatelet peptides; vasodilators (growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation accelerators); vasodilators (growth factor inhibitors, growth factor receptor antagonists, transcription inhibitors, translation inhibitors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins); immunosuppressants ("Olimus" family drugs, rapamycin analogs, macrolide antibiotics, biolimus, everolimus, zotarolimus, temsirolimus, picrolimus, novolimus, myolimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol-lowering agents; vasodilators; and drugs that interfere with intrinsic vasoactive mechanisms.

[0083] It should be understood that this disclosure is illustrative in many respects. Modifications can be made in detail, particularly with respect to shape, size, and process configuration, without exceeding the scope of this disclosure. This may include, to a reasonable extent, using any feature of one exemplary embodiment in other embodiments. The scope of this disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. A device to assist in recapturing medical devices, A long shaft, The system comprises an expandable sheath extension attached to the distal end of the elongated shaft, The expandable sheath extension is offset laterally from the elongated shaft, The expandable sheath extension is self-biased toward a radially compressed form in the device.

2. The expandable sheath extension extends circumferentially around a central longitudinal axis that extends parallel to the elongated shaft, The device according to claim 1, wherein the expandable sheath extension is discontinuous in the circumferential direction.

3. The device according to claim 1 or 2, wherein the expandable sheath extension includes a C-shaped collar positioned near the proximal end of the expandable sheath extension.

4. The device according to claim 3, wherein the C-shaped collar is fixedly attached to the elongated shaft.

5. The device according to claim 3 or 4, wherein the C-shaped collar is formed from a metal material.

6. The device according to any one of claims 3 to 5, wherein the expandable sheath extension includes at least one polymer sheet wound around the tubular member in the radially compressed form.

7. The device according to claim 6, wherein the C-shaped collar is at least partially embedded within the at least one polymer sheet.

8. The device according to claim 6 or 7, wherein the tubular member has an outer diameter of less than 4.667 millimeters in the radially compressed form.

9. The device according to any one of claims 6 to 8, wherein at least one polymer sheet is expanded radially and circumferentially by applying a radially outward force to the inner surface of the expandable sheath extension.

10. A system for deploying and recapturing medical devices, A deployment catheter comprising a long tubular member having a lumen extending inside, wherein the lumen is configured to slidably receive a medical device, and the deployment catheter, A device according to any one of claims 1 to 9, comprising: The system is configured such that the elongated shaft advances the expandable sheath extension through the lumen of the elongated tubular member to a guide position where the proximal end of the expandable sheath extension is positioned within the lumen of the elongated tubular member and the distal end of the expandable sheath extension is positioned distal to the elongated tubular member.

11. The system according to claim 10, wherein, at the guide position, the expandable sheath extension is configured to guide the medical device radially inward toward the lumen of the elongated tubular member when the medical device is retracted proximally.

12. The system according to claim 10 or 11, wherein the medical device, in an unrestrained configuration, has an outer dimension larger than the inner diameter of the elongated tubular member at the distal end of the elongated tubular member.

13. The system according to any one of claims 10 to 12, wherein the expandable sheath extension is moved laterally parallel to a longitudinal member extending proximal to the medical device through the lumen of the longitudinal tubular member, thereby shifting the expandable sheath extension from a first position along the lateral to the longitudinal member to a second position where the longitudinal member extends longitudinally through the expandable sheath extension.

14. The system according to claim 13, wherein the elongated shaft is sized and configured to slide longitudinally along the elongated member within the lumen of the elongated tubular member.

15. A method for deploying and recapturing a medical device, A step of deploying a medical device from a deployment catheter, wherein the deployment catheter includes an elongated tubular member having a lumen extending inside, and the lumen is configured to slidably receive the medical device positioned at the distal end of the elongated member, A step of positioning an expandable sheath extension, coupled to the distal end of an elongated shaft, at a first position along the lateral side of the elongated member, wherein the expandable sheath extension is offset laterally from the elongated shaft and is self-biased toward a radially compressed form; The steps include moving the expandable sheath extension from the first position to a second position where the elongated member extends longitudinally through the expandable sheath extension, in a lateral direction relative to the elongated member. The steps include: advancing the expandable sheath extension along the elongated member to a guide position near the distal end of the elongated tubular member; A method comprising the step of drawing the medical device proximal into the elongated tubular member through the expandable sheath extension.

Images