Constraining sleeve

Abstract

An endoprosthesis delivery system comprising an endoprosthesis, and an endoprosthesis constraining sleeve configured to constrain the endoprosthesis. The endoprosthesis constraining sleeve includes a tubular member defining a main lumen extending longitudinally through the tubular member, wherein the tubular member configured to at least partially evert such that the tubular member includes an inner portion and an outer portion, and a removable deployment line coupled to the tubular member along at least a portion of a longitudinal length of the tubular member, wherein the main lumen is subdivided into at least two secondary lumens when the removable deployment line is coupled to the tubular member.

Description

CONSTRAINING SLEEVECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of Provisional Application No. 63 / 564,075, filed March 12, 2024, which is incorporated herein by reference in its entirety for all purposes.FIELD

[0002] The present disclosure relates generally to apparatuses, systems, and methods for constraining and delivering endoprostheses. More specifically, the disclosure relates to apparatuses, systems, and methods for providing constraining sleeves that reduce overall diameter of the delivery systems and / or facilitate removal of the sleeves after implantation of an endoprosthesis.BACKGROUND

[0003] Endoprostheses used to treat a treatment area of the vasculature of a patient are typically delivered via a delivery system including a catheter. Such endoprostheses may comprise, for example, expandable implants. Expandable endoprostheses can be comprised of a graft or a stent component with or without a graft covering over the stent. They can be designed to expand when a restraint, such as a sleeve is removed or be balloon-expanded from a delivery diameter to a predetermined functional diameter. During delivery, the endoprostheses generally need to be constrained to a small diameter in order to deliver the endoprostheses to the target site from a remote insertion site. In order to advance the endoprostheses through the lumen (e.g., vasculature), the endoprostheses are generally constrained to limit resistance to advancement, damage to surrounding tissue, and so forth. Thus, systems and methods for providing delivery systems for delivery of endoprostheses are needed.SUMMARY

[0004] The present disclosure relates to constraining sleeves and delivery systems that are configured to deliver and release endoprostheses at a target location. The constraining sleeves and delivery systems provide for a reduced delivery profile.

[0005] According to one example (“Example 1”), an endoprosthesis delivery system includes an endoprosthesis; and an endoprosthesis constraining sleeve configured to constrain the endoprosthesis, the endoprosthesis constraining sleeve including a tubular member defining a main lumen extending longitudinally through the tubular member, wherein the tubular member configured to at least partially evert such that the tubular member includes an inner portion and an outer portion; and a removable deployment line coupled to the tubular member along at least a portion of a longitudinal length of the tubular member, wherein the main lumen is subdivided into at least two secondary lumens when the removable deployment line is coupled to the tubular member.

[0006] According to another example (Example 2), further to Example 1 , wherein the tubular member includes a delivery configuration, and intermediate deployment configuration, and a full deployment configuration.

[0007] According to another example (Example 3), further to Example 2, wherein the tubular member is configured to transition from the intermediate deployment configuration to the full deployment configuration when the tubular member is everted and not surrounding the endoprosthesis.

[0008] According to another example (Example 4), further to either Example 2 or Example 3, further comprising a second deployment line extending from the tubular member, the second deployment operable to evert the inner portion of the tubular member when actuated.

[0009] According to another example (Example 5), further to any one of Examples 2-4, wherein the second deployment line extends from the outer portion of the tubular member.

[0010] According to another example (Example 6), further to any one of Examples 2-5, wherein the tubular member is configured to transition from the delivery configuration to the intermediate deployment configuration when the removable deployment line is actuated and at least partially decoupled from the tubular member.

[0011] According to another example (Example 7), further to any one of Examples 2-6, wherein the tubular member includes at least two longitudinal folds.

[0012] According to another example (Example 8), further to Example 7, wherein the removable deployment line is coupled to the tubular member such that the at least two longitudinal folds are maintained when the removable deploymentline is coupled to the tubular member and the at least two longitudinal folds are configured to be released when the removable deployment line is at least partially decoupled from the tubular member.

[0013] According to another example (Example 9), further to any one of the preceding Examples, wherein the outer portion of the tubular member defines at least one window.

[0014] According to another example (Example 10), further to any one of the preceding Examples, wherein the tubular member includes a tapered profile such that the inner portion of the tubular member transitions from a first diameter at a first longitudinal position to a second diameter at a second longitudinal position, wherein the first diameter is greater than the second diameter.

[0015] According to another example (Example 11 ), an endoprosthesis delivery system includes an endoprosthesis; and an endoprosthesis constraining sleeve configured to constrain the endoprosthesis, the endoprosthesis constraining sleeve including a tubular member defining a main lumen extending longitudinally through the tubular member, wherein the tubular member is configured to at least partially evert such that the tubular member includes an inner portion and an outer portion; a first deployment line removably coupled to tubular member along at least a portion of a longitudinal length of the tubular member; and a second deployment line extending from the outer portion of the tubular member.

[0016] According to another example (Example 12), further to Example 11 , wherein the tubular member includes a delivery configuration, an intermediate deployment configuration, and a full deployment configuration.

[0017] According to another example (Example 13), further to Example 12, wherein the tubular member is operable to transition from the delivery configuration to the intermediate deployment configuration when the first deployment line is actuated and decoupled from the tubular member.

[0018] According to another example (Example 14), further to either Example 12 or Example 13, wherein the tubular member is operable to transition from the intermediate deployment configuration to the full deployment configuration when the second deployment line is actuated to evert the inner portion of the tubular member.

[0019] According to another example (Example 15), further to any one of Examples 11-13, wherein the tubular member defines a plurality of lumens when the first deployment line is coupled to the tubular member.

[0020] According to another example (Example 16), a method of manufacturing a constraining sleeve includes providing a tubular member defining a main lumen extending longitudinally through the tubular member, the tubular member including a first longitudinal edge and a second longitudinal edge opposite the first longitudinal edge; everting a first longitudinal edge of the tubular member defining an inner portion and an outer portion; providing a fold in the tubular member along at least a portion of a longitudinal length of the tubular member; and coupling a first deployment line to the tubular member, the first deployment line and the fold defining at least a portion of at least one secondary lumen, the at least one secondary lumen having a smaller diameter than the main lumen.

[0021] According to another example (Example 17), further to Example 16, further comprising removing material from the outer portion of the tubular member.

[0022] According to another example (Example 18), further to any either Examples 16 or 17, wherein removing material includes defining a plurality of strips in the outer portion.

[0023] According to another example (Example 19), further to Example 18, forming a second deployment line from the plurality of strips.

[0024] According to another example (Example 20), further to any one of Examples 16-19, wherein providing the fold in the tubular member includes defining the fold to provide a parallel edges along a longitudinal length of the tubular member when the tubular member includes a tapered profile.

[0025] The foregoing Examples are just that and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant 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 rather than restrictive in nature.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] 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.

[0027] FIG. 1 is an illustration of an embodiment of a delivery system including a constraining sleeve constraining an endoprosthesis, in accordance with an embodiment;

[0028] FIG. 2 is an illustration of an embodiment of a constraining sleeve defined by a tubular member having first and second deployment lines constraining an endoprosthesis in a constrained configuration, in accordance with an embodiment;

[0029] FIG. 3 is an illustration of the constraining sleeve of FIG. 2 in which the first deployment line is released, in accordance with an embodiment;

[0030] FIG. 4 is an illustration of the constraining sleeve of FIG. 2 in which the first deployment line is released and the endoprosthesis expands to an intermediate configuration, in accordance with an embodiment;

[0031] FIG. 5 is an illustration of the constraining sleeve of FIG. 2 in which the second deployment line is actuated to evert a portion of the tubular member, in accordance with an embodiment;

[0032] FIG. 6 is an illustration of the constraining sleeve of FIG. 2 in which the tubular member is full everted and the endoprosthesis is released and expanded to a deployed configuration, in accordance with an embodiment;

[0033] FIGS. 7-10 are illustrations of deployment sequence of a constraining sleeve in which an endoprosthesis is expanded from a delivery configuration to an intermediate configuration and from the intermediate configuration to a deployed configuration, in accordance with an embodiment;

[0034] FIGS. 11A-11C are illustrations of a constraining sleeve with secondary lumens, in accordance with an embodiment;

[0035] FIGS. 12-13B illustrate various folding patterns, in accordance with an embodiment;

[0036] FIG. 14A-14B illustrate various configurations of a constraining sleeve, in accordance with an embodiment; and

[0037] FIGS. 15A-15C illustrate one folding pattern of a tapered constraining sleeve, in accordance with an embodiment.DETAILED DESCRIPTIONDefinitions and Terminology

[0038] This disclosure is not meant to be read in a restrictive manner. Forexample, the terminology used in the application should be read broadly in the context of the meaning those in the field would attribute such terminology.

[0039] With respect to terminology of inexactitude, the terms “about” and “approximately” may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. Such deviations may be attributable to measurement error, differences in measurement and / or manufacturing equipment calibration, human error in reading and / or setting measurements, minor adjustments made to optimize performance and / or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and / or manipulation of objects by a person or machine, and / or the like, for example. In the event it is determined that individuals having ordinary skill in the relevant arts would not readily ascertain values for such reasonably small differences, the terms “about” and “approximately” can be understood to mean plus or minus 10% of the stated value.Description of Various Embodiments

[0040] Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.

[0041] The delivery system 10 shown in FIG. 1 is provided as an example of the various features of the system and devices discussed herein and, although the combination of those illustrated features is clearly within the scope of invention, that example and its illustration is not meant to suggest the inventive concepts provided herein are limited from fewer features, additional features, or alternative features to one or more of those features shown in FIG. 1 . For example, in various embodiments, a constraining sleeve 16 defined by a sheet 100 and deployment line 200 of the delivery system 10 shown in FIG. 1 may include the configurations of thesheet 100 and deployment line 200 described with reference to FIGS. 2-9. It should also be understood that the reverse is true as well. One or more of the components depicted in FIG. 1 can be employed in addition to, or as an alternative to components depicted in FIGS. 2-9. For example, the elongate member 12, endoprosthesis 14 (e.g., an endoprosthesis), and other components of the delivery system 10 shown in FIG. 1 may be employed in connection with the sheet 100 and deployment line 200 shown in FIGS. 2-9.

[0042] Referring to FIG. 1 , a delivery system 10 can include an elongate member 12 (e.g., a catheter), an endoprosthesis 14 (e.g., an expandable device including but not limited to a stent graft), a constraining sleeve 16 disposed about the endoprosthesis 14, and an end cap 18 adjacent to either the distal or proximal edge of the constraining sleeve 16. The constraining sleeve 16 can extend beyond an end of the endoprosthesis 14.

[0043] In some embodiments, the endoprosthesis 14 is delivered to a target site for implantation. The endoprosthesis 14 may be self-expanding, expandable (e.g., balloon expandable), or otherwise implantable at a target location. When the endoprosthesis 14 has been advanced to the target site within the vasculature of a patient, the endoprosthesis 14 is deployed from the constraining sleeve 16 at the target site. Because some vasculature is relatively narrow, it is important for the components of the delivery system 10 to be compact to allow for atraumatic and easier navigation through the vasculature. This includes reducing the size of the endoprosthesis 14 and constraining sleeve 16 when the endoprosthesis 14 is in the constrained configuration. The constraining sleeve 16 is configured to reduce the radial profile during delivery.

[0044] Referring to FIG. 2, a constraining sleeve 16 is provided that facilitates constraining the endoprosthesis 14 to a delivery diameter in the delivery configuration and to an intermediate diameter in an intermediate configuration and is configured to release the endoprosthesis 14 to a deployed diameter when the constraining sleeve 16 is in a released configuration (e.g., released from radially constraining the endoprosthesis 14). The constraining sleeve 16 may be provided as a tubular member 100 (e.g., a film, membrane, etc.) defining a main lumen 102 with at least one deployment line 200. As shown in FIG. 2, the constraining sleeve 16 includes a first deployment line 200A and a second deployment line 200B.

[0045] In some embodiments, the first deployment line 200A is a removabledeployment line that is removably coupled to the tubular member 100 and the second deployment line 200B extends from the tubular member 100. The second deployment line 200B may be coupled to or integral with the tubular member 100. The first and the second deployment lines 200 may be actuated in order to actuate a specific step in the delivery sequence of the endoprosthesis 14. For example, the first deployment line 200A may be actuated in order to deploy the tubular member 100 and endoprosthesis 14 from the delivery configuration toward an intermediate configuration. The endoprosthesis 14 may include a diameter that is smaller in the delivery configuration than in the intermediate configuration. The second deployment line 200B may be actuated to deploy the tubular member 100 and the endoprosthesis 14 from the intermediate configuration toward a deployed configuration. The endoprosthesis 14 may include a diameter that is smaller in the intermediate configuration than in the deployed configuration. It is understood that the diameters of the endoprosthesis 14 and the changes in diameter may be a result of self-expansion or a result of expansion by other structures (e.g., balloon expandable). Additionally, diameter in this context is not meant to be construed as requiring a circular profile, but is to be understood as generally discussing the size of the endoprosthesis 14 (and as appropriate, the lumens of the tubular member 100) in its various configurations.

[0046] Still referring to FIG. 2, the first deployment line 200A is coupled to the tubular member 100 along at least a portion of the longitudinal length of the tubular member 100. The first deployment line 200A may be stitched, sewn, or knitted onto the tubular member 100. The first deployment line 100 defines secondary lumens 103 (see FIGS. 11 B and 11 C) within the tubular member 100 when coupled to the tubular member 100. Each of the secondary lumens 103 has a diameter that is smaller than the diameter of the main lumen 102. For example, the main lumen 102 is subdivided into a plurality of secondary lumens 103 when the first deployment line 200A is coupled to the tubular member 100. Various configurations of defining the secondary lumens 103 is discussed hereafter. Each of the secondary lumens 103 is operable to receive the endoprosthesis 14 in the delivery configuration. When the first deployment line 200A is selectively released from the tubular member 100, the secondary lumens 103 are de-defined and the tubular member 100 is operable to release to include the single, main lumen 102. As described herein, the secondary lumens 103 are defined within a portion of the main lumen 102 such that anendoprosthesis 14 positioned within a secondary lumen 103 is constrained to a delivery configuration in the secondary lumen and can be constrained to an intermediate configuration within the main lumen 102 when the first deployment line 200A is released from the tubular member 100.

[0047] In order to release the endoprosthesis 14 from the intermediate configuration to the deployed configuration, the second deployment line 200B may be actuated. The second deployment line 200B extends from (e.g., integral with or coupled to) the tubular member 100. The constraining sleeve 16 includes a first end 20 and a second end 22. Generally, the first end 20 of the constraining sleeve 16 is positioned proximally and the second end 22 is positioned distally. The tubular member 100 includes a first longitudinal end 104 and a second longitudinal end 106. In some embodiments, the tubular member 100 is partially everted. Because at least a portion of the tubular member 100 is everted, the first longitudinal end 104 of the tubular member 100 may not correspond directly to the first end 20 of the constraining sleeve 16. Furthermore, because a portion of the tubular member 100 is everted, the tubular member defines an inner portion 108 (e.g., the non-everted portion) and an outer portion 110 (e.g., the everted portion). The second longitudinal end 106 may be the end that is at least partially everted and the end from which the second deployment line 200B extends. As the second deployment line 200B is actuated, the second longitudinal end 106 of the tubular member 100 is operable to slide along the surface of the inner portion 108. As the second deployment line 200B is actuated, portions of the inner portion 108 (e.g., non-everted portion) transition to being part of the outer portion 110 (e.g., everted portion). As the second deployment line 200B is actuated and the tubular member 100 progressively everts, the first end 20 of the constraining sleeve 16 retreats and portions of the endoprosthesis 14 are released from the constraining sheath 16. The tubular member 100 is configured to transition from the intermediate deployment configuration to the full deployment configuration when the tubular member 100 is everted to an extent to where the endoprosthesis 14 is no longer surrounded or in contact with the tubular member 100. For example, the tubular member 100 may be fully everted and removed from surrounding the endoprosthesis 14.

[0048] Referring to FIGS. 2-6, the deployment sequence is illustrated in which an endoprosthesis 14 is constrained in a delivery configuration, deployed to an intermediate configuration, and deployed to a deployed configuration. As previouslydescribed, FIG. 2 depicts the endoprosthesis 14 and constraining sleeve 16 in the delivery configuration. The first deployment line 200A is removably coupled to the tubular member 100 of the constraining sleeve 16 to define the secondary lumen 103 within which the endoprosthesis 14 is positioned. The second deployment line 200B extends from the outer portion 110 of the tubular member 100.

[0049] FIG. 3 depicts the constraining sleeve 16 when the first deployment line 200A has been removed from the tubular member 100. The secondary lumen 103 is de-defined when the first deployment line 200A is released such that the main lumen 102 is not subdivided or constrained to a smaller diameter. The endoprosthesis 14 can either self-expand to fill the main lumen 102 when the first deployment line 200A is released or can be expanded (e.g., balloon expanded). FIG. 4 depicts the endoprosthesis 14 expanded to the intermediate diameter to fill the main lumen 102. The intermediate diameter may have several benefits, including but not limited to better visualization of the endoprosthesis 14 prior to full deployment, opportunity for more refined placement of the endoprosthesis 14 at the delivery site prior to full deployment, reduced actuation force on the second deployment line 200B for eversion of the tubular member 100 (e.g., for a self-expanding endoprosthesis 14, the outward radial force exerted by the endoprosthesis 14 in the intermediate diameter is less than in the delivery configuration, where the reduced force facilitates reduced friction between the inner and outer portions 108, 110 of the tubular member 100), which facilitates more accurate placement of the endoprosthesis, and so forth.

[0050] FIG. 5 depicts the tubular member 100 as it is being removed from the endoprosthesis 14 via eversion of tubular member 100. The tubular member 100 is everted as the second deployment line 200B is actuated and the tubular member 100 is pulled away from the endoprosthesis 14. The endoprosthesis 14 may deploy progressively as the tubular member 100 is progressively removed from the endoprosthesis 14. FIG. 6 depicts the endoprosthesis 14 in the deployed configuration and the constraining sleeve 16 being fully removed from radially surrounding the endoprosthesis 14.

[0051] Referring to FIGS. 7-10, a similar deployment process is illustrated, the figures illustrating a section view of the constraining sleeve 10. FIG. 7 generally corresponds with FIG. 2 with the delivery system 10 in the delivery configuration, FIG. 8 generally corresponds with FIG. 4 with the delivery system 10 in theintermediate configuration, FIG. 9 generally corresponds with FIG. 5 while the delivery system 10 is transitioning from the intermediate configuration toward the deployed configuration, and FIG. 10 generally corresponds with the FIG. 6 with the endoprosthesis 14 in the deployed configuration.

[0052] Referring to FIGS. 11A-13B, various folding patterns and positions at which the first deployment line 200B is coupled to the tubular member 100 are illustrated. The various examples are just that, examples, and are not necessarily intended to be limiting. Referring to FIG. 11 A, the tubular member 100 is shown folded in thirds (e.g., two longitudinal folds 112). The first deployment line 200A is not shown coupled to the tubular member 100 in order to show the folding pattern more clearly. FIGS. 11 B and 11 C illustrate the various secondary lumens 103 that result from the folding of the tubular member and the coupling of the first deployment line 200A (not shown) to the tubular member 100. The endoprosthesis 14 (not shown) could be accommodated in either of the secondary lumens 103 illustrated in order to constrain the endoprosthesis 14 to the delivery configuration. FIG. 12 illustrates the tubular member 100 folded in fourths (e.g., three longitudinal folds 112). Any number of folds 112 may be implemented. The various folding patterns may be implemented to provide for a specific delivery diameter, to provide additional lumens within which different components may be delivered, and so forth. FIGS. 13A and 13B illustrate that the folds 112 may be provided at different locations of the tubular member 100. The secondary lumen 103 may be provided at different locations via the folds 112 and the specific positions are not necessarily meant to be limiting. As previously discussed, the first deployment line 200A is coupled to the tubular member 100 such that the longitudinal folds 112 are maintained when the removable deployment line is coupled to the tubular member and the longitudinal folds 112 are released when the first deployment line 200A is at least partially decoupled from the tubular member 100 (e.g., may still be coupled to the tubular member 100 but not constraining the delivery system to the delivery configuration).

[0053] Referring to FIGS. 14A and 14B, in some embodiments, the outer portion 110 of the tubular member 100 defines at least one window 114, such that the outer portion 110 does not completely encompass a circumference of the inner portion 108 at a longitudinal position. The windows 114 can be provided any number of shapes and configurations. The windows 114 facilitate a reduced crush profile (e.g., delivery diameter of the delivery system 10), reduced friction between at leasta portion of the inner portion 110 and the outer portion 110 during eversion, and can be provided to define strips 116 that may be implemented as the second deployment line 200B (see FIG. 14A).

[0054] Referring to FIGS 15A-15C, in some embodiments the tubular member 100 includes a tapered profile. The tapered profile is such that the inner portion 110 of the tubular member transitions from a first diameter at a first longitudinal position to a second diameter at a second longitudinal position, wherein the first diameter is greater than the second diameter. The tapered profile of the tubular member 100 facilitates decreased resistance between the inner portion 100 and the outer portion 110 during deployment. FIG. 15A illustrates the general profile of the tubular member 100 having a tapered profile. FIG. 15A illustrates a first fold of the tubular member 100 which squares up the tubular member 100. FIGS. 15B and 15C illustrate additional folds as previously discussed for reducing the diameter, coupling of the first deployment line (not shown) and provision of the secondary lumens 103.

[0055] Turning to a discussion of a method of manufacture, in some embodiments, a constraining sleeve 16 may be manufactured using a tubular member 100 as discussed herein and a deployment line 200 as discussed herein. As previously included, the tubular member 100 includes a first longitudinal end 104 and a second longitudinal end 106 opposite the first longitudinal end 104. The first longitudinal end 104 is everted over a portion of the tubular member 100 to define an inner portion 108 and an outer portion 110. At least one longitudinal fold 112 is provided along at least a portion the longitudinal length of the tubular member 100. As previously discussed, the longitudinal fold(s) 112 can be positioned in various configurations and numbers. Once the longitudinal fold(s) 112 have been provided, a first deployment line 200A is coupled to the tubular member. The first deployment line 200A is configured to hold the longitudinal fold(s). The first deployment line 200A and the longitudinal fold 112 define at least a portion of at least one secondary lumen 103. The secondary lumen 103 has a smaller diameter than the main lumen 102. In some embodiments, a second deployment line 200B is coupled to the first longitudinal end 104. In some embodiments, material may be removed from the outer portion 110 of the tubular member 100. The removed material defines a window 114. The material may be removed in order to define strips 116 in the outer portion 110. In some embodiments, the method includes defining or forming thesecond deployment line 200B. In some embodiments in which the tubular member 100 includes a tapered profile, the method includes squaring the edges by providing a fold that provides parallel edges along the longitudinal length of the tubular member 100.

[0056] In the some embodiments, the sheet of material 100 includes an expanded polytetrafluoroethylene (ePTFE) base layer. In some of such embodiments, the sheet of material 100 may include a thermoplastic coating on one side of the ePTFE base layer. In some embodiments, the sheet of material 100 includes a fluorinated ethylene propylene (FEP) layer. In some embodiments, the sheet of material 100 is formed of ePTFE, polyester, polyurethane, fluoropolymers, such as perfluoroelastomers and the like, polytetrafluoroethylene, silicones, urethanes, polyethylene such as ultra-high molecular weight polyethylene, aramid fibers, or combinations thereof. Other examples for the sheet of material 100 can 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.) and combinations thereof, including combinations of previously introduced materials. The sheet of material 100 may include various constructions, including films, laminates, membranes, tapes, and so forth.

[0057] In some embodiments, the deployment line 200 may be formed of various materials. For example, the deployment line 200 may be formed of any material suitable for sutures such as ePTFE, nylon, polypropylene, surgical cotton, surgical silk, surgical steel, polyester, and so forth.

[0058] The invention of this application has been described above both generically and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

Claims

WHAT IS CLAIMED IS:DRAFT CLAIMS1 . An endoprosthesis delivery system comprising: an endoprosthesis; and an endoprosthesis constraining sleeve configured to constrain the endoprosthesis, the endoprosthesis constraining sleeve including: a tubular member defining a main lumen extending longitudinally through the tubular member, wherein the tubular member configured to at least partially evert such that the tubular member includes an inner portion and an outer portion; and a removable deployment line coupled to the tubular member along at least a portion of a longitudinal length of the tubular member, wherein the main lumen is subdivided into at least two secondary lumens when the removable deployment line is coupled to the tubular member.

2. The endoprosthesis delivery system of claim 1 , wherein the tubular member includes a delivery configuration, and intermediate deployment configuration, and a full deployment configuration.

3. The endoprosthesis delivery system of claim 2, wherein the tubular member is configured to transition from the intermediate deployment configuration to the full deployment configuration when the tubular member is everted and not surrounding the endoprosthesis.

4. The endoprosthesis delivery system of either claim 2 or claim 3, further comprising a second deployment line extending from the tubular member, the second deployment operable to evert the inner portion of the tubular member when actuated.

5. The endoprosthesis delivery system of any one of claims 2-4, wherein the second deployment line extends from the outer portion of the tubular member.

6. The endoprosthesis delivery system of any one of claims 2-5, wherein the tubular member is configured to transition from the delivery configuration to the intermediatedeployment configuration when the removable deployment line is actuated and at least partially decoupled from the tubular member.

7. The endoprosthesis delivery system of any one of claims 2-6, wherein the tubular member includes at least two longitudinal folds.

8. The endoprosthesis delivery system of claim 7, wherein the removable deployment line is coupled to the tubular member such that the at least two longitudinal folds are maintained when the removable deployment line is coupled to the tubular member and the at least two longitudinal folds are configured to be released when the removable deployment line is at least partially decoupled from the tubular member.

9. The endoprosthesis delivery system of any one of the preceding claims, wherein the outer portion of the tubular member defines at least one window.

10. The endoprosthesis delivery system of any one of the preceding claims, wherein the tubular member includes a tapered profile such that the inner portion of the tubular member transitions from a first diameter at a first longitudinal position to a second diameter at a second longitudinal position, wherein the first diameter is greater than the second diameter.11 . An endoprosthesis delivery system comprising an endoprosthesis; and an endoprosthesis constraining sleeve configured to constrain the endoprosthesis, the endoprosthesis constraining sleeve including: a tubular member defining a main lumen extending longitudinally through the tubular member, wherein the tubular member is configured to at least partially evert such that the tubular member includes an inner portion and an outer portion; a first deployment line removably coupled to tubular member along at least a portion of a longitudinal length of the tubular member; and a second deployment line extending from the outer portion of the tubular member.

12. The endoprosthesis delivery system of claim 11 , wherein the tubular member includes a delivery configuration, an intermediate deployment configuration, and a full deployment configuration.

13. The endoprosthesis delivery system of claim 12, wherein the tubular member is operable to transition from the delivery configuration to the intermediate deployment configuration when the first deployment line is actuated and decoupled from the tubular member.

14. The endoprosthesis delivery system of either claim 12 or claim 13, wherein the tubular member is operable to transition from the intermediate deployment configuration to the full deployment configuration when the second deployment line is actuated to evert the inner portion of the tubular member.

15. The endoprosthesis delivery system of any one of claims 1 1-13, wherein the tubular member defines a plurality of lumens when the first deployment line is coupled to the tubular member.

16. A method of manufacturing a constraining sleeve comprising: providing a tubular member defining a main lumen extending longitudinally through the tubular member, the tubular member including a first longitudinal edge and a second longitudinal edge opposite the first longitudinal edge; everting a first longitudinal edge of the tubular member defining an inner portion and an outer portion; providing a fold in the tubular member along at least a portion of a longitudinal length of the tubular member; and coupling a first deployment line to the tubular member, the first deployment line and the fold defining at least a portion of at least one secondary lumen, the at least one secondary lumen having a smaller diameter than the main lumen.

17. The method of claim 16, further comprising removing material from the outer portion of the tubular member.

18. The method of any either claims 16 or 17, wherein removing material includes defining a plurality of strips in the outer portion.

19. The method of claim 18, forming a second deployment line from the plurality of strips.

20. The method of any one of claims 16-19, wherein providing the fold in the tubular member includes defining the fold to provide a parallel edges along a longitudinal length of the tubular member when the tubular member includes a tapered profile.