Multiple diameter 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 lateral edge, a second lateral edge opposite the first edge, and an intermediate portion defining a fold between the first lateral edge and the second lateral edge, a first line coupled to the sheet of material along at least a portion of the first lateral edge and the second lateral edge, and a second line coupled to the sheet of material along at least a portion of at least one of the first lateral edge and the second lateral edge and along at least a portion of the intermediate portion proximate the fold.

Description

MULTIPLE DIAMETER SLEEVECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of Provisional Application No. 63 / 564,056, filed March 12, 2024, which is incorporated herein by reference in its entirety for all purposes.FIELD

[0002] The present disclosure relates generally to endoprostheses delivery systems, and more particularly to an expandable multiple diameter sleeve for constraining and guiding an endoprostheses to desired locations.BACKGROUND

[0003] Many endoprostheses (or endoprosthetic devices), such as, for example, stent grafts, are constructed to reinforce, replace, bridge, or otherwise treat a part of a blood vessel. In many cases, endoprostheses are constrained within a covering member or sheath, and when the covering member is removed, as during deployment, the devices expand to assume a larger diameter.

[0004] Endoprosthesis delivery sleeves are used to guide and deliver the endoprosthesis to a target site within the body. Delivery sleeves must be compatible with a variety of endoprosthesis sizes and designs. Ensuring a secure fit and smooth delivery of the endoprosthesis while accommodating variations in device dimensions can be challenging. Delivery sleeves must be trackable through the vasculature and flexible enough to navigate through the blood vessels. In addition, the manufacturing of delivery sleeves is challenging because of the tight tolerances and demand for different designs. The present disclosure is addresses these and other needs.SUMMARY

[0005] The present disclosure includes an endoprosthesis delivery system comprising a constraining sleeve which is formed from a folded sheet of material which may be stitched together at various points. Advantageously, the constraining sleeve may employ a variety of folding patterns which create custom lumen sizes with different strength profiles. The manufacturing of such devices is efficient because a variety of sizes and strengths may be achieved starting from the samesheet of material.

[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 lateral edge, a second lateral edge opposite the first edge, and an intermediate portion defining a fold between the first lateral edge and the second lateral edge; a first line coupled to the sheet of material along at least a portion of the first lateral edge and the second lateral edge; and a second line coupled to the sheet of material along at least a portion of at least one of the first lateral edge and the second lateral edge and along at least a portion of the intermediate portion proximate the fold.

[0007] According to another example (Example 2) further to Example 1 , the first line is coupled to the sheet of material along at least a portion of the first edge and the second edge is configured such that the sheet of material defines a first lumen and wherein the second line is coupled along at least a portion of one of the first surface and the second surface and along the first surface adjacent the fold, wherein the second line defines a lumen smaller in circumference than the first lumen.

[0008] According to another example (Example 3) further to of any one of the preceding Examples, the second line is coupled to the sheet of material along at least a portion of at least one of the first edge and the second edge and along at least a portion of the intermediate portion proximate the fold is configured such that the sheet of material defines at least a second lumen.

[0009] According to another example (Example 4) further to any one of the preceding Examples, the endoprosthesis constraining sleeve is asymmetrical when the first line and second line are coupled to the sheet relative to a plane extending through the first line and the second line.

[0010] According to another example (Example 5) further to any one of the preceding Examples, the first and second edges are non-overlapping.

[0011] According to another example (Example 6) further to any one of the preceding Examples, the enlarged diameter of the endoprosthesis constraining sleeve is from 100% to 1000% greater than the constrained diameter of the endoprosthesis constraining sleeve.

[0012] According to another example (Example 7) further to any one of the preceding Examples, the sheet is formed from a flattened tubular member.

[0013] According to another example (Example 8) further to any one of the preceding Examples, the intermediate portion is folded over itself once such that the second line is coupled to the sheet of material along two portions of the intermediate portion.

[0014] According to another example (Example 9) further to any one of the preceding Examples, the intermediate portion is folded over itself twice such that the second line is coupled to the sheet of material along three portions of the intermediate portion.

[0015] According to another example (Example 10) further to any one of the preceding Examples, the intermediate portion is folded over itself three times such that the second line is coupled to the sheet of material along four portions of the intermediate portion.

[0016] 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 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 first line removably coupled to the sheet of material such that the sheet of material defines a first lumen; a second line removably coupled to the sheet of material such that the sheet of material defines at least a second lumen, wherein the endoprosthesis constraining sleeve is asymmetrical when the first line and the second line are coupled to the sheet relative to a plane extending through the first line and the second line.

[0017] According to another example (Example 12) further to Example 11 , the first lumen is associated with a first strength profile and the second lumen is associated with a second strength profile.

[0018] According to another example (Example 13) further to Example 11 or Example 12, the first strength profile is different from the second strength profile.

[0019] According to another example (Example 14) further to any one of Examples 11-13, the first line or second line is coupled to the sheet of material along a portion of the first edge which is shorter than the length of the first edge.

[0020] According to another example (Example 15) further to any one ofExamples 11-14, the first and second lines are sewn to the sheet of material.

[0021] According to another example (Example 16) further to Example 15, the first and second lines are sewn in a chain stitch.

[0022] According to another example (Example 17) a method of manufacturing an endoprosthesis constraining sleeve, includes positioning a sheet of material including a first surface, a second surface opposite the first surface, a first edge, a second edge opposite the first edge, and an intermediate portion defining a fold between the first edge and the second edge; folding the sheet of material such that the first edge and the second edge are positioned proximate each other; coupling at least a portion of the first edge to the second edge of the sheet of material; folding the sheet of material such that the intermediate portion, the first edge, and the second edge are positioned proximate each other; and coupling at least a portion of the intermediate portion to at least one of the first edge and the second edge of the sheet of material.

[0023] According to another example (Example 18) further to Example 17, the at least a portion of the first edge is coupled to the second edge with a first deployment line and wherein the at least a portion of the intermediate portion is coupled to at least one of the first edge and the second edge of the sheet of material with a second deployment line.

[0024] According to another example (Example 19) further to Example 18, the line is chain stitched.

[0025] According to another example (Example 20) further to any one of Examples 17-19, the sheet is an ePTFE membrane.

[0026] According to another example (Example 21 ) further to any one of Examples 17-20, the method further including folding the sheet of material multiple an additional 1 to 10 times before coupling the at least a portion of the intermediate portion to at least one of the first edge and the second edge of the sheet of material.

[0027] 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

[0028] 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.

[0029] FIG. 1 illustrates an endoprosthesis delivery system, in accordance with one embodiment of the disclosure.

[0030] FIG. 2A is a cross sectional view of a sleeve provided with multiple lumens and multiple stitch lines, in accordance with an embodiment.

[0031] FIG. 2B is a cross sectional view of a sleeve provided with multiple lumens and multiple stitch lines, in accordance with an embodiment.

[0032] FIG. 3 is a cross sectional view of the sleeve of FIG. 2A and 2B partially deployed to an intermediate configuration.

[0033] FIG. 4 illustrates first step in a method of manufacture in which a sleeve folded once, and an approximate stitch line is provided, in accordance with an embodiment.

[0034] FIG. 5 illustrates a subsequent step in the method of manufacture of the sleeve of FIG. 4, in which a sleeve is subsequently folded, and an approximate stitch line is provided.

[0035] 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.DETAILED DESCRIPTION

[0036] 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.

[0037] 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 arereasonably 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.

[0038] The terms "endoprosthetic device," "endoprosthesis," "vascular device," and the like can refer, throughout the specification and in the claims, to any medical device capable of being implanted and / or deployed within a body lumen. In various embodiments, an endoprosthesis can comprise a stent, a stent-graft, graft, a filter, an occluder, a balloon, a lead, and energy transmission device, a deployable patch, an indwelling catheter, and the like.

[0039] In addition, throughout this specification and claims, the delivery systems described herein can, in general, include an endoprosthesis constrained by a "covering member” or “sheath.” The covering member or sheath can, in various embodiments, comprise a sheet of material that is fitted about an endoprosthesis.

[0040] Further, throughout this specification and in the claims, the term "distal" refers to a relative location that is farther from a location in the body at which the medical device was introduced. Similarly, the term "distally" refers to a direction away from a location in the body at which the medical device was introduced.

[0041] The term "proximal" refers, throughout the specification and in the claims, to a relative location that is closer to the location in the body at which the medical device was introduced. Similarly, the term "proximally" refers to a direction towards a location in the body at which the medical device was introduced.

[0042] With continuing regard to the terms proximal and distal, this disclosure should not be narrowly construed with respect to these terms. Rather, the devices and methods described herein may be altered and / or adjusted relative to theanatomy of a patient.

[0043] As used herein, the term "constrain" may mean (i) to limit expansion, occurring either through self-expansion or expansion assisted by a device, of the diameter of an expandable implant, or (ii) to cover or surround, but not otherwise restrain, an expandable implant (e.g., for storage or biocompatibility reasons and / or to provide protection to the expandable implant and / or the vasculature).

[0044] Description of Various Embodiments

[0045] 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.

[0046] The endoprosthesis delivery system 100 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, the constraining sleeve 104 and deployment line 124 of the system shown in FIG. 1 may include the configurations of the constraining sleeve 104 and deployment line 124 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. 2-5. For example, the elongate member 102, endoprosthesis, and other components of the endoluminal delivery system 10 shown in FIG. 1 may be employed in connection with the sleeve 100 and deployment line 124 shown in FIGS. 2-5.

[0047] Referring to FIG. 1. an endoprosthesis delivery system 10 can include an elongate member 102 (e.g., a catheter), an endoprosthesis (not shown) (e.g., an expandable device including but not limited to a stent graft), a constraining sleeve 100 disposed about the endoprosthesis, and an end cap 106 adjacent to either the distal or proximal edge of the constraining sleeve 104. The constraining sleeve 104can extend beyond an end of the endoprosthesis.

[0048] In some embodiments, the endoprosthesis is delivered to a target site for implantation. The endoprosthesis may either be self-expanding or expandable (e.g., balloon expandable). When the endoprosthesis has been advanced to the target site within the vasculature of a patient, the endoprosthesis is deployed from the constraining sleeve 104 at the target site. In order to provide an accurate placement of the device, the endoprosthesis may be initially deployed to an intermediate diameter in order to allow the user to maintain the ability to further manipulate positioning of the endoprosthesis prior to full deployment. For example, the intermediate diameter is larger than the delivery diameter and smaller than the fully deployed diameter.

[0049] Referring to FIGS. 2A and 2B, a cross section of the constraining sleeve 104 is provided that facilitates constraining the endoprosthesis to a delivery diameter in the delivery configuration, to an intermediate diameter in the intermediate configuration, and to a delivery diameter when the constraining sleeve 104 in a released configuration (e.g., released from radially constraining the endoprosthesis. The constraining sleeve 104 may be provided as a single sheet of material (e.g., a film, membrane, etc.) which is folded over itself and secured with a plurality of deployment lines 206 and 208. The constraining sleeve 104 defines a plurality of lumens 210 and 214.

[0050] In some embodiments, the constraining sleeve 104 may be deployed to an intermediate configuration while navigating through a patient’s vasculature. This intermediate deployment may allow a physician to place the endoprosthesis more precisely in a difficult location. The intermediate diameters of the constraining sleeve 104 may be tuned depending on how many times the sheet of material is folded and the locations where the deployment lines are stitched. The ability to produce multiple constraining sleeves with different intermediate diameters is possible when starting from the same size of sheet material. From a manufacturing perspective, this feature is beneficial because it improves material efficiency, reduces cost, and streamlines the production process.

[0051] To remove the delivery system 100 from the body lumen of a patient, a physician can withdraw the elongate member 102 which will retract proximally through the covering member 104 with end cap 106.

[0052] In various embodiments, an endoprosthesis delivery system 100 canbe manufactured or constructed as follows. Generally, a wrapping procedure can be followed by positioning a suitable covering member 104 with a first edge 202, a second edge 204, and an intermediate portion 212. The covering member 104 may be folded over itself such that the first edge 202 and second edge 204 are proximate to each other. Then, at least a portion of the first edge 202 may be coupled to at least a portion of the second edge 204 using stitch line 206 as shown in FIG. 3. Next, the covering member 104 may be folded again such that the intermediate portion 212, the first edge 202, and the second edge 204 are all proximate to each other. Then, at least a portion of the intermediate portion 212 may be coupled to at least a portion of at least one of the first edge 202 or the second edge 204, as shown in FIG. 2A.

[0053] Referring to FIGS.1-3, the endoprosthesis delivery system 100 may comprise an endoprosthesis (not shown) and a constraining sleeve 104 configured to constrain the endoprosthesis. The constraining sleeve 104 includes a sheet of material including a first surface 203, a second surface 205 opposite the first surface, a first edge 202, a second edge 204 opposite the first edge. The first surface 203 faces a first direction that is opposite a second direction in which the second surface 205 faces. For example, in some embodiments, the sheet of material is a flat sheet of material such as a membrane or a 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 203 and 205 facing away from each other. The first edge 202 is defined at one end of the sheet of material and the second edge 204 is defined at an opposite end of the sheet of material. The edges 202, 204 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. An intermediate portion 216 of the sheet of material defines a fold 212 between the first edge 202 and the second edge 204. The fold 212 may be positioned along the sheet of material at any position between the first edge 202 and the second edge 204. The fold 212 may be defined at a single position along the intermediate portion 216 or may be defined along a length of at least a portion of the intermediate portion 216. The fold 212 does not necessarily have to be defined at a midpoint between the edges 202, 204, but may be at any position and along any length along the intermediate portion 216. This provides the ability to provide various diameters of the deployment system 100 for the deployment and / or intermediateconfigurations and is discussed in greater detail hereafter. The endoprosthesis delivery system 100 further includes a first line 206 is coupled to the sheet of material along at least a portion of the first edge 202 and the second edge 204. The first deployment line 206 couples the first and second edges 202, 204 such that a lumen 210 is defined by the sheet of material. The first deployment line 202, 204 may be sewed along or near the first and second edges 202, 204, either parallel or at an angle to the first and second edges 202, 204. The endoprosthesis delivery system 100 further includes a second deployment line 208 coupled to the sheet of material along at least a portion of at least one of the first edge 204 and the second edge 202 and along at least a portion of the intermediate portion 216 proximate the fold. The second deployment line 204 couples the first edge 204, the second edge 202, and a portion of the intermediate portion 212 proximate to the fold 212 such that a lumen 214 is defined by the sheet of material. The second deployment line 208 may be sewed along or near the first and second edges 204 and 202, and a portion of the intermediate portion 216, either parallel to or at an angle to the first and second edges 202, 204. The lumen 210 is configured to maintain the endoprosthesis in an intermediate configuration when the lumen 210 is in an expanded configuration.

[0054] In some embodiments, the constraining sleeve 104 may be asymmetrical when the first line 206 and second line 208 are coupled to the sheet relative to a plane 250 extending through the first line and the second line (FIG. 2A).

[0055] FIG. 2B depicts another configuration of the constraining sleeve 104. As shown therein, the fold with intermediate portion 212 points upwards away from lumens 214 and 210.

[0056] In other embodiments, the first and second edges 204 and 202 may be non-overlapping. When the edges are non-overlapping, they do not touch or cross over each over when the constraining sleeve 104 is folded over itself. For example, as shown in FIG. 4, the edges of the folded sheet of material are parallel to each other and do not overlap.

[0057] Once a user deploys the endoprosthesis delivery sleeve by pulling the first deployment line 206, the endoprosthesis will enlarge until it fills the volume of lumen 210 (FIG. 3) The diameter of the constraining sleeve 104 in its intermediate deployment as shown in FIG. 3 may be from about 100% to about 1000% greater than the diameter of the constraining sleeve 104 in the delivery configuration (FIG.2A). For example, the diameter of the constraining sleeve 104 in the intermediate configuration is from about 100% to about 200%, from about 200% to about 300%, from about 300% to about 400%, from about 400% to about 500%, from about 500% to about 600%, from about 600% to about 700%, from about 700% to about 800%, from about 800% to about 900%, and from about 900% to about 1000% greater than the diameter of the constraining sleeve 104 in the delivery configuration.

[0058] In some embodiments, the intermediate portion 216 of the endoprosthesis constraining sleeve 104 may be folded over itself once, twice, three, or four times forming multiple lumens. As shown in FIG. 2A and FIG. 5, folding the constraining sleeve 104 over itself two times forms two lumens 210 and 214.

[0059] Referring again to FIG. 2A, the present disclosure also encompasses an endoprosthesis delivery system 100 comprising an endoprosthesis and an endoprosthesis constraining sleeve 104. The endoprosthesis constraining sleeve 104 is configured to constrain the endoprosthesis. The endoprosthesis constraining sleeve 104 includes a sheet of material including a first surface 205 and a second surface 203 opposite the first surface. The endoprosthesis constraining sleeve 104 also includes a first edge 202, and a second edge 204 opposite the first edge and on the same sheet of material. A first deployment line 206 may be removably coupled to the sheet of material such that the sheet of material defines a first lumen 210 and a second deployment line 208 may be removably coupled to the sheet of material such that the sheet of material defines at least a second lumen 214. In some embodiments, the endoprosthesis constraining sleeve 104 is asymmetrical when the first line 202 and the second line 204 are coupled to the sheet relative to a plane 250 extending through the first line deployment line 202 and second deployment line 204 (FIG. 2A and 2B). As shown in FIGS. 2A and 2B, the plane 250 extends through the approximate stitch line 208. The first and second lumens 210, 214 are representative of the space defined by the folds and stitch lines. Each of the first and second lumens 210, 214 may be implemented for different deployment sequences and / or sizes. For example, the first lumen 210 may be implemented such that the endoprosthesis can be constrained in a delivery configuration and then expanded and constrained to an intermediate configuration when the second deployment line 208 is released. The endoprosthesis may then further expand for a deployed configuration when the first deployment line 206 is released. The second lumen 214 may be implemented when an endoprosthesis needs to be constrained only to adelivery configuration and can be released from the delivery configuration to the deployed configuration. The first and second lumens 210, 214 may be implemented together such that a first endoprosthesis is positioned in the first lumen 210 and a second endoprosthesis is positioned in the second lumen 214. It is understood that a plurality of lumens may be provided by including additional folds and deployment lines.

[0060] In some embodiments, the first lumen 210 and second lumen 214 may be associated with different strength profiles. In some embodiments, the strength profile of the first lumen 210 in the fully constrained sleeve may be higher to withstand the full compression of the endoprosthesis. Advantageously, this allows for the constraining sleeve 104 to be tailored to precisely constrain any specific endoprosthesis.

[0061] The deployment lines 202 and 204 may be coupled to the sheet of material along a portion of the first edge which is shorter than the length of the first edge. In some embodiments, they may be sewn to the sheet of material. In some embodiments, the sewing may be in the form of a chain stitch.

[0062] Referring to FIG. 3, a cross section of endoprosthesis delivery system 100 in its intermediate deployment is shown. In this configuration, covering member 104 is coupled to itself with stitch line 206 along as least a portion of first edge 202 and at least a portion of second edge 204. This coupling forms the first lumen 210 which may house the endoprosthesis (not shown). Once the delivery system is maneuvered to the correct position in a patient’s body, stitch line 206 may be removed allowing the covering member 104 to open completely and deploy the endoprosthesis.

[0063] The present disclosure also provides a method for manufacturing an endoprosthesis constraining sleeve.

[0064] Referring to FIGS.1-3, the method of manufacturing includes positioning a sheet of material including a first surface 203, a second surface 205 opposite the first surface 203, a first edge 202, a second edge 204 opposite the first edge, and an intermediate portion 212 defining a fold between the first edge and the second edge. Referring to FIGS. 3 and 4, the first step may involve folding the sheet of material such that the first edge 202 and the second edge 204 are positioned proximate each other; coupling at least a portion of the first edge to the second edge of the sheet of material. This first folding and coupling step forms lumen 210 asshown in FIG. 3 Next, the sheet of material may be folded such that the intermediate portion 212, the first edge 202, and the second edge 204 are positioned proximate each other. Referring to FIGS. 2 and 5, the edges 202 and 204 may be coupled to at least a portion of the intermediate portion and to at least one of the first edge 202 and the second edge 204 of the sheet of material.

[0065] In some embodiments, at least a portion of the first edge 202 is coupled to the second edge 204 with a first deployment line and wherein at least a portion of the intermediate portion is coupled to at least one of the first edge 202 and the second edge 204 of the sheet of material with a second deployment line. These deployment lines may be chain stitched to the sheet of material in the approximate locations shown by lines 206 and 208 in FIGS. 4 and 5.

[0066] In the manufacturing method, the sheet of material may be folded an additional 1 to 10 times before coupling the at least a portion of the intermediate portion to at least one of the first edge and the second edge of the sheet of material.

[0067] In some embodiments, the endoprosthesis may be a stent, graft, or stent-graft configured to replace or support a missing or damaged part of the body. The endoprosthesis may be made up of any material which is suitable for use in the chosen body lumen. In addition, the endoprosthesis may comprise multiple layers of material, which can be the same or different.

[0068] In some embodiments, the sheet of material includes an expanded polytetrafluoroethylene (ePTFE) base layer. In some of such embodiments, the sheet of material may include a thermoplastic coating on one side of the ePTFE base layer. In some embodiments, the sheet of material includes a fluorinated ethylene propylene (FEP) layer. In some embodiments, the sheet of material is formed of ePTFE, polyester, polyurethane, fluoropolymers, such as perfouorelastomers 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 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 may include various constructions, including films, laminates, membranes, tapes, and so forth.

[0069] In some embodiments, the first or second deployment lines 206 and208 may be formed of various materials. For example, the deployment lines 206 and 208 may be formed of any material suitable for sutures such as ePTFE, nylon, polypropylene, surgical cotton, surgical silk, surgical steel, polyester, and so forth.

[0070] 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

CLAIMSWhat 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 lateral edge, a second lateral edge opposite the first edge, and an intermediate portion defining a fold between the first lateral edge and the second lateral edge; a first line coupled to the sheet of material along at least a portion of the first lateral edge and the second lateral edge; and a second line coupled to the sheet of material along at least a portion of at least one of the first lateral edge and the second lateral edge and along at least a portion of the intermediate portion proximate the fold.

2. The endoprosthesis delivery system of claim 1 , wherein the first line is coupled to the sheet of material along at least a portion of the first edge and the second edge is configured such that the sheet of material defines a first lumen and wherein the second line is coupled along at least a portion of one of the first surface and the second surface and along the first surface adjacent the fold, wherein the second line defines a lumen smaller in circumference than the first lumen.

3. The endoprosthesis delivery system of any one of the preceding claims, wherein the second line is coupled to the sheet of material along at least a portion of at least one of the first edge and the second edge and along at least a portion of the intermediate portion proximate the fold is configured such that the sheet of material defines at least a second lumen.

4. The endoprosthesis delivery system of any one of the preceding claims, wherein the endoprosthesis constraining sleeve is asymmetrical when the first line and second line are coupled to the sheet relative to a plane extending through the first line and the second line.

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

6. The endoprosthesis delivery system of any one of the preceding claims, wherein the enlarged diameter of the endoprosthesis constraining sleeve is from 100% to 1000% greater than the constrained diameter of the endoprosthesis constraining sleeve.

7. The endoprosthesis delivery system of any one of the preceding claims, wherein the sheet is formed from a flattened tubular member.

8. The endoprosthesis delivery system of any one of the preceding claims, wherein the intermediate portion is folded over itself once such that the second line is coupled to the sheet of material along two portions of the intermediate portion.

9. The endoprosthesis delivery system of any one of the preceding claims, wherein the intermediate portion is folded over itself twice such that the second line is coupled to the sheet of material along three portions of the intermediate portion.

10. The endoprosthesis delivery system of any one of the preceding claims, wherein the intermediate portion is folded over itself three times such that the second line is coupled to the sheet of material along four portions of the intermediate portion.

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 first line removably coupled to the sheet of material such that the sheet of material defines a first lumen; a second line removably coupled to the sheet of material such that the sheet of material defines at least a second lumen,wherein the endoprosthesis constraining sleeve is asymmetrical when the first line and the second line are coupled to the sheet relative to a plane extending through the first line and the second line.

12. The endoprosthesis delivery system of claim 11 , wherein the first lumen is associated with a first strength profile and the second lumen is associated with a second strength profile.

13. The endoprosthesis delivery system of either claim 11 or claim 12, wherein the first strength profile is different from the second strength profile.

14. The endoprosthesis delivery system of any one of claims 11-13, wherein the first line or second line is coupled to the sheet of material along a portion of the first edge which is shorter than the length of the first edge.

15. The endoprosthesis delivery system of any one of claims 11-14, wherein the first and second lines are sewn to the sheet of material.

16. The endoprosthesis delivery system of claim 15, wherein the first and second lines are sewn in a chain stitch.

17. A method of manufacturing an endoprosthesis constraining sleeve, comprising: positioning a sheet of material including a first surface, a second surface opposite the first surface, a first edge, a second edge opposite the first edge, and an intermediate portion defining a fold between the first edge and the second edge; folding the sheet of material such that the first edge and the second edge are positioned proximate each other; coupling at least a portion of the first edge to the second edge of the sheet of material; folding the sheet of material such that the intermediate portion, the first edge, and the second edge are positioned proximate each other; and coupling at least a portion of the intermediate portion to at least one of the first edge and the second edge of the sheet of material.

18. The method of claim 17, wherein the at least a portion of the first edge is coupled to the second edge with a first deployment line and wherein the at least a portion of the intermediate portion is coupled to at least one of the first edge and the second edge of the sheet of material with a second deployment line.

19. The method of claim 18, wherein the line is chain stitched.

20. The method of any one of claims 17-19, wherein the sheet is an ePTFE membrane.21 . The method of any one of claims 17-20, further comprising folding the sheet of material multiple an additional 1 to 10 times before coupling the at least a portion of the intermediate portion to at least one of the first edge and the second edge of the sheet of material.