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 sheet of material including a first surface, a second surface opposite the first surface, a first edge, and a second edge opposite the first edge, and a deployment line coupled to the sheet of material along at least a portion of the first edge and along at least a portion of the second edge, wherein the sheet of material defines a lumen for receiving the endoprosthesis, and wherein the first surface of the sheet of material is facing toward the lumen at the first and second edges and the second surface of the sheet of material is facing away from the lumen at the first and second edges.

Description

CONSTRAINING SLEEVECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of Provisional Application No. 63 / 564,044, 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 provide simplified manufacture and deployment of delivery systems.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.

[0004] 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 interstices. They can be designed to expand when a restraint, such as a sleeve is removed or be balloon-expanded from a deliverydiameter to a pre-determined functional diameter. During delivery, the endoprostheses 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 must be constrained to limit resistance to advancement, damage to surrounding tissue, and so forth. Thus, systems and methods for providing delivery systems with reduced diameters for delivery of endoprostheses are needed.SUMMARY

[0005] The present disclosure relates to constraining sleeves and deployment systems that are configured to deliver and release endoprostheses at a target location. The constraining sleeves and deployment systems provide for a reduced delivery profile.

[0006] 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 sheet of material including a first surface, a second surface opposite the first surface, a first edge, and a second edge opposite the first edge, and a deployment line coupled to the sheet of material along at least a portion of the first edge and along at least a portion of the second edge, wherein the sheet of material defines a lumen for receiving the endoprosthesis, and wherein the first surface of the sheet of material is facing toward the lumen at the first and second edges and the second surface of the sheet of material is facing away from the lumen at the first and second edges.

[0007] According to one example (“Example 2”), further to Example 1 , the first and second edges are non-overlapping.

[0008] According to one example (“Example 3”), further to any one of the preceding Examples, the deployment line includes a stitched portion and a nonstitched portion,

[0009] According to one example (“Example 4”), further to Example 3, at least a portion of the non-stitched portion is positioned within the lumen.

[0010] According to one example (“Example 5”), further to Example 3, the stitched portion is warp knit.

[0011] According to one example (“Example 6”), further to any one of thepreceding Examples, the first and second edges are overlapping.

[0012] According to one example (“Example 7”), further to Example 6, the deployment line is chain stitched.

[0013] According to one example (“Example 8”), further to Example 7, the deployment line includes a chain stitch at a stitched portion.

[0014] According to one example (“Example 9”), further to Example 8, the chain stitch defines looped portions on one of an interior side and an exterior side of the constraining sleeve.

[0015] According to one example (“Example 10”), further to Example 9, the looped portions of the chain stitch are positioned on an exterior side of the constraining sleeve and a non-stitched portion of the deployment line is positioned extending through at least a portion of the lumen of the constraining sleeve.

[0016] According to one 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 sheet of material including a first surface, a second surface opposite the first surface, a first edge, and a second edge opposite the first edge; and a deployment line coupled to the sheet of material along at least a portion of the first edge and along at least a portion of the second edge, the deployment line includes loops defining a warp knit along at least a portion of a length along the first and second edges.

[0017] According to one example (“Example 12”), further to Example 11 , the first and second edges are non-overlapping.

[0018] According to one example (“Example 13”), further to either further to Example 11 or further to Example 12, the deployment line includes a stitched portion and a non-stitched portion,

[0019] According to one example (“Example 14”), further to Example 13, at least a portion of the non-stitched portion is positioned within a lumen defined by the sheet of material.

[0020] According to one example (“Example 15”), further to any one of Examples 11-15, the first and second edges are overlapping.

[0021] According to one example (“Example 16”), further to any one of Examples 11-16, the first and second edges are abutting each other.

[0022] According to one example (“Example 17”), a method of manufacturinga constraining sleeve includes providing a sheet of material including a first surface, a second surface opposite the first surface, a first edge, and a second edge opposite the first edge; positioning the sheet of material such that the first edge and the second edge are facing each other and the sheet of material defines a lumen, wherein the first surface of the sheet of material is facing toward the lumen at the first and second edges and the second surface of the sheet of material is facing away from the lumen at the first and second edges; and coupling a deployment line to the sheet of material along at least a portion of a longitudinal length of the first and second edges of the sheet of material, wherein the sheet of material and the deployment line define a constraining sleeve.

[0023] According to one example (“Example 18”), further to Example 17, coupling the deployment line includes forming a knit along the longitudinal length of the sheet of material.

[0024] According to one example (“Example 19”), further to Example 17, coupling the deployment line includes forming a chain stitch along the longitudinal length of the sheet of material.

[0025] According to one example (“Example 20”), further to of any one of Examples 17-19, further comprising everting the constraining sleeve.

[0026] 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

[0027] 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.

[0028] FIG. 1 is an illustration of an embodiment of a delivery system including a constraining sleeve constraining an endoprosthesis, in accordance with an embodiment;

[0029] FIG. 2 is an illustration of an embodiment of a constraining sleeve defined by a sheet of material and a deployment line, in accordance with an embodiment;

[0030] FIGS. 3A-3D are sectional views of constraining sleeves in various configurations, in accordance with various embodiments;

[0031] FIGS. 4A and 4B are top views of constraining sleeves implementing a warp knit to releasably couple edges of a sheet of material, in accordance with various embodiments;

[0032] FIGS. 5A and 5B are top views of constraining sleeves implementing a chain stitch to releasably coupled edges of a sheet of material, wherein FIG. 5B shows the constraining sleeve inverted, in accordance with various embodiments; and

[0033] FIG. 6 illustrates a cross sectional view of a constraining sleeve implementing a chain stitch to releasably coupled edges of a sheet of material, in accordance with an embodiment.DETAILED DESCRIPTIONDefinitions and Terminology

[0034] This disclosure is not meant to be read in a restrictive manner. For example, the terminology used in the application should be read broadly in the context of the meaning those in the field would attribute such terminology.

[0035] 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 individualshaving 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

[0036] 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.

[0037] The deployment 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 14 defined by a sheet 100 and deployment line 200 of the deployment system 10 shown in FIG. 1 may include the configurations of the sheet 100 and deployment line 200 described with reference to FIGS. 2-6. 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. 2-6. For example, the elongate member 12, implantable device 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. 2-6.

[0038] 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.

[0039] In some embodiments, the endoprosthesis 14 is delivered to a targetsite for implantation. The endoprosthesis 14 may either 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.

[0040] 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 release of 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 sheet of material 100 (e.g., a film, membrane, etc.) with a deployment line 200. The sheet 100 defines a lumen 102 when coupled to the deployment line 200, the lumen 102 configured to accommodate the endoprosthesis 14.

[0041] The constraining sleeve 16 includes a first end 20 and a second end 22 which correspond to a first end 104 and a second end 106 of the sheet 100. The lumen 102 is defined along a longitudinal length of the constraining sleeve 16 between the first end 104 and the second end 106. The deployment line 200 is releasably coupled to the sheet 100 along a first edge 108 and a second edge 110. The first and second edges 108, 110 are positioned adjacent to each other when the sheet is coupled to the deployment line 200 to define the lumen 102, the first and second edges 108, 110 extending along at least a portion of the longitudinal length of the constraining sleeve 16.

[0042] The sheet 100 further includes a first surface 112 and a second surface 114 (see FIGS. 3A-3D). The first surface 112 is configured to be positioned facing inward and defines a boundary of the lumen 102 and the second surface 114 faces outward when the sheet is coupled to the deployment line 200 to define the constraining sleeve 16. The first surface 112 faces a first direction that is opposite a second direction in which the second surface 114 faces. For example, in some embodiments, the sheet of material is a flat sheet of material such as a membrane ora film. In some embodiments, the sheet of material is a tubular member that is flattened to form a flat sheet, wherein the flattened tubular member defines the first and second surfaces 112 , 114 facing away from each other. The first edge 108 is defined at one end of the sheet of material and the second edge 110 is defined at an opposite end of the sheet of material. The edges 108, 110 may represent the ends of the sheet of material (e.g., the ends of a membrane or film) or may represent ends defined by folds of a tubular member.

[0043] FIG. 2 depicts one embodiment of the deployment line 200, where the deployment line is coupled to the sheet 100 along the first and second edges 108, 110. Referring to FIGS. 3A-3D, in some embodiments, when the deployment line 200 is coupled to the sheet along or proximate the first and second edges 108, 110, the first surface 112 of the sheet 100 is facing toward the lumen 102 at the first and second edges 108, 110 and the second surface 114 of the sheet 100 is facing away from the lumen 102 at the first and second edges 108, 110. This facilitates the ability to reduce the profile of the constraining sleeve 16 by allowing the first surface 112 of the sheet 100 to sit flush or substantially flush against the endoprosthesis 14 in the constrained configuration. The reduced profile allows for the delivery system 10 to include a more compact delivery configuration for navigation and advancement through biological lumens of a patient. Chain stitched or other sleeves in which the ends of a sheet of material are coupled together such that the first or second surface are constrained to themselves creates a protrusion (e.g., mohawk) either on the exterior side of the constraining sleeve 16 or a protrusion into the lumen, both of which may result in increased diameter of the delivery system. Thus, the systems and devices discussed herein provide for reduced diameter of the delivery system 10. Additionally, the delivery system 10 may reduce snagging of endoprostheses and / or tissue on the sheet 100 or deployment line 200 during delivery.

[0044] Referring to FIGS. 3B and 3C, in some embodiments, the first and second edges 108, 110 are non-overlapping. In these embodiments, the first and second edges 108, 110 may be spaced from each other over at least a portion of the first and second edges 108, 110 (see FIG. 3B), may be spaced along an entire length of the first and second edges 108, 110, or may be abutting along a portion or an entire length of the first and second edges 108, 110 (see FIG. 3C). However, to reduce the profile of the delivery system 10, the first and second edges 108, 110 are non-overlapping, meaning that the first and second edges 108, 110 are non-overlapping along a circumference of the endoprosthesis 14. Stated otherwise, the first and second edges 108, 110 are non-overlapping such that the sheet 100 does not overlap about a circumference and the first surface 112 does not contact the second surface 114 when in the delivery configuration.

[0045] Referring to FIG. 3D, in some embodiments, the first and second edges 108, 110 may overlap along at least a portion of the length of the first and second edges 108, 110. When the first and second edges 108, 110 overlap, the sheet is configured such that the first and second surface 112, 114 are still oriented as previously discussed. For example, the first surface 112 may be oriented or facing toward the lumen 102 and the second surface 114 may be oriented toward an exterior of the delivery system (e.g., substantially radially outward). By having the first and second edges 108, 110 overlapping, the endoprosthesis 14 may be fully, circumferentially surrounded by the sheet 100 such that the endoprosthesis 14 is not exposed to biological lumen walls during delivery. FIG. 3A depicts one way in which the deployment line 200 may be coupled to the sheet 100 at the first and second edges 108, 110. Although this is one method of coupling the deployment line 200 to the sheet 100, it is understood that various other methods may be implemented to arrive at the configurations as depicted and described herein. For example, FIG. 3A depicts the deployment line 200 coupled to the sheet 100 at the first and second edges 108, 110 in a first orientation in which the first and second edges 108, 110 are brought close together and are positioned such that the first surface 112 and the second surface 114 are facing each other at the first and second edges 108, 110. However, the stitch that is implemented via the deployment line 200 facilitates rotation and / or movement of the deployment line 200 with respect to the sheet 100 that allows the first and second edges 108, 110 to slide down to any of the positions described with respect to FIGS. 3B-3C, such that the first surface 112 is facing toward the lumen 102 at the first and second edges 108, 110 and the second surface is facing outward (e.g., radially outward) from the first and second edges 108, 110.

[0046] Referring again to FIG. 2, in some embodiments the deployment line 200 includes a stitched portion 202 and a non-stitched portion 204. The stitched portion 202 is the portion of the deployment line 200 that is coupled to (e.g., directly coupled, sewn through, and so forth) the sheet 100. The stitched portion 202 is releasable such that the deployment line 200 can be released from the sheet 100 and the endoprosthesis 14 is free to deploy (e.g., self-expand, balloon expanded,and so forth). The non-stitched portion 204 is a portion of the deployment line 200 that is not coupled directly to the sheet 100 such that the non-stitched portion 204 extends away from the sheet 100. The non-stitched portion 204 extends such that a user can access the non-stitched portion 204 in order to apply a force to deploy the endoprosthesis 14. For example, the non-stitched portion 204, when actuated, facilitates release of the stitched portion 202 from the sheet 100. The stitched portions 202 that are released from the sheet 100 are still continuous with the deployment line 200 and thus transition from being stitched portions 202 to being non-stitched portions 204 as they are released from the sheet. The non-stitched portion 204 may extend from the stitched portion 202 either back across at least a portion of the length of the sheet 100. The non-stitched portion 204 may extend through or exterior to the lumen 102 formed by the sheet. This allows the endoprosthesis 14 to be deployed from a proximal end toward a distal end. It is understood that the direction of sewing may be provided in various directions (e.g., such that the endoprosthesis 14 can deploy from a distal end toward a proximal end or other combination) and is therefore not limited to the specific directions discussed herein. It is also understood that the sheet 100 may include predefined apertures (see FIG. 1) through which the stitched portion 202 extends or the deployment line 200 may be stitched directly into the sheet 100.

[0047] In some embodiments, the stitched portion 202 of the deployment line 200 may be coupled to the sheet 100 in a warp knit pattern. The warp knit pattern facilitates the ability of the deployment line 200 to be released by pulling on the non- stitched portion 204. That is, the deployment line 200 is provided and coupled to the sheet 100 such that the deployment line 200 holds the first and second edges 108, 110 together at the positions at which the deployment line 200 is coupled to the sheet 100 (e.g., stitched portions 202) and the portions of the deployment line 200 extending away from the sheet (e.g., the non-stitched portions 204) can be actuated to release the stitched portions 202 from the sheet 100. In some embodiments, this is accomplished using a warp knit such that the stitched portion 202 of the deployment line 200 is stitched through or coupled to the sheet 100 in such a way that the stitched portion 202 of the deployment line 200 is warp knit.

[0048] Referring to FIGS. 5A-6, in some embodiments, the deployment line 200 is flat stitched on the sheet 100. For example, the stitched portion 202 of the deployment line 200 is coupled to the sheet 100 along the first and second edges108, 110 in a flat stitched configuration that is releasable from the sheet for deployment of the endoprosthesis 14 from the deployment system 10. In some embodiments, the stitched portion is a chain stitch. Referring to FIGS. 5A and 5B, the sheet 100 may be arranged such that the looped portions 210 of the chain stitch are positioned on either the exterior side of the sheet 100 (see FIG. 5A) or on an interior side of the sheet (see FIG. 5B). When the looped portions 210 are positioned on the exterior side of the sheet 100, the non-stitched portion 204 extends from the interior side of the sheet 100. This may be used to facilitate the deployment line extending through at least a portion of the lumen 102. This allows the non-stitched portion 204 to be protected within the lumen 102 during deployment such that the deployment line is not damaged or does not cause damage to biological tissue at the target site during deployment. Alternatively, when the looped portions 210 are positioned on the interior side (e.g., when the constraining sleeve 16 is everted), the non-stitched portion 204 extend on an exterior side of the tubular member defined by the sheet 100. This arrangement may be advantageous in embodiments in which there is increased chances of the deployment line 200 snagging or damaging an endoprosthesis that is positioned within the lumen 102.

[0049] Turning to a discussion of a method of manufacture, in some embodiments, a constraining sleeve 16 may be manufactured using a sheet of material 100 as discussed herein and a deployment line 200 as discussed herein. As previously included, the sheet of material 100 includes a first surface 112, a second surface 114 opposite the first surface 112, a first edge 108, and a second edge 110 opposite the first edge 108. The sheet of material 100 is positioned such that the first edge 108 and the second edge 110 are facing each other and the sheet of material 100 defines a lumen 102, wherein the first surface 112 of the sheet of material is facing toward the lumen 102 at the first and second edges 108, 110 and the second surface 114 of the sheet of material 100 is facing away from the lumen 102 at the first and second edges 108, 110. The deployment line 200 is then coupled to the sheet of material 100 along at least a portion of a longitudinal length of the first and second edges 108, 110 of the sheet of material 100, wherein the sheet of material 100 and the deployment line 200 define a constraining sleeve 16.

[0050] In some embodiments, the method includes forming a knit or stitch along the longitudinal length of the sheet of material 100. The knit or stitch may be those described previously herein. For example, in some embodiments, coupling thedeployment line 200 includes forming a chain stitch along the longitudinal length of the sheet of material 100. The method may further include everting the constraining sleeve 16.

[0051] 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.

[0052] 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.

[0053] 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:1 . An endoprosthesis delivery system comprising: an endoprosthesis; and an endoprosthesis constraining sleeve configured to constrain the endoprosthesis, the endoprosthesis constraining sleeve including: a sheet of material including a first surface, a second surface opposite the first surface, a first edge, and a second edge opposite the first edge; and a deployment line coupled to the sheet of material along at least a portion of the first edge and along at least a portion of the second edge, wherein the sheet of material defines a lumen for receiving the endoprosthesis, and wherein the first surface of the sheet of material is facing toward the lumen at the first and second edges and the second surface of the sheet of material is facing away from the lumen at the first and second edges.

2. The endoprosthesis delivery system of claim 1 , wherein the first and second edges are non-overlapping.

3. The endoprosthesis delivery system of any one of the preceding claims, wherein the deployment line includes a stitched portion and a non-stitched portion,4. The endoprosthesis delivery system of claim 3, wherein at least a portion of the nonstitched portion is positioned within the lumen.

5. The endoprosthesis delivery system of claim 3, wherein the stitched portion is warp knit.

6. The endoprosthesis delivery system of any one of the preceding claims, wherein the first and second edges are overlapping.

7. The endoprosthesis delivery system of claim 6, wherein the deployment line is chain stitched.

8. The endoprosthesis delivery system of claim 7, wherein the deployment line includes a chain stitch at a stitched portion.

9. The endoprosthesis delivery system of claim 8, wherein the chain stitch defines looped portions on one of an interior side and an exterior side of the constraining sleeve.

10. The endoprosthesis delivery system of claim 9, wherein the looped portions of the chain stitch are positioned on an exterior side of the constraining sleeve and a nonstitched portion of the deployment line is positioned extending through at least a portion of the lumen of the constraining sleeve.11 . An endoprosthesis delivery system comprising: an endoprosthesis; and an endoprosthesis constraining sleeve configured to constrain the endoprosthesis, the endoprosthesis constraining sleeve including: a sheet of material including a first surface, a second surface opposite the first surface, a first edge, and a second edge opposite the first edge; and a deployment line coupled to the sheet of material along at least a portion of the first edge and along at least a portion of the second edge, wherein the deployment line includes loops defining a warp knit along at least a portion of a length along the first and second edges.

12. The endoprosthesis delivery system of claim 11 , wherein the first and second edges are non-overlapping.

13. The endoprosthesis delivery system of either claim 11 or claim 12, wherein the deployment line includes a stitched portion and a non-stitched portion,14. The endoprosthesis delivery system of claim 13, wherein at least a portion of the non-stitched portion is positioned within a lumen defined by the sheet of material.

15. The endoprosthesis delivery system of any one of claims 11-15, wherein the first and second edges are overlapping.

16. The endoprosthesis delivery system of any one of claims 11-16, wherein the first and second edges are abutting each other.

17. A method of manufacturing a constraining sleeve comprising: providing a sheet of material including a first surface, a second surface opposite the first surface, a first edge, and a second edge opposite the first edge; positioning the sheet of material such that the first edge and the second edge are facing each other and the sheet of material defines a lumen, wherein the first surface of the sheet of material is facing toward the lumen at the first and second edges and the second surface of the sheet of material is facing away from the lumen at the first and second edges; and coupling a deployment line to the sheet of material along at least a portion of a longitudinal length of the first and second edges of the sheet of material, wherein the sheet of material and the deployment line define a constraining sleeve.

18. The method of claim 17, wherein coupling the deployment line includes forming a knit along the longitudinal length of the sheet of material.

19. The method of claim 17, wherein coupling the deployment line includes forming a chain stitch along the longitudinal length of the sheet of material.

20. The method of any one of claims 17-19, further comprising everting the constraining sleeve.