Two-stage deployment sheath system and method

Abstract

To provide an excellent implantable medical device.SOLUTION: An implantable medical device includes an expandable device having a longitudinal length and operable to be compressed to a first diameter and deployed to a second diameter, wherein the second diameter is greater than the first diameter, a first portion is smaller than the longitudinal length of the expandable device and a second portion is shorter than the longitudinal length of the expandable device. The medical device includes a first constraining member operable to constrain the first portion of the expandable device at the first diameter and a second constraining member operable to constrain the second portion of the expandable device at the first diameter.SELECTED DRAWING: Figure 5a

Description

[Technical Field]

[0001] Field FIELD OF THE DISCLOSURE The present disclosure relates generally to apparatus, systems, and methods including covers for use in the delivery of implantable medical devices, and more particularly to apparatus, systems, and methods including covers for constraining expandable implantable medical devices during device delivery. [Background technology]

[0002] background Minimally invasive delivery techniques for implantable medical devices offer various advantages, including reduced trauma, risk of infection, and recovery time. Examples of implantable medical devices include stents and stent-grafts, which are utilized to radially support, treat, and / or otherwise augment tubular passageways within the body, including arteries, veins, airways, gastrointestinal tracts, and biliary tracts. Further examples of implantable medical devices include prosthetic valves (e.g., prosthetic heart valves). Transcatheter delivery is a technique for delivering such implantable medical devices, in which the delivered medical device begins in a diametrically compressed state for delivery and is subsequently expanded (e.g., self-expanding or manually expandable) at the treatment site within the patient's body.

[0003] Stents, stent grafts, prosthetic valves, filters and other implantables can be deployed by plastic deformation (e.g., using an inflatable balloon), or can be self-expanding, allowing them to elastically recover from a collapsed or constrained delivery diameter to an expanded deployed diameter.

[0004] For example, U.S. Patent No. 6,224,627, filed June 15, 1998, and entitled "Remotely Removable Cover and Support," describes, among other things, a thin, tubular, multifilament (film or fiber) structure capable of holding high internal pressure. When desired, the filament extensions can be pulled in any direction to expand the structure. This structure can be useful for restraining and deploying self-expanding stent or stent-graft delivery systems, balloon dilatation catheters, removable guidewire lumens for catheters, drug infusion or aspiration catheters, guidewire bundling casings, removable filters, removable wire insulation, removable packaging, and other applications. Summary of the Invention

[0005] Abstract Various disclosed concepts relate to an implantable medical device. According to one example ("Example 1"), the implantable medical device includes an expandable device having a longitudinal length and operable to be compressed to a first diameter and expanded to a second diameter, the second diameter being greater than the first diameter, a first portion shorter than the longitudinal length of the expandable device and a second portion shorter than the longitudinal length of the expandable device defined on the expandable device, a first restraining member operable to restrain the first portion of the expandable device at the first diameter, and a second restraining member operable to restrain the second portion of the expandable device at the first diameter.

[0006] In addition to Example 1, according to another example ("Example 2"), the first restraining member defines a first release zone and the second restraining member defines a second release zone.

[0007] In addition to Example 2, according to another example ("Example 3"), the first restraint member further includes a first deployment line configured to release the first restraint member along the first release zone by applying tension to the first deployment line, and the second restraint member further includes a second deployment line configured to release the second restraint member along the second release zone by applying tension to the second deployment line.

[0008] In addition to Example 3, according to another example ("Example 4"), the first release zone is configured to release when a first tension is applied across the first deployment line, and the second release zone is configured to release when a second tension is applied across the second deployment line, the first tension being greater than the second tension.

[0009] In addition to Example 3, according to another example ("Example 5"), the first release zone is configured to release when a first tension is applied across the first deployment line, and the second release zone is configured to release when a second tension is applied across the second deployment line, the first tension being less than the second tension.

[0010] According to another example ("Example 6"), in addition to any of the previous examples, the second restraining member extends across at least a portion of the first portion of the expandable member.

[0011] In addition to Example 6, according to another example ("Example 7"), the second restraining member is disposed between the first restraining member and the expandable member, and the second restraining member extends over at least a portion of the first portion of the expandable member.

[0012] In addition to Example 6, according to another example ("Example 8"), the second restraining member is disposed outside the first restraining member and the expandable member, and the second restraining member extends over at least a portion of the first portion of the expandable member.

[0013] According to another example ("Example 9"), in addition to any of the preceding examples, the second restraining member includes an everted portion.

[0014] In addition to Example 9, according to another example ("Example 10"), the everted portion of the second restraining member is disposed around the first portion of the expandable member and at least a portion of the first restraining member.

[0015] In addition to Example 10, according to another example ("Example 11"), the everted portion of the second restraining member is positioned along the longitudinal length of the expandable member.

[0016] According to another example ("Example 12"), in addition to any of the previous examples, the first restraining member includes a first knitted sleeve including a first plurality of strands.

[0017] According to another example ("Example 13"), in addition to any of the preceding examples, the second restraining member includes a second knitted sleeve including a second plurality of strands.

[0018] In addition to Examples 12 or 13, according to another example ("Example 14"), the first knitted sleeve and the second knitted sleeve are knitted.

[0019] According to another example ("Example 15"), in addition to any of the previous examples, the first restraining member and the second restraining member are warp knitted.

[0020] According to another example ("Example 16"), in addition to any of the previous examples, the first restraining member is operable to release after the second restraining member is released.

[0021] According to another example ("Example 17") in addition to any one of Examples 3-16, the first deployment line engages with the second restraining member such that when the second restraining member is released, the first deployment line is accessible to actuate the release of the first restraining member.

[0022] In addition to Example 17, according to another example ("Example 18"), the first deployment line is coupled to the second restraining member such that when the second restraining member translates away from the expandable member, tension is applied to the first deployment line, actuating the release of the first restraining member.

[0023] According to another example ("Example 19"), in addition to any one of Examples 12-18, the first plurality of strands and the second plurality of strands include matching strand properties, including any one or combination of strand thickness, strand denier, strand coefficient of friction, strand material, strand coating, strand treatment, and strand stiffness.

[0024] According to another example ("Example 20"), in addition to any one of Examples 12-18, the first plurality of strands and the second plurality of strands include different strand properties, including any one or combination of strand thickness, strand denier, strand coefficient of friction, strand material, strand coating, strand treatment, and strand stiffness.

[0025] According to any one of Examples 12-20, plus another example ("Example 21"), the second plurality of strands extend from the first plurality of strands.

[0026] According to one example ("Example 22"), an implantable medical device is included, comprising: an expandable member having a proximal end and a distal end, wherein the expandable member has a longitudinal length defined between the proximal end and the distal end; a first constraining member disposed about the expandable member along a first portion less than the entire longitudinal length of the expandable member, wherein the first constraining member maintains the expandable member at a constrained diameter along the first portion; and a second constraining member including a first segment and an everted segment, wherein the first segment of the second constraining member is disposed about the expandable member at a stabilizing portion, which is the remaining portion of the longitudinal length where the first constraining member is not disposed about the expandable member, the second constraining member maintains the expandable member at the constrained diameter along the stabilizing portion, and the everted segment of the second constraining member is disposed about the first segment of the second constraining member and the stabilizing portion of the expandable member.

[0027] In addition to Example 22, according to one example ("Example 23"), the first restraint member further includes a first release zone and a first deployment line, and the second restraint member further includes a second release zone and a second deployment line.

[0028] In addition to Example 23, according to one example ("Example 24"), the first deployment line is operable to release the first release zone when at least a first deployment force is applied to the first deployment line, and the second deployment line is operable to release the second release zone when at least a second deployment force is applied to the second deployment line.

[0029] In addition to Example 24, according to one example ("Example 25"), the first deployment force is greater than the second deployment force.

[0030] In addition to Example 25, according to one example ("Example 26"), the first deployment force is less than the second deployment force.

[0031] According to another example ("Example 27") in addition to any one of Examples 22-26, the first restraining member includes a first plurality of warp knitted strands.

[0032] According to another example ("Example 28") in addition to any one of Examples 22-27, the second restraining member includes a second plurality of warp knitted strands.

[0033] According to another example ("Example 29"), in addition to any one of Examples 22-28, the inverted segment of the second restraining member is disposed around the first restraining member.

[0034] According to another example ("Example 30") in addition to any one of Examples 22-29, the stabilizing portion of the expandable member is operable to deploy to a second diameter when the second restraining member is detached from the expandable member.

[0035] According to another example ("Example 31") in addition to any one of Examples 22 to 30, the first deployment line is engaged with the second restraining member such that the first restraining member is operable to be released after the second restraining member is released and the stabilizing portion of the expandable member is deployed.

[0036] According to another example ("Example 32") in addition to any one of Examples 22-31, the first portion of the expandable member extends to the proximal end of the expandable member.

[0037] According to another example ("Example 33") in addition to any one of Examples 22-32, the stabilizing portion of the expandable member extends to a distal end of the expandable member.

[0038] According to another example ("Example 34") in addition to any one of Examples 22-33, the second sheath is configured to be released so that the proximal end of the expandable member is deployed first.

[0039] In addition to any one of Examples 22 to 34, according to another example ("Example 35"), the first sheath is configured to be released after the second sheath is released so that the proximal end of the expandable member is deployed after the distal end is deployed.

[0040] According to one example ("Example 36"), a method of manufacturing an implantable medical device is included, the method including: compressing an expandable member radially inward; braiding a first plurality of strands to form a first restraining member having a first deployment line; attaching the first restraining member to a first portion of the expandable member; braiding a second plurality of strands to form a second restraining member; attaching the second restraining member to a second portion of the expandable member; and inverting a segment of the second restraining member onto the second portion of the expandable member.

[0041] In addition to Example 36, according to another example ("Example 37"), the method further includes initiating release of a first release zone of the first restraint member and a second release zone of the second restraint member.

[0042] In addition to Example 37, according to another example ("Example 38"), the method further includes partially releasing the first release zone until a first end of the first release zone is located near the proximal end of the expandable member.

[0043] In addition to Example 38, according to another example ("Example 39"), the method further includes partially releasing the second release zone until a second end of the second release zone is located near the proximal end of the expandable member.

[0044] According to one example ("Example 40"), a method of deploying an implantable medical device is included, the method including: placing an expandable member within a lumen of a patient, wherein a first portion of the implantable medical device is constrained by a first restraining member in a compressed configuration and a second portion of the expandable member is constrained by a second restraining member in a compressed configuration; removing the second restraining member from the second portion of the expandable member; and removing the first restraining member from the first portion of the expandable member.

[0045] In addition to Example 40, according to another example ("Example 41"), the method further includes holding a free end of a second deployment line away from the expandable medical device, wherein the second deployment line is engaged with a second release zone of the second restraining member configured to disengage the second restraining member from the expandable member; and applying sufficient force to the free end of the second deployment line to actuate the second release zone.

[0046] In addition to Example 41, according to another example ("Example 42"), the method includes applying sufficient force to a free end of a first deployment line to activate a release zone of a first restraining member, the first deployment line engaged with the release zone of the first restraining member, the release zone of the first restraining member configured to disengage the first restraining member from the expandable member.

[0047] The foregoing examples are merely illustrative and should not be construed as limiting or otherwise narrowing the scope of the inventive concepts otherwise provided by this disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. [Brief explanation of the drawings]

[0048] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrate embodiments and, together with the description, serve to explain the principles of the disclosure.

[0049] [Figure 1] FIG. 1 is a medical device delivery system according to one embodiment.

[0050] [Figure 2] FIG. 2 illustrates an expandable member constrained to a first diameter, according to one embodiment.

[0051] [Figure 3] FIG. 3 is a cross-sectional view of a removable restraint according to one embodiment.

[0052] [Figure 4a] FIG. 4a is a cross-sectional view of FIG. 4b, a removable restraint that restrains the device, according to one embodiment. [Figure 4b] FIG. 4a is a cross-sectional view of FIG. 4b, a removable restraint that restrains the device, according to one embodiment.

[0053] [Figure 5a] FIG. 5a is a cross-sectional view of FIG. 5b, a removable restraint restraining a device, according to one embodiment, with the outer layer of the removable restraint partially released. [Figure 5b] FIG. 5a is a cross-sectional view of FIG. 5b, a removable restraint restraining a device, according to one embodiment, with the outer layer of the removable restraint partially released.

[0054] [Figure 6a] FIG. 6a is a cross-sectional view of FIG. 6b, a removable restraint restraining a device according to one embodiment, with the outer layer of the removable restraint partially released to expose a second segment of the removable restraint. [Figure 6b]FIG. 6a is a cross-sectional view of FIG. 6b, a removable restraint restraining device according to one embodiment, with the outer layer of the removable restraint partially released to expose a second segment of the removable restraint.

[0055] [Figure 7a] FIG. 7a is a cross-sectional view of FIG. 7b, a removable restraint restraining device according to one embodiment, with the outer layer of the removable restraint partially released to expose a second segment of the removable restraint and the inner layer of the first segment exposed. [Figure 7b] FIG. 7a is a cross-sectional view of FIG. 7b, a removable restraint restraining device according to one embodiment, with the outer layer of the removable restraint partially released to expose a second segment of the removable restraint and the inner layer of the first segment exposed.

[0056] [Figure 8a] FIG. 8a is a cross-sectional view of FIG. 8b, a removable restraint restraining a device according to one embodiment, with the outer layer of the removable restraint completely released, thereby exposing a second segment of the removable restraint, and the inner layer of the first segment completely exposed and partially released, thereby partially unrestraining the device. [Figure 8b] FIG. 8a is a cross-sectional view of FIG. 8b, a removable restraint restraining a device according to one embodiment, with the outer layer of the removable restraint completely released, thereby exposing a second segment of the removable restraint, and the inner layer of the first segment completely exposed and partially released, thereby partially unrestraining the device.

[0057] [Figure 9a]FIG. 9a is a cross-sectional view of FIG. 9b, a removable restraint restraining a device according to one embodiment, with the outer layer of the removable restraint fully released, the first segment fully released, and a portion of the second segment partially released, thereby partially unrestraining the device. [Figure 9b] FIG. 9a is a cross-sectional view of FIG. 9b, a removable restraint restraining a device according to one embodiment, with the outer layer of the removable restraint fully released, the first segment fully released, and a portion of the second segment partially released, thereby partially unrestraining the device.

[0058] [Figure 10a] FIG. 10a is a cross-sectional view of FIG. 10b, a removable restraint restraining the device according to one embodiment, with the outer layer of the removable restraint fully released, the first segment fully released, and a portion of the second segment partially released, thereby leaving the device partially unconstrained and nearly fully deployed. [Figure 10b] FIG. 10a is a cross-sectional view of FIG. 10b, a removable restraint restraining the device according to one embodiment, with the outer layer of the removable restraint fully released, the first segment fully released, and a portion of the second segment partially released, thereby leaving the device partially unconstrained and nearly fully deployed.

[0059] [Figure 11a] FIG. 11a is a cross-sectional view of FIG. 11b, showing the removable restraint completely released from the device so that the device is in an unconstrained configuration, according to one embodiment. [Figure 11b] FIG. 11a is a cross-sectional view of FIG. 11b, showing the removable restraint completely released from the device so that the device is in an unconstrained configuration, according to one embodiment.

[0060] [Figure 12]FIG. 12 is a cross-sectional view of a removable restraint having two segments, one segment partially inverted onto itself, according to one embodiment.

[0061] [Figure 13] FIG. 13 is a cross-sectional view of a removable restraint having two segments, one segment including a deployment line attached to or extending from a portion of the other segment, according to one embodiment.

[0062] [Figure 14] FIG. 14 is a cross-sectional view of a removable restraint having two segments, according to one embodiment, where the first segment is coaxially aligned with the device along a portion of the length of the device and the second segment is coaxially aligned along the entire length of the device.

[0063] [Figure 15] FIG. 15 is a cross-sectional view of a removable restraint having two segments with different characteristics, according to one embodiment.

[0064] [Figure 16] FIG. 16 is a cross-sectional view of a removable restraint having two segments with different characteristics, according to one embodiment, one of which surrounds the entire length of the device and is inverted over a portion of itself. DETAILED DESCRIPTION OF THE INVENTION

[0065] Detailed Description Definitions and Terminology This disclosure is not intended to be read in a limiting sense, for example, the terms used in this application should be read broadly in the context of the meanings ascribed to such terms by experts in the field.

[0066] With respect to the term imprecision, the terms "about" and "approximately" may be used interchangeably to refer to measurements that include the stated measurement and any measurement that is reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount, as understood and easily ascertained by one of ordinary skill in the relevant art. Such deviations may result from measurement error, differences in calibration of measuring and / or manufacturing equipment, human error in reading and / or setting measurements, fine-tuning made to optimize performance and / or structural parameters given differences in measurements associated with other components, specific implementation scenarios, imprecise adjustment and / or manipulation of objects by humans or machines, etc. If it is determined that the value of such a reasonably small difference would not be easily ascertainable by one of ordinary skill in the relevant art, the terms "about" and "approximately" may be understood to mean plus or minus 10% of the stated value.

[0067] Outward radial expansion force or radial force generally refers to a device-induced force acting on a removable restraint at any point during device deployment. The radial force can be due to a self-expanding member. Such a self-expanding member can include a shape memory alloy that exerts an outward radial expansion force when compressed and / or restrained. Outward radial expansion force can also refer to other forces that cause a device or member to expand radially outward, such as the inflation of an angioplasty balloon.

[0068] Constraining force generally refers to the force that a constraining member resists when constraining a device, in some embodiments, a self-expanding device. The constraining force can be thought of as a force normal to the outward radial expansion force. In some embodiments, the constraining force can be limited to a threshold amount until the constraining member can no longer resist the outward radial expansion force of the self-expanding device, at which point the medical device can be deployed by the outward radial expansion force overcoming the constraining force of the constraining member and disengaging the constraining member.

[0069] Deployment force generally refers to the force required to deploy a medical device by disengaging a restraining member. In some embodiments, the deployment force is the force required to apply tension to the actuation line of the restraining member to actuate the disengagement of the restraining member from the medical device.

[0070] For reference, the term "perimeter" should be understood broadly to refer to the outer surface or dimensions of the removable restraint, without requiring a circular cross section.

[0071] Description of Various Embodiments Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0072] The devices disclosed herein can provide the ability to perform controlled deployment of expandable and self-expanding devices. The restraints discussed herein include, but are not limited to, features that allow for precise positioning of the device during deployment. The restraint (e.g., a braided restraint) provides sufficient restraining force to maintain a self-expanding device in a restrained configuration while also allowing the self-expanding device to be released by applying a low level of force to minimize displacement of the device from the desired deployment position. The restraint can also accommodate the variable force required to release a removable restraint from the device, thereby allowing the expandable device to partially deploy at the desired deployment position and function as an anchor there. The descriptions of systems, devices, and methods included below illustrate these and other objects of the present disclosure.

[0073] The system shown in FIG. 1 is provided as an example of various system features, and while combinations of these illustrated features are clearly within the scope of the present invention, the example and its illustration are not intended to suggest that the inventive concepts provided herein are limited by fewer features, additional features, or features substituted for one or more of those features shown in FIG. 1 . FIG. 1 is a plan view of a delivery system 100 including a catheter 102 including a removable restraint 104, according to some embodiments. As shown in FIG. 1 , the removable restraint 104 is configured to restrain an implantable medical device 106 in a delivery configuration. The removable restraint 104 may include one or more fibers or strands 108 disposed about the device 106 to maintain the device 106 and the removable restraint 104 in the restrained or delivery configuration. The removable restraint 104 may include various configurations and structures such as those discussed in U.S. Patent No. 6,224,627, issued May 1, 2001, to Armstrong, which is incorporated herein by reference in its entirety for all purposes.

[0074] The removable restraint 104 is coaxially positioned along the length of the device 106. The removable restraint 104 may also be circumferentially positioned around the device 106 to substantially cover the device 106 for delivery. The one or more strands 108 may be positioned within a lumen (not shown) of the catheter 102, extend toward the proximal end of the catheter 102, and then be positioned outside the patient's body during delivery of the device 106. The one or more strands 108 may include a proximal end that a user can pull to release the removable restraint 104 and deploy the device 106.

[0075] In certain instances, one or more strands 108 release such that interlocking portions (e.g., overlapping fibers or knits) release sequentially along the length of the device 106. As described in more detail below, a removable restraint 104 is formed on the device 106 by interlocking one or more strands 106 together. One or more strands 108 may form a release region of the device 106 or release the device 106. The device 106 may be a stent, stent graft, balloon, prosthetic valve, filter, anastomosis device, occluder, or similar device.

[0076] The system shown in Figure 1 is provided as an example of various features of the system. While combinations of these illustrated features are clearly within the scope of the present invention, the example shown in Figure 1 and its illustrations are not intended to suggest that the inventive concepts provided herein are limited to one or more of the features shown in the figure, from fewer, additional, or alternative features.

[0077] 2 is a side view of a device 106 including a removable restraint 104, according to one embodiment. As shown, the device 106 includes a delivery diameter D1 and a deployed diameter D2 (not shown) that is larger than the delivery diameter D1. The removable restraint 104 is disposed about the device 106 at the delivery diameter D1. When the removable restraint 104 is removed from the device 106, the device expands to the deployed diameter D2. In some embodiments, the deployed diameter D2 is the diameter of the device 106 when unconstrained. In other embodiments, the deployed diameter D2 is the diameter of the device 106 when it is delivered to the target site and engages the lumen wall at the target site.

[0078] Device 106 can have a desired deployed diameter D2, e.g., from about 5 mm to about 15 mm, or from about 6 mm to about 9 mm, or from about 6 mm to about 12 mm, and a delivery diameter D1 that is smaller than the deployed diameter D2. For example, in some instances, the ratio of the delivery diameter D1 of device 106 to the deployed diameter D2 (not shown) of device 106 is less than about 0.3, less than about 0.29, less than about 0.28, less than about 0.27, or less than about 0.26.

[0079] 1 and 2, the removable restraint 104 includes at least two interlocking strands 108 in warp knit form. For example, the removable restraint 104 can include a first interlocking strand 112 and a second interlocking strand 114. The first interlocking strand and / or the second interlocking strand 112, 114 can act as, for example, a first deployment line 120. The first deployment line 120 can be configured to release the removable restraint 104 and release the device 106 from a delivery diameter D1 to a deployed diameter D2 in response to a deployment force applied to the first deployment line 120. It is within the scope of the present disclosure to form a removable restraint using two, four, six, eight, or any even number of interlocking strands, or any odd number of interlocking strands.

[0080] The device 106 has a radial force at the delivery diameter D1. Radial force generally refers to a force generated by the device 106 that acts on the removable restraint 104 at any point during deployment of the device 106. As described above, the interlocking strands 112, 114 are adapted to be detached by a deployment force applied to the deployment line 120. The radial force of the device 106 can be compared in ratio to a deployment force to detach the removable restraint 104 from the device 106. In some instances, the ratio of this radial force of the device 106 to the deployment force applied to the deployment line 120 is less than about 500:1. In other instances, the ratio of this radial force of the device 106 to the deployment force applied to the deployment line 120 is less than about 475. Furthermore, the ratio of this radial force of the device 106 to the deployment force applied to the deployment line 120 is less than about 450. Additionally, this ratio of radial force of device 106 to deployment force applied to deployment line 120 is, in other examples, less than about 425. Additionally, the ratio of radial force to deployment force can be between about 0.01 and 7000 (or any value therebetween).

[0081] It is understood that a device deployment force is applied to the deployment line 120 of the removable restraint 104 at or near the point where the deployment line 120 and the body of the removable restraint 104 contact each other, and is sufficient to cause at least partial deployment of the device 106. In some embodiments, the delivery system 100 may affect how much force the user must apply to the deployment line 120 (e.g., frictional forces, pulleys, gears, etc.), so for purposes of discussion, the deployment force refers to a force applied near the device 106. Furthermore, in some embodiments, the deployment force can be modified based on the device 106 being constrained. For example, if the device 106 has a high radial force when constrained at a particular diameter, the radial force of the device 106 can reduce the deployment force required to remove the removable restraint 104. In some embodiments, the radial force can be such that the removable restraint 104 may experience accelerated deployment as the radial force overcomes the removable restraint 104. While accelerated deployment is generally undesirable, in some embodiments, accelerated deployment may be advantageous. For example, accelerated deployment may be desirable to rapidly deploy a portion of device 106 so that the deployed portion of device 106 can act as an anchor while the remainder of device 106 deploys. These concepts are described in more detail below. It is also understood that the deployment force of removable restraint 104 may vary across device 106 depending on the amount of radial force transmitted to removable restraint 104.

[0082] In some embodiments, one or more strands 108, which may include interlocking strands 112, 114, may be formed from a variety of materials, including, for example, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers such as perfluoroelastomers, polytetrafluoroethylene, silicone, urethane, ultra-high molecular weight polyethylene, aramid fiber, and combinations thereof. Other embodiments of interlocking strands 112, 114 may include high-strength polymer fibers, such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). Generally, any of the foregoing properties may be evaluated using ASTM or other recognized measurement techniques and standards, as will be understood by those skilled in the art.

[0083] One or more strands 108 may be selected to have specific properties, such as strand thickness, strand denier, strand coefficient of friction, strand material, strand treatment, strand coating, and strand stiffness. Similar to different diameters, using different strand materials for the strands 108 can increase friction between the first interlocking strand and the second interlocking strand 108 and help maintain the device 106 in the delivery configuration. Each of the various strands may be selected to have the same or different strand properties based on the application for which the removable restraint will be used. It will be appreciated that, in addition to material selection, the properties of the strands 108 may also be altered by treatment, configuration, and modification. For example, the strands may include filler or core materials and may be surface treated by etching, vapor deposition, or corona or other plasma treatment, among other treatment types, including coating with an appropriate coating material.

[0084] Referring now to FIG. 3 , the device 106 may be restrained by a removable restraint 104. The removable restraint 104 may include two sleeves and / or portions, including a first segment 130 and a second segment 132. The first segment 130 may include a first set of characteristics, and the second segment 132 may include a second set of characteristics. Note that while at least some of the characteristics discussed with respect to the first segment 130 and the second segment 132 are different, some characteristics may be shared. For example, characteristics that may be shared or different between the first segment 130 and the second segment 132 may include thickness, denier, strand coefficient of friction, material, treatment, coating, and stiffness. For example, in some embodiments, the first segment 130 of the removable restraint 104 may include a first material having a first coefficient of friction, while the second segment 132 may include a second material having a second coefficient of friction, where the first coefficient of friction is higher than the second coefficient of friction.

[0085] In some embodiments, the first segment 130 can have different properties than the second segment 132 to facilitate various functions. For example, the first segment 130 can incorporate certain properties into its material that promote a higher confinement force of the device 106. As a result of the increased confinement force of the device 106 by the first segment, in some embodiments, the deployment force can also be increased. This can make it difficult to accurately deploy the device 106 within the patient's lumen. Therefore, in some embodiments, the second segment 132 can incorporate properties into its material that promote certain properties, such as reducing the deployment force applied to the second segment 132 to release it from the device 106 and deploy it. Various examples and combinations of properties can be implemented in the first and second segments 130, 132 to facilitate improved preparation, delivery, and deployment of the device 106. These examples should not be construed as limiting, and any number of combinations are within the scope of this disclosure.

[0086] In some embodiments, the removable restraint 104 includes an axially inner layer 150 and an axially outer layer 152. The axially inner layer 150 can be positioned against or adjacent to the device 106. In some embodiments, there are various elements disposed within the axially inner layer 150 of the removable restraint 104, such as films and wraps, among others. However, compared to the axially outer layer 152, the axially inner layer 150 more directly surrounds the device 106. A removable restraint having an axially inner layer 150 and an axially outer layer 152 can comprise two coaxially arranged sleeves, or in other embodiments, the layers 150, 152 can be formed by inverting one of the first segment 130 or the second segment 132 of the removable restraint.

[0087] In some embodiments, the first segment and / or the second segment 130, 132 of the removable restraint 104 can include an everted section 134. For example, the first segment 130 can be everted such that the everted section 134 of the second segment 132 is coaxially disposed with the device 106. By including the everted portion 134, the device 106 can be restrained along at least a portion of its longitudinal length by the two layers of the removable restraint 104. In some embodiments, the everted portion 134 can extend the entire longitudinal length of the device 106, as seen in FIG. 3 .

[0088] 3 illustrates a device 106 and a removable constraint 104 for treating tissue within a patient's body, according to some examples. In some embodiments, the device 106 can include various features. The device 106 can be represented by a first portion 140 and a second portion 142. The first portion 140 and the second portion 142 of the device 106 can be defined by the first segment 130 and the second segment 132 of the removable constraint 104. The first portion 140 of the device 106 can correspond to the first segment 130 of the removable constraint 104, and the second portion 142 of the device can correspond to the second segment 132 of the removable constraint 104. In embodiments in which the first segment 130 is everted, the first portion 140 of the device 106 can be defined by the un-everted section of the first segment 130.

[0089] The first portion 140 of the device is defined by the length of the un-everted section of the first segment 130 of the removable restraint 104, in some embodiments, and may represent between about 5% and about 95% of the longitudinal length of the device 106. In some embodiments, the first portion may represent about 5% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 10% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 15% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 20% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 25% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 30% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 35% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 40% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 45% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 50% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 55% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 60% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 65% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 70% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 75% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 80% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 85% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 90% of the longitudinal length of the device 106. In some embodiments, the first portion represents about 95% of the longitudinal length of the device 106.

[0090] An example implementation of the system 100 discussed herein is provided. In some embodiments including a first and second segment 130, 132 of a removable restraint, the first portion 140 of the device 106 can be deployed prior to deployment of the second portion 142 of the device 106. The first segment 130 of the removable restraint 104 can be actuated such that the first segment 130 releases the first portion 140 of the device 106. For example, the first segment 130 of the removable restraint 104 can have a deployment line 120 extending therefrom. The deployment line 120 can be actuated to initiate or resume the release of the removable restraint 104 from the device 106. As the deployment line 120 continues to be actuated, the removable restraint 104 is released sequentially along the length of the device 106. As can be seen in FIG. 3 , some embodiments include a first segment 130 having an everted portion 134 that is at least partially coaxial with the second segment 132. When everted portion 134 of first segment 130 is deployed, device 106 remains restrained by second segment 132 of removable restraint 104 and the unreleased portion of first segment 130. When everted portion 134 of first segment 130 is released, the remaining portion of removable restraint 104 is exposed from beneath everted portion 134.

[0091] Once the everted portion 134 of the first segment 130 is fully released by actuation of the deployment line 120, and as the deployment line 120 continues to be actuated, the portion of the removable restraint 104 that was radially inward from the everted portion 134 (in some embodiments, part of the axially inner layer 150) begins to sequentially release. As the radially inner portion of the removable restraint 104 is released, the device 106 is no longer constrained in the area where the radially inner portion of the removable restraint previously constrained it. In embodiments in which the device 106 is deployable either by self-expansion or by an additional device (e.g., a balloon), the device 106 is released from the removable restraint 104 and can be further deployed or deployed. For example, in embodiments in which the device 106 is a self-expanding member, the portion of the device 106 that is released from the removable restraint 104 can expand to a second, larger diameter D2.

[0092] The deployment line 120 can continue to be actuated until the removable restraint 104 is completely released from the device 106. The removable restraint 104 can include a separate deployment line for each of the segments 130, 132 of the removable restraint 104. For example, the first segment 130 can include a first deployment line 120a, and the second segment can include a second deployment line 120b. In some embodiments, the second deployment line 120b remains inaccessible until the first segment 130 is released or at least partially released from the device 106.

[0093] For example, in one embodiment, the second deployment line 120b is positioned so that it is hidden until a sufficient portion of the first segment 130 is released. The second deployment line 120b can be hidden within the first segment 130, within the catheter 102, within the first deployment line 120a, or elsewhere. In some embodiments, the second deployment line 120b can be coupled to or extend from the first segment 130 such that translation of the first segment 130 away from the device 106 via actuation of the first deployment line 120a initiates deployment of the second segment 132. The second segment 132 can be released after the first segment 130 is completely released from the device 106. It can be appreciated that in some embodiments, at least a portion of the first segment 130, once released, functions as the second deployment line 120b for the second segment 132.

[0094] Exemplary Devices and Removable Restraints

[0095] 4a-11b illustrate an exemplary embodiment and its deployment. As seen in FIGS. 4a and 4b, a device 106 having a proximal end 110 and a distal end 111 is constrained to a first diameter D1. The device 106 is constrained by a removable restraint 104 including a first segment 130 and a second segment 132. The removable restraint 104 may also be defined by an axially inner layer 150 and an axially outer layer 152. The axially outer layer 152 includes the everted portion 134 of the first segment 130. The axially inner layer 150 includes the second segment 132 and the un-everted portion 136 of the first segment 130. Device 106 includes a first portion 140 and a second portion 142, with first portion 140 along a first longitudinal length of device 106 at distal end 111 defined by uneverted portion 136 of first segment 130 of removable restraint 104. Second portion 142 of device 106 along a second longitudinal length of device 106 at proximal end 110 defined by second segment 132.

[0096] In a particular example, a first segment 130 of removable restraint 104 is operable to restrain at least a first portion 140 of device 106, and a second segment 132 of removable restraint 104 is operable to restrain a second portion 142 of device 106. First segment 130 includes first deployment line 120a, and second segment 132 includes second deployment line 120b (not shown in FIGS. 4a-11b). Second deployment line 120b in this embodiment is coupled to first segment 130 of removable restraint 104.

[0097] The everted portion 134 of the first segment 130 can be disposed around the periphery of the device. In a particular example, the everted portion 134 of the first segment 130 can be disposed along the length of the device 106, and the deployment line 120 can extend from the everted portion 134 at the proximal end 110 of the device 106. When the deployment line 120 is actuated, the first segments 130 are sequentially released from the device 106, starting from the proximal end 110 toward the distal end 111 of the device 106. In a non-limiting example, the first segment 130 can be operable to be deployed as a result of a first deployment force applied to the first deployment line 120a. The second segment 132 can be operable to be deployed as a result of a second deployment force applied to the second deployment line 120b. In this example, the first deployment force can be lower than the second deployment force, for reasons described in more detail below.

[0098] Because everted portion 134 is located radially outward relative to second segment 132 and un-everted portion 136 of first segment 130, when everted portion 134 is released, second segment 132 and un-everted portion 136 of first segment 130 are released along the length of device 106. When everted portion 134 of first segment 130 is released from device 106, un-everted portions 136 begin to release sequentially from distal end 111 to proximal end 110 of device 106. When un-everted portion 136 is released, first portion 140 of device 106 is free to expand. In certain instances, when un-everted portion 136 of first segment 130 is completely removed from device 106, distal end 111 of device 106 is expanded from a first diameter to a second diameter. When this occurs within the patient's anatomy (e.g., vasculature), the distal end 111 of the device 106 expands to engage the patient's tissue. The engagement can occur via an outward radial force of the device 106 acting on the patient's tissue. Thus, when the device 106 is deployed within the patient, the second diameter D2 can be a diameter to which the device can expand while accounting for the resistance offered by the patient's tissue. The device 106 can include an engagement device (e.g., an anchor, not shown) for engaging the device 106 with the patient's tissue, or an interference fit can be provided by the radial force of the device 106 and the tissue.

[0099] When the distal end 111 of the device 106 is deployed to engage the patient's tissue, the distal end serves as an anchor to the patient's lumen against relative movement between the device 106 and the patient's lumen during deployment of the remainder of the device 106. In some instances, because the device 106 is constrained to a relatively small diameter, the device 106 is able to exert a relatively large radial force. High radial forces on the removable restraint 104 may require the use of a removable restraint 104 that is operable to withstand increased radial forces without deployment. However, in some circumstances, increasing the removable restraint 104's ability to resist large radial forces may also increase the deployment force required to actuate the release of the removable restraint 104 from the device 106. In this embodiment, first segment 130 is operable to require a relatively low deployment force to release, thereby enabling first portion 140 of device 106 to deploy and act as an anchor to the patient's lumen against relative movement between device 106 and the patient's lumen while second segment 132 is deployed. Because first segment 130 deploys with a lower deployment force, a surgeon may position and deploy first portion 140 of device 106 with greater accuracy and / or precision.

[0100] As shown in FIGS. 4a-11b, because the first segment 130 is warp knitted and the first segment 130 releases sequentially, starting or continuing from a location outside of the second segment 132, unintentional release or “creep” or release of the restraint 104 is reduced because the second segment 132 is configured to apply sufficient restraining force to the device 106 without unintentional deployment. Because release of the first segment 130 is unlikely to occur due to “creep” occurring at the interface between the first segment 130 and the first deployment line 120a, the first segment is less likely to release unintentionally because unintentional deployment would require severing one of the strands 108 to cause release. Because the removable restraint 104 is configured to release sequentially, unintentional release of the removable restraint 104 at a location other than the forward end where the deployment line 120 interfaces with the removable restraint 104 is reduced and less likely.

[0101] Once first segment 130 is released and first portion 140 of device 106 is deployed and serves as an anchor for the patient's lumen, second segment 132 may be released from second portion 142 of device 106. Because second segment 132 increases resistance to radial expansion of device 106, the second deployment force may also increase. Although the second deployment force may increase, because first portion 140 of device 106 is already deployed and engaged with the patient's lumen, second segment 132 may be released with less likelihood of deployment at a non-target location within the lumen.

[0102] The second segment 132 is deployed by applying a second deployment force to or across the second deployment line 120b. As shown in FIGS. 4a-11b, the second deployment line 120b can be coupled to or extend from the first segment 130. Thus, the second segment 132 can be deployed by applying a second deployment force to the first deployment line 120a and transferring that same force to the second deployment line 120b. As the second segment 132 continues to release, the second portion 142 of the device 106 is deployed. Once the second segment 132 is fully released, the removable restraint 104 is fully released and can be removed from the patient via a catheter or other method.

[0103] Manufacturing method

[0104] The present disclosure also relates to a method of manufacturing an expandable medical device delivery system. The method can include compressing the device radially inward to a first compressed diameter. A plurality of strands can be braided to form a first segment of a removable restraint. The plurality of strands can be knitted directly onto the compressed device or can be knitted and then attached to the compression device. The plurality of strands can be braided into a first segment of a removable restraint having a length that is shorter than the longitudinal length of the device. A second segment of the removable restraint is also braided, and the second segment can be compressed and knitted directly onto the device or can be braided and then attached to the compression device.

[0105] The method can include providing a first free end of a first deployment line such that at least a portion of the first deployment line extends away from the removable restraint. The first free end can be operable to disassemble the removable restraint when tensioned. A second deployment line can also be provided. The second deployment line can extend away from the removable restraint. The method can also include coupling the second deployment line to a first segment of the removable restraint. Coupling the second deployment line to the first segment can include fusing, weaving, or welding.

[0106] In some embodiments, the second segment is first placed and / or organized on the device. Once the second segment is placed, the first segment can be placed and / or organized on the device. When placing and / or organizing the first segment, the method can include turning the first segment inside out.

[0107] The manufacturing method can also include weakening at least one of the strands comprising the cover member to allow the strand to break. When at least one strand breaks, release of the segment can occur. Thus, in some embodiments, one strand from each segment can be weakened to facilitate breaking of the strand from each segment. In some embodiments, the weakened strand constitutes the deployment line of the knitted row. In other embodiments, the unweakened strand comprises the deployment line of the knitted row such that when the unweakened strand is pulled, the unweakened strand remains intact and the weakened strand breaks, thereby initiating release of the segment. Tension can be initially applied to the segment to provide the initial break. Tension can then be applied to the unbroken unweakened strand to continue release of the segment as portions of the removable restraint release, thereby releasing the segment under tension. The breakage of the strand continues to release the removable restraint, thereby allowing the removable restraint to release or separate. Weakening the strands can be accomplished by scoring, cutting, treating, or otherwise damaging the strands so that they can break under predetermined conditions, such as tension.

[0108] As part of the manufacturing process, deployment of the removable restraint can be initiated by breaking at least one strand from each of the knit rows. The removable restraint can be deployed to a desired length relative to the device. For example, the removable restraint can be knitted to a length longer than the expandable member. The cover member can be actuated to initiate release. The removable restraint can be partially released until a desired length of the removable restraint is achieved, such as a length that encircles the device, as described above. When the desired length of the removable restraint segment is achieved, deployment can be halted until the medical device is ready to be deployed at the target site. It is understood that the removable restraint can be partially deployed to any desired length. The partially deployed removable restraint, constraining the expandable member, can then be prepared for packaging, use, attachment to a catheter, or any other desired operation.

[0109] In some embodiments, the manufacturing method includes compressing the device simultaneously with knitting the removable restraint, such that the multiple strands exert a compressive force on the device when knitted around the device.

[0110] In some embodiments, the removable restraint can be knitted on a mandrel. Once the removable restraint is knitted, and in some embodiments, partially deployed, the removable restraint can be removed from the mandrel and applied over the radially compressed implantable medical device. In this embodiment, the step of attaching a first segment of the removable restraint over the radially compressed implantable medical device can include inverting a portion of the first segment of the removable restraint over the radially compressed implantable medical device. This step can also include hiding a second deployment line between the first and second segments of the removable restraint.

[0111] Various embodiments of a removable restraint

[0112] Various embodiments are provided in Figures 12-15. For example, Figure 12 includes a removable restraint having first and second segments 130, 132. The first segment 130 is partially everted, with the everted portion extending only a portion of the longitudinal length of the device 106. Figure 13 provides an exemplary embodiment in which the first segment 130 is not everted. The removable restraint 104 also includes a second deployment line 120b coupled to a portion of the first segment 130. The second deployment line 130b is also disposed within the first segment 130 such that the second deployment line 120b appears after the first segment 130 is released.

[0113] 14 provides an exemplary embodiment in which the first segment 130 is coaxially disposed with the second segment 132, with the second segment 132 positioned inside the first segment 130. While it is within the scope of this disclosure for the first segment 130 to be releasable from the distal end 111, the first segment 130 is operable to release from the proximal end 110. The first segment 130 may not be everted and may cover or conceal at least a portion of the second deployment line 120b. The first portion 140 of the device 106 may deploy and provide an anchoring portion when the first segment 130 is released from the device 106. The second segment 132 may then be released from the device 106, thereby fully deploying the device 106.

[0114] FIG. 15 provides an exemplary embodiment in which various characteristics of the first and second segments 130, 132 of the removable restraint 104 may be varied. For example, in this embodiment, the first segment 130 may be operable to resist a greater expansive force than the second segment 132. This may be a result of the strand characteristics achieved in various embodiments. However, FIG. 15 should not be construed as depicting and achieving any one set of strand characteristics to the exclusion of others. As discussed above, various characteristics may be achieved for a variety of reasons.

[0115] 16 provides an exemplary embodiment in which various characteristics of the first and second segments 130, 132 of the removable restraint can be varied, with the second segment 132 surrounding the device from the first end of the device to the second end of the device. The second segment 132 is everted at one end of the device such that the everted portion of the second segment 132 surrounds a portion of the non-everted portion of the second segment 132. The first segment 130 surrounds the remainder of the non-everted portion of the second segment 132, which is not surrounded by the everted portion of the second segment 132.

[0116] The invention of this application has been described both generically and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of the present disclosure. Therefore, it is intended that the embodiments cover the modifications and variations of the present invention provided they come within the scope of the appended claims and their equivalents.

Claims

1. an expandable device having a longitudinal length and operable to be compressed to a first diameter and expanded to a second diameter, the second diameter being greater than the first diameter, the expandable device defining a first portion shorter than the longitudinal length of the expandable device and a second portion shorter than the longitudinal length of the expandable device; a first restraining member operable to restrain the first portion of the expandable device at the first diameter; and a second restraining member operable to restrain the second portion of the expandable device at the first diameter; 1. An implantable medical device, including

2. 10. The implantable medical device of claim 1, wherein the first restraining member defines a first release zone and the second restraining member defines a second release zone.

3. the first restraining member further includes a first deployment line configured to release the first restraining member along the first release zone by applying tension to the first deployment line; and 3. The implantable medical device of claim 2, wherein the second restraint member further comprises a second deployment line configured to release the second restraint member along the second release zone by applying tension to the second deployment line.

4. the first release zone is configured to release upon application of a first tension force across the first deployment line; the second release zone is configured to release upon application of a second tension force across the second deployment line; The implantable medical device of claim 3 , wherein the first tension is greater than the second tension.

5. the first release zone is configured to release upon application of a first tension force across the first deployment line; the second release zone is configured to release upon application of a second tension force across the second deployment line; and The implantable medical device of claim 3 , wherein the first tension is less than the second tension.

6. 10. The implantable medical device of any one of the preceding claims, wherein the second restraining member extends over at least a portion of the first portion of the expandable member.

7. 7. The implantable medical device of claim 6, wherein the second restraining member is disposed between the first restraining member and the expandable member, and the second restraining member extends over at least a portion of the first portion of the expandable member.

8. 7. The implantable medical device of claim 6, wherein the second restraining member is positioned outside the first restraining member and the expandable member, and the second restraining member extends over at least a portion of the first portion of the expandable member.

9. 10. The implantable medical device of any one of the preceding claims, wherein the second restraining member includes an everted portion.

10. 10. The implantable medical device of claim 9, wherein the everted portion of the second restraining member is disposed around the first portion of the expandable member and at least a portion of the first restraining member.

11. 11. The implantable medical device of claim 10, wherein the everted portion of the second restraining member is disposed along the longitudinal length of the expandable member.

12. 10. The implantable medical device of any one of the preceding claims, wherein the first restraining member comprises a first knitted sleeve including a first plurality of strands.

13. 10. The implantable medical device of any one of the preceding claims, wherein the second restraining member comprises a second knitted sleeve including a second plurality of strands.

14. 14. The implantable medical device of claim 12 or 13, wherein the first knitted sleeve and the second knitted sleeve are knitted.

15. 10. The implantable medical device of any one of the preceding claims, wherein the first and second restraining members are warp knitted.

16. 10. The implantable medical device of any one of the preceding claims, wherein the first restraining member is operable to release after the second restraining member is released.

17. 17. The implantable medical device of any one of claims 3 to 16, wherein the first deployment line is engaged with the second restraining member such that when the second restraining member is released, the first deployment line is accessible to actuate the release of the first restraining member.

18. 18. The implantable medical device of claim 17, wherein the first deployment line is coupled to the second restraining member such that when the second restraining member translates away from the expandable member, tension is applied to the first deployment line, actuating the release of the first restraining member.

19. 19. The implantable medical device of any one of claims 12-18, wherein the first plurality of strands and the second plurality of strands comprise matching strand properties, including any one or combination of strand thickness, strand denier, strand coefficient of friction, strand material, strand coating, strand treatment, and strand stiffness.

20. 19. The implantable medical device of any one of claims 12-18, wherein the first plurality of strands and the second plurality of strands comprise different strand properties, including any one or combination of strand thickness, strand denier, strand coefficient of friction, strand material, strand coating, strand treatment, and strand stiffness.

21. The implantable medical device of any one of claims 12 to 20, wherein the second plurality of strands extends from the first plurality of strands.

22. an expandable member having a proximal end and a distal end, wherein the expandable member has a longitudinal length defined between the proximal end and the distal end; a first constraining member disposed about the expandable member along a first portion less than the entire longitudinal length of the expandable member, wherein the first constraining member maintains the expandable member at a constrained diameter along the first portion; and a second constraining member including a first segment and an everted segment, wherein the first segment of the second constraining member is disposed around the expandable member at a stabilizing portion, which is the remaining portion of the longitudinal length where the first constraining member is not disposed around the expandable member, the second constraining member maintains the expandable member at the constraining diameter at the stabilizing portion, and the everted segment of the second constraining member is disposed around the first segment of the second constraining member and the stabilizing portion of the expandable member; 1. An implantable medical device, including

23. 23. The implantable medical device of claim 22, wherein the first restraining member further comprises a first release zone and a first deployment line, and the second restraining member further comprises a second release zone and a second deployment line.

24. 24. The implantable medical device of claim 23, wherein the first deployment line is operable to release the first release zone when at least a first deployment force is applied to the first deployment line, and the second deployment line is operable to release the second release zone when at least a second deployment force is applied to the second deployment line.

25. 25. The implantable medical device of claim 24, wherein the first deployment force is greater than the second deployment force.

26. 25. The implantable medical device of claim 24, wherein the first deployment force is less than the second deployment force.

27. The implantable medical device of any one of claims 22 to 26, wherein the first restraining member comprises a first plurality of warp knitted strands.

28. The implantable medical device of any one of claims 22 to 27, wherein the second restraining member comprises a second plurality of warp knitted strands.

29. The implantable medical device of any one of claims 22 to 28, wherein the everted segment of the second restraining member is disposed around the first restraining member.

30. 30. The implantable medical device of any one of claims 22-29, wherein the stabilizing portion of the expandable member is operable to expand to a second diameter when the second restraining member is detached from the expandable member.

31. 31. The implantable medical device of any one of claims 23 to 30, wherein the first deployment line engages with the second restraining member such that the first restraining member is operable to be released after the second restraining member is released and the stabilizing portion of the expandable member is deployed.

32. The implantable medical device of any one of claims 22 to 31, wherein the first portion of the expandable member extends to a proximal end of the expandable member.

33. The implantable medical device of any one of claims 22 to 32, wherein the stabilizing portion of the expandable member extends to a distal end of the expandable member.

34. The implantable medical device of any one of claims 22 to 33, wherein the second sheath is configured to be released so that the proximal end of the expandable member is deployed first.

35. 35. The implantable medical device of any one of claims 22 to 34, wherein the first sheath is configured to be released after the second sheath is released so that the proximal end of the expandable member is deployed after the distal end is deployed.

36. compressing the expandable member radially inward; braiding a first plurality of strands to form a first restraining member having a first deployment line; attaching the first restraining member to a first portion of the expandable member; braiding a second plurality of strands to form a second restraining member; attaching the second restraining member to a second portion of the expandable member; and inverting a segment of the second restraining member over a second portion of the expandable member; 1. A method for manufacturing an implantable medical device, comprising:

37. 38. The method of claim 37, further comprising initiating release of a first release zone of the first restraining member and a second release zone of the second restraining member.

38. 38. The method of claim 37, further comprising partially releasing the first release zone until a first end of the first release zone is located near the proximal end of the expandable member.

39. 39. The method of claim 38, further comprising partially releasing the second release zone until a second end of the second release zone is located near the proximal end of the expandable member.

40. 1. A method of deploying an implantable medical device, comprising: placing an expandable member within a lumen of a patient, wherein a first portion of the implantable medical device is constrained by a first constraining member in a compressed configuration and a second portion of the expandable member is constrained by a second constraining member in a compressed configuration; removing the second restraining member from the second portion of the expandable member; removing the first restraining member from the first portion of the expandable member; A method comprising:

41. holding a free end of a second deployment line away from the expandable medical device, wherein the second deployment line is engaged with a second release zone of the second restraining member configured to disengage the second restraining member from the expandable member; and applying sufficient force to the free end of the second deployment line to actuate the second release zone; 41. The method of claim 40, further comprising:

42. 42. The method of claim 41, further comprising applying sufficient force to a free end of a first deployment line to actuate a release zone of the first restraining member, the first deployment line engaged with the release zone of the first restraining member, the release zone of the first restraining member configured to disengage the first restraining member from the expandable member.

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