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 tubular member defining a main lumen extending longitudinally through the tubular member, wherein the tubular member is configured to be at least partially inverted such that the tubular member includes an inner portion and an outer portion; and a removable deployment line coupled to the tubular member along at least a portion of a longitudinal length of the tubular member, wherein the main lumen is subdivided into at least two secondary lumens when the removable deployment line is coupled to the tubular member.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of Provisional Application No. 63 / 564,075, 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 apparatus, systems, and methods for restraining and delivering embedded prostheses. More specifically, this disclosure relates to apparatus, 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 for treating a patient's vascular system 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 tubular member defining a main lumen extending longitudinally through the tubular member, wherein the tubular member is configured to be at least partially flipped such that the tubular member includes an inner portion and an outer portion; and a removable unfolding line coupled to the tubular member along at least a portion of the longitudinal length of the tubular member, wherein when the removable unfolding line is coupled to the tubular member, the main lumen is subdivided into at least two secondary lumens.

[0007] According to another example (Example 2) that goes a step further than Example 1, the tubular member includes a delivery configuration, an intermediate unfolding configuration, and a fully unfolded configuration.

[0008] According to another example (Example 3) that goes a step further than Example 2, the tubular member is configured to transition from an intermediate unfolded configuration to a fully unfolded configuration when the tubular member is flipped and not surrounding the built-in prosthesis.

[0009] According to another example (Example 4) that goes further than either Example 2 or Example 3, a second unfolding line extending from the tubular member is also included, which, when actuated, is capable of flipping the interior portion of the tubular member.

[0010] According to another example (Example 5) that goes further than any of Examples 2 to 4, the second unfolding line extends from the outer portion of the tubular member.

[0011] According to another example (Example 6) that goes further than any of Examples 2 to 5, the tubular member is configured to transition from a delivery configuration to an intermediate deployment configuration when the removable deployment line is actuated and at least partially detached from the tubular member.

[0012] According to another example (Example 7) that goes further than any of Examples 2 to 6, the tubular member includes at least two longitudinal folds.

[0013] According to another example (Example 8) that goes further than Example 7, the removable unfolding line is coupled to the tubular member such that at least two longitudinal folds are held when the removable unfolding line is coupled to the tubular member, and at least two longitudinal folds are configured to be released when the removable unfolding line is at least partially disengaged from the tubular member.

[0014] According to another example (Example 9) that goes further than any of the preceding examples, the outer portion of the tubular member defines at least one window.

[0015] According to another example (Example 10) that goes further than any of the preceding examples, the tubular member includes a tapered profile such that the interior portion of the tubular member transitions from a first diameter at a first longitudinal position to a second diameter at a second longitudinal position, wherein the first diameter is larger than the second diameter.

[0016] According to another example (Example 11), 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 tubular member defining a main lumen extending longitudinally through the tubular member, wherein the tubular member is configured to be at least partially flipped such that the tubular member includes an inner portion and an outer portion; a first unfolding line removably coupled to the tubular member along at least a portion of the longitudinal length of the tubular member; and a second unfolding line extending from the outer portion of the tubular member.

[0017] According to another example (Example 12) that goes further than Example 11, the tubular member includes a delivery configuration, an intermediate unfolding configuration, and a fully unfolded configuration.

[0018] According to another example (Example 13) that goes further than Example 12, the tubular member is able to transition from a delivery configuration to an intermediate deployment configuration when the first deployment line is actuated and detached from the tubular member.

[0019] According to another example (Example 14) that goes further than either Example 12 or Example 13, the tubular member is able to transition from an intermediate unfolded configuration to a fully unfolded configuration when the second unfolding line is actuated to flip the inner portion of the tubular member.

[0020] According to another example (Example 15) that goes further than any of Examples 11 to 13, the tubular member defines a plurality of lumens when the first development line is connected to the tubular member.

[0021] According to another example (Example 16), a method of manufacturing a constraint sleeve includes: providing a tubular member defining a main lumen extending longitudinally through the tubular member, the tubular member including a first longitudinal edge and a second longitudinal edge opposite to the first longitudinal edge; flipping the first longitudinal edge of the tubular member, the first longitudinal edge defining an inner portion and an outer portion; providing a fold in the tubular member along at least a portion of the longitudinal length of the tubular member; and connecting a first unfolded line to the tubular member, the first unfolded line and the fold defining at least a portion of at least one secondary lumen, the diameter of the at least one secondary lumen being smaller than the diameter of the main lumen.

[0022] According to another example (Example 17) that goes further than Example 16, it also includes removing material from the outer portion of the tubular member.

[0023] According to another example (Example 18) that goes further than Example 16 or Example 17, the removal of material includes defining multiple strips in the outer portion.

[0024] According to another example (Example 19) that goes further than Example 18, a second unfolding line is formed by multiple strips.

[0025] According to another example (Example 20) that goes further than any of Examples 16 to 19, providing a fold in the tubular member includes defining the fold to provide parallel edges along the longitudinal length of the tubular member when the tubular member includes a tapered profile.

[0026] 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

[0027] 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.

[0028] 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 tubular member having a first development line and a second development line, constraining an internal prosthesis in a constrained configuration; Figure 3 According to one embodiment Figure 2 The diagram shows the constraint sleeve, where the first unfolded line is released; Figure 4 According to one embodiment Figure 2 The illustration shows a constraint sleeve in which the first unfolding line is released and the built-in prosthesis expands to the intermediate configuration; Figure 5 According to one embodiment Figure 2 The illustration shows a constraint sleeve in which the second unfolded line is actuated to flip a portion of the tubular member; Figure 6 According to one embodiment Figure 2 The illustration shows a constraint sleeve in which the tubular member is fully flipped over and the built-in prosthesis is released and expanded into an unfolded configuration; Figures 7 to 10 This is an illustration of the unfolding sequence of a constraint sleeve according to one embodiment, wherein the built-in prosthesis expands from a delivery configuration to an intermediate configuration and from the intermediate configuration to an unfolded configuration; Figures 11A to 11C This is an illustration of a constraint sleeve having a secondary lumen according to one embodiment; Figures 12 to 13B Various folding patterns are shown according to one embodiment; Figures 14A to 14B Various configurations of the constraint sleeve are illustrated according to one embodiment; and Figures 15A to 15C One embodiment illustrates a folding pattern of a tapered constraint sleeve. Detailed Implementation

[0029] Definitions and Terms

[0030] 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.

[0031] Regarding the term "imprecise," the terms "approximately" and "approximately" are 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 can 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 "approximately" and "approximately" can be understood as the value plus or minus 10%.

[0032] Description of various embodiments

[0033] Those skilled in the art will readily understand that various aspects of this disclosure can be implemented by any number of methods and devices configured to perform the intended function. 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.

[0034] 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 material sheet 100 and the unfolding line 200 of the delivery system 10 shown may include reference Figures 2 to 9 The configuration of the material sheet 100 and the unfolding lines 200 is described. It should also be understood that the reverse is also true. Figure 1 One or more components depicted may be attached to or replaced. Figures 2 to 9 Use the components depicted in the image. 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 Figures 2 to 9The material sheet 100 and the unfolding line 200 shown are used together.

[0035] 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.

[0036] In some embodiments, the implantable prosthesis 14 is delivered to a target site for implantation. The implantable prosthesis 14 may be self-expanding, expandable (e.g., balloon-expandable), or otherwise implantable at the target location. As the implantable 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 implantable prosthesis 14 and the restraint sleeve 16 when the implantable prosthesis 14 is in a restrained configuration. The restraint sleeve 16 is configured to reduce its radial profile during delivery.

[0037] Reference Figure 2 A constraint sleeve 16 is provided that facilitates constraining an internal prosthesis 14 to a delivery diameter in a delivery configuration, to an intermediate diameter in an intermediate configuration, and is configured to release the internal prosthesis 14 to an unfolding diameter when the constraint sleeve 16 is in a release configuration (e.g., release from radially constrained internal prosthesis 14). The constraint sleeve 16 may be provided as a tubular member 100 (e.g., a membrane, film, etc.) along with at least one unfolding line 200 defining a main lumen 102. Figure 2 As shown, the constraint sleeve 16 includes a first development line 200A and a second development line 200B.

[0038] In some embodiments, the first deployment line 200A is a removable deployment line removably coupled to the tubular member 100, and the second deployment line 200B extends from the tubular member 100. The second deployment line 200B may be coupled to or integral with the tubular member 100. The first and second deployment lines 200 can be actuated to actuate specific steps in the delivery sequence of the implanted prosthesis 14. For example, the first deployment line 200A may be actuated to deploy the tubular member 100 and the implanted prosthesis 14 from a delivery configuration toward an intermediate configuration. The diameter of the implanted prosthesis 14 in the delivery configuration may be smaller than its diameter in the intermediate configuration. The second deployment line 200B may be actuated to deploy the tubular member 100 and the implanted prosthesis 14 from the intermediate configuration toward a deployment configuration. The diameter of the implanted prosthesis 14 in the intermediate configuration may be smaller than its diameter in the deployment configuration. It should be understood that the diameter and diameter variation of the implanted prosthesis 14 may be the result of self-expansion or expansion by other structures (e.g., balloon expandable). Furthermore, the diameter in this context is not intended to be interpreted as requiring a circular profile, but rather to be understood as a general discussion of the dimensions of the built-in prosthesis 14 (and, where appropriate, the lumen of the tubular member 100) in its various configurations.

[0039] Continue to refer to Figure 2 A first unfolded thread 200A is attached to at least a portion of the longitudinal length of the tubular member 100. The first unfolded thread 200A can be sewn, stitched, or braided onto the tubular member 100. When attached to the tubular member 100, the first unfolded thread 100 defines a secondary lumen 103 within the tubular member 100 (see...). Figure 11B and Figure 11C Each secondary lumen 103 has a smaller diameter than the main lumen 102. For example, when the first deployment line 200A is coupled to the tubular member 100, the main lumen 102 is subdivided into a plurality of secondary lumens 103. Various configurations defining the secondary lumens 103 are discussed below. Each secondary lumen 103 is capable of receiving an embedded prosthesis 14 in a delivery configuration. When the first deployment line 200A is selectively released from the tubular member 100, the secondary lumen 103 is dedefined, and the tubular member 100 is capable of being released to include a single main lumen 102. As described herein, the secondary lumens 103 are defined within a portion of the main lumen 102 such that the embedded prosthesis 14 positioned within the secondary lumen 103 is constrained in the secondary lumen to a delivery configuration and can be constrained in the main lumen 102 to an intermediate configuration when the first deployment line 200A is released from the tubular member 100.

[0040] To release the built-in prosthesis 14 from the intermediate configuration to the deployed configuration, the second deployment line 200B can be actuated. The second deployment line 200B extends from the tubular member 100 (e.g., integral with or coupled to the tubular member 100). The restraint sleeve 16 includes a first end 20 and a second end 22. Typically, the first end 20 of the restraint sleeve 16 is positioned proximally, and the second end 22 is positioned distally. The tubular member 100 includes a first longitudinal end 104 and a second longitudinal end 106. In some embodiments, the tubular member 100 is partially flipped. Due to the flipping of at least a portion of the tubular member 100, the first longitudinal end 104 of the tubular member 100 may not directly correspond to the first end 20 of the restraint sleeve 16. Furthermore, due to the partial flipping of the tubular member 100, the tubular member defines an inner portion 108 (e.g., an unflipped portion) and an outer portion 110 (e.g., a flipped portion). The second longitudinal end 106 may be at least partially flipped and is the end from which the second deployment line 200B extends. When the second deployment line 200B is actuated, the second longitudinal end 106 of the tubular member 100 is able to slide along the surface of the inner portion 108. When the second deployment line 200B is actuated, a portion of the inner portion 108 (e.g., the unflipped portion) transitions to become part of the outer portion 110 (e.g., the flipped portion). As the second deployment line 200B is actuated and the tubular member 100 gradually flips, the first end 20 of the restraint sleeve 16 retracts, and a portion of the built-in prosthesis 14 is released from the restraint sleeve 16. The tubular member 100 is configured to transition from an intermediate deployment configuration to a fully deployed configuration when the tubular member 100 flips to the point where the built-in prosthesis 14 is no longer surrounded or contacted by the tubular member 100. For example, the tubular member 100 can be fully flipped and removed from around the built-in prosthesis 14.

[0041] Reference Figures 2 to 6 The expansion sequence is shown, where the built-in spur 14 is constrained in the delivery configuration, expands to the intermediate configuration, and expands to the expanded configuration. As previously stated, Figure 2 An internal prosthesis 14 and a restraint sleeve 16 are depicted in a delivery configuration. A first development line 200A is removably coupled to a tubular member 100 of the restraint sleeve 16 to define a secondary lumen 103 in which the internal prosthesis 14 is positioned. A second development line 200B extends from an outer portion 110 of the tubular member 100.

[0042] Figure 3 The constraint sleeve 16 is depicted when the first deployment line 200A has been removed from the tubular member 100. When the first deployment line 200A is released, the secondary lumen 103 is delimited, such that the main lumen 102 is not subdivided or constrained to a smaller diameter. When the first deployment line 200A is released, the built-in prosthesis 14 can self-expand to fill the main lumen 102, or it can be expanded (e.g., balloon dilation). Figure 4 The internal prosthesis 14 is depicted expanding to an intermediate diameter to fill the main tube lumen 102. The intermediate diameter can have several benefits, including, but not limited to: better visualization of the internal prosthesis 14 before full expansion, more precise placement of the internal prosthesis 14 at the delivery site before full expansion, reduced actuation forces on the second expansion line 200B for flipping the tubular member 100 (e.g., for a self-expanding internal prosthesis 14, the outward radial force exerted by the internal prosthesis 14 at the intermediate diameter is less than that in the delivery configuration, and the reduced force facilitates reduction of friction between the inner portion 108 and the outer portion 110 of the tubular member 100), which facilitates more accurate placement of the internal prosthesis, and so on.

[0043] Figure 5 The illustration depicts the state of the tubular member 100 being removed from the internal prosthesis 14 via the flipping of the tubular member 100. The tubular member 100 flips as the second deployment line 200B is actuated and the tubular member 100 is pulled away from the internal prosthesis 14. As the tubular member 100 is gradually removed from the internal prosthesis 14, the internal prosthesis 14 can gradually deploy. Figure 6 The image depicts an internal prosthesis 14 in an unfolded configuration and a constraint sleeve 16 completely removed radially around the internal prosthesis 14.

[0044] Reference Figures 7 to 10 The figures show a similar unfolding process, and these figures show a cross-sectional view of the constraint sleeve 10. Figure 7 Roughly corresponding to Figure 2 Delivery system 10 is in delivery configuration; Figure 8 Roughly corresponding to Figure 4 Delivery system 10 is in an intermediate configuration; Figure 9 Roughly corresponding to Figure 5 Delivery system 10 is transitioning from an intermediate configuration to an expanded configuration; and Figure 10 Roughly corresponding to Figure 6 The built-in prosthesis 14 is in the unfolded configuration.

[0045] Reference Figures 11A to 13B The diagram illustrates various folding patterns and the location of the first unfolding line 200B connecting to the tubular member 100. These examples are for illustrative purposes only and are not intended to be limiting. See also... Figure 11A The diagram shows the tubular member 100 folded into three parts (e.g., two longitudinal folds 112). The first unfolding line 200A is not shown as a connection to the tubular member 100, in order to show the folding pattern more clearly. Figure 11B and Figure 11CVarious secondary lumens 103 are shown, created by the folding of the tubular member and the connection of a first unfolding line 200A (not shown) to the tubular member 100. An internal prosthesis 14 (not shown) can be accommodated in any of the shown secondary lumens 103 to constrain the internal prosthesis 14 to a delivery configuration. Figure 12 The diagram shows a tubular member 100 folded into four parts (e.g., three longitudinal folds 112). Any number of folds 112 can be implemented. Various folding patterns can be implemented to provide a specific delivery diameter, provide additional lumens (in which different components can be delivered), and so on. Figure 13A and Figure 13B The fold 112 is shown to be located at different positions on the tubular member 100. The secondary lumen 103 can be located at different positions via the fold 112, and the specific locations are not necessarily intended to be restrictive. As previously described, the first unfolding line 200A is coupled to the tubular member 100 such that the longitudinal fold 112 is held when the removable unfolding line is coupled to the tubular member, and the longitudinal fold 112 is released when the first unfolding line 200A is at least partially disengaged from the tubular member 100 (e.g., it may still be coupled to the tubular member 100 but without constraining the delivery system to a delivery configuration).

[0046] Reference Figure 14A and Figure 14B In some embodiments, the outer portion 110 of the tubular member 100 defines at least one window 114 such that the outer portion 110 does not completely enclose the circumference of the inner portion 108 in a longitudinal position. The window 114 can be provided with any number of shapes and configurations. The window 114 facilitates reducing the flattened profile (e.g., the delivery diameter of the delivery system 10), reducing friction between at least a portion of the inner portion 110 and the outer portion 110 during flipping, and can be configured to define a strip 116 that can be implemented as a second unfolding line 200B (see...). Figure 14A ).

[0047] Reference Figures 15A to 15C In some embodiments, the tubular member 100 includes a tapered profile. The tapered profile causes the inner portion 110 of the tubular member to transition from a first diameter at a first longitudinal position to a second diameter at a second longitudinal position, wherein the first diameter is larger than the second diameter. The tapered profile of the tubular member 100 facilitates reducing drag between the inner portion 100 and the outer portion 110 during deployment. Figure 15A The general outline of the tubular member 100 with a tapered profile is shown. Figure 15A A first fold of the tubular member 100 is shown, which makes the tubular member 100 square. Figure 15B and Figure 15C An additional fold, as described above, is shown for reducing the diameter, connecting the first unfolding line (not shown), and providing a secondary lumen 103.

[0048] Turning to the discussion of manufacturing methods, in some embodiments, the constraint sleeve 16 can be manufactured using a tubular member 100 as discussed herein and a development line 200 as discussed herein. As previously described, the tubular member 100 includes a first longitudinal end 104 and a second longitudinal end 106 opposite to the first longitudinal end 104. The first longitudinal end 104 is flipped over a portion of the tubular member 100 to define an inner portion 108 and an outer portion 110. At least one longitudinal fold 112 is provided along at least a portion of the longitudinal length of the tubular member 100. As previously described, one or more longitudinal folds 112 can be provided in various configurations and numbers. Once the longitudinal folds 112 are provided, a first development line 200A is coupled to the tubular member. The first development line 200A is configured to hold the longitudinal folds. The first development line 200A and the longitudinal folds 112 define at least a portion of at least one secondary lumen 103. The diameter of the secondary lumen 103 is smaller than the diameter of the main lumen 102. In some embodiments, the second unfolded line 200B is coupled to the first longitudinal end 104. In some embodiments, material can be removed from the outer portion 110 of the tubular member 100. The removed material defines a window 114. Material can be removed to define a strip 116 in the outer portion 110. In some embodiments, the method includes defining or forming the second unfolded line 200B. In some embodiments where the tubular member 100 includes a tapered profile, the method includes squarening the edges by providing folds that provide parallel edges along the longitudinal length of the tubular member 100.

[0049] In some embodiments, the material sheet 100 comprises an expanded polytetrafluoroethylene (ePTFE) base layer. In some of these embodiments, the material sheet 100 may include a thermoplastic coating on one side of the ePTFE base layer. In some embodiments, the material sheet 100 comprises a fluorinated ethylene propylene (FEP) layer. In some embodiments, the material 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 the material 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. The material sheet 100 may include various constructions, including films, laminates, membranes, tapes, etc.

[0050] 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.

[0051] 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 tubular member defining a main lumen extending longitudinally through the tubular member, wherein the tubular member is configured to be at least partially overturned such that the tubular member includes an inner portion and an outer portion; and A removable unfolding line is connected to the tubular member along at least a portion of the longitudinal length of the tubular member, wherein when the removable unfolding line is connected to the tubular member, the main lumen is subdivided into at least two secondary lumens.

2. The built-in prosthesis delivery system according to claim 1, characterized in that, The tubular component includes a delivery configuration, an intermediate unfolding configuration, and a fully unfolded configuration.

3. The built-in prosthesis delivery system according to claim 2, characterized in that, The tubular member is configured to transition from the intermediate unfolding configuration to the fully unfolded configuration when the tubular member is flipped over and not surrounding the built-in prosthesis.

4. The built-in prosthesis delivery system according to claim 2 or claim 3, characterized in that, It also includes a second spread line extending from the tubular member, which, when actuated, is capable of flipping the interior portion of the tubular member.

5. The built-in prosthesis delivery system according to any one of claims 2 to 4, characterized in that, The second development line extends from the outer portion of the tubular member.

6. The built-in prosthesis delivery system according to any one of claims 2 to 5, characterized in that, The tubular member is configured to transition from the delivery configuration to the intermediate deployment configuration when the removable deployment line is actuated and at least partially detached from the tubular member.

7. The built-in prosthesis delivery system according to any one of claims 2 to 6, characterized in that, The tubular member includes at least two longitudinal folds.

8. The built-in prosthesis delivery system according to claim 7, characterized in that, The removable unfolding line is coupled to the tubular member such that the at least two longitudinal folds are held when the removable unfolding line is coupled to the tubular member, and the at least two longitudinal folds are configured to be released when the removable unfolding line is at least partially disengaged from the tubular member.

9. The built-in prosthesis delivery system according to any one of the preceding claims, characterized in that, The outer portion of the tubular member defines at least one window.

10. The built-in prosthesis delivery system according to any one of the preceding claims, characterized in that, The tubular member includes a tapered profile such that the inner portion of the tubular member transitions from a first diameter at a first longitudinal position to a second diameter at a second longitudinal position, wherein the first diameter is larger than the second diameter.

11. 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 tubular member defining a main lumen extending longitudinally through the tubular member, wherein the tubular member is configured to be at least partially flipped such that the tubular member includes an inner portion and an outer portion; A first development line, wherein at least a portion of the longitudinal length of the tubular member is removably connected to the tubular member; and A second development line extends from the outer portion of the tubular member.

12. The built-in prosthesis delivery system according to claim 11, characterized in that, The tubular component includes a delivery configuration, an intermediate unfolding configuration, and a fully unfolded configuration.

13. The built-in prosthesis delivery system according to claim 12, characterized in that, The tubular member can transition from the delivery configuration to the intermediate deployment configuration when the first deployment line is actuated and detached from the tubular member.

14. The built-in prosthesis delivery system according to claim 12 or claim 13, characterized in that, The tubular member can transition from the intermediate unfolded configuration to the fully unfolded configuration when the second unfolding line is actuated to flip the inner portion of the tubular member.

15. The built-in prosthesis delivery system according to any one of claims 11 to 13, characterized in that, When the first development line is connected to the tubular member, the tubular member defines a plurality of lumens.

16. A method for manufacturing a constraint sleeve, comprising: A tubular member is provided that defines a main lumen extending longitudinally through the tubular member, the tubular member including a first longitudinal edge and a second longitudinal edge opposite to the first longitudinal edge; Flip the first longitudinal edge of the tubular member, the first longitudinal edge defining an inner portion and an outer portion; At least a portion of the longitudinal length of the tubular member is provided with a fold in the tubular member; as well as A first unfolding line is connected to the tubular member, the first unfolding line and the fold define at least a portion of at least one secondary lumen, the diameter of the at least one secondary lumen being smaller than the diameter of the main lumen.

17. The method according to claim 16, characterized in that, It also includes removing material from the outer portion of the tubular member.

18. The method according to claim 16 or claim 17, characterized in that, Removing material includes defining multiple strips in the outer portion.

19. The method according to claim 18, characterized in that, The second development line is formed by the plurality of strips.

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

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