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

Abstract

A device for assisting in the retrieval of 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 may be laterally offset from the elongate shaft and may be self-biased toward a radially collapsed configuration. A system for deploying and retrieving a medical device may include a deployment catheter comprising an elongate tubular member and a device; the elongate tubular member has a lumen configured to slidably receive a medical device; and the device is used for assisting in recycling the medical device after the medical device is deployed. The elongate shaft may be configured to slidably advance the expandable sheath extension through the lumen to a guide position; in the guide position, a proximal end of the expandable sheath extension is disposed within the lumen and a distal end of the expandable sheath extension is disposed distal to the elongate tubular member.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 530,727, filed on August 4, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0002] This disclosure relates in general to apparatus, systems, and methods for deploying and / or recovering medical devices. Background Technology

[0003] In some cases, performing percutaneous medical procedures may require the insertion and / or manipulation of expandable medical devices through a patient's blood vessels. However, inserting a medical device into a blood vessel can result in undesirable forces being applied to the vessel wall. Furthermore, expandable medical devices may need to be retrieved, repositioned, and / or removed after expansion. Each known device, system, and method for deploying and / or retrieving medical devices has certain advantages and disadvantages. There is a continuing need to provide alternative devices, systems, and / or methods. Summary of the Invention

[0004] In one example, a device for assisting in the retrieval of a medical device may include an elongated shaft and an expandable sheath extension coupled to a distal end of the elongated shaft. The expandable sheath extension may be laterally offset from the elongated shaft. The expandable sheath extension may be self-biased toward a radially collapsed morphology.

[0005] Except for any examples disclosed herein or alternatively, the expandable sheath extension extends circumferentially about a central longitudinal axis that extends parallel to the elongated axis.

[0006] Except for any examples disclosed herein or alternatively, the expandable sheath extension is circumferentially discontinuous.

[0007] In addition to any examples disclosed herein or alternatively, the expandable sheath extension includes a C-shaped collar on the proximal side of the proximal end of the expandable sheath extension.

[0008] Except for any examples disclosed herein or alternatively, the C-shaped collar is securely attached to the elongated shaft.

[0009] Except for any examples disclosed herein or alternatively, the C-shaped collar is formed of a metallic material.

[0010] In addition to any examples disclosed herein or alternatively, the expandable sheath extension includes at least one polymer sheet wound into a tubular member in a radially collapsed configuration.

[0011] Except for any examples disclosed herein or alternatively, the C-shaped collar is at least partially embedded within at least one polymer sheet.

[0012] Except for any examples disclosed herein or alternatively, tubular members have an outer diameter of less than 4.667 mm in radially collapsed morphology.

[0013] In addition to any of the examples disclosed herein or alternatively, applying a radially outward force against the inner surface of the expandable sheath extension causes at least one polymer sheet to expand radially and circumferentially.

[0014] In addition to any examples disclosed herein or alternatively, a system for deploying and retrieving a medical device may include a deployment catheter and a device; the deployment catheter includes an elongated tubular member having a lumen extending therethrough, the lumen configured to slidably receive a medical device; the device is used to assist in the retrieval of the medical device after it has been deployed away from the elongated tubular member. The device may include an elongated shaft and an expandable sheath extension coupled to a distal end of the elongated shaft. The expandable sheath extension may be laterally offset from the elongated shaft. The expandable sheath extension may be self-biased toward a radially collapsed morphology.

[0015] In addition to any of the examples disclosed herein or alternatively, the elongated shaft is configured to slidably advance the expandable sheath extension through the cavity of the elongated tubular member to a guide position; in the guide position, the proximal end of the expandable sheath extension is disposed within the cavity of the elongated tubular member and the distal end of the expandable sheath extension is disposed distal to the elongated tubular member.

[0016] In addition to any of the examples disclosed herein or alternatively, in the guiding position, the expandable device is configured to guide the medical device toward the radially inner sheath extension of the lumen of the elongated tubular member when the medical device is pulled proximally.

[0017] In addition to any examples disclosed herein or alternatively, the medical device in an unconstrained form has an outer extent that is greater than the inner diameter of the elongated tubular member at its distal end.

[0018] In addition to any examples disclosed herein or alternatively, the expandable sheath extension is configured to translate in a lateral direction relative to an elongated member extending proximally through a cavity of the elongated member from the medical device, such that the expandable sheath extension is displaced from a first position alongside the elongated member to a second position; the elongated member is expanded to extend longitudinally through the expandable sheath extension in the second position.

[0019] In addition to any of the examples disclosed herein or alternatively, the elongated shaft is sized and configured to slide longitudinally alongside the elongated tubular member within the cavity of the elongated tubular member.

[0020] In addition to any examples disclosed herein or alternatively, methods for deploying and retrieving a medical device may include: deploying a medical device from a deployment catheter comprising an elongated tubular member having a lumen extending therethrough, wherein the lumen is configured to slidably receive a medical device disposed at a distal end of the elongated member; positioning an expandable sheath extension coupled to a distal end of an elongated shaft in a first position parallel to the elongated member, wherein the expandable sheath extension is laterally offset from the elongated shaft, and wherein the expandable sheath extension is in a radially collapsed configuration from the offset; translating the expandable sheath extension laterally relative to the elongated member from the first position to a second position in which the elongated member extends longitudinally through the expandable sheath extension; advancing the expandable sheath extension along the elongated member to a guide position adjacent to the distal end of the elongated tubular member; and retracting the medical device proximally through the expandable sheath extension into the elongated tubular member.

[0021] In addition to any of the examples disclosed herein or alternatively, at least a portion of the expandable sheath extension is configured to expand radially when engaged with a medical device.

[0022] In addition to any examples disclosed herein or alternatively, when the expandable sheath extension is disposed in the second position in a radially collapsed configuration, at least a portion of the expandable sheath extension completely surrounds the elongated tubular member.

[0023] In addition to any examples disclosed herein or alternatively, after a medical device is deployed from a deployment catheter, the medical device expands radially to an outer extent that is greater than the inner diameter of the elongated tubular member at its distal end.

[0024] Except for any examples disclosed herein or alternatively, the expandable sheath extension is circumferentially discontinuous.

[0025] In addition to any of the examples disclosed herein or alternatively, the expandable sheath extensions overlap circumferentially to form a tubular member in a radially collapsed morphology.

[0026] The above summary of some embodiments, aspects, and / or examples is not intended to describe every disclosed embodiment or every implementation of this disclosure. These embodiments are illustrated more specifically by the following drawings and detailed description. Attached Figure Description

[0027] This disclosure can be more fully understood in light of the following detailed description taken in conjunction with the accompanying drawings, wherein:

[0028] Figure 1 A schematic diagram illustrating the deployment of a catheter and selected aspects of the medical device from which it is deployed;

[0029] Figure 2 To demonstrate an attempt to utilize Figure 1A schematic diagram of the selected aspects of deploying catheters to retrieve medical devices;

[0030] Figure 3 A schematic diagram illustrating selected aspects for assisting in the retrieval of medical devices; and

[0031] Figure 4 To illustrate the connection of the medical device Figure 3 A schematic diagram of the selected aspects of the device; and

[0032] Figures 5 to 8 The use of schematically illustrates Figures 3 to 4 The selected aspects of the method for deploying and / or recovering medical devices.

[0033] While various aspects of this disclosure may be modified and alternatively implemented, their details have been illustrated by way of example in the drawings and will be described in detail. However, it should be understood that this disclosure is not intended to limit its aspects to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure. Detailed Implementation

[0034] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, and similar reference numerals indicate similar elements in some of the drawings. The detailed description and drawings are intended to illustrate but not limit this disclosure. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of this disclosure. The detailed description and drawings illustrate exemplary embodiments of this disclosure.

[0035] With respect to the terms defined below, these definitions shall apply unless different definitions are given elsewhere in the claims or this specification.

[0036] All numerical values ​​herein are assumed to be modified by the term "about," whether explicitly indicated or not. In the context of numerical values, the term "about" generally refers to a range of exponents that those skilled in the art will consider equivalent to the values ​​expressed (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. Other uses of the term "about" (e.g., in contexts other than numerical values) are assumed to have their common and conventional definitions, as understood and consistent with the context of the specification, unless otherwise specified.

[0037] The range of values ​​expressed by endpoints includes all numbers in that range, including the endpoints (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0038] Although some suitable dimensions, ranges and / or values ​​belonging to various components, features and / or specifications are disclosed, those skilled in the art (to which this disclosure belongs) will understand that dimensions, ranges and / or values ​​may deviate from those explicitly disclosed.

[0039] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used in its meaning to include “and / or” unless the context clearly indicates otherwise. It should be noted that, for ease of understanding, certain features of this disclosure may be described in the singular form, even if such features may be plural or repeated within one or more disclosed embodiments. Each of these features may include and / or be covered by the singular disclosure unless expressly stated to the contrary. For example, a reference to a feature may equivalently refer to all examples and quantities other than one of the features stated, unless expressly stated to the contrary. Therefore, it will be understood that the following discussion may be equivalently applied to any and / or all of the more than one component within the device, unless expressly stated to the contrary.

[0040] Relative terms (such as “proximal,” “distal,” “advance,” “retract,” variations thereof, etc.) may generally be considered relative to the positioning, orientation, and / or operation of various elements relative to the user / operator / manipulator of the device, wherein “proximal” and “retract” indicate or refer to being closer to or toward the user, and “distal” and “advance” indicate or refer to being farther from or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily designated to facilitate the understanding of this disclosure, and such cases will be 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 cavity (such as a body cavity, blood vessel) or within the device. Other relative terms (such as “axial,” “circumferential,” “longitudinal,” “lateral,” “radial,” etc., and / or variations thereof) generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0041] The term “range” is understood to mean the maximum measurement of the stated and / or identified dimension, unless the range or dimension prefix considered is or is identified as “minimum,” which is understood to mean the minimum measurement of the stated and / or identified dimension. For example, “external range” is understood to mean an external dimension, “radial range” is understood to mean a radial dimension, “longitudinal range” is understood to mean a longitudinal dimension, and so on. Each example of “range” may be different (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be obvious to a person skilled in the art depending on the context of its intended use. Generally, “range” may be indicated as the maximum possible dimension measured according to its intended use, while “minimum range” may be indicated as the minimum possible dimension measured according to its intended use. In some cases, “range” may be measured orthogonally in a plane and / or cross-section; however, as will be obvious from the particular context, it may be measured in different ways, such as, but not limited to, angular, radial, circumferential (e.g., along an arc), etc.

[0042] The terms “integral” and “monolithic” should generally refer to one or more elements made of or composed of a single structure or basic unit / element. Integral and / or monolithic elements should not include structures and / or features made by assembling or otherwise combining multiple discrete structures or elements.

[0043] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include specific features, structures, or characteristics, but each embodiment may not necessarily include that specific feature, structure, or characteristic. Furthermore, such references may not necessarily refer to the same embodiment. Additionally, when a specific feature, structure, or characteristic is described in conjunction with one embodiment, those skilled in the art will understand that the feature, structure, or characteristic can be implemented in conjunction with other embodiments (whether explicitly described or not), unless explicitly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a specific combination, are contemplated as combinable or arrangeable to form other additional embodiments or to supplement and / or enrich the described embodiments, as will be understood by those skilled in the art.

[0044] For clarity, certain identifying numerical names (e.g., first, second, third, fourth, etc.) may be used throughout the detailed description and / or claims to name various described and / or claimed features and / or to distinguish them. It should be understood that the numerical names are not intended to be restrictive and are merely exemplary. In some embodiments, for brevity and clarity, the previously used numerical naming may be changed or deviated from. That is, a feature identified as a “first” element may subsequently be referred to as a “second” element, a “third” element, etc., or may be omitted entirely, and / or different features may be referred to as a “first” element. In each case, the meaning and / or designation will be obvious to those skilled in the art.

[0045] Furthermore, it should be noted that in any given drawing, some features may not be shown or may be shown schematically for clarity and / or simplicity. Additional details regarding some components and / or methods may be shown in more detail in other drawings. The apparatus and / or methods disclosed herein may provide several desirable features and benefits as described in more detail below.

[0046] Figure 1 Selected aspects of the deployment catheter 100 are shown. In some embodiments, the term "deployment catheter" may be used interchangeably with the term "guide," etc. In some embodiments, the deployment catheter 100 may include an elongated tubular member 110 having a lumen 120 extending therethrough. In some embodiments, the deployment catheter 100 may include a proximal connector (hub) 130 disposed at and / or coupled to the proximal end of the elongated tubular member 110. The proximal connector 130 may be in fluid communication with the lumen 120. In some embodiments, the proximal connector 130 may include a hemostatic valve or seal disposed therein.

[0047] In some embodiments, the elongated tubular member 110 may include an outer sheath 112 and an inner liner 114. In some embodiments, a cavity 120 may extend within and / or through the inner liner 114. In some embodiments, the outer sheath 112 may be disposed on, around, and / or around the inner liner 114. In some embodiments, the elongated tubular member 110 may include a tapered region disposed adjacent to a 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.

[0048] The liner 114 may include at least one folded portion that extends along at least a distal region of the elongated tubular member 110 in a delivery configuration and / or a folded configuration. In some embodiments, the liner 114 may extend along at least a distal region and a tapered region of the elongated tubular member 110 in a delivery configuration and / or a folded configuration. In some embodiments, the at least one folded portion may extend along the entire length of the liner 114 and / or the elongated tubular member 110 in a delivery configuration and / or a folded configuration. In some embodiments, the at least one folded portion may include one folded portion, two folded portions, three folded portions, four folded portions, five folded portions, or more folded portions as required by a particular configuration. The liner 114 may be disposed radially inward from the outer sheath 112. In some embodiments, each and / or some of the at least one folded portion may fold back itself when viewed in cross-section of the delivery configuration and / or the folded configuration to form, for example, a wave shape, an S-shape, a T-shape, a Z-shape, and / or combinations thereof. Other shapes and / or configurations are also contemplated.

[0049] In the delivery configuration, the liner 114 may have a generally annular shape. Other shapes and / or configurations are also envisioned. In the delivery and / or folded configurations, the cavity 120 has a first inner diameter and / or a first internal range at the distal region and / or distal end of the elongated tubular member 110, which is measured through and perpendicular to a central longitudinal axis defined by the inner surface of the liner 114. When subjected to radially outward forces within the cavity 120, the liner 114 may be configured to radially expand from the delivery and / or folded configuration to an expanded configuration, such as... Figure 1 What I saw.

[0050] In the expanded configuration, the cavity 120 may have a second inner diameter and / or a second internal range, measured through and perpendicular to the central longitudinal axis, at the distal region and / or distal end of the elongated tubular member 110, which is larger than the first inner diameter and / or the first internal range. When the liner 114 expands radially from the delivery configuration and / or folded configuration toward and / or to the expanded configuration, at least one of at least one folded portion may be at least partially unfolded. Similarly, in the delivery configuration and / or folded configuration, the liner 114 may have a first outer diameter and / or a first outer range, measured through and perpendicular to the central longitudinal axis defined by the outer surface of the liner 114, at the distal region and / or distal end of the elongated tubular member 110. In the expanded configuration, the liner 114 may have a second outer diameter and / or second outer extent, measured through and perpendicular to the central longitudinal axis, at the distal region and / or distal end of the elongated tubular member 110, which is larger than the first outer diameter and / or first outer extent.

[0051] In some embodiments, the liner 114 may be configured to allow the cavity 120 to expand radially from a first inner diameter and / or a first internal range toward a second inner diameter and / or a second internal range when subjected to radially outward forces within the cavity 120. In some embodiments, the liner 114 may be configured to expand radially outward from the first inner diameter and / or the first internal range to a predetermined second inner diameter and / or a predetermined second internal range. For example, the second inner diameter and / or the second internal range may have a predetermined value, and the liner 114 may be configured to prevent radially outward stretching or expansion beyond that predetermined value.

[0052] In at least some embodiments, the liner 114 may be generally and / or fully compliant, and / or the liner 114 may be without radial self-biasing. For example, the liner 114 may be without radial inward self-biasing and / or without radial outward self-biasing. In at least some embodiments, the liner 114 may be non-self-supporting and may not include mechanisms for self-radial expansion and / or opening (e.g., in the absence of radial outward force applied to the liner 114 within the cavity 120). For example, the liner 114 may require a device or object (e.g., a medical device, etc.) to radially push and / or press the liner 114 radially outward from a delivery configuration and / or folded configuration toward an expanded configuration; the device or object having an outer diameter greater than a first inner diameter and / or a first internal range of the cavity 120.

[0053] In some embodiments, when no device, object, etc. is disposed within the cavity 120, the liner 114 may collapse radially inward without applying a radially inward force to its outer surface. For example, the liner 114 may not remain open or self-maintain a specific expansion size, or the liner 114 may be non-self-supporting. Similarly, the liner 114 may collapse radially inward on its own without being biased. For example, after expanding from a delivery form and / or a folded form toward and / or into an expanded form, the liner 114 may take the shape and / or form of the surrounding tissue, and / or the outer surface of the liner 114 may be aligned with and / or in contact with the surrounding tissue. In one example, in the absence of a radially outward force, object, device, etc., to expand the liner 114, the constriction of a blood vessel or body cavity in which the liner 114 is disposed may push the liner 114 radially inward, but the liner 114 does not self-bias itself radially inward (e.g., the liner 114 may have zero return force after expansion / opening).

[0054] In some embodiments, the liner 114 may be formed of a compliant material. In some embodiments, the liner 114 may be formed of a non-elastic material. In another embodiment, the liner 114 may be formed of an elastic material or a combination of non-elastic and elastic materials. In some embodiments, the liner 114 may be configured to prevent the liner 114 from being stretched axially along the cavity 120. For example, the liner 114 may be configured to expand radially outward from a central longitudinal axis, rather than being stretched or expanded in the axial or longitudinal direction along a central longitudinal axis. In some embodiments, the liner 114 may be formed of a polymer and / or plastic material. In some embodiments, the liner 114 may be formed of a non-thermoplastic material designed to prevent melting when heat is applied to reflow other and / or adjacent components as discussed herein. For example, in at least some embodiments, the liner 114 may be formed of 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, liner 114, etc., are discussed below.

[0055] In some embodiments, the inner surface of the wall of the liner 114 may include one or more layers or coatings, such as, but not limited to, a lubricating coating, a hydrophilic coating, a hydrophobic coating, and / or other suitable coatings. In some embodiments, the liner 114 may include a lubricant disposed on the inner surface of the wall of the liner 114 and / or disposed within the cavity 120. In some embodiments, the outer surface of the outer sheath 112 may include one or more layers or coatings, such as, but not limited to, a lubricating coating, a hydrophilic coating, a hydrophobic coating, and / or other suitable coatings. In some embodiments, the outer sheath 112 may include a lubricant disposed on the outer surface of the outer sheath 112.

[0056] In some embodiments, the elongated tubular member 110 may include one or more reinforcing members extending along its length. In some embodiments, the one or more reinforcing members may include a plurality of longitudinal ridges circumferentially spaced about a central longitudinal axis. In some embodiments, the one or more reinforcing members may be securely attached to and / or embedded therein in an outer sheath 112. Other configurations are also contemplated.

[0057] 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 orifice, at least one window, at least one opening, etc.), the at least one perforation 113 being formed in and / or extending along at least a portion of the wall of the outer sheath 112, and / or extending along at least a portion of the length of the outer sheath 112.

[0058] In some embodiments, at least one perforation 113 may include and / or define a plurality of elements therein (e.g., a plurality of orifices, a plurality of windows, a plurality of openings, a plurality of notches, a plurality of holes, a plurality of weakening features, etc.). In some embodiments, at least one perforation may extend laterally and / or laterally through 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 laterally through 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 generally “thinner” segment 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 circumference of the liner 114. In some embodiments, at least a portion of the outer sheath 112 may be discontinuous.

[0059] In some embodiments, at least one perforation 113 forms a preferred and / or preferential tear line along the outer sheath 112, the tear line being configured to separate in response to the expansion of the liner 114 from a delivery configuration and / or folded configuration toward an expanded configuration. In some embodiments, the outer sheath 112 may be configured to separate, detach, perforate, and / or tear as the liner 114 expands radially outward from a delivery configuration and / or folded configuration toward an expanded configuration. In some embodiments, the outer sheath 112 may be configured to separate, detach, 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, detach, perforate, and / or tear, wherein the outer sheath 112 is discontinuous and / or constituted and / or formed of a thinner material.

[0060] In at least some embodiments, at least one perforation 113 may be axially aligned with a central longitudinal axis. In some embodiments, the outer sheath 112 includes at least one perforation 113, which is disposed on each fold of the inner liner 114, radially aligned with it, and / or circumferentially overlapping it. In some embodiments, at least one perforation 113 is arranged along one or more longitudinal and / or axial lines along the length of the outer sheath 112. In some embodiments, one or more longitudinal and / or axial lines may directly correspond to and / or be aligned with at least one fold.

[0061] The outer sheath 112 may include a given wall thickness at various locations 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 taper around the circumference of the inner liner 114, such that the reduced thickness region of the outer sheath 112 is positioned adjacent to, radially outward from, circumferentially aligned with, communicates with, and / or directly disposed thereon of at least one folded portion. In some embodiments, the reduced thickness region is at least one perforation 113.

[0062] In some embodiments, at least one perforation may be spaced apart from each other axially, longitudinally, and / or circumferentially, etc. In some embodiments, at least one perforation 113 on the proximal side of the distal end of the outer sheath 112 may have elements spaced apart from each other by a first distance. In some embodiments, at least one perforation 113 on the proximal side of the proximal end of the outer sheath 112 may have elements spaced apart from each other by a second distance, wherein 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 a combination thereof along the length of the outer sheath 112.

[0063] In some embodiments, at least one perforation 113 may have and / or define a surface area. As used herein, the term “surface area” relative to at least one perforation 113 may be defined as the “area” defined by the shape, profile, 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 rhombus shape, or any other suitable shape. For example, in embodiments where at least one perforation 113 each has a polygonal shape, the “surface area” of a given element may be defined as the area defined by a single polygon. In some embodiments, the surface area of ​​at least one perforation 113 may be constant and / or equivalent 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 toward the proximal end of the outer sheath 112. In one example, at least one perforation 113 may include a plurality of windows, the size of which may decrease from the distal end of the outer sheath 112 toward the proximal end of the outer sheath 112. Other configurations are also contemplated, including but not limited to combinations of features described herein.

[0064] In some embodiments, the elongated tubular member 110 and / or cavity 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 cavity 120 and / or the elongated tubular member 110. In some embodiments, the medical device 200 may be self-expanding and / or self-biased toward an expanded morphology. For illustrative purposes only, the medical device 200 is shown and / or named in the figures as a dashed ellipse. In some embodiments, the medical device 200 may be and / or may include a replacement heart valve implant, an occlusive implant, an inflatable balloon, an embolism protection device, or other expandable device. In at least some embodiments, the elongated member 210 may extend proximally from the medical device 200, and / or the elongated member 210 may be slidably disposed within the elongated tubular member 110 and / or cavity 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 removably coupled to and / or attached to the medical device 200.

[0065] In some embodiments, the medical device 200 may have a first outer extent in a radially constrained configuration, which is greater than a first inner diameter and / or a first inner extent of the elongated tubular member 110 and / or the cavity 120 and / or the liner 114 at the distal region and / or distal end of the elongated tubular member 110. Therefore, as the medical device 200 is advanced through the cavity 120, the medical device 200 may apply a radially outward force against the liner 114; and the liner 114 may radially expand from a delivery configuration and / or a folded configuration toward an expanded configuration; and / or as the liner 114 radially expands outward from the delivery configuration and / or the folded configuration toward the expanded configuration, the outer sheath 112 may separate, detach, perforate, and / or tear, thereby allowing the medical device 200 to pass through it in a radially constrained configuration.

[0066] Alternatively, in some embodiments, a separate dilator (not shown) may be inserted and / or advanced through the elongated tubular member 110 and / or cavity 120 before the medical device 200 is advanced through the elongated tubular member 110 and / or cavity 120. The dilator may have an outer extent that is larger than a first inner diameter and / or a first inner extent of the liner 114. The dilator may apply a radially outward force against the liner 114 to radially expand the liner 114 from a delivery configuration and / or folded configuration toward an expanded configuration, and / or to cause the outer sheath 112 to separate, detach, perforate, and / or tear as the liner 114 radially expands outward from the delivery configuration and / or folded configuration toward the expanded configuration. The dilator may then be removed from the cavity 120, and the medical device 200 may be inserted into and / or advanced through the cavity 120.

[0067] After the medical device 200 is deployed from the elongated tubular member 110 and / or cavity 120 to the treatment site, the medical device 200 may be configured to expand radially when not constrained by the elongated tubular member 110, such as Figure 1 As shown. In some embodiments, deployment of the medical device 200 from the elongated tubular member 110 and / or cavity 120 may include advancing the medical device 200 and / or the elongated member 210 through the cavity 120.

[0068] In some embodiments, the medical device 200, when unconstrained and / or in an unconstrained configuration, may have a second outer extent that is larger than the first outer extent of the medical device 200, and / or larger than the second inner diameter and / or second inner extent of the liner 114 and / or the elongated tubular member 110 at the distal region and / or distal end of the elongated tubular member 110. In some procedures, retrieval, repositioning, and / or removal of the medical device 200 may be required after initial deployment. However, retrieval from the unconstrained configuration can sometimes be difficult after the medical device 200 has expanded from a radially constrained configuration. In some cases, the medical device 200 may not be easily collapsed, and / or may wrap around, wrinkle, or otherwise interfere with the distal end of the elongated tubular member 110, such as... Figure 2 As shown, this prevents the medical device 200 from being retrieved and / or withdrawn into the cavity 120 and / or causes damage to the distal end of the elongated tubular member 110; such damage could subsequently cause injury to the patient as the elongated tubular member 110 moves within the patient's anatomy (e.g., during the withdrawal of the elongated tubular member 110, etc.).

[0069] Figure 3 Selected aspects of a device 300 for assisting in the retrieval of a medical device 200 are shown. The device 300 may include 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 include a handle member 312 disposed at the proximal end of the elongated shaft 310 and / or proximal to the proximal end of the elongated shaft 310. For illustrative purposes, the handle member 312 is shown as a rectangular frame in the figures, but those skilled in the art will understand 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, a knurled surface, or other known handle configurations.

[0070] 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 extends laterally from the elongated shaft 310 and / or may be laterally offset from 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 extend distally at the distal end of the elongated shaft 310. In at least some embodiments, the elongated shaft 310 may be formed of a metallic material. In some embodiments, the elongated shaft 310 may be formed of a polymeric material. Some suitable but non-limiting examples of materials for the elongated shaft 310 are described below, including metallic materials, polymeric materials, and / or combinations thereof.

[0071] In some embodiments, the expandable sheath extension 320 may extend axially about and / or about a central longitudinal axis 322, which extends parallel to the elongated shaft 310 and / or the longitudinal axis of the elongated shaft 310, such as... Figure 3 As seen. In some embodiments, the expandable sheath extension 320 may extend along and / or parallel to the central longitudinal axis 322. In some embodiments, the expandable sheath extension 320 may be circumferentially discontinuous. In some embodiments, the expandable sheath extension 320 may form a tubular structure or tubular member, but is not composed of a single piece of tubular material.

[0072] In some embodiments, the expandable sheath extension 320 may include a C-shaped collar 330 proximal to the proximal end of the expandable sheath extension 320. In some embodiments, the C-shaped collar 330 may be disposed 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 securely attached to an elongated shaft 310. In some embodiments, the C-shaped collar 330 may be securely 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 of a metallic material. In some embodiments, the C-shaped collar 330 may be formed of a polymeric material. Some suitable but non-limiting examples of materials for the C-shaped collar 330 are described below, including metallic materials, polymeric materials, and / or combinations thereof.

[0073] In some embodiments, the expandable sheath extension 320 may include at least one polymer sheet 340. In some embodiments, the expandable sheath extension 320 and / or at least one polymer sheet 340 may include multiple polymer sheets. In some embodiments, the expandable sheath extension 320, at least one polymer sheet 340, and / or multiple polymer sheets may include two polymer sheets, three polymer sheets, four polymer sheets, etc. In some embodiments, multiple polymer sheets may be laminated together and / or bonded together to form a layered structure. In some embodiments, multiple polymer sheets may be melted, melt-bonded, molecularly crosslinked, and / or co-extruded together to form a single structure. In some embodiments, multiple polymer sheets may be integrally formed and / or integrally formed with each other. In some embodiments, multiple polymer sheets may expand from a common ridge or base element. Other configurations are also contemplated.

[0074] In some embodiments, at least one polymer sheet 340 may be wound into a tubular member. In some embodiments, the expandable sheath extension 320 may be biased towards a radially collapsed shape and / or biased towards a radially collapsed shape (e.g., Figure 3In some embodiments, at least one polymer sheet 340 may be wound into a tubular member in a radially collapsed configuration. In some embodiments, the expandable sheath extension 320 may overlap itself circumferentially to form a tubular member in a radially collapsed configuration. In some embodiments, at least one polymer sheet 340 and / or multiple polymer sheets may overlap each other circumferentially to form a tubular member in a radially collapsed configuration.

[0075] In some embodiments, when a radially outward force is applied against the inner surface of the expandable sheath extension 320, 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 collapsed shape, such as... Figure 4 As seen in some embodiments, the application of a radially outward force against the inner surface of the expandable sheath extension 320 causes the expandable sheath extension 320 and / or at least one polymer sheet 340 to expand radially and / or circumferentially.

[0076] 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 circumferentially discontinuous. In some embodiments, the C-shaped collar 330 may include a gap 332 defined by a first end 334 and a second end 336 of the C-shaped collar 330, the second end 336 being positioned opposite the first end 334. In some embodiments, the gap 332 may be positioned substantially opposite to an elongated shaft 310. In some embodiments, the C-shaped collar 330 does not self-circumferentially overlap in any configuration. In some alternative embodiments, the C-shaped collar 330 may self-circumferentially overlap in a radially collapsed configuration; and does not self-circumferentially overlap when expanding radially and / or circumferentially from the radially collapsed configuration.

[0077] In some embodiments, the expandable sheath extension 320 and / or the tubular member may have a first outer diameter in a radially collapsed configuration and a second outer diameter greater than the first outer diameter when radially and / or circumferentially expanded. In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or the tubular member may be less than 6.000 mm (0.236 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or the tubular member may be less than 5.667 mm (0.223 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or the tubular member may be less than 5.333 mm (0.210 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or the tubular member may be less than 5.000 mm (0.197 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or the tubular member may be less than 4.667 mm (0.184 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or the tubular member may be less than 4.333 mm (0.170 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or the tubular member may be less than 4.000 mm (0.158 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or the tubular member may be less than 3.667 mm (0.144 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or the tubular member may be less than 3.333 mm (0.131 inches). In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or the tubular member may be less than 3.000 mm (0.118 inches). Other configurations are also contemplated.

[0078] In some embodiments, the first outer diameter of the expandable sheath extension 320 and / or the tubular member may be smaller than the first inner diameter and / or first internal range of the elongated tubular member 110 and / or the cavity 120 and / or the liner 114 at 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 the tubular member may be smaller than the second inner diameter and / or second internal range of the elongated tubular member 110 and / or the cavity 120 and / or the liner 114 at the distal region and / or distal end of the elongated tubular member 110.

[0079] In some embodiments, the expandable sheath extension 320 and / or the tubular member may have a first inner diameter in a radially collapsed configuration and a second inner diameter greater than the first inner diameter when radially and / or circumferentially expanded. In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or the tubular member may be at least 1.000 mm (0.039 inches). In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or the tubular member may be at least 1.333 mm (0.053 inches). In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or the tubular member may be at least 1.667 mm (0.066 inches). In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or the tubular member may be at least 2.000 mm (0.079 inches). In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or the tubular member may be at least 2.333 mm (0.092 inches). In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or the tubular member may be at least 2.667 mm (0.105 inches). Other configurations are also contemplated. In some embodiments, the first inner diameter of the expandable sheath extension 320 and / or the tubular member may be greater than the outer diameter of the elongated member 210.

[0080] A system for deploying and retrieving medical device 200 may include a deployment catheter 100 and a device 300 as described herein; after the medical device 200 has been deployed distal to the elongated tubular member 110 of the deployment catheter 100, the device 300 assists in retrieving the medical device 200, such as Figures 5 to 6 As seen. In some embodiments, the elongated shaft 310 of the device 300 may be configured to slidably advance the expandable sheath extension 320 through the elongated tubular member 110 and / or the 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 slidably advance the expandable sheath extension 320 through the elongated tubular member 110 and / or the lumen 120 of the deployment catheter 100 to a guide position. Figure 7 As shown. In some embodiments, the size and shape of the elongated shaft 310 of the device 300 may be set and / or configured to slide longitudinally and / or axially alongside the elongated member 210 within the cavity 120 and / or liner 114 of the elongated tubular member 210.

[0081] In some embodiments, in the guide position, the proximal end of the expandable sheath extension 320 may be disposed within the lumen 120 and / or the liner 114 of the elongated tubular member 110, and the distal end of the expandable sheath extension 320 may be disposed distal to the distal end of the elongated tubular member 110. The expandable sheath extension 320 may be advanced through the lumen 120 of the elongated tubular member 110 and / or the deployment catheter 100 to the guide position in a radially collapsed configuration. The expandable sheath extension 320 may expand radially and / or circumferentially when the medical device 200 engages with the expandable sheath extension 320 and / or when a radially outward force is applied, for example, by the medical device 200 against the inner surface of the expandable sheath extension 320. Specifically, the distal end of the expandable sheath extension 320 can expand radially and / or circumferentially, while the proximal end of the expandable sheath extension 320 is constrained by the distal end of the elongated tubular member 110 and / or the liner 114 to a radially collapsed shape and / or its vicinity, thereby giving the expandable sheath extension 320 a generally tapered opening and / or radial expansion in the distal direction. When the medical device 200 is pulled and / or guided into the cavity 120 and / or the liner 114, the expandable sheath extension 320 can form a funnel and / or tapering structure to compress the medical device 200 radially inward. Thus, in the guided position, the expandable sheath extension 320 can be configured to guide the medical device 200 radially inward toward the cavity 120 of the elongated tubular member 110 and / or the liner 114 when the medical device 200 is pulled proximally.

[0082] Figures 5 to 8 Selected aspects of a method for deploying and retrieving a medical device 200 are schematically illustrated. In some embodiments, the method may include deploying the medical device 200 from a deployment catheter 100, the deployment catheter 100 including an elongated tubular member 110 having a lumen 120 that expands through it, such as... Figure 5 As seen. In some embodiments, the method may include pushing and / or advancing the medical device 200 through and / or out of the elongated tubular member 110, the cavity 120, and / or the liner 114, wherein the elongated member 210 extends proximally from the medical device 200. In some embodiments, the medical device 200 may be disposed at the distal end of the elongated member 210.

[0083] 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 liner 114, the medical device 200 may radially expand to an outer diameter and / or an outer extent that is greater than the inner diameter and / or inner extent of the elongated tubular member 110, the lumen 120, and / or the liner 114 at the distal end of the elongated tubular member 110. 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 liner 114, the medical device 200 may radially expand to a second outer diameter and / or a second outer extent that is greater than the second inner diameter and / or a second inner extent of the elongated tubular member 110, the lumen 120, and / or the liner 114 at the distal end of the elongated tubular member 110.

[0084] In some embodiments, the method may include positioning an expandable sheath extension 320 of the device 300 in a first position parallel to the elongated member 210, the expandable sheath extension 320 being coupled to the distal end of the elongated shaft 310 of the device 300, such as... Figure 5 As seen, the expandable sheath extension 320 may extend laterally from the elongated shaft 310, and / or may be laterally offset from the elongated shaft 310. In at least some embodiments, the expandable sheath extension 320 may be self-biased toward a radially collapsed shape.

[0085] In some embodiments, the expandable sheath extension 320 may be configured to translate laterally relative to the elongated member 210, the elongated member 210 extending proximally from the medical device 200 through the cavity 120 of the elongated tubular member 110 such that the expandable sheath extension is displaced from a first position alongside the elongated member 210 to a second position; in the second position, the elongated member 210 extends longitudinally and / or axially through the expandable sheath extension 320, and / or in the second position, the expandable sheath extension 320 surrounds the elongated member 210.

[0086] In some embodiments, the method may include translating the device 300 and / or the expandable sheath extension 320 from a first position to a second position in a lateral direction relative to and / or toward the elongated member 210; in the second position, the elongated member 210 extends longitudinally and / or axially through the expandable sheath extension 320, such as Figures 5 to 6As shown. In some embodiments, the method may include translating the device 300 and / or the expandable sheath extension 320 from a first position to a second position in a lateral direction relative to and / or toward the elongated member 210; in the second position, the expandable sheath extension 320 surrounds the elongated member 210. In some embodiments, when the expandable sheath extension 320 is disposed in the second position in a radially collapsed configuration, 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 disposed in the second position in a radially collapsed configuration, at least a portion of the tubular member completely surrounds the elongated member 210. In some embodiments, when the expandable sheath extension 320 is disposed in the second position in a radially collapsed configuration, at least one polymer sheet 340 and / or multiple polymer sheets completely surround the elongated member 210.

[0087] In some embodiments, the method may include advancing the device 300 and / or the expandable sheath extension 320 along the elongated member 210 to a guide position proximal to the distal end of the elongated tubular member 110, such as... Figures 6 to 7 As shown. In some embodiments, the method may include advancing the device 300 and / or the expandable sheath extension 320 within the elongated tubular member 110, the cavity 120, and / or the liner 114 to a guide position proximal to the distal end of the elongated tubular member 110. In some embodiments, the method may include advancing the device 300 and / or the expandable sheath extension 320 through the elongated tubular member 110, the cavity 120, and / or the liner 114 to a guide position proximal to the distal end of the elongated tubular member 110.

[0088] In some embodiments, the method may include pulling the medical device 200 proximally through the expandable sheath extension 320 of the device 300 into the elongated tubular member 110, the cavity 120, and / or the liner 114, such as Figure 8 As seen. In some embodiments, the expandable sheath extension 320 may be configured to expand radially and / or circumferentially upon engagement of 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 simultaneously when the medical device 200 is pulled into and / or pulled through the expandable sheath extension 320.

[0089] In some embodiments, the method may include retracting the expandable sheath extension 320 into the elongated tubular member 110, the cavity 120, and / or the liner 114. In some embodiments, the method may include retracting the expandable sheath extension 320 together with and / or alongside the medical device 200 into the elongated tubular member 110, the cavity 120, and / or the liner 114. In some embodiments, the method may include retracting the expandable sheath extension 320 into the elongated tubular member 110, the cavity 120, and / or the liner 114 after the medical device 200.

[0090] In some embodiments, the method may include withdrawing the deployment catheter 100 from the patient's anatomy. In some embodiments, the method may include completely withdrawing the medical device 200 through the deployment catheter 100, the elongated tubular member 110, the lumen 120, and / or the liner 114. In some embodiments, the method may include completely retracting the medical device 200 through the deployment catheter 100, the elongated tubular member 110, the lumen 120, and / or the liner 114 before withdrawing the deployment catheter 100 from the patient's anatomy. Other configurations are also contemplated.

[0091] Materials that may be used in the various components and elements of the devices and systems disclosed herein may include those commonly associated with medical devices. For simplicity, the following discussion refers to the system. However, this is not intended to limit the devices, components, and methods described herein, as the discussion is applicable to other elements, components, parts, or devices disclosed herein, such as, but not limited to, elongated shafts, expandable sheath extensions, deployment catheters, elongated tubular members, etc., and / or their elements or components.

[0092] In some embodiments, the system / or its components may be made of metal, metal alloy, polymer, metal-polymer composite, ceramic, combination thereof, or other suitable materials.

[0093] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®), polyether block copolymers, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL®), ether-based or ester-based copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as HYTREL®), polyamides (e.g., DURETHAN® or CRISTAMID®), elastic polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., PEBAX®), ethylene vinyl acetate copolymers (EVA), siloxanes, polyethylene (PE), MARLEX® high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyesters, polybutylene terephthalate (PET) Polyethylene terephthalate (PBT), polyethylene terephthalate (PET), polybutylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID®), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, polyurethane silicone copolymers (e.g., Elast-Eon® or ChronoSil®), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer / metal composites, etc. In some embodiments, the system and / or its components may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to 6% LCP.

[0094] Some examples of suitable metals and metal alloys include stainless steels (such as 304 and / or 316 stainless steel and / or their variations), mild steels, nickel-titanium alloys (such as linearly elastic and / or hyperelastic nickel-titanium), other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®; other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.), and nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY® ALLOY). B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten alloys or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003 such as ELGILOY®, PHYNOX®, etc.), platinum-rich stainless steel, titanium, platinum, palladium, gold, combinations thereof, or any other suitable material.

[0095] In at least some embodiments, some or all of the system and / or its components may also be doped with, made of, or otherwise include a radiopaque material. A radiopaque material should be understood as a material capable of producing a brighter image on a fluorescent screen or another imaging technique (e.g., ultrasound) during medical procedures. This brighter image helps the user of the system determine its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials with radiopaque fillers, etc. Furthermore, other radiopaque marking strips and / or coils may also be incorporated into the system design to achieve the same result.

[0096] In some embodiments, the systems and / or other elements disclosed herein may include suitable therapeutic agents and / or be treatable therewith. Some examples of suitable therapeutic agents may include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (d-phenylalanine-proline-arginine-chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiotensin, monoclonal antibodies that can block the proliferation of smooth muscle cells, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosteroids, budesonide, estrogens, sulfasalazine, and mesalamine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vincristine, epianthrone, endorphin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); and anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, RGD-containing...). Compounds containing peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides; angiogenesis promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); angiogenesis inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription inhibitors, translation inhibitors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules including growth factors and cytotoxins, and bifunctional molecules including antibodies and cytotoxins); immunosuppressants (such as orolimus, rapamycin analogs, macrolide antibiotics, bio-limoxicillin, everolimus, zotaolimus, tesimolimus, pimecrolimus, noviolimus, meolimus, tacrolimus, sirolimus, pimecrolimus, etc.); cholesterol lowering agents; vasodilators; and preparations that interfere with endogenous vasoactive mechanisms.

[0097] It should be understood that this disclosure is illustrative in many respects only. Variations may be made in detail without departing from the scope of this disclosure, particularly with respect to the arrangement of shapes, dimensions, and steps. To the appropriate extent, this may include the use of any of the features of an exemplary embodiment that is being used in other embodiments. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. An apparatus for assisting in the retrieval of a medical device, the apparatus comprising: Slender shaft; and An expandable sheath extension is connected to the distal end of the elongated shaft; The expandable sheath extension is offset laterally from the elongated axis; The expandable sheath extension is self-biased toward a radially collapsed shape.

2. The device of claim 1, wherein the expandable sheath extension extends circumferentially about a central longitudinal axis extending parallel to the elongated axis; The expandable sheath extension is circumferentially discontinuous.

3. The device according to any one of claims 1 to 2, wherein the expandable sheath extension includes a C-shaped collar on the proximal side of the proximal end of the expandable sheath extension.

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

5. The device according to any one of claims 3 to 4, wherein the C-shaped collar is formed of a metallic material.

6. The device according to any one of claims 3 to 5, wherein the expandable sheath extension comprises at least one polymer sheet wound into a tubular member in the radially collapsed configuration.

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

8. The apparatus according to any one of claims 6 to 7, wherein the tubular member has an outer diameter of less than 4.667 mm in the radially collapsed configuration.

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

10. A system for deploying and retrieving a medical device, the system comprising: A deployment catheter includes an elongated tubular member having a lumen extending therethrough, the lumen being configured to slidably receive a medical device; and The apparatus according to any one of claims 1 to 9; The elongated shaft is configured to slidably advance the expandable sheath extension through the cavity of the elongated tubular member to a guide position, in which the proximal end of the expandable sheath extension is disposed within the cavity of the elongated tubular member and the distal end of the expandable sheath extension is disposed on the distal side of the elongated tubular member.

11. The system of claim 10, wherein in the guided position, the expandable sheath extension is configured to guide the medical device radially inward toward the cavity of the elongated tubular member when the medical device is pulled proximally.

12. The system according to any one of claims 10 to 11, wherein the medical device has an outer extent in an unconstrained configuration, the outer extent being greater than the inner diameter of the elongated tubular member at its distal end.

13. The system according to any one of claims 10 to 12, wherein the expandable sheath extension is configured to translate in a lateral direction relative to an elongated member extending proximally through a cavity of the elongated tubular member from the medical device to move the expandable sheath extension from a first position alongside the elongated member to a second position; in the second position, the elongated member extends longitudinally through the expandable sheath extension.

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

15. A method for deploying and retrieving a medical device, the method comprising: Deployment of a medical device from a deployment catheter, the deployment catheter including an elongated tubular member having a lumen extending therethrough, wherein the lumen is configured to slidably receive the medical device disposed at a distal end of the elongated member; An expandable sheath extension coupled to the distal end of an elongated shaft is positioned in a first position parallel to the elongated member, wherein the expandable sheath extension is laterally offset from the elongated shaft, and wherein the expandable sheath extension is self-biased toward a radially collapsed shape. The expandable sheath extension is translated laterally from a first position to a second position relative to the elongated member, wherein the elongated member extends longitudinally through the expandable sheath extension; The expandable sheath extension is advanced along the elongated member to a guide position, the guide position being proximal to the distal end of the elongated tubular member; as well as The medical device is pulled proximally through the expandable sheath extension into the elongated tubular member.

Images