restraining sleeve

Abstract

An endoprosthesis delivery system includes an endoprosthesis and an endoprosthesis restraining sleeve configured to restrain the endoprosthesis. The endoprosthesis restraining sleeve includes a sheet material including a first edge portion and a second edge portion opposite the first edge portion, a first line coupled to the sheet material along at least a portion of the first edge portion, and a second line coupled to the sheet material along at least a portion of the second edge, wherein the first line and the second line are releasably interconnected, wherein when the first line and the second line are released from one another, the first line is operable to remain coupled to the first edge portion of the sheet material and the second line is operable to remain coupled to the second edge portion of the sheet material.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of Provisional Application No. 63 / 564,065, filed on March 12, 2024, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0003] This disclosure generally relates to apparatuses, systems, and methods for restraining and delivering embedded prostheses. More specifically, this disclosure relates to apparatuses, systems, and methods for providing restraint sleeves that reduce the overall diameter of the delivery system and / or facilitate removal of the restraint sleeves after implantation of the embedded prosthesis. Background Technology

[0004] Intravascular prostheses used to treat a patient's vascular system treatment area are typically delivered via a delivery system that includes a catheter. Such intravascular prostheses may include, for example, expandable implants. Expandable intravascular prostheses may consist of graft or stent components, with or without the graft covering them. They can be designed to expand upon removal of restraints such as sleeves, or to expand from a delivery diameter balloon to a predetermined functional diameter. During delivery, the intravascular prosthesis typically needs to be restrained to a smaller diameter to allow delivery from the distal insertion site to the target site. To advance the intravascular prosthesis through a lumen (e.g., the vascular system), it is typically restrained to limit advance resistance, damage to surrounding tissues, etc. Therefore, systems and methods are needed to provide delivery systems for delivering intravascular prostheses. Summary of the Invention

[0005] This disclosure relates to a constraint sleeve and delivery system configured to deliver and release an embedded prosthesis at a target location. The constraint sleeve and delivery system provide a reduced delivery profile.

[0006] According to one example (“Example 1”), an embedded prosthesis delivery system includes: an embedded prosthesis; and an embedded prosthesis restraint sleeve configured to restrain the embedded prosthesis, the embedded prosthesis restraint sleeve including a sheet including a first edge portion and a second edge portion opposite to the first edge portion; a first thread coupled to the sheet along at least a portion of the first edge portion; and a second thread coupled to the sheet along at least a portion of the second edge portion, wherein the first thread and the second thread are releasably connected to each other, wherein when the first thread and the second thread are released from each other, the first thread is operable to remain coupled to the first edge portion of the sheet, and the second thread is operable to remain coupled to the second edge portion of the sheet.

[0007] According to another example (“Example 2”) that goes further than Example 1, the sheet includes a first side and a second side opposite to the first side, wherein the first side and the second side extend between a first edge portion and a second edge portion, and wherein a first line passes through the sheet from the first side to the second side.

[0008] According to another example (“Example 3”) that goes further than any of the preceding examples, the second line passes through the sheet from the first side to the second side.

[0009] According to another example (“Example 4”) that goes further than any of the preceding examples, the first and second lines each define a plurality of loops that are interconnected when positioned on the first side to define the warp knitting.

[0010] According to another example (“Example 5”) that goes further than Example 4, the sheet can be operated to flip at a position adjacent to each of the multiple loops when each loop is released from the warp knitting.

[0011] According to another example (“Example 6”) that goes further than Example 5, the first line and the second line pass through the sheet at locations adjacent to each of the plurality of loops along the first edge portion and the second edge portion, respectively.

[0012] According to another example (“Example 7”) that goes further than Example 4 or Example 5, the first and second threads each pass through the sheet approximately twice for each of the plurality of loops.

[0013] According to another example (“Example 8”) that goes further than any of Examples 4 to 6, the loops of the first and second lines interact such that the first and second lines are simultaneously actuated to achieve the sequential release of the loops along the longitudinal length of the sheet.

[0014] According to another example (“Example 9”) that goes further than any of the preceding examples, wherein when at least one of the first and second lines is actuated to release the built-in prosthesis from the built-in prosthesis restraint sleeve, at least one of the first and second lines is operable to remain connected to the sheet.

[0015] According to another example (“Example 10”) that goes further than Example 9, wherein when at least one of the first line and the second line is actuated to release the built-in prosthesis from the built-in prosthesis restraint sleeve, at least one of the first line and the second line is operable to remain connected to the sheet at multiple locations along one of the first edge portion and the second edge portion.

[0016] According to another example (“Example 11”) that goes further than any of the foregoing examples, an elongated member is also included, around which a built-in prosthesis is constrained, wherein the sheet includes a first longitudinal end and a second longitudinal end, and wherein the second longitudinal end of the sheet is coupled to the elongated member such that after the first line and the second line are released from each other and coupled to the first edge portion and the second edge portion of the sheet respectively, when tension is applied to the first line and the second line, the sheet is held against the elongated member in a flipped configuration.

[0017] According to another example (“Example 12”) that goes further than any of the preceding examples, the first and second threads are releasably connected to each other to define one of warp knitting and chain stitch.

[0018] According to another example (“Example 13”), an embedded prosthesis delivery system includes: an embedded prosthesis; and an embedded prosthesis restraint sleeve configured to restrain the embedded prosthesis, the embedded prosthesis restraint sleeve including a sheet including a first edge portion and a second edge portion opposite to the first edge portion; and at least one thread releasably coupled to the first edge portion and the second edge portion of the sheet, wherein the at least one thread is configured to be actuated to release, and wherein when each loop is released from the warp knitting, the sheet flips at a position adjacent to each of the plurality of loops.

[0019] According to another example (“Example 14”) that goes further than Example 13, at least one line is stitched through the sheet with straight stitches.

[0020] According to another example (“Example 15”) that goes further than Example 13 or Example 14, at least one line includes a loop located on the first side of the sheet at a position where the straight stitch is positioned on the first side of the sheet.

[0021] According to another example (“Example 16”) that goes further than any of Examples 13 to 15, for each of the plurality of loops, at least one line passes through the sheet approximately twice.

[0022] According to another example (“Example 17”) that is further than Example 16, at least one line includes a first line connected to a first edge portion of the sheet and a second line connected to a second edge portion of the sheet, wherein the loops of the first line and the second line interact such that the first line and the second line can be operated to be simultaneously actuated to achieve sequential release of the loops along the longitudinal length of the sheet.

[0023] According to another example (“Example 18”), a method of manufacturing a constraint sleeve includes: providing a sheet including a first side, a second side opposite to the first side, a first edge portion, and a second edge portion opposite to the first edge portion; attaching a first line to the first edge portion of the sheet; attaching a second line to the second edge portion of the sheet; defining a plurality of first loops in the first line on the first side of the sheet; defining a plurality of second loops in the second line on the first side of the sheet; and releasably attaching the plurality of first loops and the plurality of second loops.

[0024] According to another example (“Example 19”) that goes further than Example 18, it also includes attaching a second longitudinal end of the sheet to an elongated member.

[0025] According to another example (“Example 20”) that goes further than Example 18 or Example 19, joining the first line to the first edge portion includes suturing the first line with a first straight stitch, and joining the second line to the second edge portion includes suturing the second line with a second straight stitch.

[0026] According to another example (“Example 21”) that goes further than Example 20, the plurality of first loops are defined by a segment of a first line positioned along a first straight stitch on a first side of the sheet, which defines the plurality of first loops in the first line, and the plurality of second loops are defined by a segment of a second line positioned along a second straight stitch on a second side of the sheet, which defines the plurality of second loops in the second line.

[0027] The foregoing examples are merely illustrative and should not be construed as limiting or otherwise narrowing the scope of any inventive concept separately provided in this disclosure. While several examples have been disclosed, other embodiments will become apparent to those skilled in the art from the detailed implementation shown and described below of the illustrative examples. Therefore, the drawings and detailed implementation should be considered illustrative rather than restrictive. Attached Figure Description

[0028] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and, together with the specification, serve to explain the principles of the present disclosure.

[0029] Figure 1 This is an illustration of an embodiment of a delivery system, which includes a constraint sleeve that constrains a built-in prosthesis; Figure 2 This is an illustration of an embodiment of a constraint sleeve defined by a sheet and two unfolded lines; Figure 3 According to one embodiment Figure 2 Side view of the constraint sleeve; Figures 4A to 4D This is an illustration of a constraint sleeve according to one embodiment, wherein the constraint sleeve flips when the unfolding line is actuated; Figures 5A to 5D According to one embodiment, the constraint sleeve is unfolded in a sequence that is partially flipped and uses a single unfolding line. Detailed Implementation

[0030] Definitions and Terms

[0031] This disclosure should not be read in a restrictive manner. For example, the terminology used herein should be read broadly in the context in which a person skilled in the art would assign meaning to such terms.

[0032] Regarding imprecise terms, "about" and "approximately" may be used interchangeably to refer to a measurement that includes the stated measurement value and also any measurement reasonably close to it. A measurement reasonably close to the stated measurement value deviates from the stated measurement value by a reasonably small amount, as understood and readily determined by a person skilled in the art. For example, such deviations may be attributed to measurement errors, differences in the calibration of measuring and / or manufacturing equipment, human error in reading and / or setting the measurement value, fine-tuning to optimize performance and / or structural parameters due to measurement differences related to other components, specific implementation scenarios, imprecise adjustments and / or manipulations of the object by humans or machines, etc. If it is determined that a person skilled in the art would not readily determine the value of such a reasonably small difference, then "about" and "approximately" may be understood as the value plus or minus 10%.

[0033] Description of various embodiments

[0034] Those skilled in the art will readily understand that various aspects of this disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale but may be exaggerated to illustrate various aspects of this disclosure; in this regard, the drawings should not be construed as limiting.

[0035] Figure 1 The delivery system 10 shown is provided as an example of various features of the systems and devices discussed herein, and while combinations of those features shown are clearly within the scope of the invention, this example and its illustrations are not intended to imply that the inventive concepts provided herein are limited to those shown. Figure 1 The features shown include one or more features, additional features, or alternative features. For example, in various embodiments, by Figure 1 The constraint sleeve 16 defined by the sheet 100 and unfolding line 200 of the delivery system 10 shown may include reference Figure 2The configuration of the sheet 100 and the unfolding lines 200 is shown in Figure 4. It should also be understood that the reverse is also true. Figure 1 One or more components depicted may be attached to or replaced. Figure 2 Use it for the components depicted in Figure 4. For example, Figure 1 The elongated member 12, the built-in prosthesis 14 (e.g., an internal prosthesis), and other components of the delivery system 10 shown in the figure can be coupled with Figure 2 The sheet 100 and the unfolding line 200 shown in Figure 4 are used together.

[0036] Reference Figure 1 The delivery system 10 may include an elongated member 12 (e.g., a catheter), an internal prosthesis 14 (e.g., an expandable device including but not limited to a stent graft), a restraint sleeve 16 disposed around the internal prosthesis 14, and an end cap 18 adjacent to the distal or proximal edge of the restraint sleeve 16. The restraint sleeve 16 may extend beyond the end of the internal prosthesis 14.

[0037] In some embodiments, the built-in prosthesis 14 is delivered to a target site for implantation. The built-in prosthesis 14 may be self-expanding, expandable (e.g., balloon-expandable), or otherwise implantable at the target location. As the built-in prosthesis 14 has been advanced to the target site within the patient's vascular system, it unfolds from the restraint sleeve 16 at the target site. Because some vascular systems are relatively narrow, the components of the delivery system 10 need to be compact to allow for non-invasive and easier navigation within the vascular system. This includes reducing the size of the built-in prosthesis 14 and the restraint sleeve 16 when the built-in prosthesis 14 is in a restrained configuration. The restraint sleeve 16 is configured to reduce its radial profile during delivery.

[0038] Reference Figure 2 A constraint sleeve 16 is provided that facilitates constraining the built-in prosthesis 14 to the delivery diameter in a delivery configuration, and releasing the built-in prosthesis 14 to the unfolding diameter when the constraint sleeve 16 is in a release configuration (e.g., released from radially constrained built-in prosthesis 14). The constraint sleeve 16 may be provided as a sheet 100 (e.g., film, membrane, etc.) along with at least one unfolding line 200. Figure 2As shown, the restraint sleeve 16 includes a first deployment line 200A and a second deployment line 200B. When coupled to the deployment line 200, the sheet 100 defines a lumen 102 configured to receive the implanted prosthesis 14. The restraint sleeve 16 provided herein enables the release of the implanted prosthesis 14 from a delivery configuration and removal from the patient after delivery of the implanted prosthesis 14. The disclosure provided herein relates to apparatus, systems, and methods for facilitating the deployment of the implanted prosthesis 14 and the removal of the restraint sleeve 16 from the patient, in contrast to other systems that can be configured to release the implanted prosthesis from a delivery configuration and leave the restraint sleeve within the patient (e.g., clamped between the implanted prosthesis 14 and the patient's tissue wall, such as a blood vessel wall).

[0039] The constraint sleeve 16 includes a first end 20 and a second end 22, corresponding to a first longitudinal end 104 and a second longitudinal end 106 of the sheet 100. A lumen 102 is defined along the longitudinal length of the constraint sleeve 16 between the first longitudinal end 104 and the second longitudinal end 106. One or more unfolding lines 200 are releasably coupled to the sheet 100 along a first edge 108 and a second edge 110. When the sheet is coupled to the unfolding lines 200 to define the lumen 102, the first edge 108 and the second edge 110 are positioned adjacent to each other, extending along at least a portion of the longitudinal length of the constraint sleeve 16.

[0040] Sheet 100 also includes a first side 112 and a second side 114 ( Figure 3 When sheet 100 is assembled with one or more unfolded lines 200 to define a constraint sleeve 16, a first side 112 is configured to face generally inward and define the boundary of the lumen 102, and a second side 114 faces generally outward (e.g., away from the built-in prosthesis 14). The first side 112 faces a first direction opposite to a second direction facing the second side 114. For example, in some embodiments, sheet 100 is a flat sheet, such as a membrane or film. In some embodiments, the sheet is a tubular member flattened to form a flat sheet, wherein the flattened tubular member defines a first side 112 and a second side 114 opposite to each other. A first edge 108 is defined at one end of the sheet, and a second edge 110 is defined at the opposite end of the sheet. Edges 108, 110 may represent ends of the sheet (e.g., ends of a membrane or film) or may represent ends defined by folds in the tubular member.

[0041] Continue to refer to Figure 2The restraint sleeve 16 includes a first unfolded line 200A connected to the sheet 100 along at least a portion of a first edge 108, and a second unfolded line 200B connected to the sheet 100 along at least a portion of a second edge 110. The first unfolded line 200A and the second unfolded line 200B are interconnected and, together with the sheet 100, define the restraint sleeve 16 in the form of a tubular member. The first unfolded line 200A and the second unfolded line 200B are interconnected along at least a portion of the longitudinal length of the restraint sleeve 16. The connection of the first unfolded line 200A and the second unfolded line 200B is a releasable connection, such that the first unfolded line 200A and the second unfolded line 200B can be selectively released from each other to allow the restraint sleeve 16 to open for deployment of the built-in prosthesis 14. For example, the first unfolded line 200A and the second unfolded line 200B may be releasably interconnected in warp knitting along at least a portion of the length of the restraint sleeve 16. It should be noted that at least one of the first deployment line 200A and the second deployment line 200B is configured to remain connected to the sheet 100 after the built-in prosthesis 14 is released from the restraint sleeve 16, and is discussed in more detail here. This facilitates the ability to manipulate the sheet 100 (e.g., for removing the restraint sleeve 16 from the patient) using at least one of the deployment lines 200A, 200B after the built-in prosthesis 14 has been deployed.

[0042] In some embodiments, at least one of the first unfolded thread 200A and the second unfolded thread 200B is operable to remain connected to the sheet 100 after the constraint sleeve 16 is actuated and disengaged. For example, when the first unfolded thread 200A is connected to the sheet 100 along at least a portion of the first edge 108, the first unfolded thread 200A remains connected to the sheet 100 after the first unfolded thread 200A and the second unfolded thread 200B are released from each other. Furthermore, the second unfolded thread 200B can remain connected to the sheet 100 after the first unfolded thread 200A and the second unfolded thread 200B are released from each other. The first unfolded thread 200A and the second unfolded thread 200B can be connected to their respective edges 108, 110 by stitching the unfolded threads 200A, 200B through the sheet. For example, the sheet 100 includes a first side 112 and a second side 114 opposite to the first side 112. Figure 3A first unfolding line 200A extends from the first side 112 through the sheet 100 to the second side 114. The first unfolding line 200A passes through the sheet 100 at various locations along the longitudinal length of the constraint sleeve 16, such that the first unfolding line 200A is connected to the sheet at various locations along the length of the constraint sleeve 16. Similarly, a second unfolding line 200B can extend from the first side 112 through the sheet 100 to the second side 114. The second unfolding line 200B can pass through the sheet 100 at various locations along the longitudinal length of the constraint sleeve 16, such that the second unfolding line 200B is connected to the sheet at various locations along the length of the constraint sleeve 16. The first unfolding line 200A and the second unfolding line 200B can be slidably connected to the sheet 100, such that the first unfolding line 200A and the second unfolding line 200B can move along the longitudinal direction through the sheet 100 at the locations where they are connected to the sheet 100. In some embodiments, the sheet 100 and / or the unfolded lines 200 may be configured to provide some resistance to the sliding engagement. This can be achieved by setting the size of the hole through which the unfolded lines 200 extend on the sheet 100 (the size of the hole is the same as or smaller than the diameter of the unfolded lines 200), the material type of the sheet 100 and / or the unfolded lines 200, or a coating (e.g., an adhesive coating) that increases the friction between the sheet 100 and the unfolded lines 200, a pattern for stitching the unfolded lines 200 through the sheet, and combinations thereof.

[0043] Reference Figure 2 and Figure 3 The first unfolding thread 200A and the second unfolding thread 200B define a plurality of loops 202, which are interconnected when positioned on a first side 112 of the sheet 100 to define warp knitting. When the unfolding thread 200 is actuated, the loops 202 are selectively and sequentially released from each other to release or untie the loops 202 from their engagement. The loops 202 may be formed or provided during the stitching of the thread 200 through the sheet 100, or may be formed or provided in a process after the thread 200 has been stitched through the sheet 100.

[0044] In some embodiments, the loops 202 are positioned near or adjacent to the location where the unfolding line 200 is coupled to the sheet 100. For example, in some embodiments, each loop 202 is defined between two locations where the unfolding line 200 extends through the sheet 100. Because each loop 202 is positioned adjacent to the coupling location, the sheet 100 can also be pulled in the direction in which the unfolding line is actuated when the unfolding line 200 is actuated to release the restraint sleeve 16 from the built-in prosthesis 14. In some embodiments, the sheet 100 is pulled along with the unfolding line 200 when the delivery system 10 is positioned such that the plurality of loops 202 are released from the proximal end (e.g., the first end 20) of the restraint sleeve 16 toward the distal end (e.g., the second end 20) of the restraint sleeve 16. For example, the sheet 100 can be positioned such that when a loop 202 is released, a portion of the sheet 100 adjacent to the released loop 202 is pulled away from the released portion in the built-in prosthesis 14. In some embodiments, the sheet 100 flips over when the restraint sleeve 16 is released. The position where the sheet 100 transitions to the flipped portion is adjacent to the position where the ring 202 is being released. This allows the ring 202 to be gradually released as the sheet 100 gradually flips over. Because the sheet 100 gradually flips over, this allows the sheet 100 to be removed from its position where it might be pinned or clamped between the built-in prosthesis 14 and the tissue at the target site. Since the unfolding lines 200 pass through the sheet 100 at positions adjacent to each ring 202, the connection positions of the unfolding lines 200 ensure that when the ring 202 is released, the sheet 100 also follows the path of the unfolding lines 200 after the ring 202 is released. In some embodiments, each unfolding line 200 is connected to (e.g., passed through) the sheet 100 twice for each ring 202. In some of these embodiments, each ring 202 is side-attached or surrounded on each side by the position where the unfolding lines 200 are connected to (e.g., passed through) the sheet 100.

[0045] In some embodiments, the loops 202 of the first and second unfolding lines 200 interact (e.g., warp knitting) such that the first unfolding line 200A and the second unfolding line 200B are configured to be actuated substantially simultaneously to achieve the sequential release of the loops 202 along the longitudinal length of the sheet 100. For example, if only one of the unfolding lines 200 is actuated, the warp knitting will limit the uncontrolled release of the restraint sleeve 16. This provides a safety guarantee against uncontrolled unfolding of the device during delivery.

[0046] Reference Figure 4DThe delivery system 10 includes an elongated member 12 (e.g., a catheter) around which a built-in prosthesis 14 can be restrained. In some embodiments, the sheet 100 includes a first longitudinal end 104 (e.g., a proximal end) and a second longitudinal end 106 (e.g., a distal end), wherein the second longitudinal end 106 of the sheet 100 is coupled to the elongated member 12. In use, when the second longitudinal end 106 of the sheet 100 is coupled to the elongated member 12, and after the first unfolding line 200A and the second unfolding line 200B are released from each other and coupled to the sheet 100 along at least a portion of the first edge 108 and the second edge 110, the sheet 100 is fully or almost fully flipped such that the first side 112 is positioned outward and the second side 114 is positioned inward. The sheet 100 can be held against the elongated member 12 when the restraint sleeve 16 is released and coupled to the elongated member 12. The sheet 100 remains in the flipped configuration when tension is applied to the first unfolding line 200A and the second unfolding line 200B. This allows the delivery system 10 to be removed in a compact manner, along with the restraint sleeve 16, after the built-in prosthesis 14 has been released and implanted.

[0047] Continue to refer to Figure 4D The diagram illustrates the relationship between sheet 100 and unfolded line 200. In some embodiments, unfolded line 200 may be attached to sheet using straight stitches. As unfolded line 200 alternates between a first side 112 and a second side 114 via straight stitches, loops 202 are formed in unfolded line 200 on one of the first side 112 and the second side 114. Although shown herein as loops formed on one side of sheet, it is contemplated that loops may be formed on the first side 112 or the second side 114, or a combination thereof.

[0048] Turning to the discussion of manufacturing methods, in some embodiments, the constraint sleeve 16 can be manufactured using a sheet 100 as discussed herein and unfolded threads 200 as discussed herein. As previously described, the sheet 100 includes a first side 112, a second side 114 opposite to the first side 112, a first edge 108, and a second edge 110 opposite to the first edge 108. A first unfolded thread 200A is coupled to the first edge 108 of the sheet 100. A second unfolded thread 200B is coupled to the second edge 110 of the sheet 100. A plurality of first loops 202 are defined in the first unfolded thread 200A on the first side 112 of the sheet 100, and a plurality of second loops 202 are defined in the second thread 200B on the first side 112 of the sheet 100. The plurality of first loops 202 and the plurality of second loops 202 are warp-knitted together to define a seam along at least a portion of the longitudinal length of the constraint sleeve 16. In some embodiments, connecting the first unfolded line 200A and the second unfolded line 200B includes connecting the first unfolded line 200A to the first edge 108 by stitching the first unfolded line 200A with a first straight stitch, and connecting the second unfolded line 200B to the second edge 110 by stitching the second unfolded line 200B with a second straight stitch. For example, in some embodiments, defining a plurality of first loops 202 includes a segment of the first unfolded line 200A positioned along the first straight stitch on a first side 112 of the sheet 100 defining a plurality of first loops 202 in the first unfolded line 200A, and defining a plurality of second loops 202 includes a segment of the second unfolded line 200B positioned along the second straight stitch on a second side 114 of the sheet 100 defining a plurality of second loops 202 in the second unfolded line 200B. The straight stitches need not be straight lines or parallel to each other, but rather represent a type of stitch previously discussed.

[0049] In some embodiments, the systems and methods discussed herein can be implemented by adopting other joining patterns (e.g., other than warp knitting). For example, chain stitches can be implemented. A first unfolded thread 200A can be attached to sheet 100. When the chain stitch is released, the first unfolded thread 200A can be held by a portion of sheet 100 that can be flipped as discussed herein.

[0050] It should be understood that the flipping of sheet 100 does not necessarily extend the entire length of the device or sheet 100. This can be limited by a sleeve stop (e.g., sheet 100 is directly attached to the device), or by one or more unfolding lines that can tear through sheet 100 to stop the flipping of sheet 110. For example, see reference Figures 5A to 5DThe unfolding sequence of a single unfolding line (first unfolding line 200A) is implemented, which is connected to the sheet 100 via a chain stitch. When the first unfolding line 200A is actuated, the seam is released, and the sheet 100 is partially flipped. The sheet 100 flips until the sleeve stop 300, at which point the first unfolding line 200A continues to be released, but the sheet stops flipping.

[0051] In some embodiments, the method includes attaching the second longitudinal end 106 to the elongated member 12 (e.g., a conduit). This arrangement facilitates removal as described above.

[0052] In some embodiments, sheet 100 includes an expanded polytetrafluoroethylene (ePTFE) base layer. In some of these embodiments, sheet 100 may include a thermoplastic coating on one side of the ePTFE base layer. In some embodiments, sheet 100 includes a fluorinated ethylene propylene (FEP) layer. In some embodiments, sheet 100 is formed of ePTFE, polyester, polyurethane, fluoropolymers such as perfluoroelastomers, polytetrafluoroethylene, silicone, polyurethane, polyethylene such as ultra-high molecular weight polyethylene, aramid fibers, or combinations thereof. Other examples of sheet 100 may include high-strength polymer fibers, such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.), and combinations thereof, including combinations of previously introduced materials. Sheet 100 may include various constructions, including films, laminates, membranes, tapes, etc.

[0053] In some embodiments, the unfolded suture 200 can be formed of various materials. For example, the unfolded suture 200 can be formed of any material suitable for use as a suture, such as ePTFE, nylon, polypropylene, surgical cotton, surgical silk, surgical steel, polyester, etc.

[0054] The invention of this application has been described above generally and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of this disclosure. Therefore, it is intended that these embodiments cover modifications and variations of the invention, provided that they fall within the scope of the appended claims and their equivalents.

Claims

1. A built-in prosthesis delivery system, comprising: Internal prosthesis; as well as An internal prosthesis restraint sleeve, configured to restrain the internal prosthesis, the internal prosthesis restraint sleeve comprising: A sheet material, the sheet material including a first edge portion and a second edge portion opposite to the first edge portion; A first line, the first line being connected to the sheet along at least a portion of the first edge portion; and A second thread, at least a portion of which is connected to the sheet along the second edge, wherein the first and second threads are releasably interconnected. When the first line and the second line are released from each other, the first line is operable to remain connected to a first edge portion of the sheet, and the second line is operable to remain connected to a second edge portion of the sheet.

2. The built-in prosthesis delivery system according to claim 1, characterized in that, The sheet includes a first side and a second side opposite to the first side, wherein the first side and the second side extend between a first edge portion and a second edge portion, and wherein a first line passes through the sheet from the first side to the second side.

3. The built-in prosthesis delivery system according to any one of the preceding claims, characterized in that, The second line passes through the sheet from the first side to the second side.

4. The built-in prosthesis delivery system according to any one of the preceding claims, characterized in that, The first line and the second line each define a plurality of loops, which are interconnected when positioned on the first side to define the warp knitting.

5. The built-in prosthesis delivery system according to claim 4, characterized in that, When each of the loops is released from the warp knitting, the sheet can be operated to flip at a position adjacent to each of the plurality of loops.

6. The built-in prosthesis delivery system according to claim 5, characterized in that, The first line and the second line pass through the sheet at locations adjacent to each of the plurality of loops, respectively, along the first edge portion and the second edge portion.

7. The built-in prosthesis delivery system according to claim 4 or claim 5, characterized in that, For each of the plurality of loops, the first thread and the second thread each pass through the sheet approximately twice.

8. The built-in prosthesis delivery system according to any one of claims 4 to 6, characterized in that, The loops of the first and second lines interact, causing the first and second lines to be simultaneously actuated to release the loops sequentially along the longitudinal length of the sheet.

9. The built-in prosthesis delivery system according to any one of the preceding claims, characterized in that, When at least one of the first and second lines is actuated to release the built-in prosthesis from the built-in prosthesis restraint sleeve, at least one of the first and second lines is operable to remain connected to the sheet.

10. The built-in prosthesis delivery system according to claim 9, characterized in that, When at least one of the first and second lines is actuated to release the built-in prosthesis from the built-in prosthesis restraint sleeve, at least one of the first and second lines is operable to remain connected to the sheet at multiple locations along one of the first and second edge portions.

11. The built-in prosthesis delivery system according to any one of the preceding claims, characterized in that, It also includes an elongated member around which the built-in prosthesis is constrained, wherein the sheet includes a first longitudinal end and a second longitudinal end, and wherein the second longitudinal end of the sheet is coupled to the elongated member such that after the first line and the second line are released from each other and coupled to the first edge portion and the second edge portion of the sheet respectively, when tension is applied to the first line and the second line, the sheet is held against the elongated member in a flipped configuration.

12. The built-in prosthesis delivery system according to any one of the preceding claims, characterized in that, The first and second threads are releasably interconnected to define one of warp knitting and chain stitch.

13. A built-in prosthesis delivery system, comprising: Internal prosthesis; as well as An internal prosthesis restraint sleeve, configured to restrain the internal prosthesis, the internal prosthesis restraint sleeve comprising: A sheet material, the sheet material including a first edge portion and a second edge portion opposite to the first edge portion; as well as At least one line, said at least one line being releasably connected to the first edge portion and the second edge portion of the sheet, The at least one of the lines is configured to be actuated to release, and As each loop is released from the warp knitting, the sheet flips at a position adjacent to each of the plurality of loops.

14. The built-in prosthesis delivery system according to claim 13, characterized in that, The at least one line is stitched through the sheet with straight stitches.

15. The built-in prosthesis delivery system according to claim 13 or claim 14, characterized in that, The at least one line includes a loop located on the first side of the sheet at the position where the straight stitch is positioned on the first side of the sheet.

16. The built-in prosthesis delivery system according to any one of claims 13 to 15, characterized in that, For each of the plurality of loops, the at least one line passes through the sheet approximately twice.

17. The built-in prosthesis delivery system according to claim 16, characterized in that, The at least one line includes a first line connected to a first edge portion of the sheet and a second line connected to a second edge portion of the sheet, wherein the loops of the first line and the second line interact such that the first line and the second line can be operated to be simultaneously actuated to achieve the sequential release of the loops along the longitudinal length of the sheet.

18. A method for manufacturing a constraint sleeve, comprising: A sheet is provided, the sheet including a first side, a second side opposite to the first side, a first edge portion, and a second edge portion opposite to the first edge portion; Connect the first line to the first edge portion of the sheet; Connect the second line to the second edge portion of the sheet; as well as A plurality of first loops are defined in the first line on the first side of the sheet; A plurality of second loops are defined in the second line on the first side of the sheet; as well as The plurality of first rings and the plurality of second rings are releasably connected.

19. The method according to claim 18, characterized in that, It also includes connecting the second longitudinal end of the sheet to an elongated member.

20. The method according to claim 18 or claim 19, characterized in that, Connecting the first thread to the first edge portion includes sewing the first thread with a first straight stitch, and connecting the second thread to the second edge portion includes sewing the second thread with a second straight stitch.

21. The method according to claim 20, characterized in that, The plurality of first loops are defined by a segment of a first line positioned along the first straight stitch on the first side of the sheet, in which the plurality of first loops are defined, and the plurality of second loops are defined by a segment of a second line positioned along the second straight stitch on the second side of the sheet, in which the plurality of second loops are defined.

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