Constraining sleeve

Abstract

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 edge portion and a second edge portion opposite the first edge portion, a first line coupled to the sheet of material along at least a portion of the first edge portion, and a second line coupled to the sheet of material along at least a portion of the second edge, wherein the first and the second lines are releasably interconnected, wherein the first line is operable to remain coupled to the first edge portion of the sheet of material and the second line is operable to remain coupled to the second edge portion of the sheet of material when the first line and the second line are released from each other.

Description

CONSTRAINING SLEEVECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of Provisional Application No. 63 / 564,065, 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 sheet of material including a first edge portion and a second edge portion opposite the first edge portion; a first line coupled to the sheet of material along at least a portion of the first edge portion; and a second line coupled to the sheet of material along at least a portion of the second edge, wherein the first and the second lines are releasably interconnected, wherein the first line is operable to remain coupled to the first edge portion of the sheet of material and the second line is operable to remain coupled to the second edge portion of the sheet of material when the first line and the second line are released from each other.

[0006] According to another example (Example 2), further to Example 1 , wherein the sheet of material includes a first side and a second side opposite the first side, wherein the first side and the second side extend between the first and second edge portions, and wherein the first line passes through the sheet of material from the first side to the second side.

[0007] According to another example (Example 3), further to any one of the preceding Examples, wherein the second line passes through the sheet of material from the first side to the second side.

[0008] According to another example (Example 4), further to any one of the preceding Examples, wherein the first and second lines each define a plurality of loops that are interconnected to define a warp knit when positioned on the first side.

[0009] According to another example (Example 5), further to Example 4, wherein the sheet of material is operable to evert at a position proximate each loop of the plurality of loops as each loop is released from the warp knit.

[0010] According to another example (Example 6), further to Example 5, wherein each of the first and second lines each pass through the sheet of material along the first and second edge portions respectively at positions proximate each loop of the plurality of loops.

[0011] According to another example (Example 7), further to either Example 4 or Example 5, wherein each of the first and second lines each pass through the sheet of material approximately two times for each loop of the plurality of loops.

[0012] According to another example (Example 8), further to any one of Examples 4-6, wherein loops of the first and second lines interact such that the firstand second lines are actuated simultaneously to effectuate sequential release of the loops along a longitudinal length of the sheet of material.

[0013] According to another example (Example 9), further to any one of the preceding Examples, wherein at least one of the first line and the second line is operable to remain coupled to the sheet of material when the at least one of the first line and second line is actuated to release the endoprosthesis from the endoprosthesis constraining sleeve.

[0014] According to another example (Example 10), further to Example 9, wherein the at least one of the first line and the second line is operable to remain coupled to the sheet of material at a plurality of positions along one of the first edge portion and the second edge portion when the at least one of the first line and second line is actuated to release the endoprosthesis from the endoprosthesis constraining sleeve.

[0015] According to another example (Example 11 ), further to any one of the preceding Examples, further comprising an elongate member about which the endoprosthesis is constrained, wherein the sheet of material includes a first longitudinal end and a second longitudinal end, and wherein the second longitudinal end of the sheet of material is coupled to the elongate member such that after the first and second lines are released from each other and are coupled to the first and second edge portions of the sheet of material respectively, the sheet of material is held against the elongate member when the sheet of material is an everted configuration as tension is applied to the first and second lines.

[0016] According to another example (Example 12), further to any one of the preceding Examples, wherein the first and second lines are releasably interconnected to define one of a warp knit and a chain stitch.

[0017] According to another example (Example 13), 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 edge portion and a second edge portion opposite the first edge portion; and at least one line releasably coupled to the first and second edge portions of the sheet of materials, wherein the at least one line is configured to be actuated to release, and wherein the sheet of material everts at a position proximate each loop of the plurality of loops as each loop is released from the warp knit.

[0018] According to another example (Example 14), further to Example 13, wherein the at least one line is sewn through the sheet of material in a straight stitch.

[0019] According to another example (Example 15), further to either Example 13 or Example 14, wherein the at least one line includes loops on a first side of the sheet of material at positions at which the straight stitch is positioned on the first side of the sheet of material.

[0020] According to another example (Example 16), further to any one of Examples 13-15, wherein the at least one line passes through the sheet of material approximately two times for each loop of the plurality of loops.

[0021] According to another example (Example 17), further to Example 16, wherein the at least one line includes a first line coupled to the first edge portion of the sheet of material and a second line coupled to the second edge portion of the sheet of material, wherein loops of the first and second lines interact such that the first and second lines are operable to be actuated simultaneously to effectuate sequential release of the loops along a longitudinal length of the sheet of material.

[0022] According to another example (Example 18), a method of manufacturing a constraining sleeve includes providing a sheet of material including a first side, a second side opposite the first side, a first edge portion, and a second edge portion opposite the first edge portion; coupling a first line to the first edge portion of the sheet of material; coupling a second line to the second edge portion of the sheet of material; and defining a first plurality of loops in the first line on the first side of the sheet of material; defining a second plurality of loops in the second line on the first side of the sheet of material; and releasably coupling the first plurality of loops and the second plurality of loops.

[0023] According to another example (Example 19), further to Example 18, further comprising coupling a second longitudinal end of the sheet of material to an elongate member.

[0024] According to another example (Example 20), further to either Example 18 or Example 19, wherein coupling the first line to the first edge portion includes sewing the first line in a first straight stitch, and wherein coupling the second line to the second edge portion includes sewing the second line in a second straight stitch.

[0025] According to another example (Example 21 ), further to Example 20, wherein defining the first plurality of loops includes defining the first plurality of loops in the first line along sections of the first line at which the first straight stitch ispositioned on the first side of the sheet of material and defining the second plurality of loops includes defining the second plurality of loops in the second line along sections of the second line at which the second straight stitch is positioned on the second side of the sheet of material.

[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 two deployment lines, in accordance with an embodiment;

[0030] FIG. 3 is side view of the constraining sleeve of FIG. 2, in accordance with an embodiment;

[0031] FIGS. 4A-4D is an illustration of a constraining sleeve in which the constraining sleeve everts as the deployment lines are actuated in accordance with an embodiment;

[0032] FIGS. 5A-5D are a deployment sequence of a constraining sleeve which partially everts and uses a single deployment line, in accordance with an embodiment.DETAILED DESCRIPTIONDefinitions and Terminology

[0033] 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.

[0034] 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

[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.

[0036] 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 line200 of the delivery system 10 shown in FIG. 1 may include the configurations of the sheet 100 and deployment line 200 described with reference to FIGS. 2-4. 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. 2-4. 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. 2-4.

[0037] 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.

[0038] 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.

[0039] 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 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. The sheet 100 defines a lumen 102 when coupled to the deployment line(s) 200, the lumen 102 being configured toaccommodate the endoprosthesis 14. The constraining sleeve 16 provided herein is capable of releasing the endoprosthesis 14 from the delivery configuration and being removeable from the patient after delivery of the endoprosthesis 14. The disclosure provided herein relates to the devices, systems, and methods for facilitating deployment of the endoprosthesis 14 and removal of the constraining sleeve 16 from the patient in contrast to other systems which may be configured to release an endoprosthesis from a delivery configuration and which leave the constraining sleeve within the patient (e.g., sandwiched between the endoprosthesis 14 and the tissue wall of the patient, such as a vessel wall).

[0040] The constraining sleeve 16 includes a first end 20 and a second end 22 which correspond to a first longitudinal end 104 and a second longitudinal end 106 of the sheet 100. The lumen 102 is defined along a longitudinal length of the constraining sleeve 16 between the first longitudinal end 104 and the second longitudinal end 106. The deployment line(s) 200 is(are) 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.

[0041] The sheet 100 further includes a first side 112 and a second side 114 (FIG. 3). When the sheet 100 is assembled with the deployment line(s) 200 to define the constraining sleeve 16, the first side 112 is configured to be positioned facing generally inward and defines a boundary of the lumen 102 and the second side 114 faces generally outward (e.g., away from the endoprosthesis 14). The first side 112 faces a first direction that is opposite a second direction in which the second side 114 faces. For example, in some embodiments, the sheet of material 100 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 sides 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.

[0042] Referring still to FIG. 2, the constraining sleeve 16 includes a first deployment line 200A coupled to the sheet of material 100 along at least a portion of the first edge 108 and a second deployment line 200B coupled to the sheet of material 100 along at least a portion of the second edge 110. The first and second deployment lines 200A, 200B are coupled to each other, and together with the sheet of material 100 define the constraining sleeve 16 in the form of a tubular member. The first and second deployment lines 200A, 200B are coupled to each other along at least a portion of the longitudinal length of the constraining sleeve 16. The coupling of the first and second deployment lines 200A, 200B is a releasable coupling such that the first and second deployment lines 200A, 200B can be selectively released from each other to allow for the constraining sleeve 16 to open in order to deploy the endoprosthesis 14. For example, the first and second deployment lines 200A, 200B may be releasably coupled to each other in a warp knit along at least a portion of the length of the constraining sleeve 16. It is noted that at least one of the first and second deployment lines 200A, 200B is configured to remain coupled to the sheet 100 after release of the endoprosthesis 14 from the constraining sleeve 16 and is discussed in more detail herein. This facilitates the ability to use at least one of the deployment lines 200A, 200B, to manipulate the sheet 100 after deployment of the endoprosthesis 14 (e.g., for removal of the constraining sleeve 16 from the body of the patient).

[0043] In some embodiments, at least one of the first deployment line 200A and the second deployment line 200B is operable to remain coupled to the sheet of material 100 after the actuation and disengagement of the constraining sleeve 16. For example, when the first deployment line 200A is coupled to the sheet of material 100 along at least a portion of the first edge 108, the first deployment line 200A remains coupled to the sheet of material 100 after the first and second deployment lines 200A, 200B are released from each other. Additionally, the second deployment line 200B may remain coupled to the sheet of material 100 after the first and second deployment lines 200A, 200B are released from each other. The first and second deployment lines 200A, 200B may be coupled to the respective edges 108, 110 by sewing the deployment lines 200A, 200B through the sheet of material. For example, the sheet of material 100 includes the first side 112 and a second side 114 opposite the first side 112 (FIG. 3). The first deployment line 200A passes through the sheet of material 100 from the first side 112 to the second side 114. The first deploymentline 200A passes through the sheet of material 100 at various positions along the longitudinal length of the constraining sleeve 16 such that the first deployment line 200A is coupled to the sheet of material at various positions along the length of the constraining sleeve 16. Similarly, the second deployment line 200B may pass through the sheet of material 100 from the first side 112 to the second side 114. The second deployment line 200B may pass through the sheet of material 100 at various positions along the longitudinal length of the constraining sleeve 16 such that the second deployment line 200B is coupled to the sheet of material at various positions along the length of the constraining sleeve 16. The first and second deployment lines 200A, 200B may be coupled to the sheet of material 100 in a sliding engagement such that the first and second deployment lines 200A, 200B are capable of at least longitudinal movement through the sheet of material 100 at the positions through which the first and second deployment lines 200A, 200B are coupled to the sheet of material 100. In some embodiments, the sheet of material 100 and / or the deployment lines 200 may be configured to provide some resistance to the sliding engagement. This may be accomplished by the sizing of apertures on the sheet of material 100 through which the deployment lines 200 extend (apertures being the same size or smaller than the diameter of the deployment lines 200), material types of the sheet of material 100 and / or deployment lines 200 or coatings that increase friction between the sheet of material 100 and the deployment lines 200 (e.g., a tacky coating), patterns of sewing the deployment lines 200 through the sheet of materials, and combinations thereof.

[0044] Referring to FIGS. 2 and 3, the first and second deployment lines 200A, 200B define a plurality of loops 202 that are interconnected to define a warp knit when positioned on the first side 112 of the sheet of material 100. The loops 202 are selectively, and sequentially releasable from each other as the deployment lines 200 are actuated in order to release or unravel the loops 202 from engagement with each other. The loops 202 may be formed or provided during sewing of the lines 200 through the sheet of material 100 or may be formed or provided in a process after the lines 200 have been sewn through the sheet of material 100.

[0045] In some embodiments, the loops 202 are provided near or proximate locations at which the deployment lines 200 are coupled to the sheet of material 100. For example, in some embodiments, each loop 202 is defined between two positions at which the deployment line 200 extends through the sheet of material 100.Because each loop 202 is positioned proximate coupling positions, as the deployment lines 200 are actuated to release the constraining sleeve 16 from the endoprosthesis 14, the sheet of material 100 may also be pulled toward the direction in which the deployment lines are actuated. In some embodiments, when the delivery system 10 is positioned such that the plurality of loops 202 release from a proximal end (e.g., the first end 20) of the constraining sleeve 16 toward the distal end (e.g., the second end 20) of the constraining sleeve 16, the sheet of material 100 is pulled with the deployment lines 200. For example, the sheet of material 100 may be positioned such that as the loops 202 are released, the portions of the sheet of material 100 that are proximate the loops 202 that are being released are pulled away from the portions of the endoprosthesis 14 that are released. In some embodiments, the sheet of material 100 everts as the constraining sleeve 16 is released. The position at which the transition to the everted portion of the sheet of material 100 occurs is proximate the position at which the loops 202 are being released. This allows the loops 202 to be progressively released as the sheet of material 100 progressively everts. Because the sheet of material 100 is everting progressively, this allows the sheet of material 100 to be removed from a position at which it may be pinned or sandwiched between the endoprosthesis 14 and tissue at the target site. Because the deployment lines 200 pass through the sheet of material 100 at positions proximate each loop 202, the deployment lines 200 coupling positions ensure that as the loops 202 are released, the sheet of material 100 is also follows the pathway of the deployment lines 200 after release of the loops 202. In some embodiments, each deployment line 200 is coupled to (e.g., passes through) the sheet of material 100 twice for each time a loop 202. In some of these embodiments, each loop 202 is flanked or surrounded on each side by a position at which the deployment line 200 is coupled to (e.g., passes through) the sheet of material 100.

[0046] In some embodiments, the respective loops 202 of the first and second deployment lines 200 are interacting (e.g., warp knit) such that the first and second deployment lines 200A, 200B are configured to be actuated substantially simultaneously to effectuate sequential release of the loops 202 along a longitudinal length of the sheet of material 100. For example, the warp knit would limit uncontrolled release of the constraining sleeve 16 if only one of the deployment lines200 is actuated. This provides a safeguard against uncontrolled deployment of the device during delivery.

[0047] Referring to FIG. 4D, the delivery system 10 includes an elongate member 12 (e.g., a catheter) about which the endoprosthesis 14 may be constrained. In some embodiments, the sheet of material 100 includes the first longitudinal end 104 (e.g., a proximal end) and the second longitudinal end 106 (e.g., a distal end), wherein the second longitudinal end 106 of the sheet of material 100 is coupled to the elongate member 12. In use, when the second longitudinal end 106 of the sheet of material 100 is coupled to the elongate member 12, and after the first and second deployment lines 200A, 200B are released from each other and are coupled to the sheet of material 100 along at least a portion of the first and second edges 108, 110, the sheet of material 100 is fully or nearly-fully everted such that the first side 112 is positioned facing outward and the second side 114 is positioned facing inward. The sheet of material 100 can be held against the elongate member 12 when coupled to the elongate member 12 after the constraining sleeve 16 is released. The sheet of material 100 is held in an everted configuration as tension is applied to the first and second deployment lines 200A, 200B. This allows for the delivery system 10 to be removed in a compact manner with the constraining sleeve 16 after the endoprosthesis 14 has been released and implanted.

[0048] Referring still to FIG. 4D, the relationship between the sheet of material 100 and the deployment lines 200 is illustrated. In some embodiments, the deployment lines 200 may be coupled to the sheet of material using a straight stitch. As the deployment lines 200 alternate between the first side 112 and the second side 114 via the straight stitch, the loops 202 are formed in the deployment lines 200 on one of the first side 112 and the second side 114. Although illustrated herein as the loops being formed on one side of the sheet of material, it is contemplated that loops could be formed on either the first side 112 or the second side 114, or a combination thereof.

[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 side 112, a second side 114 opposite the first side 112, a first edge 108, and a second edge 110 opposite the first edge 108. A first deployment line 200A is coupled to the first edge 108 of thesheet of material 100. A second deployment line 200B is coupled to the second edge 110 of the sheet of material 100. A first plurality of loops 202 are defined in the first deployment line 200A on the first side 112 of the sheet of material 100 and a second plurality of loops 202 are defined in the second line 200B on the first side 112 of the sheet of material 100. The first plurality and second plurality of loops 202 are warp knit together to define a seam along at least a portion of the longitudinal length of the constraining sleeve 16. In some embodiments, coupling the first and second deployment lines 200A, 200B includes coupling the first deployment line 200A to the first edge 108 by sewing the first deployment line 200A in a first straight stitch and the second deployment line 200B to the second edge 110 by sewing the second deployment line 200B in a second straight stitch. For example, in some embodiments, defining the first plurality of loops 202 includes defining the first plurality of loops 202 in the first deployment line 200A along sections of the first deployment line 200A at which the first straight stitch is positioned on the first side 112 of the sheet of material 100 and additionally defining the second plurality of loops 202 includes defining the second plurality of loops 202 in the second deployment line 200B along sections of the second deployment line 200B at which the second straight stitch is positioned on the second side 114 of the sheet of material 100. The straight stitches need not be in a straight line or parallel to each other, but indicate the type of stitch, which was previously discussed.

[0050] In some embodiments, the systems and methods discussed herein may be accomplished implementing other coupling patterns (e.g., other than warp knitting). For example, a chain stitch may be implemented. The first deployment line 200A may be coupled to the sheet of material 100. As the chain stitch is released, the first deployment line 200A may be retained by a portion of the sheet of material 100 which may evert as discussed herein.

[0051] It is understood that the eversion of the sheet of material 100 does not have to extend an entire length of the device or sheet of material 100. This may be limited via a sleeve stop (e.g., the sheet of material 100 being coupled directly to the device) or the deployment line(s) may rip through the sheet of material 100 to cease eversion of the sheet of material 110. For example, referring to FIGS. 5A-5D, a deployment sequence of a one a single deployment line (first deployment line 200A) is implemented and is coupled to the sheet of material 100 via a chain stitch. As the first deployment line 200A is actuated, the seam is released and the sheet ofmaterial 100 partially everts. The sheet of material 100 everts until a sleeve stop 300, at which point the first deployment line 200A continues to release but the sheet of material ceases eversion.

[0052] In some embodiments, the method includes coupling a second longitudinal end 106 to an elongate member 12 (e.g., a catheter). This arrangement facilitates removal as previously discussed.

[0053] In 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.

[0054] 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.

[0055] 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 sheet of material including a first edge portion and a second edge portion opposite the first edge portion; a first line coupled to the sheet of material along at least a portion of the first edge portion; and a second line coupled to the sheet of material along at least a portion of the second edge, wherein the first and the second lines are releasably interconnected, wherein the first line is operable to remain coupled to the first edge portion of the sheet of material and the second line is operable to remain coupled to the second edge portion of the sheet of material when the first line and the second line are released from each other.

2. The endoprosthesis delivery system of claim 1 , wherein the sheet of material includes a first side and a second side opposite the first side, wherein the first side and the second side extend between the first and second edge portions, and wherein the first line passes through the sheet of material from the first side to the second side.

3. The endoprosthesis delivery system of any one of the preceding claims, wherein the second line passes through the sheet of material from the first side to the second side.

4. The endoprosthesis delivery system of any one of the preceding claims, wherein the first and second lines each define a plurality of loops that are interconnected to define a warp knit when positioned on the first side.

5. The endoprosthesis delivery system of claim 4, wherein the sheet of material is operable to evert at a position proximate each loop of the plurality of loops as each loop is released from the warp knit.

6. The endoprosthesis delivery system of claim 5, wherein each of the first and second lines each pass through the sheet of material along the first and second edge portions respectively at positions proximate each loop of the plurality of loops.

7. The endoprosthesis delivery system of either claim 4 or claim 5, wherein each of the first and second lines each pass through the sheet of material approximately two times for each loop of the plurality of loops.

8. The endoprosthesis delivery system of any one of claims 4-6, wherein loops of the first and second lines interact such that the first and second lines are actuated simultaneously to effectuate sequential release of the loops along a longitudinal length of the sheet of material.

9. The endoprosthesis delivery system of any one of the preceding claims, wherein at least one of the first line and the second line is operable to remain coupled to the sheet of material when the at least one of the first line and second line is actuated to release the endoprosthesis from the endoprosthesis constraining sleeve.

10. The endoprosthesis delivery system of claim 9, wherein the at least one of the first line and the second line is operable to remain coupled to the sheet of material at a plurality of positions along one of the first edge portion and the second edge portion when the at least one of the first line and second line is actuated to release the endoprosthesis from the endoprosthesis constraining sleeve.11 . The endoprosthesis delivery system of any one of the preceding claims, further comprising an elongate member about which the endoprosthesis is constrained, wherein the sheet of material includes a first longitudinal end and a second longitudinal end, and wherein the second longitudinal end of the sheet of material is coupled to the elongate member such that after the first and second lines are released from each other and are coupled to the first and second edge portions of the sheet of material respectively, the sheet of material is held against the elongate member when the sheet of material is an everted configuration as tension is applied to the first and second lines.

12. The endoprosthesis delivery system of any one of the preceding claims, wherein the first and second lines are releasably interconnected to define one of a warp knit and a chain stitch.

13. 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 edge portion and a second edge portion opposite the first edge portion; and at least one line releasably coupled to the first and second edge portions of the sheet of materials, wherein the at least one line is configured to be actuated to release, and wherein the sheet of material everts at a position proximate each loop of the plurality of loops as each loop is released from the warp knit.

14. The endoprosthesis delivery system of claim 13, wherein the at least one line is sewn through the sheet of material in a straight stitch.

15. The endoprosthesis delivery system of either claim 13 or claim 14, wherein the at least one line includes loops on a first side of the sheet of material at positions at which the straight stitch is positioned on the first side of the sheet of material.

16. The endoprosthesis delivery system of any one of claims 13-15, wherein the at least one line passes through the sheet of material approximately two times for each loop of the plurality of loops.

17. The endoprosthesis delivery system of claim 16, wherein the at least one line includes a first line coupled to the first edge portion of the sheet of material and a second line coupled to the second edge portion of the sheet of material, wherein loops of the first and second lines interact such that the first and second lines are operable to be actuated simultaneously to effectuate sequential release of the loops along a longitudinal length of the sheet of material.

18. A method of manufacturing a constraining sleeve comprising: providing a sheet of material including a first side, a second side opposite the first side, a first edge portion, and a second edge portion opposite the first edge portion; coupling a first line to the first edge portion of the sheet of material; coupling a second line to the second edge portion of the sheet of material; and defining a first plurality of loops in the first line on the first side of the sheet of material; defining a second plurality of loops in the second line on the first side of the sheet of material; and releasably coupling the first plurality of loops and the second plurality of loops.

19. The method of claim 18, further comprising coupling a second longitudinal end of the sheet of material to an elongate member.

20. The method of either claim 18 or claim 19, wherein coupling the first line to the first edge portion includes sewing the first line in a first straight stitch, and wherein coupling the second line to the second edge portion includes sewing the second line in a second straight stitch.21 .The method of claim 20, wherein defining the first plurality of loops includes defining the first plurality of loops in the first line along sections of the first line at which the first straight stitch is positioned on the first side of the sheet of material and defining the second plurality of loops includes defining the second plurality of loops in the second line along sections of the second line at which the second straight stitch is positioned on the second side of the sheet of material.